LTC providers ‘win’ with new regs on drug repackaging, group says

DATE: January 18, 2017

Published by McKnight’s

Guidance on medication repackaging recently published by the U.S. Food and Drug Administration is earning praise from one long-term care pharmacy group, which says the final guidelines help reduce drug-related risks for residents.

The final guidance, published Thursday, included the elimination of a proposed 14-day limit on pre-packaging medications that could have put residents at risk and added significant compliance costs for long-term care pharmacies, the Senior Care Pharmacy Coalition said. Long-term care pharmacies can repackage medications under the final guidance, as long as the drugs do not leave the pharmacy without a patient-specific prescription or chart order.

The FDA’s guidelines also permit long-term care pharmacies to continue to use remote dispensing technology, and supply non-sterile products to facilities in emergency kits.

“The Agency heard our concerns about the unintended consequences of its original draft and agreed to exercise enforcement discretion to permit needed medication packaging and emergency kit practices to continue,” said Alan G. Rosenbloom, president and CEO of SCPC.

Rosenbloom added that the FDA’s guidance “represents a strong start for the LTC pharmacy sector in 2017, and more broadly recognizes LTC pharmacies’ unique value in the U.S. health care continuum.”

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