Generally recognized as safe and effective

The conditions whereby dandmff, seborrheic dermatitis, and psoriasis dmg products are generally recognized as safe and effective and are not misbranded is available (70). Specific active iagredients that can be used as well as the statement of identity, iadications for use, and required warnings, are identified. Products that do not meet all of these requirements are considered new dmgs and must have an approved NDA for the nonmonograph conditions. 

The two most important diphenylmethanes are phenolphthalein and bisacodyl. Senna and cascara are the sources of anthraquinone laxatives. However, although still available in some countries phenolphthalein is now removed from most markets because of concerns over carcinogenicity. As recent as 2006 the United States Food and Drug Administration (FDA) has categorized castor oil as generally recognized as safe and effective (GRASE) for over-the-counter use as a laxative. On the other hand, in 2002 cascara was banned by the FDA. 

A new drug application, described in part 314. Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded. Described in part 330. 

Department of Health, Human Services, Food, Drug Administration. 21 CFR 330. Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final Rule Fed Reg 2002 67(15) 3060-3076. 

Category I. Generally recognized as safe and effective for the claimed therapeutic indication... 

The (US) Food and Drug Administration has issued a final rule in 2003, in the form of a final monograph establishing conditions under which over-the-counter antiperspirant drug products (including deodorants) are generally recognized as safe and effective. This rule has been in effect from December 2004. 

Category II not generally recognized as safe and effective or unacceptable for the claimed indications... 

Government Performance and Results Act Generally Recognized as Safe Generally Recognized as Safe and Effective Good Review Practice... 

Artificial organs and implants to replace diseased, defective, or destroyed components of the body are used by essentially every medical specialty. Medical grade silicone elastomer is the only elastomer generally recognized as safe and effective as a material of construction for soft, flexible, elastomeric implants. Carefully controlled formulations have been qualified by chronic biocompatibility and biodurability studies to provide a soft, flexible, elastomeric material of construction to meet many of the needs in these applications. 

Category I conditions under which OTC ingredients are generally recognized as safe and effective and are not misbranded. 

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