Course opens: 
01/20/2015

Staying Current and Compliant with Regulations & Standards in your Compounding Practice

Course Format

1-day live virtual seminar (8 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!

Course Description

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. Most importantly, it provides a space for you to leverage the experience and expertise of our subject-matter expert – USP-approved instructor, former Associate Director of Pharmacy at ACHC and former Surveyor for the Joint Commission, with over 30 years of compounding pharmacy experience – Mr. Joe Cabaleiro.

Intended audience

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.


Learning Objectives

FOR PHARMACISTS:
  1. Review current Federal guidance documents, State Board of Pharmacy standards, and best practices in the compounding industry.
  2. Identify USP requirements for sterile, non-sterile, and hazardous drug compounding. 
  3. Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
  4. Manage a step-by-step process required to thoroughly self-inspect your pharmacy.
  5. Describe key compliance indicators to assess during your pharmacy walkthrough.
  6. Organize recordkeeping and pharmacy documentation.
  7. Recognize the importance of a quality improvement plan.
  8. Develop corrective and preventive action plans.
  9. Examine standard operating procedure requirements.
  10. Discuss the legal and ethical consequences of non-adherence to compounding standards and requirements.
FOR PHARMACY TECHNICIANS:
  1. Review current Federal guidance documents, State Board of Pharmacy standards, and best practices in the compounding industry.
  2. Identify USP requirements for sterile, non-sterile, and hazardous drug compounding. 
  3. Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
  4. Outline a step-by-step process required to thoroughly self-inspect your pharmacy.
  5. List key compliance indicators to assess during your pharmacy walkthrough.
  6. Organize recordkeeping and pharmacy documentation.
  7. Describe the importance of a quality improvement plan.
  8. Implement corrective and preventive action plans.
  9. Apply standard operating procedure requirements.
  10. Recognize the legal and ethical consequences of non-adherence to compounding standards and requirements. 

Financial Support

This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.


Copyright

This CE Activity is Copyright © 2016-2020 LP3 Network.

Course summary
Available credit: 
  • 0.80 CEU (ACPE)
  • 8.00 Contact Hours
Price:
$595.00

JOE CABALEIRO, BS Pharm, RPh
Senior Associate, Gates Healthcare Associates
Disclosure: Consultant, Accreditation Commission for Health Care; Consultant, Gates Healthcare Associates; Consultant, Healthrx Group

Mr. Cabaleiro is the former Associate Director of Pharmacy for the Accreditation Commission for Health Care (ACHC); responsible for the development of compounding quality standards. He is also the former Executive Director for the Pharmacy Compounding Accreditation Board (PCAB), and a former surveyor for the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In addition, Mr. Cabaleiro has served on the United States Pharmacopeia’s Council of the Convention.

A pharmacist for more than 30 years, Mr. Cabaleiro is a nationally recognized expert in non-sterile and sterile compounding, pharmacy quality, accreditation standards, and compounding pharmacy management and operations. Mr. Cabaleiro began his career in home-infusion therapy as pharmacy manager. In 1982, he developed an innovative compounding computer system used nationwide that combined a notebook computer, barcode reader, and electronic balance to permit the safe preparation of complex total parenteral nutrition solutions. He served multiple facilities in the roles of operations and general management during this period of his professional career.

In 1989, Mr. Cabaleiro founded and led a compounding pharmacy, catering to both human and veterinary patients in Cary, North Carolina. During his ownership of the pharmacy, he helped establish the Pharmacy Compounding Accreditation Board (PCAB) and served on various committees that developed industry standards. His pharmacy was among the first to receive PCAB accreditation. After selling the pharmacy, Mr. Cabaleiro joined PCAB during the organization’s most dynamic period of growth.

Mr. Cabaleiro received his Bachelor of Science in Pharmacy from the University of Florida. He has served as an adjunct professor at the University of North Carolina, and has written numerous articles in professional journals, as well as policy and procedure manuals for home-infusion and compounding pharmacies.


Editors

ADAM BEACH, PhD
Learning Technology Manager
Disclosure: None
 


 

Pharmacists & Pharmacy Technicians

The Live Event is accredited for Pharmacists and Pharmacy Technicians by the Accreditation Council for Pharmacy Education (ACPE) under ACPE Topic Designator 03 – Law through CPE Consultants, LLC., and may meet your law-specific CE requirements. Please verify with your state board of pharmacy.

Total CPE Credits: 8 CPE Hours = 0.8 CEUs

Type

Application-based

UAN

0864-9999-18-027-L03-P/T

Credits

8 CPE hours = 0.8 CEUs

Release Date

May 15, 2020

Expiration Date

June 15, 2021

Completion Requirements

  1. Attend the live seminar in full (log in and logout times will be recorded).
  2. 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.
accreditorCPE 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.


TRANSFER POLICY:

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.


 

Price

Price:
$595.00
 
Status
Price
Title
$595.00Included
Please login to Enroll or Add to Waitlist
$595.00Included
Please login to Enroll or Add to Waitlist
$595.00Included
Please login to Enroll or Add to Waitlist
$595.00Included
Please login to Enroll or Add to Waitlist
Please login to Enroll or Add to Waitlist
Course expires: 
12/31/2024