The Verifying Authority and Legality in Drug Compounding Act of 2012, also known as the VALID Compounding Act, was introduced by Rep. Edward Markey, D-Mass., in response to the fungal meningitis outbreak caused by tainted compounded products from the New England Compounding Center. The proposed legislation would provide FDA with broader enforcement powers over compounding centers engaging in large-scale distribution of compounded drugs. The following are the key features of the bill:
- Individually Identified Patient Compounding. FDA will not regulate as manufacturers any compounders of drug products based on recommendations of physicians for individually identified patients.
- Drug-Specific Individual Patient Waivers. Specified drugs may be compounded even if not for an individually identified patient (“office use”) if FDA has determined that drug is subject to shortage or it is otherwise to protect the public health.
- Pharmacist/Pharmacy-Specific Individual Patient Waivers. Specified pharmacists and pharmacies may apply for permission to dispense office use compounded drugs.
- To the extent FDA authorizes the State to grant such waivers, the waiver will only apply to compounded drug products sold or dispensed within that state.
If you have questions regarding the proposed legislation or legal issues associated with drug compounding, please contact one of the authors.