[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: 21CFR201.161]
[Page 73]
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 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.
Back to Top
© 2007 Betterchem Corp.
|
