On September 12, Reps. Morgan Griffith (R-VA), Gene Greene (D-TX), and Diana DeGette (D-CO) introduced a compounding bill that is intended to clarify FDA authority over compounding in the wake of the ongoing fungal meningitis tragedy. Named the Compounding Clarity Act (H.R. 3089), the long-awaited, bipartisan bill is expected to pass the Republican-controlled House.
“We are in the process of reviewing the legislation,” APhA Senior Lobbyist Michael Spira told pharmacist.com. “I have been told that the House will more than likely pass the bill before the end of the month. The two chambers [the House and the Senate] are still working towards a bipartisan, bicameral solution. We have met and continue to work with both House and Senate staff throughout the process.”
Griffith’s 34-page proposed legislation would keep traditional pharmacies under the jurisdiction of state boards of pharmacy and exempt from FDA’s manufacturing authority, according to a news release from Griffith’s office.
All compounding would have to be done with a patient-specific prescription but there could be anticipatory compounding with a preexisting relationship with a patient or physician. The legislation would establish an enforceable safety standard for all compounded drugs. It would maintain the practice of office use, but require a prescription or patient name to be reconciled back to the pharmacy within 7 days, and there would be a volume limitation.
The proposed legislation would require implementation of a notification system among the state boards of pharmacy and FDA. It would also clarify FDA authority over large-scale compounding facilities—these would be compounding entities that exceed volume limitations—and make them subject to annual registration, reporting and listing of the drugs they compound, labeling, adverse event reporting, inspections, and user fees.
The House Energy & Commerce Subcommittee on Health had held a key compounding hearing on July 16 that compared Griffith’s discussion draft (an early version of the bill before it was introduced) with the Senate Health, Education, Labor, & Pensions Committee bill (S. 959), and a bill introduced by former House Democrat Sen. Ed Markey (D-MA) (H.R. 2186).