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In April 2026, the FDA published a formal proposal in the Federal Register to remove semaglutide, tirzepatide, and liraglutide from the 503B outsourcing bulks list, with a public comment period open through June 2026
Its review standards closely align with the Federal Trade Commission (FTC) Act and FTC guidelines
Patients on the highest dose (12 mg) lost an average of 71.2 pounds28.7% of body weightover 68 weeks, with a 75.8% reduction in knee osteoarthritis pain
Four studies [31, 33, 35, 40] reported severe hypoglycaemia, with 3075 events observed among the 70,828 (4%) participants in the combination therapy group compared with 2284 events among the 72,657 (3%) participants in the monotherapy group (ESM Table 8)
**Nausea and Vomiting**: These are the most common side effects, especially when starting the medication or increasing the dose
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