Peptide America / Glossary Glossary
The vocabulary this index uses PA By Peptide America
Almost every question on this site turns on a handful of terms of art that a general reader has never met: a section of the Food, Drug, and Cosmetic Act, a list with categories, a nomination, an advisory vote, a labeling posture. A reference index that assumes them is a reference index its own audience cannot read.
Each entry below states where in this site the definition is drawn from, so a reader can see the term used in the record rather than only defined in the abstract. No entry introduces a fact that the pages it cites do not already carry.
Category 1 Substances under FDA review without identified safety concerns; pharmacies may compound them while review continues. Category 2 Substances with identified safety concerns; placement bars pharmacy compounding, and removal from it authorizes nothing. Category 3 Substances whose nomination to the 503A bulks list did not contain enough for the FDA to evaluate. Compounded drug A drug prepared by a pharmacy rather than manufactured under an approval. FDA does not approve it or review it for safety, effectiveness, or quality. Dietary supplement A separate regulatory regime with no pre-market approval requirement and a much lower evidentiary threshold. Documented clinical need The standard a prescriber must meet to compound a copy of an approved drug. The FDA has rejected price as satisfying it. Essentially a copy A compounded preparation duplicating a commercially available approved drug, which section 503A restricts. Final rule The FDA action that would actually change a substance's compounding status. Until one issues, an advisory recommendation changes nothing. Nomination A request that the FDA place a bulk substance on the 503A list. It can be granted, refused, or withdrawn by its nominators. Provocation test A study that administers a substance to measure a hormonal response, not to treat anything. Research-use-only A labeling posture that places material outside drug regulation. It is not a safety statement and it does not make sale for human use lawful. Secretagogue A compound that stimulates the body's own release of a hormone rather than supplying the hormone itself. Section 503A The provision under which a licensed pharmacy compounds a drug for an individual patient with a valid prescription. The interim 503A bulks list The FDA's interim list of bulk drug substances nominated for use in 503A compounding, sorted into categories. The Prohibited List The World Anti-Doping Agency's annual list of substances and methods prohibited in sport.