Skip to main content
 

21 CFR 201.15 - Drugs; prominence of required label statements.

There is 1 rule appearing in the Federal Register for 21 CFR 201. Select the tab below to view, or View eCFR (GPOAccess)
§ 201.15
Drugs; prominence of required label statements.
(a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 502(c) of the act by reason, among other reasons, of:
(1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase;
(2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed;
(3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information;
(4) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;
(5) Insufficiency of label space for the prominent placing of such word, statement, or information, resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or
(6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter.
(b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 502 (b) or (e) of the act, shall apply if such insufficiency is caused by:
(1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label;
(2) The use of label space to give greater conspicuousness to any word, statement, or other information than is required by section 502(c) of the act; or
(3) The use of label space for any representation in a foreign language.
(c) (1) All words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for English.
(2) If the label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label shall appear thereon in the foreign language.
(3) If the labeling contains any representation in a foreign language, all words, statements, and other information required by or under authority of the act to appear on the label or labeling shall appear on the labeling in the foreign language.
[41 FR 6908, Feb. 13, 1976]

Title 21 published on 2012-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2012-05-11; vol. 77 # 92 - Friday, May 11, 2012
    1. 77 FR 27591 - Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Delay of Compliance Dates
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; delay of compliance dates; request for comments.
      Effective Date: This final rule is effective June 18, 2012. The final rule published at 76 FR 35620 on June 17, 2011, remains effective June 18, 2012. Comment date: Submit written or electronic comments on the delay of compliance dates by May 21, 2012. Compliance Dates: The compliance dates for the final rule published at 76 FR 35620 on June 17, 2011, including the lifting of the delay of implementation date for 21 CFR 201.66 as published at 69 FR 53801, September 3, 2004, are delayed until December 17, 2013, for products with annual sales of less than $25,000, and until December 17, 2012 for all other products subject to the rule.
      21 CFR Parts 201 and 310

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


United States Code
USC : Title 21 - FOOD AND DRUGS

§ 351 - Adulterated drugs and devices

§ 352 - Misbranded drugs and devices

§ 353 - Exemptions and consideration for certain drugs, devices, and biological products

§ 358 - Authority to designate official names

§ 360 - Registration of producers of drugs or devices

§ 360b - New animal drugs

§ 360ss - State standards

21 USC § 221 to 237 - Repealed. July 1, 1944, ch. 373, title XIII,

U.S.C. : Title 42 - THE PUBLIC HEALTH AND WELFARE

§ 216 - Regulations

§ 241 - Research and investigations generally

Title 21 published on 2012-04-01

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

  • 2013-02-06; vol. 78 # 25 - Wednesday, February 6, 2013
    1. 78 FR 8446 - Center for Drug Evaluation and Research; Prescription Drug Labeling Improvement and Enhancement Initiative; Request for Comments and Information
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Notification of an initiative; request for comments and information.
      Submit either electronic or written comments by March 8, 2013.
      21 CFR Parts 201, 314, and 601