Environmental Sustainability

Product Stewardship

Pharmaceuticals in the
Environment

Pharmaceuticals in the
Environment
Product Stewardship

We are committed to understanding and managing the environmental impacts of our products throughout their life cycles—from discovery through manufacturing, use and disposal.

We conduct environmental risk assessments on our products from the development phase through product launch to understand and manage product impacts from manufacturing and patient use. We assess products in a manner consistent with the most stringent applicable global regulations, including the regulatory review processes of the the U.S. Food and Drug Administration and the European Medicines Agency. Product environmental safety profiles are reassessed during periodic renewals of product filings, and risk-mitigation actions are implemented when needed.

We carefully monitor scientific research on the issue of pharmaceuticals in the environment, in particular studies that evaluate the potential effects pharmaceutical products may have on the aquatic environment and human health.

Pharmaceutical compounds have been found to enter the environment primarily through the use of medicines by humans and animals, and the subsequent excretion into wastewater treatment systems, water bodies or soil. Other potential environmental routes include manufacturing wastewater discharges and waste disposal.

We use the information from our risk assessments to establish or update our internal, compound-specific Environmental Quality Criteria (EQC), which are used to assure that wastewaters discharged from our facilities do not contain residual products that present a risk to human health or the environment. Manufacturing facilities are required to use these EQC, along with industry-accepted risk-assessment methods, to establish procedures for managing and controlling active pharmaceutical ingredients (APIs) in their wastewater. Our production facilities have, or are currently being provided with, API-treatment technology to ensure that our wastewater meets these internal EQC standards. Our facilities are also required to incinerate any product-containing solid waste streams, unless restricted by local regulation.

We carefully monitor scientific research on the issue of pharmaceuticals in the environment (PIE)—in particular, studies that evaluate the potential effects pharmaceutical products may have on the aquatic environment and human health. We support the use of science-based environmental risk assessments, and we will continue to collaborate with regulatory, academic, health care and research organizations to identify additional needs for data on the migration, duration and effects of pharmaceuticals in the environment.

For more information about how we reduce the impacts of our products in the process design stage, read about our Green & Sustainable Science program.