Drug Enforcement Administration October 2023 – Federal Register Recent Federal Regulation Documents
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Proposed Adjustments to the Aggregate Production Quotas for Schedule I and II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine, Pseudoephedrine, and Phenylpropanolamine for 2023
The Drug Enforcement Administration (DEA) proposes to adjust the 2023 aggregate production quotas for several controlled substances in schedules I and II of the Controlled Substances Act (CSA) and the assessment of annual needs for the list I chemical phenylpropanolamine.
Designation of Halides of 4-Anilinopiperidine as List I Chemicals
The Drug Enforcement Administration (DEA) is finalizing the modification of 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. This rule finalizes the modification of the listing of 4-anilinopiperidine as a list I chemical.
Controlled Substance Destruction Alternatives to Incineration
The Drug Enforcement Administration (DEA) is seeking information about destruction processes which may be used to render controlled substances to a non-retrievable state. DEA invites comment from stakeholders in the controlled substance disposal industry, as well as registrants engaged in the destruction and disposal of controlled substances in their possession or inventory, to the questions provided below.
Schedules of Controlled Substances: Placement of Zuranolone in Schedule IV
On August 4, 2023, the United States Food and Drug Administration approved a new drug application for ZURZUVAE (zuranolone) capsules for the treatment of post-partum depression. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place zuranolone and its salts in schedule IV of the Controlled Substances Act (CSA). In accordance with the CSA, as amended by the Improving Regulatory Transparency for New Medical Therapies Act, DEA is hereby issuing an interim final rule placing zuranolone, including its salts, in schedule IV of the CSA. This action facilitates the public availability of zuranolone as a schedule IV controlled substance.
Schedules of Controlled Substances: Temporary Placement of N-Desethyl Isotonitazene and N-Piperidinyl Etonitazene in Schedule I
The Administrator of the Drug Enforcement Administration is issuing this notice of intent to publish a temporary order to schedule two synthetic benzimidazole-opioid substances, including their isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible, in schedule I of the Controlled Substances Act. When it is issued, the temporary scheduling order will impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis, or possess) or propose to handle these two specified substances.
Special Surveillance List of Chemicals, Products, Materials and Equipment Used in the Manufacture of Controlled Substances and Listed Chemicals
The Controlled Substances Act provides for civil penalties for the distribution of a laboratory supply to a person who uses, or attempts to use, that laboratory supply to manufacture a controlled substance or a listed chemical, if that distribution was made with reckless disregard for the illegal uses to which such laboratory supply will be put. The term laboratory supply is defined as a listed chemical or any chemical, substance, or item on a special surveillance list published by the Attorney General which contains chemicals, products, materials, or equipment used in the manufacture of controlled substances and listed chemicals. The Drug Enforcement Administration is hereby publishing a final notice to update the Special Surveillance List.
Additions to Listing of Exempt Chemical Mixtures
Under this direct final rule, the Drug Enforcement Administration (DEA) is updating the Table of Exempt Chemical Mixtures to include the listing of nine additional preparations. This action is in response to DEA's review of new applications for exemption. Having reviewed applications and relevant information, DEA has found that these preparations meet the applicable exemption criteria. Therefore, this rule amends the regulations to codify that these products are exempted from the application of certain provisions of the Controlled Substances Act.
Importer of Controlled Substances Application: Nexus Pharmaceuticals, Inc.
Nexus Pharmaceuticals, 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.
Importer of Controlled Substances Application: Fresenius Kabi USA, LLC
Fresenius Kabi USA, 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.
Bulk Manufacturer of Controlled Substances Application: Cayman Chemical Company
Cayman Chemical Company 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.
Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals, Inc.
Chattem Chemicals, 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.
Bulk Manufacturer of Controlled Substances Application: Cerilliant Corporation
Cerilliant Corporation, 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.
Bulk Manufacturer of Controlled Substances Application: Curia New York, Inc
Curia New York, 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.
Bulk Manufacturer of Controlled Substances Application: Cambridge Isotope Laboratories, Inc
Cambridge Isotope 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.
Propionyl Chloride
The Drug Enforcement Administration finds that propionyl chloride is used in the illicit manufacture of the controlled substance fentanyl, as well as fentanyl analogues, and fentanyl-related substances and is important to the manufacture of these substances because it is often used in synthetic pathways to illicitly manufacture fentanyl, fentanyl analogues, and fentanyl-related substances. Prior to proposing to list propionyl chloride as a list I chemical, DEA is soliciting information on the current uses of propionyl chloride (other than for the synthesis of fentanyl) in order to properly determine the effect such a proposed action would have on legitimate industry.
Second Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications
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. On May 10, 2023, following initial review of the comments received, DEA, jointly with HHS, issued a temporary rule (First Temporary Rule) extending certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID-19 Public Health Emergency (COVID-19 PHE). These exceptions were granted in order to avoid lapses in care for patients. In particular, with respect to practitioner-patient relationships formed after the May 11, 2023, expiration of the COVID-19 PHE, the First Temporary Rule extended the temporary exceptions until November 11, 2023. In this second temporary rule, as DEA and HHS continue to consider revisions to the proposed rules set forth in the March 1, 2023 NPRMs and in light of Telemedicine Listening Sessions that DEA hosted on September 12 and 13, 2023, DEA and HHS are further extending such exceptions to existing DEA regulations for new practitioner-patient relationships through December 31, 2024.
Importer of Controlled Substances Application: Fisher Clinical Services, Inc.
Fisher Clinical Services, 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.
Adjustment to the Aggregate Production Quota for Methylphenidate (for Sale) for 2023
The Drug Enforcement Administration is adjusting the 2023 aggregate production quota for the schedule II controlled substance methylphenidate (for sale).
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