§ 201.50. Statement of identity.

122 words·~1 min read·/us/cfr/t21/s§ 201.50·

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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. [40 FR 13998, Mar. 27, 1975, as amended at 63 FR 26698, May 13, 1998]

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§ 201.50

Statement of identity.

Fed. Reg.×2

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