[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR99.103]



[Page 446-447]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                                SERVICES

 

PART 99_DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED 

DRUGS, BIOLOGICS, AND DEVICES--Table of Contents

 

                Subpart B_Information To Be Disseminated

 

Sec.  99.103  Mandatory statements and information.



    (a) Any information disseminated under this part shall include:

    (1) A prominently displayed statement disclosing:

    (i) For a drug, ``This information concerns a use that has not been 

approved by the Food and Drug Administration.'' For devices, the 

statement shall read, ``This information concerns a use that has not 

been approved or cleared by the Food and Drug Administration.'' If the 

information to be disseminated includes both an approved and unapproved 

use or uses or a cleared and uncleared use or uses, the manufacturer 

shall modify the statement to identify the unapproved or uncleared new 

use or uses. The manufacturer shall permanently affix the statement to 

the front of each reprint or copy of an article from a scientific or 

medical journal and to the front of each reference publication 

disseminated under this part;

    (ii) If applicable, the information is being disseminated at the 

expense of the manufacturer;

    (iii) If applicable, the names of any authors of the information who 

were employees of, or consultants to, or received compensation from the 

manufacturer, or who had a significant financial interest in the 

manufacturer during the time that the study that is the subject of the 

dissemination was conducted up through 1 year after the time the 

article/reference publication was written and published;

    (iv) If applicable, a statement that there are products or 

treatments that have been approved or cleared for the use that is the 

subject of the information being disseminated; and

    (v) The identification of any person that has provided funding for 

the conduct of a study relating to the new use of a drug or device for 

which such information is being disseminated; and

    (2) The official labeling for the drug or device;

    (3) A bibliography of other articles (that concern reports of 

clinical investigations both supporting and not supporting the new use) 

from a scientific reference publication or scientific or medical journal 

that have been previously published about the new use of the drug or 

device covered by the information that is being disseminated, unless the 

disseminated information already includes such a bibliography; and

    (4) Any additional information required by FDA under Sec.  

99.301(a)(2). Such



[[Page 447]]



information shall be attached to the front of the disseminated 

information or, if attached to the back of the disseminated information, 

its presence shall be made known to the reader by a sticker or notation 

on the front of the disseminated information and may consist of:

    (i) Objective and scientifically sound information pertaining to the 

safety or effectiveness of the new use of the drug or device and which 

FDA determines is necessary to provide objectivity and balance. This may 

include information that the manufacturer has submitted to FDA or, where 

appropriate, a summary of such information and any other information 

that can be made publicly available; and

    (ii) An objective statement prepared by FDA, based on data or other 

scientifically sound information, bearing on the safety or effectiveness 

of the new use of the drug or device.

    (b) Except as provided in paragraphs (a)(1)(i) and (a)(4) of this 

section, the statements, bibliography, and other information required by 

this section shall be attached to such disseminated information.

    (c) For purposes of this section, factors to be considered in 

determining whether a statement is ``prominently displayed'' may 

include, but are not limited to, type size, font, layout, contrast, 

graphic design, headlines, spacing, and any other technique to achieve 

emphasis or notice. The required statements shall be outlined, boxed, 

highlighted, or otherwise graphically designed and presented in a manner 

that achieves emphasis or notice and is distinct from the other 

information being disseminated.