[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: 21CFR201.313]
[Page 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. 201.313 Estradiol labeling.
The article presently recognized in The National Formulary under the
heading ``Estradiol'' and which is said to be ``17-cis-beta estradiol''
is the same substance formerly recognized in the United States
Pharmacopeia under the designation ``Alpha Estradiol.'' The substance
should no longer be referred to in drug labeling as ``Alpha Estradiol.''
The Food and Drug Administration would not object to label references to
the article as simply ``Estradiol''; nor would it object if the label of
a preparation containing this substance referred to the presence of
``Estradiol (formerly known as Alpha Estradiol).''
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