C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER C—DRUGS: GENERAL › PART 201—LABELING › Subpart D—Exemptions From Adequate Directions for Use

21 C.F.R. § 201.128

Meaning of “intended uses”

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The words intended uses or words of similar import in §§ 201.5, 201.115, 201.117, 201.119, 201.120, 201.122, and 1100.5 of this chapter refer to the objective intent of the persons legally responsible for the labeling of an article (or their representatives). The intent may be shown by such persons' expressions, the design or composition of the article, or by the circumstances surrounding the distribution of the article. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. Objective intent may be shown, for example, by circumstances in which the article is, with the knowledge of such persons or their representatives, offered or used for a purpose for which it is neither labeled nor advertised; provided, however, that a firm would not be regarded as intending an unapproved new use for an approved drug based solely on that firm's knowledge that such drug was being prescribed or used by health care providers for such use. The intended uses of an article may change after it has been introduced into interstate commerce by its manufacturer. If, for example, a packer, distributor, or seller intends an article for different uses than those intended by the person from whom he or she received the article, such packer, distributor, or seller is required to supply adequate labeling in accordance with the new intended uses.

[86 FR 41401, Aug. 2, 2021]
Notes of Decisions
Cited in 26 cases (4 in the last 5 years), 1981–2025 · leading case: United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).
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United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). · cites it 6× “" 21 C.F.R. § 201.128 . The consequences for misbranding are criminal.”
United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 (2d Cir. 2016). · cites it 2× “5 ; see also 21 C.F.R. § 201.128 (definition of "intended uses").”
Coyne Beahm, Inc. v. United States Food & Drug Admin., 966 F. Supp. 1374 (M.D.N.C. 1997). · cites it 3× “See 21 C.F.R. §§ 201.128 , 801.4 (defining “intended use” regarding drugs and devices, respectively).”
United States v. Kasz Enter., Inc., 855 F. Supp. 534 (D.R.I. 1994). · cites it 3× “See 21 C.F.R. § 201.128 ; Sudden Change, 409 F.”
United States v. Caronia, 576 F. Supp. 2d 385 (E.D.N.Y 2008). · cites it 2× “” 21 C.F.R. § 201.128 ; see also Action on Smoking and Health v.”
Knipe v. Smithkline Beecham, 583 F. Supp. 2d 602 (E.D. Pa. 2008). “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 to be used for conditions, purposes or uses other than the one for which he offers it, he is required to provide…”
Aventis Pharm., Inc. v. Barr Labs., Inc., 411 F. Supp. 2d 490 (D.N.J. 2006). · cites it 2× “Plaintiffs point to 21 C.F.R. § 201.128 , which, in conjunction with 21 C.”
Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir. 2013). “” 21 C.F.R. § 201.128 . Objective intent “is determined by such persons’ expressions or may be shown by the circumstances surrounding the distribution of the article,” including “labeling claims, advertising matter, or oral or written statements by such persons or their…”
Spectrum Pharm., Inc v. Sylvia Burwell, 824 F.3d 1062 (D.C. Cir. 2016). “” 21 C.F.R. § 201.128 . Under that regulation, intent “is determined by such persons’ expressions” or “may be shown by the circumstances surrounding the distribution” of the drugs.”
Smoking Everywhere, Inc. v. U.S. Food & Drug Admin., 680 F. Supp. 2d 62 (D.D.C. 2010). “21 C.F.R. § 201.128 . Objective intent may be shown, for example, “by labeling claims, advertising matter, or oral or written statements” by the labeler.”
United States v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014). “be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives”).”
United States v. H. Ray Evers, M. D., an Individual, Doing Bus. as Ra-Mar Clinic, Ann H. Garrett, Defendants-Intervenors, 643 F.2d 1043 (5th Cir. 1981). “” 21 C.F.R. § 201.128 . Since Dr. Evers clearly intended to use Calcium EDTA for the treatment of arteriosclerosis, these provisions would seem to require him to provide adequate directions in lay terms to his patients for the use of Calcium EDTA in the treatment of…”
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