# 21 C.F.R. § 201.5 (2026): Drugs; adequate directions for use

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_5

## Section

- **Citation:** 21 C.F.R. § 201.5 (2026)
- **Heading:** Drugs; adequate directions for use
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 201 / Subpart A / § 201.5: § 201.5   Drugs › adequate directions for use.

## Text

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]

## Nearby sections

- [21 C.F.R. § 201.1 (2026) § 201.1   Drugs; name and place of business of manufacturer, packer, or distributor.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_1.md)
- [21 C.F.R. § 201.2 (2026) § 201.2   Drugs and devices; National Drug Code numbers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_2.md)
- [21 C.F.R. § 201.5 (2026) § 201.5   Drugs; adequate directions for use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_5.md)
- [21 C.F.R. § 201.6 (2026) § 201.6   Drugs; misleading statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_6.md)
- [21 C.F.R. § 201.10 (2026) § 201.10   Drugs; statement of ingredients.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_10.md)
- [21 C.F.R. § 201.15 (2026) § 201.15   Drugs; prominence of required label statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_15.md)
- [21 C.F.R. § 201.16 (2026) § 201.16   Drugs; Spanish-language version of certain required statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_16.md)
- [21 C.F.R. § 201.17 (2026) § 201.17   Drugs; location of expiration date.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_17.md)
- [21 C.F.R. § 201.18 (2026) § 201.18   Drugs; significance of control numbers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_18.md)
- [21 C.F.R. § 201.19 (2026) § 201.19   Drugs; use of term “infant”.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_19.md)
- [21 C.F.R. § 201.20 (2026) § 201.20   Declaration of presence of FD&C Yellow No. 5 and/or FD&C Yellow No. 6 in certain drugs for human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_20.md)
- [21 C.F.R. § 201.21 (2026) § 201.21   Declaration of presence of phenylalanine as a component of aspartame in over-the-counter and prescription drugs for human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_21.md)
- [21 C.F.R. § 201.22 (2026) § 201.22   Prescription drugs containing sulfites; required warning statements.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_22.md)
- [21 C.F.R. § 201.23 (2026) § 201.23   Required pediatric studies.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_23.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_5. Check the current official text before relying on it. Not legal advice.