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We require a verified purity of 99% or higher and perform independent third-party spot testing to confirm that select lots meet our internal standards for identity, purity, and composition

Animal-model topical studies have used 0.050.2% (w/v) formulations

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As a result, and as explained in prior rulemaking (88 FR 79170), we believe the assignment methodology minimizes the potential for a beneficiary to be assigned based on specialty care