The shortage resolution has significant legal implications for compounding pharmacies: under Section 503A, compounding of commercially available drugs is only permitted when the drug is on the FDA shortage list
Additionally, tirzepatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis
It may also help identify permeation enhancers and novel drug candidates for advanced transdermal patches in applications, including diabetes, weight management, and others
MRI, which produces a series of cross-sectional images of the back, can help to illustrate the degree of stenosis as well any nerve root involvement
This case underscores the growing tension between branded drug makers seeking to protect market share and compounding pharmacies leveraging clinical demand and legal frameworks to expand patient access