After months of negotiation, the U.S. Senate just approved H.R. 3204, the Drug Quality and Security Act, which is designed to improve the safety of compounded drug products. The bill 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 provides Food and Drug Administration (FDA) oversight of large compounding entities known as “outsourcing facilities.”
“Although it is a scaled-back version of earlier legislation, this bill is an important first step in assuring that compounded sterile products are prepared safely,” 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. The House passed the bill in September and President Obama is expected to sign the bill into law.
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.
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. “While ASHP is somewhat disappointed that the final agreement makes this category voluntary rather than mandatory, 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,” said Abramowitz. “In addition, ASHP remains committed to work with FDA and state boards to ensure a safe marketplace for sterile compounded medications.”
ASHP is the national professional organization whose 40,000 members include pharmacists, pharmacy technicians, and student pharmacists who provide patient care services in hospitals, health systems, and ambulatory clinics. For 70 years, the Society has been on the forefront of efforts to improve medication use and enhance patient safety. For more information about the wide array of ASHP activities and the many ways in which pharmacists help people make the best use of medicines, visit ASHP's website, www.ashp.org, or its consumer website, www.safemedication.com.