Thursday, June 6, 2013
Updated House Bill Would Require FDA to Regulate Pharmacies Involved in High-Risk Compounding and Interstate Commerce June 5, 2013 5:20 pm
United States Representative Edward Markey (D-MA) filed an updated version (PDF) of the Verifying Authority and Legality in Drug (VALID)
Compounding Act of 2013 on May, 23, 2013. The bill would give FDA sole authority over compounding pharmacies that ship products across state lines and engage in high-risk sterile compounding. States would retain authority over small traditional compounding pharmacies dispensing patient-specific drugs pursuant to an individual prescription. The bill also includes provisions to allow compounding pharmacies to prepare non-patient-specific drug products under certain circumstances. In addition, FDA would be required to share information on inspected compounding pharmacies with the relevant state agencies. Markey first introduced the VALID Act in November 2012.