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FDA panel recommends including brilliant blue on list of bulk substances for use in compounding
By a vote of 10 in favor, two against and no abstentions, with two members not voting, the FDA Center for Drug Evaluation and Research Pharmacy Compounding Advisory Committee recommended yesterday that brilliant blue G be included on a list of bulk drug substances that may be used for compounding. Section 503A of the Food, Drug and Cosmetic Act (FDCA) “provides that a drug product can be compounded using bulk drug substances that do not have an applicable [U. S. Pharmacopoeia] or [National Formulary] monograph and are not components of (Read more...)