Search Results for keywords:"503B Bulks List"

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Search Results: keywords:"503B Bulks List"

  • Type:Notice
    Citation:86 FR 1515
    Reading Time:about 5 minutes

    The Food and Drug Administration (FDA) is giving people more time to comment on a notice about certain drug ingredients they are considering for inclusion or exclusion on a special list called the 503B Bulks List. The initial comment period ended on September 29, 2020, but due to requests for more time, especially because of COVID-19 challenges, the FDA has reopened the comment period until February 8, 2021. The original list includes four ingredients proposed for inclusion and 19 others that FDA suggests not to include. Interested parties can submit their comments electronically or in writing, ensuring they follow specific guidelines to protect confidential information.

    Simple Explanation

    The FDA is asking people to share their thoughts on whether some special medicine ingredients should be allowed for making certain drugs, and they're giving extra time to do this because of the difficulties many faced due to COVID-19. People have until February 8, 2021, to say what they think in a safe and proper way.