December 2024 Electronic Mailbags
December 12, 2024
December 19, 2024
NAPLEX Domain Crosswalk
In September, we informed you that the National Association of Boards of Pharmacy® (NABP®) had conducted a comprehensive analysis of entry-level pharmacy practice that resulted in the need to update the North American Pharmacist Licensure Examination® (NAPLEX®) blueprint. Additionally, we alerted you that the format of the blueprint was being revised to be organized as a content outline rather than the competency statement format we have used in the past. The updated NAPLEX blueprint in the content outline format was posted on our website on October 1, 2024. The NAPLEX content outline will take effect for exams administered on or after May 1, 2025. For additional information on the practice analysis and the reorganization of the domains, please visit the NAPLEX content outline blog.
While the NAPLEX content outline will have a different format and structure than the NAPLEX competency statements, much of the content on the exam remains the same. In response to feedback from the schools and colleges of pharmacy, NABP has worked to include more granularity to assist stakeholders in narrowing the scope of domains. The NAPLEX content outline will continue to provide the content areas assessed on the NAPLEX, along with the approximate number of questions that will be asked for each major content area.
To further support this transition, NABP has developed a content crosswalk that highlights the relationship between current competency statements and upcoming domains, including notation of new domains, in the content outline.
If you have any questions, please contact us at compassess@nabp.pharmacy.
FDA Issues Declaratory Order Confirming Tirzepatide Shortage Resolution
On December 19, 2024, Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research issued a declaratory order confirming its determination that the tirzepatide shortage has been resolved.
The order states that the agency does not intend to take action against compounders for violations of the Food, Drug, and Cosmetic Act (FD&C Act) arising from conditions that depend on the inclusion of tirzepatide injection products on FDA’s drug shortage list:
- For a state-licensed pharmacy under Section 503A of the FD&C Act compounding, distributing, or dispensing tirzepatide injections within 60 calendar days from FDA’s announcement, until February 18, 2025.
- For outsourcing facilities under Section 503B compounding, distributing, or dispensing tirzepatide injections within 90 calendar days from FDA’s announcement, until March 19, 2025.
FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe.