Section 9CFR113.113



[Code of Federal Regulations]
[Title 9, Volume 1]
[Revised as of January 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 9CFR113.113]

[Page 641-644]
 
                  TITLE 9--ANIMALS AND ANIMAL PRODUCTS
 
  CHAPTER I--ANIMAL AND PLANT HEALTH INSPECTION SERVICE, DEPARTMENT OF 
                               AGRICULTURE
 
PART 113--STANDARD REQUIREMENTS--Table of Contents
 
Sec. 113.113  Autogenous biologics.

    Autogenous biologics shall be prepared from cultures of 
microorganisms which have been inactivated and are nontoxic. Such 
products shall be prepared only for use by or under the direction of a 
veterinarian under a veterinarian-client-patient relationship, Provided, 
That, such products may be prepared for use under the direction of a 
person of appropriate expertise in specialized situations such as 
aquaculture, if approved by the Administrator.
    Each serial of an autogenous biologic shall meet the requirements in 
this section, and if found unsatisfactory by any prescribed test shall 
not be used.
    (a) Seed requirements. The microorganisms used as seed to prepare 
autogenous biologics shall be microorganisms which are isolated from 
sick or dead animals in the herd of origin and which there is reason to 
believe are the causative agent(s) of the current disease affecting such 
animals.
    (1) More than one microorganism isolated from the same herd may be 
used as seed.
    (2) Under normal circumstances, microorganisms from one herd must 
not be used to prepare an autogenous biologic for another herd. The 
Administrator, however, may authorize preparation of an autogenous 
biologic for use in herds adjacent to the herd of origin, when adjacent 
herds are considered to be at risk. To request authorization to prepare 
a product for use in herds adjacent to the herd of origin, the 
establishment seeking authorization must submit to the Administrator (in 
c/o the Director, Center for Veterinary Biologics, Inspection and 
Compliance, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) the 
following information. (If any of the data are unavailable, the 
applicant for authorization should indicate that such data are 
unavailable and why.)
    (i) Name, address, and phone number of the owner of the herd of 
origin.
    (ii) Attending veterinarian's name, address, and phone number.
    (iii) Animal species and number in herd of origin.
    (iv) Identification of microorganism(s), at least to genus.

[[Page 642]]

    (v) Diagnosis or clinical signs of the disease observed.
    (vi) Name and address of the person who isolated the 
microorganism(s) and the date of isolation.
    (vii) Number of doses of autogenous biologic requested and 
vaccination schedule.
    (viii) Each adjacent herd owner's name, address, and phone number.
    (ix) Number of animals and species in each adjacent herd.
    (x) The attending veterinarian's or approved specialist's assessment 
of the involvement of the adjacent herd(s) with the disease observed.

The applicant shall give notice to the State Veterinarian or other 
appropriate State Official in writing when an autogenous biologic is to 
be used in adjacent herds.
    (3) The Administrator may authorize preparation of an autogenous 
biologic for use in herds which are not adjacent to the herd of origin, 
but which he or she considers to be at risk of infection with the same 
microorganism(s). Except as provided below, the same information which 
is required for preparation of such product for use in herds adjacent to 
the herd of origin must be submitted to the Administrator (in c/o the 
Director, Center for Veterinary Biologics, Inspection and Compliance, 
510 South 17th Street, Suite 104, Ames, IA 50010-8197) for authorization 
to prepare a product for use in herds not adjacent to the herd of 
origin. Because the recipient herd involved may not be known when 
autogenous biologics are to be used in other geographic areas, the 
following data may be used in place of the data required in paragraphs 
(a)(2)(viii) and (a)(2)(ix) of this section.
    (i) Names and addresses of practitioners in the area in place of the 
name, address, and phone number of the adjacent herd owner.
    (ii) The geographic designations of the area involved.
    (iii) A summary of the epidemiology of the disease situation that 
links the designated geographic areas with the herd of origin.

In addition, an applicant for authorization under this paragraph (a)(3) 
shall provide written approval from the State Veterinarian or other 
appropriate State Official in the State in which the autogenous biologic 
is to be used in nonadjacent herds.
    (4) Under normal circumstances, microorganism(s) used for the 
production of autogenous biologics may not be older than 15 months from 
the date of isolation, or 12 months from the date of harvest of the 
first serial of product produced from the microorganism(s), whichever 
comes first. The Administrator, however, may authorize production of 
additional serials from microorganism(s) older than the above stated 
time periods, Provided, That, the person requesting such authorization 
submits the following supporting information to the address listed in 
paragraph (a)(3):
    (i) The attending veterinarian's or approved specialist's current 
assessment of the continued involvement of a herd with the originally 
isolated microorganism(s), including a summary of the diagnostic work 
that has been done to support this assessment.
    (ii) Evidence of satisfactory protection from the previous use of 
the autogenous biologic produced from the microorganisms involved.
    (iii) Any other information the Administrator may require in order 
to determine the need to use the microorganism to make additional 
serials.
    (b) Restrictions. Unless otherwise authorized by the Administrator, 
each serial of an autogenous biologic shall be subject to the following 
restrictions:
    (1) Microorganisms used to prepare autogenous biologics shall not be 
maintained in the licensed establishment beyond the time authorized for 
use in production.
    (2) The expiration date of the autogenous biologic shall not exceed 
18 months from the date of harvest.
    (c) Testing requirements for autogenous biologics. (1) Final 
container samples of completed product from the first serial or 
subserial of an autogenous biologic produced from an isolate shall be 
tested for purity as prescribed in Sec. 113.26, and for safety as 
prescribed in Sec. 113.33(b) or Sec. 113.38 except that:
    (i) When the number of final containers in a serial or subserial is 
50 or less, two final container samples from each serial and subserial 
shall be tested as prescribed in Sec. 113.26(b): Provided, That, 1 ml 
aliquots from each sample

[[Page 643]]

may be inoculated into five corresponding individual test vessels of 
each of the test media required.
    (ii) Serials which are satisfactory after the third day of 
observation of purity test cultures and of safety test animals may be 
released for shipment to the customer and the tests continued throughout 
the required period; and
    (iii) Serials released on the basis of satisfactory results of third 
day observations shall be immediately recalled if evidence of 
contamination occurs in test cultures or if any of the test animals used 
to demonstrate product safety, sicken, or die during the observation 
period.
    (iv) Test summaries must be submitted to the Administrator (in c/o 
the Director, Center for Veterinary Biologics, Inspection and 
Compliance, 510 South 17th Street, Suite 104, Ames, IA 50010-8197) on a 
quarterly basis by the 21st day of January, April, July, and October or 
more often as required by the Administrator.
    (2) Each serial or subserial of autogenous bacterial product other 
than the first serial or subserial produced from an isolate shall meet 
the applicable general requirements prescribed in Sec. 113.100 and the 
special requirements prescribed in this section. Each serial or 
subserial of autogenous viral product other than the first serial or 
subserial produced from an isolate shall meet the applicable general 
requirements prescribed in Sec. 113.200 and the special requirements 
prescribed in this section. A serial or subserial found unsatisfactory 
by any prescribed test shall not be released.
    (i) Purity test. Final container samples of completed product from 
each serial and subserial shall be tested for viable bacteria and fungi 
as provided in Sec. 113.26. When the number of final containers in a 
serial or subserial is 50 or less, two final container samples from each 
serial and subserial shall be tested as prescribed in Sec. 113.26(b): 
Provided, That, 1 ml aliquots from each sample may be inoculated into 
five corresponding individual test vessels of each of the test media 
required.
    (ii) Safety test. Bulk of final container samples of completed 
product from each serial shall be tested for safety as provided in 
Sec. 113.33 (b) or Sec. 113.38.
    (iii) Identification. All microorganisms used for the production of 
autogenous biologics shall be identified as follows: Bacteria, fungi, 
and mycoplasma shall be identified at least to genus and species. 
Viruses shall be identified at least to family. After 15 months from the 
date of isolation, or 12 months from the harvest date of the first 
serial of autogenous product produced from a microorganism, whichever 
comes first, characterization and identification shall be completed to 
strain and/or serotype before such microorganism may be used for 
production.
    (iv) Antigenicity, or immunogenicity, and potency. Persons seeking 
authorization to prepare additional serials of autogenous biologics from 
microorganisms that are older than 24 months from the date of isolation, 
shall be required to conduct the following additional tests:
    (A) Completed product shall be tested for antigenicity or 
immunogenicity in the species for which the product is recommended or in 
another animal species whose immunological response has been shown in 
the scientific literature to correlate with the response of the species 
for which the product is recommended. Such tests shall be conducted in 
accordance with a protocol developed by the licensee and approved by the 
Administrator and the results submitted to the Director, Center for 
Veterinary Biologics, Licensing and Policy Development, 510 South 17th 
Street, Suite 104, Ames, IA 50010-8197 for review. Microorganisms not 
shown to be antigenic (that is, not shown to induce a significant 
serological response) or immunogenic by such approved tests shall not be 
used for the preparation of such product.
    (B) Bulk or final container samples of completed product from each 
serial of such autogenous biologics containing fractions for which 
standard requirement potency test procedures have been established shall 
be tested for potency in accordance with applicable standard requirement 
potency tests provided in 9 CFR part 113. If the culture of 
microorganisms used to produce

[[Page 644]]

such fractions is shown to be of a different strain or serotype than the 
reagent or challenge microorganisms used in the standard requirement 
potency test, reagents or challenges of the same strain or serotype as 
the microorganism used for production may be used.
    (C) If no standard requirement potency test procedures have been 
established for a fraction(s) in the autogenous biologic, such 
fraction(s) of each serial of product shall be tested for potency using 
a developmental potency test described in the filed outline of 
production or shall at least be standardized to contain an antigenic 
mass for such fraction(s) that has been shown to be antigenic or 
immunogenic in accordance with paragraph (c)(2)(iv)(A) of this section.

[57 FR 38756, Aug. 27, 1992, as amended at 59 FR 67616, Dec. 30, 1994; 
64 FR 43044, Aug. 9, 1999; 67 FR 15714, Apr. 3, 2002]