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The proposed guardrails included: a substance-specific Green List FDA-registered and qualified API manufacturers lot-specific Certificates of Analysis validated identity, purity, and potency testing impurity and aggregation controls sterility and endotoxin testing where applicable stability requirements patient-specific prescriptions clear, non-alarmist disclosures regarding investigational status adverse-event reporting and structured post-market surveillance Online-safety and clinical stakeholders have identified substantially similar safeguards, including supplier qualification, identity testing, potency, sterility, endotoxin testing, stability, labeling, valid prescriptions, clinical oversight, and adverse-event reporting
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Size:1 Gram
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