The manufacturing and distribution route that a drug approval actually covers. Material sold outside it is not the approved product regardless of what the label says. This is the distinction between an approved medicine and research-market material carrying the same molecule name.

A published quality standard for a substance in the United States Pharmacopeia. No monograph means there is no agreed specification for what the material should be.

A substance is nominated for the compounding bulk drug lists, and the nomination can be withdrawn before a decision is reached. Withdrawal removes it from the list without the FDA having found it safe or eligible.

The specific condition a drug is approved to treat. Approval attaches to an indication, not to a molecule in general.

The equivalent of FDA approval granted by another country’s regulator. Approval elsewhere is not approval here and does not transfer.

The submission a company makes asking the FDA to approve a drug. Filing one is not approval.

A compound approved for use in a medical test rather than as a treatment. GHRP-2 is approved in Japan on this basis, which is narrower than it sounds.

A product the FDA has reviewed and authorized for a specific use. Approval attaches to a specific product and indication, not to a molecule in general. Material sold outside the approved supply chain is not the approved product, regardless of labeling.

Not reviewed or authorized by the FDA for any use. Most compounds sold in research markets are unapproved.

In clinical trials but not approved. An investigational compound is generally available only to trial participants.