AHCA, pharmacy groups buck federal drug regulations

Long-term care pharmacies should be exempt from the new drug repackaging guidelines proposed by FDA, according to several health care groups. The guidelines, first proposed last year, would impose harsher regulations on drug repackaging, including repackaging timeframes and where the packaging can take place. The American Health Care Association, the Senior Care Pharmacy Coalition (SCPC), and the American Society of Consultant Pharmacists assert in a recent letter to FDA that “there is no evidence that LTC pharmacy repackaging has ever created a health or safety issue for LTC residents.” Alan Rosenbloom, president and CEO of SCPC, added that the regulations would increase product waste and increase costs by requiring LTC pharmacies to outsource or limit their repackaging activities. The groups said that if the FDA guidance is finalized as proposed, it “would require all LTC pharmacies to either leave the LTC business or register as repackagers—something that the typical LTC pharmacy consisting of a single facility with under $5 million in revenue can ill afford to do.”