80 FR 29053 - Farmacia Yani; Decision and Order
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 80, Issue 97 (May 20, 2015)
Drug Enforcement Administration
Federal Register Volume 80, Issue 97 (May 20, 2015)
| Page Range | 29053-29067 | |
| FR Document | 2015-12130 |
[Federal Register Volume 80, Number 97 (Wednesday, May 20, 2015)] [Notices] [Pages 29053-29067] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2015-12130] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 13-31] Farmacia Yani; Decision and Order On April 10, 2013, the Deputy Assistant Administrator, Office of Diversion Control, Drug Enforcement Administration, issued an Order to Show Cause to Farmacia Yani (Respondent), of San Sebastian, Puerto Rico. ALJ Ex. 1. The Show Cause Order proposed the denial of Respondent's application for a DEA Certificate of Registration as a retail pharmacy, on the ground that its registration ``would be inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id. at 1. The Show Cause Order specifically alleged that on March 27, 2012, Respondent submitted an application for a registration as a retail pharmacy, seeking authority to dispense controlled substances in schedules II through V, at a location in San Sebastian, Puerto Rico. Id. The Order further alleged that Respondent held a registration at the same location, which it ``had surrendered for cause on December 2, 2011,'' and that a DEA investigation found ``that from February 2009 through November 2011, [it] filled approximately 218 prescriptions for controlled substances issued by a medical doctor who did not possess a valid DEA registration, in violation of Federal law and regulations.'' Id. (citing 21 U.S.C. 843(a)(2); 21 CFR 1306.04). The Government then alleged that Respondent's ``violations of Federal law and regulations render granting its application for a [registration] inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f) and 824(a)). On May 10, 2013, Respondent, through its counsel, requested a hearing on the allegations and the matter was placed on the docket of the Office of Administrative Law Judges. ALJ Ex. 2. Thereafter, an Administrative Law Judge (ALJ) proceeded to conduct pre-hearing procedures. ALJ Ex. 3. In its Supplemental Prehearing Statement, the Government provided notice to Respondent that it intended to elicit testimony from an Agency Diversion Investigator (DI) that Respondent had ``filled twenty- nine (29) prescriptions for Suboxone that were written by two doctors who did not possess authority to issue these controlled substances,'' that the ``prescriptions were written by Dr. Aguilar-Amieva and Dr. Cesar I. Vargas-Quinones,'' and that a review of ``the DEA registration database . . . found that these two physicians were never registered with DEA as data-waived practitioners, in violation of 21 CFR 1301.28.'' ALJ Ex. 7, at 3. The Government also provided notice that it intended to question Respondent's owner ``about the circumstances of the pharmacy's prior surrender of its . . . registration, and about her failure to note the previous surrender on Respondent's new application for registration.'' Id. On July 16, 2013, the ALJ conducted an evidentiary hearing in Guaynabo, Puerto Rico.\1\ Tr. 27. At the hearing, the [[Page 29054]] Government elicited the testimony of a DI and Ms. Yanira Santiago-Soto, Respondent's owner and pharmacist in charge; Respondent also elicited the testimony of Ms. Santiago-Soto. Both parties also introduced documentary evidence into the record. Following the hearing, both parties submitted briefs containing their proposed findings of fact, conclusions of law, and argument. --------------------------------------------------------------------------- \1\ On June 18, 2013, the ALJ had conducted the first day of the hearing, during which he reviewed the parties' proposed stipulations and admitted several documents into the record, while holding the admission of two Government exhibits in abeyance. See Tr. 4-14 (June 18, 2013). After Respondent's counsel objected to the admission of some of the Government's exhibits because they contained prescriptions issued by a doctor whose prescriptions were not the basis of what it had previously alleged, the Government announced that it would be filing a supplemental prehearing statement during which it would ``outline that the Government discovered some prescriptions by Dr. Cesar Vargas-Quinones.'' Id. at 14. After the ALJ ruled that these exhibits would ``be held in abeyance until after we've had the opportunity to see what the Government sets forth in its supplemental prehearing statement,'' the ALJ explained that the deadline for both parties to file their supplemental prehearing statements would ``be simultaneous''; the ALJ also told Respondent's counsel that ``you really won't have a chance to reply in your--in your response in the prehearing statement,'' but that she would be able ``to object to these exhibits during the hearing itself.'' Id. at 15-16. Notably, during the June 18 hearing, the Government made no mention of its intent to raise the material falsification issue. Moreover, the ALJ subsequently ordered that the parties file any supplemental prehearing statements with the Office of Administrative Law Judges ``not later than 2:00 p.m. on the 9th of July 2013.'' Id. at 18-19. The same day, the ALJ also issued an Order memorializing these instructions. See Order (June 18, 2013). Therein, the ALJ further instructed that ``[a]fter this deadline, Prehearing Statements may only be supplemented upon the filing of a motion for extension of time and after a favorable ruling by me. Any new documents identified in a supplemental prehearing statement also need to be exchanged by the parties no later than July 9, 2013.'' Id. at 4. --------------------------------------------------------------------------- On September 26, 2013, the ALJ issued his Recommended Decision (hereinafter, cited as R.D.) Therein, the ALJ found that the Government had established a prima facie case that granting Respondent's application ``would be inconsistent with the public interest.'' R.D. 36. The ALJ further found that Respondent had ``failed to rebut'' the Government's case. Id. The ALJ thus recommended that Respondent's application be denied. Respondent filed Exceptions to the Recommended Decision. Having reviewed Respondent's Exceptions along with the entire record, I find that several of them are well taken and that the ALJ committed multiple prejudicial errors. These include: (1) Barring Respondent from using a document, which, according to Respondent's offer, was from DEA's Web site, to impeach a Government witness, because it was not submitted in advance of the hearing; (2) barring Respondent from introducing evidence of an email its principal sent to an Agency Investigator the day after she submitted the application, which according to Respondent's offer, memorialized a phone conversation in which she asked if she had correctly answered an application question, also on the ground that it was not submitted in advance of the hearing, notwithstanding that the Government did not even disclose that it was pursuing the material falsification allegation until one week before the hearing; and (3) finding that Respondent's principal materially falsified its application based on the answer she gave to Question Four when the Government never provided notice that the answer to this question was at issue in the Show Cause Order, its pre-hearing statements, or its opening statement, nor even questioned her about her answer to this question, even though it called her to testify in its case-in-chief. Because I reject the ALJ's legal conclusions that Respondent's principal materially falsified its application and that Respondent violated its corresponding responsibility under 21 CFR 1306.04(a) when it dispensed prescriptions issued by a physician whose registration had expired, and these errors solely affect these two allegations, I conclude that a remand is not warranted. While I agree with the ALJ's legal conclusion that Respondent violated federal law when it dispensed Suboxone prescriptions, which were issued to provide maintenance or detoxification treatment and the prescribers lacked the requisite authority to prescribe the drug for this purpose, I do not find that the record as a whole supports the proposed outright denial of the Application. Accordingly, I will order that Respondent be granted a registration subject to conditions set forth in this decision. I make the following findings of fact. Findings Respondent's License and Registration Status Respondent is a corporation which owns a retail pharmacy located at Carretera 109, Kilometer 26.7, Barrio Culebrina, San Sebastian, Puerto Rico. Tr. 9; GX 1. Ms. Yanira Santiago-Soto is the owner of Respondent and its pharmacist-in-charge. Tr. 106. Respondent is licensed as a pharmacy by the Commonwealth of Puerto Rico Department of Health; this license does not expire until June 26, 2015. RX D1, at 3. Respondent also holds a controlled substance registration, which was also issued by the Commonwealth's Department of Health.\2\ RX E4. --------------------------------------------------------------------------- \2\ According to the certificate, the registration was due to expire on September 30, 2013. RX E, at 4. --------------------------------------------------------------------------- Respondent previously held DEA Certificate of Registration FF1070894, pursuant to which it was authorized to dispense controlled substances in schedules II through V. GX 5, at 1. While this registration was not due to expire until September 30, 2014, on November 30, 2011, Ms. Santiago-Soto surrendered Respondent's registration.\3\ Id.; see also RX I. On March 26, 2012, Ms. Santiago- Soto applied on Respondent's behalf for a new registration. GX 1, at 1- 2. It is this application which is at issue in this proceeding. --------------------------------------------------------------------------- \3\ The day before, Ms. Santiago-Soto had been indicted along with thirty-two other defendants, on two felony counts of violating the Controlled Substances Act. The charges were: (1) Conspiring to possess and dispense, with intent to distribute, various controlled substances, in violation of 21 U.S.C. 841(a)(1), 846, and 860; and (2) aiding and abetting each other and ``knowingly and intentionally possess[ing] and dispens[ing] with intent to distribute various'' schedule II through IV controlled substances, ``outside the scope of professional practice and not for a legitimate medical purpose,'' in violation of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. RX B, at 1-13. Several months later, the Government moved to dismiss the charges with prejudice, and on March 23, 2012, the District Court entered a Judgment of Dismissal. RX C. --------------------------------------------------------------------------- On the application, Respondent was required to answer four questions. Id. at 1. The second of these asked: ``Has the applicant ever surrendered (for cause) or had a federal controlled substance registration revoked, suspended, restricted or denied, or is any such action pending?'' GX 1, at 1. Ms. Santiago-Soto answered the question by checking the ``no'' box. Id. The fourth question asked, in relevant part: If the applicant is a corporation (other than a corporation whose stock is owned and traded by the public), association, partnership, or pharmacy, has any officer, partner, stockholder or proprietor been convicted of a crime in connection with controlled substance(s) under state or federal law, or ever surrendered or had a federal controlled substance registration revoked, suspended, restricted or denied, or ever had a state professional license or controlled substance registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending? Id. Respondent also answered this question, by checking the ``no'' box. Id. The Investigation of Respondent Following Ms. Santiago-Soto's submission of Respondent's application, a Diversion Investigator with the Ponce, Puerto Rico DEA Office was assigned to investigate the application. Tr. 40-41. Upon doing so, the DI determined that on November 30, 2011, a search warrant had been executed at Respondent during which various items of evidence, including prescriptions, were seized. Id. at 43. Some of the evidence was sent to the DEA digital evidence laboratory for further analysis; according to the DI, the lab extracted various data and sent a CD containing the data to his office. Id. at 44. In addition, prescriptions were seized from Respondent and scanned by the Ponce DEA office. Id. Upon reviewing the data provide by the digital evidence lab, the DI determined that ``there were two main violations.'' Id. at 46. According to the DI, the first set of violations involved Respondent's having ``illegally filled'' some ``241 prescriptions'' which were issued by a Doctor Hector J. Aguilar-Amieva after the latter's registration was retired by DEA on January 31, 2009 and ``he was no longer authorized to prescribe any controlled substances. Id. at 46-47; see also GX 6 (affidavit of Chief, Registration and Program Support Section, Drug Enforcement Administration, stating that Dr. Aguilar- Amieva's registration expired on June 30, 2008 and was retired from the DEA computer system on January 31, 2009). As for the second set of violations, the DI stated that they involved [[Page 29055]] Respondent's having filled twenty-nine prescriptions issued by both Dr. Aguilar-Amieva and Dr. Cesar Vargas-Quinones for Suboxone (buprenorphine). Tr. 47, 49. According to the DI, the prescriptions were unlawful because the doctors ``were not authorized to'' prescribe Suboxone (buprenorphine) ``because they were not DATA-waived \4\ practitioners.'' Id. at 48. The DI further explained that a DATA-waived practitioner is a physician who is approved by ``the Center of Substance Abuse'' (actually, the Center for Substance Abuse Treatment, a component of the Substance Abuse and Mental Health Services Administration) to prescribe Suboxone (buprenorphine) to treat narcotic addiction and that these physicians are issued ``a specific registration that is distinguished with an X number,'' which ``should be on the prescription[s]'' they issued for these drugs. Id. at 49. However, none of these prescriptions bore an X number (even though seventeen of the twenty-nine prescriptions listed a diagnosis of opiate addiction or dependence). Id. at 49-50; see also GX 3, at 410-56. --------------------------------------------------------------------------- \4\ See Drug Addiction Treatment Act of 2000, Pub. L. 106-310, Div. B, Title XXXV, Sec. 3502(a), 114 Stat. 1222 (2000) (codified at 21 U.S.C. 823(g)(2)). --------------------------------------------------------------------------- The DI further testified that Respondent's application contained a falsification because in answering ``[q]uestion [n]umber 3,'' Ms. Santiago-Soto failed to disclose that the pharmacy had previously surrendered its registration. Tr. 45. While the DI was not present when Ms. Santiago-Soto surrendered Respondent's registration, he testified that he had read a report that stated that she ``voluntarily surrendered the pharmacy's license'' and that he had also seen the document that she signed, and that the document said that she ``voluntarily surrendered'' the registration. Id. at 60-61. The DI further explained that based on the inconsistencies between what he read in the report and the answers to the application's questions, he concluded that Ms. Santiago-Soto had falsified the application. Id. at 62-63. Later, on cross-examination, the DI conceded that the criminal charges which were filed against Ms. Santiago-Soto were voluntarily dismissed with prejudice. Id. at 72. Moreover, when asked whether Ms. Santiago-Soto had violated any federal law or regulation, the DI answered: The conclusion, once again, is based on our records, what I see in the records, and it's based on the evidence. Whenever an application is submitted to the DEA, and we are required to analyze this application, and based on the pharmacy's, for example, that the applicant is dispensing controlled substances. Id. at 72-73. Respondent's counsel then asked if anyone had found that Ms. Santiago-Soto ``has violated any federal law in dispensing those prescriptions that are part of the evidence here today?'' Id. at 73. The Government objected on the ground that the question ``ha[d] been asked and answered'' and the ALJ sustained the objection, noting that he knew that the charges were dismissed and that there was no evidence that Ms. Santiago-Soto had been convicted of any federal offense.\5\ Id. --------------------------------------------------------------------------- \5\ Contrary to the ALJ's understanding, this was an undue restriction on Respondent's right of cross-examination, especially given that the answer was not responsive. Later in the proceedings, the Government called Respondent's owner in its case-in-chief. Id. at 106. During cross-examination, the Government objected to Ms. Santiago-Soto's testimony (well after the question was asked and well into her answer) regarding a conversation she had in April 2012 with the group supervisor on the ground that it was ``[o]utside the scope of the pre-hearing statement'' and ``[t]here [was] no proffer that they were going to be introducing testimony from DEA agents.'' Tr. 134. The ALJ sustained the objection on the ground that ``it goes beyond the scope of what you informed in the amended pre-hearing statement.'' Id. Here again, the ALJ erred in sustaining the objection. Even if Respondent's pre-hearing statements did not disclose that Ms. Santiago-Soto would testify regarding this issue, its pre-hearing statement only limited the scope of what she could testify to on direct examination in Respondent's case-in-chief and had no bearing on the appropriate scope of cross-examination given that Ms. Santiago-Soto was still testifying as a Government witness. Moreover, the Government did not argue that the testimony was beyond the scope of its direct examination. --------------------------------------------------------------------------- Respondent's counsel then asked the DI if there was any official Web site or registry where a pharmacist can verify if a DEA number is active. Id. at 74. The DI testified that there is such a registry, that he ``believe[d]'' that the registry was available in 2009 through 2011 and was located at the DEA Diversion Web site, and that he believed that if a person was registered, they could access the Web site. Id. Subsequently, the DI testified that he could confirm that the registry has been available since 2009, but ``[t]o [his] knowledge . . . physicians have been informed at least from 2010, [and] that she should have been able to do that.'' Id. at 75-76. However, later in his testimony, Government counsel raised the possibility that this service had been discontinued, when he asked the DI: ``But you're not aware of when it started, and when it stopped?'' and the DI answered: ``That is correct.'' Id. at 92. Respondent's counsel then asked the DI ``why the DEA site, as of today, states that you cannot verify a DEA number online?'' Id. at 76. The DI replied: ``[t]hat is new to me.'' Id. Respondent's counsel then asked if he could show a document to the DI which, according to the proffer, was from the Agency's Web site and was contrary to the DI's testimony. Id. at 76-78. The ALJ barred Respondent's counsel from doing so even for the purpose of impeachment, explaining that his prehearing orders were clear that if documents ``were not presented to the Government, in advance of the hearing,'' he would not ``allow it.'' Id. at 77. Respondent's counsel then asked the DI if, in order to verify a DEA number, one had to pay for a program. Id. at 78-79. The DI answered that this was correct but that that ``if there are [sic] any reason to verify, you can call our office at any time, and you can ask for a verification.'' Id.; see also id. at 92. Next, when asked if ``the law requires that any dispensing pharmacist calls the DEA to verify if a physician's license is active,'' the DI answered ``yes.'' Id. at 79. When then asked what statute or agency regulation requires this, the DI could not identify one. Id. at 79-80. Moreover, the DI then testified that there is no law or regulation that requires a pharmacy to subscribe to the database provided by the National Technical Information Service. Id. at 80. Still later, when asked if ``it is the responsibility of the doctor [to have] a valid DEA license when prescribing a controlled substance,'' the DI answered: ``It is the responsibility of both the doctor and the pharmacist. The pharmacy has the responsibility.'' Id. at 86-87. The DI then acknowledged that the prescriptions in Government Exhibit 3 contained the required information and that he could not identify a prescription that was ``suspicious or irregular without knowing that the physician's license has been revoked or expired.'' Id. at 87-88. However, on re-direct examination, the DI explained that the Suboxone prescriptions were suspicious because they did not include an X number for the physician. Id. at 90-91. Respondent's counsel then asked whether he had ``any evidence'' that Ms. Santiago-Soto ``ha[d] acted with the intention or knowledge'' in dispensing either Dr. Aguilar's or Dr. Vargas' prescriptions. Id. at 88. The DI answered that he did not ``base [his] evaluations on intentions'' but ``on the documents'' that he had ``seen.'' Id. Also on redirect, the DI was asked whether part of the process of granting the applications of pharmacies involves ``explaining to the pharmacies that they have the burden to verify all prescriptions.'' Id. at 91. The DI answered ``that is correct,'' and agreed [[Page 29056]] that this is a requirement for maintaining a DEA registration ``under the code of regulations.'' Id. Still later in his testimony, when no question was pending, the DI proceeded to state that even aside from the Suboxone prescriptions, the 241 prescriptions at issue were suspicious because they were for oxycodone and alprazolam, which are highly abused drugs. Id. at 95-96. The DI then explained that ``if physicians regularly prescribe those drugs only, those should be of concern to any pharmacist who is . . . trying to ensure the public health and safety.'' Id. at 96. The Government did not produce any evidence, however, to show that these were the only drugs which were being prescribed by Dr. Aguilar-Amieva and being filled by Respondent. The Government also called Ms. Santiago-Soto as a witness. Tr. 105. Ms. Santiago-Soto acknowledged that she has been Respondent's owner and pharmacist-in-charge since she opened the pharmacy.\6\ Id. at 106. Asked by the Government whether the pharmacy had filled ``241 prescriptions for Dr. Aguilar-Amieva from February 2009 to October 2009,'' Ms. Santiago-Soto answered ``yes.'' Id. However, when asked whether she knew ``that his registration had been revoked in January of 2009,'' Ms. Santiago-Soto answered that she ``didn't know'' at the time.\7\ Id. at 106-07. --------------------------------------------------------------------------- \6\ Ms. Santiago-Soto testified that she had worked at four other pharmacies prior to opening Respondent. Tr. 139-40. She also testified that Respondent had been inspected by the Commonwealth's Health Department and the AMSCA, which is the Commonwealth agency that regulates controlled substances, and that she held the licenses required by the Commonwealth. Tr. 141-42. She further testified that Respondent had been inspected twice by DEA and had provided the DIs with both prescriptions and a list of various controlled medications that it had dispensed; according to Ms. Santiago-Soto, she was never notified that her pharmacy had engaged in any wrongdoing. Id. at 143. \7\ The Government's evidence does not establish that Dr. Aguilar-Amieva's registration had been revoked, in which case a Decision and Order would have been published in the Federal Register. See GX 6. Rather, the Government's evidence shows that Dr. Aguilar-Amieva's registration expired on June 30, 2008 and was retired from the DEA computer system on January 31, 2009. See id. --------------------------------------------------------------------------- Next, the Government asked Ms. Santiago-Soto whether she ``believe[d] that it's your duty to verify all prescriptions''; she replied: ``That's what I do all the time.'' Id. at 107. The Government then asked Ms. Santiago-Soto why she had filled Dr. Aguilar-Amieva's prescriptions ``if that's what you do all the time?'' Id. Ms. Santiago- Soto replied: Well to start with, I'm a pharmacist. And I revise [sic] prescriptions, and I make sure that the indications are correct, are the adequate ones, that they meet all standards and legal requirement [sic], whether they be federal or state laws. Once all those standards are met, and there is no question surrounding the prescription that might prompt me to call the physician for whatever reasons, then we proceed to dispense it. Id. at 107-8. Ms. Santiago-Soto then acknowledged that Respondent filled the twenty-nine Suboxone prescriptions issued by Drs. Aguilar-Amieva and Vargas-Quinones and that she was not aware that neither doctor was a DATA-waiver physician. Id. at 108. When asked whether Respondent had ever contacted the two doctors to verify the purpose of these prescriptions, Ms. Santiago-Soto answered: I verified the exhibit that you . . . gave me. . . And if you take a look at the Suboxone prescriptions, in their majority, they have a diagnosis that is related to the abuse of opioids, or opiates. Therefore, it was my understanding that these physicians had their license current, including some prescriptions that were invoiced to health insurance plans, and they were paid by these, even after they were reviewed. So, supposedly, that if the health insurance plan hires a physician, all the credentials should be up to date. And if they didn't come to notice this, and with them being the health insurance plan, when they are usually up to date on everything, then it was my understanding that the prescriptions were okay. Id. at 109. When then asked what her understanding was of who could prescribe Suboxone to treat substance-abuse patients, Ms. Santiago-Soto answered that she ``was aware of the use given to the medication'' and that ``[i]f you go prescription by prescription . . . the amounts are not such that would raise my suspicions that something is running amok.'' Id. at 109-10. She then reiterated that, at the time, she ``was not aware of the X DEA number'' that is required to prescribe Suboxone and buprenorphine to treat narcotic-dependent patients. Id. at 110. Upon questioning by the Government, Ms. Santiago-Soto acknowledged that a DATA-waiver physician must meet certain requirements and that ``not all physicians may prescribe'' Suboxone, and that a physician who prescribes Suboxone for this purpose must have an X-number. Id. The Government then asked Ms. Santiago-Soto why she did not know this when she ``became accredited as a pharmacist?'' Id. Ms. Santiago-Soto explained that she graduated in 1995, that the DATA was enacted in 2000, and that Suboxone and buprenorphine were not approved for this purpose until 2002. Id. She then contended that ``the DEA in Puerto Rico never has provided any guidance to her whether through an orientation or conference, online guidance, or by letters.'' Id. She further asserted that in none of the continuing education classes that she was required to take to maintain her pharmacist license was there any training offered by DEA on the DATA's requirements. Id. at 111. Ms. Santiago-Soto testified that she did not become aware of the DATA's requirements until Respondent was audited by a health insurance plan and the buprenorphine prescriptions were discussed with her.\8\ Id. at 112. However, she acknowledged that she should have learned of these requirements earlier. Id. at 114. After describing what she was taught at pharmacy school about spotting diversion, id. at 114-16, the Government asked Ms. Santiago-Soto whether she found ``anything suspicious with Dr. Aguilar-Amieva's prescriptions?'' Id. at 116. She replied: --------------------------------------------------------------------------- \8\ Ms. Santiago-Soto denied that she had not learned about the DATA's requirements until after being served with the Show Cause Order. Tr. 112. Ms. Santiago-Soto testified that the insurance plan audit occurred several months before the search warrant was executed at her pharmacy. Id. at 113. It is noted that the Government's evidence shows that Respondent did not dispense any Suboxone prescriptions after July 3, 2011. GX 4, at 23-24. The prescriptions met all legal parameters. The patients would come over to the drug store, and the ones that I did dispense, their reputation wasn't in doubt, in my judgment, because many of them would also bring me prescriptions of their medications that they --------------------------------------------------------------------------- took for continuous use. Id. The Government then asked Ms. Santiago-Soto whether she analyzed the prescribing practices of a physician for signs of diversion when filling a prescription. Id. at 117. Ms. Santiago-Soto replied: I don't speak with the doctors. There is a confidentiality law between doctor and patient. I review that the prescription meets the law and that it shouldn't raise the least suspicion possible in me, that this medication is not intended, particularly intended for this patient, for medical use. Id. at 117. When then asked whether she ``went through [Respondent's] computer system looking for patterns,'' Ms. Santiago-Soto answered that she ``kept a manual inventory and . . . from it I couldn't necessarily discern that something was out of place.'' Id. at 119. She then explained that in 2009, she dispensed a total of 30,000 prescriptions (including 27,000 for non-controlled drugs), of which 66 had been written by [[Page 29057]] Dr. Aguilar-Amieva.\9\ Id. She further stated that Dr. Aguilar-Amieva's prescriptions did not raise any suspicion. Id. at 122. --------------------------------------------------------------------------- \9\ In Respondent's case in chief, Ms. Santiago-Soto testified that Respondent dispensed 104 prescriptions in 2010 and 63 prescriptions in 2011 which were issued by Dr. Aguilar-Amieva. Tr. 151. --------------------------------------------------------------------------- Turning to the application, Ms. Santiago-Soto acknowledged that she understood both questions two and three.\10\ Id. at 123-24. When then asked whether she had surrendered her DEA registration for cause in November 2011, Ms. Santiago-Soto replied: ``In my judgment, I surrendered the license, but not with cause.'' Id. at 124. She then explained that: --------------------------------------------------------------------------- \10\ Question three asks whether ``the applicant [has] ever surrendered (for cause) or had a state professional license or controlled substances registration revoked, suspended, denied, restricted, or placed on probation, or is any such action pending?'' GX 1, at 1. There is no evidence, however, that the Commonwealth took any of these actions against Respondent's (or Ms. Santiago- Soto's) professional license or controlled substance registration. Thus, it is unclear why Ms. Santiago-Soto was asked about this question rather than question four. . . . . In my judgment, this is simple. When I surrendered my license, it was in a situation where I was under arrest, and I had no other choice but to sign the document that was placed in front of me. Moreover, at the moment of having to sign the document, an agent came out speaking or yelling, ``was her rights read to Yanira Santiago, was her Miranda rights''--and just before I signed that paper that said ``surrender,'' I had my Miranda rights read. And I was practically signing simultaneously. Agent [P.N.], from the Ponce DEA, explained to me that I had to sign that surrender because of the criminal charges against me. And not because of what I'm being told of here. * * * * * I'm handcuffed, and I had to sign a document that they demand from me to sign because I had no other option. Because, according to what they were saying, I was part of a scheme. When I proceed to answer this questions [sic] that is posed in the new application and quote/unquote, it puts the words ``with cause.'' It's my understanding, as of this day, that I surrendered the license without cause, because it was taken away from me because of my criminal case [an]d not because of what I'm being told here. Id. at 124-26. See also id. at 132 (``I signed the document, because he told me that I had to surrender the license because of a criminal charge against me.''). Ms. Santiago-Soto then explained that when she filled out the application ``that question raised doubts in my mind.'' Id. at 126. Accordingly, the next day, she called ``the regional director for the DEA in Ponce \11\ . . . and . . . told her . . . that I was unsure if I had answered the question correctly'' and that she had ``answered `no,' because, quote/unquote, it said `with cause.' '' Id. Ms. Santiago-Soto further testified that the official said ``that she would look into it and verify if that was answered correctly, because she didn't know. And she also told me that, since I had informed her about it, eventually, if any situation came up, she could appear as a witness and say that I had that doubt, and I had asked her about it, and that she had answered me.'' Id. at 126-27. Ms. Santiago-Soto testified that she memorialized the conversation in an email. Id. at 127. However, as of the date of the hearing, the official had not replied to the email. Id. at 136. --------------------------------------------------------------------------- \11\ I have taken official notice that the official is actually a group supervisor. --------------------------------------------------------------------------- The Government then asked Ms. Santiago-Soto ``if you had to fill this application out again today, what would you put for the Question No. 3?'' Id. at 128. Ms. Santiago-Soto replied: I would answer it the same way. I would answer the same thing. Because of the statement ``with cause,'' if that statement wouldn't have been there, I would have no reason to answer ``no.'' I would've answered ``yes.'' Because I surrendered. But since it stated, in parentheses, ``with cause,'' that's not my issue. Because I surrendered my DEA license because of the criminal case against me. Not because of this intervention right now, that we're having today. Id. Throughout her testimony, Ms. Santiago-Soto maintained that she did not voluntarily surrender Respondent's registration, but rather was coerced into surrendering it. Id. at 132. She also testified that the various prescriptions which form the basis of the allegations regarding the dispensing violations were taken from Respondent on the date she was arrested. Id. at 135-36. Upon the conclusion of Respondent's cross-examination of Ms. Santiago-Soto, Respondent's counsel attempted to move into evidence a copy of the email which she had sent to the group supervisor and explained that he had shown a copy of the email to the Government. Id. at 137. The ALJ denied the motion, explaining: ``That may be true, Counsel, but I don't have it. It's not evidence before me. I don't have any reason to understand why it wasn't presented ahead of time, so I could evaluate it.'' Id. at 137-38. As found above, the email appears to have been relevant to the issue of whether Ms. Santiago-Soto falsified Respondent's application. And contrary to the ALJ's on the record explanation for denying the motion, there was ample reason for why the document was not ``presented ahead of time.'' Specifically, the ALJ ignored that the Government did not provide any notice that it intended to litigate the issue of material falsification until its supplemental pre-hearing statement, which it filed one week before the hearing, and on which date Respondent was also required to file its supplemental pre-hearing statement. Moreover, the ALJ's June 18 order did not address what procedure Respondent was required to follow in the event the Government raised an entirely new allegation at this stage of the proceeding. See ALJ Ex. 7. Finally, the document was not included with the transmitted record as a rejected exhibit as it should have been. See 21 CFR 1316.60. Ms. Santiago-Soto also testified in Respondent's case-in-chief. Ms. Santiago-Soto testified that prior to her arrest on November 30, 2011, she had been inspected twice by DEA. Tr. 142-43. The first of these inspections occurred on September 2, 2010; the second on September 7, 2011. RXs G & H. While Agency Investigators apparently reviewed the controlled-substance prescriptions and her dispensing records, they never notified her of ``any findings or wrongdoings on'' the part of Respondent. Tr. 143. Nor did they advise that Dr. Aguilar-Amieva or any other doctor was under investigation. Id. at 144. Ms. Santiago-Soto further testified that there is a ``question and answer section'' on the DEA diversion Web site which includes a question regarding whether the Agency can verify a DEA registration. Id. at 145-46. According to Ms. Santiago-Soto, ``the answer that the DEA gives . . . is `no' '' and that she has to buy a program from the National Technical Information Service ``to be able to have access on several occasions to that registry.'' Id. at 146. Ms. Santiago-Soto further testified that it ``costs over $2,000 on an annual basis . . . for one user.'' Id. However, she then explained that she would buy the program if she is issued a registration. Id. at 146-47. Still later, she testified that the NTIS is ``costly for a drugstore that's just starting out'' and that she did not ``know of any small community pharmacy that has purchased'' a subscription to the NTIS database, ``because the law does not require that it be purchased.'' Id. at 149. However, she reiterated that she would purchase the database. Id.; see also id. at 154-55. Moreover, Ms. Santiago-Soto testified that if she was granted a registration, she would be willing to consider any [[Page 29058]] recommendations made by the Agency. Id. at 155. Regarding the allegation that she dispensed prescriptions written by Dr. Aguilar-Amieva, whose registration had expired, Ms. Santiago- Soto explained that she had reviewed the DEA Pharmacist's Manual, and that while the Manual contains extensive information as to what must be provided on a prescription, ``[n]owhere in the law am I told that I have to be checking each one of the licenses at every moment.'' Id. at 148. She also testified that during the period at issue, she ``would check the list of those physicians that had been criminally charged because of their prescriptions,'' id., and that if the name of a doctor was not on the list, she ``proceeded to dispense the prescription.'' Id. at 161. However, neither Dr. Aguilar-Amieva nor Dr. Vargas-Quinones appeared on the various lists for the years 2008 through 2013.\12\ Id. at 148-49. Finally, Ms. Santiago-Soto denied that she had ever knowingly dispensed a prescription which had not been lawfully issued. Id. at 154. --------------------------------------------------------------------------- \12\ On cross-examination by the Government, Ms. Santiago-Soto acknowledged that these lists may actually have been of those physicians who were subjected to administrative proceedings. Tr. 158. When the Government suggested that her review of these lists was inadequate because they were lists of final agency actions and would not ``contain the names of doctors that voluntarily surrendered'' their registrations, Ms. Santiago-Soto replied that ``I can't make any supposition, as you've been telling me. You're asking me to suppose something, and I'm not here to suppose anything. I'm here with facts. I'm being shown facts. So I have to answer with facts.'' Id. However, upon questioning by the ALJ, Ms. Santiago-Soto admitted that if a doctor who voluntarily surrendered his registration was not identified on the Web site, she ``wouldn't know'' that the doctor did not have the requisite authority. Id. at 161-62. --------------------------------------------------------------------------- Following the conclusion of Ms. Santiago-Soto's testimony, Respondent's counsel requested that the ALJ take official notice of various documents, including the Web page containing various questions and answers which Respondent's counsel had previously sought to use to impeach the testimony of the DI to the effect that Ms. Santiago-Soto could have verified whether the physicians were registered by calling DEA. Tr. 162-67. After the ALJ asserted that the document's ``relationship to the narrative . . . attributed to'' Respondent should have been clear to its counsel when she filed its amended pre-hearing statements, Respondent's counsel again argued that it had no ``knowledge that the witness for the DEA would provide testimony . . . under oath, that contradicts the information the DEA provided on that Web page.'' Id. at 167. However, the ALJ again rejected Respondent's request. Id. Discussion Section 303(f) of the Controlled Substances Act (CSA) provides that an application for a practitioner's registration may be denied upon a determination ``that the issuance of such registration would be inconsistent with the public interest.'' 21 U.S.C. 823(f). In making the public interest determination, the CSA requires the consideration of the following factors: (1) The recommendation of the appropriate State licensing board or professional disciplinary authority. (2) The applicant's experience in dispensing . . . controlled substances. (3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances. (4) Compliance with applicable State, Federal, or local laws relating to controlled substances. (5) Such other conduct which may threaten the public health and safety. Id. ``These factors are . . . considered in the disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or a combination of factors, and may give each factor the weight [I] deem[] appropriate in determining whether . . . an application for registration [should be] denied.'' Id. Moreover, I am not required to make findings as to all of the factors.\13\ Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). --------------------------------------------------------------------------- \13\ I have considered Respondent's evidence that it is currently licensed by the Commonwealth of Puerto Rico as a pharmacy and holds a registration from the Commonwealth which authorizes it to dispense controlled substances. I have also considered Respondent's evidence that the Pharmaceutical Board took no action against Ms. Santiago-Soto's pharmacist's license. However, none of these documents constitute a recommendation from the state licensing board as to whether DEA should grant the application, see 21 U.S.C. 823(f)(1), and while Respondent clearly possesses authority to dispense controlled substances under the laws of the Commonwealth and thus meets a prerequisite for obtaining a registration, this finding is not dispositive of the public interest inquiry. So too, I acknowledge that neither Respondent, nor Ms. Santiago-Soto, has been convicted of an offense under either federal or Puerto Rico law ``relating to the manufacture, distribution or dispensing of controlled substances.'' 21 U.S.C. 823(f)(3). However, while the charges against Ms. Santiago-Soto were dismissed, this finding is not dispositive of the allegations that Respondent filled unlawful prescriptions because this proceeding involves different allegations than those brought in the criminal proceeding and is subject to a lower standard of proof (the preponderance standard) than that applied in a criminal proceeding. --------------------------------------------------------------------------- Under Section 304(a)(1), a registration may be revoked or suspended ``upon a finding that the registrant . . . has materially falsified any application filed pursuant to or required by this subchapter.'' 21 U.S.C. 824(a)(1). Under agency precedent, the various grounds for revocation or suspension of an existing registration that Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also properly considered in deciding whether to grant or deny an application under section 303. See The Lawsons, Inc., 72 FR 74334, 74337 (2007); Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R. Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 (1993). Thus, the allegation that Respondent materially falsified its application is properly considered in this proceeding. See The Lawsons, 72 FR at 74337; Samuel S. Jackson, 72 FR 23848, 23852 (2007). Moreover, just as materially falsifying an application provides a basis for revoking an existing registration without proof of any other misconduct, see 21 U.S.C. 824(a)(1), it also provides an independent and adequate ground for denying an application. The Lawsons, 72 FR at 74338; cf. Bobby Watts, M.D., 58 FR 46995 (1993). In this matter, the Government alleged that Ms. Santiago-Soto materially falsified Respondent's application for registration by failing to disclose that it had previously surrendered its prior registration for cause. Gov. Post-Hearing Br., at 6-9. It also alleged that Respondent's registration is inconsistent with the public interest because it violated 21 U.S.C. 843(a)(2), as well as 21 CFR 1306.04 and 1306.06, when: (1) Between February 2009 and October 2009, it filled 241 prescriptions which were issued by Dr. Aguilar-Amieva, whose registration had been retired by the Agency; and (2) it filled Suboxone prescriptions issued by Dr. Aguilar-Amieva and Dr. Vargas-Quinones to treat narcotic addiction, when neither doctor was authorized under Federal law to do so. See Gov. Post-Hearing Br., at 11-12. The Material Falsification Allegation The Government argues that Ms. Santiago-Soto materially falsified Respondent's application for registration because she failed to disclose the November 30, 2011 surrender of its registration. More specifically, the Government contends that Ms. Santiago-Soto materially falsified the application, when she provided a ``no'' answer to question two, which asked: ``Has the applicant ever surrendered (for cause) or had a federal controlled substances registration revoked, suspended, [[Page 29059]] restricted or denied, or is any such action pending?'' Gov. Br. at 7 (citing GX 1, at 1). Moreover, in its post-hearing brief, the Government contends--for the first time in the proceeding--that Ms. Santiago-Soto also materially falsified the application when she provided a ``no'' answer to question four, which asked: ``If the applicant is a corporation . . . or pharmacy . . . has any officer, partner, stockholder or proprietor . . . ever surrendered or had a federal controlled substances registration revoked, suspended, restricted, or denied . . . .?'' Id. at 8. I reject the allegations. One of the fundamental tenets of Due Process is that an Agency must provide a Respondent with notice of those acts which the Agency intends to rely on in seeking the revocation of its registration so as to provide a full and fair opportunity to challenge the factual and legal basis for the Agency's action. See NLRB v. I.W.G., Inc. 144 F.3d 685, 688-89 (10th Cir. 1998); Pergament United Sales, Inc. v. NLRB, 920 F.2d 130, 134 (2d Cir. 1990). Because the Government did not allege in the Order to Show Cause that Respondent had materially falsified its application, before proceeding to address whether the evidence supports the Government's contention, it is necessary determine whether the Government otherwise provided adequate notice of its intent to litigate the issue. See 5 U.S.C. 554(b) (``Persons entitled to notice of an agency hearing shall be timely informed of . . . the matters of fact and law asserted.''). `` `Pleadings in administrative proceedings are not judged by the standards applied to an indictment at common law.' '' Aloha Airlines v. Civil Aeronautics Bd., 598 F.2d 250, 262 (D.C. Cir. 1979) (quoted in CBS Wholesale Distributors, 74 FR 36746, 36749 (2009)); accord Citizens State Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th Cir. 1984). Accordingly, ``the failure of the Government to disclose an allegation in the Order to Show Cause is not dispositive and an issue can be litigated if the Government otherwise timely notifies a [r]espondent of its intent to litigate the issue.'' CBS Wholesale, 74 FR at 36570. Thus, while the Agency has held that ``the parameters of the hearing are determined by the prehearing statements,'' consistent with numerous court decisions, it has also recognized that even where an allegation was not raised in either the Show Cause Order or the pre-hearing statements, the parties may nonetheless litigate an issue by consent. Pergament United Sales, 920 F.2d at 135-37; see also Duane v. Department of Defense, 275 F.3d 988, 995 (10th Cir. 2002) (discussing Facet Enterprises, Inc. v. NLRB, 907 F.2d 963, 974 (10th Cir. 1990); ``we held that defendant had constructive notice of an alternate theory of liability not described in the formal charge when the agency detailed that theory during its opening argument and at other points during the hearing and when the defendant's conduct revealed that it understood and attempted to defend against that theory'').\14\ --------------------------------------------------------------------------- \14\ See also Grider Drug #1 & Grider Drug #2, 77 FR 44070, 44077 n.23 (2012) (holding that while the Government did not provide adequate notice of its intent to litigate an allegation in either the Show Cause Order or its pre-hearing statements, where respondents ``did not object that the allegation was beyond the scope of the proceeding and that they were denied adequate notice of it'' and ``fully litigated the issue,'' the allegation was litigated by consent) (citing Citizens State Bank, 751 F.2d at 213; Kuhn v. Civil Aeronautics Bd., 183 F.2d 839, 841-42 (D.C. Cir. 1950); and Yellow Freight System, Inc. v. Martin, 954 F.2d 353, 358 (6th Cir. 1992)). --------------------------------------------------------------------------- ``The primary function of notice is to afford [a] respondent an opportunity to prepare a defense by investigating the basis of the complaint and fashioning an explanation that refutes the charge of unlawful behavior.'' Pergament United Sales, 920 F.2d at 135 (citation omitted). While the issue of whether an allegation ``has been fully and fairly litigated [by consent] is so peculiarly fact-bound as to make every case unique,'' id. at 136, ``the simple presentation of evidence important to an alternative [allegation] does not satisfy the requirement'' that a respondent be afforded with a full and fair opportunity to litigate the alternative allegation. I.W.G., 144 F.3d at 688 (quoting NLRB v. Quality C.A.T.V., Inc., 824 F.2d 542, 547 (7th Cir. 1987) (other citation omitted)). ``An agency may not base its decision upon an issue the parties tried inadvertently. Implied consent is not established merely because one party introduced evidence relevant to an unpleaded issue and the opposing party failed to object to its introduction. It must appear that the parties understood the evidence to be aimed at the unpleaded issue.'' Yellow Freight System, Inc. v. Martin, 954 F.2d 353, 358 (6th Cir. 1992) (citation omitted). Accordingly, where the Government's case ``focus[es] on another issue and [the] evidence of [an] uncharged violation [is] `at most incidental,' '' the Government has not satisfied its constitutional obligation to provide a full and fair opportunity to litigate the issue and it cannot rely on the incidental issue as the basis for imposing a sanction. Pergament, 920 F.2d at 136 (quoting NLRB v. Majestic Weaving Co., 355 F.2d 854, 861-62 (2d Cir. 1966)). In its initial Pre-Hearing Statement, the Government again failed to allege that the application was materially false. Nor, in summarizing the testimony of its proposed witnesses therein, did the Government provide notice that it intended to put forward any evidence which would lead Respondent to conclude that the material falsification of its application was an issue in the case. Instead, the Government did not provide notice that it intended to litigate the issue of whether the application contained a material falsification until its Supplemental Pre-Hearing Statement, which was not filed until one week before the evidence-taking phase of the proceeding convened. Even then, the Supplemental Pre-Hearing Statement did not identify which specific statements on the applications were allegedly false. Rather, the Supplemental Pre-Hearing Statement merely stated that ``Ms. Soto will be asked about the circumstances of the pharmacy's prior surrender of its DEA certificate of registration, and about her failure to note the previous surrender on Respondent's new application for registration.'' ALJ Ex. 7, at 3. Because the Government's Supplemental Pre-Hearing Statement did not specifically identify which of the various application statements it was alleging to be materially false, only those issues which the record shows were litigated by consent can support a finding (if proved by substantial evidence) that Ms. Santiago-Soto materially falsified the application and the imposition of a sanction. Notably, while at the evidentiary phase of the hearing the Government made an opening statement, here again, it did not identify the specific statements which were allegedly false. Rather, it confined its opening statement to the following: ``Your Honor, the Government seeks a recommendation of a denial of application based on Sections 823 and 824 of the Controlled Substances Act, on the basis of a material falsification on the application, and the fact that Respondent's registration would be inconsistent with the public interest.'' Tr. 39. Moreover, in questioning both the DI and Ms. Santiago-Soto, the Government did not elicit any testimony regarding Question Four. Rather, it focused entirely on the answers Ms. Santiago-Soto had given to Question Two, and, notwithstanding that there was no evidence that the Commonwealth of Puerto Rico had taken any action against either Respondent or Ms. Santiago-Soto, Question Three. See Tr. 45 (testimony of DI that Respondent's application [[Page 29060]] contained a falsification at ``Question Number 3''); id. at 123-24 (Government's questioning of Ms. Santiago-Soto regarding Questions Two and Three). Indeed, it was not until its post-hearing brief that the Government finally argued that Ms. Santiago-Soto had provided a materially false answer to Question Four. This, however, is simply too late in the day to provide a meaningful opportunity to refute the allegation. See Pergament United Sales, 920 F.2d at 135.\15\ --------------------------------------------------------------------------- \15\ Indeed, even if an allegation could be refuted without further factual development because it involves a matter of law, because DEA proceedings customarily require the parties to file their post-hearing briefs simultaneously (as was done here), there is no meaningful opportunity to respond prior to the issuance of an ALJ's recommended decision. --------------------------------------------------------------------------- Thus, I hold that the Government provided adequate notice to support a finding that the parties litigated by consent the issue of whether Ms. Santiago-Soto's answer to Question Two was materially false. However, I further hold that the record does not support a finding that the parties litigated by consent whether her answer to Question Four was also materially false. Turning to the merits of the allegation pertaining to Question Two, the evidence showed that on November 29, 2011, Ms. Santiago-Soto was indicted (along with thirty-two other persons) on two felony counts of violating the Controlled Substance Act, including: (1) By conspiring to possess and dispense, with intent to distribute, various controlled substances, in violation of 21 U.S.C. 841(a)(1), 846, and 860; and (2) by aiding and abetting each other and ``knowingly and intentionally possess[ing] and dispens[ing] with intent to distribute various'' schedule II through IV controlled substances, ``outside the scope of professional practice and not for a legitimate medical purpose,'' in violation of 21 U.S.C. 841(a)(1) and 18 U.S.C. 2. RX B, at 1-13. On November 30, 2011, Ms. Santiago-Soto was arrested early in the morning and taken to her pharmacy where, after receiving the Miranda warnings, she was told by P.N., a DI,\16\ that she had to surrender her registration ``because of the criminal charges against'' her and that she ``had no other options'' because she was ``part of a scheme.'' Tr. 125-26. The evidence further showed that Ms. Santiago-Soto executed a Voluntary Surrender form, which was witnessed by P.N. (as well as another DI). RX I. This form stated that she had been ``fully advised of my rights, and underst[ood] that I am not required to surrender my controlled substance privileges,'' and that ``[i]n view of my alleged failure to comply with the Federal requirements pertaining to controlled substances, and as an indication of my good faith in desiring to remedy any incorrect or unlawful practices on my part'' she was ``voluntarily surrender[ing] my . . . Certificate of Registration.'' Id. --------------------------------------------------------------------------- \16\ In her testimony, Ms. Santiago-Soto referred to this person as an Agent; however, on the Voluntary Surrender form, this person signed as a witness and listed his title as ``Diversion Investigator.'' RX I. --------------------------------------------------------------------------- As found above, the DI who testified for the Government did not personally participate in the arrest of Ms. Santiago-Soto and did not witness the events surrounding her execution of the Voluntary Surrender form. Tr. 60-61. Nor did the Government call as a witness any other person who witnessed the execution of the surrender form. Thus, there is no evidence that, at the time she surrendered Respondent's registration, Ms. Santiago-Soto was confronted with any allegations of misconduct aside from those which comprised the criminal case. Subsequently, the U.S. Attorney moved to dismiss with prejudice both of the charges against Ms. Santiago-Soto. RX C. On March 23, 2012, the District Court granted the Government's motion and entered a Judgment of Dismissal and discharged her. Id. The consequence of this was that the charges could not be refiled against her. The Government nonetheless argues that Ms. Santiago-Soto ``could not under any reasonable circumstances have answered the relevant liability questions . . . in the negative'' and that she ``placed undue emphasis on the words `for cause' in liability question #2.'' Gov. Post-Hrng. Br., at 7. The Government further notes Ms. Santiago-Soto's claim that she signed the surrender form ``under duress.'' Id. I need not decide whether surrendering a registration under duress constitutes a valid defense to a charge of material falsification of Question Two or whether the facts here would support such a defense.\17\ This is so because I find unpersuasive the Government's contentions that Ms. Santiago-Soto could not have reasonably answered Question Two in the negative and that she ``placed undue emphasis on the words `for cause.' '' --------------------------------------------------------------------------- \17\ Of consequence, Question Two did not ask whether Respondent had ``ever voluntarily surrendered (for cause)'' but only if it had ``ever surrendered (for cause)'' its registration. GX 1, at 1. Moreover, notwithstanding that Ms. Santiago-Soto was under arrest at the time she surrendered Respondent's registration, in signing the Voluntary Form, she acknowledged that she had been ``fully advised of [her] rights'' and understood that she was ``not required to surrender my controlled substances privileges''; she then acknowledged that she was ``freely execut[ing]'' the form and ``choos[ing] to'' voluntarily surrender her registration. RX I. --------------------------------------------------------------------------- As for the latter contention, Ms. Santiago-Soto was only required to answer Question Two as it was written on the application and not as it otherwise could have been written (such as without those words). Indeed, the Government does not explain how Ms. Santiago-Soto could have ``placed undue emphasis on the words `for cause,' '' when those words were part of the question and the application contains no explanation of what the term ``surrender for cause'' means. There is no Agency regulation which defines the term ``for cause'' as it is applied in the context of an application for registration. However, two regulations do define the term in the context of imposing requirements on practitioners in the employment of persons who handle or have access to controlled substances, see 21 CFR 1301.76(a), as well as on manufacturers and distributors (among others) in the employment of persons who will have access to listed chemicals. See 21 CFR 1309.72(a). Under these provisions, ``the term `for cause' means a surrender in lieu of, or as a consequence of, any Federal or State administrative, civil or criminal actions resulting from an investigation of the handling of controlled substances or listed chemicals.'' 21 CFR 1301.76(a); id. at 1309.72(a). However, even if this definition was applied to Respondent's application, it would offer no support to the Government. Here, there is no evidence that Ms. Santiago-Soto was advised that if she did not surrender the registration, Respondent would face an Order to Show Cause. Thus, she did not surrender the registration ``in lieu of'' a hearing. Moreover, while she had been indicted prior to the surrender, there is no evidence that she surrendered the registration in lieu of facing the criminal charges, which were not dismissed until several months later.\18\ --------------------------------------------------------------------------- \18\ Nor does the evidence support a finding that she surrendered the registration as a consequence of the criminal action. Ms. Santiago-Soto did not surrender the registration as part of a pre-trial diversion agreement, a plea agreement, or as part of a sentence imposed by a court. Rather, the criminal case against Ms. Santiago-Soto was dismissed with prejudice. --------------------------------------------------------------------------- Notably, Ms. Santiago-Soto's testimony that she was told that she had to surrender her registration because of her involvement in a criminal scheme stands unrefuted, and there is no evidence that, at the time of the surrender, she was told by Agency personnel that the Agency was alleging additional violations of the CSA or DEA [[Page 29061]] regulations beyond the offenses for which she was indicted.\19\ Moreover, the consequence of the district court's dismissal of the charges ``with prejudice,'' on motion of the Government (and apparently before trial), was that she could be not re-charged for the same offenses. Under these circumstances, a layperson could, in good faith, conclude that there was no basis for both the charges and the DI's demand that she surrender her registration, and given the absence of any definition of the limiting term, a layperson could also, in good faith, conclude that she had not surrendered her registration ``for cause.'' \20\ --------------------------------------------------------------------------- \19\ It is acknowledged that on the Voluntary Surrender form the box was checked which indicates that Ms. Santiago-Soto surrendered Respondent's registration ``[i]n view of my alleged failure to comply with the Federal requirements pertaining to controlled substances.'' RX I. However, the Voluntary Surrender form did not list (nor is there a space to list) what those alleged failures were. See id. Given the absence of any evidence that at the time the surrender occurred, Ms. Santiago-Soto was told of additional allegations against her, the Voluntary Surrender form does not refute her testimony that because the criminal case was dismissed, she did not believe that she had surrendered for cause. \20\ The Government does not argue that the mere fact that she was indicted was sufficient to place her on notice that she had surrendered her registration for cause. --------------------------------------------------------------------------- Even had I concluded otherwise, I would hold that there are mitigating circumstances that substantially diminish the egregiousness of the alleged misconduct. Ms. Santiago-Soto testified that the day after she submitted the application, she contacted the Diversion Group Supervisor and explained to her that she answered the question ``no'' and ``was unsure if [she] had answered the question correctly'' because the question used the words ``with cause.'' Tr. 126. Ms. Santiago-Soto also testified that the Group Supervisor told her that she did not know, but that she would look into it and get back to her. Id. at 126- 27. Ms. Santiago-Soto further testified that she had memorialized the conversation in an email to the Group Supervisor. Id. at 127. However, the Group Supervisor did not respond to her. Id. Notably, all of this testimony was unrefuted by the Government. While the ALJ acknowledged this testimony in his summary of the testimony, see R.D. at 5-6, in his discussion of whether Ms. Santiago- Soto had materially falsified the application, he entirely ignored it and offered no explanation for why he apparently rejected it even as a mitigating circumstance. Id. at 27-28. However, in concluding that Ms. Santiago-Soto had materially falsified the application, the ALJ repeatedly noted that Santiago-Soto had also provided a ``no'' answer to Question Four, which does not use the words ``for cause'' to modify the scope of surrenders which must be disclosed. Id. at 27-29. Moreover, in his earlier summary of the testimony, the ALJ noted that ``[t]here is no evidence indicating that Ms. Santiago-Soto also inquired about Question Four during her conversation with'' the Group Supervisor, id. at 5, and that in her testimony, she did not address her answer to Question Four. He also explained that the Group Supervisor ``did not testify at the hearing, and [that] neither party sought such testimony.'' Id. The ALJ further observed that ``the record before me does not include a copy of'' the email which Ms. Santiago- Soto testified she had sent to the Group Supervisor. Id. at 6. Thus, it appears that the ALJ rejected Santiago-Soto's testimony regarding the phone call and email to the Group Supervisor because she did not claim to have asked about Question Four. However, to the extent this is an accurate discernment of the ALJ's unexplained reasoning, it not surprising that there is no evidence as to why Ms. Santiago-Soto answered Question Four as she did. This is so because the Government never asked her why she did, nor otherwise adequately put her on notice that her answer to this question was at issue in the proceeding.\21\ --------------------------------------------------------------------------- \21\ For this reason, in testifying regarding the phone call, Ms. Santiago-Soto had no obligation to address whether she had also discussed her answer to Question Four with the Group Supervisor. In its Post-Hearing Brief, the Government asserts that Ms. Santiago-Soto's ``failure to testify on this question supports an adverse inference that she knew the statement was false.'' Gov. Post-Hrng. Br., at 8. The Government ignores that it called Ms. Santiago-Soto to testify in its case in chief and could have--but failed to--ask her about her answer to Question Four. Nor did the Government, at any time prior to filing its Post-Hearing Brief, provide notice to Santiago-Soto that her answer to Question Four was at issue. I therefore hold that the Government is not entitled to an adverse inference regarding her answer to Question Four. --------------------------------------------------------------------------- This, however, is not the only problematic aspect of the ALJ's failure to adequately explain why he gave no weight to Ms. Santiago- Soto's testimony regarding the phone call she made to the Group Supervisor. As explained above, the ALJ's decision also suggests that he gave no weight to her testimony because the Group Supervisor was not called to testify and the email was not part of the record. As for the failure to obtain the Group Supervisor's testimony, Respondent was not required to call the Group Supervisor in order to establish that her testimony was credible. As for the ALJ's observation that the email is not part of the record, it should have been (indeed, notwithstanding the Agency's regulation, which requires that an ALJ forward a rejected exhibit to the Administrator's Office, it was not). As found above, the ALJ allowed the Government to delay filing its supplemental prehearing statement until one week before the hearing and imposed the same deadline on Respondent. Moreover, the ALJ failed to provide any direction to Respondent as to what steps it must take in the event the Government raised an entirely new allegation at this state of the proceeding and wished to present evidence to refute the allegation. As for the ALJ's on-the-record explanation that the email had to be presented ``ahead of time, so [he] could evaluate it,'' Tr. 138, this begs the question: Evaluate it for what? Even in jury trials (where there is a manifest to need to protect the factfinder from being misled or confused), judges routinely rule from the bench on the admissibility of evidence. And here, where there is no jury, the ALJ could have evaluated this evidence at the same time he evaluated the testimony. Finally, the Government offered no objection to the email; nor could it reasonably claim prejudice given that it waited until one week before the hearing to finally make the allegation. Under these circumstances, I conclude that the ALJ's refusal to admit the email was arbitrary and capricious. I further reject the ALJ's findings that Ms. Santiago-Soto materially falsified Respondent's application when she provided a ``no'' answer to Question Two and Four. R.D. at 29, 30-31. I further reject the ALJ's Conclusions of Law with respect to this issue. See id. at 35. Factors Two and Four--The Applicant's Experience in Dispensing Controlled Substances and Compliance With Applicable Laws Related to Controlled Substances With respect to Factors Two and Four, the Government made two allegations. First, it alleged that ``from February 2009 to October 2009,'' Respondent ``filled approximately 241 prescriptions'' which were issued by Dr. Aguilar-Amieva, after his registration had been retired by the Agency. Gov. Post-Hrng. Br., at 11. The Government alleged that this ``conduct violated 21 U.S.C. 843(a)(2), 21 CFR 1306.04 and 1306.06.'' Id. Second, it alleged that Respondent filled twenty-nine Suboxone prescriptions, which were issued by both Dr. Aguilar-Amieva and Dr. Vargas-Quinones, neither of whom were authorized to prescribe this drug to [[Page 29062]] treat narcotic addiction. See id. at 11-12. The Government alleged that this conduct also violated 21 U.S.C. 843(a)(2), 21 CFR 1306.04 and 1306.06. Allegation One--Respondent's Filling of Prescriptions Issued By A Physician Who Was No Longer Registered As found above, the evidence showed that Dr. Hector J. Aguilar- Amieva's registration expired on June 30, 2008 and was retired from the DEA computer system on January 31, 2009. GX 6. The evidence, which was not objected to, further showed that Respondent filled more than two hundred controlled-substance prescriptions which were issued by Dr. Aguilar-Amieva from February 2, 2009 through August 8, 2011.\22\ GX 4. --------------------------------------------------------------------------- \22\ At the hearing, Respondent did not challenge the admission of this evidence on the ground of lack of foundation. Nor did it raise such a challenge in its Exceptions. Notably, the only Government witness to testify did not participate in the execution of the search warrant and did not specifically identify the prescriptions submitted by the Government as those which were seized when the warrant was issued. Moreover, the prescription labels (which were apparently affixed to the back of the prescriptions), do not identify Respondent as the dispensing pharmacy. Nor did the Government submit any documentary evidence tending to establish that the prescriptions were those which were seized from Respondent. --------------------------------------------------------------------------- Except for in limited circumstances which are not implicated here, the Controlled Substances Act requires that ``[e]very person who dispenses . . . any controlled substance [ ] shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him.'' 21 U.S.C. 822(a)(2).\23\ Moreover, under a DEA regulation, ``[a] prescription for a controlled substance may be issued only by an individual practitioner who is: (1) [a]uthorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession and (2) [e]ither registered or exempted from registration pursuant to 1301.22(c) and 1301.23 of this chapter.'' 21 CFR 1306.03(a). Also, it is ``unlawful for any person knowingly or intentionally . . . to use in the course of the . . . dispensing of a controlled substance . . . a registration number which is fictitious, revoked, suspended, expired, or issued to another person.'' 21 U.S.C. 843(a)(2). Thus, it is clear (and undisputed) that Dr. Aguilar-Amieva repeatedly violated the CSA by issuing controlled-substance prescriptions using his expired registration number. --------------------------------------------------------------------------- \23\ See 21 U.S.C. 822(c); 21 CFR 1301.22. --------------------------------------------------------------------------- The issue in this matter, however, is whether liability can be imposed on Respondent because its principal filled Dr. Aguilar-Amieva's prescriptions. As explained above, the Government contends that Respondent's conduct violated section 843(a)(2); the Agency's corresponding responsibility rule, see 21 CFR 1306.04(a); as well as a further regulation, 21 CFR 1304.06. Contrary to the Government's understanding, its evidence does not support a finding that Respondent violated any of the three provisions in dispensing these prescriptions. As explained above, section 843(a)(2) imposes criminal liability on any person who uses, in the course of dispensing a controlled substance, an expired registration number. While no case has been cited by the Government where a pharmacist has been convicted of violating this provision because it filled prescriptions issued by a physician whose registration had expired, given that a prescription provides the lawful authority for a pharmacist to dispense a controlled substance, see 21 U.S.C. 829(a) & (b), it is clear that a pharmacist can held liable for dispensing a controlled substance prescription issued by a physician who no longer holds a registration. However, the statute imposes liability only where a pharmacist does so knowingly or intentionally. See 21 U.S.C. 843(a)(2). As for 21 CFR 1306.04(a), it requires that a controlled substance prescription ``be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice'' and imposes ``a corresponding responsibility'' on the pharmacist who fills a prescription which was not issued ``in the usual course of professional treatment.'' However, here again, the regulation imposes liability only on a ``person knowingly filling such a purported prescription.'' Id. (emphasis added). While the plain language of both of these provisions requires proof that a pharmacist dispensed a prescription knowing that the issuer lacked the requisite authority, the Government produced no evidence that Ms. Santiago-Soto knew (or was even willfully blind) to the fact that Dr. Aguilar-Amieva did not hold a DEA registration. Indeed, while in its brief the Government argues that Ms. Santiago-Soto admitted that Respondent had filled the prescriptions, Ms. Santiago-Soto expressly denied that she knew that Aguilar-Amieva's registration ``had been revoked in January 2009.'' Tr. 106-07.\24\ Thus, although it is true that Ms. Santiago-Soto admitted that Respondent had filled the prescriptions, her admission satisfies the Government's evidentiary burden only with respect to showing that the dispensings occurred. Moreover, when asked whether he had any evidence that Ms. Santiago-Soto had ``acted with the intention or knowledge [of] illegal activity when dispensing Dr. Aguilar's . . . prescriptions,'' the DI gave an unresponsive answer, stating that he did not ``base [his] evaluations on intentions,'' and when asked a follow-up question, the ALJ interjected (without the DI even answering the question): ``I'll take it as a no.'' Thus, I hold that the Government did not prove that Ms. Santiago-Soto acted with the requisite knowledge to sustain a violation of either 21 U.S.C. 843(a)(2) or 21 CFR 1306.04(a), with respect to this allegation. --------------------------------------------------------------------------- \24\ The quotation is from the Government's question. The Government's evidence did not establish that the Agency had revoked Dr. Aguilar-Amieva's registration, but only that Aguilar-Amieva let his registration expire after which his number was retired from the DEA registrant database. Had Aguilar-Amieva's registration been revoked, an order doing so would have been published in the Federal Register and on the Agency's Web site. --------------------------------------------------------------------------- The Government also alleged that Respondent's filling of the 241prescriptions violated 21 CFR 1306.06. In relevant part, this regulation provides that ``[a] prescription for a controlled substance may only be filled by a pharmacist, acting in the usual course of his professional practice.'' 21 CFR 1306.06. Thus, on its face, this regulation does not require proof of knowledge to sustain a violation. However, the regulation does require that the Government establish what the standards of pharmacy practice require, through either expert testimony or by reference to federal or state laws, pharmacy board or Agency regulations, or decisional law (whether of administrative bodies or the courts). Here, while the Government's evidence establishes that Respondent dispensed some 241 controlled substance prescriptions over a period of approximately thirty months, which were written by a physician who was not registered, the Government did not put on any expert testimony establishing that pharmacists have a duty to verify the registration status of the prescribers whose prescriptions they fill. Nor did the Government cite to any other rule or decision imposing such a duty. Notwithstanding that the Government neither produced any evidence establishing that the usual course of professional practice requires that a pharmacist verify the registration status of prescribers, nor cited any law, regulation, or other authority, which imposes such a requirement, the ALJ found that when ``she filled these prescriptions[,] Ms. Santiago-Soto failed [[Page 29063]] to conform to regulations relating to the distribution of controlled substances and failed to act in the usual course of professional pharmacy practice.'' R.D. at 34. Apparently, this was based on the ALJ's earlier conclusion that ``[o]ne way or another, pharmacists must ensure that they are filling only those controlled substance prescriptions that have been written by persons registered with the DEA. A pharmacy applicant who fails to appreciate the need to verify DEA credentials of prescribing doctors (either by contacting the DEA \25\ or subscribing to a private verification service) demonstrates a lack of experience material to the application.'' Id. at 23 (emphasis added). Thus, the ALJ applied a standard of strict liability in concluding that Ms. Santiago-Soto had ``failed to act in the usual course of professional pharmacy practice.'' Id. at 34. --------------------------------------------------------------------------- \25\ Based on the testimony of the DI, the ALJ found that ``[i]n order to determine whether a medical provider is authorized by the DEA to prescribe controlled substances, a pharmacist may contact the DEA by telephone and inquire.'' R.D. 31 (FoF #13); see also id. at 23 (``Although it might be a cumbersome and time-consuming verification process, the DEA does permit a pharmacist to call into a field office to confirm the status of a given prescribing source.''). However, as found above, the ALJ barred Respondent from using a Question and Answer printout from the DEA Web page to impeach the DI's testimony to this effect, reasoning that the Respondent was required to disclose this document in advance of the hearing. Tr. 164. It is true that under the Agency's rule, a party is generally required to provide a copy of any proposed exhibit which is being offered as substantive evidence in the matter. However, contrary to the ALJ's understanding, a party is not required to disclose, in advance of the hearing, a document which is being used to impeach a witness. I therefore reject this finding. As for the NTIS database, the ALJ acknowledged that subscribing to this service is expensive. However, he then opined that ``[i]t is no answer to complain that the NTIS program costs a lot of money; nor is it a sufficient legal response to argue that DEA regulations do not require pharmacists to purchase the program.'' R.D. at 23. To the extent this comment might be understood as creating an obligation on all pharmacies to subscribe to this service, it is rejected. While it was not fully developed on the record of this proceeding, DEA provides a web tool which allows a registrant to verify the registration of another person or entity. --------------------------------------------------------------------------- Contrary to the ALJ's understanding, no Agency regulation requires that a pharmacist ascertain that each prescription presented to him/her has been issued by a practitioner who possesses a valid DEA registration and the Agency expressly disclaimed the existence of such a duty in 2010, when it promulgated its Interim Final Rule on Electronic Prescriptions for Controlled Substances. See 75 FR 16236, 16266 (2010). Therein, the Agency noted that it had proposed requiring pharmacies ``to confirm that the [prescriber's] DEA registration . . . was valid at the time'' the prescription was signed. Id. However, several commenters objected ``that pharmacies are not required to check DEA registrations for paper prescriptions unless they suspect something is wrong with a prescription.'' Id. In its response (which appears to be missing pertinent text), the Agency stated that it ``agrees with those commenters that expressed the view that, when filling a paper prescription, it is not necessary for a pharmacist who receives an electronic prescription for a controlled substance to check the CSA database in every instance to confirm that the prescribing practitioner is properly registered with DEA.'' Id. The Agency thus removed the requirement from the Interim Final Rule, but ``made clear that a pharmacist continues to have a corresponding responsibility to fill only those prescriptions that conform in all respects with the requirements of the [CSA] and DEA regulations, including the requirement that the prescribing practitioner be properly registered.'' Id. However, as explained above, the corresponding responsibility does not impose strict liability on pharmacists but rather requires proof that a pharmacist filled a controlled-substance prescription either knowing that it was unlawful or with willful blindness or deliberate ignorance of the fact that the prescription was unlawful.\26\ --------------------------------------------------------------------------- \26\ Notwithstanding the Agency's pronouncement in the Interim Rule, the Agency's corresponding responsibility rule is not the only potential basis for finding a violation where a pharmacist dispenses a controlled substance prescription issued by a practitioner who does not hold the requisite authority. Upon a showing that such conduct is outside of ``the usual course of professional practice,'' 21 CFR 1306.06, a pharmacist may be held to have violated DEA regulations and to have committed acts which render her pharmacy's registration inconsistent with the public interest. Moreover, in Medicine Shoppe--Jonesborough, 73 FR 364, 381 (2008), the ALJ found that a pharmacist had filled a large number of controlled-substance prescriptions which were issued by a veterinarian who did not hold either a state license or DEA registration. The ALJ further found that this conduct constituted such other conduct which may threaten public health and safety, reasoning, in part, that a pharmacy has a duty to periodically verify whether a prescriber retains authority to practice medicine and dispense controlled substances. I found a violation of 21 CFR 1306.04(a), based on the evidence that the prescriptions were being presented on a daily basis by the veterinarian's brother and were for drugs that were toxic for certain animals. However, in dictum, I noted that ``[a] pharmacy has a duty to periodically check to see that a practitioner retains the authority to practice medicine and dispense a controlled substance.'' Id. at n.45. I also noted my agreement with the ALJ's reasoning that failing ``to do so could threaten public health and safety because there is usually a good reason for why a practitioner has lost his or her state license and DEA registration.'' Id. The Government does not rely on this theory and no case (until recently) has presented the question of how frequently a pharmacy must re-verify the credentials of prescribers. Nor has the Agency published any guidance to the regulated community setting forth the parameters of this duty. What is clear, however, is that a pharmacy is not required to verify the credentials of the prescriber for every prescription it fills. --------------------------------------------------------------------------- Accordingly, I reject the ALJ's reasoning as contrary to the published guidance of the Agency. And because the Government failed to put forward either: (1) any evidence to show that Ms. Santiago-Soto either knew or was willfully blind to the fact that Dr. Aguilar-Amieva was no longer registered, or (2) any evidence or legal authority establishing that Ms. Santiago-Soto acted outside of the usual course of professional practice, I reject the Government's contention that Respondent violated federal law and DEA regulations in filling these prescriptions. Allegation Two--Respondent's Filling of Suboxone Prescriptions Regarding this allegation, the evidence shows that Respondent filled twenty-nine Suboxone prescriptions, which were issued by Dr. Aguilar-Amieva and Dr. Vargas-Quinones, see GX 4, at 23-24; and Ms. Santiago-Soto admitted that a majority of the prescriptions (17 of the 29) listed ``a diagnosis that is related to the abuse of opioids[] or opiates.'' Tr. 108. It was undisputed that neither Dr. Aguilar-Amieva nor Dr. Vargas-Quinones was qualified to prescribe Suboxone to treat narcotic addiction. See GX 6, at 1 & 5. A physician who seeks to prescribe Suboxone (or other schedule III through V drugs approved by FDA) for maintenance or detoxification treatment must meet certain conditions (including that the physician either holds various certifications or has training or experience in the management of opiate-dependent patients) and must provide a notification (which includes various certifications) to the Secretary of the Department of Health and Human Services, who must then determine (within 45 days from the date of receipt of the notification) whether the physician meets the requirements for a waiver under 21 U.S.C. 823(g)(2)(B). 21 CFR 1301.28(a)-(d). If the practitioner holds ``the appropriate registration'' and the Secretary either makes ``a positive determination'' or fails to act within the 45 day period, DEA issues an identification number, which is otherwise known as an X-number to the practitioner. Id. Sec. 1301.28(d)(1); see also Tr. 48-49. Moreover, under DEA's regulation: A prescription may not be issued for ``detoxification treatment'' or ``maintenance treatment,'' unless the prescription is for a [[Page 29064]] Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with requirements in Sec. 1301.28 of this chapter. 21 CFR 1306.04(c) (emphasis added). So too, pursuant to 21 CFR 1306.05(b), ``[a] prescription for a Schedule III, IV, or V narcotic drug approved by FDA specifically for `detoxification treatment' or `maintenance treatment' must include the identification number issued by the Administrator under 1301.28(d) of this chapter or a written notice stating that the practitioner is acting under the good faith exception of [21 CFR] 1301.28(e).'' \27\ (emphasis added). This information is in addition to the prescriber's DEA registration number. See 21 CFR 1306.05(a). Also, under 21 CFR 1306.05(f), ``[a] corresponding liability rests upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.'' However, none of the Suboxone prescriptions issued by either Dr. Aguilar-Amieva or Dr. Vargas-Quinones bore either an X number or a statement that the physician was ``acting under the good faith exception.'' See GX 3, at 410-456. --------------------------------------------------------------------------- \27\ The good faith exception applies only during the period before the practitioner receives his X-number from the Agency and only if ``[t]he Secretary has not notified the registrant that he/ she is not qualified'' to provide such treatment. 21 CFR 1301.28(e). --------------------------------------------------------------------------- The Government contends that Respondent violated, inter alia, 21 CFR 1306.04 and 1306.06, because it ``does not contest that [it] acted outside the usual course of professional practice'' when it dispensed the Suboxone prescriptions. Gov. Post-Hrng. Br., at 12. Contrary to the Government's understanding, Ms. Santiago-Soto made no such admission and the Government put forward no evidence as to what the usual course of professional practice requires of a pharmacist who is presented with prescriptions that are clearly marked as being issued for the purpose of providing maintenance or detoxification treatment for narcotic- dependent patients and yet are missing the requisite X number or good faith statement. However, the evidence does establish that Ms. Santiago-Soto violated 21 CFR 1306.05(f) when she filled at least seventeen of these prescriptions.\28\ With respect to the seventeen Suboxone prescriptions which contained a notation by the doctor that he had diagnosed the patient as being opioid dependent, Ms. Santiago-Soto knew that the prescriptions were issued to provide either maintenance or detoxification treatment.\29\ Moreover, notwithstanding the clear requirement that the prescriptions include (in addition to the prescriber's DEA number), either his DATA-waiver identification number or the practitioner's statement that he was ``acting under the good faith exception of Sec. 1301.28(e),'' none of the prescriptions contained either an X-number or the good faith statement. --------------------------------------------------------------------------- \28\ While the Government alleged that Respondent violated 21 CFR 1306.04 in filling the Suboxone prescriptions, it did not identify the specific subsection which it alleges was violated. See Gov. Post-Hrng. Br. at 12. Notably, in contrast to subsection a of this regulation, which imposes a corresponding responsibility on a pharmacist to not knowingly fill a prescription that is issued outside of the usual course of professional practice and which lacks a legitimate medical purpose, subsection c impose duties only on the issuer of the prescription which has been issued to provide maintenance or detoxification treatment. See 21 U.S.C. 1306.04(c). However, as explained above, 21 CFR 1306.05(f), imposes ``[a] corresponding liability . . . upon the pharmacist . . . who fills a prescription not prepared in the form prescribed by DEA regulations.'' \29\ I do not find any violations with respect to those prescriptions which did not contain a diagnosis of narcotic dependence. Under federal law, a doctor may prescribe a drug for a legitimate off-label use and absent evidence that the prescriptions, which lacked a diagnosis of narcotic dependence, were actually being issued for this purpose, I do not find a violation proved. The Government offers no argument to the effect that a doctor cannot prescribe Suboxone for any legitimate medical purpose unless they have X-number. Nor did it offer evidence that when a pharmacist is presented with a Suboxone prescription that does not list a diagnosis and lacks an X number, the standards of professional practice require the pharmacist to call the physician and determine the purpose of the prescription. --------------------------------------------------------------------------- In her testimony, Ms. Santiago-Soto maintained that she ``was not aware'' that the X number had to be on the prescription ``for that medication in particular,'' Tr. 110, and that she ``was not aware that buprenorphine [the generic name for Suboxone] fell among the medications that required the X DEA number.'' Id. at 112. However, Ms. Santiago-Soto did know that the purpose of most of the Suboxone prescriptions was to treat narcotic addiction. And as explained above, under the Agency's regulation, a prescription could not be issued for a Schedule III through V controlled substance such as Suboxone for this purpose unless the drug was approved by FDA for this purpose and the practitioner met the requirements for prescribing for this purpose. Accordingly, her testimony does not establish that she made a mistake of fact but rather that she was ignorant of the regulations. This, of course is not a defense. See United States v. International Minerals & Chem. Corp., 402 U.S. 558, 563 (1971) (``The principle that ignorance of the law is no defense applies whether the law be a statute or a duly promulgated and published regulation.''). Indeed, Ms. Santiago-Soto's testimony regarding the allegation was most unpersuasive. More specifically, Ms. Santiago-Soto testified that she had graduated from pharmacy school in 1995, and that the DATA law was passed in 2000, but after 2002, when Suboxone was approved by FDA for the purpose of treating narcotic addiction, ``the DEA in Puerto Rico never has provided any orientation or guidance online, or by way of a conference, or through continuing education, or by letters, letting me know, or providing me these kinds of guidelines.'' Tr. 110.\30\ --------------------------------------------------------------------------- \30\ The Government offered no evidence regarding the contents of the package insert for Suboxone and whether it contained any special instructions regarding the prescribing and dispensing of Suboxone following the FDA's approval of the drug for use in providing maintenance or detoxification treatment. --------------------------------------------------------------------------- However, in 2003, the Agency published in the Federal Register a notice of proposed rulemaking, and in 2005, the Agency published its final rule, which promulgated the various provisions set forth above, including 21 CFR 1301.28 (requirements for obtaining an X-number and the good faith exception), 21 CFR 1306.04(c) (prohibiting a prescription for maintenance or detoxification treatment unless the drug has been approved by FDA for this purpose and the practitioner is in compliance with 1301.28), 21 CFR 1306.05(a) (requiring that such prescription include either the prescriber's X number or a good faith statement), and 21 CFR 1306.07 (allowing a practitioner to administer, dispense or prescribe a Schedule III through V drug specifically approved by FDA for use in maintenance or detoxification treatment if the practitioner complies with 1301.28). See DEA, Authority for Practitioners to Dispense or Prescribe Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment, 70 FR 36338 (2005); see also DEA, Authority for Practitioners to Dispense or Prescribe Approved Narcotic Controlled Substances for Maintenance or Detoxification Treatment, 68 FR 37429 (2003) (Notice of Proposed Rulemaking). Indeed, prior to the 2005 issuance of the final rule, no narcotic controlled substance could be prescribed by a physician (including those authorized to conduct a narcotic treatment program under 21 U.S.C. 823(g)(1)) to treat narcotic addiction and no pharmacy could have lawfully [[Page 29065]] dispensed such a prescription. See id. at 37429. As the 2003 Notice of Proposed Rulemaking explained: [t]he Controlled Substances Act (CSA) and current regulations requires that practitioners who want to conduct maintenance or detoxification treatment using narcotic (opioid) controlled drugs be registered with DEA as narcotic treatment programs (NTPs) in addition to the practitioners' personal registrations. The separate NTP registrations authorize the practitioners to dispense or administer, but not prescribe narcotic (opioid) controlled drugs. Id. The Notice also observed that ``[o]n October 8, 2002, FDA approved two products containing buprenorphine, [S]ubutex and [S]uboxone, Schedule III controlled drugs, for use in maintenance and detoxification treatment,'' and that the proposed rule would ``[p]ermit pharmacies to fill prescriptions for Schedule III, IV, and V narcotic (opioid) controlled drugs approved by FDA specifically for use in maintenance or detoxification treatment.'' Id. at 37430. The dispensing of controlled substances is a highly regulated industry, and as a participant in this industry, Ms. Santiago-Soto is properly charged with knowledge of the applicable regulations, including: (1) The requirement that a Suboxone prescription, which has been issued to provide treatment for opiate addiction, can only be issued by a person who meets the requirements of 21 CFR 1301.28; as well as (2) that the prescription must bear either the prescriber's X- number or the good faith statement. See International Minerals, 402 U.S. at 565 (where ``dangerous or deleterious . . . products . . . are involved, the probability of regulation is so great that anyone who is aware that he is in possession of them or dealing with them must be presumed to be aware of the regulation''); United States v. Southern Union Co., 630 F.3d 17, 31 (1st Cir. 2010) (``[T]hose who manage companies in highly regulated industries are not unsophisticated. It is part of [their] business to keep abreast of government regulation.'') (citing United States v. Lachman, 387 F.3d 42, 56-57 (1st Cir. 2004)), rev'd on other grounds, 132 S.Ct. 2344 (2012). I therefore find that Ms. Santiago-Soto knowingly dispensed the seventeen Suboxone prescriptions which were issued for maintenance or detoxification purposes in violation of federal law by the respective physicians and thus also violated federal law in doing so. 21 CFR 1306.04(c); see also 21 U.S.C. 841(a)(1). While it is true, as Ms. Santiago-Soto testified, that the amounts of most of the prescriptions were limited (most being for ten tablets or less), there were also two prescriptions for sixty tablets issued to the same patient, which contained a diagnosis of opiate dependence. Thus, I am not persuaded by her testimony ``that the amounts are not such that would raise my suspicions that something is running amok.'' Tr. 109-10. However, Ms. Santiago-Soto testified that she had become aware of the DATA of 2000 during an audit by a health insurance plan, which occurred months before she was arrested and surrendered her registration, and that she then went online and familiarized herself with the statute's requirements. Tr. 112. Most significantly, the Government's own evidence shows that Respondent dispensed the last Suboxone prescription on July 3, 2011, nearly five months before Ms. Santiago-Soto was arrested and surrendered its registration.\31\ See GX 4, at 23-24. Finally, in her testimony, Ms. Santiago-Soto demonstrated some degree of knowledge of the requirements pertaining to the prescribing of Suboxone to identify those prescriptions which do not comply with the DATA requirements and should not be dispensed. Tr. 110. --------------------------------------------------------------------------- \31\ It is also noted that Respondent had stopped dispensing these prescriptions two months before a DEA inspection which occurred on September 7, 2011. See RX H. While DEA had also inspected Respondent on September 2, 2010, see RX G, as of that date, Respondent had dispensed but a single prescription (only three days earlier) for fourteen tablets. GX 4, at 23-24. No evidence was put forward by the Government as to whether this prescription was discussed with Ms. Santiago-Soto. --------------------------------------------------------------------------- Thus, while I conclude that the Government has proved that Respondent committed acts which are ``inconsistent with the public interest,'' 21 US.C. Sec. 823(f), I also find that there are several factors which mitigate the violations. Sanction Under Agency precedent, where, as here, ``the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must `` `present sufficient mitigating evidence to assure the Administrator that it can be entrusted with the responsibility carried by such a registration.' '' '' Medicine Shoppe- Jonesborough, 73 FR 364, 387 (2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting Leo R. Miller, 53 FR 21931, 21932 (1988))). ``Moreover, because `past performance is the best predictor of future performance,' ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.1995), [DEA] has repeatedly held that where a registrant has committed acts inconsistent with the public interest, the registrant must accept responsibility for its actions and demonstrate that it will not engage in future misconduct.'' Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853; John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419 F.3d at 483 (``admitting fault'' is ``properly consider[ed]'' by DEA to be an ``important factor[]'' in the public interest determination). While a registrant must accept responsibility and demonstrate that it will not engage in future misconduct in order to establish that its registration is consistent with the public interest, DEA has repeatedly held these are not the only factors that are relevant in determining the appropriate sanction. See, e.g., Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and extent of a registrant's misconduct are significant factors in determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386, 19387-88 (2011) (explaining that a respondent can ``argue that even though the Government has made out a prima facie case, his conduct was not so egregious as to warrant revocation''); Paul H. Volkman, 73 FR 30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369 (2010) (imposing six-month suspension, noting that the evidence was not limited to security and recordkeeping violations found at first inspection and ``manifested a disturbing pattern of indifference on the part of [r]espondent to his obligations as a registrant''); Gregory D. Owens, 74 FR 36751, 36757 n.22 (2009). So too, the Agency can consider the need to deter similar acts, both with respect to the respondent in a particular case and the community of registrants. See Gaudio, 74 FR at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406 F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of ``deterrence, both specific and general, as a component in analyzing the remedial efficacy of sanctions''). As found above, the only allegation sustainable on the record is that Respondent filled seventeen Suboxone prescriptions that were issued to provide maintenance or detoxification treatment by two physicians who were not DATA-waived physicians. As explained above, I find that Ms. Santiago knowingly violated federal law by dispensing these prescriptions because the purpose of the prescriptions was clearly identified on them and none of the prescriptions had the physician's [[Page 29066]] identification number or the requisite good faith statement. Moreover, the Government's interest in deterring pharmacists from dispensing Suboxone prescriptions, which have been issued to treat narcotic- dependent patients by physicians, who lack the requisite qualifications to treat such patients, is manifest. Regarding these violations, Respondent's evidence of its acceptance of responsibility was less than unequivocal. While Ms. Santiago-Soto admitted that she was aware that the prescriptions were issued to treat substance abuse patients and that she should have learned about the requirements applicable to the prescribing of Suboxone for this purpose earlier than she did, she also attempted to minimize her misconduct by attributing it to the failure of the DEA office in Puerto Rico to provide any guidance to her regarding the requirements. DEA did, however, publish, in the Federal Register, both a Notice of Proposed Rulemaking and a Final Rule, which provided legally sufficient notice that Suboxone could only be prescribed for maintenance or detoxification purposes by a qualified physician, and that such a physician was required to either list his identification number or provide a good faith statement on the prescriptions. Yet, while Ms. Santiago-Soto is presumed to have knowledge of the applicable regulations and thus violated federal law in dispensing those Suboxone prescriptions which bore a diagnosis indicating that they were issued to treat narcotic addiction, the egregiousness of her misconduct is diminished by two factors. First, the violations were limited in scope, as the total amount of the unlawful dispensings was 224 tablets. Second, Ms. Santiago-Soto had determined, prior to the Agency's bringing it to her attention, that the Suboxone prescriptions were illegal, and at the time she surrendered Respondent's registration, had long since ceased the offending practice.\32\ --------------------------------------------------------------------------- \32\ In rejecting Respondent's evidence of remediation, the ALJ faulted Ms. Santiago-Soto for testifying that DEA ``maintained information on its Web site that is contradictory to what the Diversion Investigator said during the hearing.'' R.D. at 29. Given that the ALJ improperly precluded Respondent from using a printout from the Agency's Web site to impeach the DI, there is no basis for this finding. The ALJ further found that there is ``scant evidence that Ms. Santiago-Soto has engaged in a course of conduct that would ensure that she remains properly informed about changes in DEA controlled substance regulations.'' Id. at 30. Continuing, he explained that ``[t]here was no suggestion that she would accept responsibility for keeping up with changes in the DATA-waived list in the future, for example.'' Id. There is, however, no evidence in the record that a DATA-waived list exists, whether maintained by DEA or any other agency. It may be that the ALJ actually meant to say that he does not believe that Ms. Santiago-Soto will properly verify that the issuers of Suboxone prescriptions for addiction treatment will have the requisite qualifications. If this was the ALJ's intent, it is refuted by his acknowledgment--one page earlier in his decision--of Ms. Santiago-Soto's testimony that she would subscribe to the NTIS service and that ``[t]his would appear to be an effective remedial step [which] possibly could lessen the risk of filling prescriptions for Suboxone if the prescribing provider was not a DATA-waived'' physician. Id. at 29. (Indeed, I have taken official notice that the DEA registration validation web-tool provides this information. See 21 CFR 1316.59(e)). Moreover, the ALJ entirely ignored Ms. Santiago- Soto's testimony (which is corroborated by the Government's evidence), that following the audit by a health plan, she reviewed the requirements applicable to prescribing Suboxone to treat narcotic addiction, and the evidence that she had ceased dispensing the Suboxone prescriptions long before DEA raised this as an issue with her. See R.D. at 29-30. --------------------------------------------------------------------------- In its Exceptions, Respondent argues that the ALJ's recommended sanction of denial ``is drastic and overly broad.'' Exceptions at 15. It argues, inter alia, that the Agency ``could grant a license with a monetary sanction or provide in its determination that it can be issued after a determined period of additional time''; it also argues that it ``is willing to undertake and place into action any diverse measures the DEA requires as a condition for approving the'' application. Id. at 16. ``Proceedings under sections 303 and 304 of the CSA are . . . non- punitive.'' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (citing Leo R. Miller, 53 FR 21931, 21932 (1988)). As the Agency previously recognized, ``this proceeding `is a remedial measure, based upon the public interest and the [need] to protect the public from those individuals who have misused their'' registrations and ``who have not presented sufficient mitigating evidence to assure the Administrator that they can be entrusted with the responsibility'' attendant with holding a registration. Id. (quoting Miller, 53 FR at 21932). I agree with Respondent that the outright denial of its application is not supported by the record and that its application can be granted ``after a determined period of additional time,'' subject to Respondent meeting various conditions. First, while I acknowledge Ms. Santiago- Soto's testimony as to the steps she took to familiarize herself with the requirements pertaining to the prescribing of Suboxone, she also testified that while she reviews a prescription to ensure that it meets legal requirements and is not suspicious, she does not ``speak with the doctors'' because ``[t]here is a confidentiality law between doctor and patient.'' Tr. 117. While the Government did not address the validity of this statement in its post-hearing brief, it is flatly inconsistent with long-standing authority setting forth the scope of a pharmacist's corresponding responsibility under the Controlled Substances Act. See, e.g., United States v. Hayes, 595 F.2d 258, 260 (5th Cir. 1979); see also Medicine Shoppe--Jonesborough v. DEA, 300 Fed. App'x 409, 412 (6th Cir. 2008) (quoting Ralph J. Bertolino, 55 FR 4729, 4730 (1990) (`` `When [pharmacists'] suspicions are aroused as reasonable professionals,' they must at least verify the prescription's propriety, and if not satisfied by the answer they must `refuse to dispense.' '')). Accordingly, I will order that Ms. Santiago-Soto take a course on controlled substance dispensing and the corresponding responsibility of a pharmacist under federal law. Said course must be completed and a certificate of such completion must be presented to the Agency prior to the granting of Respondent's application. I will further order that Respondent's application be held in abeyance for six months from the date of this order (not the date of publication) at which time, its application shall be granted provided Respondent has provided evidence to DEA that Ms. Santiago-Soto has completed the above-described course and commits no violation of federal or commonwealth controlled substance laws. If, however, Ms. Santiago-Soto fails to provide evidence that she has completed such course within the six-month period, Respondent's application shall be denied. Upon the granting of the registration, Respondent shall be placed on probation for a period of three years. During the period of the probation, Respondent and its principal shall agree to consent to unannounced inspections by DEA personnel and shall waive its right to require DEA personnel to obtain an Administrative Inspection Warrant prior to conducting an inspection. Ms. Santiago-Soto shall provide a letter to DEA manifesting Respondent's consent to unannounced inspections by DEA and waiving its right to require DEA personnel to obtain an Administrative Inspection Warrant prior to the issuance of its registration. Respondent shall provide a copy of its controlled substance dispensing log on a quarterly basis to the DEA Ponce Office. Said quarters shall end on March 31st, June 30th, September 30th, and December 31st of each year, and the log shall be provided to the DEA Ponce Office no later than ten (10) calendar [[Page 29067]] days following the last day of each quarter. Respondent and Ms. Santiago-Soto shall notify the DEA Ponce Office of any disciplinary action undertaken against its pharmacy license and Puerto Rico controlled substance registration, as well as any action taken against Ms. Santiago-Soto's pharmacist license, including the initiation of any proceeding by the Commonwealth's authorities to suspend or revoke any of the licenses or registration. Such notification shall occur no later than three business days following service on Respondent or Ms. Santiago-Soto of any document initiating such a proceeding, any interim or emergency order of suspension, and any final order. The above conditions shall terminate upon Respondent's completion of the period of probation, provided Respondent fully complies with each term of its probation. Any violation of these conditions shall constitute an act inconsistent with the public interest and grounds for the suspension or revocation of Respondent's registration. Order Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well as 28 CFR 0.100(b), I order that the Application of Farmacia Yani be, and it hereby is, held in abeyance for a period of six months to begin on the date of this ORDER. I further order that upon the conclusion of the six-month period, the Application of Farmacia Yani shall be granted or denied as set forth above. I also order that in the event that Ms. Santiago-Soto complies with the condition that she complete a course in controlled substance dispensing and the corresponding responsibility, Farmacia Yani's Application shall be granted subject to the probationary conditions set forth above. This ORDER is effective immediately. Dated: May 12, 2015. Michele M. Leonhart, Administrator. [FR Doc. 2015-12130 Filed 5-19-15; 8:45 am] BILLING CODE 4410-09-P
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the experience of the applicant in dispensing insufficient evidence of remediation. Thereafter, an Administrative Law Judge
controlled substances is of such character Accordingly, the Government has established (ALJ) proceeded to conduct pre-hearing
and quality that registration is not in the cause to deny this application. procedures. ALJ Ex. 3.
public interest. This requires evidence of
both the qualitative manner and quantitative Recommendation In its Supplemental Prehearing
volume of the applicant’s experience. Where As the Government has established its Statement, the Government provided
evidence of the applicant’s experience, as prima facie case by at least a preponderance notice to Respondent that it intended to
expressed through its employees and officers, of the evidence, the Respondent’s application elicit testimony from an Agency
establishes that the business plan provides for a retail-pharmacy DEA Certificate of Diversion Investigator (DI) that
for the active daily involvement of no one Registration should be DENIED. Respondent had ‘‘filled twenty-nine (29)
having experience applying DEA controlled Dated: April 23, 2013. prescriptions for Suboxone that were
substance diversion regulations in a retail
pharmacy setting, and provides only for the Christopher B. McNeil, written by two doctors who did not
involvement of an employee familiar with Administrative Law Judge. possess authority to issue these
the regulations applicable to Registered [FR Doc. 2015–12131 Filed 5–19–15; 8:45 am]
controlled substances,’’ that the
Nurses whose duties include dispensing ‘‘prescriptions were written by Dr.
BILLING CODE 4410–09–P
medication, in such an application there is Aguilar-Amieva and Dr. Cesar I. Vargas-
sufficient evidence proving, by at least a Quinones,’’ and that a review of ‘‘the
preponderance, that granting such an DEA registration database . . . found
application would be inconsistent with the DEPARTMENT OF JUSTICE
that these two physicians were never
public interest.
4. When proposing to deny a retail- Drug Enforcement Administration registered with DEA as data-waived
pharmacy application under Factor Two practitioners, in violation of 21 CFR
[Docket No. 13–31] 1301.28.’’ ALJ Ex. 7, at 3. The
based on the prior association and dispensing
history of a third party, the Government must Farmacia Yani; Decision and Order Government also provided notice that it
demonstrate that the third party’s past intended to question Respondent’s
negative experience in dispensing controlled On April 10, 2013, the Deputy owner ‘‘about the circumstances of the
substances warrants a finding that his or her Assistant Administrator, Office of pharmacy’s prior surrender of its . . .
association with the applicant would be Diversion Control, Drug Enforcement registration, and about her failure to
inconsistent with the public interest. Where,
Administration, issued an Order to note the previous surrender on
as here, the third party is the husband of the
applicant’s majority shareholder but has no Show Cause to Farmacia Yani Respondent’s new application for
clearly demonstrated role in either the (Respondent), of San Sebastian, Puerto registration.’’ Id.
corporation (as a shareholder or an officer), Rico. ALJ Ex. 1. The Show Cause Order On July 16, 2013, the ALJ conducted
or in the retail pharmacy (as an employee or proposed the denial of Respondent’s an evidentiary hearing in Guaynabo,
manager), and where there is insufficient application for a DEA Certificate of Puerto Rico.1 Tr. 27. At the hearing, the
evidence demonstrating the third party’s past Registration as a retail pharmacy, on the
negative experience will have any impact on ground that its registration ‘‘would be 1 On June 18, 2013, the ALJ had conducted the
the operation of the retail pharmacy, the inconsistent with the public interest, as first day of the hearing, during which he reviewed
Government has not met its burden of
that term is defined in 21 U.S.C. 823(f).’’ the parties’ proposed stipulations and admitted
proving a basis to deny the application under several documents into the record, while holding
Factor Two. Id. at 1.
the admission of two Government exhibits in
5. In order to establish a basis for denying The Show Cause Order specifically abeyance. See Tr. 4–14 (June 18, 2013). After
a new application for a retail-pharmacy alleged that on March 27, 2012, Respondent’s counsel objected to the admission of
Certificate of Registration based on the Respondent submitted an application some of the Government’s exhibits because they
provisions of 21 U.S.C. 823 (f)(5) (Factor for a registration as a retail pharmacy, contained prescriptions issued by a doctor whose
prescriptions were not the basis of what it had
Five), the Government must present evidence seeking authority to dispense controlled previously alleged, the Government announced that
establishing, by at least a preponderance, substances in schedules II through V, at it would be filing a supplemental prehearing
other conduct (i.e., conduct not covered a location in San Sebastian, Puerto Rico. statement during which it would ‘‘outline that the
within the scope of Factors One through Government discovered some prescriptions by Dr.
Id. The Order further alleged that
Four) which may threaten the public health Cesar Vargas-Quinones.’’ Id. at 14. After the ALJ
and safety. Where, as here, the evidence Respondent held a registration at the ruled that these exhibits would ‘‘be held in
establishes that when called upon by DEA same location, which it ‘‘had abeyance until after we’ve had the opportunity to
investigators to identify the person or surrendered for cause on December 2, see what the Government sets forth in its
2011,’’ and that a DEA investigation supplemental prehearing statement,’’ the ALJ
persons who would be familiar with DEA explained that the deadline for both parties to file
diversion control regulations and would be found ‘‘that from February 2009 through their supplemental prehearing statements would
present at the retail pharmacy to ensure November 2011, [it] filled ‘‘be simultaneous’’; the ALJ also told Respondent’s
compliance with those regulations, the approximately 218 prescriptions for counsel that ‘‘you really won’t have a chance to
applicant’s sole officer and both of its two controlled substances issued by a reply in your—in your response in the prehearing
shareholders made material statement,’’ but that she would be able ‘‘to object
medical doctor who did not possess a to these exhibits during the hearing itself.’’ Id. at
misrepresentations about having such person
or persons present, there is substantial valid DEA registration, in violation of 15–16. Notably, during the June 18 hearing, the
evidence of conduct that may threaten the Federal law and regulations.’’ Id. (citing Government made no mention of its intent to raise
21 U.S.C. 843(a)(2); 21 CFR 1306.04). the material falsification issue. Moreover, the ALJ
public health and safety. In such an subsequently ordered that the parties file any
application there is sufficient evidence The Government then alleged that supplemental prehearing statements with the Office
proving, by at least a preponderance, that Respondent’s ‘‘violations of Federal law of Administrative Law Judges ‘‘not later than 2:00
granting such an application would be and regulations render granting its p.m. on the 9th of July 2013.’’ Id. at 18–19.
inconsistent with the public interest. The same day, the ALJ also issued an Order
mstockstill on DSK4VPTVN1PROD with NOTICES
application for a [registration]
6. Upon such evidence, the Government memorializing these instructions. See Order (June
inconsistent with the public interest.’’ 18, 2013). Therein, the ALJ further instructed that
has met its burden and has made a prima
Id. (citing 21 U.S.C. 823(f) and 824(a)). ‘‘[a]fter this deadline, Prehearing Statements may
facie case in support of the proposed order
denying the Respondent’s application for a On May 10, 2013, Respondent, only be supplemented upon the filing of a motion
through its counsel, requested a hearing for extension of time and after a favorable ruling by
retail-pharmacy Certificate of Registration. me. Any new documents identified in a
7. Upon a review of the record as a whole, on the allegations and the matter was supplemental prehearing statement also need to be
including all claims made in the placed on the docket of the Office of exchanged by the parties no later than July 9,
Respondent’s post-hearing brief, there is Administrative Law Judges. ALJ Ex. 2. 2013.’’ Id. at 4.
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Government elicited the testimony of a whose registration had expired, and application which is at issue in this
DI and Ms. Yanira Santiago-Soto, these errors solely affect these two proceeding.
Respondent’s owner and pharmacist in allegations, I conclude that a remand is On the application, Respondent was
charge; Respondent also elicited the not warranted. While I agree with the required to answer four questions. Id. at
testimony of Ms. Santiago-Soto. Both ALJ’s legal conclusion that Respondent 1. The second of these asked: ‘‘Has the
parties also introduced documentary violated federal law when it dispensed applicant ever surrendered (for cause) or
evidence into the record. Following the Suboxone prescriptions, which were had a federal controlled substance
hearing, both parties submitted briefs issued to provide maintenance or registration revoked, suspended,
containing their proposed findings of detoxification treatment and the restricted or denied, or is any such
fact, conclusions of law, and argument. prescribers lacked the requisite action pending?’’ GX 1, at 1. Ms.
On September 26, 2013, the ALJ authority to prescribe the drug for this Santiago-Soto answered the question by
issued his Recommended Decision purpose, I do not find that the record as checking the ‘‘no’’ box. Id. The fourth
(hereinafter, cited as R.D.) Therein, the a whole supports the proposed outright question asked, in relevant part:
ALJ found that the Government had denial of the Application. Accordingly, If the applicant is a corporation (other than
established a prima facie case that I will order that Respondent be granted a corporation whose stock is owned and
granting Respondent’s application a registration subject to conditions set traded by the public), association,
‘‘would be inconsistent with the public forth in this decision. I make the partnership, or pharmacy, has any officer,
interest.’’ R.D. 36. The ALJ further found following findings of fact. partner, stockholder or proprietor been
that Respondent had ‘‘failed to rebut’’ convicted of a crime in connection with
the Government’s case. Id. The ALJ thus Findings controlled substance(s) under state or federal
law, or ever surrendered or had a federal
recommended that Respondent’s Respondent’s License and Registration controlled substance registration revoked,
application be denied. Status suspended, restricted or denied, or ever had
Respondent filed Exceptions to the a state professional license or controlled
Recommended Decision. Having Respondent is a corporation which substance registration revoked, suspended,
reviewed Respondent’s Exceptions owns a retail pharmacy located at denied, restricted, or placed on probation, or
along with the entire record, I find that Carretera 109, Kilometer 26.7, Barrio is any such action pending?
several of them are well taken and that Culebrina, San Sebastian, Puerto Rico. Id. Respondent also answered this
the ALJ committed multiple prejudicial Tr. 9; GX 1. Ms. Yanira Santiago-Soto is question, by checking the ‘‘no’’ box. Id.
errors. These include: the owner of Respondent and its
(1) Barring Respondent from using a pharmacist-in-charge. Tr. 106. The Investigation of Respondent
document, which, according to Respondent is licensed as a pharmacy Following Ms. Santiago-Soto’s
Respondent’s offer, was from DEA’s by the Commonwealth of Puerto Rico submission of Respondent’s application,
Web site, to impeach a Government Department of Health; this license does a Diversion Investigator with the Ponce,
witness, because it was not submitted in not expire until June 26, 2015. RX D1, Puerto Rico DEA Office was assigned to
advance of the hearing; at 3. Respondent also holds a controlled investigate the application. Tr. 40–41.
(2) barring Respondent from substance registration, which was also Upon doing so, the DI determined that
introducing evidence of an email its issued by the Commonwealth’s on November 30, 2011, a search warrant
principal sent to an Agency Investigator Department of Health.2 RX E4. had been executed at Respondent
the day after she submitted the Respondent previously held DEA during which various items of evidence,
application, which according to Certificate of Registration FF1070894, including prescriptions, were seized. Id.
Respondent’s offer, memorialized a pursuant to which it was authorized to at 43. Some of the evidence was sent to
phone conversation in which she asked dispense controlled substances in the DEA digital evidence laboratory for
if she had correctly answered an schedules II through V. GX 5, at 1. further analysis; according to the DI, the
application question, also on the ground While this registration was not due to lab extracted various data and sent a CD
that it was not submitted in advance of expire until September 30, 2014, on containing the data to his office. Id. at
the hearing, notwithstanding that the November 30, 2011, Ms. Santiago-Soto 44. In addition, prescriptions were
Government did not even disclose that surrendered Respondent’s seized from Respondent and scanned by
it was pursuing the material falsification registration.3 Id.; see also RX I. On the Ponce DEA office. Id.
allegation until one week before the March 26, 2012, Ms. Santiago-Soto Upon reviewing the data provide by
hearing; and applied on Respondent’s behalf for a the digital evidence lab, the DI
(3) finding that Respondent’s determined that ‘‘there were two main
new registration. GX 1, at 1–2. It is this
principal materially falsified its violations.’’ Id. at 46. According to the
application based on the answer she 2 According to the certificate, the registration was
DI, the first set of violations involved
gave to Question Four when the due to expire on September 30, 2013. RX E, at 4.
Respondent’s having ‘‘illegally filled’’
Government never provided notice that 3 The day before, Ms. Santiago-Soto had been some ‘‘241 prescriptions’’ which were
the answer to this question was at issue indicted along with thirty-two other defendants, on issued by a Doctor Hector J. Aguilar-
in the Show Cause Order, its pre- two felony counts of violating the Controlled Amieva after the latter’s registration was
hearing statements, or its opening Substances Act. The charges were: (1) Conspiring to retired by DEA on January 31, 2009 and
possess and dispense, with intent to distribute,
statement, nor even questioned her various controlled substances, in violation of 21 ‘‘he was no longer authorized to
about her answer to this question, even U.S.C. 841(a)(1), 846, and 860; and (2) aiding and prescribe any controlled substances. Id.
though it called her to testify in its case- abetting each other and ‘‘knowingly and at 46–47; see also GX 6 (affidavit of
intentionally possess[ing] and dispens[ing] with
mstockstill on DSK4VPTVN1PROD with NOTICES
in-chief. Chief, Registration and Program Support
intent to distribute various’’ schedule II through IV
Because I reject the ALJ’s legal controlled substances, ‘‘outside the scope of Section, Drug Enforcement
conclusions that Respondent’s principal professional practice and not for a legitimate Administration, stating that Dr. Aguilar-
materially falsified its application and medical purpose,’’ in violation of 21 U.S.C. Amieva’s registration expired on June
that Respondent violated its 841(a)(1) and 18 U.S.C. 2. RX B, at 1–13. Several 30, 2008 and was retired from the DEA
months later, the Government moved to dismiss the
corresponding responsibility under 21 charges with prejudice, and on March 23, 2012, the computer system on January 31, 2009).
CFR 1306.04(a) when it dispensed District Court entered a Judgment of Dismissal. RX As for the second set of violations, the
prescriptions issued by a physician C. DI stated that they involved
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Respondent’s having filled twenty-nine the applicant is dispensing controlled ‘‘[t]hat is new to me.’’ Id. Respondent’s
prescriptions issued by both Dr. substances. counsel then asked if he could show a
Aguilar-Amieva and Dr. Cesar Vargas- Id. at 72–73. Respondent’s counsel then document to the DI which, according to
Quinones for Suboxone asked if anyone had found that Ms. the proffer, was from the Agency’s Web
(buprenorphine). Tr. 47, 49. According Santiago-Soto ‘‘has violated any federal site and was contrary to the DI’s
to the DI, the prescriptions were law in dispensing those prescriptions testimony. Id. at 76–78. The ALJ barred
unlawful because the doctors ‘‘were not that are part of the evidence here Respondent’s counsel from doing so
authorized to’’ prescribe Suboxone today?’’ Id. at 73. The Government even for the purpose of impeachment,
(buprenorphine) ‘‘because they were not objected on the ground that the question explaining that his prehearing orders
DATA-waived 4 practitioners.’’ Id. at 48. ‘‘ha[d] been asked and answered’’ and were clear that if documents ‘‘were not
The DI further explained that a DATA- the ALJ sustained the objection, noting presented to the Government, in
waived practitioner is a physician who that he knew that the charges were advance of the hearing,’’ he would not
is approved by ‘‘the Center of Substance dismissed and that there was no ‘‘allow it.’’ Id. at 77.
Abuse’’ (actually, the Center for evidence that Ms. Santiago-Soto had Respondent’s counsel then asked the
Substance Abuse Treatment, a been convicted of any federal offense.5 DI if, in order to verify a DEA number,
component of the Substance Abuse and Id. one had to pay for a program. Id. at 78–
Mental Health Services Administration) Respondent’s counsel then asked the 79. The DI answered that this was
to prescribe Suboxone (buprenorphine) DI if there was any official Web site or correct but that that ‘‘if there are [sic]
to treat narcotic addiction and that these registry where a pharmacist can verify if any reason to verify, you can call our
physicians are issued ‘‘a specific a DEA number is active. Id. at 74. The office at any time, and you can ask for
registration that is distinguished with an DI testified that there is such a registry, a verification.’’ Id.; see also id. at 92.
X number,’’ which ‘‘should be on the that he ‘‘believe[d]’’ that the registry was Next, when asked if ‘‘the law requires
prescription[s]’’ they issued for these available in 2009 through 2011 and was that any dispensing pharmacist calls the
drugs. Id. at 49. However, none of these located at the DEA Diversion Web site, DEA to verify if a physician’s license is
prescriptions bore an X number (even and that he believed that if a person was active,’’ the DI answered ‘‘yes.’’ Id. at
though seventeen of the twenty-nine registered, they could access the Web 79. When then asked what statute or
prescriptions listed a diagnosis of opiate site. Id. Subsequently, the DI testified agency regulation requires this, the DI
addiction or dependence). Id. at 49–50; that he could confirm that the registry could not identify one. Id. at 79–80.
see also GX 3, at 410–56. has been available since 2009, but ‘‘[t]o Moreover, the DI then testified that
The DI further testified that [his] knowledge . . . physicians have there is no law or regulation that
Respondent’s application contained a been informed at least from 2010, [and] requires a pharmacy to subscribe to the
falsification because in answering that she should have been able to do database provided by the National
‘‘[q]uestion [n]umber 3,’’ Ms. Santiago- that.’’ Id. at 75–76. However, later in his Technical Information Service. Id. at 80.
Soto failed to disclose that the testimony, Government counsel raised Still later, when asked if ‘‘it is the
pharmacy had previously surrendered the possibility that this service had been responsibility of the doctor [to have] a
its registration. Tr. 45. While the DI was discontinued, when he asked the DI: valid DEA license when prescribing a
not present when Ms. Santiago-Soto ‘‘But you’re not aware of when it controlled substance,’’ the DI answered:
surrendered Respondent’s registration, started, and when it stopped?’’ and the ‘‘It is the responsibility of both the
he testified that he had read a report doctor and the pharmacist. The
DI answered: ‘‘That is correct.’’ Id. at 92.
Respondent’s counsel then asked the pharmacy has the responsibility.’’ Id. at
that stated that she ‘‘voluntarily
DI ‘‘why the DEA site, as of today, states 86–87. The DI then acknowledged that
surrendered the pharmacy’s license’’
that you cannot verify a DEA number the prescriptions in Government Exhibit
and that he had also seen the document
online?’’ Id. at 76. The DI replied: 3 contained the required information
that she signed, and that the document
and that he could not identify a
said that she ‘‘voluntarily surrendered’’
prescription that was ‘‘suspicious or
the registration. Id. at 60–61. The DI 5 Contrary to the ALJ’s understanding, this was an
undue restriction on Respondent’s right of cross- irregular without knowing that the
further explained that based on the
examination, especially given that the answer was physician’s license has been revoked or
inconsistencies between what he read in not responsive. expired.’’ Id. at 87–88. However, on re-
the report and the answers to the Later in the proceedings, the Government called direct examination, the DI explained
application’s questions, he concluded Respondent’s owner in its case-in-chief. Id. at 106.
During cross-examination, the Government objected that the Suboxone prescriptions were
that Ms. Santiago-Soto had falsified the suspicious because they did not include
to Ms. Santiago-Soto’s testimony (well after the
application. Id. at 62–63. question was asked and well into her answer) an X number for the physician. Id. at
Later, on cross-examination, the DI regarding a conversation she had in April 2012 with 90–91.
conceded that the criminal charges the group supervisor on the ground that it was
Respondent’s counsel then asked
which were filed against Ms. Santiago- ‘‘[o]utside the scope of the pre-hearing statement’’
and ‘‘[t]here [was] no proffer that they were going whether he had ‘‘any evidence’’ that Ms.
Soto were voluntarily dismissed with to be introducing testimony from DEA agents.’’ Tr. Santiago-Soto ‘‘ha[d] acted with the
prejudice. Id. at 72. Moreover, when 134. The ALJ sustained the objection on the ground intention or knowledge’’ in dispensing
asked whether Ms. Santiago-Soto had that ‘‘it goes beyond the scope of what you
either Dr. Aguilar’s or Dr. Vargas’
violated any federal law or regulation, informed in the amended pre-hearing statement.’’
Id. prescriptions. Id. at 88. The DI answered
the DI answered: that he did not ‘‘base [his] evaluations
Here again, the ALJ erred in sustaining the
The conclusion, once again, is based on objection. Even if Respondent’s pre-hearing on intentions’’ but ‘‘on the documents’’
our records, what I see in the records, and statements did not disclose that Ms. Santiago-Soto
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that he had ‘‘seen.’’ Id.
it’s based on the evidence. Whenever an would testify regarding this issue, its pre-hearing
statement only limited the scope of what she could
Also on redirect, the DI was asked
application is submitted to the DEA, and we whether part of the process of granting
testify to on direct examination in Respondent’s
are required to analyze this application, and
case-in-chief and had no bearing on the appropriate the applications of pharmacies involves
based on the pharmacy’s, for example, that scope of cross-examination given that Ms. Santiago- ‘‘explaining to the pharmacies that they
Soto was still testifying as a Government witness.
4 See Drug Addiction Treatment Act of 2000, Pub. Moreover, the Government did not argue that the
have the burden to verify all
L. 106–310, Div. B, Title XXXV, § 3502(a), 114 Stat. testimony was beyond the scope of its direct prescriptions.’’ Id. at 91. The DI
1222 (2000) (codified at 21 U.S.C. 823(g)(2)). examination. answered ‘‘that is correct,’’ and agreed
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that this is a requirement for that the indications are correct, are the this purpose until 2002. Id. She then
maintaining a DEA registration ‘‘under adequate ones, that they meet all standards contended that ‘‘the DEA in Puerto Rico
the code of regulations.’’ Id. and legal requirement [sic], whether they be never has provided any guidance to her
Still later in his testimony, when no federal or state laws. whether through an orientation or
question was pending, the DI proceeded Once all those standards are met, and there
is no question surrounding the prescription
conference, online guidance, or by
to state that even aside from the that might prompt me to call the physician letters.’’ Id. She further asserted that in
Suboxone prescriptions, the 241 for whatever reasons, then we proceed to none of the continuing education
prescriptions at issue were suspicious dispense it. classes that she was required to take to
because they were for oxycodone and maintain her pharmacist license was
alprazolam, which are highly abused Id. at 107–8.
Ms. Santiago-Soto then acknowledged there any training offered by DEA on the
drugs. Id. at 95–96. The DI then DATA’s requirements. Id. at 111.
explained that ‘‘if physicians regularly that Respondent filled the twenty-nine
Suboxone prescriptions issued by Drs. Ms. Santiago-Soto testified that she
prescribe those drugs only, those should did not become aware of the DATA’s
be of concern to any pharmacist who is Aguilar-Amieva and Vargas-Quinones
and that she was not aware that neither requirements until Respondent was
. . . trying to ensure the public health audited by a health insurance plan and
and safety.’’ Id. at 96. The Government doctor was a DATA-waiver physician.
Id. at 108. When asked whether the buprenorphine prescriptions were
did not produce any evidence, however, discussed with her.8 Id. at 112.
to show that these were the only drugs Respondent had ever contacted the two
doctors to verify the purpose of these However, she acknowledged that she
which were being prescribed by Dr. should have learned of these
Aguilar-Amieva and being filled by prescriptions, Ms. Santiago-Soto
answered: requirements earlier. Id. at 114. After
Respondent. describing what she was taught at
The Government also called Ms. I verified the exhibit that you . . . gave
pharmacy school about spotting
Santiago-Soto as a witness. Tr. 105. Ms. me. . . And if you take a look at the
Suboxone prescriptions, in their majority, diversion, id. at 114–16, the
Santiago-Soto acknowledged that she
they have a diagnosis that is related to the Government asked Ms. Santiago-Soto
has been Respondent’s owner and
abuse of opioids, or opiates. whether she found ‘‘anything suspicious
pharmacist-in-charge since she opened
Therefore, it was my understanding that with Dr. Aguilar-Amieva’s
the pharmacy.6 Id. at 106. Asked by the
these physicians had their license current, prescriptions?’’ Id. at 116. She replied:
Government whether the pharmacy had including some prescriptions that were
filled ‘‘241 prescriptions for Dr. Aguilar- The prescriptions met all legal parameters.
invoiced to health insurance plans, and they
Amieva from February 2009 to October The patients would come over to the drug
were paid by these, even after they were
2009,’’ Ms. Santiago-Soto answered store, and the ones that I did dispense, their
reviewed.
reputation wasn’t in doubt, in my judgment,
‘‘yes.’’ Id. However, when asked So, supposedly, that if the health insurance
because many of them would also bring me
whether she knew ‘‘that his registration plan hires a physician, all the credentials
prescriptions of their medications that they
had been revoked in January of 2009,’’ should be up to date. And if they didn’t come
took for continuous use.
Ms. Santiago-Soto answered that she to notice this, and with them being the health
‘‘didn’t know’’ at the time.7 Id. at 106– insurance plan, when they are usually up to Id.
date on everything, then it was my The Government then asked Ms.
07.
understanding that the prescriptions were
Next, the Government asked Ms. Santiago-Soto whether she analyzed the
okay.
Santiago-Soto whether she ‘‘believe[d] prescribing practices of a physician for
that it’s your duty to verify all Id. at 109. When then asked what her signs of diversion when filling a
prescriptions’’; she replied: ‘‘That’s understanding was of who could prescription. Id. at 117. Ms. Santiago-
what I do all the time.’’ Id. at 107. The prescribe Suboxone to treat substance- Soto replied:
Government then asked Ms. Santiago- abuse patients, Ms. Santiago-Soto
I don’t speak with the doctors. There is a
Soto why she had filled Dr. Aguilar- answered that she ‘‘was aware of the use confidentiality law between doctor and
Amieva’s prescriptions ‘‘if that’s what given to the medication’’ and that ‘‘[i]f patient. I review that the prescription meets
you do all the time?’’ Id. Ms. Santiago- you go prescription by prescription . . . the law and that it shouldn’t raise the least
Soto replied: the amounts are not such that would suspicion possible in me, that this
Well to start with, I’m a pharmacist. And
raise my suspicions that something is medication is not intended, particularly
I revise [sic] prescriptions, and I make sure running amok.’’ Id. at 109–10. She then intended for this patient, for medical use.
reiterated that, at the time, she ‘‘was not
Id. at 117. When then asked whether she
6 Ms. Santiago-Soto testified that she had worked aware of the X DEA number’’ that is
‘‘went through [Respondent’s] computer
at four other pharmacies prior to opening required to prescribe Suboxone and
Respondent. Tr. 139–40. She also testified that
system looking for patterns,’’ Ms.
buprenorphine to treat narcotic-
Respondent had been inspected by the Santiago-Soto answered that she ‘‘kept a
dependent patients. Id. at 110.
Commonwealth’s Health Department and the manual inventory and . . . from it I
AMSCA, which is the Commonwealth agency that Upon questioning by the Government,
couldn’t necessarily discern that
regulates controlled substances, and that she held Ms. Santiago-Soto acknowledged that a
something was out of place.’’ Id. at 119.
the licenses required by the Commonwealth. Tr. DATA-waiver physician must meet
141–42. She further testified that Respondent had She then explained that in 2009, she
certain requirements and that ‘‘not all
been inspected twice by DEA and had provided the dispensed a total of 30,000 prescriptions
DIs with both prescriptions and a list of various physicians may prescribe’’ Suboxone,
(including 27,000 for non-controlled
controlled medications that it had dispensed; and that a physician who prescribes
drugs), of which 66 had been written by
according to Ms. Santiago-Soto, she was never Suboxone for this purpose must have an
notified that her pharmacy had engaged in any
mstockstill on DSK4VPTVN1PROD with NOTICES
X-number. Id. The Government then
wrongdoing. Id. at 143. 8 Ms. Santiago-Soto denied that she had not
7 The Government’s evidence does not establish asked Ms. Santiago-Soto why she did learned about the DATA’s requirements until after
that Dr. Aguilar-Amieva’s registration had been not know this when she ‘‘became being served with the Show Cause Order. Tr. 112.
revoked, in which case a Decision and Order would accredited as a pharmacist?’’ Id. Ms. Ms. Santiago-Soto testified that the insurance plan
have been published in the Federal Register. See Santiago-Soto explained that she audit occurred several months before the search
GX 6. Rather, the Government’s evidence shows warrant was executed at her pharmacy. Id. at 113.
that Dr. Aguilar-Amieva’s registration expired on
graduated in 1995, that the DATA was It is noted that the Government’s evidence shows
June 30, 2008 and was retired from the DEA enacted in 2000, and that Suboxone and that Respondent did not dispense any Suboxone
computer system on January 31, 2009. See id. buprenorphine were not approved for prescriptions after July 3, 2011. GX 4, at 23–24.
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Dr. Aguilar-Amieva.9 Id. She further the DEA in Ponce 11 . . . and . . . told to the ALJ’s on the record explanation
stated that Dr. Aguilar-Amieva’s her . . . that I was unsure if I had for denying the motion, there was ample
prescriptions did not raise any answered the question correctly’’ and reason for why the document was not
suspicion. Id. at 122. that she had ‘‘answered ‘no,’ because, ‘‘presented ahead of time.’’ Specifically,
Turning to the application, Ms. quote/unquote, it said ‘with cause.’ ’’ Id. the ALJ ignored that the Government
Santiago-Soto acknowledged that she Ms. Santiago-Soto further testified that did not provide any notice that it
understood both questions two and the official said ‘‘that she would look intended to litigate the issue of material
three.10 Id. at 123–24. When then asked into it and verify if that was answered falsification until its supplemental pre-
whether she had surrendered her DEA correctly, because she didn’t know. And hearing statement, which it filed one
registration for cause in November 2011, she also told me that, since I had week before the hearing, and on which
Ms. Santiago-Soto replied: ‘‘In my informed her about it, eventually, if any date Respondent was also required to
judgment, I surrendered the license, but situation came up, she could appear as file its supplemental pre-hearing
not with cause.’’ Id. at 124. She then a witness and say that I had that doubt, statement. Moreover, the ALJ’s June 18
explained that: and I had asked her about it, and that order did not address what procedure
. . . . In my judgment, this is simple. she had answered me.’’ Id. at 126–27. Respondent was required to follow in
When I surrendered my license, it was in a Ms. Santiago-Soto testified that she the event the Government raised an
situation where I was under arrest, and I had memorialized the conversation in an entirely new allegation at this stage of
no other choice but to sign the document that email. Id. at 127. However, as of the date the proceeding. See ALJ Ex. 7. Finally,
was placed in front of me. of the hearing, the official had not the document was not included with the
Moreover, at the moment of having to sign replied to the email. Id. at 136. transmitted record as a rejected exhibit
the document, an agent came out speaking or as it should have been. See 21 CFR
yelling, ‘‘was her rights read to Yanira The Government then asked Ms.
Santiago-Soto ‘‘if you had to fill this 1316.60.
Santiago, was her Miranda rights’’—and just
before I signed that paper that said application out again today, what would Ms. Santiago-Soto also testified in
‘‘surrender,’’ I had my Miranda rights read. you put for the Question No. 3?’’ Id. at Respondent’s case-in-chief. Ms.
And I was practically signing 128. Ms. Santiago-Soto replied: Santiago-Soto testified that prior to her
simultaneously. arrest on November 30, 2011, she had
I would answer it the same way. I would been inspected twice by DEA. Tr. 142–
Agent [P.N.], from the Ponce DEA,
answer the same thing. Because of the
explained to me that I had to sign that
statement ‘‘with cause,’’ if that statement
43. The first of these inspections
surrender because of the criminal charges occurred on September 2, 2010; the
against me. And not because of what I’m wouldn’t have been there, I would have no
reason to answer ‘‘no.’’ I would’ve answered second on September 7, 2011. RXs
being told of here. G & H. While Agency Investigators
‘‘yes.’’ Because I surrendered.
* * * * * But since it stated, in parentheses, ‘‘with apparently reviewed the controlled-
I’m handcuffed, and I had to sign a cause,’’ that’s not my issue. Because I substance prescriptions and her
document that they demand from me to sign surrendered my DEA license because of the dispensing records, they never notified
because I had no other option. Because, criminal case against me. Not because of this
according to what they were saying, I was
her of ‘‘any findings or wrongdoings on’’
intervention right now, that we’re having the part of Respondent. Tr. 143. Nor did
part of a scheme. today.
When I proceed to answer this questions they advise that Dr. Aguilar-Amieva or
[sic] that is posed in the new application and Id. any other doctor was under
quote/unquote, it puts the words ‘‘with Throughout her testimony, Ms. investigation. Id. at 144.
cause.’’ Santiago-Soto maintained that she did Ms. Santiago-Soto further testified
It’s my understanding, as of this day, that not voluntarily surrender Respondent’s that there is a ‘‘question and answer
I surrendered the license without cause, registration, but rather was coerced into section’’ on the DEA diversion Web site
because it was taken away from me because surrendering it. Id. at 132. She also which includes a question regarding
of my criminal case [an]d not because of
testified that the various prescriptions whether the Agency can verify a DEA
what I’m being told here.
which form the basis of the allegations registration. Id. at 145–46. According to
Id. at 124–26. See also id. at 132 (‘‘I regarding the dispensing violations were Ms. Santiago-Soto, ‘‘the answer that the
signed the document, because he told taken from Respondent on the date she DEA gives . . . is ‘no’ ’’ and that she has
me that I had to surrender the license was arrested. Id. at 135–36. to buy a program from the National
because of a criminal charge against Upon the conclusion of Respondent’s Technical Information Service ‘‘to be
me.’’). cross-examination of Ms. Santiago-Soto, able to have access on several occasions
Ms. Santiago-Soto then explained that Respondent’s counsel attempted to to that registry.’’ Id. at 146. Ms.
when she filled out the application move into evidence a copy of the email Santiago-Soto further testified that it
‘‘that question raised doubts in my which she had sent to the group ‘‘costs over $2,000 on an annual basis
mind.’’ Id. at 126. Accordingly, the next supervisor and explained that he had . . . for one user.’’ Id. However, she
day, she called ‘‘the regional director for shown a copy of the email to the then explained that she would buy the
Government. Id. at 137. The ALJ denied program if she is issued a registration.
9 In Respondent’s case in chief, Ms. Santiago-Soto
the motion, explaining: ‘‘That may be Id. at 146–47. Still later, she testified
testified that Respondent dispensed 104
prescriptions in 2010 and 63 prescriptions in 2011 true, Counsel, but I don’t have it. It’s not that the NTIS is ‘‘costly for a drugstore
which were issued by Dr. Aguilar-Amieva. Tr. 151. evidence before me. I don’t have any that’s just starting out’’ and that she did
10 Question three asks whether ‘‘the applicant
reason to understand why it wasn’t not ‘‘know of any small community
[has] ever surrendered (for cause) or had a state presented ahead of time, so I could pharmacy that has purchased’’ a
professional license or controlled substances
mstockstill on DSK4VPTVN1PROD with NOTICES
evaluate it.’’ Id. at 137–38. subscription to the NTIS database,
registration revoked, suspended, denied, restricted,
or placed on probation, or is any such action As found above, the email appears to ‘‘because the law does not require that
pending?’’ GX 1, at 1. There is no evidence, have been relevant to the issue of it be purchased.’’ Id. at 149. However,
however, that the Commonwealth took any of these whether Ms. Santiago-Soto falsified she reiterated that she would purchase
actions against Respondent’s (or Ms. Santiago- the database. Id.; see also id. at 154–55.
Soto’s) professional license or controlled substance Respondent’s application. And contrary
registration. Thus, it is unclear why Ms. Santiago-
Moreover, Ms. Santiago-Soto testified
Soto was asked about this question rather than 11 I have taken official notice that the official is that if she was granted a registration,
question four. actually a group supervisor. she would be willing to consider any
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recommendations made by the Agency. However, the ALJ again rejected finding that the registrant . . . has
Id. at 155. Respondent’s request. Id. materially falsified any application filed
Regarding the allegation that she pursuant to or required by this
Discussion
dispensed prescriptions written by Dr. subchapter.’’ 21 U.S.C. 824(a)(1). Under
Aguilar-Amieva, whose registration had Section 303(f) of the Controlled agency precedent, the various grounds
expired, Ms. Santiago-Soto explained Substances Act (CSA) provides that an for revocation or suspension of an
that she had reviewed the DEA application for a practitioner’s existing registration that Congress
Pharmacist’s Manual, and that while the registration may be denied upon a enumerated in section 304(a), 21 U.S.C.
Manual contains extensive information determination ‘‘that the issuance of such 824(a), are also properly considered in
as to what must be provided on a registration would be inconsistent with deciding whether to grant or deny an
prescription, ‘‘[n]owhere in the law am the public interest.’’ 21 U.S.C. 823(f). In application under section 303. See The
I told that I have to be checking each making the public interest Lawsons, Inc., 72 FR 74334, 74337
one of the licenses at every moment.’’ determination, the CSA requires the (2007); Anthony D. Funches, 64 FR
Id. at 148. She also testified that during consideration of the following factors: 14267, 14268 (1999); Alan R.
the period at issue, she ‘‘would check (1) The recommendation of the appropriate Schankman, 63 FR 45260 (1998); Kuen
the list of those physicians that had State licensing board or professional H. Chen, 58 FR 65401, 65402 (1993).
been criminally charged because of their disciplinary authority. Thus, the allegation that Respondent
prescriptions,’’ id., and that if the name (2) The applicant’s experience in materially falsified its application is
of a doctor was not on the list, she dispensing . . . controlled substances. properly considered in this proceeding.
(3) The applicant’s conviction record under See The Lawsons, 72 FR at 74337;
‘‘proceeded to dispense the Federal or State laws relating to the
prescription.’’ Id. at 161. Samuel S. Jackson, 72 FR 23848, 23852
manufacture, distribution, or dispensing of
However, neither Dr. Aguilar-Amieva controlled substances. (2007). Moreover, just as materially
nor Dr. Vargas-Quinones appeared on (4) Compliance with applicable State, falsifying an application provides a
the various lists for the years 2008 Federal, or local laws relating to controlled basis for revoking an existing
through 2013.12 Id. at 148–49. Finally, substances. registration without proof of any other
Ms. Santiago-Soto denied that she had (5) Such other conduct which may threaten misconduct, see 21 U.S.C. 824(a)(1), it
ever knowingly dispensed a the public health and safety. also provides an independent and
prescription which had not been Id. adequate ground for denying an
lawfully issued. Id. at 154. ‘‘These factors are . . . considered in application. The Lawsons, 72 FR at
Following the conclusion of Ms. the disjunctive.’’ Robert A. Leslie, M.D., 74338; cf. Bobby Watts, M.D., 58 FR
Santiago-Soto’s testimony, Respondent’s 68 FR 15227, 15230 (2003). I ‘‘may rely 46995 (1993).
counsel requested that the ALJ take on any one or a combination of factors, In this matter, the Government alleged
official notice of various documents, and may give each factor the weight [I] that Ms. Santiago-Soto materially
including the Web page containing deem[] appropriate in determining falsified Respondent’s application for
various questions and answers which whether . . . an application for registration by failing to disclose that it
Respondent’s counsel had previously registration [should be] denied.’’ Id. had previously surrendered its prior
sought to use to impeach the testimony registration for cause. Gov. Post-Hearing
Moreover, I am not required to make
of the DI to the effect that Ms. Santiago- Br., at 6–9. It also alleged that
findings as to all of the factors.13
Soto could have verified whether the Respondent’s registration is inconsistent
Volkman v. DEA, 567 F.3d 215, 222 (6th
with the public interest because it
physicians were registered by calling Cir. 2009); Hoxie v. DEA, 419 F.3d 477,
violated 21 U.S.C. 843(a)(2), as well as
DEA. Tr. 162–67. After the ALJ asserted 482 (6th Cir. 2005).
Under Section 304(a)(1), a registration 21 CFR 1306.04 and 1306.06, when: (1)
that the document’s ‘‘relationship to the
may be revoked or suspended ‘‘upon a Between February 2009 and October
narrative . . . attributed to’’ Respondent
2009, it filled 241 prescriptions which
should have been clear to its counsel
were issued by Dr. Aguilar-Amieva,
when she filed its amended pre-hearing 13 I have considered Respondent’s evidence that
it is currently licensed by the Commonwealth of whose registration had been retired by
statements, Respondent’s counsel again
Puerto Rico as a pharmacy and holds a registration the Agency; and (2) it filled Suboxone
argued that it had no ‘‘knowledge that from the Commonwealth which authorizes it to prescriptions issued by Dr. Aguilar-
the witness for the DEA would provide dispense controlled substances. I have also
Amieva and Dr. Vargas-Quinones to
testimony . . . under oath, that considered Respondent’s evidence that the
treat narcotic addiction, when neither
contradicts the information the DEA Pharmaceutical Board took no action against Ms.
Santiago-Soto’s pharmacist’s license. However, doctor was authorized under Federal
provided on that Web page.’’ Id. at 167. none of these documents constitute a law to do so. See Gov. Post-Hearing Br.,
recommendation from the state licensing board as at 11–12.
12 On cross-examination by the Government, Ms. to whether DEA should grant the application, see
Santiago-Soto acknowledged that these lists may 21 U.S.C. 823(f)(1), and while Respondent clearly The Material Falsification Allegation
actually have been of those physicians who were possesses authority to dispense controlled
subjected to administrative proceedings. Tr. 158. substances under the laws of the Commonwealth The Government argues that Ms.
When the Government suggested that her review of and thus meets a prerequisite for obtaining a Santiago-Soto materially falsified
these lists was inadequate because they were lists registration, this finding is not dispositive of the Respondent’s application for
of final agency actions and would not ‘‘contain the public interest inquiry.
names of doctors that voluntarily surrendered’’ So too, I acknowledge that neither Respondent,
registration because she failed to
their registrations, Ms. Santiago-Soto replied that ‘‘I nor Ms. Santiago-Soto, has been convicted of an disclose the November 30, 2011
can’t make any supposition, as you’ve been telling offense under either federal or Puerto Rico law surrender of its registration. More
me. You’re asking me to suppose something, and ‘‘relating to the manufacture, distribution or
mstockstill on DSK4VPTVN1PROD with NOTICES
specifically, the Government contends
I’m not here to suppose anything. I’m here with dispensing of controlled substances.’’ 21 U.S.C.
facts. I’m being shown facts. So I have to answer 823(f)(3). However, while the charges against Ms.
that Ms. Santiago-Soto materially
with facts.’’ Id. Santiago-Soto were dismissed, this finding is not falsified the application, when she
However, upon questioning by the ALJ, Ms. dispositive of the allegations that Respondent filled provided a ‘‘no’’ answer to question
Santiago-Soto admitted that if a doctor who unlawful prescriptions because this proceeding two, which asked: ‘‘Has the applicant
voluntarily surrendered his registration was not involves different allegations than those brought in
identified on the Web site, she ‘‘wouldn’t know’’ the criminal proceeding and is subject to a lower
ever surrendered (for cause) or had a
that the doctor did not have the requisite authority. standard of proof (the preponderance standard) federal controlled substances
Id. at 161–62. than that applied in a criminal proceeding. registration revoked, suspended,
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restricted or denied, or is any such 995 (10th Cir. 2002) (discussing Facet In its initial Pre-Hearing Statement,
action pending?’’ Gov. Br. at 7 (citing Enterprises, Inc. v. NLRB, 907 F.2d 963, the Government again failed to allege
GX 1, at 1). Moreover, in its post-hearing 974 (10th Cir. 1990); ‘‘we held that that the application was materially false.
brief, the Government contends—for the defendant had constructive notice of an Nor, in summarizing the testimony of its
first time in the proceeding—that Ms. alternate theory of liability not proposed witnesses therein, did the
Santiago-Soto also materially falsified described in the formal charge when the Government provide notice that it
the application when she provided a agency detailed that theory during its intended to put forward any evidence
‘‘no’’ answer to question four, which opening argument and at other points which would lead Respondent to
asked: ‘‘If the applicant is a corporation during the hearing and when the conclude that the material falsification
. . . or pharmacy . . . has any officer, defendant’s conduct revealed that it of its application was an issue in the
partner, stockholder or proprietor . . . understood and attempted to defend case.
ever surrendered or had a federal against that theory’’).14 Instead, the Government did not
controlled substances registration ‘‘The primary function of notice is to provide notice that it intended to litigate
revoked, suspended, restricted, or afford [a] respondent an opportunity to the issue of whether the application
denied . . . .?’’ Id. at 8. I reject the prepare a defense by investigating the contained a material falsification until
allegations. basis of the complaint and fashioning an its Supplemental Pre-Hearing
One of the fundamental tenets of Due explanation that refutes the charge of Statement, which was not filed until
Process is that an Agency must provide unlawful behavior.’’ Pergament United one week before the evidence-taking
a Respondent with notice of those acts Sales, 920 F.2d at 135 (citation omitted). phase of the proceeding convened. Even
which the Agency intends to rely on in While the issue of whether an allegation then, the Supplemental Pre-Hearing
seeking the revocation of its registration ‘‘has been fully and fairly litigated [by Statement did not identify which
so as to provide a full and fair consent] is so peculiarly fact-bound as specific statements on the applications
opportunity to challenge the factual and to make every case unique,’’ id. at 136, were allegedly false. Rather, the
legal basis for the Agency’s action. See ‘‘the simple presentation of evidence Supplemental Pre-Hearing Statement
NLRB v. I.W.G., Inc. 144 F.3d 685, 688– important to an alternative [allegation] merely stated that ‘‘Ms. Soto will be
89 (10th Cir. 1998); Pergament United does not satisfy the requirement’’ that a asked about the circumstances of the
Sales, Inc. v. NLRB, 920 F.2d 130, 134 respondent be afforded with a full and pharmacy’s prior surrender of its DEA
(2d Cir. 1990). Because the Government fair opportunity to litigate the certificate of registration, and about her
did not allege in the Order to Show alternative allegation. I.W.G., 144 F.3d failure to note the previous surrender on
Cause that Respondent had materially at 688 (quoting NLRB v. Quality Respondent’s new application for
falsified its application, before C.A.T.V., Inc., 824 F.2d 542, 547 (7th registration.’’ ALJ Ex. 7, at 3. Because
proceeding to address whether the Cir. 1987) (other citation omitted)). the Government’s Supplemental Pre-
evidence supports the Government’s ‘‘An agency may not base its decision Hearing Statement did not specifically
contention, it is necessary determine upon an issue the parties tried identify which of the various
whether the Government otherwise inadvertently. Implied consent is not application statements it was alleging to
provided adequate notice of its intent to established merely because one party be materially false, only those issues
litigate the issue. See 5 U.S.C. 554(b) introduced evidence relevant to an which the record shows were litigated
(‘‘Persons entitled to notice of an agency unpleaded issue and the opposing party by consent can support a finding (if
hearing shall be timely informed of . . . failed to object to its introduction. It proved by substantial evidence) that Ms.
the matters of fact and law asserted.’’). must appear that the parties understood Santiago-Soto materially falsified the
‘‘ ‘Pleadings in administrative the evidence to be aimed at the application and the imposition of a
proceedings are not judged by the unpleaded issue.’’ Yellow Freight sanction.
standards applied to an indictment at System, Inc. v. Martin, 954 F.2d 353, Notably, while at the evidentiary
common law.’ ’’ Aloha Airlines v. Civil 358 (6th Cir. 1992) (citation omitted). phase of the hearing the Government
Aeronautics Bd., 598 F.2d 250, 262 (D.C. Accordingly, where the Government’s made an opening statement, here again,
Cir. 1979) (quoted in CBS Wholesale case ‘‘focus[es] on another issue and it did not identify the specific
Distributors, 74 FR 36746, 36749 [the] evidence of [an] uncharged statements which were allegedly false.
(2009)); accord Citizens State Bank of violation [is] ‘at most incidental,’ ’’ the Rather, it confined its opening statement
Marshfield v. FDIC, 751 F.2d 209, 213 Government has not satisfied its to the following: ‘‘Your Honor, the
(8th Cir. 1984). Accordingly, ‘‘the failure constitutional obligation to provide a Government seeks a recommendation of
of the Government to disclose an full and fair opportunity to litigate the a denial of application based on
allegation in the Order to Show Cause issue and it cannot rely on the Sections 823 and 824 of the Controlled
is not dispositive and an issue can be incidental issue as the basis for Substances Act, on the basis of a
litigated if the Government otherwise imposing a sanction. Pergament, 920 material falsification on the application,
timely notifies a [r]espondent of its F.2d at 136 (quoting NLRB v. Majestic and the fact that Respondent’s
intent to litigate the issue.’’ CBS Weaving Co., 355 F.2d 854, 861–62 (2d registration would be inconsistent with
Wholesale, 74 FR at 36570. Thus, while Cir. 1966)). the public interest.’’ Tr. 39.
the Agency has held that ‘‘the Moreover, in questioning both the DI
parameters of the hearing are 14 See also Grider Drug #1 & Grider Drug #2, 77 and Ms. Santiago-Soto, the Government
determined by the prehearing FR 44070, 44077 n.23 (2012) (holding that while the did not elicit any testimony regarding
statements,’’ consistent with numerous Government did not provide adequate notice of its Question Four. Rather, it focused
intent to litigate an allegation in either the Show
mstockstill on DSK4VPTVN1PROD with NOTICES
court decisions, it has also recognized entirely on the answers Ms. Santiago-
Cause Order or its pre-hearing statements, where
that even where an allegation was not respondents ‘‘did not object that the allegation was
Soto had given to Question Two, and,
raised in either the Show Cause Order beyond the scope of the proceeding and that they notwithstanding that there was no
or the pre-hearing statements, the were denied adequate notice of it’’ and ‘‘fully evidence that the Commonwealth of
parties may nonetheless litigate an issue litigated the issue,’’ the allegation was litigated by Puerto Rico had taken any action against
consent) (citing Citizens State Bank, 751 F.2d at
by consent. Pergament United Sales, 213; Kuhn v. Civil Aeronautics Bd., 183 F.2d 839,
either Respondent or Ms. Santiago-Soto,
920 F.2d at 135–37; see also Duane v. 841–42 (D.C. Cir. 1950); and Yellow Freight System, Question Three. See Tr. 45 (testimony of
Department of Defense, 275 F.3d 988, Inc. v. Martin, 954 F.2d 353, 358 (6th Cir. 1992)). DI that Respondent’s application
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contained a falsification at ‘‘Question underst[ood] that I am not required to she ‘‘placed undue emphasis on the
Number 3’’); id. at 123–24 surrender my controlled substance words ‘for cause.’ ’’
(Government’s questioning of Ms. privileges,’’ and that ‘‘[i]n view of my As for the latter contention, Ms.
Santiago-Soto regarding Questions Two alleged failure to comply with the Santiago-Soto was only required to
and Three). Indeed, it was not until its Federal requirements pertaining to answer Question Two as it was written
post-hearing brief that the Government controlled substances, and as an on the application and not as it
finally argued that Ms. Santiago-Soto indication of my good faith in desiring otherwise could have been written (such
had provided a materially false answer to remedy any incorrect or unlawful as without those words). Indeed, the
to Question Four. This, however, is practices on my part’’ she was Government does not explain how Ms.
simply too late in the day to provide a ‘‘voluntarily surrender[ing] my . . . Santiago-Soto could have ‘‘placed
meaningful opportunity to refute the Certificate of Registration.’’ Id. undue emphasis on the words ‘for
allegation. See Pergament United Sales, As found above, the DI who testified cause,’ ’’ when those words were part of
920 F.2d at 135.15 for the Government did not personally the question and the application
Thus, I hold that the Government participate in the arrest of Ms. Santiago- contains no explanation of what the
provided adequate notice to support a Soto and did not witness the events term ‘‘surrender for cause’’ means.
finding that the parties litigated by surrounding her execution of the There is no Agency regulation which
consent the issue of whether Ms. Voluntary Surrender form. Tr. 60–61. defines the term ‘‘for cause’’ as it is
Santiago-Soto’s answer to Question Two Nor did the Government call as a applied in the context of an application
was materially false. However, I further witness any other person who witnessed for registration. However, two
hold that the record does not support a the execution of the surrender form. regulations do define the term in the
finding that the parties litigated by Thus, there is no evidence that, at the context of imposing requirements on
consent whether her answer to Question time she surrendered Respondent’s practitioners in the employment of
Four was also materially false. registration, Ms. Santiago-Soto was persons who handle or have access to
Turning to the merits of the allegation confronted with any allegations of controlled substances, see 21 CFR
pertaining to Question Two, the misconduct aside from those which 1301.76(a), as well as on manufacturers
evidence showed that on November 29, comprised the criminal case. and distributors (among others) in the
2011, Ms. Santiago-Soto was indicted Subsequently, the U.S. Attorney employment of persons who will have
(along with thirty-two other persons) on moved to dismiss with prejudice both of access to listed chemicals. See 21 CFR
two felony counts of violating the the charges against Ms. Santiago-Soto. 1309.72(a). Under these provisions, ‘‘the
Controlled Substance Act, including: (1) RX C. On March 23, 2012, the District term ‘for cause’ means a surrender in
By conspiring to possess and dispense, Court granted the Government’s motion lieu of, or as a consequence of, any
with intent to distribute, various and entered a Judgment of Dismissal Federal or State administrative, civil or
controlled substances, in violation of 21 and discharged her. Id. The criminal actions resulting from an
U.S.C. 841(a)(1), 846, and 860; and (2) consequence of this was that the charges investigation of the handling of
by aiding and abetting each other and could not be refiled against her. controlled substances or listed
‘‘knowingly and intentionally The Government nonetheless argues chemicals.’’ 21 CFR 1301.76(a); id. at
possess[ing] and dispens[ing] with that Ms. Santiago-Soto ‘‘could not under 1309.72(a).
intent to distribute various’’ schedule II any reasonable circumstances have However, even if this definition was
through IV controlled substances, answered the relevant liability questions applied to Respondent’s application, it
‘‘outside the scope of professional . . . in the negative’’ and that she would offer no support to the
practice and not for a legitimate medical ‘‘placed undue emphasis on the words Government. Here, there is no evidence
purpose,’’ in violation of 21 U.S.C. ‘for cause’ in liability question #2.’’ Gov. that Ms. Santiago-Soto was advised that
841(a)(1) and 18 U.S.C. 2. RX B, at 1– Post-Hrng. Br., at 7. The Government if she did not surrender the registration,
13. further notes Ms. Santiago-Soto’s claim Respondent would face an Order to
On November 30, 2011, Ms. Santiago- Show Cause. Thus, she did not
that she signed the surrender form
Soto was arrested early in the morning surrender the registration ‘‘in lieu of’’ a
‘‘under duress.’’ Id.
and taken to her pharmacy where, after hearing. Moreover, while she had been
I need not decide whether
receiving the Miranda warnings, she indicted prior to the surrender, there is
surrendering a registration under duress
was told by P.N., a DI,16 that she had to no evidence that she surrendered the
constitutes a valid defense to a charge
surrender her registration ‘‘because of registration in lieu of facing the criminal
the criminal charges against’’ her and of material falsification of Question Two
or whether the facts here would support charges, which were not dismissed until
that she ‘‘had no other options’’ because several months later.18
she was ‘‘part of a scheme.’’ Tr. 125–26. such a defense.17 This is so because I
find unpersuasive the Government’s Notably, Ms. Santiago-Soto’s
The evidence further showed that Ms. testimony that she was told that she had
Santiago-Soto executed a Voluntary contentions that Ms. Santiago-Soto
could not have reasonably answered to surrender her registration because of
Surrender form, which was witnessed her involvement in a criminal scheme
by P.N. (as well as another DI). RX I. Question Two in the negative and that
stands unrefuted, and there is no
This form stated that she had been 17 Of consequence, Question Two did not ask evidence that, at the time of the
‘‘fully advised of my rights, and whether Respondent had ‘‘ever voluntarily surrender, she was told by Agency
surrendered (for cause)’’ but only if it had ‘‘ever personnel that the Agency was alleging
15 Indeed, even if an allegation could be refuted surrendered (for cause)’’ its registration. GX 1, at 1.
without further factual development because it Moreover, notwithstanding that Ms. Santiago-Soto additional violations of the CSA or DEA
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involves a matter of law, because DEA proceedings was under arrest at the time she surrendered
customarily require the parties to file their post- Respondent’s registration, in signing the Voluntary 18 Nor does the evidence support a finding that
hearing briefs simultaneously (as was done here), Form, she acknowledged that she had been ‘‘fully she surrendered the registration as a consequence
there is no meaningful opportunity to respond prior advised of [her] rights’’ and understood that she of the criminal action. Ms. Santiago-Soto did not
to the issuance of an ALJ’s recommended decision. was ‘‘not required to surrender my controlled surrender the registration as part of a pre-trial
16 In her testimony, Ms. Santiago-Soto referred to substances privileges’’; she then acknowledged that diversion agreement, a plea agreement, or as part of
this person as an Agent; however, on the Voluntary she was ‘‘freely execut[ing]’’ the form and a sentence imposed by a court. Rather, the criminal
Surrender form, this person signed as a witness and ‘‘choos[ing] to’’ voluntarily surrender her case against Ms. Santiago-Soto was dismissed with
listed his title as ‘‘Diversion Investigator.’’ RX I. registration. RX I. prejudice.
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regulations beyond the offenses for ALJ repeatedly noted that Santiago-Soto observation that the email is not part of
which she was indicted.19 Moreover, the had also provided a ‘‘no’’ answer to the record, it should have been (indeed,
consequence of the district court’s Question Four, which does not use the notwithstanding the Agency’s
dismissal of the charges ‘‘with words ‘‘for cause’’ to modify the scope regulation, which requires that an ALJ
prejudice,’’ on motion of the of surrenders which must be disclosed. forward a rejected exhibit to the
Government (and apparently before Id. at 27–29. Moreover, in his earlier Administrator’s Office, it was not). As
trial), was that she could be not re- summary of the testimony, the ALJ found above, the ALJ allowed the
charged for the same offenses. Under noted that ‘‘[t]here is no evidence Government to delay filing its
these circumstances, a layperson could, indicating that Ms. Santiago-Soto also supplemental prehearing statement
in good faith, conclude that there was inquired about Question Four during until one week before the hearing and
no basis for both the charges and the her conversation with’’ the Group imposed the same deadline on
DI’s demand that she surrender her Supervisor, id. at 5, and that in her Respondent. Moreover, the ALJ failed to
registration, and given the absence of testimony, she did not address her provide any direction to Respondent as
any definition of the limiting term, a answer to Question Four. He also to what steps it must take in the event
layperson could also, in good faith, explained that the Group Supervisor the Government raised an entirely new
conclude that she had not surrendered ‘‘did not testify at the hearing, and [that] allegation at this state of the proceeding
her registration ‘‘for cause.’’ 20 neither party sought such testimony.’’ and wished to present evidence to refute
Even had I concluded otherwise, I Id. The ALJ further observed that ‘‘the the allegation.
would hold that there are mitigating record before me does not include a As for the ALJ’s on-the-record
circumstances that substantially copy of’’ the email which Ms. Santiago- explanation that the email had to be
diminish the egregiousness of the Soto testified she had sent to the Group presented ‘‘ahead of time, so [he] could
alleged misconduct. Ms. Santiago-Soto Supervisor. Id. at 6. evaluate it,’’ Tr. 138, this begs the
testified that the day after she submitted Thus, it appears that the ALJ rejected question: Evaluate it for what? Even in
the application, she contacted the Santiago-Soto’s testimony regarding the jury trials (where there is a manifest to
Diversion Group Supervisor and phone call and email to the Group need to protect the factfinder from being
explained to her that she answered the Supervisor because she did not claim to misled or confused), judges routinely
question ‘‘no’’ and ‘‘was unsure if [she] have asked about Question Four. rule from the bench on the admissibility
had answered the question correctly’’ However, to the extent this is an of evidence. And here, where there is no
because the question used the words accurate discernment of the ALJ’s jury, the ALJ could have evaluated this
‘‘with cause.’’ Tr. 126. Ms. Santiago- unexplained reasoning, it not surprising evidence at the same time he evaluated
Soto also testified that the Group that there is no evidence as to why Ms. the testimony. Finally, the Government
Supervisor told her that she did not Santiago-Soto answered Question Four offered no objection to the email; nor
know, but that she would look into it as she did. This is so because the could it reasonably claim prejudice
and get back to her. Id. at 126–27. Ms. Government never asked her why she given that it waited until one week
Santiago-Soto further testified that she did, nor otherwise adequately put her before the hearing to finally make the
had memorialized the conversation in on notice that her answer to this allegation. Under these circumstances, I
an email to the Group Supervisor. Id. at question was at issue in the conclude that the ALJ’s refusal to admit
127. However, the Group Supervisor did proceeding.21 the email was arbitrary and capricious.
not respond to her. Id. Notably, all of This, however, is not the only I further reject the ALJ’s findings that
this testimony was unrefuted by the problematic aspect of the ALJ’s failure Ms. Santiago-Soto materially falsified
Government. to adequately explain why he gave no Respondent’s application when she
While the ALJ acknowledged this weight to Ms. Santiago-Soto’s testimony provided a ‘‘no’’ answer to Question
testimony in his summary of the regarding the phone call she made to the Two and Four. R.D. at 29, 30–31. I
testimony, see R.D. at 5–6, in his Group Supervisor. As explained above, further reject the ALJ’s Conclusions of
discussion of whether Ms. Santiago-Soto the ALJ’s decision also suggests that he Law with respect to this issue. See id.
had materially falsified the application, gave no weight to her testimony because at 35.
he entirely ignored it and offered no the Group Supervisor was not called to
Factors Two and Four—The Applicant’s
explanation for why he apparently testify and the email was not part of the Experience in Dispensing Controlled
rejected it even as a mitigating record. Substances and Compliance With
circumstance. Id. at 27–28. However, in As for the failure to obtain the Group
Applicable Laws Related to Controlled
concluding that Ms. Santiago-Soto had Supervisor’s testimony, Respondent was
Substances
materially falsified the application, the not required to call the Group
Supervisor in order to establish that her With respect to Factors Two and Four,
19 It is acknowledged that on the Voluntary testimony was credible. As for the ALJ’s the Government made two allegations.
Surrender form the box was checked which First, it alleged that ‘‘from February
indicates that Ms. Santiago-Soto surrendered 21 For this reason, in testifying regarding the 2009 to October 2009,’’ Respondent
Respondent’s registration ‘‘[i]n view of my alleged phone call, Ms. Santiago-Soto had no obligation to ‘‘filled approximately 241
failure to comply with the Federal requirements address whether she had also discussed her answer prescriptions’’ which were issued by Dr.
pertaining to controlled substances.’’ RX I. to Question Four with the Group Supervisor.
However, the Voluntary Surrender form did not list In its Post-Hearing Brief, the Government asserts
Aguilar-Amieva, after his registration
(nor is there a space to list) what those alleged that Ms. Santiago-Soto’s ‘‘failure to testify on this had been retired by the Agency. Gov.
failures were. See id. Given the absence of any question supports an adverse inference that she Post-Hrng. Br., at 11. The Government
evidence that at the time the surrender occurred, knew the statement was false.’’ Gov. Post-Hrng. Br.,
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alleged that this ‘‘conduct violated 21
Ms. Santiago-Soto was told of additional allegations at 8. The Government ignores that it called Ms.
against her, the Voluntary Surrender form does not Santiago-Soto to testify in its case in chief and
U.S.C. 843(a)(2), 21 CFR 1306.04 and
refute her testimony that because the criminal case could have—but failed to—ask her about her 1306.06.’’ Id. Second, it alleged that
was dismissed, she did not believe that she had answer to Question Four. Nor did the Government, Respondent filled twenty-nine
surrendered for cause. at any time prior to filing its Post-Hearing Brief, Suboxone prescriptions, which were
20 The Government does not argue that the mere provide notice to Santiago-Soto that her answer to
fact that she was indicted was sufficient to place Question Four was at issue. I therefore hold that the
issued by both Dr. Aguilar-Amieva and
her on notice that she had surrendered her Government is not entitled to an adverse inference Dr. Vargas-Quinones, neither of whom
registration for cause. regarding her answer to Question Four. were authorized to prescribe this drug to
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treat narcotic addiction. See id. at 11– contends that Respondent’s conduct Ms. Santiago-Soto admitted that
12. The Government alleged that this violated section 843(a)(2); the Agency’s Respondent had filled the prescriptions,
conduct also violated 21 U.S.C. corresponding responsibility rule, see her admission satisfies the
843(a)(2), 21 CFR 1306.04 and 1306.06. 21 CFR 1306.04(a); as well as a further Government’s evidentiary burden only
regulation, 21 CFR 1304.06. Contrary to with respect to showing that the
Allegation One—Respondent’s Filling of
the Government’s understanding, its dispensings occurred. Moreover, when
Prescriptions Issued By A Physician
evidence does not support a finding that asked whether he had any evidence that
Who Was No Longer Registered
Respondent violated any of the three Ms. Santiago-Soto had ‘‘acted with the
As found above, the evidence showed provisions in dispensing these intention or knowledge [of] illegal
that Dr. Hector J. Aguilar-Amieva’s prescriptions. activity when dispensing Dr. Aguilar’s
registration expired on June 30, 2008 As explained above, section 843(a)(2) . . . prescriptions,’’ the DI gave an
and was retired from the DEA computer imposes criminal liability on any person unresponsive answer, stating that he did
system on January 31, 2009. GX 6. The who uses, in the course of dispensing a not ‘‘base [his] evaluations on
evidence, which was not objected to, controlled substance, an expired intentions,’’ and when asked a follow-
further showed that Respondent filled registration number. While no case has up question, the ALJ interjected
more than two hundred controlled- been cited by the Government where a (without the DI even answering the
substance prescriptions which were pharmacist has been convicted of question): ‘‘I’ll take it as a no.’’ Thus, I
issued by Dr. Aguilar-Amieva from violating this provision because it filled hold that the Government did not prove
February 2, 2009 through August 8, prescriptions issued by a physician that Ms. Santiago-Soto acted with the
2011.22 GX 4. whose registration had expired, given requisite knowledge to sustain a
Except for in limited circumstances that a prescription provides the lawful violation of either 21 U.S.C. 843(a)(2) or
which are not implicated here, the authority for a pharmacist to dispense a 21 CFR 1306.04(a), with respect to this
Controlled Substances Act requires that controlled substance, see 21 U.S.C. allegation.
‘‘[e]very person who dispenses . . . any 829(a) & (b), it is clear that a pharmacist The Government also alleged that
controlled substance [ ] shall obtain can held liable for dispensing a Respondent’s filling of the
from the Attorney General a registration controlled substance prescription issued 241prescriptions violated 21 CFR
issued in accordance with the rules and by a physician who no longer holds a 1306.06. In relevant part, this regulation
regulations promulgated by him.’’ 21 registration. However, the statute provides that ‘‘[a] prescription for a
U.S.C. 822(a)(2).23 Moreover, under a imposes liability only where a controlled substance may only be filled
DEA regulation, ‘‘[a] prescription for a pharmacist does so knowingly or by a pharmacist, acting in the usual
controlled substance may be issued only intentionally. See 21 U.S.C. 843(a)(2). course of his professional practice.’’ 21
by an individual practitioner who is: (1) As for 21 CFR 1306.04(a), it requires CFR 1306.06. Thus, on its face, this
[a]uthorized to prescribe controlled that a controlled substance prescription regulation does not require proof of
substances by the jurisdiction in which ‘‘be issued for a legitimate medical knowledge to sustain a violation.
he is licensed to practice his profession purpose by an individual practitioner However, the regulation does require
and (2) [e]ither registered or exempted acting in the usual course of that the Government establish what the
from registration pursuant to 1301.22(c) professional practice’’ and imposes ‘‘a standards of pharmacy practice require,
and 1301.23 of this chapter.’’ 21 CFR corresponding responsibility’’ on the through either expert testimony or by
1306.03(a). Also, it is ‘‘unlawful for any pharmacist who fills a prescription reference to federal or state laws,
person knowingly or intentionally . . . which was not issued ‘‘in the usual pharmacy board or Agency regulations,
to use in the course of the . . . course of professional treatment.’’ or decisional law (whether of
dispensing of a controlled substance However, here again, the regulation administrative bodies or the courts).
. . . a registration number which is imposes liability only on a ‘‘person Here, while the Government’s evidence
fictitious, revoked, suspended, expired, knowingly filling such a purported establishes that Respondent dispensed
or issued to another person.’’ 21 U.S.C. prescription.’’ Id. (emphasis added). some 241 controlled substance
843(a)(2). Thus, it is clear (and While the plain language of both of prescriptions over a period of
undisputed) that Dr. Aguilar-Amieva these provisions requires proof that a approximately thirty months, which
repeatedly violated the CSA by issuing pharmacist dispensed a prescription were written by a physician who was
controlled-substance prescriptions using knowing that the issuer lacked the not registered, the Government did not
his expired registration number. requisite authority, the Government put on any expert testimony
The issue in this matter, however, is produced no evidence that Ms. establishing that pharmacists have a
whether liability can be imposed on Santiago-Soto knew (or was even duty to verify the registration status of
Respondent because its principal filled willfully blind) to the fact that Dr. the prescribers whose prescriptions they
Dr. Aguilar-Amieva’s prescriptions. As Aguilar-Amieva did not hold a DEA fill. Nor did the Government cite to any
explained above, the Government registration. Indeed, while in its brief other rule or decision imposing such a
22 At the hearing, Respondent did not challenge
the Government argues that Ms. duty.
the admission of this evidence on the ground of
Santiago-Soto admitted that Respondent Notwithstanding that the Government
lack of foundation. Nor did it raise such a challenge had filled the prescriptions, Ms. neither produced any evidence
in its Exceptions. Notably, the only Government Santiago-Soto expressly denied that she establishing that the usual course of
witness to testify did not participate in the knew that Aguilar-Amieva’s registration professional practice requires that a
execution of the search warrant and did not
specifically identify the prescriptions submitted by
‘‘had been revoked in January 2009.’’ Tr. pharmacist verify the registration status
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the Government as those which were seized when 106–07.24 Thus, although it is true that of prescribers, nor cited any law,
the warrant was issued. Moreover, the prescription regulation, or other authority, which
labels (which were apparently affixed to the back 24 The quotation is from the Government’s
imposes such a requirement, the ALJ
of the prescriptions), do not identify Respondent as question. The Government’s evidence did not
the dispensing pharmacy. Nor did the Government
found that when ‘‘she filled these
establish that the Agency had revoked Dr. Aguilar-
submit any documentary evidence tending to Amieva’s registration, but only that Aguilar-Amieva prescriptions[,] Ms. Santiago-Soto failed
establish that the prescriptions were those which let his registration expire after which his number
were seized from Respondent. was retired from the DEA registrant database. Had order doing so would have been published in the
23 See 21 U.S.C. 822(c); 21 CFR 1301.22. Aguilar-Amieva’s registration been revoked, an Federal Register and on the Agency’s Web site.
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to conform to regulations relating to the However, several commenters objected Accordingly, I reject the ALJ’s
distribution of controlled substances ‘‘that pharmacies are not required to reasoning as contrary to the published
and failed to act in the usual course of check DEA registrations for paper guidance of the Agency. And because
professional pharmacy practice.’’ R.D. at prescriptions unless they suspect the Government failed to put forward
34. Apparently, this was based on the something is wrong with a either: (1) any evidence to show that Ms.
ALJ’s earlier conclusion that ‘‘[o]ne way prescription.’’ Id. Santiago-Soto either knew or was
or another, pharmacists must ensure In its response (which appears to be willfully blind to the fact that Dr.
that they are filling only those missing pertinent text), the Agency Aguilar-Amieva was no longer
controlled substance prescriptions that stated that it ‘‘agrees with those registered, or (2) any evidence or legal
have been written by persons registered commenters that expressed the view authority establishing that Ms. Santiago-
with the DEA. A pharmacy applicant that, when filling a paper prescription, Soto acted outside of the usual course
who fails to appreciate the need to it is not necessary for a pharmacist who of professional practice, I reject the
verify DEA credentials of prescribing receives an electronic prescription for a Government’s contention that
doctors (either by contacting the DEA 25 controlled substance to check the CSA Respondent violated federal law and
or subscribing to a private verification database in every instance to confirm DEA regulations in filling these
service) demonstrates a lack of that the prescribing practitioner is prescriptions.
experience material to the application.’’ properly registered with DEA.’’ Id. The
Agency thus removed the requirement Allegation Two—Respondent’s Filling
Id. at 23 (emphasis added). Thus, the
from the Interim Final Rule, but ‘‘made of Suboxone Prescriptions
ALJ applied a standard of strict liability
in concluding that Ms. Santiago-Soto clear that a pharmacist continues to Regarding this allegation, the
had ‘‘failed to act in the usual course of have a corresponding responsibility to evidence shows that Respondent filled
professional pharmacy practice.’’ Id. at fill only those prescriptions that twenty-nine Suboxone prescriptions,
34. conform in all respects with the which were issued by Dr. Aguilar-
Contrary to the ALJ’s understanding, requirements of the [CSA] and DEA Amieva and Dr. Vargas-Quinones, see
no Agency regulation requires that a regulations, including the requirement GX 4, at 23–24; and Ms. Santiago-Soto
pharmacist ascertain that each that the prescribing practitioner be admitted that a majority of the
prescription presented to him/her has properly registered.’’ Id. However, as prescriptions (17 of the 29) listed ‘‘a
been issued by a practitioner who explained above, the corresponding diagnosis that is related to the abuse of
possesses a valid DEA registration and responsibility does not impose strict opioids[] or opiates.’’ Tr. 108. It was
the Agency expressly disclaimed the liability on pharmacists but rather undisputed that neither Dr. Aguilar-
existence of such a duty in 2010, when requires proof that a pharmacist filled a Amieva nor Dr. Vargas-Quinones was
it promulgated its Interim Final Rule on controlled-substance prescription either qualified to prescribe Suboxone to treat
Electronic Prescriptions for Controlled knowing that it was unlawful or with narcotic addiction. See GX 6, at 1 & 5.
Substances. See 75 FR 16236, 16266 willful blindness or deliberate ignorance A physician who seeks to prescribe
(2010). Therein, the Agency noted that of the fact that the prescription was Suboxone (or other schedule III through
it had proposed requiring pharmacies unlawful.26 V drugs approved by FDA) for
‘‘to confirm that the [prescriber’s] DEA maintenance or detoxification treatment
registration . . . was valid at the time’’ 26 Notwithstanding the Agency’s pronouncement must meet certain conditions (including
the prescription was signed. Id. in the Interim Rule, the Agency’s corresponding that the physician either holds various
responsibility rule is not the only potential basis for certifications or has training or
finding a violation where a pharmacist dispenses a
25 Based on the testimony of the DI, the ALJ found
controlled substance prescription issued by a
experience in the management of opiate-
that ‘‘[i]n order to determine whether a medical practitioner who does not hold the requisite dependent patients) and must provide a
provider is authorized by the DEA to prescribe authority. Upon a showing that such conduct is notification (which includes various
controlled substances, a pharmacist may contact the
DEA by telephone and inquire.’’ R.D. 31 (FoF #13);
outside of ‘‘the usual course of professional certifications) to the Secretary of the
practice,’’ 21 CFR 1306.06, a pharmacist may be Department of Health and Human
see also id. at 23 (‘‘Although it might be a
held to have violated DEA regulations and to have
cumbersome and time-consuming verification
committed acts which render her pharmacy’s Services, who must then determine
process, the DEA does permit a pharmacist to call
into a field office to confirm the status of a given registration inconsistent with the public interest. (within 45 days from the date of receipt
prescribing source.’’). However, as found above, the Moreover, in Medicine Shoppe—Jonesborough, of the notification) whether the
ALJ barred Respondent from using a Question and 73 FR 364, 381 (2008), the ALJ found that a physician meets the requirements for a
Answer printout from the DEA Web page to pharmacist had filled a large number of controlled-
substance prescriptions which were issued by a
waiver under 21 U.S.C. 823(g)(2)(B). 21
impeach the DI’s testimony to this effect, reasoning
that the Respondent was required to disclose this veterinarian who did not hold either a state license CFR 1301.28(a)–(d). If the practitioner
document in advance of the hearing. Tr. 164. or DEA registration. The ALJ further found that this holds ‘‘the appropriate registration’’ and
It is true that under the Agency’s rule, a party is conduct constituted such other conduct which may the Secretary either makes ‘‘a positive
generally required to provide a copy of any threaten public health and safety, reasoning, in part,
that a pharmacy has a duty to periodically verify
determination’’ or fails to act within the
proposed exhibit which is being offered as
substantive evidence in the matter. However, whether a prescriber retains authority to practice 45 day period, DEA issues an
contrary to the ALJ’s understanding, a party is not medicine and dispense controlled substances. I identification number, which is
required to disclose, in advance of the hearing, a found a violation of 21 CFR 1306.04(a), based on otherwise known as an X-number to the
document which is being used to impeach a the evidence that the prescriptions were being
presented on a daily basis by the veterinarian’s
practitioner. Id. § 1301.28(d)(1); see also
witness. I therefore reject this finding.
As for the NTIS database, the ALJ acknowledged brother and were for drugs that were toxic for Tr. 48–49.
that subscribing to this service is expensive. certain animals. However, in dictum, I noted that Moreover, under DEA’s regulation:
However, he then opined that ‘‘[i]t is no answer to ‘‘[a] pharmacy has a duty to periodically check to
A prescription may not be issued for
see that a practitioner retains the authority to
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complain that the NTIS program costs a lot of ‘‘detoxification treatment’’ or ‘‘maintenance
money; nor is it a sufficient legal response to argue practice medicine and dispense a controlled
substance.’’ Id. at n.45. I also noted my agreement treatment,’’ unless the prescription is for a
that DEA regulations do not require pharmacists to
purchase the program.’’ R.D. at 23. To the extent with the ALJ’s reasoning that failing ‘‘to do so could
this comment might be understood as creating an threaten public health and safety because there is credentials of prescribers. Nor has the Agency
obligation on all pharmacies to subscribe to this usually a good reason for why a practitioner has lost published any guidance to the regulated community
service, it is rejected. While it was not fully his or her state license and DEA registration.’’ Id. setting forth the parameters of this duty. What is
developed on the record of this proceeding, DEA The Government does not rely on this theory and clear, however, is that a pharmacy is not required
provides a web tool which allows a registrant to no case (until recently) has presented the question to verify the credentials of the prescriber for every
verify the registration of another person or entity. of how frequently a pharmacy must re-verify the prescription it fills.
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Schedule III, IV, or V narcotic drug approved respect to the seventeen Suboxone that ignorance of the law is no defense
by the Food and Drug Administration prescriptions which contained a applies whether the law be a statute or
specifically for use in maintenance or notation by the doctor that he had a duly promulgated and published
detoxification treatment and the practitioner
diagnosed the patient as being opioid regulation.’’).
is in compliance with requirements in
§ 1301.28 of this chapter. dependent, Ms. Santiago-Soto knew that Indeed, Ms. Santiago-Soto’s testimony
the prescriptions were issued to provide regarding the allegation was most
21 CFR 1306.04(c) (emphasis added). either maintenance or detoxification unpersuasive. More specifically, Ms.
So too, pursuant to 21 CFR treatment.29 Moreover, notwithstanding Santiago-Soto testified that she had
1306.05(b), ‘‘[a] prescription for a the clear requirement that the graduated from pharmacy school in
Schedule III, IV, or V narcotic drug prescriptions include (in addition to the 1995, and that the DATA law was
approved by FDA specifically for prescriber’s DEA number), either his passed in 2000, but after 2002, when
‘detoxification treatment’ or DATA-waiver identification number or Suboxone was approved by FDA for the
‘maintenance treatment’ must include the practitioner’s statement that he was purpose of treating narcotic addiction,
the identification number issued by the ‘‘acting under the good faith exception ‘‘the DEA in Puerto Rico never has
Administrator under 1301.28(d) of this of § 1301.28(e),’’ none of the provided any orientation or guidance
chapter or a written notice stating that prescriptions contained either an X- online, or by way of a conference, or
the practitioner is acting under the good number or the good faith statement. through continuing education, or by
faith exception of [21 CFR] In her testimony, Ms. Santiago-Soto letters, letting me know, or providing
1301.28(e).’’ 27 (emphasis added). This maintained that she ‘‘was not aware’’ me these kinds of guidelines.’’ Tr. 110.30
information is in addition to the that the X number had to be on the
prescription ‘‘for that medication in However, in 2003, the Agency
prescriber’s DEA registration number.
particular,’’ Tr. 110, and that she ‘‘was published in the Federal Register a
See 21 CFR 1306.05(a). Also, under 21
not aware that buprenorphine [the notice of proposed rulemaking, and in
CFR 1306.05(f), ‘‘[a] corresponding
generic name for Suboxone] fell among 2005, the Agency published its final
liability rests upon the pharmacist . . .
the medications that required the X DEA rule, which promulgated the various
who fills a prescription not prepared in
number.’’ Id. at 112. However, Ms. provisions set forth above, including 21
the form prescribed by DEA
Santiago-Soto did know that the CFR 1301.28 (requirements for obtaining
regulations.’’ However, none of the
purpose of most of the Suboxone an X-number and the good faith
Suboxone prescriptions issued by either
prescriptions was to treat narcotic exception), 21 CFR 1306.04(c)
Dr. Aguilar-Amieva or Dr. Vargas-
addiction. And as explained above, (prohibiting a prescription for
Quinones bore either an X number or a
under the Agency’s regulation, a maintenance or detoxification treatment
statement that the physician was ‘‘acting
prescription could not be issued for a unless the drug has been approved by
under the good faith exception.’’ See GX
Schedule III through V controlled FDA for this purpose and the
3, at 410–456.
The Government contends that substance such as Suboxone for this practitioner is in compliance with
Respondent violated, inter alia, 21 CFR purpose unless the drug was approved 1301.28), 21 CFR 1306.05(a) (requiring
1306.04 and 1306.06, because it ‘‘does by FDA for this purpose and the that such prescription include either the
not contest that [it] acted outside the practitioner met the requirements for prescriber’s X number or a good faith
usual course of professional practice’’ prescribing for this purpose. statement), and 21 CFR 1306.07
when it dispensed the Suboxone Accordingly, her testimony does not (allowing a practitioner to administer,
prescriptions. Gov. Post-Hrng. Br., at 12. establish that she made a mistake of fact dispense or prescribe a Schedule III
Contrary to the Government’s but rather that she was ignorant of the through V drug specifically approved by
understanding, Ms. Santiago-Soto made regulations. This, of course is not a FDA for use in maintenance or
no such admission and the Government defense. See United States v. detoxification treatment if the
put forward no evidence as to what the International Minerals & Chem. Corp., practitioner complies with 1301.28). See
usual course of professional practice 402 U.S. 558, 563 (1971) (‘‘The principle DEA, Authority for Practitioners to
requires of a pharmacist who is Dispense or Prescribe Approved
presented with prescriptions that are knowingly fill a prescription that is issued outside Narcotic Controlled Substances for
clearly marked as being issued for the of the usual course of professional practice and Maintenance or Detoxification
which lacks a legitimate medical purpose, Treatment, 70 FR 36338 (2005); see also
purpose of providing maintenance or subsection c impose duties only on the issuer of the
detoxification treatment for narcotic- prescription which has been issued to provide
DEA, Authority for Practitioners to
dependent patients and yet are missing maintenance or detoxification treatment. See 21 Dispense or Prescribe Approved
the requisite X number or good faith U.S.C. 1306.04(c). However, as explained above, 21 Narcotic Controlled Substances for
CFR 1306.05(f), imposes ‘‘[a] corresponding liability Maintenance or Detoxification
statement. . . . upon the pharmacist . . . who fills a
However, the evidence does establish prescription not prepared in the form prescribed by
Treatment, 68 FR 37429 (2003) (Notice
that Ms. Santiago-Soto violated 21 CFR DEA regulations.’’ of Proposed Rulemaking). Indeed, prior
1306.05(f) when she filled at least 29 I do not find any violations with respect to to the 2005 issuance of the final rule, no
seventeen of these prescriptions.28 With those prescriptions which did not contain a narcotic controlled substance could be
diagnosis of narcotic dependence. Under federal prescribed by a physician (including
law, a doctor may prescribe a drug for a legitimate
27 The good faith exception applies only during
off-label use and absent evidence that the those authorized to conduct a narcotic
the period before the practitioner receives his X- prescriptions, which lacked a diagnosis of narcotic treatment program under 21 U.S.C.
number from the Agency and only if ‘‘[t]he dependence, were actually being issued for this 823(g)(1)) to treat narcotic addiction and
Secretary has not notified the registrant that he/she purpose, I do not find a violation proved. The
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is not qualified’’ to provide such treatment. 21 CFR
no pharmacy could have lawfully
Government offers no argument to the effect that a
1301.28(e). doctor cannot prescribe Suboxone for any legitimate
28 While the Government alleged that Respondent medical purpose unless they have X-number. Nor 30 The Government offered no evidence regarding
violated 21 CFR 1306.04 in filling the Suboxone did it offer evidence that when a pharmacist is the contents of the package insert for Suboxone and
prescriptions, it did not identify the specific presented with a Suboxone prescription that does whether it contained any special instructions
subsection which it alleges was violated. See Gov. not list a diagnosis and lacks an X number, the regarding the prescribing and dispensing of
Post-Hrng. Br. at 12. Notably, in contrast to standards of professional practice require the Suboxone following the FDA’s approval of the drug
subsection a of this regulation, which imposes a pharmacist to call the physician and determine the for use in providing maintenance or detoxification
corresponding responsibility on a pharmacist to not purpose of the prescription. treatment.
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dispensed such a prescription. See id. at for ten tablets or less), there were also inconsistent with the public interest, the
37429. two prescriptions for sixty tablets issued registrant must accept responsibility for
As the 2003 Notice of Proposed to the same patient, which contained a its actions and demonstrate that it will
Rulemaking explained: diagnosis of opiate dependence. Thus, I not engage in future misconduct.’’
[t]he Controlled Substances Act (CSA) and am not persuaded by her testimony Medicine Shoppe, 73 FR at 387; see also
current regulations requires that practitioners ‘‘that the amounts are not such that Jackson, 72 FR at 23853; John H.
who want to conduct maintenance or would raise my suspicions that Kennedy, 71 FR 35705, 35709 (2006);
detoxification treatment using narcotic something is running amok.’’ Tr. 109– Prince George Daniels, 60 FR 62884,
(opioid) controlled drugs be registered with 10. 62887 (1995). See also Hoxie v. DEA,
DEA as narcotic treatment programs (NTPs) However, Ms. Santiago-Soto testified 419 F.3d at 483 (‘‘admitting fault’’ is
in addition to the practitioners’ personal that she had become aware of the DATA ‘‘properly consider[ed]’’ by DEA to be
registrations. The separate NTP registrations
authorize the practitioners to dispense or
of 2000 during an audit by a health an ‘‘important factor[]’’ in the public
administer, but not prescribe narcotic insurance plan, which occurred months interest determination).
(opioid) controlled drugs. before she was arrested and surrendered While a registrant must accept
her registration, and that she then went responsibility and demonstrate that it
Id. The Notice also observed that ‘‘[o]n online and familiarized herself with the will not engage in future misconduct in
October 8, 2002, FDA approved two statute’s requirements. Tr. 112. Most order to establish that its registration is
products containing buprenorphine, significantly, the Government’s own consistent with the public interest, DEA
[S]ubutex and [S]uboxone, Schedule III evidence shows that Respondent has repeatedly held these are not the
controlled drugs, for use in maintenance dispensed the last Suboxone only factors that are relevant in
and detoxification treatment,’’ and that prescription on July 3, 2011, nearly five determining the appropriate sanction.
the proposed rule would ‘‘[p]ermit months before Ms. Santiago-Soto was See, e.g., Joseph Gaudio, 74 FR 10083,
pharmacies to fill prescriptions for arrested and surrendered its 10094 (2009); Southwood
Schedule III, IV, and V narcotic (opioid) registration.31 See GX 4, at 23–24. Pharmaceuticals, Inc., 72 FR 36487,
controlled drugs approved by FDA Finally, in her testimony, Ms. Santiago- 36504 (2007). Obviously, the
specifically for use in maintenance or Soto demonstrated some degree of egregiousness and extent of a
detoxification treatment.’’ Id. at 37430. knowledge of the requirements registrant’s misconduct are significant
The dispensing of controlled pertaining to the prescribing of factors in determining the appropriate
substances is a highly regulated Suboxone to identify those prescriptions sanction. See Jacobo Dreszer, 76 FR
industry, and as a participant in this which do not comply with the DATA 19386, 19387–88 (2011) (explaining that
industry, Ms. Santiago-Soto is properly requirements and should not be a respondent can ‘‘argue that even
charged with knowledge of the dispensed. Tr. 110. though the Government has made out a
applicable regulations, including: (1) Thus, while I conclude that the prima facie case, his conduct was not so
The requirement that a Suboxone Government has proved that egregious as to warrant revocation’’);
prescription, which has been issued to Respondent committed acts which are Paul H. Volkman, 73 FR 30630, 30644
provide treatment for opiate addiction, ‘‘inconsistent with the public interest,’’ (2008); see also Paul Weir Battershell,
can only be issued by a person who 21 US.C. § 823(f), I also find that there 76 FR 44359, 44369 (2010) (imposing
meets the requirements of 21 CFR are several factors which mitigate the six-month suspension, noting that the
1301.28; as well as (2) that the violations. evidence was not limited to security and
prescription must bear either the recordkeeping violations found at first
prescriber’s X-number or the good faith Sanction
inspection and ‘‘manifested a disturbing
statement. See International Minerals, Under Agency precedent, where, as pattern of indifference on the part of
402 U.S. at 565 (where ‘‘dangerous or here, ‘‘the Government has proved that [r]espondent to his obligations as a
deleterious . . . products . . . are a registrant has committed acts registrant’’); Gregory D. Owens, 74 FR
involved, the probability of regulation is inconsistent with the public interest, a 36751, 36757 n.22 (2009). So too, the
so great that anyone who is aware that registrant must ‘‘ ‘present sufficient Agency can consider the need to deter
he is in possession of them or dealing mitigating evidence to assure the similar acts, both with respect to the
with them must be presumed to be Administrator that it can be entrusted respondent in a particular case and the
aware of the regulation’’); United States with the responsibility carried by such community of registrants. See Gaudio,
v. Southern Union Co., 630 F.3d 17, 31 a registration.’ ’’ ’’ Medicine Shoppe- 74 FR at 10095 (quoting Southwood, 71
(1st Cir. 2010) (‘‘[T]hose who manage Jonesborough, 73 FR 364, 387 (2008) FR at 36503). Cf. McCarthy v. SEC, 406
companies in highly regulated (quoting Samuel S. Jackson, 72 FR F.3d 179, 188–89 (2d Cir. 2005)
industries are not unsophisticated. It is 23848, 23853 (2007) (quoting Leo R. (upholding SEC’s express adoptions of
part of [their] business to keep abreast Miller, 53 FR 21931, 21932 (1988))). ‘‘deterrence, both specific and general,
of government regulation.’’) (citing ‘‘Moreover, because ‘past performance is as a component in analyzing the
United States v. Lachman, 387 F.3d 42, the best predictor of future remedial efficacy of sanctions’’).
56–57 (1st Cir. 2004)), rev’d on other performance,’ ALRA Labs, Inc. v. DEA, As found above, the only allegation
grounds, 132 S.Ct. 2344 (2012). 54 F.3d 450, 452 (7th Cir.1995), [DEA] sustainable on the record is that
I therefore find that Ms. Santiago-Soto has repeatedly held that where a Respondent filled seventeen Suboxone
knowingly dispensed the seventeen registrant has committed acts prescriptions that were issued to
Suboxone prescriptions which were provide maintenance or detoxification
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31 It is also noted that Respondent had stopped
issued for maintenance or detoxification treatment by two physicians who were
dispensing these prescriptions two months before a
purposes in violation of federal law by DEA inspection which occurred on September 7,
not DATA-waived physicians. As
the respective physicians and thus also 2011. See RX H. While DEA had also inspected explained above, I find that Ms.
violated federal law in doing so. 21 CFR Respondent on September 2, 2010, see RX G, as of Santiago knowingly violated federal law
1306.04(c); see also 21 U.S.C. 841(a)(1). that date, Respondent had dispensed but a single by dispensing these prescriptions
prescription (only three days earlier) for fourteen
While it is true, as Ms. Santiago-Soto tablets. GX 4, at 23–24. No evidence was put
because the purpose of the prescriptions
testified, that the amounts of most of the forward by the Government as to whether this was clearly identified on them and none
prescriptions were limited (most being prescription was discussed with Ms. Santiago-Soto. of the prescriptions had the physician’s
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identification number or the requisite In its Exceptions, Respondent argues between doctor and patient.’’ Tr. 117.
good faith statement. Moreover, the that the ALJ’s recommended sanction of While the Government did not address
Government’s interest in deterring denial ‘‘is drastic and overly broad.’’ the validity of this statement in its post-
pharmacists from dispensing Suboxone Exceptions at 15. It argues, inter alia, hearing brief, it is flatly inconsistent
prescriptions, which have been issued that the Agency ‘‘could grant a license with long-standing authority setting
to treat narcotic-dependent patients by with a monetary sanction or provide in forth the scope of a pharmacist’s
physicians, who lack the requisite its determination that it can be issued corresponding responsibility under the
qualifications to treat such patients, is after a determined period of additional Controlled Substances Act. See, e.g.,
manifest. time’’; it also argues that it ‘‘is willing United States v. Hayes, 595 F.2d 258,
Regarding these violations, to undertake and place into action any 260 (5th Cir. 1979); see also Medicine
Respondent’s evidence of its acceptance diverse measures the DEA requires as a Shoppe—Jonesborough v. DEA, 300
of responsibility was less than condition for approving the’’ Fed. App’x 409, 412 (6th Cir. 2008)
unequivocal. While Ms. Santiago-Soto application. Id. at 16. (quoting Ralph J. Bertolino, 55 FR 4729,
admitted that she was aware that the ‘‘Proceedings under sections 303 and 4730 (1990) (‘‘ ‘When [pharmacists’]
prescriptions were issued to treat 304 of the CSA are . . . non-punitive.’’ suspicions are aroused as reasonable
substance abuse patients and that she Samuel S. Jackson, 72 FR 23848, 23853 professionals,’ they must at least verify
should have learned about the (2007) (citing Leo R. Miller, 53 FR the prescription’s propriety, and if not
requirements applicable to the 21931, 21932 (1988)). As the Agency satisfied by the answer they must ‘refuse
prescribing of Suboxone for this previously recognized, ‘‘this proceeding to dispense.’ ’’)). Accordingly, I will
purpose earlier than she did, she also ‘is a remedial measure, based upon the order that Ms. Santiago-Soto take a
attempted to minimize her misconduct public interest and the [need] to protect course on controlled substance
by attributing it to the failure of the DEA the public from those individuals who dispensing and the corresponding
office in Puerto Rico to provide any have misused their’’ registrations and responsibility of a pharmacist under
guidance to her regarding the ‘‘who have not presented sufficient federal law. Said course must be
requirements. DEA did, however, mitigating evidence to assure the completed and a certificate of such
publish, in the Federal Register, both a Administrator that they can be entrusted completion must be presented to the
Notice of Proposed Rulemaking and a with the responsibility’’ attendant with Agency prior to the granting of
Final Rule, which provided legally holding a registration. Id. (quoting Respondent’s application.
sufficient notice that Suboxone could Miller, 53 FR at 21932). I will further order that Respondent’s
only be prescribed for maintenance or I agree with Respondent that the
application be held in abeyance for six
detoxification purposes by a qualified outright denial of its application is not
months from the date of this order (not
physician, and that such a physician supported by the record and that its
the date of publication) at which time,
was required to either list his application can be granted ‘‘after a
its application shall be granted provided
identification number or provide a good determined period of additional time,’’
Respondent has provided evidence to
faith statement on the prescriptions. subject to Respondent meeting various
Yet, while Ms. Santiago-Soto is DEA that Ms. Santiago-Soto has
conditions. First, while I acknowledge
presumed to have knowledge of the completed the above-described course
Ms. Santiago-Soto’s testimony as to the
applicable regulations and thus violated and commits no violation of federal or
steps she took to familiarize herself with
federal law in dispensing those commonwealth controlled substance
the requirements pertaining to the
Suboxone prescriptions which bore a laws. If, however, Ms. Santiago-Soto
prescribing of Suboxone, she also
diagnosis indicating that they were fails to provide evidence that she has
testified that while she reviews a
issued to treat narcotic addiction, the completed such course within the six-
prescription to ensure that it meets legal
egregiousness of her misconduct is month period, Respondent’s application
requirements and is not suspicious, she
diminished by two factors. First, the shall be denied.
does not ‘‘speak with the doctors’’
violations were limited in scope, as the because ‘‘[t]here is a confidentiality law Upon the granting of the registration,
total amount of the unlawful Respondent shall be placed on
dispensings was 224 tablets. Second, in the future, for example.’’ Id. There is, however,
probation for a period of three years.
Ms. Santiago-Soto had determined, prior no evidence in the record that a DATA-waived list During the period of the probation,
to the Agency’s bringing it to her exists, whether maintained by DEA or any other Respondent and its principal shall agree
agency. to consent to unannounced inspections
attention, that the Suboxone It may be that the ALJ actually meant to say that
prescriptions were illegal, and at the by DEA personnel and shall waive its
he does not believe that Ms. Santiago-Soto will
time she surrendered Respondent’s properly verify that the issuers of Suboxone right to require DEA personnel to obtain
registration, had long since ceased the prescriptions for addiction treatment will have the an Administrative Inspection Warrant
offending practice.32 requisite qualifications. If this was the ALJ’s intent, prior to conducting an inspection. Ms.
it is refuted by his acknowledgment—one page Santiago-Soto shall provide a letter to
earlier in his decision—of Ms. Santiago-Soto’s
32 In rejecting Respondent’s evidence of
testimony that she would subscribe to the NTIS DEA manifesting Respondent’s consent
remediation, the ALJ faulted Ms. Santiago-Soto for service and that ‘‘[t]his would appear to be an to unannounced inspections by DEA
testifying that DEA ‘‘maintained information on its effective remedial step [which] possibly could and waiving its right to require DEA
Web site that is contradictory to what the Diversion lessen the risk of filling prescriptions for Suboxone
Investigator said during the hearing.’’ R.D. at 29.
personnel to obtain an Administrative
if the prescribing provider was not a DATA-
Given that the ALJ improperly precluded waived’’ physician. Id. at 29. (Indeed, I have taken Inspection Warrant prior to the issuance
Respondent from using a printout from the official notice that the DEA registration validation of its registration.
Agency’s Web site to impeach the DI, there is no web-tool provides this information. See 21 CFR
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Respondent shall provide a copy of its
basis for this finding. 1316.59(e)). Moreover, the ALJ entirely ignored Ms.
The ALJ further found that there is ‘‘scant Santiago-Soto’s testimony (which is corroborated by
controlled substance dispensing log on
evidence that Ms. Santiago-Soto has engaged in a the Government’s evidence), that following the a quarterly basis to the DEA Ponce
course of conduct that would ensure that she audit by a health plan, she reviewed the Office. Said quarters shall end on March
remains properly informed about changes in DEA requirements applicable to prescribing Suboxone to 31st, June 30th, September 30th, and
controlled substance regulations.’’ Id. at 30. treat narcotic addiction, and the evidence that she
Continuing, he explained that ‘‘[t]here was no had ceased dispensing the Suboxone prescriptions
December 31st of each year, and the log
suggestion that she would accept responsibility for long before DEA raised this as an issue with her. shall be provided to the DEA Ponce
keeping up with changes in the DATA-waived list See R.D. at 29–30. Office no later than ten (10) calendar
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days following the last day of each Recommended Decision.1 Respondent recommended order, except as
quarter. filed Exceptions to the Decision. discussed below. A discussion of
Respondent and Ms. Santiago-Soto Having reviewed the entire record, Respondent’s Exceptions follows.
shall notify the DEA Ponce Office of any including Respondent’s Exceptions, I
have decided to adopt the ALJ’s findings Exception One—Whether Respondent
disciplinary action undertaken against Was Denied Adequate Notice Because
its pharmacy license and Puerto Rico of fact,2 conclusions of law, and
the ALJ Relied on Matters That Were
controlled substance registration, as Not Raised in the Order To Show Cause
1 All citations to the Recommended Decision
well as any action taken against Ms.
Santiago-Soto’s pharmacist license, (hereinafter, cited as R.D.) are to the slip opinion Respondent argues that her rights
as issued by the ALJ. under the Due Process Clause and the
including the initiation of any 2 I do not adopt the ALJ’s findings that
proceeding by the Commonwealth’s hydrocodone combined with acetaminophen is a
Administrative Procedure Act were
authorities to suspend or revoke any of schedule III controlled substance. See, e.g., R.D. at violated because in the Show Cause
the licenses or registration. Such 5 n.12; id. at 20 n.42. While that was correct at the Order, the Government alleged only that
time of the underlying events, as well as on the date Respondent forged eight prescriptions
notification shall occur no later than of the issuance of the Recommended Decision, this
three business days following service on drug has since been placed in schedule II of the and the ALJ proceeded to rely on ‘‘other
Respondent or Ms. Santiago-Soto of any Controlled Substances Act. See Rescheduling of matters of fact to support’’ his
document initiating such a proceeding, Hydrocodone Combination Products from Schedule recommendation. Exceptions, at 2.
III to Schedule II, 79 FR 49661 (2014). Respondent does not, however, identify
any interim or emergency order of I also do not adopt the ALJ’s finding that the
suspension, and any final order. dispensing event which occurred on March 15,
the specific facts of which she believes
The above conditions shall terminate 2011 was based on a hard copy prescription which she was denied adequate notice, but
upon Respondent’s completion of the was dated March 11, 2011, or that the March 11 rather, simply asserts that ‘‘the matters
prescription was presented to different pharmacies determined by the ALJ to support
period of probation, provided on three occasions. See R.D. at 22–25. Rather, I find
Respondent fully complies with each that the March 15 prescription was based on a findings against Respondent as to
term of its probation. Any violation of telephone prescription which was dated March 15, factors four and five were not previously
these conditions shall constitute an act
2014. See GX 6, at 3; GX 8, at 5. As for the hard raised in the Order to Show Cause.’’ Id.
copy prescription which the ALJ cited as the at 3.
inconsistent with the public interest and evidence to support this finding, I find the date to
To the extent Respondent takes issue
grounds for the suspension or be illegible. However, this finding does not alter the
disposition of this matter because I adopt the ALJ’s with the ALJ’s decision because the
revocation of Respondent’s registration.
finding that PA Francis, whose prescribing Show Cause Order alleged only eight
Order authority was used to obtain the prescriptions, instances of forgery rather than the ten
credibly denied having issued Respondent any
Pursuant to the authority vested in me controlled substance prescriptions after the initial
instances that the ALJ found proved (as
by 21 U.S.C. 823(f), as well as 28 CFR controlled substance prescription she issued on well as the instance in which
0.100(b), I order that the Application of February 14, 2011. See R.D. at 55. Respondent filled the first prescription
Farmacia Yani be, and it hereby is, held
While I adopt the ALJ’s finding that the testimony a second time at a second pharmacy),
of Malana Diminovich, who testified that the PA her argument is not well taken.
in abeyance for a period of six months had issued the controlled substance prescriptions,
to begin on the date of this ORDER. I was not credible, as explained in my discussion of However, to the extent Respondent
further order that upon the conclusion Respondent’s fourth exception, I do not rely on his takes issue with the ALJ’s finding that
of the six-month period, the Application
reasoning to the extent it is based on the suggested Respondent engaged in conduct
inconsistency between Diminovich’s testimony that actionable under factor five because she
of Farmacia Yani shall be granted or ‘‘Respondent was never observed to be under the
denied as set forth above. I also order influence of controlled substances during the time attempted to obstruct the pharmacist
that in the event that Ms. Santiago-Soto the two worked together’’ and ‘‘that she was aware who questioned her prescription from
complies with the condition that she
that . . . Respondent was receiving controlled contacting PA Francis, her argument is
substance prescriptions from PA Francis.’’ Id. at 30– well taken.
complete a course in controlled 31.
One of the fundamental tenets of Due
substance dispensing and the In his decision, the ALJ found that ‘‘the only
evidence received on the issue supports the Process is that an Agency must provide
corresponding responsibility, Farmacia
Respondent’s claim that she had an objective a Respondent with notice of those acts
Yani’s Application shall be granted medical basis that could arguably have supported which the Agency intends to rely on in
subject to the probationary conditions the prescribing of controlled substances,’’ Id. at 62. seeking the revocation of its registration
set forth above. This ORDER is effective Given the ALJ’s findings, it is notable that the
record is devoid of evidence as to whether patients so as to provide a full and fair
immediately.
who are taking narcotics for legitimate pain would opportunity to challenge the factual and
Dated: May 12, 2015. necessarily manifest symptoms consistent with legal basis for the Agency’s action. See
Michele M. Leonhart, abuse or intoxication. NLRB v. I.W.G., Inc., 144 F.3d 685, 688–
In any event, the Government’s case primarily
Administrator. focused on Respondent’s obtaining of controlled
89 (10th Cir. 1998); Pergament United
[FR Doc. 2015–12130 Filed 5–19–15; 8:45 am] substances through fraud or misrepresentation such Sales, Inc. v. NLRB, 920 F.2d 130, 134
BILLING CODE 4410–09–P as by presenting forged prescriptions. Thus, (2d Cir. 1990); see also 5 U.S.C. 554(b)
resolution of the allegations does not require proof (‘‘Persons entitled to notice of an agency
that Respondent was abusing the controlled
substances.
hearing shall be timely informed of . . .
DEPARTMENT OF JUSTICE Also, I do not adopt the ALJ’s findings related to the matters of fact and law asserted.’’)
the dates of the phone call in which Dr. Edmonds (emphasis added).
Drug Enforcement Administration confronted Respondent as to whether she was However, ‘‘ ‘[p]leadings in
forging prescriptions which were purportedly administrative proceedings are not
mstockstill on DSK4VPTVN1PROD with NOTICES
authorized by PA Francis. In the decision, the ALJ
[Docket No. 12–62] referred to this phone call as occurring in July 2011,
judged by the standards applied to an
following Respondent’s positive urinalysis for indictment at common law.’ ’’ Aloha
Jana Marjenhoff, D.O.; Decision and opiates. See R.D. at 39. The evidence is clear, Airlines v. Civil Aeronautics Bd., 598
Order however, that this conversation did not occur in F.2d 250, 262 (D.C. Cir. 1979) (quoted in
response to the July 2011 drug test, but in
September 2011, after a pharmacist had notified PA
CBS Wholesale Distributors, 74 FR
On June 24, 2014, Chief
Francis about the prescriptions and the latter had
Administrative Law Judge (ALJ) John J. presented a printout from the State Prescription Resources Manager, who raised it with Dr.
Mulrooney, Jr., issued the attached Monitoring Program to the clinic’s Human Edmonds. See Tr. 195–202; 368; 831–32.
VerDate Sep<11>2014 23:50 May 19, 2015 Jkt 235001 PO 00000 Frm 00139 Fmt 4703 Sfmt 4703 E:\FR\FM\20MYN1.SGM 20MYN1](https://thefederalregister.org/doc/80_FR_29150/page/15.svg)
Document Created: 2018-02-21 10:29:26
Document Modified: 2018-02-21 10:29:26
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 80 FR 29053 |
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