Experienced counsel on FDA regulations and matters

Theodore Sullivan counsels and advises clients on Food and Drug Administration (FDA) regulations and matters related to:

• Prescription and over-the-counter pharmaceuticals
• Medical devices
• Biological products
• Cosmetics
• Foods and dietary supplements

Theodore's medical and FDA-related work goes beyond his time at Quarles. He was legal counsel for an international medical device company, where he worked to launch the company’s subsidiary in the U.S., obtained pre-market approval for injectable medical devices and advised the company on FDA-related advertising, labeling, import/export, clinical and manufacturing issues. Before practicing law, Theodore was an FDA biologist at FDA’s National Center for Food Safety and Technology, where he conducted research into methods for detection of food-borne pathogens and toxins.

Bar Admissions

• District of Columbia

Education

• Chicago-Kent College of Law - Illinois Institute of Technology (J.D., with honors, 1997)

• George Mason University (B.S., 1989)
  • Biological Sciences

• "ACC Indiana Corporate Counsel's Quick Guide to the FDA"
• "Compounding Pharmacy Perspectives"
• "Hot Topics in Pharmacy Law"
• "Hot Topics in Pharmacy Law"
• A Reminder to our Friends in the Food Distribution Industry: Compliance Dates for FDA Food Safety Regulations Fast Approaching
• Drug Supply Chain Security Act Compliance Extended But Trading Partners Should Still Prepare Now
• FDA Announces Draft Guidance on Outsourcing Facility Sales
• FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption
• FDA Approval of Pfizer Vaccine - Everything Prescribers, Pharmacies, & Vaccine Administrators Want to Know & Forgot to Ask
• FDA Approves Florida’s Section 804 Importation Program for Importation of Canadian Pharmaceuticals
• FDA Issues Broad Exemptions from DSCSA Enhanced Drug Distribution Security Requirements
• FDA Publishes Final Rule on Regulation of Lab-Developed Tests
• FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances
• FDA Releases Draft Interim Guidance on Bulk Drug Substances in Compounding Under Sections 503A and 503B of FDCA
• FDA Takes Action Against Curaleaf for Misbranded CBD Products
• Federal Court Deals Blow to FDA’s Compounding MOU
• Final Definitions and Considerations for Trading Partners to Prepare for DSCSA Implementation
• Importation of Pharmaceuticals From Canada Under the Section 804 Importation Program
• More Guidance Released from FDA for Drug Supply Chain Security Act Compliance
• Second Shot Across the Bow: FDA Issues Warning Letters to 15 CBD Companies
• The Clock is Ticking: Comments to Proposed Federal Rules For Wholesalers and 3PLs are Due June 6th and Here’s What We Think
• The FDA Announces Delays in DSCSA Compliance Requirements and Issues Final Version of Compounding Drug Memorandum of Understanding

Seminar

• 2021 Pharmacy Law Symposium
• 2022 Pharmacy Law Symposium
• 2023 Pharmacy Law Symposium
• 2024 Pharmacy Law Symposium