Pharmaceuticals

Beveridge & Diamond, P.C. has worked on a wide range of environmental and product-related matters for large and small pharmaceutical companies in the U.S. and overseas. Our work includes advising clients on matters of pollution control and compliance under a host of federal, state and local laws in the U.S. We also advise clients in the pharmaceuticals industry on matters arising under international environmental agreements and national laws of other countries.

Recent Matters

Recent examples of our work include:

• advising a Fortune 500 company on options for securing an essential use exemption for the continued use of chlorofluorocarbons (CFCs) under the Montreal Protocol and U.S. implementing measures under the Clean Air Act;

• assisting a number of pharmaceutical companies prepare Title V permits and revisions to Title V permits under the Clean Air Act;

• advising a Fortune 100 company on emerging new chemical notification and chemical inventory regimes in Europe, Asia and Latin America;

• advising a number of companies on Toxic Release Inventory (TRI) reporting obligations under Section 313 of the Emergency Planning and Community Right-to-Know Act (EPCRA), including responses to EPA enforcement actions;

• advising a medical device manufacturer on the viability of future product lines using substances that could qualify as ozone depleting substances and potential greenhouse gases;

• advising a Fortune 100 company on all aspects of Clean Air Act New Source Review permitting for capital projects accompanying production of major new pharmaceutical products;

• representing the industry trade association supporting EPA's Maximum Achievable Control Technology (MACT) regulation for medical waste incinerators against a lawsuit brought by an environmental organization challenging that rule in the D.C. Circuit. Although the court remanded the rule, we successfully convinced the court to reject the plaintiff's key substantive theory that would have made the standard unachievable;

• assisting a major pharmaceutical manufacturer with the development of a continuous release reporting program to ensure compliance with the emergency release reporting requirements of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) and EPCRA; and

• advising pharmaceutical industry clients on the requirements of the Toxic Substances Control Act (TSCA), including, in particular, circumstances (e.g., recycling of pharmaceutical waste steams) under which substances may not be considered "drugs" exempt from TSCA's chemical regulatory requirements.