FDA Releases 2018 Compounding Policy Priorities Plan

FDA commissioner Scott Gottlieb has released the agency’s 2018 Compounding Policy Priorities Plan that he describes as a “comprehensive work plan for how we will implement key aspects of this important law, including making changes to some proposed policies to better ensure we balance the need to preserve access to appropriately compounded drugs for patients whose needs cannot be met by FDA-approved products with our obligation to help protect patients from poor quality compounded drugs that could cause significant harm.”

The plan specifically details how the agency will: 

•          address manufacturing standards for outsourcing facilities;
•          regulate compounding from bulk drug substances;
•          restrict compounding of drugs that are essentially copies of FDA-approved drugs;
•          solidify FDA’s partnership with state regulatory authorities; and
•          provide guidance on other activities that compounders undertake.