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
WARNINGThe 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
INFORMATIONThe 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
INFORMATIONThe 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.
Notes of Decisions
Cited in
15
cases (
4 in the last 5 years), 1982–2025 · leading case:
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
“See Brief for Respondents 36; 21 CFR § 200.5 . Again, the FDA disagrees, and we defer to the agency’s views.”
Weiss v. Fujisawa Pharm. Co., 464 F. Supp. 2d 666 (E.D. Ky. 2006).
· cites it 2× “” 21 C.F.R. § 200.5 . “[Significant hazardfs] to health” are one example of the “important information” contemplated by this regulation.”
Perry v. Novartis Pharma. Corp., 456 F. Supp. 2d 678 (E.D. Pa. 2006).
“, “Dear Doctor” letters containing such information) is not prohibited by these regulations.”
Diana & Mark Sherman v. Pliva, Inc, Teva Pharm., 440 P.3d 1016 (Wash. Ct. App. 2019).
“2d 580 (2011); 21 C.F.R. 200.5. 4 Sherman initially argues that we should hold that the commissioner erred in granting discretionary review under RAP 2.”
Gaeta v. Perrigo Pharm. Co., 630 F.3d 1225 (9th Cir. 2011).
“See 21 C.F.R. § 200.5 . When the FDA first adopted its labeling regulations, well before the Hatch-Wax-man Amendments, it made clear that the labeling requirements “do not prohibit a manufacturer .”
Christopher v. Cutter Labs., 53 F.3d 1184 (11th Cir. 1995).
“21 C.F.R. § 200.5 (1983). . Whole blood is obtained from a direct blood donation and is used rarely because of the small amount of clotting Factor VIII and the potential for fatal vascular overload and congestive heart failure.”
Walls v. Armour Pharm. Co., 832 F. Supp. 1467 (M.D. Fla. 1993).
“21 C.F.R. § 200.5 (1982). This regulation further specified the type of envelope and print size for the FDA to use in such mailings.”
PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011).
· cites it 2× “See Brief for Respondents 36; 21 CFR §200.5 . Again, the FDA disagrees, and we defer to the agency’s views.”
Camejo v. Angelini Pharma Inc. (Del. Super. Ct. 2021).
“Camejo’s attempt to devise a California state-law claim for failure to warn derived from his suggested duty to send a “Dear Doctor” letter highlighting the priapism warning fails both on the law and on logic.”
Ctr. for Env't Health v. Perrigo Co. (Cal. Ct. App. 2023).
“4th 96, 104 ; see 21 C.F.R. § 200.5 .) 22 Two years later, Bartlett applied Mensing to hold that “state-law design-defect claims that turn on the adequacy of a drug’s warnings are pre- empted by federal law.”
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