Senate draft proposal would clarify FDA authority over high-risk compounding

Compounders would be subject to greater oversight and stricter standards

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:

  • Compounded drugs would be considered new drugs that are subject to the Federal Food, Drug, and Cosmetic Act. Compounders would not be allowed to compound complex dosages or biologic products made from live organisms. They would also be prohibited from compounding variations of marketed FDA-approved drugs unless the products fulfill a specific patient need or drug shortages occur. In addition, the bill would prohibit compounding of products that are subject to certain Risk Evaluation and Mitigation Strategies unless the compounders use comparable safety controls.
  • Compounding manufacturers would be required to register with FDA, inform the agency what products they have made, and compound drugs under a pharmacist’s direct oversight. They would also have to comply with current Good Manufacturing Practices, investigate and report adverse events, and label compounded products.
  • Compounding manufacturers with more than 25 employees would pay an annual fee of $15,000 (with an inflation adjustment) to defray the cost of FDA inspections.
  • Wholesaling regulations would allow only the company that compounded products to sell them, and all drugs would be labeled “not for resale.”

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.