FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
[4/1/2026] FDA reminds compounders certain conditions must be met for compounded drugs to qualify for the exemptions under sections 503A and 503B of the FD&C Act, including the highlights below.
Under section 503A:The drug product is compounded for an individual patient based on receipt of a prescription.
The compounder does not compound, regularly or in inordinate amounts, any that are essentially copies of a commercially available drug product.
As stated in guidance, the agency intends to consider a compounded drug product to be essentially a copy of a commercially available drug product if:the compounded drug product has the same active pharmaceutical ingredient(s) (API) as the commercially available drug product in the same, similar or an easily substitutable strength, and
the commercially available drug product can be used by the same route of administration (regardless of how it is labeled) prescribed for the compounded drug product.
This is unless a prescriber determines and documents the compounded drug product contains a change that produces a significant difference from the commercially available drug product for an identified individual patient.
FDA intends to consider a compounded drug product to be essentially a copy of a commercially available drug product if: the compounded drug product contains the same APIs as two or more commercially available drug products in the same, similar or easily substitutable strength and
the commercially available drug product can be used (regardless of how it is labeled) by the same route of administration prescribed for the compounded drug product, unless there is documentation of a prescriber determination of a significant difference.
For example, FDA may consider a compounded drug product that combines semaglutide API and another API, such as vitamin B12 (cyanocobalamin), to be essentially a copy of a commercially available drug product when the:drug products are used by the same route of administration – the compounded drug product is given the same way as the commercially available drug products, such as an injectable
drug products are the same, similar or easily substitutable strength – the amounts of semaglutide and vitamin B12 in the compounded drug product are within 10% of the strengths of the respective commercially available drug products.
FDA has stated, at this time, it does not intend to take action against a compounder for compounding a drug product that is essentially a copy of a commercially available drug product regularly or in inordinate amounts if the compounder fills four or fewer prescriptions of that compounded drug product during a calendar month.
Under section 503B:Outsourcing facilities are restricted from compounding drugs using bulk drug substances (or API) unless:the bulk drug substance appears on a list identifying bulk drug substances for which there is a clinical need, which is referred to as the 503B bulks list or
the drug compounded from the bulk drug substance is on FDA’s drug shortage list at the time of compounding, distribution and dispensing.
Tirzepatide and semaglutide do not currently appear on the 503B bulks list or on FDA’s drug shortage list.
