The FDA released revised guidance governing what substances pharmacies can compound. Under the guidance, 503A compounding pharmacies can continue to compound substances that are the active ingredient in an FDA-approved drug, have a U.S. Pharmacopeia monograph, or are placed in FDA's "Category 1" list (also known as "Substances Nominated for the Bulks List Currently Under Evaluation") of proposed bulk drugs that do not pose a significant safety risk but have not yet been placed on the 503A bulks list. 503A compounding pharmacies, however, would not be able to compound substances without monographs, like peptides, until a review is conducted.
Under separate revised guidance, 503B outsourcing facilities can only compound drugs on the Category 1 of the 503B bulks list, or FDA-approved drugs in shortage.
