Action Item 1: FDA will reexamine the language in 20.88 agreements to determine whether it can be modified in any way to remove disincentives to signing such agreements.
- FDA can share certain non-public information with State officials under agreements, commonly referred to as 20.88 agreements, in reference to FDA regulations in 21 CFR 20.88 that govern such sharing of information. FDA created a new Single-Signature 20.88 Long-Term Drug Compounding Information Sharing Agreement (long-term 20.88 agreement) that will last for five years, rather than one year, and will only need to be signed by the head of a state Board of Pharmacy or other agency involved in the protection of public health, rather than requiring each individual staff member’s signature, although its terms of non-disclosure will apply to subordinate staff who will have access to information shared under the agreement. FDA hopes that this new type of agreement will facilitate sharing of certain non-public information with state officials.
Action Item 2: FDA will provide to states more clarity on the commissioning process to facilitate joint oversight. The Agency will consider developing a “how to” guide for states so they may better understand the process.
- Commissioning and credentialing provide FDA mechanisms for enhancing Federal and State collaboration in the oversight of compounding.
- FDA can share with Commissioned officials non-public information, including trade secret and confidential commercial information (CCI), that has been obtained by FDA.
- Credentials allow State regulatory authorities to operate in the field under FDA authorities, for example, to conduct a joint inspection with FDA and collect samples or records as part of that inspection.
- To become commissioned or obtain credentials, there are multiple requirements. Among these requirements, the commissioned official must agree to protect from disclosure any non-public information that FDA provides as a result of the official’s commissioned status, or any information collected using the credentials to obtain access to the information. Chapter 3 of FDA’s Regulatory Procedures Manual Commissioning contains the procedures that describe how State regulatory personnel can become Commissioned and obtain Pocket Credentials.
- FDA is reviewing these procedures and may revise them. Depending upon the outcome of that review, FDA will consider developing a “how to” guide for states.
- Until a “how to” guide is available, direct any inquiries or requests for assistance concerning the commissioning or credentialing processes to ORA/Office of Partnerships for commissioning (firstname.lastname@example.org) and ORA/Office of Policy and Risk Management (infoshare-ORA@fda.hhs.gov) for credentialing information.
Action Item 3: FDA will work with the states to determine what types of information gathered during or after an FDA inspection might be necessary for a state to take rapid enforcement action to protect the public health, and explore whether that information can be made available more quickly so the states can use it.
- FDA created a chart, Compounding Domestic Inspection Information Sharing Chart (PDF - 114KB), to describe what categories of information are gathered during or after an FDA inspection, what types of non-public information might be included in the various categories of information, and the conditions under which such non-public information can be shared with a state.
- The chart is a tool to enhance communication between the FDA and the states with regard to sharing information collected during an inspection when the state has commissioned officials or is operating under a long-term 20.88 agreement.
Action Item 4: FDA will clarify what types of information acquired during an inspection are considered to be CCI and exempt from disclosure.
- The chart created for item 3 above addresses this issue.
Action Item 5: FDA will consider whether it can provide states with earlier notification of violations before posting a 483 or issuing warning letters.
- States with Commissioned Officials: FDA plans to provide commissioned officials an unredacted copy of any Form FDA-483 for a compounding facility located in that state one business day after it has been issued to the firm. FDA plans to share unredacted copies of Warning Letters with such commissioned officials the day the Warning Letter is provided to the firm and receipt by the firm is confirmed. FDA will be able to do this because it is authorized to disclose to a commissioned official the types of non-public information such documents typically contain.
- States Without Commissioned Officials: FDA plans to provide a state official that is not commissioned with a copy of a redacted Form FDA-483 or Warning Letter from which nonpublic information has been redacted for a compounding facility located in that state. We intend to provide the letter or Form FDA-483 at least one business day before it is posted, unless FDA has an urgent need to post immediately, without providing it to the state.
- FDA would redact certain information from these documents because FDA is only permitted to share certain types of non-public information with state officials that are not commissioned. (See chart in response to Action Item 3).
- If the state does not have a commissioned official, and needs a copy of the Form FDA-483 before receiving a redacted copy, it may request that a copy be provided under a 20.88 agreement. The copy would contain the types of nonpublic information that may be shared under the agreement.
Inspections and Enforcement
Action Item 1: FDA will work with states to determine ways to streamline communications, for example, by delegating one point of contact for coordination of inspections while providing advanced notification of scheduled inspections.
- FDA intends to take the following steps to provide advanced notification of scheduled inspections:
- At the time FDA’s Office of Regulatory Affairs (ORA) receives an assignment for an inspection, the FDA District Director or Director of Investigations in the relevant district will notify the state Board of Pharmacy that a compounding inspection will be conducted.
- The State Board of Pharmacy (BOP) (and Department of Health or other relevant agency) will be invited to participate in the FDA inspection.
- Every effort will be made to coordinate schedules to facilitate a joint inspection. However, inspections will not be unreasonably delayed if schedules cannot be readily coordinated so that the State can participate, and if the inspection is scheduled, it should proceed as scheduled, even if the state has an unanticipated schedule conflict.
- The FDA District Director is the designated point of contact for the state on matters related to FDA inspections.
Action Item 2: FDA will work with states to clarify the difference between joint and parallel investigations.
[FDA uses the term simultaneous inspections rather than parallel inspections, and will use that term in the response below.]
- During a joint inspection, FDA and state officials conduct the inspection together, assisting one another during the inspection, and discussing inspectional findings. During separate simultaneous inspections, FDA and state officials each conduct their own inspections, under their own authority at the same time.
- Whether a particular inspection is conducted jointly or simultaneously with state officials depends on the circumstances.
- In general, joint FDA-state inspections should be considered when state inspectors are commissioned or credentialed or there is an information sharing agreement in effect (such as a 20.88 agreement) between FDA and the state, so that information can be readily shared.
- Simultaneous inspections typically occur when there is no information sharing agreement in place. In a simultaneous inspection, each inspector collects information under their own authority, and may not be able to share the information collected with the other inspector.
Action Item 3: FDA officials will consider how to provide additional training opportunities to state investigators on how to perform sterile inspections.
- FDA intends to offer a webinar for state investigators to increase their awareness of how FDA conducts inspections of sterile drug compounding facilities.
Action Item 4: FDA will consider whether it can inspect outsourcing facilities more frequently than every three years.
- FDA plans to inspect outsourcing facilities every 12 to 18 months, resources permitting, until inspections of a facility are consistently classified “no action indicated” (NAI). After that time, inspections may be conducted less frequently, but FDA plans to inspect each outsourcing facility at least once every three years, resources permitting.
Action Item 5: FDA will work with states on improving the process for supporting the states in enforcement actions, including providing testimony, declarations and affidavits.
- FDA provided witness preparation training to 115 FDA staff members, including staff from FDA field offices and FDA headquarters, on April 24, 2014. This training will continue to be made available for employees as needed.
- Since the Inter-governmental Working Meeting on Pharmacy Compounding in March 2014, and as of January 23, 2015, FDA has received and responded to three compounding-related requests for testimony, including one request for a declaration and two requests for testimony.
- FDA will continue to work with the states to improve the process for supporting the states in enforcement actions. The ORA/Office of Policy and Risk Management/Testimony Specialist (infoshare-ORA@fda.hhs.gov) is the designated contact for requests for testimony and can be contacted about any concerns about the quality of FDA support for these actions.
Reporting Adverse Events
Action Item: FDA will consider how best to share with states adverse event reports submitted to the Agency and how to help states establish their own reporting systems that are not duplicative of the federal system.
- Commissioned officials can request that FDA provide them with unredacted adverse event reports when necessary to respond to a specific emergency such as a potential contamination issue.
- FDA is willing to have further discussions with the states and National Association of Boards of Pharmacy (NABP) about how they could develop a reporting system that might provide them with the data they are seeking.