[Code of Federal Regulations]
[Title 21, Volume 4]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR225.42]

[Page 140-141]
 
                        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 C--Product Quality Control
 
Sec. 225.42  Components.


    (a) A medicated feed, in addition to providing nutrients, is a 
vehicle for the administration of a drug, or drugs, to animals. To 
ensure proper safety and effectiveness, such medicated feeds must 
contain the labeled amounts of drugs. It is necessary that adequate 
procedures be established for the receipt, storage, and inventory 
control for all such drugs to aid in assuring their identity, strength, 
quality, and purity when incorporated into products.
    (b) The receipt, storage, and inventory of drugs, including 
undiluted drug components, medicated premixes, and semiprocessed (i.e., 
intermediate premixes, inplant premixes and concentrates) intermediate 
mixes containing drugs, which are used in the manufacture and processing 
of medicated feeds shall conform to the following:
    (1) Incoming shipments of drugs shall be visually examined for 
identity and damage. Drugs which have been subjected to conditions which 
may have adversely affected their identity, strength, quality, or purity 
shall not be accepted for use.
    (2) Packaged drugs in the storage areas shall be stored in their 
original closed containers.
    (3) Bulk drugs shall be identified and stored in a manner such that 
their identity, strength, quality, and purity will be maintained.
    (4) Drugs in the mixing areas shall be properly identified, stored, 
handled, and controlled to maintain their integrity and identity. 
Sufficient space shall be provided for the location of each drug.
    (5) A receipt record shall be prepared and maintained for each lot 
of drug received. The receipt record shall accurately indicate the 
identity and quantity of the drug, the name of the supplier, the 
supplier's lot number or an identifying number assigned by the feed 
manufacturer upon receipt which relates to the particular shipment, the 
date of receipt, the condition of the drug when received, and the return 
of any damaged drugs.
    (6) A daily inventory record for each drug used shall be maintained 
and shall list by manufacturer's lot number or the feed manufacturer's 
shipment identification number at least the following information:
    (i) The quantity of drug on hand at the beginning and end of the 
work day (the beginning amount being the same as the previous day's 
closing inventory if this amount has been established to

[[Page 141]]

be correct); the quantity shall be determined by weighing, counting, or 
measuring, as appropriate.
    (ii) The amount of each drug used, sold, or otherwise disposed of.
    (iii) The batches or production runs of medicated feed in which each 
drug was used.
    (iv) When the drug is used in the preparation of a semiprocessed 
intermediate mix intended for use in the manufacture of medicated feed, 
any additional information which may be required for the purpose of 
paragraph (b)(7) of this section.
    (v) Action taken to reconcile any discrepancies in the daily 
inventory record.
    (7) Drug inventory shall be maintained of each lot or shipment of 
drug by means of a daily comparison of the actual amount of drug used 
with the theoretical drug usage in terms of the semiprocessed, 
intermediate and finished medicated feeds manufactured. Any significant 
discrepancy shall be investigated and corrective action taken. The 
medicated feed(s) remaining on the premises which are affected by this 
discrepancy shall be detained until the discrepancy is reconciled.
    (8) All records required by this section shall be maintained on the 
premises for at least one year after complete use of a drug component of 
a specific lot number or feed manufacturer's shipment identification 
number.