Senators introduce revised draft compounding bill


New version includes clarifications submitted by ASHP and other stakeholders

Senators from the Health, Education, Labor and Pensions (HELP) Committee have introduced a revised version of its draft compounding bill to help improve the safety of compounded human and animal drugs, following feedback earlier this month from stakeholders, including the American Society of Health-System Pharmacists (ASHP).

On May 15, Senators Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Pat Roberts (R-Kan.), and Al Franken (D-Minn.), all members of the HELP Committee, introduced the new legislation, S. 959, “Pharmaceutical Compounding Quality and Accountability Act,” which clarifies the oversight responsibilities of state and federal authorities for compounding pharmaceuticals. The bill will be reviewed by the Senate HELP Committee on Wednesday, May 22, according to a press statement.

The compounding bill clearly distinguishes between traditional compounding, which will continue to be regulated by state boards of pharmacy, and compounding manufacturers, which will be regulated by the FDA. The bill defines a compounding manufacturer as “an entity that compounds a sterile drug prior to or without receiving a prescription and introduces such drug into interstate commerce, with the exception that pharmacies within health systems will not be considered a compounding manufacturer and will remain regulated as traditional pharmacies.”

ASHP provided its assistance to the Senate HELP Committee in developing the legislation. Kasey K. Thompson, PharmD, MS, of ASHP, offered testimony that supported an exemption for health systems from the “compounding manufacturers’ designation.” In an ASHP news report, he explained that “the exemption is appropriate because in hospitals and health systems, medications, compounded or otherwise, are administered to patients with patient-specific medication orders.” He also noted that hospitals are not in the retail business of selling compounded products.

For more information, go to the Senate HELP Committee’s website.

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