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353b(a)(5) (prohibiting the compounding of a drug which is essentially a copy of one or more approved drugs.) However, even if a particular drug is approved and a manufacturer has a legally authorized monopoly over it, 353b includes an important carveout allowing for the compounding of copies if the drug is on a shortage list published and maintained by FDA pursuant to 21 USC 356e

References 1 Abdel-HamidN.FaddahL.Al-RehanyM.AliA.BakeetA

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Efficacy and safety of dulaglutide in patients with type 2 diabetes: a meta-analysis and systematic review