Learning Objectives

Learning Objectives:

1. Compare and contrast 503A and 503B compounding regulations and the role of pharmacy technicians in these settings.
2. Outline training requirements for pharmacy technicians in compounding environments, including quality assurance (QA), quality control (QC), and the importance of ongoing competency assessment.
3. Describe regulations allowing compounding during FDA-declared drug shortages and its impact on direct-to-consumer telehealth services.
4. Discuss appropriate communication with manufacturers regarding bulk ingredients and vendor qualification procedures.
5. Recognize recordkeeping and documentation requirements for compounded products in each setting.

ACPE Universal Activity Number: 0121-0000-26-001-H03-T
Type of Activity: Knowledge-based

Release Date: 1/1/2026 | Expiration Date: 1/1/2029 (Must be completed by 12/31/2028 at 11:59PM CT)

2.5 HOURS CE    ACPE UAN: 0121-0000-26-001-H03-T    RELEASED: 1/1/2026    EXPIRES: 12/31/2028

Elena Rutka, MA, CPhT, CQA
Quality Assurance Specialist - Novocure, Greensboro, NC

Elena Rutka is a Certified Pharmacy Technician with extensive experience in sterile and nonsterile compounding. She began her career in a 503A compounding pharmacy, where she specialized in aseptic technique, documentation compliance, and workflow efficiency. Currently, Elena serves as a Quality Assurance Auditor in a biopharmaceutical manufacturing environment, ensuring adherence to Current Good Manufacturing Practice (cGMP) standards and supporting continuous improvement initiatives. She is a graduate of Humber College Institute of Technology and Advanced Learning’s Pharmacy Technician program. Elena’s background bridges hands-on compounding and large-scale pharmaceutical quality systems, giving her a unique perspective on technician training, regulatory compliance, and operational excellence in both pharmacy and biopharma settings.