[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: 21CFR201.301]
[Page 76]
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. 201.301 Notice to manufacturers, packers, and distributors of
estrogenic hormone preparations.
Some drug preparations fabricated wholly or in part from estradiol
and labeled as to potency in terms of international units or in terms of
international units of estrone activity have been marketed. The
international unit of the estrus-producing hormone was established by
the International Conference on the Standardization of Sex Hormones at
London, England, on August 1, 1932. This unit was defined as ``the
specific estrus-producing activity contained in 0.1 gamma (=0.0001 mg.)
of the standard'' hydroxyketonic hormone found in urine (estrone). The
International Conference declared that it did not recommend the
determination of the activity of nonhydroxyketonic forms of estrogenic
hormones in units of estrone because of the varying ratios between the
activity of such nonhydroxyketonic estrogenic hormones and estrone, when
measured by different methods on test animals. There is no international
unit for measuring the activity of estradiol and no accepted
relationship between its activity and that of estrone, either in test
animals or in humans. The declaration of potency of estradiol in terms
of international units or in terms of international units of estrone
activity is therefore considered misleading, within the meaning of 21
U.S.C. 352(a). The declaration of the estradiol content of an estrogenic
hormone preparation in terms of weight is considered appropriate.
Back to Top
© 2007 Betterchem Corp.
|
