Blogs: For the Record

Compounding Pharmacy, Part 3: Responding to FDA Enforcement Actions

Published Online: Thursday, June 13, 2013
FDA Enforcement
The FDA can enforce its regulations in a variety of ways, including: 483s, untitled letters, warning letters, injunctions, and working with the United States Attorney and Department of Justice to close facilities and levy administrative, civil, and criminal penalties including possible jail time.
Your Response
In order to avoid inappropriate consequences, you must decide whether, when, and how to respond after an inspection.
Typically, you will be required to respond to the FDA within 15 days of receiving an FDA 483 document. A person of appropriate authority, such as a pharmacist manager, must often be the signatory. This helps convince the FDA that the signatory is appropriately empowered to enforce changes.
A key point of concern for the FDA is the tendency of pharmacies, and other organizations it oversees, to overpromise and under-deliver. Single findings are typically symptoms of larger problems. As such, while it is important to fix the immediate problem, it is likely that the entire quality system has a problem, which means that both the symptom and the system must be fixed.
If you agree with the FDA’s citations, it is important to work to convince the agency that you have an understanding of the problem and that you are committed to fixing it.
Among the first steps to resolving problems is typically to perform a root-cause analysis. Asking “Why did the problem occur?” and “How can the company stay compliant?” are often good jumping off points. It is also critical to evaluate how long this analysis will take. Vague answers are often deemed unsatisfactory.
If you believe the FDA made a mistake, you must convince the agency that you are already in appropriate compliance with the relevant rules. Potential examples of mistakes in the FDA’s citations that you might identify include: (1) The FDA did not have all the facts, or (2) the FDA has inappropriately disregarded certain relevant facts.
What Not to Include
One thing to avoid doing is asserting that the FDA doesn’t understand the practice of pharmacy. Pharmacists often resort to this option instinctively. It is also important to avoid unwittingly angering the FDA through abusive statements or assertions questioning the agency’s credibility.
Outside Help
You may need outside help responding to the enforcement action if you lack legal, regulatory, or clinical experience. You may also need help addressing the enforcement issues in a technical, legal, or regulatory manner if you are not comfortable doing so. Finally, you may require outside counsel if the FDA has expressed concerns about your employees’ competence, motivation, or integrity.
—Darshan Kulkarni and Samantha Ricketts
Darshan can be reached at (215) 703-7842 or by email at You can also find him on Twitter @FDAlawyers.
Darshan Kulkarni, Kulkarni Law firm
Blog Info
Darshan Kulkarni, a pharmacist and attorney based out of Kulkarni Law firm (Philadelphia, PA), will provide insights on the legal, regulatory, administrative, and ethical issues that can affect pharmacists in their everyday practice.
Author Bio
This blog will primarily focus on informing pharmacists about how the drugs that they dispense came to be in their hands—including the ethics, the arguments, the laws, and the drama. Among the topics covered are FDA regulations, drug development, clinical trial participation, compounding drugs, social media marketing, and pharmaceutical advertising. This blog will also discuss what pharmacists need to know about dispensing certain medications.

Dr. Kulkarni holds a Doctor of Pharmacy degree, a Master of Science in Quality Assurance/ Regulatory Affairs, and a Juris Doctorate degree. He works with and/or for research sites, clinical research organizations and a variety of small and large pharmaceutical and biopharmaceutical companies to assist them in meeting their clinical, legal, regulatory, and/or compliance needs.

Dr. Kulkarni has worked, and continues to work, as a pharmacist for more than 10 years. He currently serves as Adjunct Associate Professor in the Biomedical Writing Program at the University of the Sciences and has taught courses in Regulatory Documentation Processes, Ethical and Legal Issues in Biomedical Communication, Research in Biomedical Communication, and the Promotion of Biomedical Products–Regulatory Considerations.

You can follow him on twitter at @FDALawyers ( or visit the Kulkarni Law Firm's Web site (

The opinions stated in this blog are the sole and present opinions of Dr. Kulkarni as of the time of writing of the blog in question and do not necessarily represent the legal or medical opinions of Kulkarni, LLC and/or its other attorneys. Such opinion(s) may change over time. These blog postings do not constitute legal advice, and do not create an attorney–client relationship and should not be construed as such. These blog postings also do not constitute medical advice. Please contact your physician for medical advice, and your attorney for legal advice, that is appropriate for you.
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