[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR200.5]

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                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 200--GENERAL--Table of Contents
 
                      Subpart A--General Provisions
 
Sec. 200.5  Mailing of important information about drugs.


    Manufacturers and distributors of drugs and the Food and Drug 
Administration occasionally are required to mail important information 
about drugs to physicians and others responsible for patient care. In 
the public interest, such mail should be distinctive in appearance so 
that it will be promptly recognized and read. The Food and Drug 
Administration will make such mailings in accordance with the 
specifications set forth in this section. Manufacturers and distributors 
of drugs are asked to make such mailings as prescribed by this section 
and not to use the distinctive envelopes for ordinary mail.
    (a) Use first class mail and No. 10 white envelopes.
    (b) The name and address of the agency or the drug manufacturer or 
distributor is to appear in the upper left corner of the envelope.
    (c) The following statements are to appear in the far left third of 
the envelope front, in the type and size indicated, centered in a 
rectangular space approximately 3 inches wide and 2\1/4\ inches high 
with an approximately \3/8\ inch-wide border in the color indicated:
    (1) When the information concerns a significant hazard to health, 
the statement:

                                IMPORTANT

                                  DRUG

                                 WARNING


The statement shall be in three lines, all capitals, and centered. 
``Important'' shall be in 36 point Gothic Bold type. ``Drug'' and 
``Warning'' shall be in 36 point Gothic Condensed type. The rectangle's 
border and the statement therein shall be red.
    (2) When the information concerns important changes in drug package 
labeling, the statement:

                                IMPORTANT

                               PRESCRIBING

                               INFORMATION


The statement shall be in three lines, all capitals, and centered. 
``Important'' shall be in 36 point Gothic Bold type. ``Prescribing'' and 
``Information'' shall be in 36 point Gothic Condensed type. The 
rectangle's border and the statement therein shall be blue.
    (3) When the information concerns a correction of prescription drug 
advertising or labeling, the statement:


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                                IMPORTANT

                               CORRECTION

                                 OF DRUG

                               INFORMATION


The statement shall be in four lines, all capitals, and centered. 
``Important'' shall be in 36 point Gothic Bold type. ``Correction,'' 
``Of Drug,'' and ``Information'' shall be in 36 point Gothic Condensed 
type. The rectangle's border and the statement therein shall be brown.