title: Environmental assessment requirements for live biological drugs.
abstract: Marketing approval of biological products by the US Food and Drug Administration must comply with requirements of Code of Federal Regulations title 21 part 25, "Environmental Impact Considerations." An environmental impact statement is usually not required. Environmental assessment is required unless excluded. As naturally occurring substances, biological products qualify for categorical exclusion if manufacture and use do not significantly alter their concentration or distribution in the human environment. The manufacturing process and establishment descriptions in the license application should include enough detail to ensure that waste is controlled and inactivated. During clinical development of a live biotherapeutic product, data should be collected regarding the shedding of live organisms from treated patients. The ability of the live organism to persist in the environment should be assessed, and instructions for safe handling by health care providers and consumers should be incorporated into the package insert.
authors.affiliation: The Biologics Consulting Group, Alexandria, Virginia 22314, USA. asutton@bcg-usa.com
authors.forename: Ann
authors.initials: A
authors.lastname: Sutton
mesh_terms: D001688:Biological Products / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use*; D017277:Drug Approval; D004345:Drug Industry / Q000592:standards; D004777:Environment; D004783:Environmental Microbiology / Q000592:standards; D004784:Environmental Monitoring / Q000592:standards; D019649:Food Industry / Q000592:standards; D006801:Humans; D019936:Probiotics / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use*; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
chemical_list: D001688:Biological Products