Non-Sterile Compounding: Certificate Program

Course format

The Non-Sterile Compounding: Certificate Program is a three day in-person program, comprised of three components.

1. Home Study (24 hours) pre-read that reviews fundamental concepts in non-sterile compounding to prepare you for the live event. To review the full activity description for the Home Study click here.
2. 1.5-day Live Seminar (12 hours) that provides foundational training on non-sterile compounding - everything from business basics, to scientific principles such as dosage form stability and suitability, to performing pharmaceutical calculations, to implementing regulatory guidelines, standards of practice, SOPs, and much more.
3. 1.5-day Hands on Lab Training (12 hours) where you will receive hands-on experience developing non-sterile compounding skills, and preparing eight dosage forms. Each compounded dosage form concludes with a quantitative and qualitative assessment. Participants complete a self-directed learning assessment co-signed by the program facilitator.

Course description

The Live Seminar will cover four subsections:

1. • Business Basics highlights the importance for a compounding practice to build a unique identity and deliver consistent marketing messages. Participants will construct, assess, rehearse, and deliver marketing messages through written and verbal communication. Business Basics also explores financial management as the participant reviews start-up costs, acquisition costs and expenditures, selling prices, forecasted growth and expectations, and revenue stream generators. A two-year financial plan spreadsheet identifies cornerstones and milestones for the new and expanding compounding practice.
   • Creating a Culture of Quality features implementation methods for regulatory guidelines, standards of practice, and standard operating procedures. Participants will learn how to establish a comprehensive action plan and documentation practices related to all aspects of a compounding practice.
   • Compounding Calculations provides the participant the opportunity to learn and practice common pharmacy calculations, including, interpreting drug monographs, drug conversions, drug strength adjustments applying the certificate of analysis, capsule calculations, displacement calculations, stock concentrates and aliquots for powder blends and powder-in-liquid mixtures, among more.
   • Scientific Principles teaches the participant how to ensure dosage form stability and suitability for the patient. The participant will learn to compound a medication by modifying its route of delivery and/or delivery system while optimizing drug bioavailability, patient safety and positive therapeutic outcomes. Scientific Principles also provides the participant the opportunity to apply a number of core concepts by assessing a series of clinical cases. It concludes with a comprehensive method for prescription assessment and clinical decision-making, both critical to a successful compounding practice.

The Hands on Lab Training features a series of fundamental skills followed by the preparation of eight dosage forms. This hands-on experience gives the participant the opportunity to learn and practice general compounding lab processes and procedures, compounding techniques, operating electromechanical equipment, managing a workstation, documenting standard operating procedure logs, all while operating within a compounding facility and preparing non-sterile compounded medications.

Featured fundamental skills:

• Skills Development
  • Weighing powders
  • Measuring liquids
  • Geometric Addition
  • Clean transfers of semisolids 
  • Weight variance testing
• Organoleptic assessments
• Beyond-Use-Dating assignments

Featured Dosage Forms:

• Cellulose-based hydro-alcoholic gel in an actuated dispenser
• Oral transmucosal films using syringe-to-syringe mixing technique
• Capsules using 100-count capsule machine including aliquot calculation
• PEG-based troches including mold fill calculation
• Rapid dissolve tablets
• Oral suspension including pH step
• Suppositories using a 12-count flexible mold
• Topical cream emulsion, using an electronic blade mixer, mill and planetary motion mixer (no blades)

Additionally, elements of a unique process experienced in the Live Seminar can now be realized in this Hands on Lab Training, which serves as the basis for the development, and subsequent preparation of any non-sterile dosage form containing any appropriate active pharmaceutical ingredient. The unique elements include:

• Compounding by composition (i.e., powder blends, and powder-in-liquid mixtures in the form of solutions or dispersions)
• Preparatory states-of-matter and final dosage form states-of-matter (i.e., solids, semisolids and liquids)
• Routes of delivery and delivery systems
• Sites of administration and target sites of action

Instructional design

The Live Seminar is a highly interactive application-based program that strikes a careful balance between a patient-centric and business-centric approach for the learner. Facilitators complement the program by bringing a wealth of personal and professional expertise to the learner’s experience in these two approaches. The program concludes with a learning assessment, which provides feedback to the learner.

The Hands on Lab Training is a hands-on application-based compounding skills development session followed by the preparation of eight dosage forms each with a unique chemical composition, routes of delivery and delivery system. The eight prepared compounded medications undergo a qualitative and quantitative assessment. The Practical Lab program learning assessment consists of an assessment of learned preparatory techniques, which includes those highlighted during the skills development session complemented by scores allocated to the qualitative and quantitative assessment results.

Learning objectives

Live Seminar

Pharmacists

1. Assess, write and construct marketing messages and material.
2. Practice delivering a unique marketing message through verbal communication.
3. Evaluate a two-year financial spreadsheet for a non-hazardous and hazardous compounding practice.
4. Assess acquisition costs and establish the selling price of compounded medications.
5. Summarize regulatory guidelines and standards of practice for compounding.
6. Demonstrate how to customize standard operating procedures.
7. Compare standards of practice for non-hazardous to hazardous drug compounding.
8. Design a collaborative compounding practice.
9. Relate standards of practice and workflow dynamics to facility design models.
10. Relate standard operating procedure competency and compliance with corrective action and preventive action.
11. Demonstrate compounding calculations to increase accuracy and minimize medication error.
12. Discover how to balance dosage form stability with the suitability of a compounded medication for a patient.
13. Apply the concept of customization with appropriate compromise to a compounded medication.
14. Relate dosage form design to bioavailability optimization, patient safety and a positive therapeutic outcome.
15. Summarize the importance of the steps of a prescription assessment for compounding.
16. Explain the importance of clinical decision-making processes in compounding.

Pharmacy technicians

1. Assess, write and construct marketing messages and material.
2. Practice delivering a unique marketing message through verbal communication.
3. Describe a two-year financial spreadsheet for a non-hazardous and hazardous compounding practice.
4. Compute acquisition costs and establish the selling price of compounded medications.
5. Summarize regulatory guidelines and standards of practice for compounding.
6. Demonstrate how to customize standard operating procedures.
7. Apply standards of practice for non-hazardous and hazardous drug compounding.
8. Explain a collaborative compounding practice.
9. Relate standards of practice and workflow dynamics to facility design models.
10. Relate standard operating procedure competency and compliance with corrective action and preventive action.
11. Solve compounding calculations to increase accuracy and minimize medication error.
12. Demonstrate the importance of dosage form stability with the suitability of a compounded medication for a patient.
13. Explain the concept of customization with appropriate compromise as it applies to a compounded medication.
14. Describe dosage form design as it relates to bioavailability optimization, patient safety and a positive therapeutic outcome.
15. Recognize the importance of the steps of a prescription assessment for compounding.
16. Recognize the importance of clinical decision-making processes in compounding.

Hands on Lab Training

Pharmacists

1. Demonstrate proper donning and doffing of personal protective equipment; non-hazardous and hazardous
2. Demonstrate how to manage a workstation, its equipment and chemical inventory
3. Demonstrate how to properly sanitize a workstation in a non-hazardous and hazardous drug environment
4. Demonstrate how to properly manage and dispose of waste; non-hazardous and hazardous
5. Demonstrate how to clean and disinfect an analytical balance
6. Demonstrate how to verify the internal calibration of an analytical balance
7. Record data in standard operating procedure logs
8. Demonstrate the use of electromechanical equipment, and reusable and disposable devices
9. Perform a broad range of non-sterile compounding techniques
10. Prepare a number of non-sterile compounded medications
11. Determine the beyond-use date for non-sterile compounded medications
12. Select appropriate dispensing containers for finished non-sterile dosage forms
13. Complete formulation records for finished non-sterile dosage forms
14. Analyze finished dosage forms by assessing organoleptic properties and performing weight variance testing

Pharmacy technicians

1. Demonstrate proper donning and doffing of personal protective equipment; non-hazardous and hazardous
2. Demonstrate how to manage a workstation, its equipment and chemical inventory
3. Demonstrate how to properly sanitize a workstation in a non-hazardous and hazardous drug environment
4. Demonstrate how to properly manage and dispose of waste; non-hazardous and hazardous
5. Demonstrate how to clean and disinfect an analytical balance
6. Demonstrate how to verify the internal calibration of an analytical balance
7. Record data in standard operating procedure logs
8. Demonstrate the use of electromechanical equipment, and reusable and disposable devices
9. Perform a broad range of non-sterile compounding techniques
10. Prepare a number of non-sterile compounded medications
11. Determine the beyond-use date for non-sterile compounded medications
12. Select appropriate dispensing containers for finished non-sterile dosage forms
13. Complete formulation records for finished non-sterile dosage forms
14. Analyze finished dosage forms by assessing organoleptic properties and performing weight variance testing

Testimonials

“A true hands-on experience with experts that teach the secrets of successful compounding. I learned a lot regarding compounding techniques, quality control, packaging, and the availability of compounding tools and aids. This training will help my day-to-day practice!”

Parvaneh Moussavian | Pharmacist

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 © 2002-2025 LP3 Network.