General conditions for general recognition as safe, effective and not misbranded
| Currency | Current through May 31, 2023 |
| Citation | 21 C.F.R. §330.1 |
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5 cases
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Calchi v. Topco Assocs.
...(last accessed 7/30/24). A monograph essentially sets out the federal requirements for a given category of nonprescription drugs. See 21 C.F.R. § 330.1. monograph goes through a lengthy notice-and-comment process. That process includes review by a panel of experts, two public comment period......
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Lester v. CVS Pharm.
...as safe and effective and is not misbranded if it meets each condition in this OTC monograph and each general condition established in 21 CFR 330.1.” See M003 § M003.1. The FDCA states that a “drug or device shall be deemed to be misbranded . . . [i]f its labeling is false or misleading in ......
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Gibson v. Albertsons Cos.
...setting conditions under which specific drugs may qualify as safe, effective, and not misbranded when sold over the counter. See, e.g., 21 C.F.R. § 330.1. For drugs, the FDA sets out a series of general rules and then it promulgates monographs containing specific rules for more specific cat......
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Tobin v. Procter & Gamble Co.
.... . . is not misbranded if it meets each of the conditions in [21 C.F.R. Part 341] and each of the general conditions established in § 330.1.” 21 C.F.R. § 341.1. Part provides a non-exclusive list of statements that may be used to describe cough and cold medications. 21 C.F.C. § 341.74(b). ......
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1 firm's commentaries
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Class Complaint Fails in OTC Drug MDL
...and nonmisleading statements describing only those indications for use that have been established in an applicable monograph.” 21 C.F.R. § 330.1(c)(1). “Nothing in the PE monograph or the general monograph suggests manufacturers have a freestanding duty to update their indications in respon......