The A 503A compounding pharmacy is a state-licensed pharmacy that compounds a medication for an identified individual patient based on a valid prescription. The name comes from section 503A of the Federal Food, Drug, and Cosmetic Act, which exempts those prescriptions from FDA approval requirements. Nordic Pharmacy in Poulsbo, Washington fills our Washington and Oregon prescriptions this way.
How does a 503A compounding pharmacy apply to compounded GLP-1 treatment?
A 503A pharmacy is where a compounded semaglutide or tirzepatide prescription is made, for one named patient at a time. Section 503A sets the conditions. A licensed pharmacist compounds the drug in a state-licensed pharmacy, on a valid prescription written for that patient by a licensed practitioner. The bulk ingredient comes from a manufacturer registered with FDA and arrives with a valid certificate of analysis. The pharmacy does not compound, regularly or in inordinate amounts, drugs that are essentially copies of a commercially available drug. The statute leaves out of that term a drug with a change, made for an identified individual patient, that the prescriber determines produces a significant difference for that patient. FDA restated these conditions for GLP-1 compounders on April 1, 2026. Every BrightSide prescription for compounded tirzepatide starts with a provider's review of one patient's health history.
What does 503A mean at the pharmacy?
At the pharmacy, 503A means compounding to fill prescriptions under a state license, with no FDA approval of the finished drug. A drug compounded under section 503A is exempt from three federal requirements: FDA approval before marketing, labeling with adequate directions for use, and current good manufacturing practice. Other federal law still applies, including the provisions on insanitary conditions. State boards of pharmacy have primary responsibility for day-to-day oversight of these pharmacies, and FDA conducts surveillance and for-cause inspections. Ingredients other than the bulk drug substance have to meet United States Pharmacopeia or National Formulary standards where a monograph exists. Drugs that FDA has listed as withdrawn from the market for safety or effectiveness reasons cannot be compounded at all. Our pharmacy network page covers how we choose the pharmacies we work with.
How does Washington regulate a 503A compounding pharmacy?
Washington licenses each pharmacy through the Pharmacy Quality Assurance Commission, and commission rules set the compounding standard. WAC 246-945-100 requires every commission licensee that compounds to comply, at a minimum, with United States Pharmacopeia chapter 795 for nonsterile preparations and chapter 797 for sterile preparations. Injectable medications such as compounded semaglutide and tirzepatide are sterile preparations. A pharmacy in another state that ships prescriptions to Washington patients is a nonresident pharmacy under RCW 18.64.360. It needs a Washington license, and it has to submit an inspection report issued within the past two years. Nordic Pharmacy in Poulsbo, Washington compounds BrightSide's Washington and Oregon prescriptions, and our Washington page names it alongside treatments such as compounded tirzepatide for Washington. You can search a pharmacy's Washington license in the Department of Health's provider credential search.
| 503A compounding pharmacy | 503B outsourcing facility | |
|---|---|---|
| Who it is | A state-licensed pharmacy or a licensed physician | A facility registered with FDA; it does not have to be a licensed pharmacy |
| Prescription for a named patient | Required | Not required |
| Current good manufacturing practice | Exempt | Required |
| Primary oversight | State board of pharmacy | FDA, on a risk-based inspection schedule |
| Drugs are FDA approved | No | No |
Common questions
Is a 503A compounding pharmacy approved by FDA?
No. A 503A pharmacy is licensed by its state board of pharmacy, and the drugs it compounds are not FDA approved. FDA does not verify the safety, effectiveness or quality of a compounded drug before it reaches a patient. FDA can still inspect a 503A pharmacy for cause.
Does a 503A pharmacy need a prescription before it compounds?
Yes, with one narrow exception. Section 503A covers a drug compounded for an identified individual patient based on a valid prescription. A pharmacist can compound limited quantities before the prescription arrives only when there is a history of such prescriptions within an established relationship with the patient or the prescriber.
Related terms
- 503B outsourcing facility: the FDA-registered kind of compounder, set up by section 503B.
- Compounded medication: what a 503A pharmacy makes for a named patient.
- Bulks list (503A bulk drug substances): FDA's list of ingredients a 503A pharmacy can use when no other route applies.
- Enforcement discretion: how regulators paused action on some compounding, and when that ended.
Sources
- 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, FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize, entry dated April 1, 2026: https://www.fda.gov/drugs/drug-alerts-and-statements/fda-clarifies-policies-compounders-national-glp-1-supply-begins-stabilize
- 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
- 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.
