0338 21cfr610 61 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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