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They are granted a narrow legal exemption from the standard New Drug Application (NDA) process only if they strictly adhere to the requirements of the following statutory pathways: Section 503A (Traditional Compounding): Regulates state-licensed pharmacies compounding for identified individual patients based on a valid, patient-specific prescription

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Kreuter J, Shamenkov D, Petrov V, Ramge P, Cychutek K, Koch-Brandt C, et al

[32] [35] Deficiency symptoms in children include developmental delay, regression, irritability, involuntary movements and hypotonia

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