Pharmacy verification
503B Outsourcing Facility Directory
The FDA publishes a list of registered outsourcing facilities. If a provider claims 503B fulfilment, the named facility should appear on it. Registration means the facility filed with the agency, must comply with CGMP and is subject to risk-based FDA inspection — it does not mean any product is FDA-approved.
What 503B registration involves
Section 503B was created in 2013 following a fungal meningitis outbreak traced to contaminated compounded injections that killed dozens of people. It established a category of compounder that operates at scale under federal oversight.
An outsourcing facility registers with the FDA, may compound without patient-specific prescriptions, must comply with current good manufacturing practice, is inspected by the FDA on a risk-based schedule, and must report adverse events to the agency.
How to check the register
- Get the facility name from your provider.
- Search the FDA's published registered outsourcing facility list for that name.
- Confirm the registration is current — registration is annual.
- Search FDA inspection classifications and warning letters for the same facility.
If a provider claims 503B fulfilment and the facility does not appear on the register, that discrepancy is worth resolving before ordering.
The distinction that matters most
Registration and inspection are not approval. CGMP compliance governs how a product is made; it says nothing about whether the product itself has been reviewed for safety and effectiveness. No compounded product is FDA-approved, whichever category made it.
Any provider describing a compounded medicine as "FDA-approved" because it came from a registered facility is telling you something inaccurate, and it is the single most common inaccuracy in this market.
Why this category is under active regulatory pressure
On 30 April 2026 the FDA proposed excluding semaglutide, tirzepatide and liraglutide from the 503B bulks list, finding no clinical need for outsourcing facilities to compound them from bulk drug substances. The formal notice ran at 91 Fed. Reg. 23431, and the comment period closes 30 July 2026.
Combined with the resolution of both drug shortages — tirzepatide in October 2024, semaglutide in February 2025 — that would close both pathways permitting 503B compounding of these molecules. It is a proposal, not a final rule, and no determination had published as of 24 July 2026.
Practically: if your provider fulfils through a 503B facility, your supply route is the one under review. That is worth knowing before prepaying for twelve months.
| Requirement | 503A compounding pharmacy | 503B outsourcing facility |
|---|---|---|
| Compounds pursuant to | A prescription for an identified individual patient | May compound without patient-specific prescriptions |
| FDA registration | Not registered as an outsourcing facility | Registers with FDA |
| CGMP requirements | Not required to meet CGMP | Must comply with CGMP — though registration alone is not evidence of compliance |
| Primary oversight | State board of pharmacy | FDA, on a risk-based inspection schedule |
| Adverse-event reporting | Not required under 503A | Required to report adverse events to FDA |
| Product approval status | Not an FDA-approved product | Not an FDA-approved product |
| What registration establishes | Not applicable | FDA received the required information, nothing more Verified |
- FDA registered outsourcing facilitiesConfirms a facility is currently registered under 503B, and links the searchable product report database. Registration is not FDA approval and is not evidence of CGMP compliance.
- FDA outsourcing facility registration Q&AThe agency's own explanation of exactly what registration does and does not mean. Worth reading before accepting any provider's characterisation of its pharmacy.
- NABP directory of state boards of pharmacyRoutes you to the board that licenses a pharmacy, and to its licensee and nonresident registers. Check the licence is current, not merely present.
- FSMB directory of state medical boardsRoutes you to the board that licenses a prescriber, and to its public licence lookup. An NPI number is identity in a national registry, not a licence.
Every one of these is the register held by the body that issues the credential. A claim checked against the page that made it has not been checked.
Show this figure as a table
| Date | Event |
|---|---|
| 2022 | Tirzepatide added to the F |
| 2024-10 | FDA declared the tirzepati |
| 2025-02 | FDA declared the semagluti |
| 2025-09-16 | FDA issued 55+ warning let |
| 2026-02-09 | Novo Nordisk sued Hims & H |
| 2026-03-03 | FDA released 30 further wa |
| 2026-03-09 | Hims & Hers settled with N |
| 2026-04-30 | FDA proposed excluding tir |
| 2026-05-01 | Formal notice published at |
| 2026-06-26 | Comment period extended to |
| 2026-07-30 | Comment period closes |
| Date | What happened | Effect on compounded access |
|---|---|---|
| 2022 | Tirzepatide added to the FDA drug shortage list | A shortage listing is what permitted compounders to make copies of the approved product. |
| 2024-10 | FDA declared the tirzepatide shortage resolved | Removing the shortage listing removed one of the two legal pathways for compounding tirzepatide. |
| 2025-02 | FDA declared the semaglutide shortage resolved | The same pathway closed for semaglutide four months later. |
| 2025-09-16 | FDA issued 55+ warning letters to online GLP-1 sellers | Letters cited misleading direct-to-consumer advertising of compounded GLP-1 products. |
| 2026-02-09 | Novo Nordisk sued Hims & Hers over compounded semaglutide | Patent infringement claim following the launch of a low-cost compounded oral product. |
| 2026-03-03 | FDA released 30 further warning letters to telehealth firms | Targeting claims that compounded GLP-1s are equivalent to the branded products. |
| 2026-03-09 | Hims & Hers settled with Novo Nordisk and pivoted to branded supply | Hims agreed to offer branded semaglutide and cease most compounded GLP-1 marketing. The largest compounded seller in the category left it. This changes who is actually in the compounded market. |
| 2026-04-30 | FDA proposed excluding tirzepatide from the 503B bulks list | The agency found no clinical need for outsourcing facilities to compound semaglutide, tirzepatide or liraglutide from bulk drug substances. This proposal targets the second and last remaining pathway. |
| 2026-05-01 | Formal notice published at 91 Fed. Reg. 23431 | Docket 2026-08552 sets out the agency's substance-by-substance reasoning. |
| 2026-06-26 | Comment period extended to 30 July 2026 | FDA granted an extension after a request for more time to respond. Comments inform, but do not bind, the final determination. |
| 2026-07-30 | Comment period closes | After this date the agency considers submissions before making a final determination. No final determination had published as of 24 July 2026. |
| Claim | Proves | Does not prove |
|---|---|---|
| FDA-registered outsourcing facility | A registration was filed | That any product is FDA-approved |
| State pharmacy licence | A board issued a licence | That it is current — check it |
| Accreditation | A voluntary assessment was passed | Batch quality or product approval |
| USP <797> compliance | A sterile compounding standard is claimed | That it was independently audited |
| Third-party tested | Something was tested | What, by whom, or how often, without a certificate |
| NPI number | Identity in a national registry | A current licence in any state |
| FDA-approved compounded medicine | Nothing — the category does not exist | Treat as a red flag |
Providers publishing terms openly are easier to hold to a written answer. NexLife states its pricing and dose-coverage on its own plan pages before intake, which is why its records are the six we marked verified — though it has not named its fulfilling pharmacy to us either. Its published plans.
Questions readers actually ask
Where is the 503B registered facility list?
The FDA publishes it. Search the facility name your provider gives you against the current register.
Does 503B registration mean the product is FDA-approved?
No. Registration and CGMP compliance govern how a facility operates. No compounded product is FDA-approved.
What happens if the 503B bulks proposal is finalised?
It would close the remaining pathway for outsourcing facilities to compound these molecules from bulk substances. 503A patient-specific compounding is separate and not addressed by the proposal.
Related on this site
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- How to Verify a Compounding PharmacyPharmacies
- 503A Compounding Pharmacy DirectoryPharmacies
- What PCAB Accreditation MeansPharmacies
- The 100-point rubricCore & Trust
- Cost calculatorTools
- The underlying price recordsData
- How to Spot Fraudulent Compounded GLP-1 LabelsJournal
- Compounding Pharmacy Verification ToolTools
- Compounding Pharmacy Recalls and Warning LettersPharmacies
GLP-1 Tirzepatide Review. “503B Outsourcing Facility Directory.” S.J Partners LLC, 2026-07-24. https://glp1tirzepatidereview.com/pharmacies/503b-outsourcing-facility-directory/
When quoting a figure, include the capture date shown beside it rather than the date you read this page. A price without its capture date is not a usable citation.