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Description
The FDA's bulk substance framework for compounding pharmacies established under the 2013 Drug Quality and Security Act divides peptides into three categories relevant to 503A/503B compounding: Category 1 : Affirmed for compounding

The 25% that do not appear are primarily manufacturing process patents, intermediate patents, and formulation patents that do not technically claim the approved drug product

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10.1093/rap/rky014 3 ArapidiG
