Pramiracetam

Under the Federal Food, Drug, and Cosmetic Act, a pramiracetam product intended for drug use is a new drug unless it is generally recognized as safe and effective for the conditions stated in its labeling. FDA identified a product marketed as Pramiracetam and, based on its cognitive-function claims, classified it as a new drug that did not qualify for the statutory exception for dietary supplements or conventional foods. Introduction or delivery of that drug product into interstate commerce is unlawful without an effective FDA approval. The restriction depends on the product's formulation, labeling, claims, and intended use; it does not make bare possession of the chemical a federal offense and does not determine state, district, territorial, tribal, or local law.

In the United Kingdom, a pramiracetam product that is a medicinal product is an unauthorised medicinal product under the Human Medicines Regulations 2012 only if none of the four routes listed in regulation 46(6) is in force for it in the country where it is intended to be sold or supplied, or offered for sale or supply: a UK marketing authorisation, a certificate of registration, a traditional herbal registration, or an Article 126a authorisation. No such authorisation or registration is in force for pramiracetam, Pramistar, or Neupramir. Regulation 46 prohibits selling, supplying, or offering to sell or supply an unauthorised medicinal product and prohibits possession only where the person knows or has reasonable cause to believe that it is intended for sale or supply to another person in the United Kingdom or the European Economic Area. Those prohibitions are subject to Part 10: regulation 167 disapplies them for a special medicinal product supplied in response to an unsolicited order, manufactured and assembled to an eligible prescriber's specification for a patient whose treatment that prescriber directly oversees in order to meet that patient's special needs, provided the regulation's other conditions are met. Medicinal products are exempt from the Psychoactive Substances Act 2016; whether a non-medicinal pramiracetam preparation falls within that Act depends on the statutory psychoactivity and intent requirements.