March 2024 Electronic Mailbags

DEA/HSS Joint Letter on MOUD

Representatives of the Drug Enforcement Administration (DEA) and the Department of Health and Human Services (HSS) have jointly signed a letter supporting the expansion of medications for opioid use disorder (MOUD), especially in rural or underserved areas.

See the attached announcement for more details.

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Decentralized Clinical Trials for Drugs, Biological Products, and Devices

The National Association of Boards of Pharmacy® (NABP®) is providing the following background information regarding the increasing shift from physical-site attendance clinical trials to decentralized clinical trials (DCT) and the distribution and administration of investigational product (IP). 

The Food and Drug Omnibus Report Act (FDORA) of 2022 required Food and Drug Administration (FDA) to issue or revise draft guidance for DCT that includes recommendations to clarify and advance the use of decentralized clinical studies to support the development of drugs and devices. FDORA requires the guidance to address considerations for sponsors to minimize or reduce burdens for clinical trial participants associated with participating in a clinical trial such as direct-to-participant shipping of investigational drugs and devices and provide recommendations regarding conducting DCTs to facilitate and encourage meaningful diversity among clinical trial participants including with respect to race, ethnicity, age, sex, and geographical location, as appropriate. 

In May, 2023, FDA posted Decentralized Clinical Trials for Drugs, Biological Products, and Devices Guidance for Industry, Investigators, and Other Stakeholders. Notable exerts from the guidance document include:

Further, in September, 2023, FDA issued Considerations for the Conduct of Clinical trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies Guidance for Industry, Investigators, and Institutional Review Boards.

Question #9 in the guidance states, “If patients are currently dispensed IP through a pharmacy at the clinical trial site for self-administration at home, can a sponsor switch that to home delivery without amending the protocol?” FDA’s response begins with, ” Home delivery of IP that would not raise any new safety risks may be implemented to protect patients from risks associated with coming to clinical trial sties.

FDA supports the use of DCTs and have been working with industry to help advance such trial designs. You may reach out directly to FDA by emailing or to NABP ( with any questions or concerns.

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Exam-Focused Videos Released on NABP’s YouTube Channel

The National Association of Boards of Pharmacy (NABP) is pleased to announce the release of three new examination videos on the NABP YouTube channel. The videos aim to provide candidates with a greater understanding of the examination process for the North American Pharmacist Licensure Examination, the Multistate Pharmacy Jurisprudence Examination, and the Foreign Pharmacy Graduate Equivalency Examination. NABP is committed to supporting candidates throughout the exam process by providing information, tools, and resources.

The newly released videos include:

Watch the videos to learn more, and visit the NABP website for information about the exams. Stay on the lookout for more NABP resources in the future.

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