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On April 1, 2026,the U.S. Food & Drug Administration (FDA) issued a clarifying its compliance policy on the  conditions that must be met for compounded drugs to qualify for the exemptions under Sections and of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

IMPORTANT TAKEAWAYS:

Compounded drugs are not FDA approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed. The FD&C Act restricts the compounding of drug products that are essentially copies of commercially available drug products under Section 503A or approved drug products under Section 503B, unless an exemption applies. Absent an exemption, compounded drugs may be considered misbranded which could result in enforcement action including issuance of a Warning Letter, or seizure and injunction.

This statement marks the first time FDA has expressly stated what it considers to be compounding, regularly or in inordinate amounts, a drug product that is essentially a copy of a commercially available drug product.

In its statement, FDA noted that a compounded GLP-1 product will be considered 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 prescribed for the compounded drug product, regardless of how the commercially available drug product is labeled.

FDA also stated that, at this time, it does not intend to take action against a 503A compounder for regularly or in inordinate amounts compounding a drug product that is essentially a copy of a commercially available drug product if the compounder fills four or fewer prescriptions for that compounded drug product during a calendar month.

FDA POINTS OF CLARIFICATION

503A Clarification

FDA reminded 503A compounders that, under Section 503A of the FD&C Act:

• The drug product must be compounded for an identified individual patient based on receipt of a . 
• The compounder may not compound, regularly or in inordinate amounts, drug products that are  of a commercially available drug products.

FDA also outlined factors it considers in determining whether a compounded drug product is essentially a copy of a commercially available drug product. The factors include whether:

• The compounded drug product has the same API(s) 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 prescribed for the compounded drug product, regardless of how the commercially available product is labeled.

FDA further stated that a compounded product is essentially a copy of a commercially available drug product unless the prescriber determines and documents that the compounded drug product contains a change that produces a significant difference for an identified individual patient.  

Essentially a Copy of a Commercially Available Drug Product Example:

FDA provided an illustrative example of what it considers to be essentially a copy of a commercially available drug product.

Semaglutide Example: A compounded drug product that combines semaglutide API with another API, such as vitamin B12 (cyanocobalamin), will be considered essentially a copy of a commercially available drug product when:

• The drug products are used by the same route of administration. For example, the compounded drug product is administered in the same manner as the commercially available drug product, such as by injection; and
• The drug products are the same, similar, or easily substitutable strength. For example, 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.

503B Clarification

In addition, FDA reminded 503B outsourcing facilities that they are restricted from compounding drugs using  (or API) unless:

• The bulk drug substance appears on the , which identifies bulk drug substances for which there is a clinical need; or
• The compounded drug is on  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.

IMPORTANT CONSIDERATIONS

A. This is a clarification of FDA policy — it does not have the force and effect of law.

B. This is the first time FDA has expressly stated what it considers to be essentially a copy of a commercially available drug product.

C. FDA has not provided insight into the type and amount of documentation a prescriber must create and maintain when determining that a compounded drug product contains a change that produces a significant difference from the commercially available drug product for the identified individual patient.

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