November 27, 2013
-- President Obama today signed legislation designed to improve the safety of compounded drug products. H.R. 3204, the Drug Quality and Security Act
, clarifies federal oversight for the practice of compounding by reaffirming current law under Section 503A
of the Food, Drug and Cosmetic Act (FD&C) and by creating a new section, 503B, that establishes a voluntary means for compounding outsourcers to register with and be inspected by the Food and Drug Administration (FDA).
H.R. 3204 inserts a new section into the FD&C that creates the category, “outsourcing facility.” Outsourcing facilities may voluntarily register with the FDA and be subject to risk-based inspections. In addition, state boards of pharmacy would retain authority over traditional compounding, which include compounding activities in hospital and health-system settings. No new requirements are imposed on hospitals, health systems, or other traditional pharmacy compounding settings. Further, the bill would require enhanced communication between FDA and state boards to identify compounding practices that may be operating beyond the scope of traditional pharmacy compounding.
“The new law is not perfect and will likely need to be enhanced in the future, but it nonetheless represents an important step in assuring the safety of products prepared and sold by compounding outsourcing facilities,” said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. The bill also contains provisions for tracking pharmaceutical products throughout the supply chain and puts into place a single federal standard which supersedes state laws.
In testimony before both the House and Senate earlier this year, ASHP advocated for a third category of registration with the FDA for large-scale compounding entities that operate more like a drug manufacturer than a traditional compounding pharmacy. “We believe the new category, along with the enhanced communication between state boards and FDA, will help improve the safety of products that health care providers and the public receive from compounding outsourcers that register with the FDA, however, practitioners and patients will still need to remain vigilant as the new law does not remove all risk from the system,” said Abramowitz. “In addition, ASHP remains committed to working with FDA and state boards to ensure a safe marketplace for sterile compounded medications.”