Search Results for keywords:"21 U.S.C. 952(a)(2)"

Globyz Pharma, LLC has applied to the Drug Enforcement Administration (DEA) for registration as an importer of controlled substances for analytical testing. The application does not authorize any other activities, such as importing FDA-approved finished dosage forms for sale. Interested parties, including registered manufacturers, can submit comments or objections, or request a hearing regarding this application by March 26, 2021. The DEA's decision will be based on alignment with legal requirements under 21 U.S.C. 952(a)(2).

The Drug Enforcement Administration has announced that Mylan Inc. applied for registration to import certain controlled substances. These substances will be used as bulk active pharmaceutical ingredients for internal testing, as well as finished dosage forms for analytical testing and distribution for clinical trials in foreign markets. Comments or objections regarding this application can be submitted up to March 17, 2025, and requests for a hearing must follow specific submission guidelines. The approval of these permits will only occur if the activities align with the legal requirements under U.S. law.

Groff NA Hemplex, LLC has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of controlled substances, specifically for conducting clinical trial studies with Marihuana Extracts. The notice invites written comments or objections to the application by March 31, 2021, and allows requests for a hearing within the same deadline. The DEA has specified that this registration is only for scientific study and not for the commercial import of these substances.

Fisher Clinical Services, Inc. has applied to the Drug Enforcement Administration to be registered as an importer of certain controlled substances. The purpose of this registration is solely for use in clinical trials, and not for the commercial sale of the substances. The public can submit comments or request a hearing about this application until April 14, 2025. Comments must be submitted electronically, and hearings can be requested in writing, with specific addresses provided for these submissions.

SpecGx LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company aims to import these substances for the purpose of manufacturing Active Pharmaceutical Ingredients, which will then be distributed to its customers. However, this registration does not automatically allow for permit applications to import these substances to be approved; approval will be granted only if the business activities comply with specific legal requirements. Public comments or requests for a hearing regarding this application are open until April 28, 2025, and can be submitted electronically through the Federal eRulemaking Portal.

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.

S&B Pharma LLC DBA Norac Pharma has submitted an application to the Drug Enforcement Administration (DEA) to register as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for further manufacturing and ANPP for producing other controlled substances. Public comments or objections to this application can be submitted electronically by March 28, 2025. The DEA will only approve import permits if the company's activities comply with specific federal regulations.

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.

Maridose, LLC has applied to the Drug Enforcement Administration (DEA) to become registered as an importer of certain controlled substances. This registration will allow the company to import specific synthetic cannabinoids, like synthetic cannabidiol and synthetic tetrahydrocannabinol, for research and analysis purposes. Public comments or objections regarding this application can be submitted until April 25, 2025, through the Federal eRulemaking Portal. The DEA will only approve the permit if it aligns with the specific business activities authorized under federal law.

Microgenics Corporation, a part of Thermo Fisher Scientific, has applied to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. These substances are intended for use in feasibility and cross-reactivity studies related to diagnostic products. Comments and objections regarding this application, as well as requests for a hearing, must be submitted to the DEA by March 31, 2021. The DEA will only approve the permit if the company’s activities align with specific legal requirements under U.S. law.