To ensure that veterinary biologics are pure, safe, potent, and efficacious, the process of bringing a product to full licensure
can be lengthy. However, other, more limited types of licenses are available to facilitate effective responses in emergency
situations. In addition, the use of innovative products in veterinary biologics has the potential to improve efficiency and
safety in managing animal disease, but such products bring new regulatory challenges.
The United States Congress passed the Virus-Serum-Toxin Act (21 US Code 151-159) in 1913, providing for federal regulation
of veterinary biological products in the US. The United States Department of Agriculture (USDA), Animal and Plant Health Inspection
Service's (APHIS's) Center for Veterinary Biologics (CVB) is the regulatory authority that issues licenses and permits for
these products. Regulatory oversight includes prelicense evaluation, quality manufacturing requirements, inspection, testing,
serial (batch) release, and vaccinovigilance. Administrative regulations and standards are found in Title 9, Code of Federal
Regulations (9 CFR) Parts 101-118, with additional program guidance to be found in CVB Notices, Veterinary Services Memoranda,
General Licensing Considerations, and other documents.
LICENSES FOR SPECIAL CIRCUMSTANCES
Under the standard licensing process, there is complete characterization and identification of seed material and ingredients,
laboratory and host animal safety and efficacy studies, stability studies, and postlicensing monitoring of field performance.
During the emergence of a new animal disease or during a foreign animal disease incursion, it may not be possible to provide
the complete spectrum of evaluation that candidates for full licensure typically undergo. Under emergency conditions, there
are six mechanisms for bringing a product into use more rapidly, including experimental product approvals, autogenous biologics
licenses, conditional product licenses, permits for the importation of products used elsewhere in the world, preapproved vaccine
banks, and exemptions for products used by or under the supervision of USDA.1
Experimental Product Approvals. A request to produce, distribute, and conduct experimental evaluation of unlicensed biological products in a limited number
of animals may be granted under very specific circumstances (9 CFR Part 103.3). As outlined in 9 CFR, the following information
should accompany the request:
- a permit or letter of permission from the proper state or foreign animal health authorities of each state or foreign country
involved
- a tentative list of the names of the proposed recipients and quantity of experimental product to be shipped to each individual
- a description of the product, recommendations for use, and results of preliminary research
- labels or label sketches showing the name or identification of the product and bearing the statement, "Notice! For Experimental
Use Only—Not For Sale" or equivalent (the US Veterinary License legend shall not appear on such labels)
- a general plan covering the methods and procedures for evaluating the product and for maintaining records of the quantities
prepared, shipped, and used
- data demonstrating that use of the experimental biological product in meat animals is not likely to result in the presence
of any unwholesome condition in the edible parts of animals subsequently presented for slaughter
- a statement from the research investigator or sponsor agreeing to furnish, upon the APHIS Administrator's request, additional
information concerning each group of meat animals prior to moving these animals from the test site, including the owner's
name and address; the number, species, class, and location of animals involved; the date shipment is anticipated; and the
name and address of consignee, buyer, commission firm, or abattoir
- evidence of the product's impact on the environment.
The approval of the oral bait rabies vaccine, used since 1995 in Texas to control the virus in coyotes, is an example of an
experimental product approval.
