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A pharmacy must evaluate the law and FDA policy in effect at the time of compounding, including the exact substance, formal list status, any applicable interim policy, state requirements, sourcing, formulation, and patient-specific prescription rules
doi:10.1677/joe.0.1650569 Johansen PB, Nowak J, Skjaerbaek C, et al
Animal studies use controlled purity, defined dosing, and monitoring that home use cannot replicate, and they still do not answer questions about long-term human exposure, immunogenicity, or rare serious events
Simplified criteria for the diagnosis of autoimmune hepatitis
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