Statement of identity.

21 C.F.R. § 201.50
in effectEffective: 2024-07-01
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(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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