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To spare the legal explanation, it is technically acceptable for a doctor to prescribe non-FDA-approved drugs if certain precautions are met [4]: After review, if the [doctor] decides that there is sound medical evidence and it is in the patients best interest to use a non-FDA approved device, he or she should conduct and document a thorough and careful informed consent discussion

Additionally, Safe Chain was cited for its failure to respond to an external notification of illegitimate product, which is a key underlying function of the law