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Category 2 is the FDA's designation for bulk drug substances nominated for compounding consideration that have been identified as presenting potential safety risks and are currently ineligible for routine compounding under Section 503A
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Thus, this therapeutical approach may be useful in cases of less severe GH insensitivity, while in conditions of complete GH insensitivity the rhIGF-1 represents the only therapeutical option to improve linear growth (85)
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