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Journal of Parenteral and Enteral Nutrition, 36 (2), 147154
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National Law Review (Polsinelli PC) was explicit on April 22, 2026: removing a Category 2 bulk drug substance does not, on its own, authorize use of that substance in compounding or bring it within FDAs interim enforcement discretion policy for substances in Category 1. Even Category 1 substances are only under enforcement discretion, which is short of full authorization
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