Search Results for keywords:"importer application"

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Search Results: keywords:"importer application"

  • Type:Notice
    Citation:90 FR 8154
    Reading Time:about a minute or two

    VHG Labs, doing business as LGC Standards, has applied to the Drug Enforcement Administration (DEA) to register as an importer of specific controlled substances for analytical testing purposes. The DEA has announced this in the Federal Register and is accepting comments or objections from registered bulk manufacturers and other interested parties until February 24, 2025. Requests for a hearing related to this application must also be sent to the DEA by this date. The authorization sought does not include the importation of finished dosage forms approved by the Food and Drug Administration for commercial sale.

    Simple Explanation

    VHG Labs wants permission to bring in special chemicals for testing, and people have a month to say if they agree or not. These chemicals aren't for making medicines you can buy at the store.

  • Type:Notice
    Citation:90 FR 11553
    Reading Time:about a minute or two

    LTS Therapy Systems, LLC is seeking to become a registered importer of certain controlled substances for research and development purposes. The Drug Enforcement Administration (DEA) is asking for public comments or objections to this application by April 7, 2025. Comments must be submitted electronically through the Federal eRulemaking Portal. The company is not permitted to import these substances for commercial sale, and any registration approval will align with legal requirements.

    Simple Explanation

    LTS Therapy Systems, LLC wants to bring certain special medicines into the country to help them learn more about these medicines, but they need to follow the rules. People have until April 7, 2025, to say what they think about this, but they need to do it online.

  • Type:Notice
    Citation:86 FR 10357
    Reading Time:about a minute or two

    VHG Labs, operating as LGC Standards, has submitted an application to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances, including synthetic cannabidiol and synthetic tetrahydrocannabinol. The company intends to supply these substances to research facilities for drug testing and analysis. Interested parties, such as existing manufacturers or applicants of these substances, can submit comments or request a hearing regarding this application before March 22, 2021. This notice does not permit the import of finished drugs for commercial sale.

    Simple Explanation

    VHG Labs, a company also known as LGC Standards, wants permission to bring special substances into the country to help scientists with their experiments, and people have until March 22, 2021, to share their thoughts or concerns about this plan.

  • 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: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:90 FR 9735
    Reading Time:about a minute or two

    Lonza Tampa, LLC has applied to the Drug Enforcement Administration to become registered as an importer of controlled substances, specifically focusing on the drug code 7437 (Psilocybin). They plan to use Psilocybin as a bulk active pharmaceutical ingredient for clinical trials, research, and analytical purposes. The DEA is allowing registered bulk manufacturers or applicants to submit electronic comments or objections to this application by March 20, 2025. Requests for a hearing can also be submitted by this date.

    Simple Explanation

    Lonza Tampa, LLC wants permission from the government to bring in a special kind of drug called psilocybin for science experiments and tests, and people can tell the government what they think about this until March 20, 2025.

  • Type:Notice
    Citation:86 FR 2456
    Reading Time:about a minute or two

    Medi-Physics, Inc., which does business as GE Healthcare, has submitted an application to the Drug Enforcement Administration (DEA) to become an importer of specific controlled substances. The company intends to import small amounts of Ioflupane, which is an analogue of Cocaine, for research and development purposes, as the required form is unavailable in the U.S. Anyone wishing to comment or request a hearing on this application must do so by February 11, 2021. The DEA's approval will depend on compliance with specific regulatory standards.

    Simple Explanation

    Medi-Physics, Inc., also known as GE Healthcare, wants to bring a special kind of medicine ingredient, related to Cocaine, from outside the U.S. because they can't get it here. They need it to work on how to make and check their products properly, and people can share their thoughts or concerns about this until February 11, 2021.

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

    Vici Health Sciences, LLC has applied to become an importer of specific controlled substances to support their research and clinical trials. The Drug Enforcement Administration (DEA) is accepting public comments and objections to this application until February 27, 2025. Interested parties can submit their comments electronically through the Federal eRulemaking Portal. The DEA has specified that this permit will not authorize the import of finished medication forms for sale.

    Simple Explanation

    Vici Health Sciences wants permission to bring certain special medicines into the country for research, but you can't buy these as regular medicine. The government is listening to people's opinions on this until February 28, 2025.

  • Type:Notice
    Citation:90 FR 13782
    Reading Time:about a minute or two

    Pharmaron Manufacturing Services (US) LLC has applied to be registered as an importer of certain controlled substances. The Drug Enforcement Administration (DEA) announced this application and is inviting comments and requests for hearings from other registered bulk manufacturers and applicants until April 25, 2025. The company aims to use the imported substances for analytical purposes and production processes but is not authorized for commercial sale of finished dosage forms. The submission of comments should be done electronically through the Federal eRulemaking Portal.

    Simple Explanation

    Pharmaron wants to bring in some special chemicals that are controlled and get permission to use them in their labs. The government is telling people about this and asking if anyone has any questions or wants to talk about it by April 25, 2025.

  • Type:Notice
    Citation:86 FR 11558
    Reading Time:about a minute or two

    Myonex Inc has applied for registration as an importer of specific controlled substances, according to a notice from the Drug Enforcement Administration (DEA). The substances are intended for use in clinical trials, research, and analytical purposes, and not for commercial sale of finished dosage forms. Interested parties have until March 29, 2021, to submit written comments or objections, or to request a hearing regarding this application. Written submissions should be directed to the DEA at their office in Springfield, Virginia.

    Simple Explanation

    Myonex Inc wants to bring in some special medicines from other countries to use in experiments and tests but not to sell them in stores. If anyone has questions or concerns, they can tell the people in charge by March 29, 2021.

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