LTC Pharmacies To FDA: Don't Treat Us As Compounding Repackagers

Three trade associations jointly wrote to FDA Senior Science Advisor Julie Dohm on July 15 seeking carve-outs for Long Term Care (LTC) pharmacies under the agency's draft repackaging guidance released in February 2015. The associations argue the guidance conflicts with Medicare and Medicaid requirements and would unduly force LTC pharmacies to register as repackagers in order to stay in business. FDA released a draft guidance, entitled “ Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities , ”...