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"The draft guidance documents provide information to pharmacies, outsourcing facilities, health care entities, and others about these FDA-proposed policies, which are critical to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The documents include draft guidance for entities considering whether to register as outsource facilities, draft guidance for industry about repackaging of certain human drug products by pharmacies and outsourcing facilities, and adverse event reporting by outsourcing facilities.

Product Showcase

  • Kestrel 5400 Heat Stress Tracker WBGT Monitoring for Workplace Safety

    Ensure safety with the Kestrel® 5400 Heat Stress Tracker, the go-to choice for safety professionals and endorsed by the Heat Safety & Performance Coalition. This robust, waterless WBGT meter is ideal for both indoor and outdoor environments, offering advanced monitoring and data logging essential for OSHA compliance. It features pre-programmed ACGIH guidelines and alert settings to quickly signal critical conditions. Integrated with the cloud-based Ambient Weather Network, the 5400 allows managers to view, track, and log job site conditions remotely, ensuring constant awareness of potential hazards. Its capability for real-time mobile alerts and remote data access promotes proactive safety management and workplace protection, solidifying its role as a crucial tool in industrial hygiene. Read More

  • SwabTek® Cannabis Test Kit

    The SwabTek® Cannabis Test Kit is a single-use spot test designed for use in screening for cannabis compounds in any sample type or on any surface. The test is capable of identifying the presumed presence of cannabinoids in very small quantities, with a level of detection as little as 6 μg in mass. Learn more about the SwabTek® Cannabis Test Kit and the rest of SwabTek surface drug testing solutions through the webinar titled "Everything You Want To Know About Surface Testing" Read More

  • SECUPRO MARTEGO

    FOR HIGHEST DEMANDS. A cutting tool in which function and design go hand in hand. Meet the SECUPRO MARTEGO, our prize-winning squeeze-grip safety knife with fully automatic retractable blade for safety. • Ergonomically friendly trigger mechanism to engage the blade • Durable body made of aluminum • Safer alternative to fixed blade utility knives for general cutting tasks • 9 mm Cutting depth • Easy, tool free blade change Dimensions: L 6.10" L x 0.71" W x 1.91" H Weight: 3.70 oz Cutting Depth: 9 mm Read More

Featured

Webinars