Staying Current and Compliant with Regulations & Standards in your Compounding Practice
1/2-day live virtual seminar (4 hours) that allows you to connect and interact with peers and the facilitator online, in real time, through open mic Q&A sessions, group discussions, polls, and online chats – all from the comfort of your home!
Are you up-to-date with current regulations? Is your compounding pharmacy compliant? Never assume – the likelihood of having your pharmacy inspected continues to increase.
Over the last few years, pharmaceutical compounding has come under increasing federal and state regulatory scrutiny and oversight. New laws and standards have been introduced for non-sterile, sterile, and hazardous drug compounding – many pharmacies struggle to keep up with all the changes and sometimes conflicting requirements. This program provides direction on what you need to know and comply with when it comes to current United States compounding regulations, including USP <795>, <797>, <800>, FDA Guidance Documents, State Boards of Pharmacy, and more. It takes a practical and applicable approach, teaching you how to prepare for and manage a pharmacy inspection, as well as how to resolve any issues identified. During the activity, you will be able to discuss and share actionable and practical ideas that can be implemented in your own compounding practice today.
Pharmacists, pharmacy technicians, pharmacy managers, auditors, inspectors, quality assurance officers, and compliance officers practicing in the United States who want to review and comply with the latest standards in compounding.
- Review current Federal guidance documents, State Board of Pharmacy standards, and best practices in the compounding industry.
- Identify USP requirements for sterile, non-sterile, and hazardous drug compounding.
- Recognize the legal and ethical consequences of non-adherence to compounding standards and requirements.
- Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
- Apply standard operating procedure requirements.
- Organize record-keeping and pharmacy documentation.
- Outline a step-by-step process required to thoroughly self-inspect your pharmacy.
- List key compliance indicators to assess during your pharmacy walkthrough.
- Describe the importance of a quality improvement plan.
- Implement corrective and preventive action plans.
This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.
This CE Activity is Copyright © 2016-2023 LP3 Network.
CHRISTINE ROUSSEL, PharmD, BCOP, BCSCP
Dr. Christine Roussel is a Board Certified Oncology Pharmacist and Board Certified Sterile Compounding Pharmacist with a bachelor's in Toxicology and doctorate in Pharmacy from Philadelphia College of Pharmacy. Senior Executive Director of Pharmacy, Laboratory and Medical Research at Doylestown Hospital (Pennsylvania), Adjunct Assistant Professor at USciences, Facilitator for LP3 Network, and Consultant for MEDISCA Network. On top of her day job of overseeing the clinical and operational aspects of patient care, she provides over 100 hours of education to pharmacists, pharmacy technicians, physicians, and nurses each year.
Dr. Roussel focuses on occupational exposure to hazardous drugs, sterile/non-sterile compounding, clinical and legislative topics, such as medical cannabis, opioid stewardship, drug diversion prevention, pharmaceutical waste and contamination. She is a consultant for cleanroom facility design. She has authored articles on occupational exposure to hazardous drugs, as protecting healthcare providers’ DNA is her primary passion! Her most recent publication is: Meta-analysis of chromosomal aberrations as a biomarker of exposure in healthcare workers occupationally exposed to antineoplastic drugs. In 2018, she was nationally recognized as “40 Under 40 in Oncology”
She is active in many professional organizations, including as a Delegate for the American Society of Health Systems Pharmacy, President of the Pennsylvania Society of Health Systems Pharmacy, Board of Directors for International Society of Cannabis Pharmacists, the American Industrial Hygiene Association, and the Association for Compounding Pharmacists (ACP).
In addition to pursuing her goal of educating the world about the danger of carcinogens, she is also a dedicated mother, Cub Scout leader, and enjoys teaching her kids about engineering, often in the form of marshmallow propulsion devices and rocket building!
|ADAM BEACH, PhD|
Learning Technology Manager
Pharmacists & Pharmacy Technicians
The Live Event is accredited for Pharmacists and Pharmacy Technicians by the Accreditation Council for Pharmacy Education (ACPE) through CPE Consultants, LLC.
Total CPE Credits: 4 CPE Hours = 0.4 CEUs
|Credits||4 CPE hours = 0.4 CEUs|
|Release Date||April 23, 2023|
|Expiration Date||April 23, 2026|
- Attend the live seminar in full (log in and logout times will be recorded).
- Submit a completed live event evaluation form online within 14 days.
When the aforementioned steps have been completed and approved:
- Pharmacists and Pharmacy Technicians registered in the United States will obtain a statement of completed credits on their NABP e-Profile within 60 days.
- Pharmacists and Pharmacy Technicians registered elsewhere will receive a statement of completion by email within 60 days.
- All participants will receive an automated email from LP3 Network advising participants that they can download the LP3 Network certificate.
|CPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.|
CANCELLATION AND REFUND POLICY:
In the event that LP3 Network cancels a course, LP3 Network's sole liability shall be course repayment. In no event shall LP3 Network be responsible for any costs related to travel and/or accommodation. A written request must be sent to LP3 Network Inc. requesting ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from live activity event date, then registrant will receive a 75% refund; 15-30 days a 50% refund; and less than or equal to 14 days no refund. There are no refunds, returns, or transfer requests upon purchase of a home study, digital work book, webinar, and eLearning modules. LP3 NETWORK INC. shall be excused from any delay caused by reason of any occurrence or contingency beyond its reasonable control (a “Force Majeure”), including but not limited to, acts of God, hurricane, earthquake, labour disputes, strikes, riots, war, and governmental requirements. The obligation to pay money to LP3 NETWORK INC. in a timely manner is absolute and shall not be subject to this Force Majeure provision. In such event, LP3 NETWORK INC. will not issue any refunds, only transfer to an alternate live activity event date.
The transfer policy is only in effect if requested greater than or equal to 14 days prior to the original live activity date. Failure to submit the “Transfer Request” at least 14 days prior to the original live activity date will default to the “Cancellation and Refund Policy”. The transfer policy can only be applied one (1) time. Transfer to a new live activity date must be within the current calendar year. Failure to attend the new live activity will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by LP3 Network based on the number of available seats within the selected live activity. There are no refunds, returns, or transfers upon purchase of the home study.