Packaging / cGMPs / QRM Process

House Passes Drug Quality and Security Act

Source: pharmamanufacturing,com

Sep 30, 2013

On Saturday, the U.S. House of Representatives passed a bill that promises to give the FDA more authority to regulate companies that compound sterile drugs and ship them across state lines. The legislation would also create a national set of standards to track pharmaceuticals through the distribution chain. Drugs will be labeled and tracked at the lot level (not the unit, or individual package, level) beginning in January 2015.

Some industry groups, inlcuding the International Academy of Compounding Pharmacists, have concerns about the new legislation. Read about them here.

The bill now moves to the Senate, where supporters anticipate approval. Read more.