Peptide Regulation and Lab Testing Glossary

503A pharmacy: A state-licensed pharmacy that compounds drugs for identified individual patients on prescriptions, under section 503A of the FD&C Act. More →
503B outsourcing facility: An FDA-registered facility that may compound drugs in bulk without patient-specific prescriptions. It must follow current good manufacturing practice (CGMP). More →
Bulk drug substance: An active ingredient used to compound a drug. Whether a compounder may use one depends on FDA lists and categories.
Category 1 / 2 / 3: FDA's interim categories for nominated bulk substances. Category 2 means FDA identified significant safety risks, and the agency's interim policy does not extend to compounding with those substances. More →
Certificate of analysis (COA): A lab report describing tests run on a specific sample. More →
Chromatogram: The detector trace from a chromatography run: peaks plotted over time. More →
Counter-ion: An ion (often acetate or trifluoroacetate) paired with a peptide in its solid salt form. It adds weight but is not peptide. More →
Endotoxin: Lipopolysaccharide from Gram-negative bacteria. It causes fever and inflammation if injected, and survives sterilization. Measured in EU. More →
FD&C Act: The Federal Food, Drug, and Cosmetic Act, the main U.S. law governing drugs. It defines a drug by intended use and requires approval before a new drug enters interstate commerce. More →
HPLC: High-performance liquid chromatography. It separates the components of a sample and is the usual basis for peptide purity figures. More →
Intended use: How FDA judges what a product is for. It is shown by labeling, advertising and the circumstances of sale (21 CFR 201.128). More →
LAL: Limulus amebocyte lysate, a reagent from horseshoe crab blood used to detect endotoxin. More →
LC-MS: Liquid chromatography coupled with mass spectrometry. Used to confirm identity by molecular mass. More →
Lot / batch: One production run of a product. A COA is evidence only about the lot it names. More →
Net peptide content: The share of a powder's weight that is peptide, after water, salts and counter-ions. More →
PCAC: FDA's Pharmacy Compounding Advisory Committee, which advises on bulk substances for compounding. More →
Research use only (RUO): A labeling statement from FDA's in-vitro diagnostic rules (21 CFR 809.10(c)). It does not by itself make a product legal to sell for human use. More →
Sterility test: A test for viable microorganisms. A pass applies to the units tested. More →
Unapproved new drug: A drug introduced into interstate commerce without FDA approval, prohibited by FD&C Act section 505(a). More →
Warning letter: A formal FDA notice of significant violations. It asks for a response within 15 working days, and FDA publishes them. More →
WADA S0 / S2: World Anti-Doping Agency prohibited-list classes: S0 covers non-approved substances, S2 covers peptide hormones, growth factors and related substances. More →