Course Description: Practical Compliance with USP Chapters <797> and <800> is an updated course geared towards individuals who are responsible for ensuring compliance with the USP Compounding Standards. The course is based on the currently enforceable USP chapter <797>, and the revised USP Chapter <797> and USP Chapter <800> which will be enforceable November 2023.The course focuses on the practical application of the standards from the revised USP <797> and the new USP <800>. The target audience includes pharmacists, pharmacy technicians, and others who are practicing in a sterile compounding environment and/or who are designated as responsible for the performance of a sterile compounding facility. Participants who satisfactorily complete the program will receive a certificate of completion as well as 16 hours of live ACPE-accredited continuing pharmacy education credit.
Target Audience: Pharmacists, pharmacy technicians, and others who are practicing in a sterile compounding environment and/or who are designated as responsible for the performance of a sterile compounding facility.
Location of Event: The program will be offered at the Aseptic Compounding Experience (ACE) Lab, located at 715 Sumter Street, University of South Carolina College of Pharmacy Campus in Columbia, SC.
Handouts/Slides: Will be made available to all participants to download/print prior to the course (on or around June 25) (After registration, a section titled "Course Material(s)" will appear below, where these will be housed).
Richard Capps, PharmD
Prisma Health Oconee Memorial Hospital, Seneca, SC
Shay Garrison, RPh, MPH
Prisma Health Richland Hospital, Columbia, SC
Allen Welch, PharmD
Senior Director of Compliance & Regulatory Services
Comprehensive Pharmacy Services, White Pine, TN
Vice President of Business Development
Technical Safety Services, Charleston, SC
Disclosure: Faculty, planners, reviewers, staff, and CPE committee report no financial or personal relationship with any commercial interest producing, marketing, reselling, or distributing a product or service that appears in this program. There is no commercial support for this program.
Course Requirements: It is a strong recommendation that attendees read and review USP chapters <797> and <800> prior to attending the course. The participant must physically be able to stand for a minimum of 2 hours. Participant must also have full range of motion to complete physical tasks required in the compounding process.
Accreditation: The University of South Carolina College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. For successful completion for the live certificate-based activity, participants will be required to attend the accredited program in its entirety, successfully demonstrate certificate-based competencies using planned simulations, and complete speaker and program evaluations. This certificate-based activity has been approved for 16 contact hours (1.6 CEUs) of live continuing education credit, ACPE #0062-0000-22-171-L07-P/T and Certificate program #0062-22-004-CP.
Program Registration Fees, Cancellation and Refund Policies
Registration Fees: Pharmacists/Technicians: $950
*Please note that fees will show as "Learning Express" on your credit card statement.*
Registration is limited and will be taken on a first come first served basis. Fee includes on-site training and continuing education credit. Registrants are responsible for any travel expenses. For the two-day live training program lunch will be provided. Please inform us via registration question and/or email of any dietary restrictions, dietary lifestyles, or food allergies.
- Cancellations received in writing at least 30 days prior to program date via letter or email to CE@cop.sc.edu will receive a full refund minus a $200 cancellation fee.
- USC COP reserves the right to cancel the entire program. In the event of a conference cancellation, each participant will be notified via phone and/or email at least 14 days prior to the program and a full tuition refund will be made.
- In the event of inclement weather, the decision to cancel a course will be made no later than 9:00 am Eastern time the day before the program.
- Individuals attending the course in place of the registered individual will be honored as long as the request is made in advance of the registration deadline, which is 7 days prior to the event.
- Refund requests are subject to a $200.00 cancellation fee and must be received 30 days prior to the start of the live component. All registration cancellations must be submitted in writing or by e-mail to the Continuing Education Department at the following address: University of South Carolina College of Pharmacy Continuing Education, 715 Sumter Street, Room 314B, Columbia, SC 29208, Email: CE@cop.sc.edu
- Registrants may receive 100% of the program registration fees, less the $200.00 cancellation fee up to 30 days prior to start date of the live component. No refunds are offered for cancellations fewer than 30 days prior to the start date of the live component or for no shows.
RSVP Information and cut-off date:
- Registration will be accepted until 14 days prior to the start of the program (Thursday, June 15 at 4:00pm) or until capacity has been reached.
Program Schedule and Learning Objectives
Program Schedule All times shown are Eastern (specifics subject to change):
Learning Objectives for Pharmacists and Pharmacy Technicians:
At the conclusion of this program, pharmacists and pharmacy technicians will be able to:
- Assess the USP <797> requirements for facilities and engineering controls
- Evaluate the types and placement of primary engineering controls (PEC) for non-hazardous sterile compounding
- Implement a microbial air and surface monitoring program based on requirements for viable and non-viable sampling, including proper incubation periods
- Analyze microbial air and surface sampling results to identify potential issues related to cleaning activities and other sources of contamination
- Analyze the introduction of equipment and supplies into the cleanroom suite and PEC in order to minimize particle generation and risk of contamination to the cleanroom environment and sterile compounds
- Evaluate personnel performing hand hygiene, garbing, gloved fingertip and media fill sampling according to USP <797> requirements
- Analyze the elements of an effective cleaning and disinfectant program that complies with USP <797>
- Analyze a recertification report to identify the critical elements to ensure the environmental controls in the classified areas meet the minimal requirements of USP <797> or <800>
- Differentiate between the three categories of compounded sterile preparations as defined in USP <797>
- Evaluate sterilization methods for compounded sterile preparations prepared with nonsterile components or nonsterile supplies
- Evaluate aseptic process and sterilization methods as discussed in USP <797>
- Examine the personal protective equipment (PPE) requirements of USP <800>
- Analyze USP <800> requirements for deactivating, decontaminating, cleaning, and disinfecting
- Assess the USP <800> requirements for facilities and engineering controls
- Evaluate the types and placement of containment primary engineering controls (C-PEC) for hazardous compounding
- Examine the elements of hazardous risk based on USP <800> involved in creating an assessment of risk for your formulary
- Demonstrate spill management and disposal of hazardous drug waste
- Examine the role and accountabilities of the designated person per USP