2018-10194: Partial Withdrawal of Proposed Amendment to the Tentative Final Monograph for Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Use
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The Food and Drug Administration (FDA or the Agency) is announcing a partial withdrawal of a proposed rule published in the Federal Register of August 21, 2002 (2002 proposed rule). The proposed rule, if finalized, would have amended FDA's tentative final monograph (TFM) for over-the-counter (OTC) internal analgesic, antipyretic, and antirheumatic (IAAA) drug products to include ibuprofen as a generally recognized as safe and effective (GRASE) analgesic/antipyretic active ingredient for OTC use. FDA is withdrawing this proposed rule due to changes in our understanding of ibuprofen since FDA issued the proposed rule. FDA is not withdrawing those portions of the 2002 proposed rule to amend its regulations to include consistent pregnancy and allergy warnings for OTC IAAA drug products containing nonsteroidal anti- inflammatory active ingredients.
The agency’s own summary, as published.
What this changes
Amends 2 parts of the Code of Federal Regulations — the standing rules this notice rewrites.
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