Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 201  /  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).''