21 CFR Part 201 · Labeling

§ 201.50 Statement of identity

Subpart B - Labeling Requirements for Prescription Drugs and/or Insulin Official text on eCFR Amendment history

(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 .

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Amendment history

Federal Register documents that created or amended this section.