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e-CFR data is current as of October 22, 2020

Title 21Chapter ISubchapter CPart 201Subpart B → §201.50


Title 21: Food and Drugs
PART 201—LABELING
Subpart B—Labeling Requirements for Prescription Drugs and/or Insulin


§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]

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