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Novos path forward on this issue, however, is a slog because unlike the shortage list, 353b requires that FDA implement the demonstrably difficult list by regulation. Moreover, the statute requires that FDA convene an advisory committee on compounding which shall include representatives from the National Association of Boards of Pharmacy, the United States Pharmacopeia, pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations. See 21 USC 353b(c)

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