Statement from FDA Commissioner Scott Gottlieb, M.D. and Deputy Commissioner Anna Abram on new 2019 efforts to improve the quality of compounded drugs
We’ve long recognized that compounded drugs can serve an important role for patients whose medical needs cannot be met by an FDA-approved drug product. But compounded drugs are not approved by the FDA and, therefore, have not been evaluated for safety or efficacy. We’ve seen firsthand the harm they can cause patients when they’re not appropriately compounded.
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. We anticipate that 2019 will be an equally productive year for the FDA’s compounding program, with better quality continuing to be our top priority as part of our ongoing effort to reduce the risks of these unapproved products. We have an obligation to advance our efforts to improve the quality of compounded products for consumers by ensuring we have a strong and modern regulatory framework in place.
Toward these goals, we’re pleased to share our 2019 compounding priorities. The FDA will continue to work with stakeholders to improve the quality of compounded drugs for patients who need these products.
- Maintaining Quality Manufacturing and Compliance
- Regulating Compounding from Bulk Drug Substances
- Finalizing our Memorandum of Understanding with the States
- Compounding by Hospital and Health Systems
- Additional Compounding Priorities
To learn more, please visit: FDA Statement on 2019 Compounding Priorities.
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