Resuming Compounding after FDA Inspection


In the January 2016 Intergovernmental meeting on Compounding the FDA provided a response to the Nov 2015 meeting item concerning communication from FDA to the states when compounders resume operation.  The response to this item is provided from the USFDA site:

FDA intends to provide the following information to states regarding the Agency’s recommendations to compounders to cease sterile and/or non-sterile production until they implement appropriate corrective actions. FDA may have additional, non-public information (for example, regarding a firm’s documented corrective actions in support of resumption of operations) that we can share with state officials who are commissioned or who have entered into information-sharing agreements with FDA that permit the Agency to disclose the information.

  • If FDA recommends that a compounder cease sterile and/or non-sterile operations until implementing appropriate corrective actions, FDA intends to send an email advising all states of the recommendation and include a summary of any information about the reasons for FDA’s recommendation that the Agency can share publicly. In general, FDA plans to distribute to the states a summary of FDA’s teleconference with the compounder describing the Agency’s recommendation as well as the compounder’s response to the recommendation.
  • If a compounder that ceased operations to address concerns about drug production or product quality subsequently advises FDA that it has resumed or intends to resume operations, FDA intends to send an email notifying all states of this information. FDA’s notification to the states does not mean that the Agency concurs with or objects to the compounder’s decision to resume operations.
  • If, after reviewing findings from an inspection or documented corrective actions submitted to the Agency, FDA advises a firm that that the Agency does not object to the firm resuming operations, FDA intends to distribute a copy of that correspondence, redacted as necessary, to all states.

Sometimes, a compounder resumes operations without advising FDA, but notifies state(s). FDA asks that, if possible, state(s) advise FDA if and when they become aware that a compounder that ceased operations due to concerns about production practices or product quality (at the recommendation of FDA and/or a state) has resumed or intends to resume operations.