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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3 cases
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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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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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Williams v. Galderma Labs.
...as safe and effective and is not misbranded if it meets each of the conditions in this subpart and each general condition established in § 330.1 of this The relevant monograph for acne drugs lists BPO as a permitted active ingredient and does not require manufacturers to warn consumers of b......
2 firm's commentaries
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CARES Act Dooms Claim Targeting the Marketing of “Infant” Acetaminophen
...C.F.R. § 201.66. Under 21 C.F.R. § 330.1, an OTC drug “is generally recognized as safe and effective and is not misbranded if it meets each of the conditions contained in” 21 C.F.R. Part 330 “and each of the conditions contained in any applicable monograph.” The FDA explains that “an OTC mo......
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OTC Drug User Facility Fees – Don’t Miss the Changes!
...testing methodology or a safety-related change. [6] Section 744M(a)(2) of the FFDCA. [7] Section 744M(e)(2) of the FFDCA. Ann Begley 21 CFR 330.1 (or any successor regulations), Any other change specified by the FDA pursuant to an order. Everything else qualifies as a Tier 1 OMOR, which inc......