FDA Releases Draft Documents on Drug Compounding

The documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians.

FDA on Feb. 13 released five draft documents related to drug compounding, an industry brought into sharp focus by the 2012 fungal meningitis outbreak involving the New England Compounding Center. The outbreak came to light Sept. 18, 2012, when a clinician reported a patient's culture-confirmed Aspergillus fumigatus meningitis diagnosed 46 days after epidural steroid injection at a Tennessee ambulatory surgical center. By Sept. 27, investigators had identified eight more patients in Tennessee and North Carolina. All nine patients had received an epidural steroid injection with a methylprednisolone acetate solution produced by the center. CDC ultimately concluded 751 patients were diagnosed with a fungal infection related to their injections and that 64 of them died.

FDA said the draft documents will help entities comply with important public health provisions. The documents are applicable to pharmacies, federal facilities, outsourcing facilities, and physicians; the new category of outsourcing facilities was created under the Drug Quality and Security Act, which Congress enacted in November 2013 in response to the NECC meningitis outbreak. Drugs compounded in an outsourcing facility that meet certain conditions may be entitled to exemptions from certain provisions of the Federal Food, Drug, and Cosmetic Act, including the new drug approval requirements and the requirement to label drug products with adequate directions for use. Outsourcing facilities are subject to current good manufacturing practice requirements and inspections by the FDA according to a risk-based schedule.

"The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to protecting the public health," said Dr. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research.

The documents include draft guidance for entities considering whether to register as outsource facilities, draft guidance for industry about repackaging of certain human drug products by pharmacies and outsourcing facilities, and adverse event reporting by outsourcing facilities.

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