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  1. Guidance, Compliance, & Regulatory Information

FDA Responses to Action Items From September 20-21, 2016 Inter-governmental Working Meeting on Pharmacy Compounding

FDA Responses to Action Items From September 20-21, 2016 Inter-governmental Working Meeting on Pharmacy Compounding

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  1. FDA will explore developing training for state regulators on insanitary conditions and key elements of current good manufacturing practice requirements.

    In November of 2017, FDA will provide an educational session for state compliance officers and other state regulatory personnel on FDA inspection protocols for compounding facilities, including key CGMP requirements and potential insanitary conditions assessed during outsourcing facility inspections. In addition, FDA will explore the potential of developing recorded materials covering the same topics as the educational session that may be made available to states as a resource.

    The Agency is also expanding opportunities for states to join FDA inspections of outsourcing facilities. FDA currently invites states to join inspections of outsourcing facilities that are located in their jurisdictions. In addition, states may request to attend an FDA inspection of a specific nonresident outsourcing facility that ships into their state, if the nonresident outsourcing facility has authorized the state to conduct such an inspection. FDA will describe this process in a forthcoming communication to States.

  2. FDA will explore how to provide more information to states that they can use to assess the compliance status of compounders that FDA has inspected, including the significance of particular inspectional observations and violations frequently identified in regulatory actions.

    To help states understand certain FDA inspectional observations and violations frequently identified in regulatory actions, FDA is developing a chart that describes examples of insanitary conditions and key CGMP violations, as well as corrective actions that firms take to address them.

    In addition, a chart currently available on FDA’s website describes the categories of information that are gathered during or after an FDA inspection, the types of non-public information that might be included in the various categories of information, and the conditions under which such non-public information can be shared with a state.  Additional information concerning information sharing can be found on FDA’s compounding information for states webpage.

    Finally, state officials that are commissioned or subject to an information-sharing agreement under 21 CFR 20.88 who would like to request documents generated during or based on an FDA inspection, or who would like to request a teleconference with FDA to discuss information sharing, may contact the Division of Information Disclosure Policy, Office of Strategic Planning and Operational Policy (OSPOP) at info-share@fda.hhs.gov.

  3. FDA will provide information regarding its process for initiating inspections of newly registered outsourcing facilities and evaluate what information it can share with states with respect to such facilities pending an inspection.

    As resources permit, FDA seeks to inspect newly registered outsourcing facilities within two months of initial registration, unless the facility was recently inspected before it registered as an outsourcing facility. FDA intends to continue to invite state officials to accompany FDA investigators on the inspection. In addition, FDA is developing a process to provide information on its website regarding the operating status of newly registered outsourcing facilities to inform the public of situations in which FDA has not initiated an inspection of a newly registered outsourcing facility because the facility is not operational.  FDA is also developing a process to post outsourcing facility product reports that list the drugs compounded by an outsourcing facility during the previous six-month period.

  4. FDA will explore how states can ascertain, during or after their inspections, whether a drug product compounded by a facility that they inspected was on FDA’s drug shortage list at the time of compounding.  

    FDA’s Drug Shortages Database provides information concerning current and resolved shortages. When a shortage is listed as “resolved,” the entry indicates the start and end dates of the shortage. In addition, when the status of a drug is “currently in shortage,” the entry identifies the date on which the entry was first posted. FDA encourages state officials to review FDA’s Drug Shortage Database to determine whether a drug is or has been in shortage, and to contact FDA at IGA@fda.hhs.gov with any questions. Information on historical periods of shortage may be accessed through https://archive.org/web/. Once on FDA’s archive site, enter FDA’s drug shortage page URL (www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm) to see archived versions of FDA’s shortage list.

  5. FDA will consider whether and how it can provide technical assistance when requested by states with respect to potential changes in state laws, regulations or policies related to compounding.

    FDA encourages state officials to contact FDA at IGA@fda.hhs.gov if, as they engage in potential legislative or regulatory changes, they have questions concerning similarities or differences with Federal law. FDA can provide technical assistance as requested.

  6. FDA will work with NABP, the Federation of State Medical Boards, and the Centers for Disease Control and Prevention to explore educational outreach efforts on compounding drugs regarding, for example, quality standards.   

    FDA is working to develop a webinar on insanitary conditions in compounding facilities to disseminate to stakeholders, including physicians and other practitioners.