Bill Would Empower FDA on Compounding Pharmacies

U.S. Rep. Edward Markey, D-Mass., said he will introduce his legislation Nov. 2.

The compounding pharmacy industry will face stricter scrutiny if U.S. Rep. Edward Markey, D-Mass., succeeds in enacting a bill he announced he will introduce Nov. 2. Markey's Verifying Authority and Legality in Drug (VALID) Compounding Act would give the Food and Drug Administration new oversight authority for the industry nationwide.

The New England Compounding Center (NECC), at the heart of a national fungal meningitis outbreak, is located in Framingham, part of Markey's congressional district.

"Compounding pharmacies have been governed by fragmented regulations for too long, leading to the worst public health disaster in recent memory," he said Nov. 1. "The VALID Compounding Act ends this regulatory black hole by giving the FDA new, clear authority to protect patients and oversee these companies. I look forward to working with my colleagues in Congress on a bipartisan basis to move this legislation forward."

Markey is the senior Democrat serving on the House Energy and Commerce Committee. A summary of the bill posted at his congressional website said it will:

  • Preserve state regulatory authority for traditional small compounding pharmacy activities
  • Ensure that compounding pharmacies operating as drug manufacturers are regulated by FDA as drug manufacturers
  • 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
  • Allow FDA to waive the requirement to compound drugs solely for individual patients with valid prescriptions in the event of a drug shortage or to protect public health
  • Allow FDA to waive the requirement to compound drugs only if they are not copies of commercially available drugs if doing so is necessary to protect public health or well-being
  • Increase transparency to the public by requiring that compounded drugs be labeled so end users will know the drugs have not been tested for safety or effectiveness, by publishing a "Do Not Compound" list of unsafe or ineffective drugs, and by reporting bad reactions to compounded drugs or any drug that poses a safety risk

Days earlier, Markey released a report titled "Compounding Pharmacies, Compounding Risk" that revealed even before the current outbreak, problems at compounding pharmacies led to at least 23 deaths and 86 illnesses in 34 states. It pointed out that regulation of compounding pharmacies lies mainly with states, which have inconsistently applied it.

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