[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: 21CFR225.58]

[Page 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. 225.58  Laboratory controls.

    (a) The periodic assay of medicated feeds for drug components 
provides a measure of performance of the manufacturing process in 
manufacturing a uniform product of intended potency.
    (b) The following assay requirements shall apply to medicated feeds:
    (1) For feeds requiring a medicated feed mill license (Form FDA 
3448) for their manufacture and marketing, at least three representative 
samples of medicated feed containing each drug or drug combination used 
in the establishment shall be collected and assayed by approved official 
methods, at periodic intervals during the calendar year, unless 
otherwise specified in this chapter. At least one of these assays shall 
be performed on the first batch using the drug. If a medicated feed 
contains a combination of drugs, only one of the drugs need be subject 
to analysis each time, provided the one tested is different from the 
one(s) previously tested.
    (2) [Reserved]
    (c) The originals or copies of all results of assays, including 
those from State feed control officials and any other governmental 
agency, shall be maintained on the premises for a period of not less 
than 1 year after distribution of the medicated feed. The results of 
assays performed by State feed control officials may be considered 
toward fulfillment of the periodic assay requirements of this section.
    (d) Where the results of assays indicate that the medicated feed is 
not in accord with label specifications or is not within permissible 
assay limits as specified in this chapter, investigation and corrective 
action shall be implemented and an original or copy of the record of 
such action maintained on the premises.
    (e) Corrective action shall include provisions for discontinuing 
distribution where the medicated feed fails to meet the labeled drug 
potency. Distribution of subsequent production of the particular feed 
shall not begin until it has been determined that proper control 
procedures have been established.

[41 FR 52618, Nov. 30, 1976, as amended at 51 FR 7390, Mar. 3, 1986; 55 
FR 11577, Mar. 29, 1990; 64 FR 63203, Nov. 19, 1999]