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Standard License Restrictions

Product licenses may be issued with one or more restrictions. Some types of licenses always 

require restrictions. Restrictions may be considered on a case-by-case basis for others. Table 1 

includes a list of such products. Review this list when licensing new products OR reissuing 

existing licenses, as the need for certain restrictions may change over time. Table 2 provides the 

text that corresponds to a particular restriction number. 

Table 1. 

Product/Fraction Required 

Restrictions (by 

LSRTIS Number)

Additional Restrictions 

to Consider (by LSRTIS 

Number)

Anaplasma Marginale Vaccine 42

Allergenic Extract 42

Antivenom 42

Autogenous 55

Avian Pneumovirus, live/modified live 42, 43, 44

Avian Reovirus Vaccine, Killed 43

Avian Influenza Vaccine (turkeys, nonH5, non-H743, 46 60

Avian Influenza vaccine (turkey H5, 

turkey H7, all chicken

43, 46, 58 60

Babesia caballi 45

Babesia equi 45

Bovine spongiform encephalopathy 

diagnostics

45, 62, 343 46

Bronchitis Vaccine, Live Virus (except 

Mass & Conn)

43

Brucella abortus (vaccines & kits) 42, 43

Bursal Disease Vaccine, Live Virus 43, 47

Bursal Disease Vaccine, Killed 43

Cancer products 42

Conditional licenses (“regular”) 43, 46, 48, 49, 50, 56, 

480

42, 54, 57

Chronic wasting disease diagnostics 45, 62

Duck enteritis virus 43

Ehrlichia risticii 43

Equine arteritis virus, live 43

Equine infectious anemia diagnostics 45

Feline immunodeficiency virus

(vaccine)

42 54

Mycobacterium bovis diagnostics 42, 43
Standard License Restrictions 2 of 6

Product/Fraction Required 

Restrictions (by 

LSRTIS Number)

Additional Restrictions 

to Consider (by LSRTIS 

Number)

Mycobacterium paratuberculosis 

(vaccines and kits)

43

Mycobacterium tuberculosis diagnostics 42, 43

Mycoplasma gallisepticum (vaccine & 

kits)

43

Mycoplasma synoviae (vaccines & kits) 43

Permitted products 64, 186 186 may be exempted 

from products for USDA 

emergency use if the 

Outline of Production has 

adequate assurances 

regarding Ingredients of 

Animal Origin (IAO) 

source/testing and a 

statement that IAO 

sources/testing will not 

change without approval 

of CVB

Pigeon Pox Vaccine, live 60

Platform Products (conditional) 43, 46, 48, 50, 56, 71 Contact PEL Director 

before licensing a 

platform product, as some 

restrictions are still being 

discussed.

Prescription Products 42, 43, 46, 48, 50, 54, 

55, 56, 57, 132, 200, 

540

PRRS virus, live and modified live 47

Pseudorabies virus (vaccine & kits) 43, 45

Rabies virus 43

Scrapie diagnostics 45, 46, 62

Streptococcus equi (whole cell bacterin) 42

Tenosynovitis virus, live and modified 

live

43

Tuberculin 42, 43

Vibrio salmonicida 43

Products for disease exotic to U.S. 52 46

Products with wildlife claims 46, 58, 61, 62

Components of combination packages in 

which firm with comb.pkg license does 

not have a significant step in production 

of the component

53

For further manufacture products 51
Standard License Restrictions 3 of 6

Product/Fraction Required 

Restrictions (by 

LSRTIS Number)

Additional Restrictions 

to Consider (by LSRTIS 

Number)

Products for diseases appearing on OIE 

list

45, 46

Biotechnology-derived products 

containing live vectors that can replicate 

in the vaccinated animal

46

Products with Additional Reporting 

Requirement

57

Products that are tested at a contract 

facility for any Section V test

70

Products with target animal safety testing 

exemption

57 (yearly)
Standard License Restrictions 4 of 6

Table 2 

LSRTIS License 

Restriction Number

Restriction

42 For use by, or under the supervision of, a veterinarian.

43 Distribution in each State shall be limited to authorized recipients 

designated by proper State officials--under such additional conditions 

as these authorities may require.

44 The distribution and use of this vaccine shall be limited to <specify 

state(s) and/or foreign countries>.

45 Sale and use in the United States restricted to laboratories approved 

by State and Federal (USDA) animal health officials.

46 Export distribution shall be limited to authorized recipients 

designated by proper animal health regulatory officials--under such 

additional conditions as these authorities may require.

47 Recommended use shall be restricted to premises having a history of 

the disease.

48 Reissuance of this license shall be considered in accordance with 9 

CFR Part 102.6.

49 The following statement shall appear on all labels: This product 

license is conditional. Efficacy and potency test studies in progress.

50 Trade Names shall not be used with this product.

51 For further manufacture.

52 For Export Only.

53 This product may only be marketed as a component of <other 

Product Codes>.

54 Marketing and promotional materials must be reviewed by the CVB 

prior to publication or distribution.

55 This license does not authorize production, distribution, or shipment 

of a vaccine/bacterin for foot-and-mouth disease, rinderpest, any H5 

or H7 subtype of avian influenza, any subtype of avian influenza in 

chickens, swine vesicular disease, Newcastle disease, African swine 

fever, classical swine fever, Brucella abortus, vesicular stomatitis, 

and rabbit hemorrhagic disease or any other disease the Administrator 

determines may pose a risk to animal or public health.

56 This license will terminate on <specify date or length of time>.

57 Unusual conditions or adverse events linked to vaccinated animals 

are to be reported to the CVB <specify reporting interval>.

58 Domestic distribution and use shall be under the supervision or 

control of USDA, APHIS, Veterinary Services, as part of an official 

USDA animal disease control program.

59 Recommended use shall be restricted to healthy 10- to 17-week-old 

broiler breeder replacement chickens and to premises where no other 

susceptible chickens are maintained.

60 For use in <specified species> only.

61 Restricted to use in State or Federal Rabies Control Programs.
Standard License Restrictions 5 of 6

62 Potency testing and distribution and use shall be under the 

supervision or control of USDA, APHIS, Veterinary Services--under 

such additional conditions as these authorities may require.

63 Serials may be released, subject to immediate recall, should the 

Master Seed/Cell Stocks, now under test by APHIS, be found 

unsatisfactory.

64 The producer/permittee agrees to submit to periodic reinspections of 

the production facility under terms to be specified in a Cooperative

Agreement between the parties. The permittee agrees to be 

responsible for all costs associated with these inspections.

70 The CVB has the authority to inspect TGA Sciences, Inc., No. T100, 

that performs the Serology, Clostridium botulinum Type B potency

test contracted by the Licensee.

71 The license may be renewed upon request by the firm and at the 

discretion of APHIS based on product performance, safety profile, 

manufacturing consistency, and inspections by the CVB.

132 Disposition records, maintained according to 9 CFR 116.2, shall be 

prepared in a format acceptable to APHIS and submitted to CVB at 

intervals determined by APHIS.

186 Each shipment of biological product distributed and sold under this 

permit must be accompanied by an original certificate endorsed by a 

full-time, salaried veterinarian of the agency responsible for animal 

health of the Government of <specify country>, or other assurances 

acceptable to APHIS, certifying that: 1.) Ingredients of animal origin 

are sourced from the United States or countries considered free, low 

risk, or not affected with foreign animal diseases of concern and with 

negligible or controlled risk of Bovine Spongiform Encephalopathy 

[BSE], according to APHIS' Animal Disease Status designations as 

defined in Veterinary Services Memorandum 800.51. 2.) During the 

manufacturing process, the manufacturing facility does not receive, 

store, or process any ingredients of ruminant origin from countries 

with BSE. 3.) The product complies with all other provisions of 9 

CFR 113.53.

200 The license may be renewed upon request by the firm and at the 

discretion of APHIS based on manufacturing consistency and 

inspections by the CVB. For use as a veterinary prescription. 

Efficacy and potency have not been demonstrated.

343 Use of this kit is restricted to testing conducted as part of the official 

USDA BSE surveillance program.

344 Product imported under this permit may only be received by USDA 

personnel or persons designated by the USDA, as part of an official 

USDA animal disease control program.

480 The licensee shall demonstrate acceptable progress toward 

completion of host animal efficacy and potency test studies in 

accordance with acceptable protocols filed with the CVB prior to 

reissuance.
Standard License Restrictions 6 of 6

540 Marketing and promotional materials are restricted to licensed 

veterinarians.

551 This license restricted to antigens from the VP7 gene from an 

individual Rotavirus Strain C isolate.