Letter to Secretary Burwell Re: Long-Term Care Pharmacy

DATE: August 19, 2016

The Senior Care Pharmacy Coalition (“SCPC”), on behalf of the long term care (“LTC”) pharmacies it represents and the residents of LTC facilities whom those pharmacies serve, is writing to ask your help in reconciling a conflict between two of the agencies within your Department – the Food and Drug Administration (“FDA”) and the Center for Medicare and Medicaid Services (“CMS”) – related to packaging of prescription drugs in long term care (“LTC”) pharmacies. The CMS Requirements of Participation for nursing homes require LTC pharmacies to dispense medications to residents in specialized packaging and provide emergency medications that must be kept on-site at the facility (known as “e-kits”). However a draft FDA guidance issued in 2015 entitled “Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities” (Feb. 2015) (the “Draft Guidance”) would, if finalized, prohibit LTC pharmacies for preparing the very same packaging and providing e-kits for residents of LTC facilities that the Requirements of Participation demand. The vast majority of medications dispensed for these patients are not available from manufacturers, wholesalers or licensed repackagers in the appropriate specialized packaging. Given that LTC pharmacies have for decades been safely packaging these medications in compliance with CMS and pharmacy requirements, we seek your assistance to avoid the emerging conflict.

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