A New Jersey-based sterile compounding pharmacy recently entered into a Consent Decree with the Food and Drug Administration (FDA) following an investigation by the Agency in which the pharmacy was cited for unsanitary conditions and violations of good manufacturing practice requirements. The pharmacy was also cited for producing and distributing numerous drug products without receiving patient-specific prescriptions and without having an approved new drug application or approved abbreviated new drug application for certain drug products.
As part of the Consent Decree, the pharmacy voluntarily recalled all of its sterile products and is enjoined from manufacturing, holding, and distributing drug products until it complies with certain requirements of the Food, Drug, and Cosmetic Act and all applicable regulations.
The FDA, along with State Boards of Pharmacy, have stepped up their efforts in inspecting pharmacies. Earlier this year, the FDA undertook to inspect over thirty facilities and issued citations and warning letters to numerous pharmacies. One way a pharmacy can prepare for a possible FDA inspection is by having in place carefully drafted Standard Operating Procedures (“SOPs”), outlining how the pharmacy should respond to an FDA inspection. These SOPs provide guidance for each stage of an inspection, from the minute inspectors arrive at a pharmacy’s door to post-inspection procedures. Contact Frier Levitt for assistance drafting your SOPs.
