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

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

  • Type:Notice
    Citation:90 FR 11997
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Fisher Clinical Services wants permission from the government to bring special medicines into the country, but only to use them for testing, not selling. People have time until April 14, 2025, to tell the government what they think about this or ask for a chat about it.

  • Type:Notice
    Citation:90 FR 11996
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Meridian Medical Technologies, LLC wants to bring in some special medicines from other countries just to study them, and people have until mid-April 2025 to say if they think it's a good or bad idea.

  • Type:Notice
    Citation:86 FR 11333
    Reading Time:about a minute or two

    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).

    Simple Explanation

    Globyz Pharma, a company, wants permission to bring in special medicines for testing, but they can't sell the medicines. People can share their thoughts or ask for a meeting to talk about it before the end of March 2021.

  • Type:Notice
    Citation:90 FR 11623
    Reading Time:about a minute or two

    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.

    Simple Explanation

    The Stepan Company wants permission to bring in some special chemicals so they can help make other special chemicals, but not to sell them directly. People who make those special chemicals or want to can tell the big helpers (like the government) what they think about this plan until April 9, 2025.

  • Type:Notice
    Citation:86 FR 12032
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Groff NA Hemplex, LLC wants permission from the DEA to bring special plant extracts into the country to use in science studies, and they promise not to sell them. People can write to the DEA if they have thoughts about this by the end of March 2021.

  • Type:Notice
    Citation:90 FR 13783
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Maridose, LLC wants permission from a government agency to bring special chemicals from other countries to use in studies and tests, but they need to follow strict rules, and people can say what they think about it until April 25, 2025.

  • Type:Notice
    Citation:89 FR 106589
    Reading Time:about a minute or two

    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.

    Simple Explanation

    Curia New York, Inc. wants government permission to bring in special chemicals to make medicines for other companies. People can tell the government what they think about this until January 29, 2025.

  • Type:Notice
    Citation:90 FR 13894
    Reading Time:about 2 minutes

    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.

    Simple Explanation

    SpecGx LLC wants special permission to bring certain medicines from other countries to make ingredients for other medicines, but they need to follow strict rules, and people can say what they think about this until April 28, 2025.

  • Type:Notice
    Citation:90 FR 8303
    Reading Time:about a minute or two

    Aveva Drug Delivery Systems, Inc. has applied to the Drug Enforcement Administration, a part of the Justice Department, to register as an importer of certain controlled substances. They intend to import these substances solely for analytical purposes and not for commercial sale. Interested parties can submit their comments or objections electronically, or request a hearing, by February 27, 2025. The registration is subject to specific regulations and permits as outlined in federal laws.

    Simple Explanation

    Aveva Drug Delivery Systems, Inc. wants to bring some special medicines to the U.S. so they can study them, and people have until February 27, 2025, to say what they think about it or ask for a meeting.

  • Type:Notice
    Citation:90 FR 13887
    Reading Time:about a minute or two

    Restek Corporation has applied to the Drug Enforcement Administration (DEA) to become a registered importer of certain controlled substances. These substances will be imported for use in manufacturing certified reference materials. The public can submit comments or objections to this application by April 28, 2025, through the Federal eRulemaking Portal. Approval will be granted only if the importation activities comply with legal requirements, with no permission for importing finished drug products for commercial sale.

    Simple Explanation

    Restek Corporation wants permission from a government agency to bring special kinds of medicine materials into the country for testing and not for selling as regular medicines. People can say if they think this is okay or not by sending their thoughts online before the end of April 2025.

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