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CONFERENCE

SEPTEMBER 8-9, 2017 | OKLAHOMA CITY, OK Still Not Sure What To Do About USP <800>?
2017
2 USP General Chapter <800> Hazardous Drugs – Handling non-shedding, and comply with applicable USP

BRENDA JENSEN, CPhT, MBA | COMPOUND CONSULTANTS, LLC

in Healthcare Settings goes into effect July 1, 2018 for
standards for sterile and nonsterile compounding.
facilities that handle hazardous drugs (HDs). The first step

controls (C-PECs) (i.e. CVE, BSC, CACI) must be used
scope of HD handling activities in your facility(ies). Using
the NIOSH List of Antineoplastic and Other Hazardous
for HD compounding. Externally vented means that
CONFERENCE SPONSORS CE SPONSORS to compliance with this standard is to determine the • Externally vented containment primary engineering
To learn more or register now, Drugs in Healthcare Settings, 2016 publication, make a list rooms and C-PECs must vent to the outdoors.
visit www.qcsummitrx.org that includes HD inventory, dosage forms, and handling C-PECs used in nonsterile compounding of nonvola-
activities. Remember that the NIOSH list only includes tile HDs may be equipped with redundant-HEPA
drugs for human use so don’t forget to evaluate veteri- filters in series instead of being externally vented.
The Quality Compounding Summit has the industry and regulatory SESSIONS nary drugs (such as trilostane) for inclusion on the list
updates, products, technologies, suppliers, and connections using the criteria set forth by NIOSH. Keep in mind that an assessment of risk approach may be
you need as a compounding pharmacist to help you stay at the • USP <800> CALIFORNIA BOARD OF PHARMACY IMPLEMENTATIONS: HOW PHARMACISTS CAN used for specific dosage forms to determine alternative
forefront of compounding excellence. At QCS2017, you’ll hear INCORPORATE USP <800> INTO FACILITY DESIGN Next, assess the facility and engineering controls to containment strategies and/or work practices but is not
industry leaders from across the country speak on key topics – Tony J. Park, PharmD, JD, California Pharmacy Lawyers determine what changes might be needed. Designated permitted when compounding with HD APIs or
selected to build your pharmacy's success, including best areas are required for receipt and unpacking, storage, antineoplastic drugs that requires manipulation other than
practices, safety, facility design, and regulatory issues. • ROOT CAUSE ANALYSIS FOR COMPOUNDING PHARMACISTS nonsterile compounding, and sterile compounding of counting or repackaging. After determining the scope of
– Joe Cabaliero, RPh, Gates Healthcare Associates, LLC.
Sponsored by MEDISCA, presented by LP3 Network HDs. Some of these activities may be combined within HD handling activities and evaluating which dosage forms
The Quality Compounding Summit is a 2-day intensive conference the same space so a separate room for each of these may qualify for an assessment of risk, it will be easier to
presenting key topics designed to give pharmacy professionals • COPING WITH THE CHANGING COMPOUNDING LANDSCAPE activities is not necessarily required. determine how much space will be needed for designated
and those that serve the industry, tools to succeed in the future. – Loyd V. Allen, Jr., PhD, RPh, International Journal of Pharmaceutical Compounding HD areas.
This event takes place at the Embassy Suites Downtown Medical • MICROBOLOGY TESTING: USP REQUIREMENTS FOR STERILE AND NON-STERILE PREPARATIONS • HDs must be received and unpacked in a neutral
Center, in Oklahoma City, OK. – Thomas C. Kupiec, PhD, ARL Bio Pharma or negative-pressure area. Consider how a broken A designated person who is qualified and trained must
Sponsored by DoseLogix | Topi-Click. container or spill would be handled when deciding be assigned to oversee compliance. Training starts with
“QCS is the best place to hear from industry experts and see • EXTENDING BEYOND USE DATES FOR COMPOUND PREPARATIONS where HDs should be received and unpacked. reading and understanding the requirements of the
new products and technologies that will help compounding – Thomas C. Kupiec, PhD, ARL Bio Pharma chapter. USP has addressed many frequently asked
pharmacies. No other event provides more insight into quality • HDs must be stored separately from non-HDs in a questions at http://www.usp.org/frequently-asked-
issues in compounding in just two information-packed days,” • MULTISTATE PHARMACY INSPECTION BLUEPRINT PROGRAM - STATE BOARDS OF PHARMACY negative-pressure room that is externally vented and questions/hazardous-drugs-handling-healthcare-settings.
says Dr. Thomas C. Kupiec, President of ARL Bio Pharma. REGULATORY LANDSCAPE FOR INSPECTIONS OF COMPOUNDING PHARMACIES has at least 12 air changes per hour (ACPH). HDs The designated person is responsible for ensuring that
– Elizabeth Scott Russell, RPh, National Association of Boards of Pharmacy
for sterile and nonsterile use may be stored together personnel are trained and competent and that procedures
Education offered at this year’s Quality Compounding Summit • COMPLIANCE REQUIREMENTS FOR TRADITIONAL COMPOUNDING (503A) AND OUTSOURCING in HD compounding areas. Drugs used for nonsterile are developed and implemented for monitoring and
features sessions highlighting best practices, safety, facility FACILITIES (503B): BRINGING 503B INTO 503A TO IMPROVE ORGANIZATIONAL PRACTICES compounding should not be stored in sterile cleaning the facility as well as each aspect of HD handling.
design, and regulatory issues, including USP 800 and pharmacy – Ken Speidel, Ph, BS Pharm, PharmD, FIACP, FACA, Gates Healthcare Associates. compounding areas to minimize traffic into these It is time to start working towards compliance now since
inspections. Sponsored by MEDISCA, presented by LP3 Network areas. equipment may need to be ordered and construction
Attendees will also have the opportunity to tour ARL Bio Pharma Laboratory, located just usually takes longer than anticipated. Many resources are
“I encourage everyone in pharmaceutical compounding to come steps away from the conference hotel. To reserve your spot for the tour, please contact • Sterile and nonsterile compounding rooms must available to assist with compliance but it is vitally important
and share ideas and build relationships with other professionals Amy Dean at adean@arlok.com. A light lunch will also be provided. be externally vented and have negative pressure to be educated to ensure vendors / contractors are
by attending the Quality Compounding Summit,” says Donnie between 0.01 and 0.03 inches of water column providing what is best for a specific facility.
Calhoun, Executive Vice President/CEO of the American College EXHIBITORS relative to adjacent areas. Nonsterile compounding
of Apothecaries. “You’ll see everything you need to streamline rooms and non ISO-classified sterile containment
your company and take it to the next level. In just two days, • American College of Apothecaries • ARL Bio Pharma segregated compounding rooms must have at least Brenda S. Jensen, CPhT, CNMT, MBA owns Compounding Consultants, LLC.
you’ll interact with product manufacturers, discover the latest • Cardinal Health Optifreight Logistics • DoseLogix | Topi-Click 12 ACPH while sterile ISO-classified compounding She helps compounding pharmacies with USP compliance and PCAB
innovations in the industry, and learn from leading experts to • International Journal of Pharmaceutical Compounding rooms must have at least 30 ACPH. Surfaces of accreditation. Although Brenda is a member of the USP Compounding
get a competitive advantage in the compounding marketplace.” • Oklahoma State Board of Pharmacy • Omnicell ceilings, walls, floors, and fixtures must be smooth, Expert Committee, the information presented in this article is her opinion
alone and should not be construed as official USP guidance. She can be
• Spectrum Pharmacy Products impervious, free from cracks and crevices, reached at brenda@compoundconsults.com.

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