Oxiracetam

FDA determined that an oxiracetam product marketed with cognitive-function claims was a drug under 21 U.S.C. § 321(g)(1), was not a dietary supplement or conventional food for the statutory exception, and was an unapproved new drug because it was not generally recognized as safe and effective for its claimed uses. Under 21 U.S.C. §§ 331(d) and 355(a), introducing or delivering such a new drug into interstate commerce is prohibited unless an approval under § 355(b) or (j) is effective. This classification depends on the product and its intended use; it does not make possession of oxiracetam itself a federal offense.

Whether an oxiracetam product is a medicinal product under regulation 2 of the Human Medicines Regulations 2012 depends on its presentation or intended pharmacological use. Regulation 46 prohibits the sale, supply, offer for sale or supply, and possession for the purpose of sale or supply of an unauthorised medicinal product, subject to the exceptions in Part 10. Regulation 167 permits supply for an individual patient's special clinical needs only when its specified conditions are met, while commercial importation of an unlicensed medicine requires an appropriate licence and prior notification to the Medicines and Healthcare products Regulatory Agency. The agency has stated that simple possession of the cognitive-enhancement medicines it identified, including oxiracetam, was not illegal.