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### Regulatory Status and Availability **AOD-9604:** - Never received FDA approval for any indication - Classified by the FDA as a **Category 2 bulk drug substance** not eligible for compounding under Section 503B - Removed from many international peptide supplier platforms (including Alibaba and related marketplaces) - Legal status varies by country

In the case of suspected cobalt hypersensitivity, an intradermal test dose should be administered because anaphylactic shock and death have followed parenteral administration of cyanocobalamin