[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.16]

[Page 15]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 201--LABELING--Table of Contents
 
                 Subpart A--General Labeling Provisions
 
Sec. 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 Sec. 201.15(c). Two required warnings, 
the wording of which is fixed by law in the English language, are 
presently being translated in various ways, from literal translation to 
loose interpretation. The statutory nature of these two statements 
requires that the translation must convey the meaning properly, in order 
to avoid confusion and dilution of the purposes of the warnings. The 
Commissioner of Food and Drugs hereby adopts the following Spanish-
language versions as the accepted equivalents of the English wording of 
the following:
    (a) Section 503(b)(4) of the Federal Food, Drug, and Cosmetic Act 
requires the statement ``Caution: Federal law prohibits dispensing 
without prescription.'' The Spanish version of this shall be: 
``Precaucion: La ley Federal prohibe su despacho sin prescripcion 
facultativa.''
    (b) Section 502(d) of the Federal Food, Drug, and Cosmetic Act 
requires the statement ``Warning--May be habit forming'' on habit-
forming drugs. The Spanish version of this shall be: ``Aviso--Puede 
formar habito o vicio.''

[41 FR 6908, Feb. 13, 1976]

    Effective Date Note: At 67 FR 4906, Feb. 1, 2002 Sec. 201.16 was 
revised, effective April 2, 2002. For the convenience of the user, the 
revised text is set forth as follows:

Sec. 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 Sec. 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''.