H.R. 2186, the "Verifying Authority and Legality In Drug (VALID) Compounding Act of 2013’’

Rep. Ed Markey (D-MA) introduced H.R. 2186 on May 23, 2013, following the Committee's investigation into a fungal meningitis outbreak caused by contaminated steroid injections produced by a compounding pharmacy.  The legislation provides the Food and Drug Administration (FDA) with sole regulatory authority over compounding pharmacies that engage in interstate commerce and high-risk sterile compounding without or in advance of a prescription.  The bill allows compounding pharmacies to compound drugs before receiving prescriptions for the drug provided that they register with the FDA and meet specified safety standards.  The bill also contains provisions to increase transparency for patients and consumers by mandating labeling of compounded drugs and reporting of bad reactions to compounded drugs or any drug that poses a safety risk.

No additional activity occurred on this bill in the 113th Congress.  The House instead considered H.R. 3204, the Drug Quality and Security Act.