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Also the rate-limiting steps for one substance may be in common with other substances

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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 FDA’s interim enforcement discretion policy for substances in Category 1.” Even Category 1 substances are only under enforcement discretion, which is short of full authorization