CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER C—DRUGS: GENERAL (parts 200 to 299) > PART 201—LABELING > SUBPART B—Labeling Requirements for Prescription Drugs and/or Insulin (§201.50 to §201.58) > 201.50—Statement of identity.

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 § 201.10.
(c) The statement of identity of a prescription drug shall also comply with the placement, size and prominence requirements of § 201.10.

Code of Federal Regulations

[40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]