21 CFR § 290.6
Spanish-language version of required warning
June 25, 2020
By direction of section 305(c) of the Federal Controlled Substances Act, §290.5, promulgated under section 503(b) of the Federal Food, Drug, and Cosmetic Act, requires the following warning on the label of certain drugs when dispensed to or for a patient: “Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.” The Spanish version of this is: “Precaucion: La ley Federal prohibe el transferir de esta droga a otra persona que no sea el paciente para quien fue recetada.”