Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

Royal Emerald Pharmaceuticals has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Unither Manufacturing LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

The applications for exempt chemical preparations received by the Drug Enforcement Administration between July 28, 2020, and December 31, 2022, as listed below, were accepted for filing and have been approved or denied as indicated.

On March 1, 2023 the Drug Enforcement Administration (DEA), in concert with the Department of Health and Human Services (HHS), promulgated two notices of proposed rulemakings (NPRMs) soliciting comments on proposals to allow for prescribing of controlled medications pursuant to the practice of telemedicine in instances where the prescribing practitioner has never conducted an in-person medical evaluation of the patient. Those NPRMs resulted in 38,369 public comments, which are being closely reviewed. DEA, in concert with HHS, is considering revisions to the proposed rules set forth in the NPRMs. In the meantime, and following initial review of the comments received, DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is issuing this temporary rule to extend certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID-19 Public Health Emergency (COVID-19 PHE), in order to avoid lapses in care for patients. Ultimately, there will be a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion.

The Drug Enforcement Administration (DEA) is providing notice of an application it has received from an entity applying to be registered to manufacture in bulk basic class(es) of controlled substances listed in schedule I. DEA intends to evaluate this and other pending applications according to its regulations governing the program of growing marihuana for scientific and medical research under DEA registration.

Pisgah Laboratories Inc., has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

The Drug Enforcement Administration is proposing to modify the listing of the list I chemical, N-phenylpiperidin-4-amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP) (hereinafter referred to as 4-anilinopiperidine), to include halides of 4- anilinopiperidine. The current listing of 4-anilinopiperidine includes its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act. The Drug Enforcement Administration proposes the new listing to read as follows: N-phenylpiperidin-4-amine (4-anilinopiperidine; N-phenyl-4-piperidinamine; 4-AP), its amides, its carbamates, its halides, its salts, and any combination thereof, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act.

On July 9, 2012, the President signed into law the Synthetic Drug Abuse Prevention Act of 2012. The Synthetic Drug Abuse Prevention Act of 2012 included a definition of ``cannabimimetic agents'' that are controlled under schedule I. The Drug Enforcement Administration is proposing this rule to address the broader definition of ``cannabimimetic agents,'' identify 18 additional substances that meet the definition, and consolidate most existing administration controlled substances code numbers (drug codes) into a single drug code number for substances that meet this definition. The listing for two schedule I ``cannabimimetic agents'' that are under international control, JWH-018 and AM2201, will be moved to the ``hallucinogens'' paragraph of schedule I in order to retain the existing drug codes for these two substances to facilitate quota and international reporting requirements. While the 18 additional substances are already controlled under schedule I because they meet the definition of ``cannabimimetic agents,'' this proposed rule establishes a single new drug code number for these and most other substances meeting this definition. This single drug code will simplify the registration and recordkeeping requirements for any ``cannabimimetic agents'' that the Drug Enforcement Administration may register persons to handle.

The Drug Enforcement Administration (DEA) is finalizing the control of 4-piperidone, its acetals, its amides, its carbamates, its salts, and salts of its acetals, its amides, and its carbamates, and any combination thereof, whenever the existence of such is possible, as a list I chemical under the Controlled Substances Act. DEA proposed control of 4-piperidone due to its use in clandestine laboratories to illicitly manufacture the schedule II controlled substance fentanyl. This rulemaking finalizes the control of 4-piperidone as a list I chemical.

Stepan Company has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

SpecGX, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplemental Information listed below for further drug information.

Research Triangle Institute has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Sharp Clinical Services, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Purisys, LLC, has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Sterling Pharma USA LLC. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Myonex Inc. has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Patheon Pharmaceuticals Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Lonza Tampa, LLC has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.

Caligor Coghlan Pharma Services has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.

Scottsdale Research Institute has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to SUPPLEMENTARY INFORMATION listed below for further drug information.