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21 CFR 201, Appendix A to Part 201 - Examples of Graphic Enhancements Used by FDA

There is 1 rule appearing in the Federal Register for 21 CFR 201. Select the tab below to view, or View eCFR (GPOAccess)
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View PDF at GPO Pt. 201, App. A
Appendix A to Part 201—Examples of Graphic Enhancements Used by FDA
I. Section 201.66 Standard Labeling Format
A. Overall
1. The “Drug Facts” labeling is set off in a box or similar enclosure by the use of a barline with all black type printed on a white, color contrasting background.
B. Typeface and size
1. “Drug Facts” is set in 14 point Helvetica Bold Italic, left justified.
2. “Drug Facts (continued)” is set in 8 point Helvetica Bold Italic for the words “Drug Facts” and 8 point Helvetica Regular for the word “(continued)” and is left justified.
3. The headings (e.g., “Directions”) are set in 8 point Helvetica Bold Italic, left justified.
4. The subheadings (e.g., “Ask a doctor or pharmacist before use if you are”) are set in 6 point Helvetica Bold, left justified.
5. The information is set in 6 point Helvetica Regular with 6.5 point leading, left justified.
6. The heading “Purpose” is right justified.
7. The bullet is a 5-point solid square.
8. Two em spacing separates bullets when more than one bullet is on the same line.
9. A table format is used for 3 or more dosage directions.
10. A graphic appears at the bottom of the first panel leading the reader to the next panel.
C. Barlines and hairlines
1. A 2.5-point horizontal barline extends to each end of the “Drug Facts” box (or similar enclosure), providing separation between each of the headings.
2. A 0.5-point horizontal hairline extends within 2 spaces on either side of the “Drug Facts” box (or similar enclosure), immediately following the title and immediately preceding the subheadings.
3. A 0.5-point horizontal hairline follows the title, immediately preceding the heading, when a heading appears on a subsequent panel immediately after the “Drug Facts (continued)” title.
D. Box or Enclosure
1. All information is enclosed by a 2.5-point barline.
II. Section 201.66 Modified Labeling Format
A. Overall
1. The “Drug Facts” labeling is presented in all black type printed on a white color contrasting background.
B. Typeface and size
1. “Drug Facts” is set in 9 point Helvetica Bold Italic, left justified.
2. The headings (e.g., “Directions”) are set in 8 point Helvetica Bold Italic, left justified.
3. The subheadings (e.g., “Ask a doctor or pharmacist before use if you are”) are set in 6 point Helvetica Bold, left justified.
4. The information is set in 6 point Helvetica Regular with 6.5 point leading, left justified.
5. The heading “Purpose” is right justified.
6. The bullet is a 5-point solid square.
7. Bulleted information may start on same line as headings (except for the “Warnings” heading) and subheadings, with 2 em spacing separating bullets, and need not be vertically aligned.
C. Barlines and hairlines
1. A 2.5-point horizontal barline extends to each end of the “Drug Facts” box (or similar enclosure), providing separation between each of the headings.
2. A 0.5-point horizontal hairline extends within 2 spaces on either side of the “Drug Facts” box (or similar enclosure), immediately following the title and immediately preceding the subheadings.
D. Box or Enclosure
1. All information is set off by color contrast. No barline is used.
III. Examples of § 201.66 Standard Labeling and Modified Labeling Formats
A. Section 201.66 Standard Labeling Format
B. Section 201.66 Modified Labeling Format

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

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