The A compounded medication is a drug that a licensed pharmacist or physician makes for an individual patient by combining, mixing or altering ingredients. It is not FDA approved, so FDA does not review it for safety, effectiveness or quality before use. BrightSide's compounded semaglutide and tirzepatide are filled by licensed pharmacies we name.
How does a compounded medication apply to GLP-1 treatment?
Compounded semaglutide and tirzepatide are made by a pharmacy for one patient at a time, on a prescription from a licensed provider. Federal law sets the conditions. Under section 503A of the Federal Food, Drug, and Cosmetic Act, the drug is compounded for an identified individual patient based on a valid prescription, by a licensed pharmacist in a state-licensed pharmacy or by a licensed physician. FDA says a compounded drug might be appropriate when a patient's medical need cannot be met by an FDA-approved drug, or when the FDA-approved drug is not commercially available. Both kinds of GLP-1 are on our shelf. Zepbound is an FDA-approved tirzepatide injection, and compounded tirzepatide is the compounded option. A compounded GLP-1 is a separate product from the brand-name drug, and FDA has not reviewed it. A provider reviews your health history and decides whether to prescribe, and which one.
What does a compounded medication mean at the pharmacy?
At the pharmacy, a compounded medication is made to fill a prescription for a named patient, and FDA does not approve it before it ships. State boards of pharmacy have primary responsibility for the day-to-day oversight of state-licensed pharmacies, and FDA conducts surveillance and for-cause inspections. Quality standards depend on where the drug is made. Outsourcing facilities are subject to current good manufacturing practice requirements, and pharmacies compounding under section 503A are exempt from them. Federal law on insanitary conditions applies in every setting. FDA also notes that people who buy compounded drugs online, including through telehealth platforms, may not know the identity of the compounder that produced the drug. Our pharmacy network page covers how we choose the pharmacies we work with.
How does Washington regulate a compounded medication?
Washington licenses the pharmacies that compound here and sets the standard they follow. State law defines compounding as the act of combining two or more ingredients in the preparation of a prescription, and every pharmacy is licensed by the Pharmacy Quality Assurance Commission. Commission rule WAC 246-945-100 requires licensees that compound to comply, at a minimum, with United States Pharmacopeia chapter 795 for nonsterile preparations and chapter 797 for sterile preparations. A pharmacy outside Washington that ships prescriptions to patients here is a nonresident pharmacy and needs a license from the Department of Health. Nordic Pharmacy in Poulsbo, Washington fills BrightSide's Washington and Oregon prescriptions, and our Washington page names it alongside treatments such as compounded tirzepatide for Washington. You can look up a Washington pharmacy license in the Department of Health's provider credential search.
| Brand-name drug | Generic drug | Compounded medication | |
|---|---|---|---|
| FDA approved | Yes | Yes | No |
| FDA reviews safety, effectiveness and quality before marketing | Yes | Yes | No |
| Shown to FDA to be therapeutically equivalent to a brand-name drug | Not applicable | Yes | No |
| Made for | The market | The market | An individual patient, on a prescription |
Common questions
Is a compounded medication a generic drug?
No. FDA approves a generic drug after its maker establishes therapeutic equivalence to a brand-name drug. A compounded medication goes through no FDA approval. FDA states that the two are different. A generic is made for the market, and a compounded medication is made to fill one patient's prescription.
What should you check before you pay for a compounded medication?
Check the prescriber, the pharmacy and the approval status. FDA recommends getting a prescription from a doctor and filling it at a state-licensed pharmacy. Ask which pharmacy makes the medication and look up its license. FDA's telehealth red flags include a company that claims a compounded drug matches an FDA-approved drug, and one that requires no screening and prescription by a licensed doctor.
Related terms
- 503A compounding pharmacy: the kind of state-licensed pharmacy that fills a compounded prescription for a named patient.
- 503B outsourcing facility: a compounder that registers with FDA and follows manufacturing-grade quality rules.
- Beyond use date (BUD): the date after which a compounded medication must not be used.
- Certificate of analysis (COA): the batch test report that comes with a compounding ingredient.
Sources
- FDA, Compounding and the FDA: questions and answers, content current as of September 16, 2025: https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
- FDA, FDA's concerns with unapproved GLP-1 drugs used for weight loss, content current as of October 1, 2026: https://www.fda.gov/drugs/drug-alerts-and-statements/fdas-concerns-unapproved-glp-1-drugs-used-weight-loss
- 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
- Washington Administrative Code 246-945-100, Compounding minimum standards: https://app.leg.wa.gov/wac/default.aspx?cite=246-945-100
Compounded medications are not FDA approved. They are prescribed by a licensed clinician and filled by a licensed 503A pharmacy.
