[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR610.61]

[Page 88-89]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 610_GENERAL BIOLOGICAL PRODUCTS STANDARDS--Table of Contents
 
                      Subpart G_Labeling Standards
 
Sec.  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 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

[[Page 89]]

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; 55 
FR 10423, Mar. 21, 1990; 67 FR 4907, Feb. 1, 2002]