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  6. Division of Prescription Drugs
  1. Center for Drug Evaluation and Research | CDER

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. 

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