Gonadorelin

Can a doctor prescribe this?

Small pharmacy (503A)

Never put forward to FDA

Large outsourcing facility (503B)

Category 1 — under review, allowed for now

Historically FDA-approved. Widely compounded with a prescription.

Why both lines above can be true: this compound is the active ingredient of a drug the FDA has already approved, and a pharmacy may compound with a bulk substance that is “a component of a drug approved by the Secretary” — a separate route in the law from the list of substances put forward for review. So it never had to be nominated for that list. The wording is in section 503A(b)(1)(A)(i)(II) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353a). The substance must also be made by an FDA-registered establishment and come with a certificate of analysis for each lot.

503A is a pharmacy making a single prescription for one patient. 503B is a facility making batches. They are governed by separate lists. Where a category is shown, it is a position on the FDA's list of substances that have been put forward and are still being worked through — not the final list, which is set by rulemaking. Category 1 means the FDA does not plan to act against a pharmacy that makes it while the review runs.