New Senate draft legislation introduced April 26 would give FDA greater authority over compounding pharmacies and distinguish clearly between traditional compounding pharmacies and compounding manufacturers.
Drafted by a bipartisan group from the Senate Health, Education, Labor, & Pensions (HELP) Committee led by Chair Tom Harkin (D-IA), Ranking Member Lamar Alexander (R-TN), Pat Roberts (R-KS), and Al Franken (D-MN), the draft legislation “clarifies a national, uniform set of rules for compounding manufacturers while preserving the states’ primary role in traditional pharmacy regulation,” according to a statement from the committee.
The draft legislation defines compounding manufacturers as entities that compound sterile drugs without patient-specific prescriptions and sell the drugs across state lines, whereas traditional pharmacies compound drugs based on specific prescriptions for individual patients. In addition, “any entity that pools sterile products or repackages sterile, single-use, preservative-free vials” is a compounding manufacturer, the draft proposal states, and cannot be licensed as a pharmacy.
Following are highlights of the draft proposal:
Although state boards of pharmacy would continue to license and regulate traditional compounding pharmacies, the bill would increase communication between states and FDA and encourage communication among states, according to a summary of the draft proposal. For example, if FDA received a complaint from a state regulatory agency about a traditional pharmacy or product, FDA would inform the state pharmacy board.
“By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak,” Harkin said in the committee’s statement. The HELP Committee is soliciting feedback from stakeholders on the draft legislation’s merits and potential unintended consequences, as well as how to improve the draft proposal.