Compounding act becomes law with APhA support

Last week, President Obama signed the Drug Quality and Security Act into law, providing FDA with the authority and responsibility to regulate “outsourcing facilities,” compounders that make large volumes of compounded drugs without individual prescriptions. The American Pharmacists Association (APhA) supported and helped with the drafting of the legislation.

“Throughout the process we supported protecting patients from harm by improperly manufactured drug products while ensuring patient access to needed and properly prepared compounded medications,” said Thomas E. Meninghan, BSPharm, MBA, APhA’s executive vice president, in a press statement.

The legislation distinguishes between compounders who are engaged in traditional pharmacy practice and compounders who practice outside the scope of traditional practice. The latter group can voluntarily register with FDA as an outsourcing facility and is subjected to similar FDA oversight as traditional manufacturers. Traditional pharmacies will still be overseen by State Boards of Pharmacy.

“We appreciated 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 said.

The act also helps to secure the drug supply chain with the creation of a track-and-trace pathway, which tracks drugs from the manufacturer to the pharmacy. It includes stronger licensure requirements for drug wholesalers and third-party logistics, APhA said.