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Regs.gov: Drug Enforcement Administration

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GovPing monitors Regs.gov: Drug Enforcement Administration for new healthcare & life sciences regulatory changes. Every update since tracking began is archived, classified, and available as free RSS or email alerts — 25 changes logged to date.

Friday, April 3, 2026

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P2P Methyl Glycidic Acid Control as List I Chemical

The Drug Enforcement Administration finalized control of P2P methyl glycidic acid (2-methyl-3-phenyloxirane-2-carboxylic acid, also known as BMK glycidic acid) as a List I chemical under the Controlled Substances Act. This action subjects all handlers of this precursor chemical to CSA regulatory requirements including registration, recordkeeping, and reporting obligations. The rule takes effect May 4, 2026.

Priority review Rule Pharmaceuticals
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DEA Controlled Substance Prescription Rule Correction

The Drug Enforcement Administration issued a correction to 21 CFR § 1306.07, fixing paragraph letter references in amendatory instruction 15 from '(e)' and '(f)' to '(g)' and '(h)'. This technical correction to the controlled substance prescribing rule affects entities regulated under DEA's multiple prescription provisions.

Routine Rule Pharmaceuticals
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3-Methoxyphencyclidine Placed in Schedule I

The Drug Enforcement Administration has issued a final rule placing 3-methoxyphencyclidine (3-MeO-PCP) in Schedule I of the Controlled Substances Act. This action enables the United States to meet its obligations under the 1971 Convention on Psychotropic Substances following the Commission on Narcotic Drugs' Decision 64/4. All persons handling 3-MeO-PCP will be subject to regulatory controls and administrative, civil, and criminal sanctions applicable to Schedule I controlled substances.

Priority review Rule Pharmaceuticals
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Technical Amendment to DEA Form 222 Power of Attorney Provisions

DEA issued a final rule correcting 21 CFR 1305.05(c) and (e) to align with the 2019 amendment at 21 CFR 1305.05(d)(1). The technical amendment clarifies that only a registrant, partner, or officer may execute or revoke a DEA Form 222 Power of Attorney, resolving ambiguities from an administrative error. The rule also removes obsolete transition provisions for the triplicate version of DEA Form 222.

Routine Rule Pharmaceuticals
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Temporary Scheduling of Bromazolam as Schedule I Controlled Substance

The DEA issued a temporary scheduling order placing bromazolam (8-bromo-1-methyl-6-phenyl-4H-benzo[f][1,2,4]triazolo[4,3-a][1,4]diazepine) in Schedule I of the Controlled Substances Act. The order is effective March 16, 2026, and will remain in effect until March 16, 2028. DEA determined that bromazolam poses an imminent hazard to public safety, triggering the temporary scheduling authority under 21 U.S.C. 811(h).

Urgent Rule Pharmaceuticals
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DEA Designates P2P Methyl Glycidic Acid as List I Chemical

The Drug Enforcement Administration has finalized the designation of P2P methyl glycidic acid (2-methyl-3-phenyloxirane-2-carboxylic acid) and its esters, isomers, and salts as a List I chemical under the Controlled Substances Act, effective May 4, 2026. This chemical is used in the illicit manufacture of phenylacetone, methamphetamine, and amphetamine. All handlers must obtain DEA registration and comply with CSA regulatory provisions, including transaction reporting and recordkeeping requirements.

Priority review Rule Pharmaceuticals

Thursday, April 2, 2026

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Controlled Substance Importer Registration Application - MDMA

The DEA published notice that Fisher Clinical Services, Inc. applied on March 11, 2026 to be registered as an importer of 3,4-Methylenedioxy-methamphetamine (MDMA, Schedule I, drug code 7405) for clinical trials only. The company is located in Allentown, Pennsylvania. Registered bulk manufacturers and applicants may submit comments or objections, or request a hearing, by May 1, 2026.

Routine Notice Pharmaceuticals
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Controlled Substances Importer Application - Research Triangle Institute

DEA published notice that Research Triangle Institute (Durham, NC) applied to be registered as an importer of controlled substances for 30 Schedule I drug classes including synthetic cathinones, benzodiazepine analogs, and other psychoactive substances. The application was filed March 3, 2026. Interested parties may submit comments or request hearings on the application through May 1, 2026.

Routine Notice Pharmaceuticals
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Controlled Substance Importer Registration Application - Sterling Wisconsin LLC

The Drug Enforcement Administration published notice that Sterling Wisconsin, LLC applied for registration as a Schedule I controlled substance importer (drug code 7431 - 5-Methoxy-N,N-dimethyltryptamine). The application was filed January 27, 2026. Interested parties may submit comments or hearing requests by May 1, 2026.

Routine Notice Pharmaceuticals
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Indivior Manufacturing LLC - Controlled Substances Importer Registration Application

The DEA published notice that Indivior Manufacturing LLC applied on February 26, 2026, to be registered as an importer of Thebaine (drug code 9333, Schedule II controlled substance). The company plans to import limited quantities for research, clinical trials, analytical purposes, and manufacturing process development of dosage forms. The public comment period closes on May 1, 2026.

Routine Consultation Pharmaceuticals
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Royal Emerald Pharmaceuticals Bulk Manufacturer Registration Application

The DEA published notice that Royal Emerald Pharmaceuticals applied to be registered as a bulk manufacturer of Schedule I controlled substances including Marihuana Extract (7350), Marihuana (7360), and Tetrahydrocannabinols (7370). The company, located in Desert Hot Springs, California, plans to provide cannabis botanical raw material and API to DEA-registered researchers and manufacturers. Comments and objections on the application are due June 1, 2026.

Routine Notice Pharmaceuticals
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Fisher Clinical Services DEA Importer Registration Application

DEA published notice that Fisher Clinical Services, Inc. has applied to be registered as an importer of Schedule I controlled substance 3,4-Methylenedioxymethamphetamine (MDMA, drug code 7405) for use in clinical trials. The application was filed March 11, 2026, at the company's Pennsylvania facility. Comments and hearing requests are due May 1, 2026.

Routine Notice Pharmaceuticals

Monday, March 30, 2026

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Pharmaron Manufacturing Services DEA Importer Controlled Substances Application

The Drug Enforcement Administration (DEA) has published a notice regarding an application from Pharmaron Manufacturing Services (US) LLC to be registered as an importer of Poppy Straw Concentrate (Schedule II). Interested parties may submit comments or requests for a hearing by April 29, 2026.

Priority review Notice Pharmaceuticals
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Chemos LLC Bulk Manufacturer DEA Application

The DEA has published a notice regarding an application from Chemtos, LLC to be registered as a bulk manufacturer of various Schedule I controlled substances. Registered manufacturers and applicants can submit comments or requests for a hearing by May 29, 2026.

Priority review Notice Pharmaceuticals

Thursday, March 26, 2026

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DEA: SpecGx LLC Bulk Manufacturer Controlled Substances Application Notice

The Drug Enforcement Administration (DEA) has issued a notice regarding an application from SpecGx LLC, a bulk manufacturer, to be registered for the production of various controlled substances. The notice provides a list of controlled substances and their schedules for which the company is seeking registration.

Priority review Notice Pharmaceuticals

Friday, March 20, 2026

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DEA Notice of Application for Controlled Substance Import Registration

The Drug Enforcement Administration (DEA) has published a notice regarding an application from Siegfried Grafton, Inc. to be registered as an importer of specific controlled substances, including Gamma Hydroxybutyric Acid and Marihuana. Registered bulk manufacturers and other applicants may submit comments or requests for a hearing by April 20, 2026.

Priority review Notice Pharmaceuticals
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DEA Technical Amendment for Ordering Schedule I and II Controlled Substances

The DEA issued a technical amendment to clarify regulations regarding the execution and revocation of Powers of Attorney for DEA Form 222, used for ordering Schedule I and II controlled substances. This amendment corrects administrative errors to align with previous policy decisions, ensuring clarity on who can sign these forms and removing obsolete transition provisions.

Priority review Rule Pharmaceuticals

Thursday, March 19, 2026

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DEA Bulk Manufacturer Application for Controlled Substances

The DEA has published a notice regarding an application from Sterling Wisconsin, LLC to be registered as a bulk manufacturer of Schedule I and II controlled substances, including Lysergic Acid Diethylamide, Marihuana Extract, and Oliceridine. Registered manufacturers and applicants can submit comments or hearing requests by May 18, 2026.

Priority review Notice Pharmaceuticals
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DEA Notice of Application for Bulk Controlled Substance Manufacturer Registration

The DEA has published a notice regarding an application from Siegfried Grafton, Inc. to be registered as a bulk manufacturer of various controlled substances, including Schedule I and II drugs. Interested parties can submit comments or requests for a hearing by May 18, 2026.

Priority review Notice Pharmaceuticals
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DEA Notice: Patheon API Services Importer Registration Application

The DEA has published a notice regarding an application from Patheon API Services, Inc. for registration as an importer of specific controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or hearing requests by April 20, 2026.

Routine Notice Pharmaceuticals
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DEA Notice: SpecGx LLC Importer Application for Controlled Substances

The DEA has issued a notice regarding an application from SpecGx LLC to be registered as an importer of Schedule II controlled substances, including Phenylacetone, Coca Leaves, Thebaine, Opium, Poppy Straw Concentrate, and Tapentadol. Interested parties can submit comments or objections by April 20, 2026.

Priority review Notice Pharmaceuticals

Sunday, March 15, 2026

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DEA Notice: Stepan Company Application for Bulk Controlled Substance Manufacturer

The DEA has published a notice regarding Stepan Company's application to be registered as a bulk manufacturer of cocaine and ecgonine. Interested parties can submit comments or requests for a hearing by May 12, 2026.

Priority review Notice Pharmaceuticals
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DEA Notice: Lonza Tampa LLC Application for Controlled Substance Importer Registration

The DEA has published a notice regarding an application from Lonza Tampa, LLC to be registered as an importer of psilocybin (Schedule I controlled substance). Interested parties can submit comments or requests for a hearing by April 13, 2026.

Priority review Notice Pharmaceuticals
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DEA Notice: Patheon API Services Controlled Substance Application

The DEA has published a notice regarding an application from Patheon API Services Inc. to be registered as a bulk manufacturer of controlled substances, including Dimethyltryptamine, Psilocybin, Psilocyn, Amphetamine, and Methadone. Interested parties can submit comments or requests for a hearing by May 12, 2026.

Priority review Consultation Pharmaceuticals
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DEA Designates Propionyl Chloride as List I Chemical

The DEA has finalized a rule designating propionyl chloride as a List I chemical under the Controlled Substances Act. This action subjects handlers of propionyl chloride to regulatory provisions due to its use in the illicit manufacture of fentanyl and its analogues. The rule becomes effective on April 9, 2026.

Priority review Rule Pharmaceuticals

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