Elise N. Paeffgen

Pharmaceutical, Antimicrobial, and Consumer Product Manufacturing, Labeling, Distribution, and Disposal

• 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 health care facilities on pharmaceutical and medical/infectious waste management.
• Providing EPA and FDA counsel as companies develop and market antimicrobial consumer products, coatings, treated textiles, medical devices, air filters and purifiers, disinfectants and sanitizers.
• Providing label compliance and import advice to manufacturers, private labelers, and distributors of disinfectant and antiseptic wipes.
• Counseling consumer products companies on the development of Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) exempt treated articles and minimum risk pesticides.
• Assisting with business disinfecting protocols for COVID-19.
• Providing strategic advice on cosmetic and consumer product development and acquisitions, including compliance with the Federal Food, Drug, and Cosmetic Act (FFDCA), Fair Packaging and Labeling Act (FPLA), Proposition 65, FTC Green Guides, organic standards, and country of origin labeling.
• 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 practice is centered at the intersection of EPA, FDA, and DEA regulation. Elise works with manufacturers, importers, and forward and reverse distributors to effectively navigate EPA, FDA, and DEA regulations and minimize enforcement risks. She provides counsel to FDA-regulated clients, such as pharmaceutical, medical device, and cosmetic manufacturers, on issues ranging from current good manufacturing practices (CGMP) to the management of hazardous waste pharmaceuticals. On environmental compliance and enforcement matters, Elise represents health care facilities and domestic and international companies in the consumer product, chemical, pesticide (antimicrobial), automotive, construction equipment, renewable fuel, and oil and gas industries.

In addition to a J.D., magna cum laude, from Vermont Law School, Elise earned 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. Elise received a B.A. in environmental studies and politics from Oberlin College, and was awarded high honors.

Elise has been named a Super Lawyers “Rising Star” each year since 2014.

Bar Admissions

• District of Columbia
• Ohio

Education

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

Memberships