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  1. Human Drug Compounding

FDA Responses to Action Items From November 16-17, 2015 Inter-governmental Working Meeting on Pharmacy Compounding

1. FDA will continue to explore options for sharing information with states that have sunshine laws, including whether a modified information sharing agreement could be developed.

As part of our ongoing effort to improve communication with the states, FDA has been working to address issues and concerns raised at past inter-governmental meetings on pharmacy compounding. That effort included developing a revised, five-year, single-signature 20.88 information agreement for compounding, which has been signed by ten state entities. This agreement allows FDA to respond faster to information requests from states and results in less paperwork for the states. FDA can share certain kinds of non-public information with states under the agreement, either on our own initiative or in response to a request from a state. The following entities have signed a five-year, single-signature agreement: Arizona, California Department of Justice, California Board of Pharmacy, Delaware, Maryland, New Jersey, Oregon, Texas, Utah, and Wisconsin.

Another step we have taken to further explore options for sharing information with the states is to research which states have entered into 20.88 agreements with FDA that are not specific to compounding. During the FDA/State Collaboration and Communication panel of the September 20-21, 2016 Inter-governmental Working Meeting on Pharmacy Compounding, we plan to present what we have learned about these 20.88 agreements and discuss whether the states that have entered into such agreements also may be able and willing to engage in similar 20.88 agreements specific to compounding.

2. FDA will explore whether the 5 year, single signature information sharing agreement could be adapted to cover both compounding and supply chain security so that states would not have to sign multiple agreements.

FDA has created two new information sharing agreements:

The agreement that covers drug compounding only is also still available.

3. FDA will consider whether and to what extent it could offer training to state inspectors on CGMP standards.

FDA recognizes that states may wish to independently inspect outsourcing facilities for quality assurance, particularly when a state requires more frequent inspections to maintain state licensure than FDA currently conducts. State desire to inspect outsourcing facilities has also resulted in a desire for training on conducting a CGMP inspection. FDA remains committed to supporting states by providing needed training, but would like to understand from states whether an increase in the frequency of FDA outsourcing facility inspections – which is FDA’s goal – would alter states’ desire to conduct independent inspections. Given the complexity of full CGMP inspections, we would also like to understand whether states would see utility in training on an abbreviated inspection for outsourcing facilities focusing on insanitary conditions, as well as significant potency problems. During the upcoming intergovernmental meeting, we will run breakout sessions with states dedicated to discussions of these issues so that we can have a clear understanding of state needs and establish a refined action item for the development of appropriate training.

4. FDA will determine how best to communicate with states regarding compounders who restart operations after they were asked to voluntarily cease operations, so that FDA and the states can be sure the firm took adequate steps to correct the deficiencies that led to the request to cease operations.

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.

5. FDA will consider publishing a guidance on insanitary conditions at facilities that engage in compounding.

On August 3, 2016, FDA published a draft guidance document titled, “Insanitary Conditions at Compounding Facilities.”

6. FDA will continue discussions with the states regarding coordinating with the states on the oversight of outsourcing facilities.

FDA has prepared a set of preliminary recommendations for aligning federal and state regulation of compounders registered as outsourcing facilities. FDA looks forward to discussing these recommendations with states during the September 20-21, 2016 Inter-governmental Working Meeting on Pharmacy Compounding, and welcomes written feedback from states following the meeting. At the meeting we also look forward to discussing issues related to outsourcing facility oversight not covered by this document, including CGMP inspections and outsourcing facility distribution practices.

 

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