The A 503B outsourcing facility is a compounder of sterile drugs that registers with FDA and follows current good manufacturing practice. Section 503B of the Federal Food, Drug, and Cosmetic Act created the category in 2013. An outsourcing facility can compound without a prescription for a named patient. BrightSide's compounded prescriptions are filled by 503A pharmacies, a different kind of compounder.
How does a 503B outsourcing facility apply to compounded GLP-1 treatment?
An outsourcing facility can compound from a bulk drug substance in two cases only: the substance is on FDA's 503B bulks list, or the drug is on FDA's drug shortage list at the time it is compounded, distributed and dispensed. FDA stated on April 1, 2026 that tirzepatide and semaglutide do not appear on the 503B bulks list or on the drug shortage list. FDA determined the tirzepatide injection shortage resolved in December 2024 and the semaglutide injection shortage resolved in February 2025. The periods FDA gave outsourcing facilities to wind down ended on March 19, 2025 for tirzepatide and May 22, 2025 for semaglutide. BrightSide's compounded GLP-1 prescriptions are written for individual patients and filled by state-licensed pharmacies under section 503A. That includes compounded semaglutide, which a provider prescribes for the patient named on the order.
What does 503B mean at the facility?
At the facility, 503B means FDA registration, FDA inspection and manufacturing-grade quality rules. An outsourcing facility registers with FDA each year between October 1 and December 31, and it reports the drugs it compounded twice a year, in June and December. It has to comply with current good manufacturing practice and report adverse events to FDA. Each drug label carries the statement "This is a compounded drug" along with the facility's name, the lot or batch number and an expiration date. The statute says an outsourcing facility is not required to be a licensed pharmacy, and that it may or may not obtain prescriptions for identified individual patients. Its drugs are still not FDA approved. FDA publishes a list of registered outsourcing facilities that shows each facility's last inspection date and whether FDA issued a Form 483, and it updates the list weekly.
What should a patient check?
Ask which kind of compounder made your medication, then look it up. A 503B outsourcing facility appears on FDA's public list of registered facilities by name, city and state. A 503A pharmacy does not appear there. It holds a pharmacy license from its state board. In Washington that board is the Pharmacy Quality Assurance Commission, and the Department of Health's provider credential search shows the license. Nordic Pharmacy in Poulsbo, Washington, which fills BrightSide's Washington and Oregon prescriptions and is named on our Washington page, is a compounding pharmacy that fills prescriptions for named patients, and it is not on the outsourcing facility list. FDA notes that people who buy compounded drugs online 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.
| Requirement | What the law says |
|---|---|
| Registration | With FDA, every year between October 1 and December 31 |
| Quality standard | Current good manufacturing practice |
| Inspection | By FDA, on a risk-based schedule |
| Product reports | On registering, then every June and December |
| Adverse events | Reported to FDA |
| Label | "This is a compounded drug", the facility's name, lot or batch number, expiration date |
| Bulk drug substances | Only if on the 503B bulks list, or if the drug is on the drug shortage list |
Common questions
Are drugs from a 503B outsourcing facility FDA approved?
No. Drugs compounded by an outsourcing facility can qualify for exemptions from FDA approval requirements, so they reach patients without FDA review of their safety, effectiveness or quality. The facility is registered with FDA and inspected by FDA. Registration is not an approval of the drugs it makes.
How is a 503B outsourcing facility different from a 503A pharmacy?
A 503B outsourcing facility compounds sterile drugs under current good manufacturing practice and can supply them without patient-specific prescriptions. A 503A pharmacy compounds for individual patients on prescriptions, under state pharmacy rules. FDA is the primary overseer of outsourcing facilities, and state boards of pharmacy are the primary overseers of 503A pharmacies.
Related terms
- 503A compounding pharmacy: the state-licensed pharmacy that compounds for a named patient on a prescription.
- FDA drug shortage list: the list that decides when an outsourcing facility can compound a drug.
- Bulks list (503A bulk drug substances): the separate ingredient list for 503A pharmacies.
- Compounded medication: what both kinds of compounder make.
Sources
- 21 U.S.C. 353b, Outsourcing facilities (section 503B of the Federal Food, Drug, and Cosmetic Act): https://www.govinfo.gov/content/pkg/USCODE-2024-title21/html/USCODE-2024-title21-chap9-subchapV-partA-sec353b.htm
- FDA, Information for outsourcing facilities: https://www.fda.gov/drugs/human-drug-compounding/information-outsourcing-facilities
- FDA, Registered outsourcing facilities, updated as of October 29, 2026: https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities
- 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
Compounded medications are not FDA approved. They are prescribed by a licensed clinician and filled by a licensed 503A pharmacy.
