# 21 C.F.R. § 201.16 (2026): Drugs; Spanish-language version of certain required statements

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P201_S201_16

## Section

- **Citation:** 21 C.F.R. § 201.16 (2026)
- **Heading:** Drugs; Spanish-language version of certain required statements
- **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 / § 201.16: § 201.16   Drugs › Spanish-language version of certain required statements.

## Text

An increasing number of medications restricted to prescription use only are being labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where Spanish is the predominant language. Such labeling is authorized under § 201.15(c). One required warning, the wording of which is fixed by law in the English language, could be translated in various ways, from literal translation to loose interpretation. The statutory nature of this warning requires that the translation convey the meaning properly to avoid confusion and dilution of the purpose of the warning. Section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act requires, at a minimum, that the label bear the statement “Rx only.” The Spanish-language version of this must be “Solamente Rx”. [67 FR 4906, Feb. 1, 2002]

## 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_16. Check the current official text before relying on it. Not legal advice.