Drug Enforcement Administration 2019 – Federal Register Recent Federal Regulation Documents

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 classes of controlled substances listed in schedule I. Prior to making decisions on this and other pending applications, DEA intends to promulgate regulations that govern the program of growing marihuana for scientific and medical research under DEA registration.

This final rule corrects an erroneous cross-reference in a Drug Enforcement Administration regulation involving registration and ocean vessels, aircraft, and other entities. This change will provide clarity.

The Drug Enforcement Administration proposes placing methyl 2- (1-(4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutano ate (other names: FUB-AMB, MMB-FUBINACA, AMB-FUBINACA), including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule I of the Controlled Substances Act. If finalized, this action would make permanent the existing 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, conduct instructional activities or chemical analysis, or possess), or propose to handle FUB-AMB.

The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a various classes of schedule I and II controlled substances.

The Drug Enforcement Administration (DEA) proposes to revise existing regulations that manage the quotas for controlled substances and the list I chemicals, ephedrine, pseudoephedrine, and phenylpropanolamine, held by DEA-registered manufacturers. This rule is being proposed to: Define the types of quotas, update the method to abandon quota, clarify the current language to ensure that both manufacturers and distributors are required to obtain certification of a buyer's quota, reduce overall inventories, formalize the existing practice of use-specific subcategories for individual manufacturing and procurement quotas, and modify existing deadlines to fix/issue quotas. The DEA is also amending certain regulations to implement updates to the Controlled Substances Act made by the Substance Use-Disorder Prevention that Promotes Opioid Recovery Treatment for Patients and Communities Act. The DEA emphasizes that all of these revisions and amendments would apply to both bulk and dosage-form manufacturers, as well as importers of the list I chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. The changes are necessary to reduce the potential for diversion, and would align regulations with current manufacturing business practices.

The Drug Enforcement Administration (DEA) published a document in the Federal Register on August 27, 2019, concerning a notice of applications. As that document correctly indicated, each of the applicants noticed applied to be registered with DEA to grow marihuana as a bulk manufacturer. However, certain drug codes for some of the applicants were inadvertently omitted by DEA or not listed because applicants had inadvertently omitted them from their applications.

The registrants listed below have applied for and been granted registration by the Drug Enforcement Administration (DEA) as importers of schedule I and II controlled substances.

The registrants listed below have applied for and been granted a registration by the Drug Enforcement Administration (DEA) as a bulk manufacturer of a various classes of schedule I and II controlled substances.

The Drug Enforcement Administration (DEA) is amending its regulations to implement a new single-sheet format for DEA Form 222, used by DEA registrants to order schedules I and II controlled substances. The rule provides for a two-year transition period, during which the existing triplicate version of the forms may continue to be used. The rule also includes a number of minor procedural changes.