Submitting a Monograph

Technical Information Requirements For Monograph Review

Approved April 2014

9. Toxicological Information

  1. General Toxicological Requirements:

Substances currently lawfully marketed as dietary supplements or otherwise without known safety concerns will often not require more than an integrated summary of available medical and toxicological databases.

Substances not otherwise lawfully marketed or with known or potential safety concerns shall require up to a full battery of pharmacology and toxicology information. Sponsors shall provide experimental and or bibliographic evidence of safety within the following areas as necessary: Acute and repeat dose toxicity, genotoxicity, carcinogenicity

reproductive toxicology, local tolerance, antigenicity, immunotoxicity, dependence, metabolites, impurities, other toxicology information

For both risk classifications sponsors are referred to the HPCUS Toxicology and Safety Committee document: Guideline to Toxicological Information Requirements for Admission of a Homeopathic Substance into the HPUS

Control of Drug Substance, Reference Standards of Materials, Special Storage Conditions, & Stability Literature References