The FDA restated the conditions a compounded drug must meet to qualify for the section 503A and 503B exemptions, and addressed a practice common in compounded GLP-1 products directly. It said a product combining semaglutide with another active ingredient, giving vitamin B12 (cyanocobalamin) as its example, may still be considered essentially a copy of a commercially available drug where the route of administration is the same and the amounts of each ingredient fall within 10% of the strengths of the respective approved products. The agency also stated it does not intend to act where a compounder fills four or fewer prescriptions of such a product in a calendar month.
Sources: FDA — FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
