Compounding: BIO Comments on Pharmacy Compounding Under Section 503A

 Dear Sir/Madam:

The Biotechnology Industry Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the “Draft Guidance for Industry on Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act.”
BIO represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial and environmental biotechnology products, thereby expanding the boundaries of science to benefit humanity by providing better healthcare, enhanced agriculture, and a cleaner and safer environment.
BIO and its member companies work closely with the FDA to ensure that the United States’ drug supply is safe, secure, and reliable, and that Americans can be confident that when they use an FDA-approved prescription drug or biologic, the medicine will be safe and effective and work as intended. FDA’s regulatory standards for drugs and biologics are among the most rigorous in the world and BIO’s members will continue to strictly comply with the requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA or the Act) that ensure the safety of prescription drugs, including Good Manufacturing Practices (cGMPs).
BIO recognizes that traditional pharmacy compounding, as specified under FFDCA Section 503A, can play a useful role in personalizing a treatment for an individual patient with a unique medical need, such as by changing the dosage or formulation, on a case-by-case basis. We are troubled, however, when compounding pharmacies expand beyond small, non-standardized batch compounding of prescription drugs and do not comply with the same rigorous standards for FDA pre-marketing approval, including rigorous cGMP standards for quality and sterility required of manufacturers by FDA, as patients may be placed at unnecessary risk. Such an approach fundamentally undermines patient safety and product quality safeguards. It also creates an unevencompetitive playing field for responsible drug manufacturers that have made enormousinvestments in compliance with FDA regulation.