Compounded Sterile Preparations Specialty Selected Readings: Calcium Chloride Compatibility, Technology-Assisted vs. Manual Compounding, Centralized Insourcing, and Analysis of FDA Warning Letters Issued Against Compounding Pharmacies

The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.

This activity is intended for Board Certified Sterile Compounding Pharmacists in need of recertification credit. 

Board certified pharmacists are eligible to receive up to 4 contact hours of recertification credit for completing this course. To earn recertification credit, learners must review the course content and successfully complete the online assessments by the deadline. Only completed assessments will be eligible for credit; no partial or incomplete assessments will be processed.  You are allowed only one attempt to successfully complete this assessment. 

This course is not intended for those preparing to take the BPS Compounded Sterile Preparations Pharmacy Specialty Examination for Certification. 

This activity is part of the ASHP professional development program for BCSCP recertification approved by the BPS.

Articles

1. Bracero D, Pagan CL, Rowe A, Cassano AT. Centralized insourcing of sterile compounding: One multihospital health system's journey. Am J Health-Syst Pharm. 2022; 79:1281-1289.
2. Dmour I. Content Analysis of US FDA Warning Letters Issued to Compounding Pharmacies Regarding Violations of Current Good Manufacturing Practices Between 2017 and 2022. J Pharm Innov (2022). 
3. Fan M, Yang D, Ng Becky, et al. Impact of technology-assisted versus manual sterile compounding on safety and efficiency in a Canadian community hospital. Am J Health-Syst Pharm. 2022; 79:1685-1696.
4. Kenneally AM, Agbana P, Gardner B, et al. Compatibility of calcium chloride with milrinone, epinephrine, vasopressin, and heparin via in vitro testing and Y-site administration. Am J Health-Syst Pharm. 2023; 80:164-170.

Learning Objectives 

After participating in this CPE activity, learners should be able to:

• Apply knowledge of compounded sterile preparations compatibility to identify factors that may contribute to product precipitation.
• Apply analysis of FDA Warning Letters violation data to the management of facilities responsible for compounded sterile preparations.
• Apply knowledge of federal regulations to determine appropriate dispensing activities for 503A and 503B pharmacies.
• Compare the preparation of compounded sterile products using a technology-assisted workflow system (TAWS) process versus a manual process.

Faculty bios

Becky Frederick, PharmD, BCSCP
Children's Mercy Hospital
Pharmacy Operations Coordinator
Kansas City, Missouri

Ashley Duty, PharmD, MS, BCSCP*
Pharmacy Manager
Children’s Mercy Kansas City
Adjunct Clinical Assistant Professor
UMKC School of Pharmacy
Kansas City, Missouri

*Content matter expert

Angela Cassano, PharmD, BCPS, FASHP

Paul Baker, PharmD, BCSCP
Karen Bertch, PharmD, BCSCP, FCCP
Sarah Bledsoe, PharmD, MSHA, BCSCP, CPHIMS
Anthony Campbell, PharmD, BCSCP
Lauren Conceicao, PharmD, BCSCP
Bassem Fahmi Armanious, BCPS, BCSCP
Kimberly Haverstick, PharmD, MBA, BCSCP
Eileen Hendrickson, PharmD, MBA, BCSCP
Annie Lambert, PharmD, BCSCP
Yin Shan Lim, BCSCP
Kendra Masson, PharmD, BCSCP
Melissa Messick, PharmD, BCSCP, BCNSP
Jagwant Rai, RPh, BCSCP
Arpita Sammons, PharmD, BCSCP
Shunsuke Toyoda, PharmD
Lori Watts, RPh, BCSCP
Stacy Wong, PharmD, MSHS, BCSCP

In accordance with the Accreditation Council for Continuing Medical Education’s Standards for Commercial Support and the Accreditation Council for Pharmacy Education’s Standards for Commercial Support, ASHP requires that all individuals involved in the development of activity content disclose their relevant financial relationships. A person has a relevant financial relationship if the individual of his or her spouse/partner has a financial relationship (e.g. employee, consultant, research grant recipient, speakers bureau, or stockholder) in any amount occurring the in the last 12 months with a commercial interest whose products or series may be discussed in the educational activity content over which the individual has control. The existence of these relationships is provided for the information of participants and should not be assumed to have an adverse impact on the content. 

All faculty and planners for ASHP education activities are qualified and selected by ASHP and required to disclose any relevant financial relationships with commercial interests. ASHP identifies and resolves conflicts of interest prior to an individual’s participation in development of content for an educational activity. Anyone who refuses to disclose relevant financial relationships must be disqualified from any involvement with a continuing pharmacy education activity. 

All other planners, presenters, reviewers, ASHP staff and others with an opportunity to control content report no financial relationships relevant to this activity. 

Activities consist of educational materials, assessments, and activity evaluations. In order to receive continuing pharmacy education credit, learners must:

• Complete the attestation statement
• Review all content
• Complete and pass the assessment
• Complete the evaluations 

Follow the prompts to claim, view, or print the statement of credit within 60 days after completing the activity.

These activities were developed by ASHP.