[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR225.80]

[Page 167-168]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 225_CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS--Table of Contents
 
                    Subpart D_Packaging and Labeling
 
Sec.  225.80  Labeling.


    (a) Appropriate labeling identifies the medicated feed, and provides 
the user with directions for use which, if adhered to, will assure that 
the article is safe and effective for its intended purposes.
    (b)(1) Labels and labeling, including placards, shall be received, 
handled, and stored in a manner that prevents labeling mixups and 
assures that correct labeling is employed for the medicated feed.
    (2) Labels and labeling, including placards, upon receipt from the 
printer shall be proofread against the Master Record File to verify 
their suitability and accuracy. The proofread label shall be dated, 
initialed by a responsible individual, and kept for 1 year after all the 
labels from that batch have been used.
    (3) In those instances where medicated feeds are distributed in 
bulk, complete labeling shall accompany the

[[Page 168]]

shipment and be supplied to the consignee at the time of delivery. Such 
labeling may consist of a placard or other labels attached to the 
invoice or delivery ticket, or manufacturer's invoice that identifies 
the medicated feed and includes adequate information for the safe and 
effective use of the medicated feed.
    (4) Label stock shall be reviewed periodically and discontinued 
labels shall be discarded.