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President Obama Signs Drug Compounding Bill

Compounding outsourcers will be inspected by FDA (November 27)

President Obama has 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 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 includes 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 the 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 Paul W. Abramowitz, PharmD, ScD (Hon), FASHP, CEO of the American Society of Health-System Pharmacists (ASHP). The bill also contains provisions for tracking pharmaceutical products throughout the supply chain and puts into place a single federal standard that supersedes state laws.

In testimony before both the House and Senate earlier this year, the 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.

Source: ASHP; November 27, 2013.

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