Start with the prescription label
A prescribed medication should have the patient name, medication name, concentration, route, directions, pharmacy, prescriber, lot or tracking information, beyond-use date, and storage instructions. If the label does not match what your provider told you, pause and ask.
What a COA can show
A certificate of analysis may document identity, purity, assay, impurities, or other test results for a specific batch. FDA says bulk drug substances used in 503A compounding must be accompanied by a valid COA and manufactured by an FDA-registered establishment under section 510.
A COA proves what's in the vial. It cannot prove that you should be using it.
What a COA cannot prove
A COA does not prove that a finished vial was sterile, stored correctly, shipped correctly, prescribed appropriately, or safe for you personally. It also does not replace clinical review. A COA tied to one batch does not automatically validate every vial a vendor sells.
Red flags
- No batch or lot connection between the COA and the vial.
- Illegible reports or missing test dates.
- COAs hosted only as screenshots.
- No pharmacy or prescriber information for a product being used as medication.
- Labels with vague directions such as "use as needed" for an injectable.
How Boswell thinks about documentation
Documentation should support a medical workflow: eligibility, prescription, pharmacy fulfillment, instructions, monitoring, and follow-up. If the paperwork is being used to bypass that workflow, it is doing the wrong job.
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