U.S. flag An official website of the United States government
  1. Home
  2. About FDA
  3. FDA Organization
  4. Office of Medical Products and Tobacco
  5. Center for Drug Evaluation and Research
  6. Division of Prescription Drugs
  1. Office of Medical Products and Tobacco

Division of Prescription Drugs

Division of Prescription Drugs

Director, Division of Prescription Drugs: Gail Bormel, J.D., R.Ph.

Chief, Prescription Drugs Branch: Jim Flahive, (acting)

Team Leader, Marketed Unapproved Drugs Enforcement Team: Raichell Brown, Pharm.D., J.D., (acting)

Team Leader, Regulatory Status and Labeling Team: Carolyn Volpe, PharmD, M.S., (acting)

Chief, Compounding & Pharmacy Practices Branch: Russell Fortney, (acting)

Team Leader, Compounding & Pharmacy Practices Operations Team 1: Akilah Green, R.N., M.S., RAC

Team Leader, Compounding & Pharmacy Practices Operations Team 2: Lori Cantin, R.Ph., Pharm.D., (acting)

Team Leader, Compounding & Pharmacy Practices Policy Team: Maria Edisa Gozun, Pharm.D. (acting)

Team Leader, Pharmacy Compounding Advisory Committee Team: Roselind Lawson, J.D. (acting)

Team Leader, Pharmacy Compounding Incidents Team: Ashlee Janusziewicz, Pharm.D., RAC

Team Leader, Compounding Program Operations Team: Philantha Bowen, B.S.N., M.P.H.



The Division of Prescription Drugs is responsible for directing inspections and investigations and recommending, directing and/or coordinating case development and compliance actions relating to prescription drug products; providing enforcement and litigation support and guidance for prescription drug products; providing guidance relating to drug establishment registration and drug product listing regulations and regulatory status of domestic and imported drug products marketed in the U.S. 

DPD uses risk-based assessments to identify and prioritize unapproved prescription drugs for regulatory action and develops compliance strategies to address violations; and reviews and develops legislative proposals and implementing regulations, policy and guidance documents, enforcement strategies, and outreach activities related to prescription drugs. 
 

For additional information, please visit: