1. FDA will consider, in collaboration with NABP, implementing a quarterly call with state regulators to discuss policy and oversight matters of mutual concern. The agenda for such calls would be collaboratively set by FDA and NABP in advance.
FDA intends to work with NABP to conduct calls with state regulators following the issuance of policy documents or other announcements related to drug compounding that are of relevance to states. In advance of such calls, FDA intends to work with NABP to identify other topics of interest to states for additional discussion during the call. FDA intends to hold the first of such calls in August 2018.
2. FDA will explore ways to continue to improve information sharing with states. For example, data from states can help to inform FDA’s risk-based oversight of compounding facilities so that the agency uses its inspection and enforcement resources in a way that has the greatest public health impact. Information from FDA, such as inspectional findings or adverse events related to compounding facilities, can help states address public health concerns affecting their citizens.
FDA continues to work to strengthen information-sharing between the agency and state partners in support of coordinated efforts to oversee drug compounding activities and address public health concerns.
As described in FDA’s 2018 Compounding Priorities Plan, the agency intends to issue a revised draft standard Memorandum of Understanding (MOU) pertaining to interstate distribution of compounded drugs. Once revised and issued in final form, the MOU will help ensure robust communication between the FDA and its state partners regarding compounded drugs distributed interstate, as well as complaints and investigations related to them. FDA intends to use this information, in part, to help inform the agency’s risk-based inspection approach for compounding facilities.
FDA also seeks to proactively provide information to states when possible. When appropriate, the agency currently refers inspectional findings to states for follow up, and we also intend to routinely share with states, to the extent permissible under our disclosure laws, adverse event reports or complaints involving compounded drugs that are relevant to individual states.
FDA intends to continue to engage in discussion with state partners regarding additional opportunities to share information in support of our mutual public health goals.
3. FDA will work with NABP to identify information that would be useful to states from outsourcing facility product reports. Where identified, FDA will explore ways to make this information more accessible to states.
FDA is working to improve accessibility of outsourcing facility product report information on our website, and has begun to post a single excel document containing information from all product reports provided by outsourcing facilities over the current calendar year. FDA intends to update this document at each reporting period, and to issue a communication to states when new product report information is made available. FDA has also begun to include contact information for outsourcing facilities on FDA’s website. FDA intends to continue to engage with states regarding what information in these reports may be of use to states, and will include a discussion of this topic on an upcoming FDA-state call.
4. FDA will consider holding, during the 2018 Intergovernmental Working Meeting, a session concerning the use of bulk drug substances in compounding.
FDA will include a session concerning the use of bulk drug substances in compounding during the 2018 Intergovernmental Working Meeting.