US FDA Provides Recommendations on the Statutory Prohibition on Wholesaling for Certain Compounded Drugs

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

According to FDA, this draft guidance describes the FDA’s interpretation of, and policies concerning, the prohibition on wholesaling in section 503B of the FD&C Act (21 U.S.C 353b). This draft guidance also describes examples of how the FDA intends to apply section 503B of the FD&C Act’s wholesaling provision.

It contains information on key terms, activities prohibited by the wholesaling provision, activities not prohibited, inspections and regulatory or enforcement action.

Electronic or written comments on the draft guidance should be submitted on or before August 28, 2023, to ensure that the Agency considers the comment on this draft guidance before it begins work on the final version of the guidance.

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