Recording

Sterile Compounding Pharmacies — Planning, Construction and Licensing Guidance Webinar
Gain insights from CA Board of Pharmacy, OSHPD, CDPH Licensing & Certification

Overview

Effective January 2017, hospitals that perform sterile compounding must meet new regulatory requirements from the California State Board of Pharmacy. Beyond updating processes and procedures, hospitals will be required to improve or reconfigure facilities for ventilation, install new equipment for sterility and ensure employee protections.

This process is new and requires collaboration, coordination and a focused approach for successful implementation. CHA has gathered representatives from three California government entities — the Board of Pharmacy, Office of Statewide Health Planning and Development (OSHPD) Facilities Development Division and Department of Public Health Licensing and Certification Program — to share insights crucial to compliant implementation of the sterile compounding regulations.

Recommended for:

Chief operating officers, chief compliance officers, directors of pharmacies, plant managers, construction directors and managers, architects and engineers, inspectors of record.

Program supported by:
American Institute of Architects California Council
(AIACC members may register at the CHA member rate.)

Agenda

Board of Pharmacy

  • Brief review of regulations
  • Waiver process, managing rejections and renewals
  • While under construction — strategies for maintaining services
  • Project completion and application for new sterile compounding license

OSHPD Process and New Advisory Guide

  • Why sterile compounding projects are not business-as-usual construction
  • Highlights of new OSHPD Advisory Guide
  • Preparing for construction — planning, process, timelines
  • OSHPD project numbers — when to get, what’s required, length of use
  • Steps to improve the review and speed plan approval

Licensing and Certification

  • Application and approval required — Sacramento’s Centralized Applications Unit (CAU)
  • Regulatory and statutory considerations
  • Using “Mobile Health Care Units” — approval and inspection required
  • Project completion and scheduling licensing visit — preparation for final inspection and approval prior to use

Faculty

Christine Acosta, PharmD, Supervising Inspector, California State Board of Pharmacy

Paul A. Coleman, Deputy Director, Facilities Development Division, California Office of Statewide Health Planning and Development (OSHPD)

Diana Scaturro, Supervisor, Rapid Review Unit, Facilities Development Division, OSHPD

Robert Menét, PharmD, Chief Pharmaceutical Consultant, Licensing and Certification Program, California Department of Public Health

Commands