Long-Term Care Groups Submit Comments on Draft FDA Repackaging Guidance Document

ALEXANDRIA, Va., May 26, 2015 (GLOBE NEWSWIRE) -- On May 20, 2015, a joint letter was submitted by the American Society of Consultant Pharmacists to the U S Food and Drug Administration (FDA) with comments from long-term care pharmacies, professional pharmacy associations, long-term care associations and group purchasing organizations in response to "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities." This group of organizations is committed to caring for the frailest of our citizens. As stated in the letter, "the delivery of pharmacy services to residents of nursing homes and other long-term care facilities is a specialized pharmacy category whose methods of operation have evolved over the past 25 years in order to facilitate the appropriate care of these residents. The draft repackaging guidance titled, "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities," directly conflicts with these operational standards and would result in severe disruption to the industry, as well as create a potential reduction in patient safety and quality of care for nursing home residents unless FDA makes modifications to this guidance."

In order to achieve FDA's objectives of ensuring that repackaging is performed in a safe and effective method and to accommodate the needs of the long-term care setting, as well as the operational requirements of the Medicare program, recommendations were made to create accommodations for servicing residents in these settings. These accommodations include allowance for emergency supplies of medication in the facility, an exemption for remote dispensing equipment in the facility, and to expand the allowance of repackaged drugs in anticipation of demand that are not distributed.

The groups that signed onto this letter include: Advanced Pharmacy, American Health Care Association (AHCA), American Society of Consultant Pharmacists (ASCP), AMDA – The Society for Post-Acute and Long-Term care Medicine, GeriMed, LeadingAge, Omnicare, Managed Health Care Associates (MHA), National Community Pharmacists Association (NCPA), and PharMerica. The organizations look forward to working with the agency on these issues.


Contact Data