Legislation to Strengthen Compounding Regulations Introduced to Congress

Topics: Compounding, Patient safety, and Contamination

Legislation that would give Food and Drug Administration (FDA) clear, new authority to oversee compounding pharmacy practices throughout the country was introduced to Congress on November 2, 2012, by Representative Edward J. Markey (D-MA). The Verifying Authority and Legality In Drug (VALID) Compounding Act (PDF) would preserve state regulatory authority for traditional small compounding pharmacy activities, and ensure that compounding pharmacies operating as drug manufacturers are regulated by FDA as drug manufacturers, as indicated in a press release. Further, in the event of a drug shortage or to protect public health, the bill includes provisions that would authorize FDA to waive the requirement that drugs may be compounded only for individual patients with valid prescriptions. Additional provisions would allow compounding pharmacies with a legitimate reason to compound drugs before the receipt of a valid prescription to request a waiver to enable them to do so, and allow FDA to waive the requirement that drugs may be compounded only if they are not copies of commercially available drugs if doing so is necessary to protect public health or well-being. The bill would also increase transparency to the public. For example, it would require that compounded drugs be labeled to ensure that recipients know that the drugs have not been tested by FDA for safety or effectiveness. Additional information on the bill is available in a document (PDF) posted on the Web site of Edward Markey.