[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: 21CFR201.50]
[Page 20]
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 B Labeling Requirements for Prescription Drugs and/or Insulin
Sec. 201.50 Statement of identity.
(a) The label of prescription and insulin-containing drugs in
package form shall bear as one of its principal features a statement of
the identity of the drug.
(b) Such statement of identity shall be in terms of the established
name of the drug. In the case of a prescription drug that is a mixture
and that has no established name, the requirement for statement of
identity shall be deemed to be satisfied by a listing of the
quantitative ingredient information as prescribed by Sec. 201.10.
(c) The statement of identity of a prescription drug shall also
comply with the placement, size and prominence requirements of Sec.
201.10.
[40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]
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