Drug Enforcement Administration November 2021 – Federal Register Recent Federal Regulation Documents
Results 1 - 16 of 16
Bulk Manufacturer of Controlled Substances Application: IsoSciences, LLC
IsoSciences, 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.
Bulk Manufacturer of Controlled Substances Application: Patheon API Manufacturing, Inc.
Patheon API Manufacturing, Inc., 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.
Bulk Manufacturer of Controlled Substances Application: Pisgah Laboratories Inc.
Pisgah Laboratories Inc. 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.
Bulk Manufacturer of Controlled Substances Application: Noramco
Noramco, 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.
Importer of Controlled Substances Application: Mylan Technologies, Inc.
Mylan Technologies, 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.
Designation of Methyl alpha-phenylacetoacetate, a Precursor Chemical Used in the Illicit Manufacture of Phenylacetone, Methamphetamine, and Amphetamine, as a List I Chemical
The Drug Enforcement Administration is finalizing, without change, a March 30, 2021, notice of proposed rulemaking to designate the chemical methyl alpha-phenylacetoacetate (also known as MAPA; methyl 3-oxo-2-phenylbutanoate; methyl 2-phenylacetoacetate; [alpha]- acetyl-benzeneacetic acid, methyl ester; and CAS Number: 16648-44-5) and its optical isomers as a list I chemical under the Controlled Substances Act (CSA). Methyl alpha-phenylacetoacetate is used in clandestine laboratories to illicitly manufacture the schedule II controlled substances phenylacetone (also known as phenyl-2-propanone, P2P, or benzyl methyl ketone), methamphetamine, and amphetamine and is important to the manufacture of these controlled substances. This final rulemaking subjects handlers (manufacturers, distributors, importers, and exporters) of MAPA to the chemical regulatory provisions of the CSA and its implementing regulations.
Regulation of Telepharmacy Practice
The Drug Enforcement Administration (DEA) is issuing this advanced notice of proposed rulemaking to obtain further information regarding the practice of telepharmacy. Telepharmacy is not specifically defined by the Controlled Substances Act (CSA) or DEA regulations; however, to the extent telepharmacies dispense controlled substances, they are under the purview of the CSA and DEA. DEA is considering promulgating regulations regarding telepharmacy and seeks to be fully informed about the practice, industry, and state regulation of telepharmacy.
Final Adjusted 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 2021
This final order establishes the final adjusted 2021 aggregate production quotas for controlled substances in schedules I and II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine.
Schedules of Controlled Substances: Removal of [18
The Drug Enforcement Administration proposes to remove [\18\F]FP-CIT (chemical names: [\18\F]N-[omega]-fluoropropyl-[beta]- CIT; fluorine-18-N-3-fluoropropyl-2-beta-carbomethoxy-3-beta-(4- iodophenyl)tropane; [\18\F]fluoropropylcarbomethoxy nortropane) from the schedules of the Controlled Substances Act (CSA). This scheduling action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. [\18\F]FP-CIT is currently a schedule II controlled substance because it can be derived from cocaine, a schedule II substance, via ecgonine, also a schedule II substance. This action would remove the regulatory controls and administrative, civil, and criminal sanctions applicable to controlled substances, including those specific to schedule II controlled substances, on persons who handle (manufacture, distribute, reverse distribute, dispense, conduct research, import, export, or conduct chemical analysis) or propose to handle [\18\F]FP-CIT.
Schedules of Controlled Substances: Placement of Isotonitazene in Schedule I
With the issuance of this final order, the Administrator of the Drug Enforcement Administration is permanently placing N,N-diethyl- 2-(2-(4-isopropoxybenzyl)-5-nitro-1H-benzimidazol-1-yl)ethan- 1-amine (commonly known as isotonitazene), including its isomers, esters, ethers, salts, and salts of isomers, esters, and ethers whenever the existence of such isomers, esters, ethers, and salts is possible within the specific chemical designation, in schedule I of the Controlled Substances Act. This scheduling action discharges the United States' obligations under the Single Convention on Narcotic Drugs (1961). This action continues to impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on persons who handle (manufacture, distribute, import, export, engage in research or conduct instructional activities with, or possess), or propose to handle isotonitazene.
Bulk Manufacturer of Controlled Substances Application: Nanosyn Inc.
Nanosyn Inc. 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.
Bulk Manufacturer of Controlled Substances Application: Groff Global
Groff Global 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.
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.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
