[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: 21CFR200.5]
[Page 5-6]
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:
[[Page 6]]
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.
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