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FDA releases statement on compounding pharmacies

On Thursday, FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram released a statement on the agency's priorities for compounding pharmacies.

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.

Posted on Apr 05 2019 10:52
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