Search Results for keywords:"21 CFR 1301.33(a)"

Found 6 results

Search Results: keywords:"21 CFR 1301.33(a)"

💰 Only
Oldest Newest
  • 2025-02593 — Bulk Manufacturer of Controlled Substances Application: Benuvia Operations, LLC
    Type:Notice
    Citation:90 FR 9553
    Reading Time:about a minute or two

    Benuvia Operations, LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances, which will be used for internal research and developing dosage formulations. The application was submitted on December 4, 2024. The DEA is inviting registered bulk manufacturers and applicants to submit comments or objections electronically by April 14, 2025. Comments should be submitted through the Federal eRulemaking Portal with instructions provided on the regulations.gov website.

    Simple Explanation

    Benuvia Operations, LLC wants permission to make certain special substances for research and medicine work, and people can tell the government what they think about this until April 14, 2025.

  • 2021-02980 — Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: North Star Holdings California, LLC
    Type:Notice
    Citation:86 FR 9536
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) has announced that North Star Holdings California, LLC, has applied to become a registered bulk manufacturer of marihuana, a Schedule I controlled substance. This application is part of a DEA program that regulates the cultivation of marihuana for scientific and medical research purposes. The DEA will review this and similar applications to ensure compliance with relevant laws and regulations, ensuring that adequate measures are in place to prevent illegal distribution. Interested parties may submit comments or objections to the DEA regarding this application before April 19, 2021.

    Simple Explanation

    The DEA is thinking about letting a company, North Star Holdings California, grow a special type of plant called marihuana for scientists and doctors to study. People can tell the DEA what they think about this idea until April 19, 2021.

  • 2025-05055 — Bulk Manufacturer of Controlled Substances Application: Pharmaron Manufacturing Services (US), LLC
    Type:Notice
    Citation:90 FR 13782
    Reading Time:about a minute or two

    Pharmaron Manufacturing Services (US), LLC has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of certain controlled substances. This registration is intended to allow the company to produce materials for clinical trials. Interested parties can submit comments or request a hearing on the application by May 27, 2025, via the Federal eRulemaking Portal. The application was officially filed on February 11, 2025, and no other activities related to these substances are authorized beyond clinical trial production.

    Simple Explanation

    Pharmaron wants permission from a government group to make special medicines for testing, but some details about what they'll make and how it might affect others are missing. People can say what they think about this plan by a certain date, but they might not see what others have said right away.

  • 2025-05276 — Bulk Manufacturer of Controlled Substances Application: Bulk Manufacturer of Marihuana: Baxter Research Lab
    Type:Notice
    Citation:90 FR 13884
    Reading Time:about 2 minutes

    The Drug Enforcement Administration (DEA) received an application from Baxter Research Lab to register as a bulk manufacturer of marihuana, a Schedule I controlled substance. This registration would allow Baxter to produce large quantities of active pharmaceutical ingredients (APIs) for research purposes. The DEA will review the application to ensure all legal and safety measures are in place to prevent misuse. Comments or objections regarding this application can be submitted electronically until May 27, 2025.

    Simple Explanation

    The DEA is thinking about letting a company called Baxter Research Lab make a lot of a special plant called marihuana for scientific experiments, but only if they follow all the rules to keep it safe and not let it get into the wrong hands.

  • 2025-03170 — Bulk Manufacturer of Controlled Substances Application: Groff NA Hemplex LLC
    Type:Notice
    Citation:90 FR 10830
    Reading Time:about a minute or two

    Groff Hemplex LLC has applied to the Drug Enforcement Administration to be registered as a bulk manufacturer of certain controlled substances. The company plans to use these substances for its own purposes and to sell them to approved research investigators. The public can submit comments or objections electronically by April 28, 2025, and also request a hearing on this application by the same date. This application process follows the regulations set by the DEA under 21 CFR 1301.33(a).

    Simple Explanation

    Groff Hemplex LLC wants permission from the government to make special kinds of medicines and sell them to scientists for research. People can tell the government what they think about this by April 28, 2025.

  • 2021-02973 — Bulk Manufacturer of Controlled Substances Application: PCI Synthesis
    Type:Notice
    Citation:86 FR 9539
    Reading Time:about a minute or two

    PCI Synthesis has applied to the Drug Enforcement Administration (DEA) to become a bulk manufacturer of controlled substances. They plan to use these substances for developing manufacturing processes and conducting tests. The application has been filed under notice by the DEA, and comments or objections to this application can be submitted by April 19, 2021. Additionally, PCI Synthesis has patents for the synthesis process of amphetamines.

    Simple Explanation

    PCI Synthesis wants permission to make certain special chemicals and is asking the government for approval, and people have until April 19, 2021, to say if they agree or not. They also have special recipes for how to make these chemicals.