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U.S. Department of Health and Human Services


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Rulemaking History for OTC Colloidal Silver Drug Products

Final Monographs (21 CFR 310.548):
Drug products containing colloidal silver ingredients or silver salts offered over-the-counter (OTC) for the treatment and/or prevention of disease

Colloidal Silver Drug Products
Proposed Rule Date FR Citation
Proposed Rule [PDF] 10/15/1996 61FR53685
Final Rule Date FR Citation
Final Rule: Classifies silver salts (internal or external use) as nonmonograph [PDF] 8/17/1999 64FR44653