NABP Delivers Testimony at House Subcommittee Hearing on Reforming Compounding Regulations

A United States House of Representatives subcommittee held a hearing (PDF) July 16, 2013, to examine various bills aimed to implement new frameworks for the regulation of compounding. The Committee on Energy and Commerce, Subcommittee on Health, convened to hear expert testimony from US Food and Drug Administration (FDA) and other experts in health care and pharmacy regulation. Experts were called to provide comments on the following bills:

• “Pharmaceutical Compounding Quality and Accountability Act” (S 959, sponsored by Senator Tom Harkin);
• “The Compounding Clarity Act” authored by Representative Morgan Griffith); and
• “Verifying Authority and Legality in Drug Compounding Act of 2013” (HR 2186, sponsored by Representative Ed Markey).

On behalf of the state boards of pharmacy, National Association of Boards of Pharmacy^®(NABP^®) staff presented testimony (PDF) reaffirming the Association’s support of the bill (S 959) authored by the Senate Committee on Health, Education, Labor, and Pensions. In the testimony, NABP stressed the importance of the Senate bill’s clear distinction between traditional pharmacy compounding, which would remain under the oversight of state boards of pharmacy, manufacturing, and a third category, “compounding manufacturer,” to be regulated by FDA. Regarding the House bills, NABP expressed that the proposed laws “provide mechanisms for moving forward on some of the more difficult challenges of this entire issue,” but cautioned that some provisions in the bills “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.” NABP offered for consideration several limitations and qualifiers for traditional compounders allowed to produce non-patient-specific drugs under provisions in these bills. Along with these considerations, NABP indicated that legislation “specifying that a compounding manufacturer cannot be licensed as a pharmacy must remain because it is essential to distinguishing between state-regulated compounding and FDA-regulated manufacturing.” More information on the hearing, “Reforming the Drug Compounding Regulatory Framework” and links to other testimony documents are available on the House subcommittee’s Web site.