21 CFR 201.5
Drugs; adequate directions for use
21 CFR 201.5 is the regulation titled “Drugs; adequate directions for use” in 21 CFR Part 201, Labeling. Since 2021, 209 FDA warning letters have cited it.
- Letters citing it
- 209 since 2021
- Jan 1 to Oct 30, 2026
- 30 against 25 on the same dates in 2025
- Most often cited with
- 21 CFR 201.115, in 90 letters
- Closed out
- 17% of these letters have a published close-out
Letters citing it, by year issued
Most are drug letters (205 of 209). 2026 runs to Oct 30, 2026. Pick a year to see its letters.
What FDA writes when it cites it
The finding headings that cite 21 CFR 201.5 most often, as written in the letters.
- 9 lettersBecause the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use…
- 6 lettersBecause the aforementioned drug is a prescription drug intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use…
- 5 lettersBecause the aforementioned drugs are prescription drugs intended for conditions that are not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use…
The regulation
Read the text of 21 CFR 201.5 (eCFR, as of Sep 1, 2026)
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]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 201.5.
- 21 CFR 201.115New drugs or new animal drugs90 letters cite both
- 21 CFR 201.128Meaning of “intended uses”50 letters cite both
- 21 CFR 201.100Prescription drugs for human use21 letters cite both
- 21 CFR 111.70What specifications must you establish?14 letters cite both
- 21 CFR 101.9Nutrition labeling of food13 letters cite both
- 21 CFR 101.4Food; designation of ingredients12 letters cite both
- 21 CFR 111.260What must the batch record include?12 letters cite both
- 21 CFR 111.75What must you do to determine whether specifications are met?12 letters cite both
Latest letters citing it
The 3 letters citing 21 CFR 201.5 that FDA posted most recently.
- DrugsView Cheap Medicine Shop/www.cheapmedicineshop.comInjectable semaglutide drug products sold onlineIssuedSep 24, 2026PostedOct 6, 2026
- DrugsView Online Generic Medicine/www.onlinegenericmedicine.comSemanat Injection (Semaglutide)IssuedSep 23, 2026PostedOct 6, 2026
- DrugsView Celmadebotulinum toxin type A products marketed as Wonder tox 100 and Wondertox 100 UnitIssuedSep 14, 2026PostedSep 29, 2026
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Counts include every citation in a letter, as the Letters filter does. How this database is built.