[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR801.433]

[Page 35-36]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 801--LABELING--Table of Contents
 
          Subpart H--Special Requirements for Specific Devices
 
Sec. 801.433  Warning statements for prescription and restricted device products containing or manufactured with chlorofluorocarbons or other ozone-depleting substances.

    (a)(1) All prescription and restricted device products containing or 
manufactured with chlorofluorocarbons, halons, carbon tetrachloride, 
methyl chloride, or any other class I substance designated by the 
Environmental Protection Agency (EPA) shall, except as provided in 
paragraph (b) of this section, bear the following warning statement:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    (2) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase.
    (b)(1) For prescription and restricted device products, the 
following alternative warning statement may be used:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or name of other class I substance, if 
applicable]:

    This product contains [or is manufactured with, if applicable] 
[insert name of substance], a substance which harms the environment by 
destroying ozone in the upper atmosphere.
    Your physician has determined that this product is likely to help 
your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS INSTRUCTED TO 
DO OTHERWISE BY YOUR PHYSICIAN. If you have any questions about 
alternatives, consult with your physician.
    (2) The warning statement shall be clearly legible and conspicuous 
on the product, its immediate container, its outer packaging, or other 
labeling in accordance with the requirements of 40 CFR part 82 and 
appear with such prominence and conspicuousness as to render it likely 
to be read and understood by consumers under normal conditions of 
purchase.
    (3) If the warning statement in paragraph (b)(1) of this section is 
used, the following warning statement must be placed on the package 
labeling intended to be read by the physician (physician package insert) 
after the ``How supplied'' section, which describes special handling and 
storage conditions on the physician labeling:
    Note: The indented statement below is required by the Federal 
government's Clean Air Act for all products containing or manufactured 
with chlorofluorocarbons (CFC's) [or name of other class I substance, if 
applicable]:

    Warning: Contains [or Manufactured with, if applicable] [insert name 
of substance], a substance which harms public health and environment by 
destroying ozone in the upper atmosphere.

    A notice similar to the above WARNING has been placed in the 
information for the patient [or patient information leaflet, if 
applicable] of this product under Environmental Protection Agency (EPA) 
regulations. The patient's warning states that the patient should 
consult his or her physician if there are questions about alternatives.

[[Page 36]]

    (c) This section does not replace or relieve a person from any 
requirements imposed under 40 CFR part 82.

[61 FR 20101, May 3, 1996]