Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter C - DRUGS: GENERALPart 200 - GENERAL
Subpart A - GENERAL PROVISIONS
Section 200.5 - Mailing of important information about drugs

21 C.F.R. § 200.5

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Current through October 31, 2024
Section 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 21/4 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:

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.

21 C.F.R. §200.5