LTC groups tackle pharmacy repackaging
Several long-term care groups have taken issue with the Food and Drug Administration regarding draft repackaging guidance called "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.”
The guidance directly conflicts with operational standards in the long-term care pharmacy industry and means a reduction in quality of care and patient safety in nursing homes, the groups said in submitted comments.
In a letter, they acknowledged the FDA wants to make sure repackaging is safe, but they assert that there needs to be accommodations for allowance for emergency supplies of medication in the facility, an exemption for remote dispensing equipment in the facility, and an ability to expand the allowance of repackaged drugs in anticipation of demand that are not distributed.
Advanced Pharmacy, the American Health Care Association, the American Society of Consultant Pharmacists, AMDA – The Society for Post-Acute and Long-Term Care Medicine, GeriMed, LeadingAge, Omnicare, Managed Health Care Associates, National Community Pharmacists Association, and PharMerica signed the letter.