On May 22, the Senate Health, Education, Labor and Pensions (HELP) Committee passed the Pharmaceutical Compounding Quality and Accountability Act (S. 959) by a voice vote.
This bill establishes a boundary between traditional pharmacy compounding and a new category of businesses called "compounding manufacturers," which are defined as facilities that: 1) make sterile products without a prescription and sell those products across state lines, or 2) repackage preservative free sterile products. If enacted, the bill provides that compounding manufacturers would be subject to a federal, uniform set of rules while traditional pharmacies would continue to be regulated by states. Of particular interest to anesthesiologists, the legislation specifically permits compounding manufacturers to make drugs that are in shortage.
The FDA has sought greater oversight of compounding pharmacies since the meningitis outbreak last fall. As of May 23, the CDC has reported 741 cases of fungal meningitis and 55 deaths.
The bill now awaits consideration by the full U.S. Senate. The U.S. House of Representative has not yet drafted a compounding bill, but the House Committee on Energy and Commerce’s Subcommittee on Health held a hearing covering the compounding issue.
ASA will continue to review and monitor this bill to ensure that it addresses our concerns with patient safety and anesthesiologists' ability to access the medications they need.
Read the Senate HELP Committee summary of the bill.