Compounded drugs safety bill signed into law

President Barack Obama signed into law legislation geared toward improving the overall safety of compounded drug products.

Under the Drug Quality and Security Act (H.R. 3204), federal agencies could track drugs that compounding pharmacies are making; receive reports about problems with the compounded drugs; and conduct safety inspections. The law also allows compounding pharmacies to register as outsourcing facilities and be subject to FDA oversight.

The legislation had 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.

“The new law is not perfect and will likely need to be enhanced in the future, but it nonetheless represents an important step in assuring the safety of products prepared and sold by compounding outsourcing facilities,” said American Society CEO Paul W. Abramowitz, PharmD, in a statement.