[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR201.309]
[Page 81-82]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 201 LABELING--Table of Contents
Subpart G Specific Labeling Requirements for Specific Drug Products
Sec. 201.309 Acetophenetidin (phenacetin)-containing preparations; necessary
warning statement.
(a) In 1961, the Food and Drug Administration, pursuant to its
statutory responsibility for the safety and effectiveness of drugs
shipped in interstate commerce, began an active investigation of reports
of possible toxic effects and renal damage due to misuse of the drug
acetophenetidin. This study led to the decision that there was probable
cause to conclude that misuse and prolonged use of the drug were in fact
responsible for kidney lesions and disease. The Commissioner of Food and
Drugs, in December 1963, appointed an ad hoc Advisory Committee of
Inquiry on Possible Nephrotoxicity Associated With the Abuse of
Acetophenetidin (Phenacetin)-Containing Preparations. This committee,
composed of scientists in the fields of pharmacology and medicine, on
April 23, 1964, submitted its findings and conclusions in the matter and
recommended that all acetophenetidin (phenacetin)-containing
preparations bear a warning as provided in section 502(f)(2) of the
Federal Food, Drug, and Cosmetic Act.
(b) On the basis of the studies made by the Food and Drug
Administration and the report of the Advisory Committee, the
Commissioner of Food and
[[Page 82]]
Drugs has concluded that it is necessary for the protection of users
that the label and labeling of all acetophenetidin (phenacetin)-
containing preparations bear a warning statement to the following
effect: ``Warning--This medication may damage the kidneys when used in
large amounts or for a long period of time. Do not take more than the
recommended dosage, nor take regularly for longer than 10 days without
consulting your physician.''
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