Glossary

The vocabulary this index uses

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.
Compounded drug: A drug prepared by a pharmacy rather than manufactured under an approval. It is not FDA-approved and is not reviewed for safety, effectiveness, or manufacturing quality.
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.
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 It can be granted, refused, or withdrawn by its nominators.
Pharmacy Compounding Advisory Committee: The FDA advisory committee that reviews nominated substances and recommends whether to list them. Its votes bind nothing.
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.
Section 503B and outsourcing facilities: The provision governing outsourcing facilities, which compound at scale without patient-specific prescriptions.
The interim 503A bulks list: The FDA's interim list of bulk drug substances nominated for use in 503A compounding, sorted into categories.

Where the terms are used

The molecule index files every molecule by the postures these terms define; the reference tables render the record they describe; the evidence reviews argue from both.