The Drug Quality and Security Act, passed with bipartisan support in both chambers, would boost the FDA's authority and allow compounders that mix sterile drugs without a prescription and ship across state lines to voluntarily register as outsourcing facilities. Those that do so would be regulated by the FDA rather than by state boards of pharmacy. Earlier versions of the bill would have made registration mandatory.
Traditionally, compounding pharmacies mix and prepare drugs for individual patients, some of whom have allergies or other needs. But some pharmacies morphed into manufacturers that mix and ship batches of drugs across state lines to hundreds of providers. The FDA traditionally regulates drug manufacturing. As more large-scale compounders acted like manufacturers, it became unclear whether the FDA or state agencies had authority over them.
“This bill is an important first step in assuring that compounded sterile products are prepared safely,” said Paul Abramowitz, CEO of the American Society of Health-System Pharmacists.
The legislation will reduce legal liability for hospitals, which are expected to shift their purchasing practices to the companies that register with the FDA, said Blair Childs, senior vice president of public affairs for Premier. In a Sept. 28 letter to congressional leaders, Childs said strong oversight from lawmakers will still be needed to ensure that high-risk compounders are inspected by the FDA.