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June 2024 Electronic Mailbags

June 4, 2024

June 6, 2024

June 13, 2024

June 20, 2024

June 27, 2024

MPJE State-Specific Review Survey

The National Association of Boards of Pharmacy (NABP) will host the Multistate Pharmacy Jurisprudence Examination (MPJE) State-Specific Review September 11-13, 2024, at NABP Headquarters in Mount Prospect, IL.

The State Specific Review is a collaborative effort between NABP and all participating state and jurisdictional (“State”) boards of pharmacy to help safeguard public health in the United States. The laws and regulations of each State can rapidly change, making our collaboration even more important. The review ensures that the most current and valid items are available for testing in each jurisdiction. In addition to the review, new items must be selected for pre-testing in each jurisdiction. Both the review and selection of new items are integral to the validity and the sustainability of the examination program.

The role of each State is critical in this process. We ask that you please designate up to two subject matter experts (SMEs) on your state’s law to join us for this very important work.

As a reminder, test security is a vital part of the validation process. Before participating in any of the NABP examination programs, each designated SME must sign the NABP Statement on Conflict of Interest, Copyright, and Confidentiality Agreements. The Competency Assessment department will send a separate email containing electronic versions of these agreements.

In-Person Attendance

NABP will reimburse approved expenses (travel, food, and lodging) for up to two participants from each State to attend the meeting. However, NABP may need to limit the participants from one or more States in the event of space limitations. Dedicated time and in-person collaboration to complete this work at NABP headquarters is strongly encouraged. Please respond as soon as possible to reserve your spot!

Tentative in-person meeting schedule (all times are in CDT):

In-person participants will be contacted by the NABP Meeting Services department regarding travel and hotel information approximately eight weeks before the meeting once NABP has secured the names of the attendees.

Participant arrangements will be confirmed two weeks before the meeting.

Remote Option

If your State is unable to send a representative to NABP headquarters, the item review will need to be completed remotely. Remote participants will have 4 weeks to complete the review. Scheduling specific time to dedicate to this task is a best practice shared by experienced remote reviewers in the past.

Remote work schedule:

Please submit the response form no later than Friday, July 12, 2024, and provide the contact information for the SME(s) who will attend the meeting on-site (up to 2 participants) and/or those who will complete the review remotely.

Boards should notify NABP at any time throughout the year if there is a rule change that may impact the MPJE. We are available to support an urgent ad hoc review, as needed, prior to the state specific review meeting in September.

For questions or comments, contact Santa Ardito at sardito@nabp.pharmacy.

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Resolutions Passed at the 120th NABP Annual Meeting

The resolutions passed at the 120th National Association of Boards of Pharmacy (NABP) Annual Meeting have been posted on the NABP website in the News section. Each year after the Annual Meeting, the Executive Committee reviews this information, and discusses the appropriate course of action towards completion of the Association’s directives in a timely fashion. NABP welcomes feedback on any of our current initiatives from member boards and affiliated members. Accordingly, please forward any suggestions you have for implementation of the resolutions to ExecOffice@nabp.pharmacy by Monday, July 8. All suggestions will be compiled and presented to the Executive Committee at their next meeting.

The resolutions, as originally drafted, were first forwarded to the executive officers of state boards of pharmacy prior to the NABP Annual Meeting for comment. The resolutions were also presented to the delegates at the Annual Meeting for discussion and approval.

If you have any questions, please feel free to contact Lemrey “Al” Carter via phone at 847/391-4400 or via email at ExecOffice@nabp.pharmacy.

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DSCSA Exemptions from Certain Requirements for Small Dispensers

In August 2023, the Food and Drug Administration (FDA) established a one year stabilization period to accommodate additional time for all trading partners to implement, troubleshoot and mature systems and processes to fully implement the DSCSA enhanced distribution security requirements.

On June 12, 2024, FDA issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements in section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026.

For purposes of the exemption, a dispenser is considered a “small dispenser” if the corporate entity that owns the dispenser has a total of 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians. The specific exemptions relate to portions of section 582 of the FD&C Act and primarily relate to the enhanced distribution security requirements that are detailed in the attached letter.

While NABP is still analyzing the exemptions, it is critical to point out that these exemptions do NOT exempt small dispensers from their existing compliance obligations under DSCSA. For example, small dispensers must still:

  1. Ensure they are only doing business with authorized trading partners;
  2. Conduct suspect or illegitimate product investigations in accordance with the DSCSA; and
  3. Respond to requests for transaction information from federal and state regulators as part of a recall or a suspect or illegitimate product investigation.

Dispensers can still rely on existing methods for providing transaction information, which may be the paper or electronic forms of transaction history that currently accompanies shipments of product.

State boards of pharmacy should continue to assess dispenser compliance for the existing DSCSA requirements and should work to educate the dispenser community on their existing obligations, as well as what steps they should take to satisfy the enhanced distribution security requirements. The FDA “strongly urges dispensers to continue their efforts to implement necessary measures to satisfy these [exempted …] requirements.”

To that end, NABP is developing a Dispenser Guide to Achieving DSCSA Compliance with a targeted release of early July. The Guide will also be accompanied by training that will be available to board of pharmacy staff, as well as the dispenser community. If you have any questions, please feel free to contact Josh Bolin via email at jbolin@nabp.pharmacy.

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NABP Comments to Senate Finance Committee Regarding Drug Shortages

The National Association of Boards of Pharmacy (NABP) provided the attached comments to the Senate Finance Committee’s discussion draft legislation to combat prescription drug shortages.

Pulse by NABP™ is an inclusive, accessible, and secure digital platform that simplifies the process of achieving DSCSA compliance. Once the directory is fully implemented and utilized, new functionality can be built on to the platform which could provide insights to providers, patients, and stakeholders about drug shortages.

NABP continues to engage with federal partners to find solutions to drug shortages that negatively impact public health.

Please reach out to Andrew Funk (afunk@nabp.pharmacy) for additional information or if you have any questions.

Attachment

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NABP Announces Wellbeing First Champion Challenge Training Webinar

The National Association of Boards of Pharmacy (NABP) is pleased to invite board of pharmacy executive officers to join a closed-session webinar, titled Improving Mental Health Access for Pharmacy Staff, as a follow-up to the 120th NABP Annual Meeting keynote address delivered by Corey Feist, MBA, JD. During this session, Feist and other representatives from the Dr. Lorna Breen Heroes’ Foundation will continue the discussion on provider well-being, reducing burnout, and removing overly broad and invasive mental health questions from licensure and credentialing applications. You and your staff play an important role in reducing the fear and stigma that health workers have regarding losing their ability to practice if they seek help for mental health conditions.

This webinar will provide an opportunity to learn more about the Wellbeing First Champion Challenge and other actionable information to safeguard the well-being of health professionals.

Improving Mental Health Access for Pharmacy Staff
Date: Thursday, July 11, 2024
Time: 1 PM CDT
Duration: 60 minutes

More information about the session, including registration details, can be found on the Zoom Webinars event page. After signing up for the webinar, registrants will receive a confirmation email with details on how to join the online session. This activity is not eligible for Accreditation Council for Pharmacy Education-accredited continuing pharmacy education credit.

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FDA Webinar on Environmental Monitoring in Compounding – July 30, 2024

Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research, Small Business and Industry Assistance program will be hosting a webinar on July 30, 2024, 2-3:30 PM, titled, Environmental Monitoring in Compounding. Attendees will be provided with an overview of environmental monitoring and the role it plays in ensuring product quality and patient safety. FDA will also discuss their expectations for compounding pharmacies and outsourcing facilities for environmental monitoring. This webinar is recommended for outsourcing facilities, compounding pharmacies, and their consultants, as well as for state pharmacy regulators. More information and a registration link are available here. 

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