California State Board of Pharmacy Intends to Enter the Food and Drug Administration’s Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products

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By Steven Funk

On April 29-30, 2021, the California Board of Pharmacy (Board) held a meeting [Agenda Item XI(b–c)], where the Board expressed its intention to sign the Food and Drug Administration’s (FDA) Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products (MOU). The FDA announced on October 27, 2020, that the MOU is now available for signature by state board of pharmacies or other state agencies. The MOU addresses the interstate distribution of inordinate amounts of compounded drugs and complaint investigations by state boards of pharmacy or other state agencies into compounded drugs distributed outside the state.

During the meeting, the Board’s Enforcement and Compounding Committee considered a presentation [Attachment 1] by the National Association of Board of Pharmacy (NABP), which covered the basic provisions of the MOU. The presentation also covered many of the requirements established by the MOU, including reporting and investigation activities. In particular, the presentation provided in-depth coverage on the NABP system designed to provide guidance on how to effectively implement some of the reporting requirements established by the MOU.

After the presentation by the NABP, the committee considered the substance of the MOU to determine if a recommendation to the Board to enter the MOU was appropriate. After considering policy questions, the committee decided it was appropriate to sign the MOU if the Board could meet specific conditions related to the effective regulation of the interstate distribution of compounded medications. The conditions the Board would need to complete include amending section 4110(a) and adding section 4126.9 to the Business and Professions Code, and ensuring sufficient resources for implementation are secured. In arriving at its conclusion, the committee also considered significant public comment the Board received encouraging it to sign the MOU, including what appeared to be a national petition with thousands of signatures—primarily from members of the public, practitioners, and patients throughout a wide range of states.

The committee’s draft of a statutory proposal to amend Business and Professions Code section 4110(a) adds that a licensee who undergoes the annual requirement to renew his or her license to conduct a pharmacy in California “[s]hall include the matters identified by the board in the renewal application, included but not limited to, notification to the board regarding compounding practices, including compounded prescriptions distributed outside of the State.”  In addition, the committee’s draft of a statutory proposal to add Business and Professions Code section 4126.9 requires that a pharmacy located in California may only distribute compounded drug preparations for interstate distribution if the pharmacy reports all required data into the Information Sharing Network established by the NABP in conjunction with the FDA to implement the MOU, and reports adverse drug experiences and product quality issues for all compounded products to the Board within 12 hours. The proposal to add section 4126.9 to the Business and Professions Code would also establish that “[a]ll information reported by the board to the FDA directly or through the Information Sharing Network established in conjunction with the FDA [would be] deemed confidential information as specified in California Government Code section 6254(f) if it relates to information regarding a complaint received or the investigation of any such complaint.”

On August 9, 2021, the FDA announced that it extended the time for states to decide whether to sign the MOU from October 27, 2021, to October 27, 2022. States may sign the MOU at any time, including after the extension deadline of October 27, 2022. However, at the end of the extended deadline, the FDA “intends to begin enforcing the statutory five percent limit on distribution of compounded human drug products out of the State in which they are compounded in State that do not sign the final standard MOU as of August 9, 2021.”

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