[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR99.501]

[Page 456-457]
 
                        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 
 
                   Subpart F_Recordkeeping and Reports
 
Sec.  99.501  Recordkeeping and reports.


    (a) A manufacturer disseminating information under this part shall:
    (1) Maintain records sufficient to allow the manufacturer to take 
corrective action as required by FDA. The manufacturer shall make such 
records available to FDA, upon request, for inspection and copying. Such 
records shall either:
    (i) Identify, by name, those persons receiving the disseminated 
information; or
    (ii) Identify, by category, the recipients of the disseminated 
information, unless FDA requires the manufacturer to retain records 
identifying individual recipients of the disseminated information. 
Manufacturers whose records identify recipients by category only shall:
    (A) Identify subcategories of recipients where appropriate (e.g., 
oncologists, pediatricians, obstetricians, etc.); and
    (B) Ensure that any corrective action to be taken will be 
sufficiently conspicuous to individuals within that category of 
recipients;
    (2) Maintain an identical copy of the information disseminated under 
this part; and
    (3) Upon the submission of a supplemental application to FDA, notify 
the appropriate office identified in Sec.  99.201(c) of this part.
    (b) A manufacturer disseminating information on a new use for a drug 
or device shall, on a semiannual basis, submit to the FDA office 
identified in Sec.  99.201(c) of this part:
    (1) A list containing the titles of articles and reference 
publications relating to the new use of drugs or devices that the 
manufacturer disseminated to a health care practitioner, pharmacy 
benefit manager, health insurance issuer, group health plan, or Federal 
or State Government agency. The list shall cover articles and reference 
publications disseminated in the 6-month period preceding the date on 
which the manufacturer provides the list to FDA;
    (2) A list identifying the categories of health care practitioners, 
pharmacy benefit managers, health insurance issuers, group health plans, 
or Federal or State Government agencies that received the articles and 
reference publications in the 6-month period described in paragraph 
(b)(1) of this section. The list shall also identify which category of 
recipients received a particular article or reference publication;
    (3) A notice and summary of any additional clinical research or 
other data relating to the safety or effectiveness of the new use, and, 
if the manufacturer possesses such clinical research or other data, a 
copy of the research or data. Such other data may include, but is not 
limited to, new articles published in scientific or medical journals, 
reference publications, and summaries of adverse effects that are or may 
be associated with the new use;

[[Page 457]]

    (4) If the manufacturer is conducting studies necessary for the 
submission of a supplemental application, the manufacturer shall submit 
periodic progress reports on these studies to FDA. Such reports shall 
describe the studies' current status (i.e., progress on patient 
enrollment, any significant problems that could affect the 
manufacturer's ability to complete the studies, and expected completion 
dates). If the manufacturer discontinues or terminates a study before 
completing it, the manufacturer shall, as part of the next periodic 
progress report, state the reasons for such discontinuation or 
termination; and
    (5) If the manufacturer was granted an exemption from the 
requirements to submit a supplemental application for the new use, any 
new or additional information that relates to whether the manufacturer 
continues to meet the requirements for such exemption. This information 
may include, but is not limited to, new or additional information 
regarding revenues from the product that is the subject of the 
dissemination and new or additional information regarding the 
persuasiveness of the data on the new use, including information 
regarding whether the new use is broadly accepted as current standard 
medical treatment or therapy.
    (c) A manufacturer shall maintain a copy of all information, lists, 
records, and reports required or disseminated under this part for 3 
years after it has ceased dissemination of such information and make 
such documents available to FDA for inspection and copying.