Here are three things to know.
1. The agency is developing a more restrictive policy for drug compounding pharmacies that produce medications not required to go through the agency’s approval process.
“Ultimately, there’s no question that the framework we will be laying out will place more restrictions on what they can do,” FDA Commissioner Scott Gottlieb, MD, told Reuters.
2. The FDA will issue a draft guidance in March outlining new criteria for choosing which substances can be used to manufacture bulk amounts of compounded drugs for hospitals and physician offices without individual patient prescriptions.
3. Another policy is also in the works to give state pharmacy boards more flexibility to supervise compounding pharmacies that ship drugs to other states.
To view the FDA’s full 2018 Compounding Priorities Plan, click here.
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