Letter to Secretary Burwell Re: Long-Term Care Pharmacy
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 However a draft FDA guidance issued in 2015 entitled “Draft Guidance for Industry: Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities” (Feb. 2015) (the “Draft Guidance”) would, if finalized, prohibit LTC pharmacies for preparing the very same packaging and providing e-kits for residents of LTC facilities that the Requirements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.
Recent Posts
- 
					 
					
						New Report Demonstrates Worsening Impact of Medicare Part D Negotiated Drug Prices on Long-Term Care Pharmacies and the Vulnerable Seniors They ServeHarbinger of deepening long-term care crisis in 2026 unless Congress swiftly passes essential LTC Pharmacy Fix Washington, D.C. — The Senior Care Pharmacy Coalition (SCPC), the national voice for the long-term care (LTC) pharmacy sector, today released the Economic Impact of Medicare Part D Negotiated Drug Prices on Long-Term Care Pharmacy Economics, with analytics performed […] 
- 
					 
					
						Pharmacy Community Stands Together to Protect Seniors and Prevent a Long-Term Care CrisisThe Senior Care Pharmacy Coalition (SCPC), representing the nation’s long-term care pharmacies, the American Society of Consultant Pharmacists (ASCP), representing pharmacists and pharmacies dedicated to managing medications for older adults and medically complex patients, and the National Community Pharmacists Association (NCPA), representing community pharmacists nationwide, stand united in support of immediate action—whether through legislation or […] 
- 
					 
					
						Rep. Beth Van Duyne: Congress can save seniors’ access to medications before it’s too lateSeniors in nursing homes across the country depend on round-the-clock care and medications, perhaps more than any other American patient population. In turn, the nursing homes and assisted living facilities that care for them depend on a small number of specialized long-term care (LTC) pharmacies to ensure their patients have access to the prescription meds they need. 
Stay in the Know
Get the latest news and updates on issues impacting the long-term pharmacy community.
