Code of Federal Regulations (Last Updated: July 5, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter C - Drugs: General |
Part 201 - Labeling |
Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin |
§ 201.50 - Statement of identity.
Latest version.
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§ 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.
[40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]