Veterinary biologies

Veterinary biologies are placed into two Classes, based on the properties of the preparation. Class I products include inactivated r-DNA-derived viral vaccines inactivated r-DNA derived bacterial vaccines viral, bacterial, cytokines or other subunits, monoclonal antibody products and vaccines containing live organisms modified by gene insertion or deletion, without introduction of foreign DNA. 

Class I products are deemed to have no new or unusual safety concerns, and are reviewed without special precautions. Class II products, however, involve the introduction of r-DNA constructions into live organisms and additional information is needed for full review. Issues include the competitiveness of the organism in the environment, its survivability and persistence, and whether it will transplant the wild-type organisms from the environment. The added genetic information must be well characterized, and the full nucleotide sequence may be requested. The fully documented identification of the entire insert from the foreign source is essential. Concerns for safety to humans and animals, and impact on the environment, must be addressed in an environmental assessment or environmental impact study to be evaluated by an ad hoc committee before live products can be considered for a limited field trial or licensing. 

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Detailed regulations supporting the Acts are published principally in Title 21 of the Code of Federal Regulations (21 CFR). An outline of the main sections of the Title is shown in Table 1.6. Regulations in support of veterinary biologies are contained in Title 9 of the Code of Federal Regulations, Parts 101-123 (see Table 1.7). 

Table 1.7 Contents of Title 9 of the Code of Federal Register dealing with veterinary biologies.

The US Department of Agriculture (USDA) has regulatory responsibility for veterinary biologicals, which is exercised by its Animal and Plant Health Inspection Service (APHIS). The regulated products include vaccines, bacterins and diagnostics, which are used to prevent, treat, or diagnose animal diseases. The Center for Veterinary... 

The US regulates animal trials mainly through the requirement to inform the authorities before non-approved veterinary pharmaceuticals are shipped to trial sites. Depending on whether it is classified as a drug or a biologic, information must be submitted to either the FDA Center for Veterinary Medicines (CVM) or the United States Department of Agriculture (USDA) Center for Veterinary Biologies (CVB). 

Figure 7.9 Outline of requirements for a Veterinary Biologies Establishment License.

US Code of Eederal Regulations Veterinary biologics - 9 CFR Parts 102,103 www.access.gpo.gov. 

Meetings on harmonization of veterinary biologicals were held in 1992 in Ploufragan, France in 1994 in Arlington, Virginia, US and in 1995 in Singapore. 

Imports of biological products into the USA are restricted by the requirement to have the manufacturing facilities licenced and inspected by US inspectors or by local inspectors, if these are recognized by the USA. Furthermore, biological products are subject to a permit for each individual shipment, quarantine for the product and tests by the authorities before release. Veterinary biological product licences will not be issued for products from countries "...known to have exotic diseases, including but not limited to, foot and mouth disease, rinderpest, fowl pest (fowl plague), swine vesicular disease, Newcastle disease, and African swine fewer (9 CFR 104.2). 

An information package for potential licencees is available from United States Department of Agriculture (USDA/ APHIS) Veterinary Biologies, BBEP ... 

Copies of the relevant sections of the application, are sent by courier to members of the Vcirious expert committees for evaluation. The clinical, phcirmaceutical, and cmalytical protocol committees and the bioavailability sub-committee are generally involved in the evaluation of all medicines. Specialised groups of medicines, for example dental, veterinary, biological and complementary medicines, are submitted to expert committees with expertise in the particular discipline. 

APHIS has approved the release of several veterinary biologies using genetically engineered materials. The Veterinary Services Divsion has developed a two stage procedure to conduct field... 

The regulation of biotechnology-derived veterinary biologicals proposed by USDA raised several major questions. These concerns represented both perceived and historical concerns regarding jurisdiction, as well as the need for explicit guidelines. 

There were jurisdictional concerns that an explicit statement is needed that veterinary biologicals are clearly outside the regulatory scope of the Toxic Substance Control Act enforced by EPA. 

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