A small compounding pharmacy in southeastern Pennsylvania has come to learn just how frustrating it can be to undergo an FDA investigation.

Dorneyville Pharmacy (Dorneyville) in South Whitehall Township, Pennsylvania, underwent an FDA inspection from December 9, 2015 through January 7, 2016, after which the FDA inspector issued a “Form FDA 483” to the Dorneyville management. The FDA Form 483 notifies a company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.

Fast forward a year to February 7, 2017, and Dorneyville receives a letter from the FDA indicating that it had violated the Food, Drug and Cosmetic Act, specifically, that the pharmacy did not receive valid prescriptions for “individually identified patients” and that the pharmacy showed “serious deficiencies” in the sterile conditions required of pharmacies that compound drugs. (A copy of the FDA’s letter is located here). However, Dorneyville maintains that it had already provided a 56-page response to the FDA that details the corrective actions it took when it was issued the Form 483 in 2016. Confusion reigns—Dorneyville says it has fixed the issues cited during the 2015/2016 investigation while the FDA says that the matter is still open and that the pharmacy, “… should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.” (Emphasis ours.)

Dorneyville’s negative and ongoing experience with the FDA can be instructive for others. Compounding pharmacies should be up to speed on all their compliance obligations under the Food, Drug and Cosmetic Act and other applicable state and federal laws and regulations. They should also be prepared for government inspections and the potential aftermath if the inspector finds violations.

The FisherBroyles Pharmacy and Health Care Law team is available to assist you. We offer complete compliance reviews for pharmacies and health care entities across the U.S. and can also provide counsel during, and after, a government inspection. Please contact any of the following attorneys for assistance:

Brian E. Dickerson

Anthony Calamunci

Nicole Hughes Waid

Amy Butler

Katy Wane