[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
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). 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]
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