Search Results for keywords:"comments and objections"

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Search Results: keywords:"comments and objections"

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  • 2021-03834 — Importer of Controlled Substances Application: Globyz Pharma, LLC
    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.

  • 2021-02979 — Importer of Controlled Substances Application: S and B Pharma, Inc.
    Type:Notice
    Citation:86 FR 9535
    Reading Time:about a minute or two

    S&B Pharma, Inc. has applied to the Drug Enforcement Administration (DEA) to be registered as an importer of certain controlled substances. The company intends to import intermediate forms of Tapentadol for manufacturing purposes and ANPP to produce other controlled substances, but they will not import finished products for commercial sale. Interested parties, such as registered manufacturers, can submit comments, objections, or request a hearing regarding this application by March 18, 2021.

    Simple Explanation

    S&B Pharma, Inc. wants permission to bring in special ingredients that can be used to make certain medicines, but they don't want to sell final medicine products. People who are interested can tell the boss what they think by talking or asking questions before March 18, 2021.