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FDA Pharmaceutical Science's Sheinin To Join USP After 30 Years At Agency

This article was originally published in The Tan Sheet

Executive Summary

Office of Pharmaceutical Science Deputy Director Eric Sheinin, PhD, will oversee the USP expert committees responsible for the General Chapters section of The U.S. Pharmacopeia in his new position as USP VP-general policy & requirements.

Office of Pharmaceutical Science Deputy Director Eric Sheinin, PhD, will oversee the USP expert committees responsible for the General Chapters section of The U.S. Pharmacopeia in his new position as USP VP-general policy & requirements.

The General Chapters section describes all tests, assays and procedures for handling USP-listed substances.

Sheinin, 57, will join USP at the end of February, following his Feb. 10 retirement from FDA after 30 years at the agency.

Sheinin will report to USP CEO Roger Williams, MD, who left his joint posts as Center for Drug Evaluation & Research deputy director-pharmaceutical science and director of OPS in January 2000 to join USP.

Sheinin also will work alongside former OPS Associate Director for Regulatory Standards Thomas Layloff, PhD, who departed FDA in March to join USP as VP-Pharmaceuticals Division (now renamed Actives & Excipients Division).

Sheinin's previous agency positions include director of the Office of New Drug Chemistry and chief for the Drug Standards Research Branch at the former Center for Drugs & Biologics. Sheinen's retirement at the 30-year mark was planned prior to USP's offer.

In his new role, Sheinin also will be involved in the USP Nomenclature & Labeling Committee, on which he has served for 14 years, and will be responsible for harmonization with other pharmacopeias around the world, FDA said.

Both Layloff's and Sheinin's positions were created during USP's organizational restructuring in March 1999, but the VP-general policy & requirements position had not yet been filled.

A replacement for Sheinin at FDA has not been named. OPS also still is looking for a permanent director to replace Helen Winkle, who has been serving as acting director since Williams' departure.

In addition, FDA is searching for a new director for OPS' Division of New Drug Chemistry II following the Jan. 3 retirement of John Gibbs, PhD, after 22 years at the agency. Gibbs, 63, temporarily will be replaced by Office of New Drug Chemistry Deputy Director Charles Hoiberg, PhD.

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