APhA has announced it supports the Drug Quality and Security Act (H.R. 3204). While APhA does have some concerns with the proposed legislation, the Association believes it would protect the public from harm while maintaining access for consumers to important and often life-saving compounded preparations.
In the last year, APhA has communicated constantly with Members of Congress and their staff to help develop and craft compounding legislation.
On September 28, H.R. 3204 passed the House by voice vote. The Senate is expected to take it up in the weeks ahead. On October 22, the Association sent a letter of support addressed to Sens. Tom Harkin (D-IA) and Lamar Alexander (R-TN), Chair and Ranking Member respectively of the Senate Health, Education, Labor, & Pensions (HELP) Committee.
“We appreciate that the legislation provides a clear delineation between compounders engaged in traditional pharmacy practice from those making large volumes of compounded drugs without individual prescriptions,” APhA wrote. “Our members were concerned about being forced to register with the FDA and this legislation would allow traditional pharmacies to continue to be regulated by state boards of pharmacy while creating outsourcing facilities that would be subject to FDA oversight.”
“APhA is grateful to Congress for their focus on this challenging issue,” APhA Executive Vice President and CEO Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA, told Pharmacy Today.
“We strongly support protecting patients from harm from improperly manufactured drug products while protecting patient access to pharmacists’ compounded preparations,” Menighan added.
The Drug Quality and Security Act is the new bill that addresses both compounding and track and trace on which agreement was reached by leaders of the House Energy & Commerce Committee and Senate HELP Committee.
H.R. 3204 would clarify FDA’s authority over the compounding of human drugs and create a uniform national standard for drug supply chain security, according to the House Energy & Commerce Committee in a September 27 news release. In a September 28 news release, the Senate HELP Committee said the bill would help ensure the safety of compounded drugs and would track all prescription drugs from the manufacturer to the pharmacy.
Under the proposed legislation, compounders engaged in traditional pharmacy practice would be distinguished from those making large volumes of compounded drugs without individual prescriptions. Traditional pharmacies would continue to be primarily regulated by state boards of pharmacy. But compounders who wish to practice outside the scope of traditional pharmacy practice could register as outsourcing facilities that would be subject to FDA oversight in much the same way as traditional manufacturers, according to the Senate HELP Committee.
Related to track and trace, the bill would develop a pathway to unit-level tracing in 10 years; would strengthen licensure requirements for wholesale distributors and third-party logistics providers; and would establish nationwide drug serial numbers.
The reactions of the national pharmacy groups have varied. The International Academy of Compounding Pharmacists is opposed to the bill. Among the other groups supporting the proposed legislation are the American Society of Health-System Pharmacists, National Community Pharmacists Association, and National Association of Chain Drug Stores.