PCAC (Pharmacy Compounding Advisory Committee)
Definition
The FDA advisory committee that reviews substances nominated for the compounding bulks lists, weighing the physicochemical characterisation, safety data and historical use before recommending for or against inclusion under 503A and 503B.
What this means for research sourcing
Regulatory status varies by jurisdiction and applies to research supply, not human use. Volta sells to researchers only.
Related Terms in Regulatory
Drug Shortage Declaration
An FDA finding that a drug is in shortage, which temporarily widens what compounders may prepare. The GLP-1 SM shortage was declared resolved in February 2025 and GLP-2 TZ in October 2024, which closed that allowance for both.
Class II Recall
The FDA recall class for a product whose use may cause temporary or medically reversible harm, with a remote probability of serious consequences. Every peptide-related recall to date has fallen in this class.
FDA Warning Letter
A published notice telling a company the agency believes it has broken the law, and requiring a written response. Warning letters are public and searchable, which makes them usable primary evidence about a supplier rather than hearsay.
USP (United States Pharmacopeia)
The non-governmental body that publishes public quality standards, called monographs, for drug substances and preparations. US law makes compliance with an applicable monograph a condition of several compounding pathways, and USP <797> covers sterile compounding.
Grey Market
Supply that is legal somewhere but moves outside the channel a regulated medicine would travel through. The practical consequence is that chain of custody, storage history and identity cannot be verified by the buyer.
EMA (European Medicines Agency)
The European Union agency that evaluates medicines for the EU market. Its scientific opinions lead to authorisations granted by the European Commission, so approval status in Europe can differ from the FDA's for the same molecule.
Health Canada
The federal department that authorises therapeutic products for the Canadian market and issues a Drug Identification Number to each one. Research-use material is not a therapeutic product and carries no DIN, which is the distinction that governs how peptides may be supplied in Canada.
MHRA (Medicines and Healthcare products Regulatory Agency)
The United Kingdom regulator for medicines and medical devices. It classifies most therapeutic peptides as prescription-only medicines, a category that governs supply rather than possession.
