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.
FDA Matters provides short-form analysis of FDA policy and regulatory issues. We know you are busy, so we publish 1 to 2 columns per week, each a 3-5 minute read.
FDA Matters does not report the news….we provide analysis of what’s behind the news.
FDA Matters advocates for a more effective, efficient, and fair FDA.
FDA Matters has been featured in:
States vs. Federal Rights: The Perennial Debate Over FDA and Preemption
Since the founding of our republic, there has been debate about states’ rights vs federal rights. And in times of stress, the discussion gets more heated and gains more traction. Once again, FDA is moving into the center of such debates. Federalism is at the Heart of…
FDA and the Revolving Door: Much Ado About Nothing?
The announcement that former CBER Director, Dr. Peter Marks, was joining Lilly as SVP for molecule discovery and head of infectious diseases….set the internet ablaze with unjustified outrage about his transition from a government career to industry. My multiple…
Q&A – October 06, 2025
This week’s questions: How long is the shutdown likely to continue? Did Commissioner Makary offer companies accelerated review if they make the pricing concessions requested by the Administration? Where does the farm community fit into the MAHA agenda? —— Q: How…
Desperately Needed: Special Risk-Benefit Calculations for Relentlessly Progressive Chronic Diseases
Every day, our country is failing patients with relentlessly progressive chronic neurological, neuromuscular, and genetic diseases. Their plight necessitates a significantly different risk-benefit calculation than that of patients with other types of diseases….
Q&A – September 29, 2025
This week’s questions: State public health officials are having to make difficult decisions about whether to follow CDC guidance on vaccines and other topics. Could there be a similar erosion of trust by states regarding FDA guidance? Anti-vaccine policies poll poorly…
Want More Insights from FDA Matters? Check Out the Q&A Monday Tab for This Subscriber-First Feature
Every Monday, FDA Mtters subscribers receive “Q&A Monday.” They may recirculate, quote from, or reprint it, etc., at their own discretion, which can be particularly useful for media. I do not publicly post the column until the following Monday. You can find past…