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FDA guidance could undermine safety, compliance efforts, pharmacy group maintains

May 21, 2015
by Lois A. Bowers, Senior Editor
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Repackaging and distribution guidance (PDF) proposed in February by the U.S. Food and Drug Administration (FDA) inadvertently would undermine patient/resident safety in nursing homes and other long-term care (LTC) facilities and also would threaten regulatory adherence to Medicare and Medicaid rules, the Senior Care Pharmacy Coalition (SCPC) said in a May 20 letter (PDF) to the agency. The SCPC is asking the FDA to modify its guidance.

“Unfortunately, FDA’s Draft Guidance does not reasonably accommodate—and in some instances directly conflicts with—the policy goals, certain legal requirements, and current practices applicable to LTC sites of care,” SCPC President and CEO Alan G. Rosenbloom wrote. The draft guidance should distinguish between LTC and other pharmacies as Medicare Part D and other regulations do, he added.

Specifically, the SCPC is asking the FDA to exclude all dispensing-related activities of LTC pharmacies from the scope of the guidance, since these activities already are regulated by state and federal pharmacy law, Medicare and Medicaid law and healthcare network participation requirements. “In addition, the drug products remain under the pharmacy’s control and responsibility until they are dispensed to individual patients pursuant to a prescription or chart order,” Rosenbloom wrote. “As such, they properly remain within the traditional regulation of practice of pharmacy by state and federal regulators applying well-established professional pharmacy standards.”

Rosenbloom said that the guidance, if finalized, would:

  • Limit the ability of LTC pharmacies to prepackage pharmaceutical products, including drugs that remain in the pharmacy, without receipt of a patient-specific prescription/chart order.
  • Prevent any dispatch of prepackaged/repackaged pharmaceuticals, packaged and sent from the pharmacy, in advance of receiving patient-specific prescriptions or chart orders (this specifically would affect emergency kits and remote dispensing practices).
  • Impede pharmacy practice in a manner that would affect nursing home compliance with safety requirements specified for Medicare and Medicaid.
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