Lessons from a “War” Between a Compounding Pharmacy and FDA 
​​[Posted on: Thursday, March 8, 2018]

In an interesting development, a compounding pharmacy in Arkansas this week filed for a “Temporary Restraining Order” to prevent the FDA from shutting it down after an almost 5 years of back and forth with the FDA auditors and the company being on the verge of permanent closure by FDA. Before we run to judgment it is important to review the full back story to pick a side. Cantrell Drug Company (Cantrell) is a compounding pharmacy in business since 1952 and compounds several sterile drugs primarily for hospitals. Cantrell is registered with FDA as a 503B Outsourcing Facility. In the last 65 years of operation, there were no reports of any adverse events associated with drugs manufactured by Cantrell. Cantrell’s troubles started with a nine day audit of its facilities in Oct-Nov 2013 where FDA auditors found several violations in compliance with GMP requirements. That was the same time the nation was reeling with the nationwide fungal meningitis outbreak due to contaminated steroid injections compounded at New England Compounding Center that caused infections in 751 patients, 64 of which died. FDA was on high alert to regulate compounding pharmacies and Congress gave it more powers via the Compounding Quality Act of 2013. Cantrell was audited by FDA three times between 2013 and 2017; and each time FDA 483s were issued. Each of the FDA 483 issued to the company was uncharacteristically detailed, running up to 22 pages with multiple issues identified for non-sterile practices, documentation errors, and insufficient validation. It does seem that the FDA auditors were being overtly harsh to the compounding pharmacy. Reviewing the 483s shows that FDA auditors left no stones unturned to evaluate the deficiencies at the site; the auditors spent weeks at the site, coming back to observe the operations and review documents. In all three 483s there were several repeat issues. From the documents available on FDA’s website, it is apparent that Cantrell tried to respond to the audit findings to the best of its capabilities but could not satisfy the FDA. The company hired multiple external consultants and contractors to address the deficiencies, approached FDA multiple times for feedback, and made changes, in vain. It seems that the company kept trying to comply with the industry standards for 503B compounding pharmacies, while FDA pursued pharmaceutical GMP per 21 CFR 210. Cantrell seemed to respond point by point to the FDA findings and complained that FDA did not provide feedback. The key issue seems to be miscommunication between the company and FDA. The company also did not seem to slow down its operations during the updates, which made FDA increasing worried for an impending accident. In any case, it seems the company and FDA have reached an impasse where the company decided to continue its operations, while FDA wanted it to shut it down permanently via a consent decree. In the past FDA has been successful in shutting down companies in similar situations but this time Cantrell is not willing to comply with the FDA’s wishes. Rather has picked a fight with the FDA. It filed a dueling lawsuit to counter FDA’s lawsuit asking the courts to force FDA to negotiate a resolution with Cantrell while it continues its normal business operations. Courts seldom decide against FDA but this seems to be a compelling case for the courts. If the courts decide in the favor of Cantrell, it could show other companies in similar situations a way out. If there is a case that requires courts to intervene, this seems to be it. We will follow closely.