Environmental Assessment of Human Pharmaceuticals in the United States of America
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Keith Webber, PhD Center for Drug Evaluation and Research, US Food and Drug Administration, USA Per Spindler, DVM, E-MBA, MSc BioLogue, University of Copenhagen, Denmark
Key Words Human pharmaceuticals; Human medicines; Environmental protection; Environmental assessment; Guideline; United States; FDA Correspondence Address Keith Webber, PhD, Center for Drug Evaluation and Research, US Food and Drug Administration, 5630 Fishers Lane, Rockville, MD 20852, USA (e-mail: [email protected]).
Environmental Assessment of Human Pharmaceuticals in the United States of America
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This article provides an overview of a presentation of the environmental assessment process for drugs in the United States from the joint DIA/ HESI/SAPS conference on Environmental Assessment of Human Medicines held in Stockholm, Sweden, May 22–23, 2006.
INTRODUCTION
C AT E G O R I C A L E X C L U S I O N S
The Food and Drug Administration (FDA) is the primary federal agency responsible for the regulation of pharmaceuticals and personal care products in the United States. The agency’s primary role is the assessment of applications for clinical investigation and the marketing of drugs and devices for human and animal use (see Refs. 1–3). As part of this assessment, the FDA evaluates the potential environmental impact of use of drugs in accordance with the US National Environmental Policy Act of 1969 (NEPA; 4). This law requires the US government to consider the potential environmental impact of “actions” that the government takes. Approval of a marketing application for a human or animal drug is considered to be an action under the FDA-specific NEPA regulations. We present a brief overview of the FDA’s environmental assessment (EA) procedure for drugs (Table 1) and provide relevant references for additional detail. We highlight three important elements of the assessment procedure: categorical exclusions, estimated introduction concentration (EIC), and environmental test requirements (5). Sponsors may consult the FDA and relevant guidance regarding the need and the technical requirements for an EA for pharmaceutical applications.
In 1996, the FDA Center for Drug Evaluation and Research (CDER) performed a retrospective review of available toxicity information from EAs that were previously submitted in support of drug applications. This information, which includes data from drugs that are representative of pharmacological drug classifications, demonstrated that there were no significant observed effects on relevant standard test organisms in the aquatic environment at concentrations below 1 µg/L. Subsequently, these and other conditions were codified into the FDA’s regulations as “categorical exclusion” criteria that, if met, would obviate the need for the manufacturer to submit an EA or an environmental impact statement (EIS) (4). There are a number of categorical exclusions described in the US Code of Federal Regulations (21 CFR Part 25.31). These include situations in which the manufacture can demonstrate that (1) there is no increase
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