January 09, 2014
FDA Touts the Benefits of Outsourcing Facility Registration to State Officials and Hospital Purchasers of Compounded Medications
By Karla L. Palmer –
FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 Stat. 587), specifically Title I, the Compounding Quality Act. FDA’s stated purpose of the letters is to urge state officials and hospitals to encourage outsourcing facilities to register with FDA as outsourcing facilities. The letters recount a brief history of events leading to the legislation, noting that new “problems continue to be identified at compounding pharmacies across the country, which number over 15,000.” (citing 2012 NCPA Digest In-Brief. Retrieved November 14, 2013, from National Community Pharmacists Association (“NCPA”)).
continue to read here
FDA Commissioner Margaret A. Hamburg, M.D., sent open letters (here and here) to “Hospital Purchasers” and state officials including governors, state boards of pharmacy and health departments, informing them of the passage of the Drug Quality and Security Act (Public Law 113-54,127 Stat. 587), specifically Title I, the Compounding Quality Act. FDA’s stated purpose of the letters is to urge state officials and hospitals to encourage outsourcing facilities to register with FDA as outsourcing facilities. The letters recount a brief history of events leading to the legislation, noting that new “problems continue to be identified at compounding pharmacies across the country, which number over 15,000.” (citing 2012 NCPA Digest In-Brief. Retrieved November 14, 2013, from National Community Pharmacists Association (“NCPA”)).
continue to read here
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