[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.
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