Elise N. Paeffgen

Pharmaceutical, Medical Device, Pesticide/Antimicrobial, and Consumer Product Manufacturing, Labeling, Distribution, and Disposal

• Advising health care facilities and medical waste service providers on medical/infectious waste and hazardous waste pharmaceutical management.
• Counseling pharmaceutical manufacturers, logistics providers, and forward and reverse distributors on pharmaceutical waste characterization, management, transportation, and disposal; the EPA’s Management Standards for Hazardous Waste Pharmaceuticals; DEA Disposal Act compliance; and federal and state licensure matters.
• Advising a manufacturer on environmental compliance and enforcement matters pertaining to water and waste from its pharmaceutical manufacturing operations.
• Providing EPA and FDA strategic counsel as companies develop and market antimicrobial consumer products, coatings, treated textiles, medical devices, pesticide devices, air filters and purifiers, disinfectants, and sanitizers.
• Counseling consumer products companies on the development of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) exempt treated articles and antimicrobial, biopesticide, conventional, and minimum risk pesticides.
• Providing strategic advice on cosmetic and consumer product development, marketing, and acquisitions, including compliance with the FTC Green Guides, Federal Food, Drug, and Cosmetic Act (FFDCA), Fair Packaging and Labeling Act (FPLA), and Proposition 65.
• Assisting in developing and implementing CBD and cannabis management and disposal policies and procedures.
• Providing strategic advice to drug manufacturers on compliance with pharmaceutical take-back ordinances.
• Spent more than 100 days inside pharmaceutical API, intermediate, and finished drug product manufacturing facilities in the U.S. and Europe managing FDA inspections, counseling on good manufacturing practices (GMP), and implementing significant remedial actions.

Elise Paeffgen’s environmental practice centers on health care and FDA-regulated industries. Elise works with manufacturers, importers, and forward and reverse distributors to effectively navigate EPA, FDA, and DEA regulations and minimize enforcement risks. She provides hazardous, medical, pharmaceutical, and controlled substance waste compliance counsel to companies in every facet of the supply chain. She works closely with manufacturers developing and marketing antimicrobials and products with environmental claims.

On ESG, climate, and environmental compliance and enforcement matters, Elise represents domestic and international companies in the health care, pharmaceutical, medical device, cosmetic, food and beverage, consumer product, pesticide, automotive, construction equipment, renewable fuel, and oil and gas industries.

In 2021, Elise was recognized by client counsel in Acritas Stars for outstanding service. Most recently, she was recognized for her experience by Chambers USA in Environment (District of Columbia). Elise was also named a Super Lawyers “Rising Star” from 2014-2022 and has been honored to be included for multiple years on the Capital Pro Bono Honor roll.

Elise earned a J.D., magna cum laude, from Vermont Law School and a master of environmental management from the Yale School of the Environment, with concentrations in climate change and corporate environmental management. During her joint degree program, Elise worked for the U.S. EPA Office of Enforcement and Compliance Assurance.

Bar Admissions

• District of Columbia
• Ohio
• U.S. Supreme Court

Education

• Vermont Law School (J.D., 2009)
• Yale University (M.E.M., 2009)
• Oberlin College (B.A., 2004)

Memberships