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it decreases opioid requirements)
The rapid bi-weekly dose escalation protocol may have contributed to higher GI event rates
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The FDA stated that it also considered information from telehealth companies, pharmacy compounders, associations representing pharmacy compounders and outsourcing facilities, and individuals. In an attempt to avoid disruptions to patient treatment, the FDA intends to use its enforcement discretion over those persons or facilities compounding semaglutide injection products pursuant to Section 503A or 503B of the Food, Drug, and Cosmetic Act (FDCA), as follows: While these periods of enforcement discretion are longer than the discretion period detailed in the FDAs guidance for 503B outsourcing facilities (which is normally 60 days after the drug is removed from the FDAs shortage list), the discretion periods for compounded semaglutide injection products mirror what we recently saw when the FDA deemed that the tirzepatide shortage was resolved
