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FOXO4-DRI Legal 2026 Status: Supplier Compliance Comparison
FDA-Registered Research Chemical Supplier Registered under 21 CFR Part 207 with establishment ID 'For research use only'. No therapeutic claims Universities, biotech firms, research hospitals with active protocols CoA provided with batch-specific purity analys
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- FDA-Registered Research Chemical Supplier
- Registered under 21 CFR Part 207 with establishment ID
- 'For research use only'. No therapeutic claims
- Universities, biotech firms, research hospitals with active protocols
- CoA provided with batch-specific purity analysis (≥98% by HPLC)
- Legal for qualified research entities. Full traceability
- Compounding Pharmacy (503B Facility)
- Registered as outsourcing facility under DQSA
- May compound for specific patient use under prescriber order
- Licensed prescribers only. Not direct-to-consumer
- Sterility and potency testing required per USP <797>
- Legal only if prescribed by licensed physician for specific patient
- Unregistered Peptide Vendor (Online Retailer)
- No FDA registration. Operates as supplement distributor
- Often includes anti-aging, longevity, or therapeutic language
- Direct-to-consumer. No verification required
- Rarely provides independent batch testing; relies on manufacturer CoA
- High legal risk. Violates 21 USC § 331(d) if making drug claims
- Grey-Market Wellness Clinic
- No FDA registration for chemical distribution
- Markets as 'regenerative medicine' or 'cellular therapy'
- Patients of clinic. Sold as part of treatment package
- No standardised testing. Purity and identity unverified
- Illegal drug distribution. Subject to FDA/FTC enforcement action