Piracetam

Piracetam products marketed with claims that make them drugs are unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. Such products may not be introduced or delivered for introduction into interstate commerce unless an FDA drug application is effective. Piracetam is not named in the current federal controlled-substance schedules; the Controlled Substance Analogue Enforcement Act applies only to substances meeting its statutory similarity-and-effect criteria, rather than creating a blanket control of racetams.

India prohibits the fixed-dose combination of piracetam, Ginkgo biloba extracts and vinpocetine for manufacture for sale, distribution and human use. This notification regulates that named combination rather than classifying piracetam alone as a narcotic or psychotropic substance.

NAFDAC directs discontinuation of the fixed-dose combination betahistine, Ginkgo biloba extract, vinpocetine and piracetam. The directive concerns that named combination and does not classify piracetam alone as a controlled drug.

As of May 1, 2007, piracetam was placed in Schedule 4, requiring a prescription for both purchase and importation for personal use.¹¹ Prior to this date, it could be imported legally for personal use amounts up to a three-month supply.

Reportedly does not require a prescription to legally purchase and possess.

Covered piracetam preparations are prescription-only. NMPA's current OTC-conversion service states that NMPA selects, approves, publishes and adjusts the OTC catalogue; the official NMPA piracetam notice does not announce an OTC conversion and directs patients using prescription drugs to follow medical instructions. The current 2024 national insurance list records piracetam as a reimbursable medicine in injection and oral immediate-release forms (乙类 is an insurance-payment class, not an OTC designation). The 2025 medicinal narcotic and psychotropic directories took effect on 21 July 2025 and contain no 吡拉西坦/Piracetam entry; therefore piracetam is not a scheduled narcotic or psychotropic drug, but that does not make it OTC. A licensed pharmacy may dispense prescription medicines under the prescription-review rules; ordinary consumers may not legally purchase piracetam without a prescription. Online sale to individuals requires a real, reliable prescription and real-name sale, prescription review/dispensing and duplicate-use controls. Violating those online requirements attracts correction plus RMB 30,000-50,000, or RMB 50,000-100,000 when serious (Order 58 art. 34); violating online prescription warnings/separation or providing purchase services before prescription review attracts correction and, if not corrected, RMB 50,000-100,000 (art. 36). Separately, a drug business that fails applicable GSP requirements can face Drug Administration Law art. 126: warning and correction, then RMB 100,000-500,000; serious cases RMB 500,000-2,000,000, suspension/rectification up to licence cancellation and responsible-person sanctions. These are conditional regulatory penalties for specified violations, not a claim that every reported over-the-counter sale automatically incurs a particular fine.

Listed as a medicine under the Medicines Act (Lääkelait). While not controlled as an illegal drug, importation without proper approval is prohibited.³⁶

Not a controlled substance but classified as Ordonnance-Liste II, requiring a prescription for legal purchase. Not available over the counter.

Regulated as a prescription medication according to Anlage 1 AMVV (Arzneimittelverschreibungsverordnung).³⁸

Piracetam and its salts are listed in Division A of Schedule 3 to the Pharmacy and Poisons Regulations (Cap. 138A), which requires retail sale on and in accordance with a prescription from a registered medical practitioner, dentist or veterinary surgeon. The substance is also a Part 1 poison in the Poisons List in Schedule 10; the current Drug Office product register classifies piracetam products as Part 1, Schedule 1 and Schedule 3 poisons and as prescription-only medicines. The express piracetam-and-salts listings have applied since 18 October 2020.

Requires a prescription for legal purchase.

Requires a prescription for legal purchase.

Considered a prescription drug and will be seized by the Ministry of Health if imported without documentation from a physician.⁴⁹⁴⁸

Prescription medication primarily indicated for cortical myoclonus (sudden muscle convulsions).

Available as a prescription drug under brand names including Nootropil and Memotropil.

Russian law treats registered piracetam products as prescription medicines. Piracetam is PubChem CID 4843, has the molecular formula C6H10N2O2 and the IUPAC name 2-(2-oxopyrrolidin-1-yl)acetamide, and is registered in Russia as a medicinal product under the MNN пирацетам. The Ministry's current GRLS price-register pages list active (Д) piracetam products and formulations, including Piracetam Renewal tablets (200/400/800/1200 mg), Piracetam capsules, and multiple 200 mg/ml IV or IV/IM solutions, with registrations and price decisions dated in 2025. The manufacturer's official product record for Piracetam Renewal, registration number RU ЛП-№(002999)-(РГ-RU), identifies it as a nootropic and states По рецепту врача. Under the current Order 100n, prescription dispensing is governed by the pharmacy rules effective 1 September 2025. Roszdravnadzor states that dispensing prescription medicines without a prescription is a gross breach of pharmaceutical-licensing requirements under Government Decree 547 and is subject to Article 14.1(4) КоАП РФ. Article 14.1(4)'s current text provides, for a gross licensing breach, a 4,000–8,000-ruble fine or up to 90 days' suspension for an unincorporated business, 5,000–10,000 rubles for an official, and 100,000–200,000 rubles or up to 90 days' suspension for a legal entity. These are pharmacy/licensing consequences, not a special controlled-substance possession penalty. Because the current Decree 681 text contains no occurrence of piracetam, ordinary piracetam is not a scheduled narcotic or psychotropic substance; the prescription requirement arises from medicinal-product registration and dispensing designation, not from Decree 681.

Requires a prescription for legal purchase.

Requires a prescription for legal purchase.

Läkemedelsverket classifies Nootropil 1200 mg, containing piracetam, as a prescription medicine. The Swedish record lists an approved parallel-import product that is sold.

Listed as a Category B pharmaceutical, which mandates a prescription for dispensing.⁷¹

Prescription-only drug primarily indicated for myoclonus of cortical origin.⁸ While a prescription is required for purchase, there is no penalty for personal possession or importation. Also used off-label for learning difficulties, memory loss, and sickle-cell vaso-occlusive crises.

INVIMA's 2025 official list records PIRACETAM 800 MG under sanitary registration INVIMA 2023M-05068-R5 with status Vigente. The list identifies Tecnoquímicas S.A. as the registration holder.

Piracetam is not listed as a substance subject to Brazil’s special-control regime in Anexo I to Portaria SVS/MS nº 344/1998. That annex confines special controls to the named substances in Lists A1–F4 and to the specifically defined synthetic-cannabinoid, synthetic-cathinone, and phenethylamine structural classes in List F2; piracetam is not within those entries or classes. Accordingly, the Portaria’s special-control restrictions and prohibited-use lists do not apply to piracetam.

Health Canada has not issued a Drug Identification Number (DIN) for piracetam, meaning it cannot be legally sold within the country.¹⁶ Acquisition is limited to international mail order.

The official SÚKL record identifies PIRACETAM as the active substance, gives registration 06/049/02-C, a valid marketing authorisation, oral film-coated 1200 mg tablets, and OTC dispensing; active packs 0268791 (60), 0268792 (120), and 0268793 (30) are listed, with the 60- and 120-tablet packs marked as supplied. SÚKL's database update endpoint reports medicinal-product data updated 27 August 2026. The complete current e-Sbírka text of Regulation 463/2013 (current from 25 June 2026) contains the Czech narcotic and psychotropic schedules and no occurrence of ‘piracetam’; no salt, isomer, analogue, or generic structural rule in that instrument independently brings piracetam into a schedule. Criminal Code § 283 penalizes unauthorized handling of narcotic or psychotropic substances, preparations containing them, precursors, or poisons (basic range one to five years), but piracetam's unscheduled status means that controlled-drug penalties do not attach merely to ordinary possession or sale of piracetam. This is not a statement that unauthorized manufacture/marketing of a medicinal product or other conduct cannot engage separate medicines or general criminal rules.

Widely available at drug stores without requiring a prescription.