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 13-Apr-2017 03:05

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

  • 2017-03-20; vol. 82 # 52 - Monday, March 20, 2017
    1. 82 FR 14319 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses”; Further Delayed Effective Date; Request for Comments
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      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; further delay of effective date; request for comments.
      Effective date: The effective date for the rule amending 21 CFR chapter 1 published at 82 FR 2193 on January 9, 2017, delayed at 82 FR 9501 on February 7, 2017, is further delayed until March 19, 2018. Comment date: Submit either electronic or written comments by May 19, 2017. For additional information on the comment date, see section III in SUPPLEMENTARY INFORMATION.
      21 CFR Parts 201, 801 and 1100