Importation of Prescription Drugs Final Rule Questions and Answers; Guidance for Industry: Small Entity Compliance Guide; Availability

Resumen

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Importation of Prescription Drugs Final Rule Questions and Answers." The guidance is intended to help small entities comply with the final rule entitled "Importation of Prescription Drugs." The final rule was issued to implement a provision of the Federal Food, Drug, and Cosmetic Act (FD&C Act) to allow importation of certain prescription drugs from Canada.