Progesterone

Current FDA-approved 100 mg and 200 mg oral progesterone capsules are human prescription drugs labeled "Rx only" under ANDA 211285 and the current DailyMed Structured Product Label; the label reports no DEA schedule. Under § 503(b) of the Federal Food, Drug, and Cosmetic Act, a human drug limited by its approved application to professional supervision may be dispensed only by prescription, and its label must bear "Rx only." Under 21 C.F.R. § 310.530, a topically applied progesterone-containing drug product marketed for over-the-counter use requires an approved new drug application or abbreviated new drug application; progesterone records categorized as human OTC drugs in the FDA NDC Directory carry unapproved marketing categories, and NDC listing does not establish approval. The federal classification applies only to FDA-regulated human drug products; bulk ingredient supply, pharmacy compounding, veterinary products, non-drug cosmetic uses, and state, district, territorial, tribal, and local rules fall outside that classification.

In Canada, progesterone is included within the class "Sex hormones (Natural or synthetic)" on the federal Prescription Drug List for human use and is therefore a prescription drug; the class listing took effect on 12 August 2015, and none of its enumerated exceptions covers progesterone. Under the Food and Drug Regulations, it may be sold only by a person entitled under provincial law to dispense prescription drugs and under a received verbal or written prescription, subject to the section C.01.043 exception. Health Canada's current Drug Product Database identifies marketed single-ingredient capsules sold as PROGESTERONE and PROMETRIUM, and BIJUVA capsules containing progesterone and estradiol, with the schedule PRESCRIPTION. These federal provisions regulate sale and dispensing rather than establishing a general offence for ordinary possession; provincial law determines who is entitled to dispense prescription drugs.