Testifying before a congressional committee weighing options to strengthen oversight of compounding pharmacies, National Association of Boards of Pharmacy Executive Director Carmen Catizone supported legislation proposed in the U.S. Senate.
The Committee on Energy and Commerce, Subcommittee on Health is considering several bills, including legislation sponsored by Sen. Tom Harkin (D-Iowa) and legislation sponsored by Rep. Morgan Griffith (R-Va.). Congress is considering tightening oversight of compounding pharmacies following last year’s meningitis outbreak in which contaminated injectable steroids from the New England Compounding Center killed 61 people and sickened hundreds more.
Catizone, MS, RPh, DPh, praised the “Pharmaceutical Compounding Quality and Accountability Act” proposed by Sen. Harkin. He testified that the legislation “addresses the critical concerns identified by the states and validated by NABP through its inspections of compounding pharmacies.”
In his testimony, Catizone said the Senate legislation would ensure that traditional pharmacy compounding “remains the responsibility of the state boards of pharmacy and manufacturing remains the responsibility of [FDA]. NABP supports the establishment of the new category of compounding manufacturing regulated by FDA, and supports the clear distinction between this new category and traditional pharmacy compounding.”
Catizone cautioned that provisions in some of the proposals “could unwittingly create an opportunity for manufacturing to occur under the guise of compounding and even more disconcerting, cause the recognition of such activity as permissible under federal law.”
