Compounding, Patient Safety, and the Vital Role of FDA Enforcement
Mass compounding of a commercially available product is not legal. Furthermore, compared with the manufacturing of FDA-approved branded and generic drugs, mass-compounded products are untested, uninspected, underregulated, and unproven, posing a threat to patient safety.
FDA exists for a reason. When the agency doesn’t fully enforce the Food, Drug, and Cosmetic Act, we are all vulnerable to unsupported product claims and clever marketing that plays on our dreams of quick, effective, and cheap solutions.
Individualized and shortage compounding are necessary exceptions to the FDA’s standards. Mass compounding of commercially available drugs is not.
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Spotlight: Americans for Medical Progress/Vital Role of Animals in Research
Dear FDA Matters readers: This column is the second in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. The first (here) was on the Advanced Research Projects Agency-Health (ARPA-H). Another spotlight…
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FDA Commissioner Makary has embraced the cause of faster review times for drugs and biologics, an area that holds great promise for bringing innovative drugs to patients more quickly.1 While laudable and likely to succeed, faster drug review times are just one way to…
Spotlight: Advanced Research Projects Agency for Health (ARPA-H)
Dear FDA Matters readers: This column is the first in a new series that puts a spotlight on causes and organizations that affect FDA and the FDA stakeholder community. I have a second spotlight column in process and am open to recommendations for future topics. Steven…
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There are so many interlocking and competing interests in food that it is hard to reach agreement on goals, let alone a plan for a future food system that is more coherent, effective, and better suited to each of our individual needs, desires, and situations….
RFK Jr.’s Anti-Vaccine Stance Infiltrated FDA. Trump Is Reining It In.
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Short Takes and Updates—February 20, 2026
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