What Is the FDA Category 2 Compounding List for Bulk Drug Substances?

The FDA maintains a list titled Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks. This list, commonly called the Category 2 list, names substances the agency has evaluated and found may present demonstrable difficulties for compounding or significant safety risks [1].

Who does it affect?

The list applies to compounding pharmacies that operate under Section 503A (individual prescriptions) or Section 503B (outsourcing facilities) of the Federal Food, Drug, and Cosmetic Act. These are pharmacies that prepare custom formulations. The list restricts their ability to compound using the named substances.

Which peptides are on it?

As of April 2026, GHRP-2, GHRP-6, and Ipamorelin are on the Category 2 list. The listing does not mean these substances are banned from all commerce. It means compounding pharmacies face regulatory restrictions on using them in compounded preparations.

Does it affect research-use-only sales?

Not directly. Research material suppliers that sell peptides labeled for research use only are not compounding pharmacies and are not subject to Section 503A or 503B. The Category 2 list is a compounding regulation, not a general prohibition on the substance.

How is a substance added to the list?

The FDA evaluates nominated substances based on published literature, adverse event data, and the feasibility of compounding them safely. The process includes a public comment period before a substance is finalized on the list.

Frequently asked questions

Is the Category 2 list the same as scheduling under the Controlled Substances Act?

No. The Controlled Substances Act is enforced by the DEA and concerns substances with potential for dependency. The Category 2 list is an FDA compounding regulation and has nothing to do with controlled substance scheduling.

Does being on the list mean a peptide is dangerous?

The listing means the FDA has identified safety concerns related to compounding the substance. It does not necessarily mean the substance is inherently unsafe in all contexts.