Prochlorperazine

Current DailyMed prescribing information identifies oral prochlorperazine maleate tablets as human prescription drugs, marks them ‘Rx Only’, and reports DEA Schedule: None. Under § 503(b)(1) of the Federal Food, Drug, and Cosmetic Act, covered human drugs may be dispensed only on a licensed practitioner's prescription; § 503(b)(4) requires the ‘Rx only’ symbol for drugs subject to that rule and forbids the symbol on drugs outside the rule. FDA records show that Compazine tablets containing prochlorperazine maleate were originally approved under NDA 010571 on October 23, 1956, but those original branded tablet products are now discontinued; current generic prochlorperazine maleate tablets remain available only by prescription. The prescription-dispensing classification is federal; state, district, territorial, tribal, and local rules may separately govern possession or supply.

Current AIFA Medicinali records classify authorized STEMETIL and DIFMETRE presentations containing prochlorperazine as RR, subject to a repeatable medical prescription. Under article 88 of Decreto legislativo 24 aprile 2006, n. 219, presentation of a medical prescription is the ordinary condition for sale to the public. However, article 88(2-bis), implemented by the Ministerial Decree of 31 March 2008, permits a pharmacist to supply these medicines without a prescription in narrowly specified cases of extreme necessity and urgency. An RR prescription is generally valid for six months and permits no more than ten dispensings during that period. The STEMETIL suppository and three DIFMETRE presentations are marked as in commerce, while the authorized oral STEMETIL presentation is not marked as in commerce.

The June 2026 Poisons Standard includes prochlorperazine in Schedule 3 only in divided oral preparations, in packs containing no more than 10 dosage units, for treating nausea associated with migraine. Schedule 3 is the pharmacist-only classification: professional advice is required, but the medicine should be available to the public from a pharmacist without a prescription. Prochlorperazine outside those preparation, pack-size, and indication limits is included in Schedule 4 as a prescription-only medicine. The Poisons Standard establishes the national scheduling classification, while State and Territory legislation implements scheduling controls.

UK medicine classifications attach to an authorised product and pack, not to prochlorperazine as an undifferentiated active substance. Current MHRA product information for PL 16853/0102 identifies Buccastem M as prochlorperazine maleate 3 mg buccal tablets available from pharmacists in packs of 8 (P), specifically for nausea and vomiting associated with previously diagnosed migraine in adults aged 18 years or over and for no longer than two days. Current MHRA product information for PL 16853/0101 identifies prochlorperazine 3 mg buccal tablets in packs of 30 or 50 as available only on prescription (POM). Regulation 5 of the Human Medicines Regulations 2012 defines P and POM by the terms of a product's UK marketing authorisation. Regulation 214 ordinarily requires an appropriate-practitioner prescription for the sale or supply of a POM, subject to the exemptions in Chapter 3. Regulation 220 ordinarily confines sale or supply of medicines not subject to general sale to the statutory registered-pharmacy channel under pharmacist supervision or the alternatives specified there, also subject to Chapter 3 exemptions.