[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: 21CFR20.112]
[Page 216]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 20 PUBLIC INFORMATION--Table of Contents
Subpart F Availability of Specific Categories of Records
Sec. 20.112 Voluntary drug experience reports submitted by physicians and
hospitals.
(a) A voluntary drug experience report to the Food and Drug
Administration on FDA Form 3500 shall be handled in accordance with the
rules established in Sec. 20.111(c)(3)(iii).
(b) If a person requests a copy of any such record relating to a
specific individual or a specific incident, such request will be denied
unless accompanied by the written consent to such disclosure of the
person who submitted the report to the Food and Drug Administration and
the individual who is the subject of the report.
[42 FR 15616, Mar. 22, 1977, as amended at 54 FR 9038, Mar. 3, 1989; 62
FR 52249, Oct. 7, 1997]
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