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Primarily, when a compounding pharmacy creates a copy of an approved drug which is not subject to a shortage as determined by FDA, the compounder is no longer immune from the federal misbranding and unapproved new drug statutes, both of which could result in FDA enforcement and serious regulatory consequences

One of the phase III trials, SURMOUNT-4, enrolled 783 participants living with obesity (body mass index [BMI] 30), or overweight (BMI 27) with at least one weight-related comorbidity (excluding diabetes mellitus) [15]

however, the clinical expert consulted for this review noted that this is a sufficient amount of time to observe a treatment effect in terms of A1C and body weight

Journal of Clinical Medicine, 14 (11), 3791