Compounding: FDA Stepping Up Enforcement With Warning Letters?
This article was originally published in The Pink Sheet Daily
FDA calls North Carolina compounder’s products misbranded and adulterated after the company did not receive valid prescriptions for a number of products it made and agency found several GMP violations.
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After House Republicans indicate legislation expanding agency’s oversight of compounding is unlikely, FDA could consider other regulatory options, like changing internal policies or hoping a court clarifies its regulatory authority.
Agency releases 483 forms from a post-crises inspection push; the effort may help FDA illustrate its inspection capabilities to Congress and states and indicate the agency’s oversight plans under the new authority it has proposed.
As FDA, Congress and the courts stumbled, compounding pharmacies such as NECC took advantage of a gray area of the law. Legislators will get another try; one proposed subjecting such pharmacies to cGMP requirements.