[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.161]

[Page 55]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 201--LABELING--Table of Contents
 
                       Subpart E--Other Exemptions
 
Sec. 201.161  Carbon dioxide and certain other gases.

    (a) Carbon dioxide, cyclopropane, ethylene, helium, and nitrous 
oxide gases intended for drug use are exempted from the requirements of 
Sec. 201.100(b) (2), (3), and (c)(1) provided the labeling bears, in 
addition to any other information required by the Federal Food, Drug, 
and Cosmetic Act, the following:
    (1) The warning statement ``Warning--Administration of (name of gas) 
may be hazardous or contraindicated. For use only by or under the 
supervision of a licensed practitioner who is experienced in the use and 
administration of (name of gas) and is familiar with the indications, 
effects, dosages, methods, and frequency and duration of administration, 
and with the hazards, contraindications, and side effects and the 
precautions to be taken''; and
    (2) Any needed directions concerning the conditions for storage and 
warnings against the inherent dangers in the handling of the specific 
compressed gas.
    (b) This labeling exemption does not apply to mixtures of any one or 
more of these gases with oxygen or with each other.
    (c) Regulatory action may be initiated with respect to any article 
shipped within the jurisdiction of the Act contrary to the provisions of 
this section after 60 days following publication of this section in the 
Federal Register.

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