- Advised foreign and domestic drug and drug substance manufacturers regarding FDA facility inspections, warning letters, untitled letters, requests for information, and regulatory meetings, including extended on-site work in India.
- Advised drug and drug substance manufacturers on developing concerns regarding nitrosamines, benzene, and other genotoxic impurities. This work has included guiding clients with their development of corporate-wide control strategies for nitrosamines and other genotoxic impurities, including the mitigation of nitrosamine drug substance-related impurities (NDSRIs).
- Assisted a national dermatology practice to assess the requirements under a REMS program and advocate on behalf of prescribers facing penalties for alleged non-compliance with such requirements.
- Helped a prescription medical device manufacturer and distributor navigate state requirements in states with jurisdiction over medical devices vs. states that do not regulate or license medical device establishments.
- Phone: +1 202 239 3163
- Email: anthony.fanucci@alston.com
Anthony Fanucci advises pharmaceutical companies and pharmacies on complex FDA, DEA, and state rules and regulations. His clients value his background as a practicing pharmacist and his extensive experience guiding clients through regulatory and enforcement actions at the state and federal levels. Pharmacy clients rely on Anthony for a multitude of state regulatory matters, including compliance with state board regulations, prescription drug delivery services, REMS compliance, changes in ownership, and prescription compounding operations. He also advises domestic and foreign pharmaceutical manufacturers on issues related to data integrity throughout the supply chain on FDA’s implementation of the Drug Supply Chain Security Act (DSCSA). Anthony is also experienced in navigating DEA’s controlled substance quotas, telehealth flexibilities, and DEA audits.
Before joining the firm, Anthony served as pharmacist and a pharmaceutical licensing consultant. During his years as a consultant, Anthony co-managed nationwide licensure efforts for six pharmaceutical companies and provided compliance strategies based on company structure, intended market, and products.
Chambers USA recognizes Anthony as an “Associate to Watch” for Healthcare: Pharmaceutical/Medical Products Regulatory (District of Columbia).
Bar Admissions
- District of Columbia
- Vermont (Inactive)
Education
- Pennsylvania State University (J.D., 2021)
- Wilkes University (B.S., Pharm.D., 2018)
Memberships
- Food and Drug Law Institute, New to Food and Drug Law Planning Committee
- American Society for Pharmacy Law, Communications, Member Relations, and Marketing Committee, co-chair
- Wilkes University, board of trustees