The vocabulary.

503A and 503B

Two sections of the Federal Food, Drug, and Cosmetic Act. 503A covers traditional pharmacy compounding for an identified patient; 503B covers registered outsourcing facilities, which may compound in larger quantities and are subject to cGMP.

The two operate under different rules, and a claim about one does not transfer to the other.

See alsoCompoundingcGMP

Bacteriostatic water

Sterile water containing a small proportion of benzyl alcohol, which inhibits bacterial growth and so allows a vial to be entered more than once.

Distinct from sterile water for injection, which contains no preservative and is intended for single use.

See alsoReconstitution

Batch

also: lot

A quantity of material produced in one run, under one set of conditions, and treated as a single unit for testing and traceability.

Testing is per batch because material from a different run is different material. A supplier who publishes one certificate for a product rather than one per batch is publishing a sample, not a record.

See alsoCertificate of Analysis

Bulk drug substance

An active ingredient in its raw form, before it is made into a finished preparation.

The FDA maintains lists of bulk substances that may be used in compounding. A substance being reviewed for that list is the subject of a Pharmacy Compounding Advisory Committee session.

See alsoCompoundingPharmacy Compounding Advisory Committee

Certificate of Analysis

COA

A laboratory document reporting what was measured on a specific batch of material, by which method, on what date, and by whom.

A certificate is only evidence about the batch it names. One issued for a different lot tells you nothing about the vial in your hand, which is why the batch number on the document and on the label should match.

See alsoBatchRP-HPLCIdentity, quantity, purity, metals

cGMP

current Good Manufacturing Practice

The FDA's regulations governing how a facility manufactures, tests and documents what it produces — covering premises, equipment, records and controls rather than any particular product.

Registration of a facility is not approval of a product. A facility can be registered and cGMP-compliant while making something the FDA has never evaluated.

See alsoFDA registrationResearch Use Only

Compounding

Preparing a medication for an individual patient by combining or altering ingredients, done by a licensed pharmacy or outsourcing facility rather than by a manufacturer.

Whether a given substance may be compounded at all depends on whether it appears on a list the FDA maintains — which is what the Pharmacy Compounding Advisory Committee meets to consider.

See alsoPharmacy Compounding Advisory CommitteeBulk drug substance503A and 503B

Docket

The public file for a federal proceeding, holding the submissions and comments filed to it, each with an identifier.

A docket number lets anybody retrieve the same documents the committee saw, including written comments from the public.

See alsoPharmacy Compounding Advisory Committee

FDA registration

A facility telling the FDA it exists and what it does, which establishments are required to do. It is an administrative filing.

It is not an endorsement, an inspection result, or approval of anything made there — a distinction routinely blurred in marketing copy.

See alsocGMP

Heavy metals

Trace metallic elements that can carry over from manufacture, reported as a concentration.

Reported against a specification of <50 ppb. "ppb" is parts per billion.

See alsoIdentity, quantity, purity, metals

Identity, quantity, purity, metals

The four results ReVia's certificates report: that the material is what the label says, how much peptide is in the vial, what proportion of it is the named compound, and the heavy-metal content.

A certificate reports the tests that were run. An absent result is not a passed result — assume nothing about anything the document does not mention.

See alsoCertificate of AnalysisHeavy metals

Lyophilised

freeze-dried

Dried by freezing the material and removing the water under vacuum, leaving a solid cake or powder that is stable at ordinary temperatures far longer than a solution would be.

It is why research peptides ship as a powder in a sealed vial rather than as a liquid, and why the vial is reconstituted before use.

See alsoReconstitutionBacteriostatic water

“Pharmaceutical grade”

A marketing phrase with no fixed regulatory definition in this context.

There is no standard it corresponds to and no body that awards it. The specification on a certificate is a statement; this is not.

See alsoPurity specificationResearch Use Only

Pharmacy Compounding Advisory Committee

PCAC

An FDA advisory committee that reviews substances proposed for compounding and votes on recommendations to the agency.

Its votes are recommendations. A recommendation is not a rule, and the FDA is not bound by it.

See alsoCompoundingBulk drug substanceDocket

Purity specification

The threshold a batch must meet to pass, as distinct from the figure actually measured on it.

ReVia's specification is >98%. The measured result varies from batch to batch and is printed on that batch's certificate — a headline number on a website is a specification, not a measurement.

See alsoRP-HPLCCertificate of Analysis

Reconstitution

Returning a lyophilised powder to solution by adding a measured volume of diluent to the vial.

The volume added determines the concentration. Nothing about reconstitution changes what is in the vial — a certificate describes the powder, whatever it is later dissolved in.

See alsoLyophilisedBacteriostatic water

Research Use Only

RUO

A designation meaning a material is supplied for laboratory research and is not intended for human or veterinary use. It is not a quality grade and it is not an approval — it describes the permitted use, nothing else.

A compound sold Research Use Only has not been evaluated by the FDA for safety or efficacy in people, whatever else is true about how it was made or tested.

See alsoCertificate of AnalysisCompounding

RP-HPLC

reversed-phase high-performance liquid chromatography

A separation technique that pushes a dissolved sample through a column so its components come off at different times. With a UV detector, the size of each peak gives a proportion — which is how a purity figure is produced.

It is the method named on ReVia's certificates: RP-HPLC with UV detection. "Tested" without a named method is not something you can check.

See alsoPurity specificationCertificate of Analysis

“Third-party tested”

A phrase meaning testing was performed by a laboratory other than the seller.

On its own it commits to nothing: no laboratory named, no method stated, no batch identified, and no result. It becomes checkable only when all four are present.

See alsoCertificate of AnalysisRP-HPLC

Most of these matter when you are reading a certificate. How to evaluate a supplier puts them to work.