SCPC Praises Final FDA Repackaging Guidance Recognizing LTC Pharmacies’ Unique Value in U.S. Health Care Continuum

DATE: January 17, 2017

Senior Care Pharmacy Coalition (SCPC) Lauds Elimination of 14-Day Pre-Packaging Guideline, Proceeding with Additional Analysis of LTC Pharmacy Issues

 Washington, DC – Following an initial analysis, the Senior Care Pharmacy Coalition (SCPC) today praised the Food and Drug Administration’s (FDA’s) final regulatory guidance regarding the “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” In its final guidance, the FDA eliminated a proposed limitation on pre-packaging — which would have put patients at risk and add significant compliance costs to long term care (LTC) pharmacies.

The agency also recognized the unique services LTC pharmacies provide — as well as legal and regulatory requirements that Medicare, Medicaid and state licensure provisions impose on LTC pharmacies — by exercising its enforcement discretion to allow LTC pharmacies to continue current practices regarding emergency kits and remote dispensing in LTC settings, pending further FDA review.

“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.  “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we appreciate the FDA’s decision to eliminate the proposed 14-day pre-packaging requirement in the original draft guidance, and the FDA’s recognition that additional work must be done to assure that LTC patients have timely access to needed medications. We also appreciate the bipartisan congressional support to help inform FDA officials about these pertinent issues.”

Continued Rosenbloom: “The FDA’s action 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 — which is a central objective of SCPC itself. 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 SCPC leader said the diligent and timely work of SCPC members was integral to the outcome of the FDA’s final guidance. Rosenbloom noted members’ direct intervention with FDA and CMS — combined with extensive Congressional interest in the potential conflict of laws as a result of SCPC’s advocacy — helped resolve a real threat to patient safety. “The bottom line is that SCPC, as the lead organization representing LTC pharmacies on the issue both in Congress and before the Agency, played a key role in helping shape the eventual outcome of this crucial final guidance.”

According to SCPC’s initial analysis, the following is the result of the FDA’s final guidance on three key LTCP issues:

Emergency Kits — The draft guidance limited prescription drugs from leaving “the place where they were repackaged” without a patient-specific prescription or chart order.  SCPC informed the FDA that this would prevent LTCPs from providing emergency kits to LTC facilities, contrary to federal Medicare and Medicaid laws and regulations. In the final guidance, the FDA maintains this limitation, but notes the Agency will not enforce this provision against pharmacies that supply non-sterile medications to LTC facilities.  The FDA continues to evaluate the issue, including a potential updated guidance document pertaining specifically to LTCPs.

The FDA’s enforcement discretion concerns only non-sterile products contained in e-kits. However, the final guidance does not consider allowing separate individual single doses of sterile products from manufacturer-packaged containers without opening individual containers/blisters to be dispensing.  Consequently, LTC pharmacies that do not prepare and package sterile products for inclusion in e-kits may continue current practices pending FDA’s further evaluation.

Remote Dispensing — The draft guidance would have prevented LTC pharmacies from using remote dispensing technology, which reduces medication errors and lowers drug costs over time.  As with e-kits, the final guidance continues to permit such dispensing so long as the remote dispensing equipment does not contain sterile products that were repackaged at the LTC pharmacy pending the FDA’s further consideration of LTC issues.

Pre-Packaging Limits — The draft guidance limited pre-packaging to 14 days.  The final guidance eliminates this provision entirely, such that a LTC pharmacy may repackage medications so long as the products do not leave the pharmacy without a patient-specific prescription or chart order.

Rosenbloom said SCPC will continue to analyze the FDA Final Guidance, and comment further on additional findings when warranted.

The SCPC is the national association for independent LTC pharmacies. Our member pharmacies provide care and services to patients in LTC facilities in across the country occupying approximately 675,000 beds across the country.  Visit us at www.seniorcarepharmacies.org to learn more.