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Non-sterile compounding: Home study
This activity serves as a prerequisite to the live activity, Non-Sterile Training: Seminar.
Today, operating or working in a compounding facility in the role of pharmacist or technician is more sophisticated. To distinguish your practice and meet the demands of this growing market, the adoption of a best practices model to manage a compounding pharmacy is essential. The implementation of best practices implies being efficient and effective (i.e., doing the right thing right). The overarching topics addressed in this program can be categorized into three components; standards of practice, business development, and compounding processes.
Implementing Standards of Practice
Participants will learn how to practically implement and apply standard operating procedures, competency trainings, and ongoing compliance assessments with the fundamental philosophy of continuous quality improvement.
Business Development and Growth
A well-developed business acumen is also essential in operating a successful compounding practice. This activity will provide participants with applicable marketing and business strategies to kick-start or enhance their compounding practice.
Optimizing Compounding Processes
Compounding process development brings together everything from the physicochemical properties, uses, and applications of raw ingredients to finished compounded preparations. The fundamental first steps of every compounding process is knowing what ingredient to select; how to interpret and implement information found in a monograph and certificate of analysis; pharmaceutical calculations, including potency adjustments, salt-base conversions, water-content adjustments, among more. From here, participants will review key preparatory techniques and the integration of technology when formulating different non-sterile dosage forms (e.g., oral liquids, capsules, topicals, molded dosage forms, etc.). Lastly, emphasis will be placed on verification procedures to ensure the quality, safety, and integrity of the compounded preparation.
With these three foundational components, this activity provides participants with the fundamental tools and knowledge needed to meet current compounding practice requirements. By taking this activity, the participant will realize the value, and gain the necessary knowledge and skills, to adopt and implement a best practices model for years to come.
Instructional design
The Home Study is a comprehensive knowledge-based program that introduces core concepts and a set of practice tools that guide the Pharmacist and Pharmacy Technician in their day-to-day practice. Each section of the program concludes with a learning assessment, which also provides feedback to the learner.
Course format
Home Study (24 hours) that reviews fundamental concepts in non-sterile compounding. The program concludes with a learning assessment and associated feedback.
Intended audience
- Pharmacists, Pharmacy Technicians, Pharmacy Managers, Designated persons in positions of responsibility, and Quality Assurance & Quality Control officers looking to advance their practical non-sterile compounding skills related to any professional setting.
- Auditors / Inspectors looking to hone their assessment skills in concert with the standards described and detailed in this Activity.
Learning objectives
Pharmacists
- Relate unique and essential central core concepts.
- Describe regulatory framework requirements.
- Discuss standards of practice for non-hazardous and hazardous drug compounding.
- Defend components of a standard operating procedure.
- Apply business, marketing, and sales for a successful practice.
- Explain characteristics for routes of delivery in non-sterile compounding.
- Describe the chemical composition of different dosage forms.
- Apply pharmaceutical calculations to compounding.
- Match excipients to dosage forms, chemical composition, and routes of delivery.
- Match base types to dosage forms, chemical composition, and routes of delivery.
- Employ drug monographs and certificates of analysis to compounding.
- Describe techniques and technology used during compounding.
- Apply the components of process development.
- Rewrite a master formulation record.
- Discuss the requirements of a compounding record.
Pharmacy technicians
- Relate unique and essential central core concepts.
- Review regulatory framework requirements.
- Explain standards of practice for non-hazardous and hazardous drug compounding.
- Describe components of a standard operating procedure.
- Discuss business, marketing, and sales for a successful practice.
- Explain characteristics for routes of delivery in non-sterile compounding.
- Describe the chemical composition of different dosage forms.
- Solve pharmaceutical calculations in compounding.
- Match excipients to dosage forms, chemical composition, and routes of delivery.
- Match base types to dosage forms, chemical composition, and routes of delivery.
- Relate drug monographs and certificates of analysis to compounding.
- Describe techniques and technology used during compounding.
- Outline the components of process development.
- Demonstrate the use of a master formulation record.
- Discuss the requirements of a compounding record.
Financial support
This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.
Copyright
The home study is copyright © 2002-2024 LP3 Network.