0338 21cfr610 62 2007

§ 610.61

21 CFR Ch. I (4–1–05 Edition)

(6) The statement: ‘‘ ‘Rx only’ ’’ for
prescription biologicals.
(7) If a Medication Guide is required
under part 208 of this chapter, the
statement required under § 208.24(d) of
this chapter instructing the authorized
dispenser to provide a Medication
Guide to each patient to whom the
drug is dispensed and stating how the
Medication Guide is provided, except
where the container label is too small,
the required statement may be placed
on the package label.
(b) Package label information. If the
container is not enclosed in a package,
all the items required for a package
label shall appear on the container
label.
(c) Partial label. If the container is capable of bearing only a partial label,
the container shall show as a minimum
the name (expressed either as the proper or common name), the lot number or
other lot identification and the name
of the manufacturer; in addition, for
multiple dose containers, the recommended individual dose. Containers
bearing partial labels shall be placed in
a package which bears all the items required for a package label.
(d) No container label. If the container
is incapable of bearing any label, the
items required for a container label
may be omitted, provided the container
is placed in a package which bears all
the items required for a package label.
(e) Visual inspection. When the label
has been affixed to the container a sufficient area of the container shall remain uncovered for its full length or
circumference to permit inspection of
the contents.

safety factor, the words ‘‘no preservative’’;
(f) The number of containers, if more
than one;
(g) The amount of product in the container expressed as (1) the number of
doses, (2) volume, (3) units of potency,
(4) weight, (5) equivalent volume (for
dried product to be reconstituted), or
(6) such combination of the foregoing
as needed for an accurate description of
the contents, whichever is applicable;
(h) The recommended storage temperature;
(i) The words ‘‘Shake Well’’, ‘‘Do not
Freeze’’ or the equivalent, as well as
other instructions, when indicated by
the character of the product;
(j) The recommended individual dose
if the enclosed container(s) is a multiple-dose container;
(k) The route of administration recommended, or reference to such directions in an enclosed circular;
(l) Known sensitizing substances, or
reference to an enclosed circular containing appropriate information;
(m) The type and calculated amount
of antibiotics added during manufacture;
(n) The inactive ingredients when a
safety factor, or reference to an enclosed circular containing appropriate
information;
(o) The adjuvant, if present;
(p) The source of the product when a
factor in safe administration;
(q) The identity of each microorganism used in manufacture, and, where
applicable, the production medium and
the method of inactivation, or reference to an enclosed circular containing appropriate information;
(r) Minimum potency of product expressed in terms of official standard of
potency or, if potency is a factor and
no U.S. standard of potency has been
prescribed, the words ‘‘No U.S. standard of potency.’’
(s) The statement: ‘‘ ‘Rx only’ ’’ for
prescription biologicals.

[38 FR 32056, Nov. 20, 1973, as amended at 47
FR 22518, May 25, 1982; 63 FR 66400, Dec. 1,
1998; 67 FR 4907, Feb. 1, 2002]

§ 610.61 Package label.
The following items shall appear on
the label affixed to each package containing a product:
(a) The proper name of the product;
(b) The name, address, and license
number of manufacturer;
(c) The lot number or other lot identification;
(d) The expiration date;
(e) The preservative used and its concentration, or if no preservative is used
and the absence of a preservative is a

[38 FR 32056, Nov. 20, 1973, as amended at 47
FR 22518, May 25, 1982; 55 FR 10423, Mar. 21,
1990; 67 FR 4907, Feb. 1, 2002]

§ 610.62 Proper name; package label;
legible type.
(a) Position. The proper name of the
product on the package label shall be

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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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