Final answer:
The student's question relates to the procedures a pharmacy must follow regarding the anticipated discontinuance or closure, specifically the requirement to notify 15 days in advance. This requirement echoes the WARN Act's premise, but it is tailored to pharmacy operations and adheres to FDA regulations such as reporting adverse drug experiences.
Step-by-step explanation:
The question pertains to the regulatory requirements for a pharmacy when there is an anticipated discontinuance or closure. In particular, it references the need for the permit holder to provide a written notification 15 days prior to an event. While businesses, including pharmacies, may have specific regulations to follow, this request, in general, reflects a principle similar to the Worker Adjustment and Retraining Notification (WARN) Act which requires employers with more than 100 employees to provide written notice 60 days before plant closings or large layoffs. However, the WARN Act is more often associated with manufacturing and large-scale layoffs, whereas regulatory requirements for pharmacies involve the Food and Drug Administration (FDA). According to LibreTexts™, after New Drug Application (NDA) approval, a sponsor must report each adverse drug experience, with serious and fatal adverse events requiring a report within 15 days.