BioCentury
ARTICLE | Politics & Policy

Proposed bill to give FDA authority over compounding pharmacies

November 3, 2012 1:08 AM UTC

On Friday, Rep. Edward Markey (D-Mass.) introduced the Verifying Authority and Legality in Drug (VALID) Compounding Act, which would give FDA authority to oversee compounding pharmacy practices. Under the bill, compounding pharmacies classified by FDA as "being more akin to drug manufacturing" would be required to register with the agency as manufacturers, instead of pharmacies, and would be subject to the same FDA inspection authority as drug manufacturers. FDA would also define requirements for safety, testing, inspection and reporting for compounding pharmacies not classified as manufacturers that want to compound drugs before receiving a valid prescription for a specific patient.

The bill would preserve state authority over "traditional" small compounding pharmacy activities, so long as the pharmacies compound drugs for a specific patient with a valid prescription using sterile drug products and the compounded drugs are not copies of commercially available drugs. The bill would mandate labeling for all compounded drugs. ...