21 C.F.R. § 201.5
Drugs; adequate directions for use
Adequate directions for use means directions under which the layman can use a drug safely and for the purposes for which it is intended. (Section 201.128 defines “intended use.”) Directions for use may be inadequate because, among other reasons, of omission, in whole or in part, or incorrect specification of:
(a) Statements of all conditions, purposes, or uses for which such drug is intended, including conditions, purposes, or uses for which it is prescribed, recommended, or suggested in its oral, written, printed, or graphic advertising, and conditions, purposes, or uses for which the drug is commonly used; except that such statements shall not refer to conditions, uses, or purposes for which the drug can be safely used only under the supervision of a practitioner licensed by law and for which it is advertised solely to such practitioner.
(b) Quantity of dose, including usual quantities for each of the uses for which it is intended and usual quantities for persons of different ages and different physical conditions.
(c) Frequency of administration or application.
(d) Duration of administration or application.
(e) Time of administration or application (in relation to time of meals, time of onset of symptoms, or other time factors).
(f) Route or method of administration or application.
(g) Preparation for use, i.e., shaking, dilution, adjustment of temperature, or, other manipulation or process.
Notes of Decisions
Cited in 31
cases (3 in the last 5 years), 1978–2024 · leading case: United States v. Caronia, 703 F.3d 149 (2d Cir. 2012).
United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). “See 21 C.F.R. § 201.5 . Off-label promotional statements could thus presumably constitute evidence of an intended use of a drug that the FDA has not approved.”
FDA v. All. for Hippocratic Med., 602 U.S. 367 (2024). “21 CFR §§ 201.5 , 314.50 (2022). If FDA determines that additional safety requirements are necessary, FDA may impose extra requirements on pre- scription and use of the drug.”
United States v. Articles of Drug, 625 F.2d 665 (5th Cir. 1980). “21 C.F.R. § 201.5 (1980). The Government states that not only has this been its interpretation for the twenty-eight years since the regulation was published, but that the regulation merely codified agency practice since 1938.”
United States ex rel. Polansky v. Pfizer, Inc., 822 F.3d 613 (2d Cir. 2016). “§ 352 (f)(1); 21 C.F.R. § 201.5 ; see also 21 C.F.R. § 201.”
United States v. Sene X Eleemosynary Corp., Inc., 479 F. Supp. 970 (S.D. Fla. 1979). “Photographs, established to be all of the labeling on the drum of procaine, show that there are no adequate directions for use, as defined in the applicable regulation, 21 CFR 201.5, on the bulk component (PX 305).”
Amarin Pharma, Inc. v. United States Food & Drug Admin., 119 F. Supp. 3d 196 (S.D.N.Y. 2015). “” 21 C.F.R. § 201.5 . It has defined “intended use” as “the objective intent of the persons legally responsible for the labeling of drugs”; “intended use” may be demonstrated by “oral or written statements by such persons or their representatives” and “the circumstances that the…”
In Re Avandia Mktg. Sales Practices & Prods. Liab. Litig., 588 F. App'x 171 (3rd Cir. 2014). “§ 355; 21 C.F.R. § 201.5 . 20 . See Conn. Gen.Stat.”
In Re Trasylol Prods. Liab. Litig., 709 F. Supp. 2d 1323 (S.D. Fla. 2010). “§ 352 and 21 CFR § 201.5 in Opinion # 2, the section “Bases of Opinions #1 & #2” does not analyze Bayer’s actions under the cited statute and regulation but rather provides a general background on the FDA process and the role of the FDA.”
Spectrum Pharm., Inc v. Sylvia Burwell, 824 F.3d 1062 (D.C. Cir. 2016). “2014) (recognizing that to satisfy the statutory requirement that a drug’s label provide “ ‘adequate directions for use,’ a drug’s label must provide ‘directions under which the layman can use a drug safely and for the purposes for which it is intended’ ” (quoting 21 C.F.R. §…”
United States v. Regenerative Sciences, LLC, 741 F.3d 1314 (D.C. Cir. 2014). “” 21 C.F.R. § 201.5 (emphasis added). A prescription drug, however, is by definition “not safe for use except under the supervision of a practitioner licensed by law to administer such drug.”
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). “That interpretation begins with 21 C.F.R. § 201.5 (1980), which defines “adequate directions for use” as “directions under which the layman can use a drug safely and for the purposes for which it is intended.”
FDA v. All. for Hippocratic Med., 602 U.S. 367 (2024). “21 CFR §§201.5 , 314.50 (2022). If FDA determines that additional safety requirements are necessary, FDA may impose extra requirements on prescription and use of the drug.”
United States v. Articles of Drug, Etc. Appeal of the Lannett Co., Inc, 585 F.2d 575 (3rd Cir. 1978). “Adequate directions for use “means directions under which the layman can use a drug safely and for the purposes for which it is intended,” 21 C.F.R. § 201.5 (1977). In its complaint the Government argued that Lannett’s drugs, as prescription drugs, by their very nature could not…”
United States v. US Stem Cell Clinic, LLC, 998 F.3d 1302 (11th Cir. 2021). “§ 352 (f)(1); see 21 C.F.R. § 201.5 . In fact, the FDA argued, the Clinic could not label the stromal-vascular fraction solution in compliance with the FDCA because “there is no scientifically valid evidence to show that it is safe or effective for any indication.”
United States v. Caronia, 576 F. Supp. 2d 385 (E.D.N.Y 2008). “” FDA regulations provide that “adequate directions for use” are directions "under which the layman can use a drug safely and for the purposes for which it is intended!,]” 21 C.F.R. § 201.5 , and further provide that a drug's “intended use” is determined by considering the…”
United States v. Algon Chem. Inc., a Corp., & Edward Latinsky, an Individual, 879 F.2d 1154 (3rd Cir. 1989). “21 C.F.R. § 201.5 . In the present case, the labeling on the bulk drugs sold by Algon consisted merely of the name of the drug, the country of origin and numerical information such as the net weight of the contents, although some of the labeling also contained the following…”
United States ex rel. Polansky v. Pfizer, Inc., 914 F. Supp. 2d 259 (E.D.N.Y 2012). “21 CFR § 201.5 . These directions must indicate the purposes for which the drug has been found to be both safe and effective.”
United States v. Undetermined Quantities of Articles of Drug, 145 F. Supp. 2d 692 (D. Maryland 2001). “A product is misbranded if it fails to include adequate directions for use. See 21 U.S.C. § 352 (f)(1). “ ‘Adequate directions for use’ means directions under which the layman can use a drug safely and for the purposes for which it is intended.”
Aventis Pharm., Inc. v. Barr Labs., Inc., 411 F. Supp. 2d 490 (D.N.J. 2006). “128 , which, in conjunction with 21 C.F.R. § 201.5 , requires adequate labeling for all intended uses of a drug, and expressly states: The words ‘intended uses’ .”
United States v. Regenerative Sciences, LLC, 878 F. Supp. 2d 248 (D.D.C. 2012). “” 21 C.F.R. § 201.5 . However, a prescription drug by its very definition cannot bear “adequate directions for use” by a layman.”
United States v. Williams, 549 F. App'x 813 (10th Cir. 2013). “” 21 C.F.R. § 201.5 . The “intended use” of the drug is the “objective intent of the person legally responsible for the labeling of the drug,” and may be determined for example, by labeling claims, advertising matter, or oral or written statements by such persons or their…”
United States v. Jerry J. Colahan, 635 F.2d 564 (6th Cir. 1980). “In this connection, FDA relies on 21 C.F.R. § 201.5 which provides in part: “Adequate directions for use” means directions under which the layman can use a drug safely and for the purposes for which it is intended.”
United States v. Baxter Healthcare Corp., 712 F. Supp. 1352 (N.D. Ill. 1989). “” 21 C.F.R. § 201.5 . Since Baxter restricted distribution of these products to prescription use only, perforce its labels are not “adequate” for use.”
United States v. Cole, 84 F. Supp. 3d 1159 (D. Or. 2015). “” 21 C.F.R. § 201.5 . Such directions, which might include indications, contraindications, dosages, routes of administration, warnings, side effects, and necessary collateral measures, must be premised on clinical data derived from scientifically controlled investigation—the…”
United States v. Jerry J. Colahan, D/B/A Iba of Ohio Norman F. Bauer John D. Burrows Russell C. Humphrey, Jr. Simon E. Miller Iba, Inc. Daniel Belsito, 811 F.2d 287 (6th Cir. 1987). “” 21 C.F.R. § 201.5 . The statute requiring adequate directions contains a proviso that if such directions are “not necessary for the protection of the public, the Secretary shall promulgate regulations exempting such drug .”
United States v. 9/1 KG Containers, More or Less of an Article of Drug for Veterinary Use, 674 F. Supp. 1344 (C.D. Ill. 1987). “21 C.F.R. § 201.5 defines "adequate directions for use” as "directions under which a layman can use a drug safely and for the purposes for which it is intended.”
Zeltiq Aesthetics, Inc. v. BTL Indus., Inc., 32 F. Supp. 3d 1088 (N.D. Cal. 2014). “” 21 C.F.R. § 201.5 (emphasis added). Zeltiq argues that the Vanquish device is misbranded because its labeling fails to include “adequate directions for use” in fat reduction procedures.”
Gardner v. Vanda Pharm. Inc. (D.D.C. 2020). “§ 352(f), in other words, if it lacks “directions under which the layman can use a drug safely and for the purposes for which it is intended,” 21 C.F.R. § 201.5 . The FDA takes the position that “[a]n approved drug that is marketed for an unapproved use (whether in labeling or…”
United States v. Vinod Patwardhan, 422 F. App'x 614 (9th Cir. 2011). “See 21 C.F.R. § 201.5 ; see also United States v.”
Leonard Tesoro, M.D. v. Emma Alvarez (Tex. App. 2009). “2008) (setting out labeling provisions); see also 21 C.F.R. § 201.5 (2008) (defining "adequate directions for use" as "directions under which the layman can use a device safely and for the purposes for which it is intended").”
Leonard Tesoro, M.D. v. Emma Alvarez (Tex. App. 2009). “2008) (setting out labeling provisions); see also 21 C.F.R. § 201.5 (2008) (defining "adequate directions for use" as "directions under which the layman can use a device safely and for the purposes for which it is intended").”
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