21 C.F.R. § 201.50 Statement of identity.
Title 21 - Food and Drugs
(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 §201.10. (c) The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of §201.10. [40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]
Title 21: Food and Drugs
PART 201—LABELING
Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin
§ 201.50 Statement of identity.
