FDA drug guidance may threaten compliance for “literally every LTC facility,” pharmacy group says

DATE: June 12, 2016

New repackaging guidelines from the Food and Drug Administration could place “literally every LTC facility and associated pharmacy in America” at risk of failing to meet Medicare and Medicaid regulatory requirements, a senior care executive said last week.

During a June 6 FDA listening session, Senior Care Pharmacy Coalition President and CEO Alan Rosenbloom said the added regulations under the Drug Quality and Security Act could place the health and safety of LTC patients at risk.

Under the new policy, repacking drug products would become subject to a variety of different regulations, including repackaging timeframes and where the packaging can take place.

In a previous letter sent to the FDA by Rosenbloom in December 2015, he said the DQSA provisions would force pharmacies and regulatory reviewers to severely alter their policies, placing an increased financial burden on the repacking process.

He expressed these same concerns in the recent session, saying the provisions would “materially alter long-standing LTC pharmacy practices and procedures.”

He also said other organizations in the industry share his opinion.

Due to the high number of comments the FDA had received from those who would be affected by the provisions, Rosenbloom suggested an additional listening session take place before the guidelines were finalized.

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