Anthony Fanucci, PharmD

Associate,

Washington, D.C.

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.

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.

Healthy Byte | DEA and HHS Finalize Rule on Prescribing Buprenorphine via Telemedicine – Or Did They?

Sean Sullivan, Sofia Molodanof, and Anthony Fanucci examine the final rule on prescribing buprenorphine via telemedicine that was published on January 15, 2025. They discuss the key components of the rule, the implication it leaves for stakeholders, and whether the Trump Administration could revise or kill the rule.

Healthy Byte | DEA Again Extends Flexibilities for Prescribing Controlled Substances Via Telemedicine

Sean Sullivan, Sofia Molodanof, and Anthony Fanucci discuss the motivations behind the extension and what’s holding up the final rule and speculate on whether the new Administration might alter the course of this rule.

Healthy Byte | Will the DEA Limit COVID-19 Telemedicine Flexibilities?

Sean Sullivan, Sofia Molodanof, and Anthony Fanucci report on when we might see a final rule, the likely new limitations, and how the new rule will impact providers.

Healthy Byte | SAMHSA Releases its Final Rule on Prescribing for Treatment of Opioid Use Disorder

Sean Sullivan, Anthony Fanucci, and Sofia Molodanof discuss how the final rule updates accreditation and certification standards, reduces the barrier for prescriptions, and provides flexibilities for the use of telemedicine.

Healthy Byte | DEA and HHS Extend COVID-19-Era Rules for Prescribing Controlled Substances Via Telemedicine

Anthony Fanucci, Sofia Molodanof, and Sean Sullivan discuss the new temporary rule, why the DEA and HHS decided to extend guidance, and how long you can expect the flexibility for prescribing controlled medications via telemedicine to continue.

Healthy Byte | DEA Temporary Rule Extends Telemedicine Flexibilities

Sean Sullivan, Sofia Molodanof, and Anthony Fanucci discuss the recent DEA temporary rule that allows telehealth prescribing of certain controlled substances after the Public Health Emergency.

Healthy Byte | DEA Proposes New Telehealth Exceptions and Extending Telehealth Rx of Controlled Substances

Sean Sullivan, Anthony Fanucci, and Sofia Molodanof discuss the two long-awaited proposed rules creating new telehealth exceptions to the Ryan Haight Act: --Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient Have Not Had a Prior In-Person Medical Evaluation --Expansion of Induction of Buprenorphine via Telemedicine Encounter They also discuss how the proposed rules impact providers and how to weigh in on the rulemaking.