Blogs: For the Record

Compounding Pharmacy, Part 2: Preparing for an FDA Inspection

Published Online: Thursday, May 23, 2013
Pre-planning for an FDA inspection of your compounding pharmacy will help prevent rash decisions after the inspectors walk in the door.
 
Decide whether to let inspectors in.
 
If you decide not to let them in, they will typically get a court order and make their way into the facility sooner or later. This may simply prove to be an expensive delaying tactic that results in an antagonistic relationship. However, under certain circumstances, this may be the appropriate strategy. Nonetheless, barring the inspectors will typically escalate the situation and may lead to a more intense inspection featuring warning letters and/or subpoenas.
 
On the other hand, letting the inspectors in right away may help the pharmacy appear compliant and lead to less serious fines if problems are found. However, it is important to recognize that everything the inspectors observe once you let them in can and will be treated as evidence and may be used against you.
 
Have your war room ready.
 
Your planning should include setting up a war room in which key personnel can respond to inspectors’ requests, prepare the required documents, and monitor the inspection proceedings.
 
A war room plan will typically start by setting up 4 core teams: (1) a point of contact team, (2) an inspection team, (3) an agency response team, and (4) a media response team (for larger companies). Some or all of the following people may be present in your war room:
  • The point of contact team typically consists of 1 or more people who are likely to first greet the inspector. The team’s members will be responsible for assembling the inspection team and sending out necessary information.
  • The inspection team typically consists of a leader to consult with stakeholders, a spokesperson, a lawyer and/or regulatory person, and multiple note takers to create a record of all proceedings.
  • Finally, the agency response team can include different people, depending on your decisions. It may include: a lawyer, pharmacist, manager, and/or technician representative. This team will likely come together to write a response to the FDA after the inspection.
Decide what information you will let inspectors have.
  • Are you going to “waive privilege” for information that you don’t need to disclose?
  • Have you marked and defined areas that are deemed a trade secret? How much access will you give the FDA to trade secret materials?
  • Will you disclose financial information?
  • Will the FDA have access to internal audit records?
Have standard operating procedures in place.
  • Identify all non-essential personnel. Will these personnel be present during an inspection?
  • Will your lawyers be present in the war room or the audit room?
  • Do you have a template email ready to send out to inform employees when an inspection occurs?
  • Have you had a discussion with employees to make them “audit ready”?
  • Never leave the inspectors alone.
—Darshan Kulkarni and Samantha Ricketts
 
Darshan can be reached at (215) 703-7842 or by email at Darshan@conformlaw.com. You can also find him on Twitter @FDAlawyers.
About
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 (http://www.twitter.com/FDALawyers) or visit the Kulkarni Law Firm's Web site (http://www.conformlaw.com/).

Disclaimer
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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