The FDA and USP seem to be converging on similar compounding standards for hospital and health system based compounding…

“Over the past year, we’ve taken significant new steps to modernize and clarify our policies related to the quality of compounding in an effort to ensure continued access to compounded drugs for patients who need them, while also protecting patients from the risks of contaminated or otherwise harmful products. We’ve worked to refine our existing practices, shape new policies and increase the frequency of our communications with industry, Congress, states and patients concerning our programs.”

Read the full Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs.

Evaluating a new 503B partner, or just auditing your current partner?

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