Drug Enforcement Administration – Federal Register Recent Federal Regulation Documents

The Drug Enforcement Administration (DEA) published an interim final rule in the Federal Register on March 31, 2010, which provides practitioners with the option of writing prescriptions for controlled substances electronically. Since publishing the interim final rule, DEA has received questions and requests for clarification on various issues concerning the implementation and technical requirements for the electronic prescribing of controlled substances. DEA is therefore reopening the March 31, 2010, interim final rule to solicit comments from the public on specific issues outlined below regarding the electronic prescribing of controlled substances in anticipation of subsequently publishing a final rule on these topics.

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 proposed regulations that, if finalized, would govern the program of growing marihuana for scientific and medical research under DEA registration.

The Drug Enforcement Administration (DEA) is finalizing the designation of N-(1-benzylpiperidin-4-yl)-N-phenylpropionamide (also known as benzylfentanyl), including its salts, and N-phenylpiperidin-4- amine (also known as 4-anilinopiperidine; N-phenyl-4-piperidinamine; 4- AP) (hereinafter referred to as 4-anilinopiperidine), including its amides, its carbamates, and its salts, as list I chemicals under the Controlled Substances Act (CSA). DEA proposed control of benzylfentanyl and 4-anilinopiperidine due to their use in clandestine laboratories to illicitly manufacture the schedule II controlled substance fentanyl. This rulemaking finalizes the control of benzylfentanyl and 4- anilinopiperidine as list I chemicals.

In the February 6, 2018, issue of the Federal Register, the Drug Enforcement Administration published a temporary scheduling order placing fentanyl-related substances, as defined in the order, and their isomers, esters, ethers, salts and salts of isomers, esters, and ethers in schedule I of the Controlled Substances Act. That order was set to expire on February 6, 2020. However, the ``Temporary Reauthorization and Study of the Emergency Scheduling of Fentanyl Analogues Act,'' which became law on February 6, 2020, extended the temporary control of fentanyl-related substances until May 6, 2021. This correcting amendment reflects the new expiration date mandated by Congress for the temporary scheduling order.

The Drug Enforcement Administration proposes placing the substance 4,4'-DMAR (Chemical name: 4,4'-dimethylaminorex), including its salts, isomers, and salts of isomers, in schedule I of the Controlled Substances Act. This action is being taken to enable the United States to meet its obligations under the 1971 Convention on Psychotropic Substances. If finalized, this action would 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 with, or possess), or propose to handle 4,4'-DMAR.

The Drug Enforcement Administration (DEA) places methyl 2-(1- (4-fluorobenzyl)-1H-indazole-3-carboxamido)-3-methylbutanoate (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. This action continues the imposition of 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, conduct instructional activities or chemical analysis, or possess), or propose to handle FUB-AMB.

The Drug Enforcement Administration proposes adjusting the fee schedule for registration and reregistration fees necessary to recover the costs of its Diversion Control Program relating to the registration and control of the manufacture, distribution, dispensing, importation and exportation of controlled substances and list I chemicals as mandated by the Controlled Substances Act.

The Drug Enforcement Administration (DEA) proposes to revise the existing regulations for narcotic treatment programs (NTPs) to allow a mobile component associated with the registered program to be considered a coincident activity. The NTP registrants that operate or wish to operate mobile components (in the state that the registrant is registered in) to dispense narcotic drugs in schedules II-V at a remote location for the purpose of maintenance or detoxification treatment would not be required to obtain a separate registration for a mobile component. This proposed rule would waive the requirement of a separate registration at each principal place of business or professional practice where controlled substances are dispensed for those NTPs with mobile components that fully comply with the requirements of the proposed rule, once finalized. These revisions to the regulations are intended to make maintenance or detoxification treatments more widely available, while ensuring that safeguards are in place to reduce the likelihood of 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 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.