Business Talk

FDA publishes guidance on its drug importation final rule

This week the FDA issued final guidance on the importation of prescription drugs final rule to help small entities better under the regulatory requirements. The guidance is intended to serve as a companion guide and streamline some of the key information in the final rule.

Under 21 USC 384, also known as Section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act), HHS has the authority to issue regulations allowing wholesale drug importation.  Fill out the form to read the full article.