[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.103]

[Page 449-450]
 
                        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 450]]

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.