[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR116.1]

[Page 759-760]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 116_RECORDS AND REPORTS--Table of Contents
 
Sec. 116.1  Applicability and general considerations.




Sec.
116.1 Applicability and general considerations.
116.2 Inventory and disposition records.
116.3 Label records.
116.4 Sterilization and pasteurization records.
116.5 Reports.
116.6 Animal records.
116.7 Test records.
116.8 Completion and retention of records.

    Authority: 21 U.S.C. 151-159; 7 CFR 2.22, 2.80, and 371.4.


    (a) Each licensee, permittee, and foreign manufacturer of biological 
products imported into the United States shall maintain, at the licensed 
or foreign establishment in which the products are prepared, detailed 
records of information necessary to give a complete accounting of all 
the activities within each establishment. Such records shall include, 
but shall not be limited to, the items enumerated in this part.
    (1) Records shall be made concurrently with the performance of 
successive steps in the development and preparation of biological 
products, including new products under development. Such records shall 
include the date and where critical, the time that each essential step 
was taken, the identity and quantity of ingredients added or removed at 
each step, and any gain or loss of product from the beginning to the end 
of product preparation.
    (2) Records shall be legible and indelible; shall be as detailed as 
necessary for a clear understanding of each step by one experienced in 
the preparation of biological products; and shall be verified by 
initials or signature of the person immediately responsible for the 
action taken.
    (3) Records (other than disposition records) required by this part 
shall be completed by the licensee or the foreign manufacturer, as the 
case may be,

[[Page 760]]

before any portion of a serial of any product shall be marketed in the 
United States or exported.
    (b) In the case of imported products, each permittee shall maintain 
at the permittee's place of business detailed and accurate records that 
are relevant to each imported product and that include, but are not 
limited to, importation documents, sampling records, test summaries, 
shipping records, and inventory and disposition records as required in 
Sec. 116.2.
    (c) When authorized by the Administrator, the licensee, permittee, 
or foreign manufacturer may maintain and retain records required under 
this part at an alternative location. Such authorization shall be 
confirmed by the filing of an addendum to the plot plan legend. The 
addendum shall list the location of the records and the condition of 
their storage and shall permit the inspection of the records by APHIS 
inspectors, or foreign inspectors acting on behalf of APHIS.

(Approved by the Office of Management and Budget under control number 
0579-0013)

[39 FR 16872, May 10, 1974, as amended at 48 FR 57473, Dec. 30, 1983; 61 
FR 52874, Oct. 9, 1996; 66 FR 21064, Apr. 27, 2001]