The The bulks list is FDA's list of bulk drug substances that pharmacies can compound with under section 503A when no other legal route applies. The list is set by regulation at 21 CFR 216.23 and holds six substances. Semaglutide and tirzepatide are not on it. The six peptides BrightSide plans to offer are covered by a separate federal policy.
How does the bulks list apply to compounded GLP-1 treatment?
The bulks list does not decide whether semaglutide or tirzepatide can be compounded, because those two ingredients reach a pharmacy by a different legal route. Section 503A allows a pharmacy to compound with a bulk drug substance in three cases. The substance complies with a United States Pharmacopeia or National Formulary monograph, or it is a component of an FDA-approved drug, or it appears on the bulks list. The list only matters for a substance that has no monograph and is not part of an approved drug. Semaglutide and tirzepatide are components of FDA-approved drugs. That eligibility covers the ingredient only. The compounded medication made from it is not FDA approved. In all three cases the bulk substance has to come from a manufacturer registered with FDA and arrive with a valid certificate of analysis. BrightSide's compounded semaglutide is filled by a licensed pharmacy, and our pharmacy network page covers how we choose pharmacies.
What does the bulks list mean at the pharmacy?
At the pharmacy, the bulks list decides whether an ingredient with no monograph and no approved drug behind it can be compounded at all. FDA set the list by regulation in February 2019. It names six substances, among them cantharidin and thymol iodide for topical use only, and it names four substances FDA decided to leave off. FDA is still evaluating substances that were nominated starting in 2015. While that work continues, an interim policy sorts nominated substances into three categories. FDA does not intend to take action against a pharmacy that compounds with a Category 1 substance when the conditions in its guidance are met. Category 2 substances are ones where FDA has identified significant safety risks. FDA adds substances to the list through notice-and-comment rulemaking, in consultation with its Pharmacy Compounding Advisory Committee.
How does the bulks list affect peptides?
Six peptides are being considered for the bulks list and are covered in the meantime by a separate policy. On October 30, 2026 the Department of Health and Human Services published a draft enforcement discretion policy for 503A compounding with BPC-157, TB-500, Epitalon, KPV, MOTS-c and Semax. HHS states that it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician that compounds with one of these peptides, while the bulks list is developed through rulemaking. The notice says FDA's future rulemakings may propose adding some or all of them to the list. The policy is a draft and is not binding on HHS or the public, and HHS opened a two-week comment period with it. BrightSide's peptides will be available by prescription once prescribing opens. You can join the peptide list on our peptide hub.
| Route | When it applies |
|---|---|
| USP or NF monograph | An applicable monograph exists, and the substance complies with it |
| Component of an FDA-approved drug | No monograph exists, and the substance is part of an approved drug |
| The 503A bulks list | No monograph exists, the substance is not part of an approved drug, and FDA listed it by regulation, as it did for cantharidin (topical use only) |
Common questions
Is semaglutide on the 503A bulks list?
No. The list at 21 CFR 216.23 names six substances, and semaglutide and tirzepatide are not among them. Both are components of FDA-approved drugs, and the bulks list is only for substances that are not. Section 503A has separate routes for a pharmacy to compound with those ingredients on an individual patient's prescription.
Does a place on the bulks list mean a drug is FDA approved?
No. The regulation says there are inadequate data to demonstrate the safety or efficacy of any drug compounded with a listed substance. It also says that representing such a compounded drug as FDA approved, or as endorsed by FDA, causes the drug to be misbranded.
Related terms
- 503A compounding pharmacy: the kind of pharmacy the bulks list applies to.
- Enforcement discretion: the kind of policy that covers the six peptides while the list is developed.
- Active pharmaceutical ingredient (API): another name for a bulk drug substance.
- Certificate of analysis (COA): the batch report that comes with a bulk drug substance.
Sources
- 21 CFR 216.23, the 503A bulks list: https://www.govinfo.gov/content/pkg/CFR-2025-title21-vol4/xml/CFR-2025-title21-vol4-sec216-23.xml
- FDA, Bulk drug substances used in compounding under section 503A of the FD&C Act, content current as of May 14, 2026: https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
- 21 U.S.C. 353a, Pharmacy compounding (section 503A of the Federal Food, Drug, and Cosmetic Act): https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapV-partA-sec353a.htm
- HHS, notice of availability of the peptide enforcement discretion policy, 91 FR 68526, October 30, 2026: https://www.govinfo.gov/content/pkg/FR-2026-10-30/html/2026-22192.htm
Compounded medications are not FDA approved. They are prescribed by a licensed clinician and filled by a licensed 503A pharmacy.
