Markey Compounding Bill

Key Features of the Proposed Verifying Authority and Legality in Drug Compounding Act of 2012

November 16, 2012

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.
  • Safety or Effectiveness Concerns. Any compounded drug deemed by FDA as adverse to safety or effectiveness is prohibited from being compounded.
  • Labeling Requirements. Compounders under FDA regulation will be required to include on their product labels the statement “This drug has not been tested for safety and effectiveness and is not approved by the FDA. Serious adverse reactions to this drug should be reported to the pharmacy where it was received and the FDA.”
  • Registration and Inspections. The VALID Compounding Act proposes to amend the FFDCA so that compounding pharmacies are subject to FDA registration and inspection to the extent they manufacture drugs, as determined by the secretary.
  • States Maintain Regulatory Authority Over Traditional Compounders. The legislation distinguishes between traditional compounders and bulk compounders. The law essentially codifies FDA’s current thinking on traditional versus nontraditional compounding activities, and exempts pharmacies pursuing those activities.

If you have questions regarding the proposed legislation or legal issues associated with drug compounding, please contact one of the authors.

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