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Nomenclature changes to part 201 appear at 69 FR 13717, Mar. 24, 2004.
(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]