Director: Kalah Auchincloss, J.D., MPH
Team Leader, Compounding Operations Team: Pamela Lee, J.D., P.A.
Team Leader, Regulatory Status and Labeling Team: Kim Simmons, J.D., R.Ph.
Team Leader, Marketed Unapproved Drugs Enforcement Team: Barbara Wise, Ph.D., RN, CPNP
Project Management Officer: Kelisha Turner, MS, CMQ/OE
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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