October 2, 2018

On Sept. 24, 2018, the U.S. Food and Drug Administration (FDA) convened its seventh inter-governmental working meeting as part of its commitment to maintaining close communication with its state co-regulating partners to assure more robust oversight of compounders. As part of the collaborative efforts undertaken to reduce risk, these annual face-to-face proceedings bring key FDA officials together with representatives of the fifty states including officials from the state Boards of Pharmacy and Health Departments and organizations that represent state officials, including the National Association of Boards of Pharmacy and the Federation of State Medical Boards, and representatives from the Centers for Disease Control and Prevention. FDA also engages with the states on an ongoing basis through joint state and federal inspection activity, co-participation in recall discussions with noncompliant firms, sharing of federal inspection and enforcement information (including nonpublic information with those who have entered into information-sharing agreements that allow FDA to share such nonpublic information in accordance with Federal law) and individual stakeholder meetings upon request (as resources permit).

As a practical matter, the enforcement tools available to the FDA differ from those available to the states and when aligned, these federal and state powers can have a significant impact. For example, although the FDA can recommend recalls of compounded drug products, it does not have the authority to require them. Nevertheless, the FDA’s inspectional findings indicating lack of sterility assurance have, when shared with state boards, contributed to the more than 200 recalls conducted by compounders since 2012. And while the FDA does have the authority to issue injunctions and seizures when deemed necessary to protect public health, in the event of immediate public health risk, it is the state boards that can act most rapidly through immediate state licensure suspension.

Among other topics, this year’s meeting focused on the release of three new important compounding policy documents by the FDA:

Revised Draft Guidance: Insanitary Conditions at Compounding Facilities

This revised draft guidance incorporates significant changes to the first draft guidance, which were made based upon comments received from various stakeholders (e.g., physicians, pharmacies), particularly concerning the implications of its proposed policies for physicians who prepare drugs in their offices. That draft guidance provides examples of insanitary conditions that the Agency had observed at compounding facilities and describes corrective actions that should be taken when such conditions are identified as well as the regulatory actions the FDA may take in response to identified insanitary conditions. FDA has issued this revised draft guidance to enable the public to further review and comment (by November 26, 2018) before it finalizes Agency policies concerning insanitary conditions. The draft also serves as a resource to states as they conduct day-to-day oversight activities of both sterile and non-sterile compounding facilities and to compounders who have an obligation to identify and correct insanitary conditions at their facilities. This document can be found here.

Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by State-Licensed Nuclear Pharmacies, Federal Facilities, and Certain Other Entities and Final Guidance: Compounding and Repackaging of Radiopharmaceuticals by Outsourcing Facilities

The guidances address the various needs for radiopharmaceutical compounded drugs, including minor deviations from approved radiopharmaceutical, a radiopharmaceutical compounded drug incorporating a bulk drug substance, and a repackaged radiopharmaceutical compounded drug. These three scenarios are addressed to preserve patient access while reducing risks to both patients and the integrity of the FDA’s drug approval process. These documents can be found respectively here.

If you have any questions about the FDA’s new guidance documents or to learn more about how the federal and state co-regulatory authorities engage to protect public health, please contact a member of Hancock Daniel’s Life Sciences team.


The information contained in this advisory is for general educational purposes only. It is presented with the understanding that neither the author nor Hancock, Daniel & Johnson, P.C., is offering any legal or other professional services. Since the law in many areas is complex and can change rapidly, this information may not apply to a given factual situation and can become outdated. Individuals desiring legal advice should consult legal counsel for up-to-date and fact-specific advice. Under no circumstances will the author or Hancock, Daniel & Johnson, P.C. be liable for any direct, indirect, or consequential damages resulting from the use of this material.

Print Friendly, PDF & Email