21 CFR 201.16 - Drugs; Spanish-language version of certain required statements.

§ 201.16 Drugs; Spanish-language version of certain required statements.

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]

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.

  • 2017-02-07; vol. 82 # 24 - Tuesday, February 7, 2017
    1. 82 FR 9501 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Delayed Effective Date
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of effective date.
      The effective date of the rule amending 21 CFR Chapter I published at 82 FR 2193 on January 9, 2017 is delayed until March 21, 2017.
      21 CFR Parts 201, 801, and 1100