[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: 21CFR610.60]

[Page 88]
 
                        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.  610.60  Container label.


    (a) Full label. The following items shall appear on the label 
affixed to each container of a product capable of bearing a full label:
    (1) The proper name of the product;
    (2) The name, address, and license number of manufacturer;
    (3) The lot number or other lot identification;
    (4) The expiration date;
    (5) The recommended individual dose, for multiple dose containers.
    (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 Sec.  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.

[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]