21 CFR 201.50 - Statement of identity.

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§ 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]

Title 21 published on 2015-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 201 after this date.

  • 2015-11-30; vol. 80 # 229 - Monday, November 30, 2015
    1. 80 FR 74737 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Reopening of the Comment Period
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notice of proposed rulemaking; reopening of the comment period.
      The comment period for the proposed rule published on September 25, 2015 (80 FR 57756) is extended. Submit either electronic or written comments by December 30, 2015.
      21 CFR Parts 201, 801, and 1100