How peptides are regulated
A plain-language overview. Not legal advice; rules change, so confirm current requirements.
FDA-approved peptide drugs
Approved peptide medicines (insulin, GLP-1 receptor agonists, and others) went through clinical trials and are made under cGMP. They're prescription drugs, approved for specific indications.
Compounding: 503A and 503B
- 503A pharmacies compound medications for individual patients based on a prescription, under state pharmacy board oversight.
- 503B outsourcing facilities register with the FDA, can compound in larger batches, and must follow cGMP.
Compounders can only use certain bulk drug substances. FDA maintains lists and categories for substances that have been nominated, and has raised safety concerns about compounding some peptides, including BPC-157. Check the FDA's current bulk drug substances pages before relying on any peptide's status.
"Research use only" products
Products sold as "research chemicals" are not approved or compounded drugs. FDA has issued warning letters where sellers labeled products "for research only" while promoting them for human use through dosing guides, benefit claims, or injection kits.
Marketing claims
Claims that a product treats, cures, or prevents a disease make it a drug in the eyes of the FDA. The FTC requires health claims to be backed by competent and reliable scientific evidence. Testimonials don't change that.
State rules
Who can prescribe, administer, and supervise is set by state medical, nursing, and pharmacy boards. Requirements differ by state, so check yours.