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FDA Regulation of OTC Oral Health Care Drug Products
Author(s) -
Rippere Jeanne L.
Publication year - 1992
Publication title -
journal of public health dentistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 63
eISSN - 1752-7325
pISSN - 0022-4006
DOI - 10.1111/j.1752-7325.1992.tb02297.x
Subject(s) - food and drug administration , drug , medicine , new drug application , pharmacology
The history of the involvement of the Food and Drug Administration in the regulation of over‐the‐counter (OTC) drugs is reviewed. The development of monographs containing standards for drugs, the function of the advisory panels, and the classification of dental drug products are explained. Examples of ingredients in each category are given. The current opinion of the FDA concerning antiplaque and antigingivitis claims is also discussed.