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The FDA 503A Bulks List is the list established in federal regulation for certain bulk drug substances that may be used to compound patient-specific medications under section 503A when the substance does not have an applicable United States Pharmacopeia or National Formulary drug-substance monograph and is not a component of an FDA-approved drug

Vitamin B12 is essential for red blood cell production, nerve function, energy metabolism and the synthesis of DNA

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In some embodiments, the otic formulation or composition comprises about 25% by weight of the cholesterol