US Codex
C.F.R.
Browse by date

View an earlier version

Latest
Current
Browse all versions by date
Notes

21 C.F.R. §§ 610.62–610.65

4 sections in range

§610.62. Proper name; package label; legible type.

21 C.F.R. § 610.62

(a)
Position. The proper name of the product on the package label shall be placed above any trademark or trade name identifying the product and symmetrically arranged with respect to other printing on the label.
(b)
Prominence. The point size and typeface of the proper name shall be at least as prominent as the point size and typeface used in designating the trademark and trade name. The contrast in color value between the proper name and the background shall be at least as great as the color value between the trademark and trade name and the background. Typography, layout, contrast, and other printing features shall not be used in a manner that will affect adversely the prominence of the proper name.
(c)
Legible type. All items required to be on the container label and package label shall be in legible type. “Legible type” is type of a size and character which can be read with ease when held in a good light and with normal vision.
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

Source

Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.

§610.63. Divided manufacturing responsibility to be shown.

21 C.F.R. § 610.63

If two or more licensed manufacturers participate in the manufacture of a biological product, the name, address, and license number of each must appear on the package label, and on the label of the container if capable of bearing a full label.
Notes, amendments, and revision history

Amendments

[64 FR 56453, Oct. 20, 1999]

Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

Source

Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.

Amendments

[64 FR 56453, Oct. 20, 1999]

§610.64. Name and address of distributor.

21 C.F.R. § 610.64

The name and address of the distributor of a product may appear on the label provided that the name, address, and license number of the manufacturer also appears on the label and the name of the distributor is qualified by one of the following phrases: “Manufactured for _____”, “Distributed by ______”, “Manufactured by _____ for _____”, “Manufactured for _____ by ____”, “Distributor: _____”, or “Marketed by _____”. The qualifying phrases may be abbreviated.
Notes, amendments, and revision history

Amendments

[61 FR 57330, Nov. 6, 1996]

Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

Source

Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.

Amendments

[61 FR 57330, Nov. 6, 1996]

§610.65. Products for export.

21 C.F.R. § 610.65

Labels on packages or containers of products for export may be adapted to meet specific requirements of the regulations of the country to which the product is to be exported provided that in all such cases the minimum label requirements prescribed in § 610.60 are observed.
Notes, amendments, and revision history

Authority

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a, 264.

Source

Source: 38 FR 32056, Nov. 20, 1973, unless otherwise noted.