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The FDA maintains a list of drug products that may not be compounded at all because they have been found unsafe or not effective. The agency proposes that additions to the list need not go through an advisory committee. However, going through an advisory committee makes these additions open to public comment, and that’s something we feel is vitally important. The FDA is tremendously suspicious of innovation, so the agency should not sole authority to determine what can go on the “do not compound” list.
Tell the FDA that their agency should not have sole authority to add ingredients to a “do not compound” list, and that all additions to the list should go through an advisory committee that is open to public comment.
Please personalize your comments if you have the time!
Docket ID: FDA-1999-N-0194
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]