On September 10, 2025, the Drug Enforcement Administration (DEA or Government) issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO) to St. Michael's Pharmacy of Rosenberg, Texas (Registrant). Request for Final Agency Action (RFAA), Exhibit (RFAAX) 1, at 1. The OSC/ISO informed Registrant of the ( printed page 62755) immediate suspension of its DEA Certificate of Registration, No. FS0483951, pursuant to 21 U.S.C. 824(d), alleging that Registrant's continued registration constitutes “ `an imminent danger to the public health or safety.' ” Id. (quoting 21 U.S.C. 824(d)). The OSC/ISO also proposed the revocation of Registrant's DEA Certificate of Registration, alleging that Registrant's continued registration is inconsistent with the public interest. Id. (citing 21 U.S.C. 823(g)(1); 824(a)(4)).^[1]

The OSC/ISO alleged that from at least March 2023 through February 2025, Registrant violated federal and Texas state law by continuously filling Schedule II controlled substance prescriptions despite obvious red flags of abuse and/or diversion and without addressing or resolving those red flags. RFAAX 1, at 1, 4-5. The OSC/ISO alleged that these unresolved red flags of abuse and/or diversion included pattern prescribing; prescriptions for controlled substances commonly known to be abused, prescriptions for controlled substances at their highest strength and/or in large quantities, the same patient obtaining similar drugs from multiple practitioners, and shared addresses of patients. Id. at 1-2, 5-7.

Further, the OSC/ISO alleged that as recently as March 2025, Registrant failed to maintain effective controls against diversion or otherwise comply with the obligations of a registrant. Id. at 2, 7-8. Specifically, the OSC/ISO alleged that large quantities of controlled substances were unaccounted for and that records for those controlled substances were not kept in compliance with law. Id. at 2, 7-8.

The OSC/ISO alleged that Registrant violated the following federal regulations: 21 CFR 1304.04(a); 21 CFR 1304.11(a)-(c); 21 CFR 1304.21(a); 21 CFR 1306.04(a).^[2] RFAAX 1, at 2. The OSC/ISO also alleged that Registrant violated the following Texas state regulations: Tex. Health & Safety Code Ann. § 481.074(a)(1); Tex. Health & Safety Code Ann. § 481.128(a)(1); 22 Tex. Admin. Code Ann. § 291.29(a)-(b), (f); 22 Tex. Admin. Code § 291.33(c)(2)(A)(i)-(ii), (iv); 22 Tex. Admin. Code § 291.33(c)(2)(C); 22 Tex. Admin. Code Ann. § 291.34(a), (b)(1). Id. at 3-4.

On October 20, 2025, the Government submitted an RFAA requesting that the Agency issue a default final order revoking Registrant's registration. RFAA, at 6. Further, on June 8, 2026, the Government submitted a Notice of Change of [Registrant]'s State Authority (State Authority Notice). In its State Authority Notice, the Government indicated that on March 11, 2026, the Texas State Board of Pharmacy revoked Registrant's state pharmacy license, thus rendering Registrant without authority to handle controlled substances in Texas, the state in which Registrant is registered with DEA. State Authority Notice, at 1.^[3]

On July 28, 2026, the Agency served Registrant via email with a Notice of Allegation and Briefing Order (Allegation Notice). In its Allegation Notice, the Agency notified Registrant of the Government's allegation that Registrant's lack of state authority to handle controlled substances in Texas was an additional basis for revocation of its DEA registration. Allegation Notice, at 2. Additionally in its Allegation Notion, the Agency notified Registrant that Registrant could contest the Government's allegation by submitting a written response and supporting documentary evidence within fifteen days of service of the Allegation Notice. Id. To date, the Agency has not received any correspondence from Registrant regarding the Allegation Notice.

After carefully reviewing the entire record and conducting the analysis as set forth in more detail below, the Agency grants the Government's RFAA and revokes Registrant's registration.

I. Default Determination

Under 21 CFR 1301.43, a registrant entitled to a hearing who fails to file a timely hearing request “within 30 days after the date of receipt of the [OSC/ISO] . . . shall be deemed to have waived their right to a hearing and to be in default” unless “good cause” is established for the failure. 21 CFR 1301.43(a) & (c)(1). In the absence of a demonstration of good cause, a registrant who fails to timely file an answer also is “deemed to have waived their right to a hearing and to be in default.” 21 CFR 1301.43(c)(2). Unless excused, a default is deemed to constitute “an admission of the factual allegations of the [OSC/ISO].” 21 CFR 1301.43(e).

Here, the OSC/ISO notified Registrant of its right to file a written request for hearing, and that if it failed to file such a request, it would be deemed to have waived its right to a hearing and be in default. RFAAX 1, at 9-10 (citing 21 CFR 1301.43). According to the Government's RFAA, Registrant failed to request a hearing. RFAA, at 2. Thus, the Agency finds that Registrant is in default and therefore has admitted to the factual allegations in the OSC/ISO.

21 CFR 1301.43(e).

II. Loss OF State Authority

In addition to the above failures resulting in default, Registrant failed to exercise his opportunity to be heard on his loss of state authority by not responding to the Allegation Notice.

A. Findings of Fact

According to Texas online records, of which the Agency takes official notice,^[4] Registrant's Texas pharmacy license 33705 is revoked. Texas State Board of Pharmacy, Texas Pharmacy Search, www.pharmacy.texas.gov/​dbsearch/​phy_​search.asp (last visited date of signature of this Order). Accordingly, the Agency finds that Registrant is not licensed to operate as a pharmacy in Texas, the state in which it is registered with DEA.^[5]

B. Discussion

Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized to suspend or revoke a registration issued under 21 U.S.C. 823 “upon a finding that the registrant . . . has had [its] State license or registration suspended . . . [or] revoked . . . by competent State authority and is no longer authorized by State law to engage in the . . . dispensing of controlled substances.” With respect to a practitioner, DEA has also long held that the possession of authority to dispense controlled substances under the laws of the state in which a practitioner engages in professional practice is a fundamental condition for obtaining and maintaining a practitioner's registration. Gonzales v. Oregon, 546 U.S. at 270 (“The Attorney General can register a physician to dispense controlled substances `if the applicant is authorized to dispense . . . controlled substances under the laws of the State in which he practices.' . . . The very definition of a `practitioner' eligible to prescribe includes pharmacies and physicians `licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices' to dispense controlled substances. 802(21).”). The Agency has applied these principles consistently. See, e.g.,Irina Gross, D.P.M.,91 FR 38016 (2026); Phong H. Tran, M.D.,90 FR 14383 (2025); Palafox Pharmacy,84 FR 18320 (2019).^[6]

According to Texas statute, “dispense” means “the delivery of a controlled substance in the course of professional practice or research, by a practitioner or person acting under the lawful order of a practitioner, to an ultimate user or research subject. The term includes the prescribing, administering, packaging, labeling, or compounding necessary to prepare the substance for delivery.” Tex. Health & Safety Code Ann. §  481.002(12) (West 2026). Further, a “practitioner” includes “a pharmacy, hospital, or other institution licensed, registered, or otherwise permitted to distribute, dispense, conduct research with respect to, or administer a controlled substance in the course of professional practice or research in this state.” Id. §  481.002(39)(B).

Here, the undisputed evidence in the record is that Registrant lacks authority to operate as a pharmacy in Texas because its Texas pharmacy license was revoked. As discussed above, a pharmacy must be licensed as a practitioner to dispense or prescribe a controlled substance in Texas. Thus, because Registrant currently lacks authority to operate as a pharmacy in Texas and, therefore, is not currently authorized to handle controlled substances in Texas, Registrant is not eligible to maintain a DEA registration. Accordingly, the Agency finds that Registrant's lack of state authority to handle controlled substances provides an independent basis for revocation of Registrant's DEA registration. 21 U.S.C. 824(a)(3).

III. Public Interest

A. Applicable Law

As the Supreme Court stated in Gonzales v. Raich, 545 U.S. 1 (2005), “the main objectives of the [Controlled Substances Act (CSA)] were to conquer drug abuse and control the legitimate and illegitimate traffic in controlled substances.” 545 U.S. at 12. Gonzales explained that:

Congress was particularly concerned with the need to prevent the diversion of drugs from legitimate to illicit channels. To effectuate these goals, Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA . . . . The CSA and its implementing regulations set forth strict requirements regarding registration, labeling and packaging, production quotas, drug security, and recordkeeping.

Id. at 12-14.

The OSC/ISO's allegations concern the CSA's “statutory and regulatory provisions . . . mandating . . . compliance with . . . security controls to guard against diversion, recordkeeping and reporting obligations, and prescription requirements” and, therefore, go to the heart of the CSA's “closed regulatory system” specifically designed “to conquer drug abuse and to control the legitimate and illegitimate traffic in controlled substances,” and “to prevent the diversion of drugs from legitimate to illicit channels.” Id. at 12-14, 27.

Allegation That Registrant Filled Prescriptions Without Addressing or Resolving Red Flags of Abuse and/or Diversion

According to the CSA's implementing regulations, a lawful prescription for a controlled substance is one that is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR 1306.04(a). Although “[t]he responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner . . . a corresponding responsibility rests with the pharmacist who fills the prescription.” Id. Pursuant to the CSA's implementing regulations, only a pharmacist “acting in the usual course of his [or her] professional practice” may fill a prescription for a controlled substance. 21 CFR 1306.06.

As for state law, Texas regulations state that a Texas pharmacist “shall exercise sound professional judgment with respect to the accuracy and authenticity of any prescription drug order” they dispense and “shall make every reasonable effort to ensure that any prescription drug order . . . has been issued for a legitimate medical purpose by a practitioner in the course of medical practice.” 22 Tex. Admin. Code Ann. § 291.29(a)-(b); see also 22 Tex. Admin. Code Ann. § 291.34(b)(1); RFAAX 1, at 3.

Texas Administrative Code §  291.29(f) states that “[a] pharmacist shall make every reasonable effort to prevent inappropriate dispensing due to fraudulent, forged, invalid, or medically inappropriate prescriptions in violation of a pharmacist's corresponding responsibility,” and provides a list of nineteen “patterns ( i.e., red flag factors) [that] are relevant to preventing the non-therapeutic dispensing of controlled substances.” 22 Tex. Admin. Code §  291.29(f). The statute further states that these red flags “shall be considered by evaluating the totality of the circumstances rather than any single factor.” Id. These “red flag factors” include:

(1) the pharmacy dispenses a reasonably discernible pattern of substantially identical prescriptions for the same controlled substances, potentially paired with other drugs, for numerous persons, indicating a lack of individual drug therapy in prescriptions issued by the practitioner; . . .

(3) prescriptions by a prescriber presented to the pharmacy are routinely for controlled substances commonly known to be abused drugs, including opioids, benzodiazepines, muscle relaxants, psychostimulants, and/or cough syrups containing codeine, or any combination of these drugs; . . .

(5) prescriptions for controlled substances are commonly for the highest strength of the ( printed page 62757) drug and/or for large quantities ( e.g., monthly supply), indicating a lack of individual drug therapy in prescriptions issued by the practitioner; . . .

(10) the Texas Prescription Monitoring Program indicates the person presenting the prescriptions is obtaining similar drugs from multiple practitioners, and/or that the person is being dispensed similar drugs at multiple pharmacies; [and]

(11) multiple persons with the same address present substantially similar controlled substance prescriptions from the same practitioner.

22 Tex. Admin. Code Ann. § 291.29(f); RFAAX 1, at 4.

Regarding the operational standards for a pharmacist filling a new prescription, the Texas Board of Pharmacy requires a pharmacist to: (i) review the patient's medication record and, at a minimum, identify clinically significant information such as “reasonable dose and route of administration; . . . drug-drug interactions; . . . and [ ] proper utilization, including overutilization or underutilization,” (ii) “take appropriate steps to avoid or resolve [any] problem” identified, “including consultation with the prescribing practitioner”; and (iv) resolve any questions with the prescriber and document the resolution. 22 Tex. Admin. Code Ann. § 291.33(c)(2)(A)(i)-(ii), (iv); RFAAX 1, at 3.^[7]

Texas regulations further state that “[a] pharmacist may not: (1) dispense . . . a controlled substance . . . except under a valid prescription and in the course of professional practice.” Tex. Health & Safety Code Ann. § 481.074(a)(1); RFAAX 1, at 3.^[8]

Allegation That Registrant Failed to Adequately Maintain Complete and Accurate Records

Federal law requires that pharmacies maintain current, complete, and accurate records of all controlled substances. 21 CFR 1304.11(a)-(c); 21 CFR 1304.21(a) (as referenced in 21 CFR 1304.21(c)); RFAAX 1, at 2. This includes a requirement that pharmacies take a complete and accurate inventory of all stock of controlled substances on hand from the date the pharmacy first engages in the dispensing of controlled substances. 21 CFR 1304.11(a)-(c); RFAAX 1, at 2. Such inventories must be kept for at least two years from the date of their creation. 21 CFR 1304.04(a); RFAAX 1, at 2. Federal law also requires that original signed electronic 222 order forms be retained, linked, and maintained on a central server. 21 CFR 1305.27(a), (c).

B. Findings of Fact

Allegation That Registrant Filled Prescriptions Without Addressing or Resolving Red Flags of Abuse and/or Diversion

The Agency finds that, in light of Registrant's default, the factual allegations in the OSC/ISO are deemed admitted. 21 CFR 1301.43(e). Accordingly, Registrant is deemed to have admitted and the Agency finds that from at least January 2023 through at least February 2025, Registrant repeatedly filled controlled substance prescriptions that contained multiple red flags of abuse and/or diversion without addressing or resolving those red flags. RFAAX 1, at 5-7.

Pattern Prescribing, Controlled Substances Known To Be Abused, and Highest Strength/Large Quantities

Registrant admits that “pattern prescribing” occurs when practitioners prescribe the same controlled substances in identical or substantially similar quantities, thus indicating a lack of individualized care. RFAAX 1, at 5. Registrant admits that DEA has recognized pattern prescribing to be a red flag consistent with abuse and/or diversion that needs to be addressed prior to dispensing. Id. (citing The Med. Shoppe,79 FR 59504, 59512 (2014)).

Further, as discussed above, see Section III.A., Texas regulations have recognized pattern prescribing as a red flag consistent with abuse and/or diversion that needs to be addressed prior to dispensing. 22 Tex. Admin. Code Ann. § 291.29(f)(1); RFAAX 1, at 5. Texas regulations have also recognized that prescriptions for controlled substances commonly known to be abused (such as opioids and narcotics) and prescriptions for controlled substances prescribed at the highest strength and/or in large quantities ( e.g., a monthly supply) are red flags consistent with abuse and/or diversion that need to be addressed prior to dispensing. 22 Tex. Admin. Code Ann. § 291.29(f)(3), (5); RFAAX 1, at 5.

Registrant admits that from at least January 2023 through at least February 2025, Registrant repeatedly failed to appropriately identify and resolve red flags associated with pattern prescribing. RFAAX 1, at 5-6. Moreover, the controlled substance prescriptions filled by Registrant that were indicative of pattern prescribing posed additional red flags because they were for controlled substances commonly known to be abused and were prescribed at the highest strength and/or in large quantities. Id.

Registrant admits that between January 2023 and February 2025, Registrant routinely filled prescriptions for oxycodone 30 mg (a Schedule II opioid), hydrocodone (a Schedule II opioid), and oxycodone/acetaminophen while repeatedly failing to identify and resolve the red flag of pattern prescribing from the same practitioners. Id. at 5. Specifically, Drs. C.I., D.C., A.P., C.H., L.B., and M.Q. prescribed 65% of all prescriptions that Registrant dispensed for oxycodone 30 mg (786 prescriptions out of 1,213 total); Drs. M.Q., C.I., L.N., J.R., E.N., A.J., D.C., and C.H. prescribed 53% of all prescriptions that Registrant dispensed for hydrocodone 10/325 mg (442 prescriptions out of 830 total); and Drs. S.N., J.R., T.D., Z.M., E.N., M.C., L.N., and A.J. prescribed 62% of all prescriptions that Registrant dispensed for oxycodone/acetaminophen 10/325 mg (105 prescriptions out of 170 total). Id.

Registrant also admits that it repeatedly failed to identify and resolve red flags of pattern prescribing controlled substances known to be abused and at the highest strength and/or large quantities, including the following:

Dr. C.H.: Between June 16, 2023, and January 3, 2024, Registrant filled five prescriptions for oxycodone 30 mg (100-105 tablets) issued by Dr. C.H. for D.S. RFAAX 1, at 6. Between June 9, 2023, and November 17, 2023, Registrant filled five prescriptions for oxycodone 30 mg (100-110 tablets) issued by Dr. C.H. for Q.R. Id. On November 4, 2023, Registrant filled a prescription for oxycodone 30 mg (100 tablets) issued by Dr. C.H. for J.J. Id.

Dr. C.I.: On September 29, 2023, Registrant filled a prescription for oxycodone 30 mg (103 tablets) issued by Dr. C.I. for O.J. Id. On June 14, 2023, and September 19, 2023, Registrant filled a prescription for oxycodone 30 mg (100 tablets) issued by Dr. C.I. for A.B. Id.

Dr. A.P.: On March 8, 2024, and June 15, 2024, Registrant filled a prescription for oxycodone 30 mg (100 tablets) issued by Dr. A.P. for J.J. Id. On January ( printed page 62758) 13, 2024, and April 12, 2024, Registrant filled a prescription for oxycodone 30 mg (100 tablets) issued by Dr. A.P. for T.N. Id.

Accordingly, the Agency finds substantial record evidence that Registrant dispensed over 1,000 tablets of oxycodone 30 mg over a two-year period without first resolving the red flags arising from pattern prescribing controlled substances known to be abused, and at their highest strength and/or in large quantities.

Same Patient Obtaining Similar Drugs From Multiple Practitioners

As discussed above, see Section III.A., Texas regulations have recognized that it is a red flag consistent with abuse and/or diversion that needs to be addressed prior to dispensing when “the Texas Prescription Monitoring Program indicates the person presenting the prescriptions is obtaining similar drugs from multiple practitioners, and/or that the person is being dispensed similar drugs at multiple pharmacies.” 22 Tex. Admin. Code Ann. § 291.29(f)(10); RFAAX 1, at 6.

Registrant admits that from at least September 2023 through at least February 2025, Registrant repeatedly filled prescriptions for individuals who presented prescriptions for the same or similar drugs from a combination of doctors, without resolving the red flag prior to dispensing. RFAAX 1, at 6-7. For example, Registrant filled a prescription for M.V., who received hydrocodone-acetaminophen 10/325 mg prescriptions from three doctors and filled them at five different pharmacies. Id. at 7. Registrant also filled a prescription for M.W., who received oxycodone 30 mg and hydrocodone-acetaminophen 10/325 mg prescriptions from five doctors and filled them at seven different pharmacies. Id. Registrant filled a prescription for C.G., who received oxycodone 30 mg and hydrocodone-acetaminophen 10/325 mg prescriptions from six doctors and filled them at five different pharmacies. Id. Finally, Registrant filled a prescription for J.J., who received oxycodone 30 mg prescriptions from five doctors and filled them at three different pharmacies. Id. at 7.

Accordingly, the Agency finds substantial record evidence that Registrant filled four controlled substances prescriptions for individuals who presented prescriptions for the same or similar drugs from a combination of doctors, without resolving the red flag prior to dispensing.^[9]

Expert Review

DEA retained an independent pharmacy expert to review, among other materials, Registrant's Prescription Monitoring Program data, prescriptions, prescription profiles, and patient notes. RFAAX 1, at 8. The pharmacy expert concluded, and Registrant admits, that Registrant repeatedly filled prescriptions without properly resolving red flags of drug abuse or diversion. Id. The pharmacy expert also concluded, and Registrant admits, that from March 2023 through at least February 2025, Registrant repeatedly filled prescriptions for controlled substances in violation of federal law and binding minimal standards that govern the practice of pharmacy in Texas. Id.

In consideration of all of the above, the Agency finds substantial record evidence that Registrant repeatedly dispensed the above-referenced prescriptions without first resolving the above-referenced red flags, in violation of the standard of care in Texas.

Allegation That Registrant Failed to Adequately Maintain Complete and Accurate Records

On March 25, 2025, DEA investigators conducted an on-site administrative inspection at Registrant's registered address. RFAAX 1, at 7. Registrant admits that during this inspection, DEA investigators observed that Registrant did not possess the expected physical stock of controlled substances relative to its ordering practices. Id. Registrant admits and the Agency finds that between May 1, 2023, and March 5, 2025, a comparison of Registrant's dispensing data to Registrant's distributor ordering data demonstrated that Registrant could not account for at least the following controlled substances: 43,003.5 dosage units of hydrocodone 10/325 mg tablets, which amounts to a 123.63% variance of calculated inventory; 25,960 dosage units of oxycodone 30 mg tablets, which amounts to a 39.91% variance of calculated inventory; 2,975 dosage units of oxycodone 10/325 mg tablets, which amounts to a 39.67% variance of calculated inventory; 187 dosage units of methadone 10 mg tablets (a Schedule II opioid), which amounts to a 6.93% variance of calculated inventory; 100 dosage units of dextroamphetamine 20 mg tablets (a Schedule II stimulant), which amounts to a 25% variance of calculated inventory; 1,005 dosage units of acetaminophen/codeine 300/30 mg tablets (a Schedule III narcotic analgesic combination), which amounts to a 191.43% variance of calculated inventory; and 116 dosage units of tramadol 50 mg (a Schedule IV opioid), which amounts to a 13.83% variance of calculated inventory. RFAAX 1, at 7-8.

Accordingly, the Agency finds substantial record evidence that Registrant failed to account for large quantities of controlled substances.

Further, regarding recordkeeping of controlled substances, Registrant is deemed to have admitted and the Agency finds that Registrant failed to provide complete and accurate records, failed to meet general inventory requirements, and failed to retain, link, and maintain on a central server original signed electronic 222 Order Forms. Id. at 8.

Accordingly, the Agency finds substantial record evidence that Registrant failed to keep and maintain complete and accurate controlled substance records as required by law.

C. Legal Background on Public Interest Determinations

The Attorney General “may deny, suspend, or revoke [a] registration if . . . the [registrant's] registration would be `inconsistent with the public interest.' ” Gonzales v. Oregon, 546 U.S. 243, 251 (2006) (quoting 21 U.S.C. 824(a)(4)). The Attorney General's “discretion in exercising [the authority to register and deregister practitioners] is spelled out in very broad terms.” Id. at 292 (Scalia, J., dissenting); see also Neumann's Pharmacy, L.L.C. v. Drug Enf't Admin., No. 25-60068, 2026 WL 411942 (5th Cir. Feb. 13, 2026) (“DEA unquestionably has broad authority to deregister pharmacies and substantial discretion to shape policy within statutory bounds.”). In executing this broad mandate, DEA must continuously balance the CSA's public interest goals of curbing the “illegal . . . distribution[ ] and possession[,] and improper use of controlled substances[, which has] a substantial and detrimental effect on the health and general welfare of the American people,” while ensuring that the public has access to medications that “have a useful and legitimate medical purpose and are necessary to maintain the health ( printed page 62759) and general welfare of the American people.” 21 U.S.C. 801(1), (2); see Joanna R. Lampe, Cong. Rsch. Serv., R45948, The Controlled Substances Act (CSA): A Legal Overview for the 119th Congress (2025), www.congress.gov/​crs-product/​R45948.

In the case of a “practitioner,” which is defined in 21 U.S.C. 802(21) to include a “pharmacy,” Congress directed the Attorney General to consider five factors in making the public interest determination. 21 U.S.C. 823(g)(1)(A-E).^[10] Just as the phrase “inconsistent with the public interest” is broad, the five factors that Congress directed DEA to consider in determining the public interest are similarly broad, suggesting that Congress intended for DEA to have discretion and flexibility to interpret this language as necessary to implement its critical mission to protect the public from drug abuse and diversion. See Loper Bright Enters. v. Raimondo, 603 U.S 369, 394-95 (2024) (noting that “[i]n a case involving an agency . . . the statute's meaning may well be that the agency is authorized to exercise a degree of discretion,” such as where the statute uses terms or phrases like `appropriate or reasonable' ” (internal citations omitted)). Indeed, courts have recognized the Agency's broad discretion to deny applications and deregister practitioners for a wide variety of conduct that the Agency has determined is inconsistent with the public interest. See, e.g., Orusa v. Drug Enf't Admin., No. 22-3132, 2023 WL 3886403 (6th Cir. June 8, 2023) (physician issuing prescriptions outside the usual course of professional practice and beneath the standard of care); St. Croix v. Drug Enf't Admin., No. 21-1116, 2022 WL 2092177 (D.C. Cir. June 10, 2022) (physician failing to maintain adequate records, prescribing controlled substances without a legitimate medical purposes, storing controlled substances at an unregistered location, failing to provide effective controls to guard against theft or diversion of these substances); Suntree Pharmacy v. Drug Enf't Admin., No. 20-14626, 2022 WL 444357 (11th Cir. Feb. 14, 2022), cert. denied, 143 S. Ct. 305 (2022) (pharmacy filling prescriptions outside the usual course of practice).

The CSA's five public interest factors are considered in the disjunctive. Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (“It is well established that these factors are to be considered in the disjunctive,” quoting In re Arora,60 FR 4447, 4448 (1995)); Robert A. Leslie, M.D.,68 FR 15227, 15230 (2003). Each factor is weighed on a case-by-case basis. David H. Gillis, M.D.,58 FR 37507, 37508 (1993); see Morall v. Drug Enf't Admin., 412 F.3d 165, 181 (D.C. Cir. 2005) (describing the Agency's adjudicative process as “applying a multi-factor test through case-by-case adjudication,” quoting LeMoyne-Owen Coll. v. N.L.R.B., 357 F.3d 55, 61 (D.C. Cir. 2004)). Any one factor, or combination of factors, may be decisive, David H. Gillis, M.D., 58 FR at 37508, and the Agency “may give each factor the weight . . . deem[ed] appropriate in determining whether a registration should be revoked or an application for registration denied.” Morall, 412 F.3d. at 185 n.2 (Henderson, J., concurring) (quoting Robert A. Smith, M.D.,70 FR 33207, 33208 (2007)); see also Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (D.C. Cir. 2007).

Moreover, while the Agency is required to consider each of the factors, it “need not make explicit findings as to each one.” MacKay v. Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011) (quoting Volkman v. U.S. Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009)); Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Hoxie v. Drug Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). “In short, . . . the Agency is not required to mechanically count up the factors and determine how many favor the Government and how many favor the registrant. Rather, it is an inquiry which focuses on protecting the public interest; what matters is the seriousness of the registrant's misconduct.” Jayam Krishna-Iyer, M.D.,74 FR 459, 462 (2009). Accordingly, as the Tenth Circuit has recognized, Agency decisions have explained that findings under a single factor can support the revocation of a registration. MacKay, 664 F.3d at 821.

The Government has the burden of proof in this proceeding, 21 CFR 1301.44(e), and the Agency must make its findings based on “substantial [record] evidence.” 5 U.S.C. 556(d); see5 U.S.C. 706(2); 21 U.S.C. 877. If the Government meets its burden of establishing a prima facie case that Registrant's registration is not in the public interest, then the burden shifts to Registrant to rebut the Government's case. Pharmacy Doctor Enters., Inc. v. Drug Enf't Admin., 789 Fed. Appx. 724, 729 (11th Cir. 2019) (citing Jones Total Health Care Pharmacy, 881 F.3d at 830).

Registrant is registered in Texas, and the OSC/ISO has alleged violations of state laws in Texas. RFAAX 1, at 3-4. Accordingly, the Agency must evaluate the Government's evidence under Texas law. See Henry Emery, M.D.,90 FR 46927, 46929 (2025) (explaining the Agency analyzes public interest allegations according to the laws in the state where registrant is registered with DEA); see also21 U.S.C. 903 (“No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field in which that provision operates, including criminal penalties, to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.”).

D. Discussion

While the Agency has considered all the public interest factors of 21 U.S.C. 823(g)(1), the Government's evidence in support of its prima facie case primarily implicates Factors B and D. RFAA, at 5-6; RFAAX 1, at 5. Evidence is considered under Factor B when it reflects experience dispensing controlled substances and under Factor D when it reflects compliance or non-compliance with laws related to controlled substances. Kareem Hubbard, M.D.,87 FR 21156, 21162 (2022). Although Factors B and D have some overlap such that the Agency has frequently analyzed them together, Congress must have intended Factor B to encompass conduct that is not captured under Factor D. See Kungys v. United States, 485 U.S. 759, 778 (1988) (referencing the “cardinal rule of statutory interpretation that no provision should be construed to be entirely redundant”).

i. Factor B

As already discussed, the CSA gives the Attorney General authority to revoke a registration if he determines that the registrant “has committed such acts as would render his registration . . . inconsistent with the public interest as determined under [section 823].” 21 U.S.C. 824(a). One of the five factors that the Attorney General must consider in making this determination is the registrant's “experience in dispensing ( printed page 62760) . . . controlled substances.” 21 U.S.C. 823(g)(1)(B) (Factor B). Neither the statute nor the implementing regulations defines the term “experience” or places any limitations on the type of conduct that may be considered as “experience” under Factor B.^[11]

Historically, the Agency's Factor B ^[12] analysis considered “both the qualitative manner and quantitative volume of the [practitioner's] experience . . . as expressed through his patients and employees,” and concluded that the record must contain quantitative evidence regarding the practitioner's experience for the Agency to find that Factor B weighs against a practitioner. E.g., Clair L. Pettinger,78 FR 61592, 61619 (2013). In 2015, the Agency abandoned this language, observing that the text of Factor B did not require DEA to consider the practitioner's “quantity” of prescribing. See JM Pharmacy Group, Inc.,80 FR 28667, 28667-68 (2015); see also Wesley Pope, M.D.,82 FR 14944, 14982 (2017). The Agency reviewed dictionary definitions of “experience,” including:

(1) The “direct observation of or participation in events as a basis for knowledge,” (2) “the fact or state of having been affected by or gained knowledge through direct observation or participation,” (3) “practical knowledge, skill, or practice derived from direct observation of or participation in events or in a particular activity,” and (4) “the length of such participation.”

80 FR at 28667 n.2 (citing Webster's Collegiate Dictionary 409 (10th ed. 1998);

The Random House Dictionary of the English Language 681 (2d ed. 1987)).

The word “dispense” means “to deliver a controlled substance[ ] to an ultimate user or research subject by, or pursuant to the lawful order of a practitioner, including the prescribing or administering of a controlled substance and the packaging, labeling or compounding necessary to prepare the substance for such delivery.” 21 U.S.C. 802(10). This definition encompasses, among other things, practitioners who prescribe controlled substances and pharmacies who fill controlled substance prescriptions. Id. The term “controlled substance” simply means “a drug or other substance . . . included in schedule I, II, III, IV, or V . . . .” 21 U.S.C. 802(6). Thus, the phrase “experience in dispensing” means the direct participation in the act of delivering, prescribing, dispensing, or administrating a controlled substance to an ultimate user.

The phrase “experience in dispensing” must be considered within the context of DEA's broad mandate under 21 U.S.C. 824(a) to deregister practitioners who “ha[ve] committed such acts as would render [their] registration . . . inconsistent with the public interest.” 21 U.S.C. 824(a)(4). In other words, in determining what type of conduct is relevant under Factor B, DEA's primary focus is to determine whether a registrant's “experience in dispensing” is “inconsistent with the public interest” or whether a registrant's dispensing constitutes “acts” that are inconsistent with the public interest. 21 U.S.C. 823(g)(1), 824(a)(4).

The word “inconsistent” is not defined in the CSA, but it is commonly defined as “lacking consistency: such as (a) not compatible with another fact or claim, [and] (b) containing incompatible elements.” Inconsistent, Merriam-Webster, www.merriam-webster.com/​dictionary/​inconsistent (last visited on the date of signature). “Public interest” is a broad, discretionary term not explicitly defined in the CSA, but Congress identifies the primary goals in the CSA's introductory section as ensuring access to controlled substances used for a “legitimate medical purpose” while protecting the public from the “illegal . . . distribution . . . and improper use of controlled substances[, which] have a substantial and detrimental effect on the health and general welfare of the American people.” 21 U.S.C. 801(1) & (2).

Considering these goals, DEA's Factor B analysis primarily concerns whether a registrant's “experience in dispensing” reflects illegal distribution or improper use of controlled substances that is inconsistent with the public interest. Id. In the context of a pharmacy, this would require the Agency to evaluate whether a pharmacy has dispensed controlled substances in a manner that is improper, illegal, or inconsistent with the public interest; for example, by ignoring indicators that a prescription lacked a legitimate medical purpose or would be improperly used, by filling a prescription in a manner that is inconsistent with state law or the state's standards of practice, or by distributing controlled substances in a way that creates a risk of diversion.^[13]

Of course, the Agency is not only concerned with acts of intentional diversion,^[14] as DEA has explained that “[c]areless or negligent handling of controlled substances creates the opportunity for diversion and [can] justify the revocation of an existing registration . . .” Samson K. Orusa, M.D.,87 FR 2986, 3018 (2022) (quoting Paul J. Caragine, Jr.,63 FR 51592, 51602 (1998)); see also Dewey C. MacKay, M.D.,75 FR 49956, 49974 n.35 (2010) (“Accordingly, under the public interest standard, DEA has authority to consider those prescribing practices of a physician, which, while not rising to the level of intentional or knowing misconduct, nonetheless create a substantial risk of diversion.”). Indeed, neither 21 U.S.C. 824(a) nor 21 U.S.C. 823(g) requires DEA to find that a registrant has intentionally diverted controlled substances. Ultimately, a registrant whose dispensing practices create an environment that encourages or is indifferent to the abuse or diversion of controlled substances is acting outside the public's interest. As the opioid epidemic surges and other controlled substances, such as amphetamines, ketamine, and benzodiazepines, are increasingly abused, DEA must remain vigilant to protect the public against registrants who fail to employ the CSA's safeguards to ensure the health and general wellness of the American public.

Registrants “may continue to introduce evidence as to . . . lawful . . . dispensing activities.” ^[15] However, ( printed page 62761) the Agency has found that “evidence that a practitioner has treated thousands of patients does not negate a prima facie showing that the practitioner has committed acts inconsistent with the public interest.” ^[16] Krishna-Iyer, 74 FR at 463. Accordingly, the Agency has consistently rejected registrants' arguments that acts of unlawful prescribing were mitigated by years of lawful prescribing. See, e.g., Syed-Jawed Akhtar-Zaidi,80 FR 42961, 42967 (2015), pet. for rev. denied, 841 F.3d 707, 713 (6th Cir. 2016) (rejecting respondent's argument that he was denied a “fair adjudication” because the Government seized 400 patient files but only proved the illegality of a handful of prescriptions issued during undercover visits, and finding that “the physician's prescribings to thousands of other patients do not . . . render her prescribings to the undercover officers any less unlawful, or any less acts which are inconsistent with the public interest”) (internal quotations and citations omitted).^[17]

Here, as found above, Registrant is deemed to have admitted and the Agency finds that Registrant repeatedly filled controlled substance prescriptions that contained multiple red flags of abuse and/or diversion without addressing or resolving those red flags. Registrant has further admitted that “it repeatedly filled prescriptions for controlled substances in violation of federal law and binding minimal standards that govern the practice of pharmacy in the State of Texas.” RFAAX 1, at 8-9. The Agency finds that Registrant's failure to adhere to the minimum standards governing Texas pharmacy practice and its repeated issuance of prescriptions without addressing or resolving red flags reflects “experience in dispensing . . . controlled substances” that created an opportunity for the abuse or diversion of controlled substances and was outside the public interest. Registrant also failed to maintain accurate records of controlled substances which created further opportunities for abuse and diversion—indeed Registrant could not account for over 73,000 dosage units of controlled substances. Registrant did not request a hearing and thus did not provide the Agency with any evidence related to its “experience in dispensing” that served the public's interest. Accordingly, the Agency finds that Factor B weighs strongly against Registrant's continued registration.^[18]

ii. Factor D

Under Factor D, the Agency considers a registrant's “[c]ompliance with applicable State, Federal, or local laws relating to controlled substances.” 21 U.S.C. 823(g)(1)(D). Here, as found above, Registrant is deemed to have admitted and the Agency finds that Registrant failed to account for large quantities of controlled substances—over 73,000 dosage units—and failed to keep and maintain complete and accurate controlled substance records.^[19] As such, the Agency finds substantial record evidence that Registrant violated the maintenance of records and inventories requirements of 21 CFR 1304.04(a); the inventory requirements of 21 CFR 1304.11(a)-(c); and the recordkeeping requirements of 21 CFR 1304.21(a).^[20]

The Agency finds that after considering the public interest factors of 21 U.S.C. 823(g)(1), Factors B and D weigh in favor of revocation of Registrant's registration. Accordingly, the Government has satisfied its prima facie burden of showing that Registrant's continued registration would be “inconsistent with the public interest.” 21 U.S.C. 824(a)(4). The Agency also finds that there is insufficient mitigating evidence to rebut the Government's prima facie case. Thus, the only remaining issue is whether, in spite of the public interest determination, Registrant can be trusted with a registration.

IV. Sanction

Where, as here, the Government has met the burden of showing that Registrant's registration is inconsistent with the public interest, the burden shifts to Registrant to show why it can be entrusted with a registration. Morall, 412 F.3d. at 174; Jones Total Health Care Pharmacy, LLC v. Drug Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018); Garrett Howard Smith, M.D.,83 FR 18882, 18904 (2018). The issue of trust is necessarily a fact-dependent determination based on the circumstances presented by the individual registrant. Jeffrey Stein, M.D.,84 FR 46968, 46972 (2019); see also Jones Total Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is the best predictor of future performance, the Agency requires that a registrant that has committed acts inconsistent with the public interest accept responsibility for those acts and demonstrate that it will not engage in future misconduct. See Jones Total Health Care Pharmacy, 881 F.3d at 833; ALRA Labs, Inc. v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995). The Agency requires a registrant's unequivocal acceptance of responsibility. Janet S. Pettyjohn, D.O.,89 FR 82639, 82641 (2024); Mohammed Asgar, M.D.,83 FR 29,569, 29,573 (2018); see also Jones Total Health Care Pharmacy, 881 F.3d at 830-31. In addition, a registrant's candor during the investigation and hearing is an important factor in determining acceptance of responsibility and the appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at 830-31; Hoxie, 419 F.3d at 483-84. Further, the Agency considers the egregiousness and extent of the misconduct as significant factors in determining the appropriate sanction. See Jones Total Health Care Pharmacy, 881 F.3d at 834 & n.4. The Agency also considers the need to deter similar acts by a registrant and by the community of registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.

Here, Registrant did not request a hearing and was deemed to be in default. See supra I. To date, Registrant has not filed a motion with the Office of the Administrator to excuse the default. 21 CFR 1301.43(c)(1). Registrant has thus failed to answer the allegations contained in the OSC/ISO and has not ( printed page 62762) otherwise availed itself of the opportunity to refute the Government's case. As such, Registrant has made no representations regarding its future compliance with the CSA nor made any demonstration that it can be trusted with registration. Moreover, the evidence presented by the Government shows that Registrant filled well over a thousand controlled substance prescriptions outside the usual course of professional practice in Texas and in violation of the CSA, as well as failed to maintain effective controls against diversion and failed to comply with its recordkeeping obligations, further indicating that Registrant cannot be entrusted.

Accordingly, the Agency will order the revocation of Registrant's registration.

Order

Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby revoke DEA Certificate of Registration No. FS0483951 issued to St. Michael's Pharmacy. Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by

21 U.S.C. 823(g)(1), I hereby deny any pending application of St. Michael's Pharmacy to renew or modify this registration as well as any other pending application of St. Michael's Pharmacy for additional registration in Texas. This Order is effective November 2, 2026.

Signing Authority

This document of the Drug Enforcement Administration was signed on September 25, 2026, by DEA Administrator Terrance C. Cole. That document with the original signature and date is maintained by DEA. For administrative purposes only, and in compliance with requirements of the Office of the Federal Register, the undersigned DEA Federal Register Liaison Officer has been authorized to sign and submit the document in electronic format for publication, as an official document of DEA. This administrative process in no way alters the legal effect of this document upon publication in the Federal Register .