Drug Enforcement Administration April 2020 – Federal Register Recent Federal Regulation Documents
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Electronic Prescriptions for Controlled Substances
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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Groff NA Hemplex LLC
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.
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Absolute Standards, Inc.
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.
Control of the Immediate Precursor Norfentanyl Used in the Illicit Manufacture of Fentanyl as a Schedule II Controlled Substance
The Drug Enforcement Administration (DEA) is designating the precursor chemical, N-phenyl-N-(piperidin-4-yl)propionamide (norfentanyl) as an immediate precursor for the schedule II controlled substance fentanyl. Furthermore, DEA is finalizing the control of norfentanyl as a schedule II substance under the Controlled Substances Act (CSA).
Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Denco, LLC
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.
Designation of Benzylfentanyl and 4-Anilinopiperidine, Precursor Chemicals Used in the Illicit Manufacture of Fentanyl, as List I Chemicals
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.
Adjustments to Aggregate Production Quotas for Certain Schedule II Controlled Substances and Assessment of Annual Needs for the List I Chemicals Ephedrine and Pseudoephedrine for 2020, in Response to the Coronavirus Disease 2019 Public Health Emergency
The Drug Enforcement Administration is adjusting the 2020 aggregate production quotas for certain controlled substances in schedule II of the Controlled Substances Act and the assessment of annual needs for the list I chemicals ephedrine and pseudoephedrine. This increase is in response to the current nationwide COVID-19 public health emergency as declared by the Secretary of Health and Human Services on January 31, 2020.
Schedules of Controlled Substances: Temporary Placement of Fentanyl-Related Substances in Schedule I; Correction
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.
Schedules of Controlled Substances: Placement of 4,4′-DMAR in Schedule I
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.
Schedules of Controlled Substances: Placement of Lemborexant in Schedule IV
On December 20, 2019, the U.S. Food and Drug Administration approved a new drug application for Dayvigo (lemborexant) tablets for oral use. Lemborexant is chemically known as (1R,2S)-2-[(2,4- dimethylpyrimidin-5-yl)oxymethyl]-2-(3-fluorophenyl)-N-(5- fluoropyridin-2-yl)cyclopropane-1-carboxamide. The Department of Health and Human Services provided the Drug Enforcement Administration (DEA) with a scheduling recommendation to place lemborexant 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 lemborexant, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, in schedule IV of the CSA.
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