Tags

Type your tag names separated by a space and hit enter

Regulation of homeopathic drug products.
Am J Health Syst Pharm 2006; 63(1):86-91AJ

Abstract

PURPOSE

The regulation of homeopathic drug products is discussed.

SUMMARY

Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements.

CONCLUSION

Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements.

Authors+Show Affiliations

Homeopathic Pharmacopoeia Convention of the United States, Southeastern, PA, USA. jborneman@hylands.comNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

16373470

Citation

Borneman, John P., and Robert I. Field. "Regulation of Homeopathic Drug Products." American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, vol. 63, no. 1, 2006, pp. 86-91.
Borneman JP, Field RI. Regulation of homeopathic drug products. Am J Health Syst Pharm. 2006;63(1):86-91.
Borneman, J. P., & Field, R. I. (2006). Regulation of homeopathic drug products. American Journal of Health-system Pharmacy : AJHP : Official Journal of the American Society of Health-System Pharmacists, 63(1), pp. 86-91.
Borneman JP, Field RI. Regulation of Homeopathic Drug Products. Am J Health Syst Pharm. 2006 Jan 1;63(1):86-91. PubMed PMID: 16373470.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Regulation of homeopathic drug products. AU - Borneman,John P, AU - Field,Robert I, PY - 2005/12/24/pubmed PY - 2006/3/29/medline PY - 2005/12/24/entrez SP - 86 EP - 91 JF - American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists JO - Am J Health Syst Pharm VL - 63 IS - 1 N2 - PURPOSE: The regulation of homeopathic drug products is discussed. SUMMARY: Homeopathy is a system of medicine based on the observation that high doses of pharmacologically active substances cause symptoms when administered to healthy individuals. These same substances, when prepared in very dilute form, may relieve similar symptoms in conditions resulting from different etiologies. Unlike dietary supplements, homeopathic drugs are subject to the Food, Drug, and Cosmetic Act and regulations issued by FDA. Instead of the new-drug-approval process, premarket approval for homeopathic drugs is by way of monograph approval by the Homeopathic Pharmacopoeia Convention of the United States (HPCUS). Monographs are published in the Homeopathic Pharmacopoeia of the United States (HPUS). The criteria for inclusion in the HPUS require that a homeopathic drug product be determined by HPCUS to be safe and effective and to be prepared according to the specifications of the HPUS general pharmacy section. The long history and established nature of homeopathic drug regulation may provide a model for the regulation of dietary supplements. CONCLUSION: Homeopathic drugs in the United States are subject to well-defined regulatory processes that more closely resemble those that apply to allopathic medications than to dietary supplements. SN - 1079-2082 UR - https://www.unboundmedicine.com/medline/citation/16373470/Regulation_of_homeopathic_drug_products_ L2 - https://academic.oup.com/ajhp/article-lookup/doi/10.2146/ajhp050105 DB - PRIME DP - Unbound Medicine ER -