Compounded drugs safety bill awaits president’s signature
The Senate unanimously endorsed a bipartisan bill, the Drug Quality and Security Act (H.R. 3204), which would create an electronic system to track compounded prescription drugs through the distribution chain and impose additional regulations on compounding pharmacies.
The bill, which was passed by the House of Representatives in September, is one stop short of becoming law as it awaits President Barack Obama’s endorsement. The president is expected to sign off on the bill, according to Politico.
Under the legislation, federal agencies could track drugs that compounding pharmacies are making; receive reports about problems with the compounded drugs; and conduct safety inspections. The bill also allows compounding pharmacies to register as outsourcing facilities and be subject to FDA oversight.
“This bipartisan bill represents a monumental step forward for drug safety and is a testament to what Congress can achieve when Democrats and Republicans work together,” Sen. Tom Harkin (D-Iowa) said in a statement. “Americans must have the confidence that their drugs—whether obtained at a hospital, at a doctor’s office or at the pharmacy counter—are safe, and that is exactly what this bill does.”
The legislation has received wide support from a variety of stakeholders, including the American Society of Health-System Pharmacists, the Pew Charitable Trusts, the U.S. Chamber of Commerce, the National Community Pharmacists Association, the Federation of American Hospitals, Premier Healthcare Alliance, the American Medical Student Association and the American Public Health Association, among others.
“We believe this bill helps clarify federal oversight of compounding outsourcing facilities, and seeks to create better communication channels between the FDA and state boards of pharmacy,” American Society of Health-System Pharmacists Vice President of Policy, Planning and Communications Kasey K. Thompson, PharmD, MS said in a statement.
However, the International Academy of Compounding Pharmacists adamantly opposes the bill.
“This bill, in its failure to recognize the very real problems in the draft legislation that we have identified over many meetings, will without question result in patients’ inability to obtain access to needed medications,” David Miller, RPh, the academy’s chief executive, said in an e-mailed statement to Bloomberg Businessweek. “Although states have long had sufficient authority to regulate compounding, the bill grants the FDA sweeping, unprecedented authority in determining what pharmacies can compound.”