ENVIRONMENTAL ASSESSMENT FOR LINCO-SPECTIN~R PREMFX

摘要

Pharmacia Animal Health products must meet corporate and regulatory requirements with respect to assessing the potential effects of these products on the environment. In accordance with EU Directive 92/18/EEC, an environmental assessment (EA) is required for registration or re-registration of a veterinary drug product. This is done in order to evaluate the potential harmful effects on the environment that use of the drug may have, and to identify any precautionary measures, which may be appropriate to reduce such harmful effects if any exist. Similarly, the US National Environmental Policy Act (1969) requires that drugs be assessed for potential effects on the environment, as described in the Code of Federal Regulations, 21CFR Part 25. We present herein an example of how a quantitative environmental risk assessment is conducted for the active ingredients of Linco-Spectin~R Premix, namely, lincomycin (L) and spectinomycin (S). Linco-Spectin Premix is an important product that is used to treat various diseases in swine.