- Advised foreign and domestic drug and drug substance manufacturers regarding FDA facility inspections, warning letters, untitled letters, requests for information, and regulatory meetings, including 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 the analysis of de-risking plans for sites making manufacturing changes related to impurities.
- Guided 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.
- Conducted a holistic review of drug, food, waste, and chemical permits for multiple clients and detailed CHOW requirements for all permits in advance of equity sales.
- Assisted clients on multiple DEA matters, including navigating DEA’s controlled substance quotas and telehealth flexibilities.
- Helped guide a medical device startup with the importation and distribution of FDA-authorized COVID-19 antigen tests under COVID-19-modified state licensing requirements to fulfill critical needs.
- 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.
- Assisted a product delivery company by analyzing state regulatory requirements for the delivery of cannabis-derived products and recommending an operational strategy that minimized enforcement risks.
- Drafted a legal opinion emphasizing the inapplicability of a state’s medical device distribution regulations, which enabled the client to continue its activities in the state in question.
Associate,
- Phone: +1 202 239 3163
- Email: anthony.fanucci@alston.com
Anthony, a licensed pharmacist, relies on his pharmacy background and experience as a pharmaceutical licensing consultant to guide FDA-regulated clients through regulatory and enforcement actions.
Anthony Fanucci is an associate in Alston & Bird’s Health Care FDA Group and a member of the Food, Drug & Device/FDA Team. Anthony advises pharmaceutical and medical device companies on complex FDA rules and regulations. His clients value his experience in pharmaceutical analytical chemistry, biopharmaceutics, and pharmaceutical dosage forms and drug delivery systems.
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.
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Advisories March 12, 2025FDA/Food, Drug & Device / Health Care Advisory | FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other ProvidersNow that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have developed an initial checklist for providers to consider during the FDA’s enforcement discretion period.Advisories March 12, 2025FDA/Food, Drug & Device / Health Care Advisory | FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other ProvidersNow that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have developed an initial checklist for providers to consider during the FDA’s enforcement discretion period.
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Healthy Byte January 30, 2025Healthy Byte | DEA and HHS Finalize Rule on Prescribing Buprenorphine via Telemedicine – Or Did They?This Healthy Byte examines the final rule on prescribing buprenorphine via telemedicine that was published on January 15, 2025.Healthy Byte January 30, 2025Healthy Byte | DEA and HHS Finalize Rule on Prescribing Buprenorphine via Telemedicine – Or Did They?This Healthy Byte examines the final rule on prescribing buprenorphine via telemedicine that was published on January 15, 2025.
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Advisories January 8, 2025FDA/Food, Drug & Device Advisory | Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.Advisories January 8, 2025FDA/Food, Drug & Device Advisory | Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.
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Healthy Byte December 16, 2024Healthy Byte | DEA Again Extends Flexibilities for Prescribing Controlled Substances Via TelemedicineThis Healthy Byte discusses the recent Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.Healthy Byte December 16, 2024Healthy Byte | DEA Again Extends Flexibilities for Prescribing Controlled Substances Via TelemedicineThis Healthy Byte discusses the recent Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications.
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Healthy Byte September 20, 2024Healthy Byte | Will the DEA Limit COVID-19 Telemedicine Flexibilities?
This Healthy Byte discusses how the Drug Enforcement Administration may drastically limit providers’ abilities to prescribe controlled substances via telemedicine.
Healthy Byte September 20, 2024Healthy Byte | Will the DEA Limit COVID-19 Telemedicine Flexibilities?This Healthy Byte discusses how the Drug Enforcement Administration may drastically limit providers’ abilities to prescribe controlled substances via telemedicine.
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General Publications April 5, 2024“HHS Opioid Rule Generally Benefits Providers And Patients,” Law360, April 5, 2024.This article discusses SAMHSA’s finalized rule, which significantly affects opioid use disorder treatment.General Publications April 5, 2024“HHS Opioid Rule Generally Benefits Providers And Patients,” Law360, April 5, 2024.This article discusses SAMHSA’s finalized rule, which significantly affects opioid use disorder treatment.
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In the News December 7, 2023News@Wilkes | Wilkes University Welcomes New Members to the Board of TrusteesAnthony Fanucci is noted for joining Wilkes University’s board of trustees.In the News December 7, 2023News@Wilkes | Wilkes University Welcomes New Members to the Board of TrusteesAnthony Fanucci is noted for joining Wilkes University’s board of trustees.
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Healthy Byte October 18, 2023Healthy Byte: DEA and HHS Extend COVID-19-Era Rules for Prescribing Controlled Substances Via TelemedicineAnthony Fanucci, Sofia Molodanof, and Sean Sullivan discuss the extension of the DEA and HHS’s rules on prescribing controlled substances via telemedicine.Healthy Byte October 18, 2023Healthy Byte: DEA and HHS Extend COVID-19-Era Rules for Prescribing Controlled Substances Via TelemedicineAnthony Fanucci, Sofia Molodanof, and Sean Sullivan discuss the extension of the DEA and HHS’s rules on prescribing controlled substances via telemedicine.
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Advisories September 8, 2023FDA Compliance & Enforcement Advisory: FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFA
On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug manufacturing facilities should consider when attempting this avenue for obtaining preliminary FDA feedback.
Advisories September 8, 2023FDA Compliance & Enforcement Advisory: FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFAOn September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug manufacturing facilities should consider when attempting this avenue for obtaining preliminary FDA feedback.
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Speaking Engagement May 25, 2023When FDA Comes Knocking: What to Expect in InspectionsCathy Burgess and Anthony Fanucci will present this webinar hosted by the Food and Drug Law Institute (FDLI).Speaking Engagement May 25, 2023When FDA Comes Knocking: What to Expect in InspectionsCathy Burgess and Anthony Fanucci will present this webinar hosted by the Food and Drug Law Institute (FDLI).
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