Home E-Weekly February 6, 2018

FDA Increases Oversight of Compounding Pharmacies

The agency hopes more compounders will register as outsourcing facilities, which are subjected to higher levels of regulation.

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DRUG PROBLEM The 2012 fungal meningitis outbreak highlighted the need for increased scrutiny of compounders.

The FDA's newly released 2018 Compounding Policy Priorities Plan outlines how the agency intends to improve oversight of compounding pharmacies as part of its continuing response to the deadliest medication contamination case in U.S. history.

The 2012 nationwide fungal meningitis outbreak occurred when at least 76 facilities bought supposedly sterile steroids prepared at the New England Compounding Center in Boston, Mass. The tainted steroids sickened 750 patients and resulted in 60 deaths across 20 states.

In November 2013, Congress reacted to the outbreak by passing the Drug Quality and Security Act (DQSA), which created 2 kinds of compounders: 503A state-licensed pharmacies, which compound medications for patient-specific prescriptions, and 503B facilities, which are outsourcing facilities that prepare and distribute compounded medications without prescriptions. FDA-registered outsourcing facilities are required to comply with current good manufacturing practices (CGMPs), undergo regular inspections, report adverse events and include certain information on product labels.

The FDA intends to create a more flexible, risk-based approach to ensuring outsourcing facilities comply with CGMPs. As a result, the FDA hopes more compounders will register as outsourcing facilities, which are subjected to higher levels of regulation. The FDA's new plan also outlines ways the agency will improve implementation of DQSA, including:

  • Regulating bulk drug substances. The FDA will release a draft guidance document in March that will propose criteria for establishing the 503B bulks drug substances list. Bulk substances will be approved for use during compounding based on clinical need.
  • Limit medication compounding. Compounded drugs are subject to a lower regulatory standard and should only be distributed to treat patients whose conditions cannot be met by FDA-approved drugs, according to the plan.
  • Improved coordination with state regulators. The FDA will focus its resources on compounders that present the greatest risks and will clarify circumstances in which the agency will rely on state partners to oversee compounding operations.

"The FDA is fully committed to implementing these requirements in a way that preserves the legitimate practice of pharmacy and promotes access to these important drugs while protecting patients," says FDA Commissioner Scott Gottlieb, MD. "Our policies will aim to foster the continued development of reliable compounding by traditional compounding pharmacies and outsourcing facilities, so that patients have access to quality compounded drugs when they need them."

Daniel Cook

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