Senate passes compounding, track-and-trace legislation

Today the U.S. Senate passed the Drug Quality and Security Act (H.R. 3204) that, when likely signed by the president, creates “outsourcing facilities.” Pharmacies conducting large-scale compounding of sterile drugs would voluntarily register for FDA oversight. Provisions of the bill would allow FDA to conduct risk-based inspections of such facilities. After months of work with the House and the Senate, APhA wrote a letter in support of this bill, which the House passed in late September.