81 FR 47411 - Turning Tide, Inc. Decision and Order; Procedural History
DEPARTMENT OF JUSTICE
Drug Enforcement Administration Federal Register Volume 81, Issue 140 (July 21, 2016)
Drug Enforcement Administration
Federal Register Volume 81, Issue 140 (July 21, 2016)
| Page Range | 47411-47416 | |
| FR Document | 2016-17245 |
[Federal Register Volume 81, Number 140 (Thursday, July 21, 2016)] [Notices] [Pages 47411-47416] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17245] ----------------------------------------------------------------------- DEPARTMENT OF JUSTICE Drug Enforcement Administration [Docket No. 10-71] Turning Tide, Inc. Decision and Order; Procedural History On August 17, 2010, the former Administrator of the Drug Enforcement Administration issued an Order to Show Cause and Immediate Suspension of Registration (hereinafter, Show Cause Order or Order) to Turning Tide, Inc. (Respondent), of Rockland, Maine. Show Cause Order, at 1. The Show Cause Order proposed the revocation of Respondent's DEA Certificate of Registration RT0370015,\1\ which authorized it to dispense controlled substances as a Narcotic Treatment Program pursuant to 21 U.S.C. 823(g)(1), and the denial of any pending applications to renew or modify its registration, on the ground that its ``continued registration is inconsistent with the public interest, as that term is defined in 21 U.S.C. 823(f).'' Id. at 1. --------------------------------------------------------------------------- \1\ The Order alleged that Respondent's registration was due to expire on November 30, 2010. --------------------------------------------------------------------------- The Show Cause Order specifically alleged that ``Respondent is owned by Angel Fuller-McMahan'' and that its ``registration is conditioned upon a Memorandum of Agreement (MOA) with DEA which prohibits Ms. Fuller-McMahan from (1) having physical access to Respondent's premises; (2) ordering controlled substances on behalf of Respondent; and (3) executing any renewal applications . . . on behalf of Respondent.'' Id. at 1-2. The Order then alleged that Ms. Fuller- McMahan had been arrested on July 13, 2010 and charged with unlawful possession of cocaine, and that at the time of her arrest, she had in her possession approximately 25 grams of cocaine and two hypodermic needles.\2\ Id. at 2. The Order further alleged that Ms. Fuller-McMahan had ``arranged to purchase cocaine'' from both a patient and an employee of Respondent. Id. The Order also alleged that ``[w]hile serving as Respondent's Program Director, Ms. Fuller-McMahan approached another patient . . . and offered to trade methadone for cocaine'' by ``creat[ing] a fraudulent order for methadone,'' even though she was then prohibited by the MOA from ordering controlled substances on behalf of Respondent. Id. The Order then alleged that Ms. Fuller- McMahan had purchased cocaine in three separate ``illegal drug transactions with another of Respondent's patients.'' Id. --------------------------------------------------------------------------- \2\ The Order also alleged that on August 31, 2001, Ms. Fuller- McMahan had been convicted in state court of unlawful possession of heroin. Show Cause Order, at 2. --------------------------------------------------------------------------- Next, the Show Cause Order alleged that notwithstanding the MOA's terms, ``Ms. Fuller-McMahan continues to retain control and have supervisory authority over key aspects of Respondent's operation,'' that she had represented to a patient ``that she has access to controlled substances which are ordered on behalf of Respondent,'' and that she has ``repeatedly violated the terms of the MOA by entering the physical premises of [Respondent] and executing a renewal application on [its] behalf.'' Id. Finally, the Order alleged that Respondent ``continued to employ Ms. Fuller-McMahan's husband, Vance McMahan, despite the fact that Mr. McMahan has been convicted of illegal drug possession and has access to Respondent's controlled substances and confidential patient information.'' Id. Based on the above allegations, the former Administrator concluded that Respondent's continued registration during the pending of the proceeding would ``constitute an imminent danger to the public health and safety'' and therefore ordered that its registration be suspended immediately. Id. at 3 (citing 21 U.S.C. 824(d)). The former Administrator also authorized the Special Agents and Diversion Investigators who served the Order to either ``place under seal or to remove for safekeeping all controlled substances that [Respondent] possesses pursuant to the registration which [was] suspended.'' Id. (citing 21 U.S.C. 824(f) and 21 CFR 1301.36(f)). Thereafter, Respondent requested a hearing on the allegations and the matter was placed on the docket of the Agency's Administrative Law Judges (ALJ). Following the ALJ's issuance of an Order for Pre-Hearing Statements, the Government moved for summary disposition on the ground that on September 7, 2010, the Maine Department of Health and Human Services (MDHHS) had temporarily suspended Respondent's Substance Abuse Treatment license. ALJ Dec., at 3. As support for the motion, the Government attached a letter dated September 7, 2010 from the Director of the MDHHS's Division of Licenses & Regulatory Services to Ms. Fuller-McMahan. Mot. for Summ. Disp., at Ex. 2. Therein, the Director stated that MDHHS was ``revoking on an emergency basis for a period not to exceed thirty days the agency's licenses to operate an Opioid Treatment Program and . . . Outpatient Substances Abuse Services.'' Id. (citing 14-118 C.M.R. Ch. 5, Sec. 2.10.9). The letter further stated that ``[t]he Department reserves its right to petition the District Court to extend the period of license revocation in accordance with 4 M.R.S.A. Sec. 184(6) and 5 M.R.S.A. Sec. 10003.'' Id. at 2. Upon reviewing the motion, the ALJ directed Respondent to file a response to the Government's motion, which Respondent did after obtaining an extension.\3\ ALJ Dec., at 3. Thereafter, the Government filed a further pleading in which it noted that MDHHS had filed a complaint in state court seeking the temporary suspension and permanent revocation of Respondent's Maine [[Page 47412]] Alcohol and Drug Treatment Certificate of Licensure. Reply to Opposition to Gov. Mot. for Summ. Disp., at 2. As support for its position, the Government attached a copy of the State's complaint with supporting exhibits, the summons and return of service, and a draft of an order entitled: Order Relating To Plaintiff's Application For Temporary Suspension Of License Pending Judicial Review. However, absent from the evidence was a court order extending the revocation of Respondent's state license. --------------------------------------------------------------------------- \3\ Respondent argued that the proposed revocation of its DEA registration would violate its right to due process because it was based on the MDHHS suspension, which in turn, was based on the DEA Order to Show Cause and Immediate Suspension of Registration. See Response In Opposition To The DEA Motion For Summary Disposition, at 2-5. --------------------------------------------------------------------------- On October 6, 2010, the ALJ issued her recommended decision. Notwithstanding that the temporary suspension ordered by the Director of the MDHHS was due to expire on the following day and could not be extended without a court order, the ALJ granted the Government's motion for summary disposition on the ground that it was undisputed that Respondent ``lacks the authority to currently handle controlled substances under state law,'' and thus, it was not entitled to maintain its DEA registration. ALJ at 5-6. The ALJ therefore recommended that Respondent's registration be revoked. Id. at 10. On October 27, 2010, the ALJ forwarded the record to the Administrator's Office for final agency action. However, at no time did the Government move to supplement the record with evidence showing that the state court had extended the suspension of Respondent's state license. Upon review of the record, the former Administrator noted that Respondent's DEA registration had expired on November 30, 2010. A subsequent query of the Agency's registration records determined that Respondent had not filed a renewal application. Moreover, public records of the State indicated that Respondent was no longer in business. Accordingly, the former Administrator directed the parties to address why the case was not moot and to specifically identify what collateral consequence existed which precluded a finding of mootness. Order of the Administrator (Sept. 20, 2011), at 1-2 (citing RX Direct Pharmacy, Inc., 72 FR 54070 (2007)). Only the Government filed a response. Therein, the Government noted that upon service of the Immediate Suspension Order, it ``seized and placed under seal various controlled substances from Respondent's facility.'' Id. at 1 (citing Affidavit of DI). According to the DI, the Agency seized 121 unopened 500 ml bottles of methadone 10mg/ml; 18 opened 500 ml bottles of methadone 10mg/ml ``containing various amounts of methadone''; and 23 individual ``take home'' doses of methadone. GX 10, at 3. Noting that under the Controlled Substances Act, `` `[a]ll right, title and interest in' any controlled substances seized pursuant to a suspension order `vests in the United States upon a revocation order being[sic] final' and `shall be forfeited to the United States,' '' the Government argued that if the case ``is declared moot and dismissed, title to the controlled substances will be left undetermined.'' Id. (quoting 21 U.S.C. 824(f)). The Government further noted that `` `DEA has previously held that ``a litigant cannot defeat the effect of this provision by simply allowing its registration to expire.'' ' '' Id. (quoting East Main Street Pharmacy, 75 FR 66149 (2010) (other citation omitted)). Id. The Government thus maintained that the ``case remain[ed] a live controversy'' and requested the issuance of a final order. Id. at 2. Upon review of the matter, the former Administrator agreed with the Government that the case was not moot. Order Remanding for Proceedings, at 6 (May 20, 2013). She concluded, however, that a final order based on Respondent's lack of state authority could not resolve the issue of title to the drugs that were seized for two reasons. First, she explained that the Immediate Suspension Order, which provided authority for the seizure, was not based on Respondent's lack of state authority. Id. at 6. Second, she observed that ``even if a subsequent loss of state authority could be used to support the forfeiture of drugs which have been seized based on entirely different factual allegations and legal grounds, the Government [was] not entitled to prevail'' because the ``contention that Respondent lacked state authority was not supported by substantial evidence.'' Id. at 7. The former Administrator then observed that the MDHHS' suspension order was due to expire the day after the ALJ issued her recommended decision (and even before the record was forwarded to the Administrator's Office) and that while the Government had submitted a copy of the State's complaint which sought to extend the suspension, a summons, and an unsigned proposed order extending the suspension, the Government produced no evidence ``that the state court had continued the suspension past the initial thirty days imposed by the MDHHS.'' Id. Because the record did not support the finding required under 21 U.S.C. 824(a)(3), the former Administrator remanded the case for further proceedings consistent with her opinion. Id. at 8. On remand, the ALJ ordered the parties to file and serve their respective prehearing statements. Order for Prehearing Statements (GX 11), at 1. The Government timely complied. Termination Order (GX 12), at 1. Thereafter, Respondent moved to enlarge the time for filing its prehearing statement. Id. While the ALJ granted the motion and extended the due date of Respondent's statement by three weeks, Respondent failed to comply. Id. Accordingly, twelve days later, the ALJ held, sua sponte, that ``Respondent ha[d] constructively waived its right to a hearing'' and ordered that the hearing be terminated. Id. at 2. Thereafter, the Government submitted a Request for Final Agency Action along with the investigative record to the Administrator's Office. Upon review of the record, the former Administrator adopted the ALJ's finding that Respondent had waived its right to a hearing as to the validity of the Immediate Suspension Order and the seizure of the controlled substances. However, the former Administrator denied the Government's Request for Final Agency Action, reasoning that the public interest provisions of 21 U.S.C. 823(f) and 824(a)(4), which the Government relied on as the source of its authority to immediately suspend Respondent's registration, do not apply to a Narcotic Treatment Program. Order Denying Government's Request for Final Agency Action, at 9 (May 11, 2015). As the former Administrator explained, Respondent was registered under 21 U.S.C. 823(g)(1). Under this provision, ``[t]he Attorney General shall register an applicant to dispense narcotic drugs to individuals for maintenance [and/] or detoxification treatment'' if the following three conditions are met: (A) if the applicant is a practitioner who is determined by the Secretary to be qualified (under standards established by the Secretary) to engage in the treatment with respect to which registration is sought; (B) if the Attorney General determines that the applicant will comply with standards established by the Attorney General respecting (i) security of stocks of narcotic drugs for such treatment, and (ii) the maintenance of records (in accordance with section 827 of this title) on such drugs; and (C) if the Secretary determines that the applicant will comply with standards established by the Secretary (after consultation with the Attorney General) respecting the quantities of narcotic drugs which may be provided for unsupervised use by individuals in such treatment. 21 U.S.C. 823(g)(1). The former Administrator explained that in contrast to every other category of registration set forth in section 823, this provision does not grant the Attorney General authority to deny an [[Page 47413]] application upon a determination ``that the issuance of such registration . . . would be inconsistent with the public interest.'' Order Denying Govt.'s Req., at 9 (comparing 21 U.S.C. 823(g)(1) with id. Sec. 823(f); see also id. Sec. 823(a), (b), (c), (d), (e), and (h). The former Administrator also observed that, in contrast to every other category of registration set forth in section 823, Congress did not characterize these three provisions as ``factors'' to be considered and given discretionary weight ``[i]n determining the public interest.'' Order Denying Govt.'s Req., at 9 (comparing Sec. 823(g) with id. Sec. 823(f); see also id. Sec. 823(a), (b), (c), (d), (e), and (h). Rather, the three subparagraphs of section 823(g)(1) are conditions for registration. With respect to the Agency's authority to revoke a registration, the former Administrator noted that while 21 U.S.C. 824(a) sets forth five different ground for revoking a registration, it also contains a specific provision which governs the Agency's authority to revoke a registration with respect to a Narcotic Treatment Program. This provision states that: A registration pursuant to section 823(g)(1) of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(g)(1) of this title. Id. Sec. 824(a). So too, section 824(d) provides that ``[a] failure to comply with a standard referred to in section 823(g)(1) of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section.'' Id. Sec. 824(d). The former Administrator noted that section 824(a)(4) authorizes the revocation of a registration upon a finding that a registrant ``has committed such acts as would render [its] registration under section 823 of this title inconsistent with the public interest as determined under such section.'' Order Denying Govt.'s Req., at 7. However, based on the provisions of section 823(g)(1) and the specific provision governing the revocation of an NTP registration for non-compliance with any standard referred to in 823(g)(1), the former Administrator explained that even assuming that the public interest revocation authority of section 824(a)(4) could be invoked in this proceeding, this provision does not grant the Government any additional authority because the determination must be made by reference to the standards set forth in section 823(g)(1). Id. at 8-9. The former Administrator further noted that because Respondent's registration was issued pursuant to section 823(g)(1), it was clear that the public interest standard of section 823(f) has no application in this proceeding. Id. at 9. She then held that, consistent with section 824(a), the suspension order could only be sustained if the Government put forward sufficient evidence to support ``a finding that the registrant has failed to comply with any standard referred to in section 823(g)(1).'' Id. The former Administrator noted, however, that the allegations of the Order to Show Cause and Immediate Suspension Order may, if supported by substantial evidence, establish that Respondent failed to comply with the standards of section 823(g)(1). Id. However, because in its Request for Final Agency Action, the Government had not addressed which of the standards had been violated and how so, the former Administrator denied the Government's Request for Final Agency Action. Id. Analogizing the Government's Request to a motion for summary judgment, the former Administrator then explained that just as the denial of a motion for summary judgment is an interlocutory order and not a final decision, so too the denial of the Government's Request for Final Agency Action is an interlocutory order and not a final decision of the Agency. Id. (citing, inter alia, R.R. Donnelley & Sons Co. v. FTC, 931 F.2d 430, 431 (7th Cir. 1991) (holding that the denial of a motion for summary judgment is an interlocutory order and not a final judgment)). The former Administrator thus provided the Government with the opportunity to file a successive Request for Final Agency Action. Id. Thereafter, the Government attempted to establish that this matter had become moot because there was no need to determine title to the drugs that were seized pursuant to the ISO. The basis for the Government's contention was that: (1) The drugs had since passed their expiration date, (2) Respondent's successor-in-interest (Ms. Fuller- McMahan) had not responded to a letter from the Special Agent in Charge of the local Field Division which offered her the opportunity to make arrangements for the disposal of the drugs, and (3) in a phone call with an Agency Investigator months later, Ms. Fuller-McMahan permitted the Agency to destroy the drugs. I found, however, that Ms. Fuller- McMahan's actions did not relinquish Respondent's title to the property. Order, at 1-2 (Mar. 16, 2016). Subsequently, the Government again suggested that the case was moot because it had determined that a creditor (Coastal Enterprises, Inc.) had placed a lien against Respondent assets, and that Coastal had executed a release of its claims against the drugs the Agency had seized. I rejected this as sufficient to establish mootness because the Government continued to acknowledge that Ms. Fuller-McMahan is Respondent's successor-in-interest and because the Government produced no evidence that Coastal had foreclosed on its lien and/or obtained a judgment against Respondent. Order, at 1 (May 4, 2016). Thereafter, the Government resubmitted its Request for Final Agency Action. See Second Req. for Final Agency Action. Ms. Fuller-McMahan also submitted a letter to me stating that she has in her ``possession documents and recordings that refute these allegations.'' Letter from Angel Fuller-McMahan to the Acting Administrator (May 20, 2106). However, Ms. Fuller-McMahan did not provide either the documents or the recordings, and in any event, the former-Administrator remanded this matter to the Office of Administrative Law Judges for the express purpose of allowing Respondent to challenge the Suspension Order. While Respondent initially indicated its intent to participate in the hearing, it failed to comply with the ALJ's Order and file a Prehearing Statement. As a result, the ALJ found that Respondent had waived its right to a hearing and terminated the proceeding. Thereafter, the former Administrator adopted the ALJ's waiver finding. Order Denying Government's Request for Final Agency Action, at 6 (May 11, 2015). Ms. Fuller-McMahan has offered no reason to reconsider that finding. Accordingly, based on the Investigative File submitted by the Government, I make the following finding of fact. Findings Respondent, an administratively-dissolved corporation, was formerly registered as a Narcotic Treatment Program under 21 U.S.C. 823(g)(1). Ms. Angel Fuller-McMahan was the owner of the corporation. On August 31, 2001, Ms. Fuller-McMahan, following her entry into a plea agreement, was convicted by the Maine Superior Court of the unlawful possession of heroin and given a suspended sentenced of two years imprisonment and one year of probation. GX 3, at 1. She also enrolled in a methadone maintenance program. Id. [[Page 47414]] On October 18, 2007, Ms. Fuller-McMahan filed a new application on behalf of Respondent for registration as a Narcotic Treatment Program. Id. On June 13, 2008, Ms. Fuller-McMahan entered into Memorandum of Agreement (MOA) with DEA's New England Field Division, pursuant to which the Agency granted Respondent's application subject to certain conditions. Id. at 1-2. As relevant here, these included that: (1) Ms. Fuller-McMahan ``is prohibited from ordering any controlled substances and will execute a power of attorney authorizing one of her management staff to order the controlled substances''; (2) that ``the same management staff will'' execute Respondent's renewal applications; (3) Ms. Fuller-McMahan ``will not have physical access to the registered location'' or ``any keys or codes to the alarm system''; (4) Ms. Fuller-McMahan ``will not be enrolled as a client of'' Respondent and ``will not guest dose at [it] under any circumstances.'' Id. at 1. The MOA further provided that ``[v]iolations of the terms . . . may result in an order to show cause to revoke, or revoke and immediately suspend'' its DEA registration, and that in any such proceeding, ``DEA reserves the right to introduce into evidence . . . this Agreement and violations of this Agreement.'' Id. at 1-2. On June 23, 2008, the then Special Agent in Charge of the Field Division approved the MOA, id. at 2, and on July 1, 2008, Respondent's application was approved. GX 2, at 2. On December 11, 2008, J.C., a pharmacist, executed a state board application to become Respondent's new Pharmacist-in-Charge. GX 16, at 1. On the application, J.C. listed Ms. Fuller-McMahan as an ``authorized person.'' Id. at 6. According to a regulation of the Maine Board of Pharmacy, ``[a]n `authorized person' is a person other than a pharmacy technician (e.g., computer technician, bookkeeper) who the pharmacist in charge has designated to be present in the prescription filling area in the absence of a pharmacist.'' GX 17, at 1 (copy of 02- 392 CMR Ch. 1, Sec. 1). According to the affidavit of a Supervisory Special Agent with the Maine Drug Enforcement Agency (MDEA), on November 3, 2009, he ``interviewed M.K., a former patient'' of Respondent. GX 15, at 2. The Agent further explained that M.K. had called him ``and requested to speak to [him] in exchange for consideration with M.K.'s pending drug charges.'' Id. The Agent further explained that an interview was arranged and that ``no promises were made to M.K. in exchange for any information she might divulge.'' Id. According to the Agent, during her interview, M.K. stated that Ms. Fuller-McMahan had ``approached her and asked her to procure cocaine for which [Fuller-McMahan] would be willing to trade methadone purchased on behalf of'' Respondent. Id. M.K. further stated that Ms. Fuller-McMahan had said ``that she intended to create a falsified order for methadone to be purchased by'' Respondent for the purported use by prisoners at the county jail ``for drug treatment,'' and that she would trade this methadone for cocaine. Id. The Agent also averred that M.K. had named two other persons who were obtaining methadone at Respondent for drug treatment and selling it. Id. According to the Agent, ``M.K. stated she had purchased controlled substances from these'' two persons. Id. The Agent did not, however, clarify whether M.K. had purchased methadone from these persons. While according to the Agent, M.K. offered to perform undercover buys from these persons, the Agent offered no evidence that any such buys were performed. Moreover, no further evidence was provided establishing that Respondent was improperly dispensing methadone to these two persons. See 42 CFR 8.12(i) (regulations governing ``[u]nsupervised or `take home use' ''). In his affidavit, the Agent testified that on July 13, 2010, Ms. Fuller-McMahan was arrested and charged with Possession of Cocaine, a felony offense under Maine Law. Id. at 1 (citing 17-A M.R.S.A. Sec. 1107-A). The Agent further stated that Ms. Fuller-McMahan was in possession of ``approximately 25 grams of powdered cocaine'' and two syringes which she had obtained from J.R., a patient of Respondent, who performed an undercover sale for the MDEA. Id. After her arrest, Ms. Fuller-McMahan waived her Miranda rights and was interviewed by the Agent; a video recording of the interview was provided by the Government. During the interview, Ms. Fuller-McMahan stated that she intended to deliver the cocaine to C.G., a drug and alcohol counselor employed by Respondent. Id. She also ``admitted that she was using cocaine and had ingested cocaine in the last three weeks.'' Id. During the interview, Ms. Fuller-McMahan asked the Agent: ``can you charge me with something else? Less? . . . If I agree to not go into Turning Tide . . . or to fight it, ever . . . back out completely?'' Id. at 2. Thereafter, the State charged Ms. Fuller-McMahan with two counts of unlawful possession of a scheduled drug. GX 4, at 1. Ms. Fuller-McMahan pled guilty to one of the counts, and on October 28, 2010, Ms. Fuller- McMahan was convicted by the Superior Court of a single count of unlawful possession of a scheduled drug. Id. The court sentenced Ms. Fuller-McMahan to 364 days in the county jail, but suspended all but 30 days of the sentence; the court also placed her on probation for a period of one year. Id. On some date which is not clear from the evidence, Respondent, through its attorney, surrendered its state licenses to operate an Opioid Treatment Program and Outpatient Substance Abuse Services; Respondent also surrendered its pharmacy license. GX 5. Respondent also allowed its registration to expire.\4\ --------------------------------------------------------------------------- \4\ The Government put forward no evidence in support of the allegation that Respondent ``continues to employ Ms. Fuller- McMahan's husband . . . despite the fact that [he] has been convicted of illegal drug possession and has access to Respondent's controlled substances and confidential patient information.'' GX 1, at 2. Nor did it put forward any evidence as to the allegations that she had engaged in three other illegal purchases of cocaine with another of Respondent's patients. --------------------------------------------------------------------------- Discussion As previously held, because Respondent's registration has expired, and there is no application to act upon, the only issue remaining in the proceeding is whether the Government can claim title to the controlled substances it seized pursuant to the authority granted by the Immediate Suspension Order. See S & S Pharmacy, Inc., 78 FR 57656, 57659 (2013); RX Direct Pharmacy, Inc., 72 FR 54070, 54072 (2007). Pursuant to 21 U.S.C. 824(f), In the event the Attorney General suspends or revokes a registration under section 823 of this title, all controlled substances . . . owned or possessed by the registrant pursuant to such registration at the time of suspension or the effective date of the revocation order, as the case may be, may, in the discretion of the Attorney General, be placed under seal. . . . Upon a revocation order becoming final, all such controlled substances . . . shall be forfeited to the United States; and the Attorney General shall dispose of such controlled substances . . . in accordance with section 881(e) of this title. All right, title, and interest in such controlled substances . . . shall vest in the United States upon a revocation order becoming final. DEA has previously held that a registrant, whose property has been seized pursuant to an Immediate Suspension Order, cannot defeat the effect of this provision by allowing its registration to expire. See, e.g., Meetinghouse Community Pharmacy, Inc., 74 FR 10073, 10076 n.5 (2009). [[Page 47415]] As explained above, section 824(a) sets forth a specific provision which grants the Agency authority to suspend or revoke the registration of a Narcotic Treatment Program. This provision states that: A registration pursuant to section 823(g)(1) of this title to dispense a narcotic drug for maintenance treatment or detoxification treatment may be suspended or revoked by the Attorney General upon a finding that the registrant has failed to comply with any standard referred to in section 823(g)(1) of this title. Id. Sec. 824(a). So too, section 824(d) provides that ``[a] failure to comply with a standard referred to in section 823(g)(1) of this title may be treated under this subsection as grounds for immediate suspension of a registration granted under such section.'' Id. Sec. 824(d). Thus, consistent with section 824(a), the former Administrator held that the suspension order can only be sustained if the Government puts forward sufficient evidence to support ``a finding that the registrant has failed to comply with any standard referred to in section 823(g)(1).'' Of the three standards for registration as an NTP set forth in 21 U.S.C. 823(g)(1), the Government invokes only subparagraph B. It authorizes ``the Attorney General [to] determine[] that the applicant will comply with standards established by the Attorney General respecting (i) security of stocks of narcotic drugs for such treatment, and (ii) the maintenance of records (in accordance with section 827 of this title) on such drugs.'' 21 U.S.C. 823(g)(1)(B) (emphasis added). The Government argues that ``Ms. Fuller-McMahan's conduct demonstrated that she was a security threat to [Respondent] and, accordingly, a security risk to its stocks of controlled substances.'' Second Request for Final Agency Action, at 10. It further argues that her ``continued ownership and control over Respondent's clinic constituted an imminent danger to the public health or safety.'' Id. (citing 21 U.S.C. 824(d)). And it argues that ``[b]y permitting Ms. Fuller-McMahan to act as Turning Tide's director and continue to have control over the drug treatment facility, Respondent failed to comply with standards respecting the `security of stocks of narcotic drugs for . . . treatment,' '' and thus violated section 823(g)(1)(B). Id. at 11. Invoking the terms of the MOA, the Government argues that ``the evidence paints a far different picture of Ms. Fuller-McMahan's involvement in [Respondent] than that contemplated by'' the MOA. Id. First, the Government argues that Ms. Fuller-McMahan admitted that she remained Turning Tide's director. Id. The Government does not, however, point to any provision of the MOA which prohibited Ms. Fuller-McMahan from acting as Turning Tide's director. Stronger is the Government's claim that Ms. Fuller-McMahan violated the MOA because she was entering its physical premises. The MOA specifically prohibited her from ``hav[ing] physical access to the registered location,'' GX 3, at 1; and as found above, during the interview which followed her arrest, Ms. Fuller-McMahan clearly tried to negotiate a lesser charge for agreeing not to go into the clinic. See id. Moreover, the Government produced the application filed by Respondent's PIC, in which he designated her as an ``authorized person,'' GX 16, at 4; which under Maine's regulation authorized her ``to be present in the prescription filling area in the absence of a pharmacist.'' GX 17. Yet there is no evidence that Ms. Fuller-McMahan ever actually entered the pharmacy or that she possessed the keys or the alarm code for the pharmacy.\5\ See, e.g., 21 CFR 1301.72(d) (``The controlled substances storage areas shall be accessible only to an absolute minimum of specifically authorized employees.''). Thus, while the evidence supports a finding that Ms. Fuller-McMahan had access to the clinic and thus violated the MOA, by itself, this conclusion does not support a finding that Respondent posed ``an imminent danger to the public health or safety,'' 21 U.S.C. 824(d), as is required to support the Order of Immediate Suspension. --------------------------------------------------------------------------- \5\ The record contains no evidence of interviews of any employees who might have observed her entering the pharmacy. --------------------------------------------------------------------------- The Government further argues that ``[b]y executing a renewal application in direct violation of the MOA . . . Ms. Fuller-McMahan also provided herself with the legal means to order controlled substances . . . and therefore carry out the scheme she had proposed to M.K.'' Id. at 11 (citing 21 CFR 1305.11(c); other citations omitted). While the Government then acknowledges that ``there is no evidence that this particular transaction took place,'' id., it notes that Ms. Fuller-McMahan was arrested and convicted for possessing cocaine which she had obtained from a patient and intended to deliver to an employee. Id. at 11-12. The Government then argues that ``Ms. Fuller-McMahan was predisposed to continue to engage in drug trafficking which could have involved trading Respondent's stocks of narcotic substances for cocaine'' and that ``[h]er behavior in this regard independently confirms her intent to purchase illegal substances with narcotic drugs slated for legitimate drug treatment.'' Id. at 12 (emphasis added). And arguing that her ``past performance is the best predictor of future performance,'' the Government asserts that Ms. Fuller-McMahan's conduct ``demonstrated a high likelihood that she would find a way to divert Respondent's supply of methadone in exchange for illegal drugs[,]'' and ``[t]hus, her continued access, ownership, and control over Respondent's business constituted an imminent threat to the public health or safety.'' Id. (int. quotations and citation omitted). Under DEA's regulation which is applicable to ``all registrants,'' Respondent was required to ``provide effective controls and procedures to guard against theft and diversion of controlled substances.'' 21 CFR 1301.71(a). See also 21 CFR 1301.72(d). Thus, substantial evidence that Ms. Fuller-McMahan was obtaining methadone from Respondent's stocks and trading it for other drugs would clearly establish Respondent's non- compliance with a standard established under 21 U.S.C. 823(g)(1)(B) and would clearly support the requisite finding that its continued registration posed an imminent danger to public health or safety as required by 21 U.S.C. 824(d). The Government, however, has not produced such evidence. The Government points to Ms. Fuller-McMahan's execution of the renewal application. It argues that Ms. Fuller-McMahan did this to ``provide[ ] herself with the legal means to order controlled substances.'' Second Request, at 11. Yet the Government has not produced a single order form (DEA-222) that Ms. Fuller-McMahan executed on behalf of Respondent or any other evidence that she was ordering methadone. The Government also points to Ms. Fuller-McMahan's alleged proposal to provide methadone to M.K. in exchange for cocaine as support for its assertion that she ``was predisposed to continue to engage in drug trafficking which could have involved trading Respondent's stocks of narcotic substances for cocaine.'' id. at 12. This fails too, as notwithstanding Respondent's waiver of its right to challenge the Immediate Suspension Order, the Agency's Order in this matter must be supported by ``reliable, probative, and substantial evidence.'' 5 U.S.C. 556. Under the Agency's rules, Respondent's waiver of its right to a hearing does not constitute an [[Page 47416]] admission of the allegations. Thus, the Government had the burden of proving its claim that Ms. Fuller-McMahan was likely to trade Respondent's methadone for cocaine. However, the Government's evidence as to the alleged proposal of Ms. Fuller-McMahan to trade methadone to M.K. in exchange for cocaine is so lacking in indicia of reliability that it does not support the requisite finding under section 823(g)(1). Notably, M.K.'s statement is hearsay,\6\ and there is no evidence that M.K., who has not been identified, was under oath when she provided the statement. Also, the MDEA Agent acknowledged that M.K. had offered ``to speak to [him] in exchange for consideration with M.K.'s pending drug charges.'' GX 15, at 2. Notwithstanding that the MDEA Agent further explained that ``no promises were made to M.K. in exchange for any information she might divulge,'' informants typically do not provide information without some expectation of receiving favorable treatment and have ample motive to shade their statements. Nor did the MDEA Agent's affidavit provide any additional facts tending to establish that M.K. had provided reliable information in other matters, or that the information M.K. provided regarding Ms. Fuller-McMahan was otherwise corroborated.\7\ --------------------------------------------------------------------------- \6\ While M.K.'s statement is actually hearsay within hearsay, I have no reason to question the MDEA Agent's recounting of the facts surrounding M.K.'s agreeing to provide the statement or that he has accurately testified as to the substance of M.K.'s statement. \7\ Likewise, the Government did not produce the entirety of M.K.'s statement and thus, there is no way to evaluate the internal consistency of the statement. --------------------------------------------------------------------------- In short, this type of statement has been traditionally viewed by the courts as inherently unreliable, and as such, M.K.'s statement cannot be given any weight in this decision. See, e.g., Carlos Gonzales, 76 FR 63118, 63119-20 (2011). And even if the Government had established that M.K.'s statement was reliable, this interview, which occurred more than nine months prior to the issuance of the Immediate Suspension Order, could not support a finding of imminent danger and the subsequent seizure of the drugs.\8\ See, e.g., Norman Bridge Drug Co. v. Banner, 529 F.2d 822, 829 (5th Cir. 1976). --------------------------------------------------------------------------- \8\ The record does not establish when the MDEA Agent first told DEA about M.K.'s allegations. --------------------------------------------------------------------------- Thus, the only evidence which arguably supports the Immediate Suspension Order and seizure of Respondent's methadone stock is the arrest of Ms. Fuller-McMahan for the possession of cocaine and the syringes, which she had received from J.R., a patient at Respondent, and which Ms. Fuller-McMahan admitted she intended to provide to C.G., a counselor at Respondent. Yet even here, there is no evidence that Ms. Fuller-McMahan either traded methadone for the cocaine she received from J.R. or that she intended to provide the cocaine to C.B. for methadone. Moreover, notwithstanding M.K.'s allegation, there is no evidence that the Government ever audited Respondent's recordkeeping to determine whether Respondent's methadone was missing or that it developed any reliable evidence that Ms. Fuller-McMahan was diverting methadone. See 21 U.S.C. 823(g)(1)(B). Nor did the Government produce any evidence that Respondent's recordkeeping was inadequate.\9\ Id. In short, while the Government has established that Ms. Fuller-McMahan violated the MOA and this would have supported the issuance of an Order to Show Cause, the Government's principal justification for immediately suspending Respondent's registration and seizing the drugs is not supported by substantial evidence but rests on a hunch. Accordingly, I hold that the Immediate Suspension Order is ultra vires and the resulting seizure of Respondent's methadone was unlawful. See Norman Bridge, 529 F.2d at 828 (``Such a suspension, or such a seizure, may be invoked only to avoid imminent danger to the public health and safety. In the absence of that factor there can be no suspension and no seizure without notice and an opportunity to be heard.'').\10\ --------------------------------------------------------------------------- \9\ The Government also argues that ``there was no evidence that Respondent's employees . . . were taking any steps to minimize that risk,'' i.e., the risk that Ms. Fuller-McMahan was diverting Respondent's methadone. Second Req. for Final Agency Action, at 14. However, the Government has the burden of proving that Respondent's methadone was being diverted. Moreover, it bears noting that under the Maine Board of Pharmacy's rules, Respondent was required to have a licensed pharmacist overseeing its pharmacy, and ``[t]he pharmacist in charge is responsible legally and professionally for all activities related to the practice of pharmacy within the opioid treatment program for which the licensee is registered as pharmacist in charge, and for the opioid treatment program's compliance with . . . federal and state laws and rules,'' including the CSA and DEA regulations. 02-392 CMR 36 Sec. 4; see also 02-392 CMR 29 Sec. 1. \10\ In a June 29, 2015 letter, the Special Agent in Charge of the New England Field Division wrote to Ms. Fuller-McMahan that ``[a]lthough the controlled substances were seized pursuant to an Immediate Suspension Order, they are also being held by virtue of the fact that your registration expired on November 30, 2010, resulting in your not having any authority to handle controlled substances.'' However, to the extent the Government retained possession of the controlled substances based on the expiration of Respondent's registration, 21 U.S.C. 824(g) provides that: [s]uch controlled substances . . . shall be held for the benefit of the registrant, or his successor in interest. The Attorney General shall notify a registrant, or his successor in interest, who has any controlled substance . . . seized or placed under seal of the procedures to be followed to secure the return of the controlled substance . . . and the conditions under which it will be returned. The Attorney General may not dispose of any controlled substance . . . seized or placed under seal under this subsection until the expiration of one hundred and eighty days from the date such substance . . . was seized or placed under seal. 21 U.S.C. 824(g). The Government has provided no evidence that it complied with the procedures required by this subsection. Accordingly, the propriety of the seizure must be evaluated under the standards of subsection 824(d) and (f). --------------------------------------------------------------------------- Order Pursuant to the authority vested in me by 21 U.S.C. 824(a) and (d), I hereby declare the Order of Immediate Suspension issued to Turning Tide, Inc., ultra vires. This Order is effective immediately. Dated: July 15, 2016. Chuck Rosenberg, Acting Administrator. [FR Doc. 2016-17245 Filed 7-20-16; 8:45 am] BILLING CODE 4410-09-P
![Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 47411
which he practices . . . to distribute, substances as a Narcotic Treatment Respondent’s controlled substances and
dispense, [or] administer . . . a Program pursuant to 21 U.S.C. 823(g)(1), confidential patient information.’’ Id.
controlled substance in the course of and the denial of any pending Based on the above allegations, the
professional practice.’’ Id. § 802(21). See applications to renew or modify its former Administrator concluded that
also id. § 824(a)(3) (authorizing the registration, on the ground that its Respondent’s continued registration
revocation of a registration upon a ‘‘continued registration is inconsistent during the pending of the proceeding
finding that the registrant ‘‘has had his with the public interest, as that term is would ‘‘constitute an imminent danger
State license or registration suspended, defined in 21 U.S.C. 823(f).’’ Id. at 1. to the public health and safety’’ and
revoked, or denied by competent State The Show Cause Order specifically therefore ordered that its registration be
authority and is no longer authorized by alleged that ‘‘Respondent is owned by suspended immediately. Id. at 3 (citing
State law to engage in the . . . Angel Fuller-McMahan’’ and that its 21 U.S.C. 824(d)). The former
dispensing of controlled substances’’). ‘‘registration is conditioned upon a Administrator also authorized the
Based on these provisions, the Agency Memorandum of Agreement (MOA) Special Agents and Diversion
has repeatedly held ‘‘that a practitioner with DEA which prohibits Ms. Fuller- Investigators who served the Order to
can neither obtain nor maintain a DEA McMahan from (1) having physical either ‘‘place under seal or to remove for
registration unless the practitioner access to Respondent’s premises; (2) safekeeping all controlled substances
currently has authority under state law ordering controlled substances on behalf that [Respondent] possesses pursuant to
to handle controlled substances.’’ James of Respondent; and (3) executing any the registration which [was]
L. Hooper, 76 FR 71371, 71372 (2011) renewal applications . . . on behalf of suspended.’’ Id. (citing 21 U.S.C. 824(f)
(collecting cases), pet. for rev. denied, Respondent.’’ Id. at 1–2. The Order then and 21 CFR 1301.36(f)).
Hooper v. Holder, 481 F. App’x 826 (4th alleged that Ms. Fuller-McMahan had Thereafter, Respondent requested a
Cir. 2012). been arrested on July 13, 2010 and hearing on the allegations and the
Here, there is no dispute as to the charged with unlawful possession of matter was placed on the docket of the
material fact that Respondent does not cocaine, and that at the time of her Agency’s Administrative Law Judges
hold authority under New Mexico law arrest, she had in her possession (ALJ). Following the ALJ’s issuance of
to dispense controlled substances and is approximately 25 grams of cocaine and an Order for Pre-Hearing Statements, the
thus not a practitioner within the two hypodermic needles.2 Id. at 2. The Government moved for summary
meaning of the Act. See 21 U.S.C. Order further alleged that Ms. Fuller- disposition on the ground that on
802(21). Accordingly, his application McMahan had ‘‘arranged to purchase September 7, 2010, the Maine
must be denied. 21 U.S.C. 823(f). cocaine’’ from both a patient and an Department of Health and Human
employee of Respondent. Id. The Order Services (MDHHS) had temporarily
Order suspended Respondent’s Substance
also alleged that ‘‘[w]hile serving as
Pursuant to the authority vested in me Respondent’s Program Director, Ms. Abuse Treatment license. ALJ Dec., at 3.
by 21 U.S.C. 823(f) and 28 CFR 0.100(b), Fuller-McMahan approached another As support for the motion, the
I order that the application of Nicholas patient . . . and offered to trade Government attached a letter dated
J. Nardacci, M.D., for a DEA Certificate methadone for cocaine’’ by ‘‘creat[ing] a September 7, 2010 from the Director of
of Registration as a practitioner, be, and fraudulent order for methadone,’’ even the MDHHS’s Division of Licenses &
it hereby is, denied. This Order is though she was then prohibited by the Regulatory Services to Ms. Fuller-
effective immediately. MOA from ordering controlled McMahan. Mot. for Summ. Disp., at Ex.
Dated: July 11, 2016. substances on behalf of Respondent. Id. 2. Therein, the Director stated that
Chuck Rosenberg, The Order then alleged that Ms. Fuller- MDHHS was ‘‘revoking on an
Acting Administrator. McMahan had purchased cocaine in emergency basis for a period not to
three separate ‘‘illegal drug transactions exceed thirty days the agency’s licenses
[FR Doc. 2016–17264 Filed 7–20–16; 8:45 am]
with another of Respondent’s patients.’’ to operate an Opioid Treatment Program
BILLING CODE 4410–09–P
Id. and . . . Outpatient Substances Abuse
Next, the Show Cause Order alleged Services.’’ Id. (citing 14–118 C.M.R. Ch.
DEPARTMENT OF JUSTICE that notwithstanding the MOA’s terms, 5, § 2.10.9). The letter further stated that
‘‘Ms. Fuller-McMahan continues to ‘‘[t]he Department reserves its right to
Drug Enforcement Administration retain control and have supervisory petition the District Court to extend the
authority over key aspects of period of license revocation in
[Docket No. 10–71] accordance with 4 M.R.S.A. § 184(6) and
Respondent’s operation,’’ that she had
Turning Tide, Inc. Decision and Order; represented to a patient ‘‘that she has 5 M.R.S.A. § 10003.’’ Id. at 2.
access to controlled substances which Upon reviewing the motion, the ALJ
Procedural History
are ordered on behalf of Respondent,’’ directed Respondent to file a response
On August 17, 2010, the former and that she has ‘‘repeatedly violated to the Government’s motion, which
Administrator of the Drug Enforcement the terms of the MOA by entering the Respondent did after obtaining an
Administration issued an Order to Show physical premises of [Respondent] and extension.3 ALJ Dec., at 3. Thereafter,
Cause and Immediate Suspension of executing a renewal application on [its] the Government filed a further pleading
Registration (hereinafter, Show Cause behalf.’’ Id. Finally, the Order alleged in which it noted that MDHHS had filed
Order or Order) to Turning Tide, Inc. that Respondent ‘‘continued to employ a complaint in state court seeking the
asabaliauskas on DSK3SPTVN1PROD with NOTICES
(Respondent), of Rockland, Maine. Ms. Fuller-McMahan’s husband, Vance temporary suspension and permanent
Show Cause Order, at 1. The Show McMahan, despite the fact that Mr. revocation of Respondent’s Maine
Cause Order proposed the revocation of McMahan has been convicted of illegal
Respondent’s DEA Certificate of drug possession and has access to
3 Respondent argued that the proposed revocation
Registration RT0370015,1 which of its DEA registration would violate its right to due
process because it was based on the MDHHS
authorized it to dispense controlled 2 The Order also alleged that on August 31, 2001, suspension, which in turn, was based on the DEA
Ms. Fuller-McMahan had been convicted in state Order to Show Cause and Immediate Suspension of
1 The Order alleged that Respondent’s registration court of unlawful possession of heroin. Show Cause Registration. See Response In Opposition To The
was due to expire on November 30, 2010. Order, at 2. DEA Motion For Summary Disposition, at 2–5.
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Alcohol and Drug Treatment Certificate of methadone’’; and 23 individual ‘‘take prehearing statements. Order for
of Licensure. Reply to Opposition to home’’ doses of methadone. GX 10, at 3. Prehearing Statements (GX 11), at 1. The
Gov. Mot. for Summ. Disp., at 2. As Noting that under the Controlled Government timely complied.
support for its position, the Government Substances Act, ‘‘ ‘[a]ll right, title and Termination Order (GX 12), at 1.
attached a copy of the State’s complaint interest in’ any controlled substances Thereafter, Respondent moved to
with supporting exhibits, the summons seized pursuant to a suspension order enlarge the time for filing its prehearing
and return of service, and a draft of an ‘vests in the United States upon a statement. Id. While the ALJ granted the
order entitled: Order Relating To revocation order being[sic] final’ and motion and extended the due date of
Plaintiff’s Application For Temporary ‘shall be forfeited to the United States,’ ’’ Respondent’s statement by three weeks,
Suspension Of License Pending Judicial the Government argued that if the case Respondent failed to comply. Id.
Review. However, absent from the ‘‘is declared moot and dismissed, title to Accordingly, twelve days later, the ALJ
evidence was a court order extending the controlled substances will be left held, sua sponte, that ‘‘Respondent
the revocation of Respondent’s state undetermined.’’ Id. (quoting 21 U.S.C. ha[d] constructively waived its right to
license. 824(f)). The Government further noted a hearing’’ and ordered that the hearing
On October 6, 2010, the ALJ issued that ‘‘ ‘DEA has previously held that ‘‘a be terminated. Id. at 2.
her recommended decision. litigant cannot defeat the effect of this Thereafter, the Government submitted
Notwithstanding that the temporary provision by simply allowing its a Request for Final Agency Action along
suspension ordered by the Director of registration to expire.’’ ’ ’’ Id. (quoting with the investigative record to the
the MDHHS was due to expire on the East Main Street Pharmacy, 75 FR Administrator’s Office. Upon review of
following day and could not be 66149 (2010) (other citation omitted)). the record, the former Administrator
extended without a court order, the ALJ Id. The Government thus maintained adopted the ALJ’s finding that
granted the Government’s motion for that the ‘‘case remain[ed] a live Respondent had waived its right to a
summary disposition on the ground that controversy’’ and requested the issuance hearing as to the validity of the
it was undisputed that Respondent of a final order. Id. at 2. Immediate Suspension Order and the
‘‘lacks the authority to currently handle Upon review of the matter, the former seizure of the controlled substances.
controlled substances under state law,’’ Administrator agreed with the However, the former Administrator
and thus, it was not entitled to maintain Government that the case was not moot. denied the Government’s Request for
its DEA registration. ALJ at 5–6. The ALJ Order Remanding for Proceedings, at 6 Final Agency Action, reasoning that the
therefore recommended that (May 20, 2013). She concluded, public interest provisions of 21 U.S.C.
Respondent’s registration be revoked. however, that a final order based on 823(f) and 824(a)(4), which the
Id. at 10. Respondent’s lack of state authority Government relied on as the source of
On October 27, 2010, the ALJ could not resolve the issue of title to the its authority to immediately suspend
forwarded the record to the drugs that were seized for two reasons. Respondent’s registration, do not apply
Administrator’s Office for final agency First, she explained that the Immediate to a Narcotic Treatment Program. Order
action. However, at no time did the Suspension Order, which provided Denying Government’s Request for Final
Government move to supplement the authority for the seizure, was not based Agency Action, at 9 (May 11, 2015).
record with evidence showing that the on Respondent’s lack of state authority. As the former Administrator
state court had extended the suspension Id. at 6. Second, she observed that ‘‘even explained, Respondent was registered
of Respondent’s state license. if a subsequent loss of state authority under 21 U.S.C. 823(g)(1). Under this
Upon review of the record, the former could be used to support the forfeiture provision, ‘‘[t]he Attorney General shall
Administrator noted that Respondent’s of drugs which have been seized based register an applicant to dispense
DEA registration had expired on on entirely different factual allegations narcotic drugs to individuals for
November 30, 2010. A subsequent query and legal grounds, the Government maintenance [and/] or detoxification
of the Agency’s registration records [was] not entitled to prevail’’ because treatment’’ if the following three
determined that Respondent had not the ‘‘contention that Respondent lacked conditions are met:
filed a renewal application. Moreover, state authority was not supported by
public records of the State indicated substantial evidence.’’ Id. at 7. The (A) if the applicant is a practitioner who
that Respondent was no longer in former Administrator then observed that is determined by the Secretary to be qualified
(under standards established by the
business. Accordingly, the former the MDHHS’ suspension order was due Secretary) to engage in the treatment with
Administrator directed the parties to to expire the day after the ALJ issued respect to which registration is sought;
address why the case was not moot and her recommended decision (and even (B) if the Attorney General determines that
to specifically identify what collateral before the record was forwarded to the the applicant will comply with standards
consequence existed which precluded a Administrator’s Office) and that while established by the Attorney General
finding of mootness. Order of the the Government had submitted a copy respecting (i) security of stocks of narcotic
Administrator (Sept. 20, 2011), at 1–2 of the State’s complaint which sought to drugs for such treatment, and (ii) the
(citing RX Direct Pharmacy, Inc., 72 FR extend the suspension, a summons, and maintenance of records (in accordance with
section 827 of this title) on such drugs; and
54070 (2007)). an unsigned proposed order extending (C) if the Secretary determines that the
Only the Government filed a the suspension, the Government applicant will comply with standards
response. Therein, the Government produced no evidence ‘‘that the state established by the Secretary (after
noted that upon service of the court had continued the suspension past consultation with the Attorney General)
Immediate Suspension Order, it ‘‘seized the initial thirty days imposed by the respecting the quantities of narcotic drugs
asabaliauskas on DSK3SPTVN1PROD with NOTICES
and placed under seal various MDHHS.’’ Id. Because the record did which may be provided for unsupervised use
controlled substances from not support the finding required under by individuals in such treatment.
Respondent’s facility.’’ Id. at 1 (citing 21 U.S.C. 824(a)(3), the former 21 U.S.C. 823(g)(1).
Affidavit of DI). According to the DI, the Administrator remanded the case for The former Administrator explained
Agency seized 121 unopened 500 ml further proceedings consistent with her that in contrast to every other category
bottles of methadone 10mg/ml; 18 opinion. Id. at 8. of registration set forth in section 823,
opened 500 ml bottles of methadone On remand, the ALJ ordered the this provision does not grant the
10mg/ml ‘‘containing various amounts parties to file and serve their respective Attorney General authority to deny an
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application upon a determination ‘‘that standards set forth in section 823(g)(1). Subsequently, the Government again
the issuance of such registration . . . Id. at 8–9. suggested that the case was moot
would be inconsistent with the public The former Administrator further because it had determined that a
interest.’’ Order Denying Govt.’s Req., at noted that because Respondent’s creditor (Coastal Enterprises, Inc.) had
9 (comparing 21 U.S.C. 823(g)(1) with registration was issued pursuant to placed a lien against Respondent assets,
id. § 823(f); see also id. § 823(a), (b), (c), section 823(g)(1), it was clear that the and that Coastal had executed a release
(d), (e), and (h). The former public interest standard of section 823(f) of its claims against the drugs the
Administrator also observed that, in has no application in this proceeding. Agency had seized. I rejected this as
contrast to every other category of Id. at 9. She then held that, consistent sufficient to establish mootness because
registration set forth in section 823, with section 824(a), the suspension the Government continued to
Congress did not characterize these order could only be sustained if the acknowledge that Ms. Fuller-McMahan
three provisions as ‘‘factors’’ to be Government put forward sufficient is Respondent’s successor-in-interest
considered and given discretionary evidence to support ‘‘a finding that the and because the Government produced
weight ‘‘[i]n determining the public registrant has failed to comply with any no evidence that Coastal had foreclosed
interest.’’ Order Denying Govt.’s Req., at standard referred to in section on its lien and/or obtained a judgment
9 (comparing § 823(g) with id. § 823(f); 823(g)(1).’’ Id. against Respondent. Order, at 1 (May 4,
see also id. § 823(a), (b), (c), (d), (e), and The former Administrator noted, 2016).
(h). Rather, the three subparagraphs of however, that the allegations of the Thereafter, the Government
section 823(g)(1) are conditions for Order to Show Cause and Immediate resubmitted its Request for Final
registration. Suspension Order may, if supported by Agency Action. See Second Req. for
With respect to the Agency’s authority substantial evidence, establish that Final Agency Action. Ms. Fuller-
to revoke a registration, the former Respondent failed to comply with the McMahan also submitted a letter to me
Administrator noted that while 21 standards of section 823(g)(1). Id. stating that she has in her ‘‘possession
U.S.C. 824(a) sets forth five different However, because in its Request for documents and recordings that refute
Final Agency Action, the Government these allegations.’’ Letter from Angel
ground for revoking a registration, it
had not addressed which of the Fuller-McMahan to the Acting
also contains a specific provision which
standards had been violated and how Administrator (May 20, 2106). However,
governs the Agency’s authority to
so, the former Administrator denied the Ms. Fuller-McMahan did not provide
revoke a registration with respect to a
Government’s Request for Final Agency either the documents or the recordings,
Narcotic Treatment Program. This
Action. Id. Analogizing the and in any event, the former-
provision states that:
Government’s Request to a motion for Administrator remanded this matter to
A registration pursuant to section 823(g)(1) summary judgment, the former the Office of Administrative Law Judges
of this title to dispense a narcotic drug for Administrator then explained that just for the express purpose of allowing
maintenance treatment or detoxification as the denial of a motion for summary Respondent to challenge the Suspension
treatment may be suspended or revoked by
judgment is an interlocutory order and Order. While Respondent initially
the Attorney General upon a finding that the
registrant has failed to comply with any not a final decision, so too the denial of indicated its intent to participate in the
standard referred to in section 823(g)(1) of the Government’s Request for Final hearing, it failed to comply with the
this title. Agency Action is an interlocutory order ALJ’s Order and file a Prehearing
and not a final decision of the Agency. Statement. As a result, the ALJ found
Id. § 824(a). So too, section 824(d) Id. (citing, inter alia, R.R. Donnelley & that Respondent had waived its right to
provides that ‘‘[a] failure to comply with Sons Co. v. FTC, 931 F.2d 430, 431 (7th a hearing and terminated the
a standard referred to in section Cir. 1991) (holding that the denial of a proceeding. Thereafter, the former
823(g)(1) of this title may be treated motion for summary judgment is an Administrator adopted the ALJ’s waiver
under this subsection as grounds for interlocutory order and not a final finding. Order Denying Government’s
immediate suspension of a registration judgment)). The former Administrator Request for Final Agency Action, at 6
granted under such section.’’ Id. thus provided the Government with the (May 11, 2015). Ms. Fuller-McMahan
§ 824(d). opportunity to file a successive Request has offered no reason to reconsider that
The former Administrator noted that for Final Agency Action. Id. finding. Accordingly, based on the
section 824(a)(4) authorizes the Thereafter, the Government attempted Investigative File submitted by the
revocation of a registration upon a to establish that this matter had become Government, I make the following
finding that a registrant ‘‘has committed moot because there was no need to finding of fact.
such acts as would render [its] determine title to the drugs that were
registration under section 823 of this seized pursuant to the ISO. The basis for Findings
title inconsistent with the public the Government’s contention was that: Respondent, an administratively-
interest as determined under such (1) The drugs had since passed their dissolved corporation, was formerly
section.’’ Order Denying Govt.’s Req., at expiration date, (2) Respondent’s registered as a Narcotic Treatment
7. However, based on the provisions of successor-in-interest (Ms. Fuller- Program under 21 U.S.C. 823(g)(1). Ms.
section 823(g)(1) and the specific McMahan) had not responded to a letter Angel Fuller-McMahan was the owner
provision governing the revocation of an from the Special Agent in Charge of the of the corporation.
NTP registration for non-compliance local Field Division which offered her On August 31, 2001, Ms. Fuller-
with any standard referred to in the opportunity to make arrangements McMahan, following her entry into a
asabaliauskas on DSK3SPTVN1PROD with NOTICES
823(g)(1), the former Administrator for the disposal of the drugs, and (3) in plea agreement, was convicted by the
explained that even assuming that the a phone call with an Agency Maine Superior Court of the unlawful
public interest revocation authority of Investigator months later, Ms. Fuller- possession of heroin and given a
section 824(a)(4) could be invoked in McMahan permitted the Agency to suspended sentenced of two years
this proceeding, this provision does not destroy the drugs. I found, however, that imprisonment and one year of
grant the Government any additional Ms. Fuller-McMahan’s actions did not probation. GX 3, at 1. She also enrolled
authority because the determination relinquish Respondent’s title to the in a methadone maintenance program.
must be made by reference to the property. Order, at 1–2 (Mar. 16, 2016). Id.
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On October 18, 2007, Ms. Fuller- made to M.K. in exchange for any drug. GX 4, at 1. Ms. Fuller-McMahan
McMahan filed a new application on information she might divulge.’’ Id. pled guilty to one of the counts, and on
behalf of Respondent for registration as According to the Agent, during her October 28, 2010, Ms. Fuller-McMahan
a Narcotic Treatment Program. Id. On interview, M.K. stated that Ms. Fuller- was convicted by the Superior Court of
June 13, 2008, Ms. Fuller-McMahan McMahan had ‘‘approached her and a single count of unlawful possession of
entered into Memorandum of asked her to procure cocaine for which a scheduled drug. Id. The court
Agreement (MOA) with DEA’s New [Fuller-McMahan] would be willing to sentenced Ms. Fuller-McMahan to 364
England Field Division, pursuant to trade methadone purchased on behalf days in the county jail, but suspended
which the Agency granted Respondent’s of’’ Respondent. Id. M.K. further stated all but 30 days of the sentence; the court
application subject to certain that Ms. Fuller-McMahan had said ‘‘that also placed her on probation for a
conditions. Id. at 1–2. As relevant here, she intended to create a falsified order period of one year. Id.
these included that: (1) Ms. Fuller- for methadone to be purchased by’’ On some date which is not clear from
McMahan ‘‘is prohibited from ordering Respondent for the purported use by the evidence, Respondent, through its
any controlled substances and will prisoners at the county jail ‘‘for drug attorney, surrendered its state licenses
execute a power of attorney authorizing treatment,’’ and that she would trade to operate an Opioid Treatment Program
one of her management staff to order the this methadone for cocaine. Id. and Outpatient Substance Abuse
controlled substances’’; (2) that ‘‘the The Agent also averred that M.K. had Services; Respondent also surrendered
same management staff will’’ execute named two other persons who were its pharmacy license. GX 5. Respondent
Respondent’s renewal applications; (3) obtaining methadone at Respondent for also allowed its registration to expire.4
Ms. Fuller-McMahan ‘‘will not have drug treatment and selling it. Id.
According to the Agent, ‘‘M.K. stated Discussion
physical access to the registered
location’’ or ‘‘any keys or codes to the she had purchased controlled As previously held, because
alarm system’’; (4) Ms. Fuller-McMahan substances from these’’ two persons. Id. Respondent’s registration has expired,
‘‘will not be enrolled as a client of’’ The Agent did not, however, clarify and there is no application to act upon,
Respondent and ‘‘will not guest dose at whether M.K. had purchased the only issue remaining in the
[it] under any circumstances.’’ Id. at 1. methadone from these persons. While proceeding is whether the Government
The MOA further provided that according to the Agent, M.K. offered to can claim title to the controlled
‘‘[v]iolations of the terms . . . may perform undercover buys from these substances it seized pursuant to the
result in an order to show cause to persons, the Agent offered no evidence authority granted by the Immediate
revoke, or revoke and immediately that any such buys were performed. Suspension Order. See S & S Pharmacy,
suspend’’ its DEA registration, and that Moreover, no further evidence was Inc., 78 FR 57656, 57659 (2013); RX
provided establishing that Respondent Direct Pharmacy, Inc., 72 FR 54070,
in any such proceeding, ‘‘DEA reserves
was improperly dispensing methadone 54072 (2007). Pursuant to 21 U.S.C.
the right to introduce into evidence . . .
to these two persons. See 42 CFR 8.12(i) 824(f),
this Agreement and violations of this
(regulations governing ‘‘[u]nsupervised
Agreement.’’ Id. at 1–2. On June 23, In the event the Attorney General suspends
or ‘take home use’ ’’).
2008, the then Special Agent in Charge In his affidavit, the Agent testified or revokes a registration under section 823 of
of the Field Division approved the that on July 13, 2010, Ms. Fuller- this title, all controlled substances . . . owned
MOA, id. at 2, and on July 1, 2008, McMahan was arrested and charged or possessed by the registrant pursuant to
Respondent’s application was approved. such registration at the time of suspension or
with Possession of Cocaine, a felony the effective date of the revocation order, as
GX 2, at 2. offense under Maine Law. Id. at 1 (citing the case may be, may, in the discretion of the
On December 11, 2008, J.C., a 17–A M.R.S.A. § 1107–A). The Agent Attorney General, be placed under seal. . . .
pharmacist, executed a state board further stated that Ms. Fuller-McMahan Upon a revocation order becoming final, all
application to become Respondent’s was in possession of ‘‘approximately 25 such controlled substances . . . shall be
new Pharmacist-in-Charge. GX 16, at 1. grams of powdered cocaine’’ and two forfeited to the United States; and the
On the application, J.C. listed Ms. syringes which she had obtained from Attorney General shall dispose of such
Fuller-McMahan as an ‘‘authorized J.R., a patient of Respondent, who controlled substances . . . in accordance with
person.’’ Id. at 6. According to a performed an undercover sale for the section 881(e) of this title. All right, title, and
regulation of the Maine Board of interest in such controlled substances . . .
MDEA. Id. shall vest in the United States upon a
Pharmacy, ‘‘[a]n ‘authorized person’ is a After her arrest, Ms. Fuller-McMahan revocation order becoming final.
person other than a pharmacy waived her Miranda rights and was
technician (e.g., computer technician, interviewed by the Agent; a video DEA has previously held that a
bookkeeper) who the pharmacist in recording of the interview was provided registrant, whose property has been
charge has designated to be present in by the Government. During the seized pursuant to an Immediate
the prescription filling area in the interview, Ms. Fuller-McMahan stated Suspension Order, cannot defeat the
absence of a pharmacist.’’ GX 17, at 1 that she intended to deliver the cocaine effect of this provision by allowing its
(copy of 02–392 CMR Ch. 1, § 1). to C.G., a drug and alcohol counselor registration to expire. See, e.g.,
According to the affidavit of a employed by Respondent. Id. She also Meetinghouse Community Pharmacy,
Supervisory Special Agent with the ‘‘admitted that she was using cocaine Inc., 74 FR 10073, 10076 n.5 (2009).
Maine Drug Enforcement Agency and had ingested cocaine in the last
(MDEA), on November 3, 2009, he three weeks.’’ Id. During the interview,
asabaliauskas on DSK3SPTVN1PROD with NOTICES
4 The Government put forward no evidence in
‘‘interviewed M.K., a former patient’’ of Ms. Fuller-McMahan asked the Agent: support of the allegation that Respondent
‘‘continues to employ Ms. Fuller-McMahan’s
Respondent. GX 15, at 2. The Agent ‘‘can you charge me with something husband . . . despite the fact that [he] has been
further explained that M.K. had called else? Less? . . . If I agree to not go into convicted of illegal drug possession and has access
him ‘‘and requested to speak to [him] in Turning Tide . . . or to fight it, ever to Respondent’s controlled substances and
exchange for consideration with M.K.’s . . . back out completely?’’ Id. at 2. confidential patient information.’’ GX 1, at 2. Nor
did it put forward any evidence as to the allegations
pending drug charges.’’ Id. The Agent Thereafter, the State charged Ms. that she had engaged in three other illegal
further explained that an interview was Fuller-McMahan with two counts of purchases of cocaine with another of Respondent’s
arranged and that ‘‘no promises were unlawful possession of a scheduled patients.
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![Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices 47415
As explained above, section 824(a) admitted that she remained Turning substances for cocaine’’ and that ‘‘[h]er
sets forth a specific provision which Tide’s director. Id. The Government behavior in this regard independently
grants the Agency authority to suspend does not, however, point to any confirms her intent to purchase illegal
or revoke the registration of a Narcotic provision of the MOA which prohibited substances with narcotic drugs slated
Treatment Program. This provision Ms. Fuller-McMahan from acting as for legitimate drug treatment.’’ Id. at 12
states that: Turning Tide’s director. (emphasis added). And arguing that her
A registration pursuant to section 823(g)(1) Stronger is the Government’s claim ‘‘past performance is the best predictor
of this title to dispense a narcotic drug for that Ms. Fuller-McMahan violated the of future performance,’’ the Government
maintenance treatment or detoxification MOA because she was entering its asserts that Ms. Fuller-McMahan’s
treatment may be suspended or revoked by physical premises. The MOA conduct ‘‘demonstrated a high
the Attorney General upon a finding that the specifically prohibited her from likelihood that she would find a way to
registrant has failed to comply with any ‘‘hav[ing] physical access to the divert Respondent’s supply of
standard referred to in section 823(g)(1) of registered location,’’ GX 3, at 1; and as methadone in exchange for illegal
this title.
found above, during the interview drugs[,]’’ and ‘‘[t]hus, her continued
Id. § 824(a). So too, section 824(d) which followed her arrest, Ms. Fuller- access, ownership, and control over
provides that ‘‘[a] failure to comply with McMahan clearly tried to negotiate a Respondent’s business constituted an
a standard referred to in section lesser charge for agreeing not to go into imminent threat to the public health or
823(g)(1) of this title may be treated the clinic. See id. Moreover, the safety.’’ Id. (int. quotations and citation
under this subsection as grounds for Government produced the application omitted).
immediate suspension of a registration filed by Respondent’s PIC, in which he Under DEA’s regulation which is
granted under such section.’’ Id. designated her as an ‘‘authorized applicable to ‘‘all registrants,’’
§ 824(d). Thus, consistent with section person,’’ GX 16, at 4; which under Respondent was required to ‘‘provide
824(a), the former Administrator held Maine’s regulation authorized her ‘‘to be effective controls and procedures to
that the suspension order can only be present in the prescription filling area in guard against theft and diversion of
sustained if the Government puts the absence of a pharmacist.’’ GX 17. controlled substances.’’ 21 CFR
forward sufficient evidence to support Yet there is no evidence that Ms. 1301.71(a). See also 21 CFR 1301.72(d).
‘‘a finding that the registrant has failed Fuller-McMahan ever actually entered Thus, substantial evidence that Ms.
to comply with any standard referred to the pharmacy or that she possessed the Fuller-McMahan was obtaining
in section 823(g)(1).’’ keys or the alarm code for the methadone from Respondent’s stocks
Of the three standards for registration pharmacy.5 See, e.g., 21 CFR 1301.72(d) and trading it for other drugs would
as an NTP set forth in 21 U.S.C. (‘‘The controlled substances storage clearly establish Respondent’s non-
823(g)(1), the Government invokes only areas shall be accessible only to an compliance with a standard established
subparagraph B. It authorizes ‘‘the absolute minimum of specifically under 21 U.S.C. 823(g)(1)(B) and would
Attorney General [to] determine[] that authorized employees.’’). Thus, while clearly support the requisite finding that
the applicant will comply with the evidence supports a finding that Ms. its continued registration posed an
standards established by the Attorney Fuller-McMahan had access to the clinic imminent danger to public health or
General respecting (i) security of stocks and thus violated the MOA, by itself, safety as required by 21 U.S.C. 824(d).
of narcotic drugs for such treatment, and this conclusion does not support a The Government, however, has not
(ii) the maintenance of records (in finding that Respondent posed ‘‘an produced such evidence.
accordance with section 827 of this title) imminent danger to the public health or The Government points to Ms. Fuller-
on such drugs.’’ 21 U.S.C. 823(g)(1)(B) safety,’’ 21 U.S.C. 824(d), as is required McMahan’s execution of the renewal
(emphasis added). to support the Order of Immediate application. It argues that Ms. Fuller-
The Government argues that ‘‘Ms. McMahan did this to ‘‘provide[ ] herself
Suspension.
Fuller-McMahan’s conduct The Government further argues that with the legal means to order controlled
demonstrated that she was a security ‘‘[b]y executing a renewal application in substances.’’ Second Request, at 11. Yet
threat to [Respondent] and, accordingly, direct violation of the MOA . . . Ms. the Government has not produced a
a security risk to its stocks of controlled Fuller-McMahan also provided herself single order form (DEA–222) that Ms.
substances.’’ Second Request for Final with the legal means to order controlled Fuller-McMahan executed on behalf of
Agency Action, at 10. It further argues substances . . . and therefore carry out Respondent or any other evidence that
that her ‘‘continued ownership and the scheme she had proposed to M.K.’’ she was ordering methadone.
control over Respondent’s clinic Id. at 11 (citing 21 CFR 1305.11(c); other The Government also points to Ms.
constituted an imminent danger to the Fuller-McMahan’s alleged proposal to
citations omitted). While the
public health or safety.’’ Id. (citing 21 provide methadone to M.K. in exchange
Government then acknowledges that
U.S.C. 824(d)). And it argues that ‘‘[b]y for cocaine as support for its assertion
‘‘there is no evidence that this particular
permitting Ms. Fuller-McMahan to act that she ‘‘was predisposed to continue
transaction took place,’’ id., it notes that
as Turning Tide’s director and continue to engage in drug trafficking which
Ms. Fuller-McMahan was arrested and
to have control over the drug treatment could have involved trading
convicted for possessing cocaine which
facility, Respondent failed to comply Respondent’s stocks of narcotic
she had obtained from a patient and
with standards respecting the ‘security substances for cocaine.’’ id. at 12. This
intended to deliver to an employee. Id.
of stocks of narcotic drugs for . . . fails too, as notwithstanding
at 11–12.
treatment,’ ’’ and thus violated section Respondent’s waiver of its right to
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The Government then argues that
823(g)(1)(B). Id. at 11. ‘‘Ms. Fuller-McMahan was predisposed challenge the Immediate Suspension
Invoking the terms of the MOA, the to continue to engage in drug trafficking Order, the Agency’s Order in this matter
Government argues that ‘‘the evidence which could have involved trading must be supported by ‘‘reliable,
paints a far different picture of Ms. Respondent’s stocks of narcotic probative, and substantial evidence.’’ 5
Fuller-McMahan’s involvement in U.S.C. 556.
[Respondent] than that contemplated 5 The record contains no evidence of interviews Under the Agency’s rules,
by’’ the MOA. Id. First, the Government of any employees who might have observed her Respondent’s waiver of its right to a
argues that Ms. Fuller-McMahan entering the pharmacy. hearing does not constitute an
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![47416 Federal Register / Vol. 81, No. 140 / Thursday, July 21, 2016 / Notices
admission of the allegations. Thus, the patient at Respondent, and which Ms. Order
Government had the burden of proving Fuller-McMahan admitted she intended Pursuant to the authority vested in me
its claim that Ms. Fuller-McMahan was to provide to C.G., a counselor at by 21 U.S.C. 824(a) and (d), I hereby
likely to trade Respondent’s methadone Respondent. Yet even here, there is no declare the Order of Immediate
for cocaine. evidence that Ms. Fuller-McMahan Suspension issued to Turning Tide, Inc.,
However, the Government’s evidence either traded methadone for the cocaine
ultra vires. This Order is effective
as to the alleged proposal of Ms. Fuller- she received from J.R. or that she
immediately.
McMahan to trade methadone to M.K. in intended to provide the cocaine to C.B.
exchange for cocaine is so lacking in for methadone. Dated: July 15, 2016.
indicia of reliability that it does not Moreover, notwithstanding M.K.’s Chuck Rosenberg,
support the requisite finding under allegation, there is no evidence that the Acting Administrator.
section 823(g)(1). Notably, M.K.’s Government ever audited Respondent’s [FR Doc. 2016–17245 Filed 7–20–16; 8:45 am]
statement is hearsay,6 and there is no recordkeeping to determine whether BILLING CODE 4410–09–P
evidence that M.K., who has not been Respondent’s methadone was missing or
identified, was under oath when she that it developed any reliable evidence
provided the statement. Also, the MDEA that Ms. Fuller-McMahan was diverting DEPARTMENT OF JUSTICE
Agent acknowledged that M.K. had methadone. See 21 U.S.C. 823(g)(1)(B).
offered ‘‘to speak to [him] in exchange Nor did the Government produce any Drug Enforcement Administration
for consideration with M.K.’s pending evidence that Respondent’s
drug charges.’’ GX 15, at 2. recordkeeping was inadequate.9 Id. In [Docket No. 16–12]
Notwithstanding that the MDEA Agent short, while the Government has
further explained that ‘‘no promises established that Ms. Fuller-McMahan James Dustin Chaney, D.O.; Decision
were made to M.K. in exchange for any violated the MOA and this would have and Order
information she might divulge,’’ supported the issuance of an Order to
On November 13, 2015, the Deputy
informants typically do not provide Show Cause, the Government’s
Assistant Administrator, Office of
information without some expectation principal justification for immediately
Diversion Control, issued an Order to
of receiving favorable treatment and suspending Respondent’s registration
Show Cause to James Dustin Chaney,
have ample motive to shade their and seizing the drugs is not supported
D.O. (Respondent), of Hazard, Kentucky.
statements. Nor did the MDEA Agent’s by substantial evidence but rests on a
affidavit provide any additional facts hunch. Accordingly, I hold that the The Show Cause Order proposed the
tending to establish that M.K. had Immediate Suspension Order is ultra revocation of Respondent’s DEA
provided reliable information in other vires and the resulting seizure of Certificate of Registration BC8483430,
matters, or that the information M.K. Respondent’s methadone was unlawful. pursuant to which he is authorized to
provided regarding Ms. Fuller- See Norman Bridge, 529 F.2d at 828 dispense controlled substances in
McMahan was otherwise corroborated.7 (‘‘Such a suspension, or such a seizure, schedules II through V, and the denial
In short, this type of statement has may be invoked only to avoid imminent of any pending applications to renew or
been traditionally viewed by the courts danger to the public health and safety. modify his registration or for any other
as inherently unreliable, and as such, In the absence of that factor there can be registration, on the ground that he does
M.K.’s statement cannot be given any no suspension and no seizure without not have authority to handle controlled
weight in this decision. See, e.g., Carlos notice and an opportunity to be substances in Kentucky, the State in
Gonzales, 76 FR 63118, 63119–20 heard.’’).10 which he holds his DEA registration.
(2011). And even if the Government had Show Cause Order, at 1 (citing 21 U.S.C.
established that M.K.’s statement was 9 The Government also argues that ‘‘there was no 823(f); 824(a)(3)).
reliable, this interview, which occurred evidence that Respondent’s employees . . . were The Show Cause Order alleged that
more than nine months prior to the taking any steps to minimize that risk,’’ i.e., the risk Respondent is registered as a
that Ms. Fuller-McMahan was diverting practitioner with authority to dispense
issuance of the Immediate Suspension Respondent’s methadone. Second Req. for Final
Order, could not support a finding of Agency Action, at 14. However, the Government schedule II through V controlled
imminent danger and the subsequent has the burden of proving that Respondent’s substances at the registered location of
seizure of the drugs.8 See, e.g., Norman methadone was being diverted. Moreover, it bears 1908 North Main Street, Hazard, KY. Id.
noting that under the Maine Board of Pharmacy’s The Order further alleged that while
Bridge Drug Co. v. Banner, 529 F.2d rules, Respondent was required to have a licensed
822, 829 (5th Cir. 1976). pharmacist overseeing its pharmacy, and ‘‘[t]he Respondent’s registration was due to
Thus, the only evidence which pharmacist in charge is responsible legally and expire on August 31, 2015, on August
arguably supports the Immediate professionally for all activities related to the 25, 2015, he filed a timely renewal
practice of pharmacy within the opioid treatment application and thus, his registration
Suspension Order and seizure of program for which the licensee is registered as
Respondent’s methadone stock is the pharmacist in charge, and for the opioid treatment
arrest of Ms. Fuller-McMahan for the program’s compliance with . . . federal and state the benefit of the registrant, or his successor in
possession of cocaine and the syringes, laws and rules,’’ including the CSA and DEA interest. The Attorney General shall notify a
regulations. 02–392 CMR 36 § 4; see also 02–392 registrant, or his successor in interest, who has any
which she had received from J.R., a CMR 29 § 1. controlled substance . . . seized or placed under seal
10 In a June 29, 2015 letter, the Special Agent in of the procedures to be followed to secure the
6 While M.K.’s statement is actually hearsay
Charge of the New England Field Division wrote to return of the controlled substance . . . and the
within hearsay, I have no reason to question the conditions under which it will be returned. The
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Ms. Fuller-McMahan that ‘‘[a]lthough the controlled
MDEA Agent’s recounting of the facts surrounding substances were seized pursuant to an Immediate Attorney General may not dispose of any controlled
M.K.’s agreeing to provide the statement or that he Suspension Order, they are also being held by substance . . . seized or placed under seal under this
has accurately testified as to the substance of M.K.’s virtue of the fact that your registration expired on subsection until the expiration of one hundred and
statement. November 30, 2010, resulting in your not having eighty days from the date such substance . . . was
7 Likewise, the Government did not produce the seized or placed under seal.
any authority to handle controlled substances.’’
entirety of M.K.’s statement and thus, there is no However, to the extent the Government retained 21 U.S.C. 824(g). The Government has provided
way to evaluate the internal consistency of the possession of the controlled substances based on no evidence that it complied with the procedures
statement. the expiration of Respondent’s registration, 21 required by this subsection. Accordingly, the
8 The record does not establish when the MDEA U.S.C. 824(g) provides that: propriety of the seizure must be evaluated under
Agent first told DEA about M.K.’s allegations. [s]uch controlled substances . . . shall be held for the standards of subsection 824(d) and (f).
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Document Created: 2018-02-08 07:58:56
Document Modified: 2018-02-08 07:58:56
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
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| Section | Notices | |
| FR Citation | 81 FR 47411 |
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