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

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.

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.

Mylan Pharmaceuticals Inc. has submitted an application to be recognized as an importer of controlled substances. The Drug Enforcement Administration (DEA), a part of the Justice Department, is providing notice of this application. Interested parties, such as other registered manufacturers or applicants, have the opportunity to submit written comments, objections, or requests for a hearing on this application by March 8, 2021. Comments and hearing requests should be sent to the DEA at their Springfield, Virginia address.

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.

Catalent Greenville, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to use these substances for developing bulk dosage formulations for research and clinical trials. People or organizations that have an interest in this matter can submit comments or request a hearing by March 3, 2025. Submissions can be made through the Federal eRulemaking Portal, and hearings request should be sent to the DEA at specified addresses.

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.

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.

S&B Pharma LLC, also known as Norac Pharma, has submitted an application to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company plans to import these substances in bulk to manufacture other controlled drugs for its customers. The public can submit comments or request a hearing regarding this application until February 11, 2021. All submissions should be sent to the DEA offices in Springfield, Virginia.

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.

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.