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

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. 


Intended audience

  • Pharmacists and Pharmacy Technicians
  • Pharmacy Managers
  • Auditors and Inspectors
  • Quality Assurance Officers
  • Compliance Specialists


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 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: 


An unrestricted educational grant has been provided by MEDISCA Inc.


CURRENT PROMOTION:

20% Off

Use coupon code 20LP318 upon checkout to receive 20% off this educational training. 

Course summary
Available credit: 
  • 0.80 CEU (ACPE)
  • 8.00 Contact Hours
Cost:
$600.00

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.


Editors

DAPHNEE LALONDE, BSc, MSc
Continuing Education Supervisor
Disclosure: MEDISCA Consultant

NEIL COHEN, BSc
CE Program Developer
Disclosure: MEDISCA Consultant


Contributor

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


CPE Credits: 8 CPE Hours = 0.8 CEUs
Joint Accreditation Status (University of Florida College of Pharmacy / LP3 Network)
Activity type: Application-based
UAN: 0012-9999-16-496-L03-P/T for pharmacists and technicians
Release date: February 18th, 2017
Expiration date: February 18th, 2019

To receive CPE credits for the live component, 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 can obtain a statement of credit from their NABP e-Profile. The University of Florida College of Pharmacy will report CPE credits to the CPE Monitor. Participants registered other than in the United States will receive a statement of credit by email.


International participants should verify with their respective governing board for accreditation equivalency.

Accreditation Period

Course opens: 
01/20/2015
Course expires: 
11/30/2019

CURRENT PROMOTION:

20% Off

Use coupon code 20LP318 upon checkout to receive 20% off this educational training. 

Price

Cost:
$600.00
 
Status
Price
Title
$600.00Included
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$600.00Included
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Cancellation and refund policy: 


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


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.