21 C.F.R. §201.128 - Meaning of "intended uses"
| Cite as | 21 C.F.R. §201.128 |
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124 practice notes
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Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
...a variety of factors such as circumstances surrounding the distribution of the product or the context in which it is sold (see, e.g., 21 CFR 201.128 (drugs), 21 CFR 801.4 (devices); see also U.S. v. Travia, 180 F.Supp.2d 115, 119 (D.D.C. 2001)) and sales Some examples of materials intended ......
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Food for human consumption: Food labeling Dietary supplements; effect on structure or function of body; types of statements, definition,
...refers to the objective intent of the manufacturer, which is not limited to a manufacturer's express representations. See Sec. 201.128 (21 CFR 201.128); NNFA v. Weinberger, 557 F.2d 325, 334 (2d Cir. 1977) (``the FDA is not bound by the manufacturer's subjective claims of intent,'' but may ......
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Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”
...for other uses. In addition, FDA is taking the opportunity to make changes to existing regulations at Sec. Sec. 201.128 and 801.4 (21 CFR 201.128 and 801.4), and to conform them to how the Agency currently applies these regulations to drugs and devices Summary of the Major Provisions of the......
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Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
...F.Supp.2d 553, 579-80 (E.D.Pa. Aug.28, 2008). 29. Even the FDA regulations, in theory, impose a duty to warn of off-label uses. See 21 C.F.R. § 201.128 ("if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is ......
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49 cases
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Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
...F.Supp.2d 553, 579-80 (E.D.Pa. Aug.28, 2008). 29. Even the FDA regulations, in theory, impose a duty to warn of off-label uses. See 21 C.F.R. § 201.128 ("if a manufacturer knows, or has knowledge of facts that would give him notice, that a drug introduced into interstate commerce by him is ......
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Baker v. Johnson
...contend that because the complaint contains a count alleging negligence per se on the basis of an alleged violation by Defendants of 21 C.F.R. § 201.128, the negligence per se count constitutes a separate and independent claim arising under federal law within the meaning of 28 U.S.C. § 1441......
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US v. Kasz Enterprises, Inc., Civ. A. No. 93-0455 P.
...The intended use of a product is determined by the vendor's objective intent in promoting, distributing, and selling the product. See 21 C.F.R. § 201.128; Sudden Change, 409 F.2d at 739. Objective intent can be demonstrated by, among other things, "labeling" claims, advertising material, or......
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Coyne Beahm, Inc. v. U.S. Food & Drug Admin., 2:95CV00591.
...Finally, Plaintiffs argue that FDA's own regulations require evidence of manufacturer representations to establish intended use. See 21 C.F.R. §§ 201.128, 801.4 (defining "intended use" regarding drugs and devices, respectively).15 Although the regulations defining "intended use" clearly an......
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65 firm's commentaries
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Off-Label Use – The Times They Are A Changin’
...from “express[ing]” an “intent” or merely “know[ing]” or having “notice” that its product “is to be used” off-label. 21 C.F.R. §§201.100, 201.128; see 21 U.S.C. §352(f)(1). Preliminary Injunction Motion at 2-3. Each step, the motion charges, is unconstitutional because there is no clear int......
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Business Litigation Report -- April 2013
...Caronia’s alleged off-label promotional activities were unlawful based on Sections 331(a) and 352(f) of the FDCA and 21 C.F.R. §§ 201.5 and 201.128. The government argued that these sections, when read together, provide that a drug is misbranded if it is introduced into interstate commerce ......
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Caronia, The Latest
...use.” U.S. br. at 6. That’s a distinction without a difference. An ancient FDA regulation (substantively unchanged since the 1950s), 21 C.F.R. §201.128, equates one with the other. Promoting (truthfully or otherwise) off-label automatically changes the “intended use,” and the new “intended ......
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The First Amendment and Off-Label Promotion: United States v. Caronia
...Caronia’s alleged off-label promotional activities were unlawful based on Sections 331(a) and 352(f) of the FDCA and 21 C.F.R. §§ 201.5 and 201.128. The government argued that these sections, when read together, provide that a drug is misbranded if it is introduced into interstate commerce ......
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