| FDA | CDER | Small Business and Industry Assistance INDUSTRY NEWS | | Small Entity Compliance Guide on Final Rule on Importation of Prescription Drugs from Canada Today, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription drugs from Canada. On October 1, 2020, the Secretary of Health and Human Services issued the final rule to implement section 804(b) through (h) of the Federal Food, Drug, and Cosmetic Act to allow importation of certain prescription drugs from Canada. The final rule became effective November 30, 2020. The guidance issued today does not include any new policy. It clarifies in plain language the legal requirements in the final rule. | | The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry. | | | |
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