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USP 800 and FDA cGMP:
New Regulations On the Horizon for Compounding Pharmacies
Date held: November 20, 2015
(recording and slide deck available below)

Webinar Description:
This webinar provides an overview of the current and future regulatory landscape for pharmaceutical compounders, with a focus on how this impacts cleanroom design. The 2013 Drug Quality and Security Act (DQSA) transformed the regulatory landscape by granting the FDA enforcement authority over outsourcing facilities as well as traditional compounding pharmacies, along with the implementation of Current Good Manufacturing Practices (cGMP) for non-manufacturer pharmaceutical compounding. The United States Pharmacopeia (USP) has simultaneously undertaken a revision of USP 797 guidelines for sterile compounding, with the major addition of USP 800 guidelines for hazardous drug compounding. Each new set of enforceable guidelines has a separate impact on the pharmaceutical compounding industry, and many discrepancies exist between state and federal oversight.
 
Terra Universal’s goal is to demystify these upcoming regulatory changes to ensure that a compounding pharmacy can make informed decisions when designing its cleanroom facilities.
 

Download the White Paper:
"How to Design Your Compounding Cleanroom to Meet the Standards
of the FDA and State Boards of Pharmacy"


 

Chris Munoz, PharmD and Principle Consultant at ITL Consulting
(left)
Jesse Martinez, PharmD, FASCP and Vice Dean of the College of Pharmacy, Western University of Heath Sciences
(right)

Speaker Bios

Chris Munoz, PharmD and Principle Consultant at ITL Consulting
Dr. Chris Munoz teaches pharmacy compounding at the University of Southern California (USC) School of Pharmacy, and serves on the California Pharmacists Association's Policy Committee and Board of Directors. Following Chris's earlier work in compounding pharmacies and for pharmaceutical companies, he began a consulting firm specializing in the business of, and regulatory affairs for, pharmacy compounding.
 
Jesse Martinez, PharmD, FASCP and Vice Dean of the College of Pharmacy,
Western University of Heath Sciences
Dr. Jesse Martinez has 37 years of experience in compounding, sterile/non-sterile pharmacy operations, and research. He has served on local, state and national pharmacy associations and currently teaches fourth-year pharmacy students in advanced classes that include pharmacist-in-charge training. Jesse consults for the pharmacy industry and is a recognized expert in USP 795, 797 and 800 compliance.

Ask the USP Expert

Compounding pharmacists face a challenging regulatory environment that is rapidly evolving as state standards move into compliance with FDA and USP mandates. It's important to work with an equipment supplier that understands the complexities of licensing and accreditation procedures.

Schedule a one-hour consultation with Chris Munoz, PharmD to help clarify how the regulations impact your facility and what equipment you are required to use for your compounding activities.

Chris is an active member of the International Academy of Compounding Pharmacists. He earned his Doctor of Pharmacy degree at the University of Southern California, and his Masters of Business Administration at Chapman University's George L. Argyros School of Business and Economics.

Talk to your Terra Product Specialist to arrange for a private, consultative conversation.
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