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As a reminder, under federal law a bulk drug substance that is not classified by the FDA as a biologic may be used in a drug compounded by a so-called 503A pharmacy only if it meets at least one of the following four criteria: It has a USP or NF monograph

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It can also increase the expression and activation of TNF- through toll-like receptors (such as TLR2 and TLR4) [146]

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Some lawyers feel it is an advantage to bring their cases away from the large group