In the United States, compounding pharmacies can prepare customised medicines from bulk substances under certain conditions, regulated by section 503A of the federal food and drug law. The FDA reviews which substances may be used and sorts them into lists and categories.
Category 2 groups substances the agency considers may present significant safety risks, which in practice discourages their use in compounding while they are evaluated. Several research peptides have been on that list, and their classification has changed with reviews and advisory committee meetings.
These changes should be read carefully: leaving Category 2 or being evaluated by a committee is not the same as approval as a medicine, which requires its own process with clinical trials.
Each peptide's status with the FDA changes frequently and is often quoted out of date. For the current, dated status of each compound, see this site's regulatory status page.
Related terms
Learn it in depth at the Peptide University
- Non-injectable routes: intranasal, oral and topical · Module 8
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- Hierarchy of evidence and development phases · Module 13
Definition for educational and scientific purposes. It is not medical advice or a recommendation for use. NeoPeptidos products are sold labelled for research use only (RUO).