The A certificate of analysis is a manufacturer's report on one batch of a drug ingredient that lists each test performed, its limits and the results. Section 503A of the Federal Food, Drug, and Cosmetic Act requires a valid certificate with every bulk drug substance a pharmacy compounds with. That covers the semaglutide and tirzepatide used to fill BrightSide prescriptions.
How does a certificate of analysis apply to compounded GLP-1 treatment?
The certificate of analysis is the quality record for the active ingredient in a compounded semaglutide or tirzepatide vial. Section 503A lets a pharmacy compound with a bulk drug substance only when it comes from a manufacturer registered with FDA and is accompanied by a valid certificate of analysis. FDA notes that pharmacies operating under section 503A are exempt from current good manufacturing practice, including the requirement to ensure that an ingredient meets specifications for impurities or potency. FDA's Import Alert 66-80 reports that of 48 sites making GLP-1 active ingredients that the agency evaluated, 21 percent were noncompliant. A manufacturer that asks to be added to the alert's green list is expected to document its quality, and the certificate that accompanies each lot is one of the records FDA names. Our pharmacy network page covers how we choose the pharmacies that fill treatments such as compounded tirzepatide.
What does a certificate of analysis mean at the pharmacy?
At the pharmacy, a certificate of analysis comes with each lot of bulk ingredient. FDA's guidance for ingredient makers says what belongs on it. The certificate gives the name of the ingredient and its grade, the batch number, the release date, and the expiry or retest date. It lists each test performed, with the acceptance limits and the numerical results. It is dated and signed by the manufacturer's quality unit, and it shows the name, address and telephone number of the original manufacturer. If a repacker performed the analysis, the certificate names the repacker and references the original manufacturer. A new certificate issued by a repacker or broker should reference the original batch certificate, with a copy attached. The certificate describes the bulk ingredient. Any testing a pharmacy runs on a finished vial is a separate record.
How does a certificate of analysis apply to peptides?
The certificate of analysis is central to the federal peptide policy. On October 30, 2026 the Department of Health and Human Services published a draft enforcement discretion policy for six peptides compounded under section 503A. Under its conditions, the bulk substance has to come from a facility registered with FDA and be identified in a valid certificate of analysis for that lot. The original manufacturer, and not only a repacker or distributor, has to be named on the certificate. The policy lists the testing the certificate should show, including identity, assay, peptide-related impurities, residual solvents and elemental impurities. For injectable forms it adds bioburden and bacterial endotoxins. BrightSide's peptides will be available by prescription once prescribing opens. You can join the peptide list on our peptide hub.
| Item on the certificate | What it tells you |
|---|---|
| Ingredient name and grade | Which substance the batch is |
| Batch number | Which batch the results belong to |
| Release date, and expiry or retest date | When the batch was released and how long the results stand |
| Tests, acceptance limits and results | What was measured, the allowed range and the number found |
| Date and signature of the quality unit | Who signed off on the results |
| Original manufacturer's name, address and telephone number | Where the ingredient was made |
Common questions
Is a certificate of analysis an FDA approval?
No. A certificate of analysis is the manufacturer's own report on one batch of an ingredient. FDA does not issue it. Federal law requires the certificate to accompany a bulk drug substance used in compounding, and the compounded medication made from that substance is still not FDA approved.
Can a patient ask to see a certificate of analysis?
You can ask the company you bought from. The certificate belongs to the pharmacy's records for a lot of ingredient, and pharmacies differ in what they share with patients. To find out which pharmacy fills a BrightSide prescription, email hello@jointhebrightside.com and a person answers.
Related terms
- Active pharmaceutical ingredient (API): the ingredient a certificate of analysis describes.
- 503A compounding pharmacy: the pharmacy that has to receive the certificate.
- Bulks list (503A bulk drug substances): FDA's list of ingredients a pharmacy can compound with when no other route applies.
- Enforcement discretion: the kind of policy that sets certificate requirements for peptides.
Sources
- FDA, Q7 good manufacturing practice guidance for active pharmaceutical ingredients, September 2016, section on certificates of analysis: https://www.fda.gov/files/drugs/published/Q7-Good-Manufacturing-Practice-Guidance-for-Active-Pharmaceutical-Ingredients-Guidance-for-Industry.pdf
- 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
- FDA, Import Alert 66-80, published October 9, 2026: https://www.accessdata.fda.gov/cms_ia/importalert_1186.html
- HHS, peptide enforcement discretion policy for 503A compounding (policy document, announced October 30, 2026): https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
Compounded medications are not FDA approved. They are prescribed by a licensed clinician and filled by a licensed 503A pharmacy.
