Procedures for classifying OTC drugs as generally recognized as safe and effective and not misbranded, and for establishing monographs
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §330.10 |
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5 cases
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Novotney v. Walgreen Co.
...as follows:Commenced in 1972, the OTC Drug Review established FDA's "monograph" system for regulating over-the-counter drugs. See 21 C.F.R. § 330.10; 37 Fed. Reg. 9464 (May 11, 1972). While FDA must [typically] approve drugs as [generally recognized as safe and effective ("GRAS/E")] individ......
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Bridges v. Meijer, Inc.
...as follows: Commenced in 1972, the OTC Drug Review established FDA's “monograph” system for regulating over-the-counter drugs. See 21 C.F.R. § 330.10; 37 Fed.Reg. 9464 (May 11, 1972). While FDA must approve drugs as [generally recognized as safe and effective (“GRAS/E”)] individually, the m......
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Tobin v. Procter & Gamble Co.
...as drugs generally recognized among qualified experts as safe and effective for use and as not misbranded drugs” via “drug monographs.” 21 C.F.R. § 330.10. The promulgated one such monograph relating to “cold, cough, allergy, bronchodilator, and antiasthmatic drug products for over-the-coun......
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Williams v. Galderma Labs.
...allows manufacturers of OTC drugs to sell products without FDA review so long as the manufacturer adheres to the relevant monograph. 21 C.F.R. § 330.10. monograph is a “recipe”; a “detailed regulation ... for each therapeutic class of OTC drug products” that “sets out the FDA-approved activ......
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