The United States Food and Drug Administration (FDA) has proposed a rule on “Drug Products or Categories of Drug Products that Present Demonstrable Difficulties for Compounding Under sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act”. We have put together this alert to summarize the provisions of the rule and what you need about how, if finalized, the rule could impact the drug industry.

With the rule, the FDA seeks to establish criteria for the list of drug products or categories of drug products that present demonstrable difficulties for compounding under certain sections of the federal Food, Drug, and Cosmetic Act. Additionally, the Agency is proposing to identify the first three categories of drug products on both DDC Lists. Drug products or categories of drug products that appear on the DDC Lists cannot qualify for certain statutory exemptions and therefore may not be compounded under either section 503A or section 503B, respectively.

Reed Smith will continue to follow developments on this and other issues facing compounding pharmacies and FDA regulation. If you have any questions, please reach out to the authors or to the health care lawyers at Reed Smith.