Pharmacy verification
Certificates of Analysis and Third-Party Testing
A certificate of analysis records what was tested, by whom, and the result — for a specific batch. For a sterile injectable the tests that matter are potency, sterility and endotoxin. A claim of third-party testing without a certificate names nothing. Ask for the COA covering the batch you receive, not a sample document.
What a certificate of analysis is
A COA is a document recording the testing performed on a specific batch: which assays were run, by which laboratory, against which specifications, and what the results were. It is batch-specific, which is the property that makes it useful.
A generic quality statement, a sample certificate for a different batch, or an assurance that testing occurs are all different things and none of them tells you about the vial you were sent.
The three tests that matter for an injectable
Potency. How much active ingredient is actually present, against the labelled amount. Under- and over-potency are both dosing problems.
Sterility. Whether the preparation is free of viable microorganisms. This is the test that exists because of the 2012 outbreak.
Endotoxin. Bacterial endotoxins can be present even where sterility testing passes, and they cause reactions independently of live organisms.
Some programmes also test pH, which affects stability and injection-site tolerance.
Questions that separate a real programme from a phrase
- Who performs the testing — the compounder, or an independent laboratory? "Third-party" should mean independent.
- Is testing performed on every batch, or periodically?
- Can I see the certificate for the batch I receive?
- What are the specifications, and what happens to a batch that fails?
- Is the laboratory accredited, and to what standard?
A provider who answers all five is running a quality programme. One who repeats "third-party tested" has not yet told you anything checkable.
What a COA cannot tell you
That the product is FDA-approved — no compounded product is, and testing does not change that. That the product is appropriate for you. Or that the preparation you hold matches the batch on the certificate, unless the batch number corresponds.
Check the batch number on your vial against the number on the certificate. If they do not match, you have a document about someone else's medicine.
| 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.
| 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
What should a COA include?
The batch number, the tests performed, the laboratory that performed them, the specifications and the results. For a sterile injectable, potency, sterility and endotoxin at minimum.
Is 'third-party tested' meaningful on its own?
No. Ask who tested, what was tested, whether it was batch-level, and for the certificate covering your batch.
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GLP-1 Tirzepatide Review. “Certificates of Analysis and Third-Party Testing.” S.J Partners LLC, 2026-07-24. https://glp1tirzepatidereview.com/pharmacies/coa-and-third-party-testing/
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.