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

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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 2013-04-01

no entries appear in the Federal Register after this date.