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.
[41 FR 6908, Feb. 13, 1976]
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).
· cites it 8× “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).
· cites it 4× “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 v. Sene X Eleemosynary Corp., Inc., 479 F. Supp. 970 (S.D. Fla. 1979).
· cites it 2× “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).
· cites it 2× “” 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 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.”
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.”
Annotations are extracted automatically from the opinions in the
Syfert caselaw corpus and ranked by authority, recency, and
treatment. Dots show Syfertize treatment of the citing case itself.