[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: 21CFR99.501]



[Page 454-455]

 

                        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 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 455]]



    (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.