Current Regulations and Standards for Pharmacy Compounding – How to be Compliant

A University of Florida College of Pharmacy accredited Applicaton-based Activity


Registration and Contact Information:

For more information and to register for this activity

Call 1-844-408-9453 or visit https://education.lp3network.com/live-training/current-regulations-standards-pharmacy-compounding


Activity 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 due to the inherent risks involved in this practice. As such, new laws and standards have been introduced for both sterile and non-sterile compounding to ensure patient safety and prevent future outbreaks. While these standards are vital to protecting and promoting public health, many compounding pharmacies struggle to keep up with all the changes and sometimes conflicting requirements. Our workshop will provide you with the resources needed to keep you up to date with current guidelines and regulatory standards. By attending our training, not only will you maintain your commitment to quality, you will also be able to incorporate the practical changes required to meet or exceed compliance with the latest sterile and non-sterile compounding laws and regulations.

 

Activity Offerings

The following 2017 dates represent activities offered for this activity:

February 18th – in Las Vegas, NV
July 8th – in Aventura, FL
September 30th – in New York, NY

Intended Audience

Pharmacists and Technicians

Activity Design

A one day live event with competency assessment.

Learning Objectives – Pharmacist

  • 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.
  • Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
  • Manage a step-by-step process required to thoroughly self-inspect your pharmacy.
  • Describe key compliance indicators to assess during your pharmacy walkthrough.
  • Organize recordkeeping and pharmacy documentation.
  • Recognize the importance of a quality improvement plan.
  • Develop corrective and preventive action plans.
  • Examine standard operating procedure requirements.
  • Discuss the legal and ethical consequences of non-adherence to compounding standards and requirements.

Learning Objectives – Pharmacy Technician

  • 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.
  • Prepare for a State Board of Pharmacy inspection, FDA inspection, or accreditation audit.
  • Outline a step-by-step process required to thoroughly self-inspect your pharmacy.
  • List key compliance indicators to assess during your pharmacy walkthrough.
  • Organize recordkeeping and pharmacy documentation.
  • Describe the importance of a quality improvement plan.
  • Implement corrective and preventive action plans.
  • Apply standard operating procedure requirements.
  • Recognize the legal and ethical consequences of non-adherence to compounding standards and requirements.

Activity Editors:

Daphnee Lalonde, MSc
Program Coordinator, LP3 Network Inc.
Disclosure: LP3 Network Inc., Learning Management and Logistics

Neil Cohen, BSc
Program Coordinator, LP3 Network Inc.
Disclosure: LP3 Network Inc., Director of Technical Operations

Activity Contributors:

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

Activity Facilitators:

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

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.

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Participant Completion Requirements

To receive CPE credits for the Live Program, participants must demonstrate full and satisfactory participation, and submit a completed evaluation to the University of Florida College of Pharmacy.

Participants registered in the United States: The University of Florida College of Pharmacy will report CPE credits to the CPE Monitor. A paper copy of a statement of credit may be obtained from your NABP e-profile. For participants registered in the state of Florida, UFCOP will report credits to CE Broker.

Participants registered other than in the United States: Participants will receive a statement of credit by mail.

Declarations and Disclosures

The University of Florida College of Pharmacy believes it is important for the reader to be aware of relevant affiliations and financial relationships regarding the development, design and facilitation of this activity and its financial supporter and the financial supporter’s affiliates.

This activity has been approved by, and is hosted by, the University of Florida College of Pharmacy and is independent of any known bias, prejudice or commercial interest. The University of Florida College of Pharmacy has requested that LP3 Network Inc. assist with the marketing of this activity. LP3 Network Inc.is an independent corporation. LP3 Network Inc. has an established agreement with MEDISCA Inc. ensuring that it has no influence on LP3 Network Inc. as it relates to activity offerings.

Accreditation

This activity is accredited by the University of Florida College of Pharmacy in accordance with ACPE Standards for Quality and Interpretive Guidelines. The University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as providers of continuing pharmacy education. The University of Florida College of Pharmacy has allocated 8 hours of continuing education credit (0.8 CEUs) to this application based activity. The UANs are 0012-9999-16-496-L03-P (Pharmacists) and0012-9999-16-496-L03-T (Pharmacy Technician). Release dates: 02/18/2017 – 02/18/2019

Financial Support

An unrestricted educational grant has been provided by MEDISCA Inc. toward the purchase of electromechanical equipment, reusable and disposable devices, protective and safety supplies, and chemicals specific to compounded medications prepared during laboratory sessions.

Food and Beverage

As a matter of activity programming, meals and refreshments during live activities have been provided by LP3 Network Inc.

Cancellation and Refund Policy

A written request must be sent to LP3 Network Inc. requesting a ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from the live activity event date, then the registrant will receive a 75% refund; 15-30 days is a 50% refund; and less than or equal to 14 days will result in no refund.

Transfer Policy

The transfer policy is only in effect if requested greater than or equal to 14 days prior to original live activity event date. Failure to submit the “Transfer Request” at least 14 days prior to original live activity event 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 event date must be within the current calendar year. Failure to attend the new live activity event will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by LP3 Network Inc. based on the number of available seats within the selected live activity event.

Hotel Accommodations

Special rates for hotel accommodations have been arranged for activity participants. Payment for hotel accommodations is at the expense of the activity participant.


ACPE LogoThe University of Florida College of Pharmacy is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education.