0338 21cfr610 67 2007

Food and Drug Administration, HHS

§ 630.6

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.

lations 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.
§ 610.67

Bar code label requirements.

Biological products must comply
with the bar code requirements at
§ 201.25 of this chapter. However, the
bar code requirements do not apply to
devices regulated by the Center for
Biologics Evaluation and Research or
to blood and blood components intended for transfusion. For blood and
blood components intended for transfusion,
the
requirements
at
§ 606.121(c)(13) of this chapter apply instead.
[69 FR 9171, Feb. 26, 2004]

PART
630—GENERAL
REQUIREMENTS FOR BLOOD, BLOOD
COMPONENTS, AND BLOOD DERIVATIVES

§ 610.63 Divided manufacturing responsibility to be shown.
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.

AUTHORITY: 21 U.S.C. 321, 331, 351, 352, 355,
360, 371; 42 U.S.C. 216, 262, 264.
SOURCE: 66 FR 31176, June 11, 2001, unless
otherwise noted.

§ 630.6

Donor notification.

(a) Notification of donors. You, an establishment that collects blood or
blood components, must make reasonable attempts to notify any donor, including an autologous donor, who has
been deferred based on the results of
tests for evidence of infection with a
communicable disease agent(s) as required by § 610.41 of this chapter; or
who has been determined not to be
suitable as a donor based on suitability
criteria under § 640.3 or § 640.63 of this
chapter. You must attempt to obtain
the results of supplemental testing required under § 610.40(e) of this chapter
prior to notifying a donor of the deferral. If notification occurs prior to receipt of such results, you must also notify a deferred donor of the results of
the supplemental testing. You must
notify a donor as described in paragraph (b) of this section.
(b) Content of notification. You must
provide the following information to a
donor deferred or determined not to be

[64 FR 56453, Oct. 20, 1999]

§ 610.64 Name and address of distributor.
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 lllll’’, ‘‘Distributed
by llllll’’, ‘‘Manufactured by
lllll for lllll’’, ‘‘Manufactured for lllll by llll’’, ‘‘Distributor: lllll’’, or ‘‘Marketed by
lllll’’. The qualifying phrases
may be abbreviated.
[61 FR 57330, Nov. 6, 1996]

§ 610.65 Products for export.
Labels on packages or containers of
products for export may be adapted to
meet specific requirements of the regu-

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