21 CFR 201.128 - Meaning of ''intended uses''

Cite as21 CFR 201.128
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124 practice notes
49 cases
  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...treatment, or prevention of disease” or “intended to affect the structure or any function of the body.” 21 U.S.C. § 321(g)(1); see also21 C.F.R. § 201.128 (providing that a drug's intended use is shown by “the objective intent of the persons legally responsible for the labeling of [the] dru......
  • Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • April 25, 1997
    ...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......
  • United States v. Facteau, Criminal No. 15-cr-10076-ADB
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • September 14, 2020
    ...in § 801.4 that defines "intended use" for devices. V.E. Irons, Inc. v. United States, 244 F.2d 34, 45 (1st Cir. 1957). Compare 21 C.F.R. § 201.128, with 21 C.F.R. § 801.4. Notably, the First Circuit applied the regulation to the case and affirmed the convictions without questioning the reg......
  • US v. Kasz Enterprises, Inc., Civ. A. No. 93-0455 P.
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Rhode Island
    • June 15, 1994
    ...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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64 firm's commentaries
  • Off-Label Use – The Times They Are A Changin’
    • United States
    • LexBlog United States
    • October 8, 2009
    ...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......
  • Business Litigation Report -- April 2013
    • United States
    • JD Supra United States
    • April 15, 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 ......
  • Caronia, The Latest
    • United States
    • JD Supra United States
    • September 1, 2011
    ...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 ......
  • The First Amendment and Off-Label Promotion: United States v. Caronia
    • United States
    • JD Supra United States
    • April 11, 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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