Fundamental Compounding with Pharmacy Law (Sep 23 - 25, 2021)

Fundamental Compounding with Pharmacy Law is organized by American College of Apothecaries and will be held from Sep 23 - 25, 2021 at American College of Apothecaries, Bartlett, Tennessee, United States of America.

Target Audience:
This course is designed for pharmacists, technicians, and students who are new to compounding or who have had training in the past but want a refresher. Physicians and other health care professionals are also welcome to attend.

CME Accreditation:
FUNDAMENTAL COMPOUNDING WITH PHARMACY LAW is an accredited 3-day course that combines a 20-hour (2.0 CEUs) practice-based course with a 1 hour (0.1 CEU) knowledge-based course in Fundamental Compounding Law.

Content:
This course provides didactic and hands-on experience with fundamental aspects of nonsterile compounding. Participants will learn through lecture, discussion, practice activities, and hands-on training in a fully equipped nonsterile compounding lab.

The Fundamental Law module explains key aspects of state and federal regulations pertaining to compounding and what components are acceptable to use in compounded nonsterile preparations.

Our low instructor/participant ratio allows for individual attention and interaction. The program is structured to demonstrate skills that can be immediately implemented by participants.

Learning Objectives:
Fundamental Compounding 2021 – Introduction to Compounding (8h)
• Define nonsterile compounding and practices within the scope of USP <795> Pharmaceutical Compounding – Nonsterile Preparations
• Define Quality Assurance and Quality Control
• Explain facility and environmental monitoring requirements
• Explain the use, maintenance, and cleaning of primary engineering controls
• Calibrate the electronic balance and determine minimum accurate weighable quantity
• Discuss commonly compounded nonsterile preparations (CNSPs) and potential stability issues
• Select components appropriate for use in CNSPs and evaluate information contained on the certificate of analysis
• Assign appropriate beyond-use dates to CNSPs
• Summarize necessary label and labeling information
• Demonstrate proper donning and doffing of garb/PPE and safe lab practices
• Practice mixing components using the Principles of Geometric Dilution
• Compound solutions and suspensions while demonstrating appropriate use of equipment and proper compounding techniques
• Clean and sanitize compounding equipment and work areas

Fundamental Compounding 2021 – Regulatory Update (1h)
• Identify regulations and standards pertaining to nonsterile compounding
• Explain requirements for selection of components used in compounding
• Review key FDA guidance documents

Fundamental Compounding 2021 – Documentation (2h)
• Outline the framework for a quality assurance program
• Specify SOPs needed for nonsterile compounding
• Identify master formulation record and compounding requirements
• Discuss quality control procedures
• Describe requirements for personnel training and competency
• Explain elements of a Safety Data Sheet

Fundamental Compounding 2021 – Capsules (2.5h)
• Compare characteristics of capsules
• Determine ingredient proportions
• Demonstrate proper donning and doffing of garb/PPE and safe lab practices
• Compound capsules while demonstrating appropriate use of equipment and proper compounding techniques
• Perform quality control procedures
• Clean and sanitize compounding equipment and work areas

Fundamental Compounding 2021 – Molded Dosage Forms (2.5h)
• Compare characteristics of suppositories and troches
• Discuss factors that discuss the choice of base
• Demonstrate proper donning and doffing of garb/PPE and safe lab practices
• Compound suppositories and troches while demonstrating appropriate use of equipment and proper compounding techniques
• Perform quality control procedures
• Clean and sanitize compounding equipment and work areas

Fundamental Compounding 2021 – Hazardous Drug Handling (1.5h)
• Describe facility requirements
• Differentiate between primary and secondary engineering controls
• Identify the role and responsibilities of the designated person
• Select which drugs must be included on a facility’s HD list
• List required policies and procedures
• Differentiate between deactivation, decontamination, cleaning, and disinfection
• Describe PPE requirements for nonsterile HD compounding
• Determine when an assessment of risk may be used
• List training requirements for personnel who handle HD

Fundamental Compounding 2021 – Topicals (2.5h)
• Compare characteristics of topical dosage forms
• Discuss factors that discuss the choice of base
• Demonstrate proper donning and doffing of garb/PPE and safe lab practices
• Compound a cream, ointment, and gel while demonstrating appropriate use of equipment and proper compounding techniques
• Perform quality control procedures
• Clean and sanitize compounding equipment and work areas