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On Thursday, FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram released a statement on the agency's priorities for compounding pharmacies.
TSI Global Product Manager Dave Ruhland compiled some takeaways from this statement:
- In 2018, the FDA sent 23 warning letters, and participated in 50 recalls, and 4 permanent injunctions of compounding pharmacies.
- Inspections and enforcement will continue to be a focus for the agency in 2019.
- The FDA will finalize their Memorandum of Understanding with the states in order to coordinate more closely. For example, this will increase reporting of compounding pharmacies with significant interstate shipping.
- The agency will issue new draft guidelines on how hospitals must comply with the 503a regulations.
- The FDA will continue to develop requirements for 503b outsourcing facilities.
TSI room pressure monitoring and control instruments can be valuable tools for compliance with standards like USP <797> and USP <800>. Learn about our HVAC monitoring solutions for compounding pharmacies. Room pressure monitoring and control questions? Contact Dave at david.ruhland@tsi.com.