FDA nixes 14-day drug pre-packaging rule

Long-term care pharmacies seem to have won the latest round with the Food and Drug Administration (FDA) over medication repackaging and dispensing requirements. The FDA’s final guidance, “Repackaging of Certain Human (Prescription) Drug Products by Pharmacies and Outsourcing Facilities,” includes a reversal of several restrictions on drug repackaging—and gives a serious nod toward the unique needs and settings of LTC pharmacies work.

The biggest change in the rule is the elimination of the 14-day prepackaging requirement. Previously, LTC pharmacies were forbidden to repackage medications in anything less than a 14-day course, making the stocking of emergency kits problematic. Now, LTC pharmacies are permitted to repackage medications in any way needed, as long as the drugs don’t leave the pharmacy without a physician order.

The final rule also reversed its approach to remote dispensing technology. Earlier drafts had forbidden the use of remote dispensing if drugs needed to be repackaged by the LTC pharmacy in order to stock the dispensing units.

The revisions during the rule-making process acknowledge that LTC pharmacies are substantially different from other pharmacies, both in the services they provide and the types of patients they serve, said Doug Towns, JD, General Counsel and Senior Compliance Officer at Guardian Pharmacy, Atlanta, the third-largest LTC pharmacy in the U.S. “The accommodation that the FDA made to carve out LTC pharmacies makes sense given the breadth of this rule,” he says. “Many of the FDA’s regulations don’t account for the very different industry that we serve, but this shows long-term care the respect of being a uniquely different segment.”

The Senior Care Pharmacy Coalition (SCPC) had commented strongly against the FDA’s original draft, arguing that the unique needs of long-term care pharmacies required more flexibility in packaging requirements, especially for emergency kits, short-cycle drugs and remote dispensing systems within senior care settings.

“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 the SCPC, and an association statement.  “Specifically, we appreciate the FDA’s decision to eliminate the proposed 14-day pre-packaging requirement in the original draft guidance, and the FDA’s recognition that additional work must be done to assure that LTC patients have timely access to needed medications.”

The rule revisions are a big step in recognizing the unique value and processes of the LTC pharmacy sector, Rosenbloom added. “While we clearly have more work to do in seeking a clear and complete exemption of LTC pharmacies from other federal drug repackaging requirements, the FDA obviously has recognized the conflicts between Medicare, FDA and state laws.” 

The FDA is seeking public comment on the guidance through Feb. 17, 2017.

Topics: Regulatory Compliance