Search Results for keywords:"Drug Enforcement Administration"

Mylan Pharmaceuticals, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of basic classes of controlled substances. Interested parties, such as registered bulk manufacturers, can submit electronic comments or objections about this application by March 20, 2025, or request a hearing. Comments should be submitted through the Federal eRulemaking Portal, and requests for a hearing should be sent to the DEA's specified addresses. Mylan Pharmaceuticals seeks authorization to import controlled substances in finished dosage form for commercial distribution, with certain restrictions aligning with legal requirements.

Curia New York, Inc. has applied to the Drug Enforcement Administration (DEA) to become an importer of controlled substances. The company intends to use these substances in bulk manufacturing to produce other controlled substances for their clients. Public feedback on the application can be submitted electronically until January 29, 2025. The application must align with DEA regulations and does not permit importing finished or unfinished drug products for commercial sale.

Veranova, L.P. has applied to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances. These substances include Coca Leaves, raw Opium, Poppy Straw Concentrate, Thebaine, Noroxymorphone, and Fentanyl. The company intends to use these materials to manufacture active pharmaceutical ingredients and reference standards for testing purposes. The DEA invites public comments or objections by March 17, 2025, and requests for a hearing must be sent to the designated DEA addresses.

Restek Corporation has applied to be registered as a bulk manufacturer of certain controlled substances. The application was submitted to the Drug Enforcement Administration on February 19, 2025, and the company plans to produce synthetic versions of substances like Marihuana and Tetrahydrocannabinols for specific purposes. Interested parties can file comments or objections, or request a hearing on this registration by June 17, 2025. All submissions must be made through the Federal eRulemaking Portal.

The Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HHS) have decided to delay the start date for two rules about using telemedicine to prescribe certain medications to December 31, 2025. These rules include the "Expansion of Buprenorphine Treatment via Telemedicine Encounter," which allows practitioners to prescribe medications for opioid use disorder, and "Continuity of Care via Telemedicine for Veterans Affairs Patients," which permits Veterans Affairs practitioners to prescribe controlled substances via telemedicine under specific conditions. The delay grants additional time to address any questions or issues and follows public feedback, with some comments favoring an immediate start and others requesting a postponement.

The Drug Enforcement Administration (DEA) issued an Order to Show Cause to Soroosh Armandi, D.O., proposing to revoke his DEA registration because he no longer has the authority to handle controlled substances in California. Despite being notified, Dr. Armandi did not request a hearing to contest this action. His California medical license has been revoked, making him ineligible to maintain a DEA registration. As a result, the DEA has decided to revoke his DEA Certificate of Registration and deny any pending applications for renewal or additional registrations in California.

Aphena Pharma Solutions MD, LLC has applied to the Drug Enforcement Administration (DEA) to be a registered importer of certain controlled substances. These substances will be used internally to manufacture an over-the-counter drug that is approved by the FDA. Interested parties, such as registered bulk manufacturers, can submit electronic comments or objections to this application by April 7, 2025. They can also request a hearing on the application within the same deadline.

The Drug Enforcement Administration (DEA), part of the Department of Justice, is planning to submit an information collection request to the Office of Management and Budget (OMB) for approval. This collection involves the Leadership Engagement Survey, which is administered annually to federal government employees, contractors, and task force officers working at the DEA. The survey is voluntary and takes about 20 minutes to complete, with an expected response count of around 5,000 people. The DEA is seeking authorization to conduct this survey for three years, which will not incur additional costs since it operates on an existing internal platform.

Noramco Coventry, LLC has applied to the Drug Enforcement Administration to become an importer of certain controlled substances like raw opium and poppy straw concentrate. These substances will be used to manufacture bulk active pharmaceutical ingredients (APIs) that the company distributes. They will also import other substances for comparison with their own products to ensure quality before exporting their APIs to foreign markets. Public comments or objections to this application, including requests for a hearing, can be submitted until March 18, 2021.

Stepan Company has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This request was made on January 31, 2025, and is currently open for public comment until June 17, 2025. Individuals who are already registered manufacturers of these substances or are applicants for such a registration can submit their comments or objections electronically through the Federal eRulemaking Portal. Interested parties may also request a hearing on this application before the deadline if desired.