Drug Enforcement Administration May 2023 – Federal Register Recent Federal Regulation Documents

Patheon API Manufacturing, 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.

Irvine Labs, 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.

Galephar Pharmaceuticals Research, 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.

Usona Institute 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.

VA Cooperative Studies Program 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.

Royal Emerald Pharmaceuticals 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.

Unither Manufacturing 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.

The applications for exempt chemical preparations received by the Drug Enforcement Administration between July 28, 2020, and December 31, 2022, as listed below, were accepted for filing and have been approved or denied as indicated.

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. Those NPRMs resulted in 38,369 public comments, which are being closely reviewed. DEA, in concert with HHS, is considering revisions to the proposed rules set forth in the NPRMs. In the meantime, and following initial review of the comments received, DEA, jointly with the Substance Abuse and Mental Health Services Administration (SAMHSA), is issuing this temporary rule to extend certain exceptions granted to existing DEA regulations in March 2020 as a result of the COVID-19 Public Health Emergency (COVID-19 PHE), in order to avoid lapses in care for patients. Ultimately, there will be a final set of regulations permitting the practice of telemedicine under circumstances that are consistent with public health, safety, and effective controls against diversion.