Revisions to USP 795, which went into effect November 1, 2023, introduce a new position for compounders: the Designated Person. This person or group of persons are responsible for creating and overseeing training, reviewing compounding staff competencies and maintaining training records for all compounding staff members. In this blog, we review the key responsibilities of the Designated Person for training standards and explore solutions that may help drive greater efficiencies in your compounding pharmacy’s training program.

by Jerra Banwarth, RPh, FAPC, PCCA Director of Online Education

Key Responsibilities of the Designated Person

As the guardian of pharmacy training, competency testing and recordkeeping, the Designated Person must:

1. Develop Training Programs: Create, implement and maintain a comprehensive training program that aligns with USP 795 requirements, including detailed, engaging and effective training materials.
2. Ensure Core Competencies: Competency isn't just about experience; it's about demonstrable skills. The Designated Person must ensure that all personnel involved in compounding are competent in their tasks, which involves annual assessments and practical evaluations of required competencies which are documented and tracked yearly.
3. Document and Track Training: Accurately record all staff training activities, completion rates and competency assessments; manage and track records; and make appropriate updates to training materials.
4. Implement Standard Operating Procedures (SOPs): Ensure staff members read, understand and adhere to the facility’s SOPs. This includes keeping the documents current and relevant to the pharmacy's daily operations on an annual basis.
5. Create Quality Assurance & Control with Corrective Actions: The designated person must create and manage a quality assurance and quality control program. Any deviation from those established standards will require immediate attention. The Designated Person must investigate, document and implement corrective actions for any out-of-specification events, ensuring continuous quality improvement.

Streamline Nonsterile Pharmacy Training Responsibilities with eLearning

We developed the PCCA eLearning Compounding Training & Learning Management System to simplify training and provide management efficiencies to ensure compounding pharmacies retain compliance.

1. Comprehensive eLearning Platform: Our eLearning platform delivers ready-made, interactive and USP-compliant training courses that cater to different learning styles (auditory, visual and tactile), enabling retention of information.
2. Customizable Competency Assessments: The competency assessment templates are customizable to fit specific procedures and equipment used in your pharmacy, saving significant time while ensuring assessments are relevant, consistent and comprehensive.
3. Automated Tracking and Documentation: The eLearning Management System included with the platform automates tracking and documentation of training and competency assessments. Expiration alerts serve as reminders for annual training and assessments while easy access to documents streamlines administrative processes.
4. Integration of SOPs: Integrating your facility’s SOPs into the Learning Management System can ensure that staff are not only reading but also understanding and applying these procedures. Interactive and scenario-based lessons make SOPs more relatable and easier to remember, helping staff understand and apply procedures.
5. Continuous Updates: Ongoing updates ensure training content remains current with industry changes, helping to maintain compliance and the overall quality of compounded products.

The role of the Designated Person is undeniably challenging, but with the right tools and solutions, it becomes manageable and even rewarding. By leveraging PCCA’s comprehensive eLearning Compounding Training & Learning Management System, the Designated Person can effectively implement and sustain robust training programs. This ensures compliance with USP 795 and fosters a culture of excellence and continuous improvement within your compounding pharmacy.

Click to learn more about how our eLearning Compounding Training & Learning Management System can help your pharmacy and request a free demo!

PCCA members with clinical services access may contact our Clinical Services team for help with USP 795 compliance and other compounding concerns.