HHS Issues Guidance on Importation of Prescription Drugs for Small Entities; Comments Requested

The U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the availability of a final guidance for the 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 the importation of certain prescription drugs from Canada.

The guidance represents the FDA's current thinking on the Importation of Prescription Drugs Final Rule Questions and Answers. It does not establish any rights for any person and is not binding on FDA or the public. An alternative approach can be used if it satisfies the requirements of the applicable statutes and regulations.