Search Results for keywords:"21 CFR 1301.34(a)"

The Stepan Company has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances, as per the notice from the Justice Department's DEA. The application is to import these substances to manufacture other controlled substances, but not for commercial sale in finished form. Interested parties, such as current manufacturers or applicants, can comment or request a hearing about this application until April 9, 2025. Comments and hearing requests should be submitted through specified DEA addresses or electronically via the Federal eRulemaking Portal.

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).

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.

Myonex LLC has submitted an application to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. The company plans to import these substances in dosage forms specifically for use in clinical trials, research, and analytical work, but not for commercial sales. Interested parties, including manufacturers or other applicants, are invited to submit comments or objections to this application by May 19, 2025, and they also have the option to request a hearing. No commercial activities involving the finished dosage forms are allowed under this registration.

Siegfried USA, LLC has submitted an application to the Drug Enforcement Administration (DEA) seeking approval to become an importer of certain controlled substances. The application is intended to allow the company to import these substances for the purpose of manufacturing bulk Active Pharmaceutical Ingredients for its customers. Interested parties, such as registered bulk manufacturers of these controlled substances, are invited to submit comments or objections to this application by January 29, 2025. Comments should be submitted electronically via the Federal eRulemaking Portal, and requests for a hearing can be sent to the DEA at the addresses provided in the document.

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.

Meridian Medical Technologies, LLC has applied to the Drug Enforcement Administration (DEA) to become an importer of certain controlled substances. The company plans to import these substances solely for analytical purposes and has no authorization for other activities involving these drugs. The DEA is accepting public comments or objections to this application until April 14, 2025, and has outlined procedures for submitting these electronically via regulations.gov. Requests for a hearing regarding the application must also be submitted by the same date to designated DEA offices in Springfield, Virginia.

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.

Groff NA Hemplex LLC has applied to the Drug Enforcement Administration to become a registered importer of certain controlled substances. These substances will be imported in bulk to produce research-grade materials for clinical trial studies, specifically involving Marihuana Extract compounds. The application process allows for public comments or objections and requests for a hearing until January 13, 2025. The comments should be submitted electronically through the Federal eRulemaking Portal, while hearing requests must be directed to the DEA's office in Springfield, Virginia.