ASHP Statement on Draft of Drug Quality and Security Act


September 27, 2013 -- Draft legislation circulated this week by the Senate Committee on Health, Education, Labor, and Pensions and the House Energy and Commerce Committee is a first step toward clarifying the authority of the Food and Drug Administration (FDA) and state boards of pharmacy over compounding outsourcing facilities.

The bicameral, bipartisan legislation, the Drug Quality and Security Act, inserts a new section into the Federal Food, Drug, and Cosmetic Act (FD&C) that creates the category, “outsourcing facility.” Compounding outsourcers may voluntarily register with the FDA as outsourcing facilities and be subject to risk-based inspections.

“Overall, ASHP is supportive of this proposal. The addition of the outsourcing facility category will help promote the safety of products that health care providers and the public receive from compounding outsourcers,” said ASHP CEO Paul W. Abramowitz, Pharm.D., Sc.D. (Hon.), FASHP. “However, we were disappointed that the bill did not go further to require compounding outsourcing facilities to register with the FDA, and create clearer risk-based criteria to help the FDA identify outsourcers that are operating outside the scope of traditional pharmacy compounding.”

Outsourcing facilities may choose to remain classified as traditional compounding pharmacies. ASHP remains concerned that this leaves the door open for large scale compounding pharmacies to potentially behave like manufacturers without the oversight of the FDA.

State boards of pharmacy would retain authority over traditional compounding pharmacies, which include the compounding activities in hospital and health-system settings. The legislation also amends the FD&C by deleting a provision on advertising and promotion that was found to be unconstitutional and contributed to uncertainty regarding FDA’s jurisdiction over pharmacy compounding. No new requirements are imposed on compounding activities in hospital, health system, or other traditional pharmacy settings.

Provisions in the bill also set the stage for enhanced communication between the FDA and state boards of pharmacy. State boards of pharmacy will be able to share concerns about compounding practices that should be overseen by the FDA either as a manufacturer or an “outsourcing facility.” ASHP believes that potential confusion in jurisdiction between state boards of pharmacy and the FDA could persist under this new law, and that state boards may not have complete and unredacted access to FDA inspection reports of compounding operations in their state.

The bill may be considered this weekend by the House of Representatives, followed by action by the Senate. ASHP, which has been actively engaged with Congress on this issue since last fall’s meningitis outbreak caused by contaminated medications compounded at the New England Compounding Center (NECC), plans to work closely with the FDA and state boards as they implement the new law.

“Patients should be confident that the medications they receive are appropriate, safe, and effective,” said Abramowitz. “We are determined that there not be a repeat of the NECC tragedy and will work closely with all stakeholders to ensure patient safety.”