Compounded Sterile Preparations Pharmacy Specialty Review Course for Recertification + RECERT EXAM Package (Cert # L249127)

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.

These recertification activities are intended for board certified pharmacists seeking to update their knowledge and skills in compounded sterile preparations pharmacy.

Board certified pharmacists are eligible to receive up to 24.25 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. 

ASHP provides an opportunity for remediation. Participants who are unsuccessful with the first assessment attempt may take a second assessment. The second assessment is included at no additional cost.

ASHP is approved by BPS as a provider for the recertification of BCSCP.

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

ACPE Number: 0204-0000-24-933-H07-P

Overview of Standards, Guidelines, Regulations, and Best Practices

• Compare USP <797> standards to the noncompliance findings from FDA Form 483 inspection reports.
• Analyze corrective and preventive action plans. 

Pharmacy Calculations

• Calculate doses in both weight and volume using proportions with concentrations expressed as fractions, percents, and ratios.
• Use common conversions to perform sterile compounding calculations.
• Calculate doses based on patient weight and body surface area.
• Select quantity of dosage units required to supply an order for a specified time period.
• Calculate infusion rates.
• Calculate concentrations and doses involving milliequivalents and millimoles.
• Apply the alligation method to calculate parts of two solutions with different concentrations to compound a solution with a different desired concentration. 

Cleanroom Personnel Behaviors and Competencies

• List core competencies required for sterile compounding personnel.
• Describe the testing requirements to assess appropriate garbing and aseptic technique.
• Design a training program to ensure mastery of core competencies by sterile compounding personnel.

ACPE Number: 0204-0000-24-935-H07-P

Stability and Sterility: Assigning Beyond-Use Dates

• List factors that influence beyond-use date assignments for compounded sterile preparations.
• Describe physical and chemical compatibility criteria for components.
• Recommend a beyond-use date for a final compounded sterile preparation using evidence-based information.
• Apply USP <797> risk categories to assigning a proper beyond-use date for compounded sterile preparations.
• Differentiate conditions under which sterility, potency, and endotoxin testing are required.
• Identify requirements for quality control testing.
• Interpret results of quality control testing.
• Apply USP standards to properly extend a beyond-use date. 

Compounding Non-Sterile to Sterile Preparations

• Summarize the requirements in section 503A of the Food, Drug, and Cosmetic Act regarding compounding with bulk active pharmaceutical ingredients.
• Apply USP <797> standards and guidelines to non-sterile to sterile compounding.
• Differentiate between best practices and regulatory guidance.
• Discuss key requirements for installation, calibration, and maintenance of equipment used in non-sterile to sterile compounding.
• Describe validation processes for compounding equipment.
• Compare terminal and aseptic sterilization.
• Calculate endotoxin limits for final products.
• Summarize sterility testing requirements outlined in USP <71>.
• Explain best practice quality assurance standards for non-sterile to sterile compounding. 

ACPE Number: 0204-0000-24-936-H07-P

Patient Care

• Assess patient-specific and preparation-specific parameters that affect patient outcomes.
• Differentiate methods of medication administration and delivery systems.
• Categorize elements of a patient and caregiver training program.
• Recommend communication strategies to influence patient adherence, healthcare provider practices, and address problems or concerns.
• Create a script for a pharmacist teaching a patient or caregiver how to monitor for therapeutic complications.
• Compare patient-specific risk factors with associated adverse events.
• Recommend approaches to treat or prevent adverse events.
• Analyze adverse events utilizing appropriate investigative inquiry and reporting systems.
• Explain major steps and components of a root cause analysis process. 

Sterile Preparations: Dosage Forms, Administration, and Special Compounding Considerations

• Describe the dosage forms, preparation requirements, and routes of administration.
• Differentiate between small and large volume parenterals.
• Discuss appropriate routes of administration for compounded sterile preparations.
• Describe techniques for compounding medication cassettes.
• Calculate doses and infusion rates used with medication cassettes.
• Explain how to accurately measure components using principles of volumetric accuracy.
• Describe techniques for compounding ‘specials’ including epidural, intrathecal, and ophthalmic preparations.
• Differentiate situations when sterile filtration and/or preservative-free ingredients must be utilized when compounding special administration medications. 

ACPE Number: 0204-0000-24-936-H07-P

Patient Care

• Assess patient-specific and preparation-specific parameters that affect patient outcomes.
• Differentiate methods of medication administration and delivery systems.
• Categorize elements of a patient and caregiver training program.
• Recommend communication strategies to influence patient adherence, healthcare provider practices, and address problems or concerns.
• Create a script for a pharmacist teaching a patient or caregiver how to monitor for therapeutic complications.
• Compare patient-specific risk factors with associated adverse events.
• Recommend approaches to treat or prevent adverse events.
• Analyze adverse events utilizing appropriate investigative inquiry and reporting systems.
• Explain major steps and components of a root cause analysis process. 

Sterile Preparations: Dosage Forms, Administration, and Special Compounding Considerations

• Describe the dosage forms, preparation requirements, and routes of administration.
• Differentiate between small and large volume parenterals.
• Discuss appropriate routes of administration for compounded sterile preparations.
• Describe techniques for compounding medication cassettes.
• Calculate doses and infusion rates used with medication cassettes.
• Explain how to accurately measure components using principles of volumetric accuracy.
• Describe techniques for compounding ‘specials’ including epidural, intrathecal, and ophthalmic preparations.
• Differentiate situations when sterile filtration and/or preservative-free ingredients must be utilized when compounding special administration medications. 

ACPE Number: 0204-0000-24-937-H07-P

Hazardous Drugs: Safety and Compliance

• Describe the key requirements of USP <800> Hazardous Drugs – Handling in Healthcare Settings, including limiting risk to personnel, facility design, and safe work practices.
• Define the scope of USP <800>.
• Categorize the handling of hazardous drugs in your organization to determine their eligibility for inclusion in your Assessment of Risk.
• Create an acknowledgement of risk document.
• List questions relevant to your organization after reviewing USP <800>.
•  Assess your organization's current compliance with USP <800>.
• Evaluate the organization's storage and compounding areas.
• List the three types of containment primary engineering controls used for compounding hazardous drugs.
• List the two types of containment secondary engineering controls used for storage and compounding hazardous drugs.
• Analyze your organization's most recent certification report.
• Interpret pressure gradients, air flow direction, and air changes per hour. 

Hazardous Drugs: Training and Work Practices

• List the key responsibilities of the Designated Person.
• Differentiate personal protective equipment used in hazardous drug compounding from that used in non-hazardous compounding.
• Describe work practice from receiving through compounding.
• Design a policy and procedure for handling spills.
• Apply appropriate strategies to achieve compliance identified in gap analyses.
• Create a checklist that can be used for daily, monthly, and annual monitors for facilities and personnel.

ACPE Number: 0204-0000-24-938-H07-P

Parenteral Nutrition Products

• Assess automated compounding devices for safety, interoperability, and overall functionality.
• Differentiate among available parenteral nutrition products.
• Compare advantages and disadvantages of standardized commercially-available parenteral nutrition products versus customized parenteral nutrition formulations.
• Select parenteral nutrition products based on relevant patient characteristics, availability, stability and compatibility.
• Recommend strategies for handling parenteral nutrition product shortages.
• Assess the parenteral nutrition compatibility issues for a given formulation.
• Differentiate between stability concerns for 2-in-1 parenteral nutrition versus total nutrient admixture formulations.
• Describe educational instruction techniques for home preparation of parenteral nutrition.
• Identify factors that influence the selection of an appropriate vascular access device for parenteral nutrition.
• Compare and contrast the vascular access options available for administering parenteral nutrition.
• Describe strategies for preventing potential complications of vascular access devices. 

Intro to Parenteral Nutrition

• Explain the components and role of parenteral nutrition.
• Evaluate parenteral nutrition orders and processes.
• Assess automated compounding devices for safety, interoperability, and overall functionality.

ACPE Number: 0204-0000-24-939-H07-P

Managing Compounded Sterile Preparations until Final Check or Disposal

• Choose appropriate methods to verify the appropriateness of source ingredients.
• List cold-chain requirements for refrigerated and frozen products.
• Identify USP <797> requirements and best practices to introduce materials into a controlled environment.
• Differentiate storage requirements for hazardous and non-hazardous drugs.
• Compare cleanroom storage options for high-risk medications, controlled drugs, investigational drugs, non-sterile bulk ingredients, and bulk chemicals.
• Define preparation labeling guidance and best practices.
• Apply FDA repackaging guidance to sterile preparations.
• Compare storage options for finished compounded sterile preparations prior to administration.
• Describe requirements and best practices for transport of finished sterile preparations within and outside of the facility.
• Identify appropriate waste streams for unused compounded sterile preparations, controlled drugs, and used supplies.
• Differentiate the elements of a master formulation record and a compounding record.
• Compare the advantages and disadvantages of available final preparation verification methods.
• Describe the requirements and best practices for controlled substance documentation. 

Quality Management

• Identify key components of quality management associated with compounding hazardous and nonhazardous sterile preparations.
• Explain how quality management processes serve as a safety tool for nonhazardous and hazardous sterile compounding activities.
• Apply the four pillars of quality management to cleanroom operations.
• Recommend corrective action and preventive action plans based on discoveries from continuous quality improvement processes.
• Discuss the challenges and pitfalls associated with implementing a quality management program.
• Differentiate between 503A and 503B.
• Create standards for documentation including master formulation records, compounding records, and standard operating procedures.
• Assess outsourced products and services to ensure compliance with established processes and facility requirements.

ACPE Number: 0204-0000-24-934-H07-P

Compounding Facilities and Engineering Controls

• Differentiate between a segregated compounding area and a clean room.
• Discuss essential design elements for a sterile compounding facility.
• Analyze the advantages and disadvantages of available finish materials.
• Contrast the ancillary equipment and automated compounding devices used in compounding sterile preparations.
• Assess selection, placement, calibration, and maintenance of ancillary equipment and automated compounding devices.
• Describe equipment and cleanroom certification and maintenance requirements.
• Develop a downtime plan for secondary and primary engineering control maintenance or failure. 

Compounding Materials, Equipment, and Resources

• Interpret several types of patient medication labels.
• Create a master formulation record and a compounding record.
• Use tertiary resources to find necessary drug information. 

Managing and Maintaining the Cleanroom Environment

• Assess the different reagents and processes used to clean primary engineering controls.
• Describe how to clean primary and secondary engineering controls used for compounding hazardous and non-hazardous preparations to ensure regulatory compliance.
• Summarize how cleaning regimens impact environmental monitoring results.
• Design an environmental monitoring performance qualification plan including regularly scheduled monitoring.
• Recommend appropriate action plans based on personnel and environmental monitoring data. 

The Core Therapeutic Modules Review Package consists of 10 activities in which faculty review clinical topics and practice skills using a case-based approach. The activities are designed to assist the learner in identifying knowledge gaps in preparation for a pharmacy specialty board examination. In addition to a recorded presentation, each activity includes links to resources for further self-study and a practice test developed in the same format and rigor as the specialty exam.

After participating in these CPE activities, learners should be able to:

Select Topics in Acid-Base Disorders
ACPE #: 0204-0000-21-610-H01-P

For the following specific acid/base disorders - respiratory, metabolic acid base disorders including anion gap/non-anion gap acidosis, renal tubular acidosis, as well as delta gap equation:

•  Interpret laboratory and diagnostic tests.
• Recommend the most appropriate treatment and monitoring plans based on patient-specific information and current guidelines

Select Topics in Infectious Diseases in Critical Care Patients
ACPE #: 0204-0000-22-643-H01-P

For the following specific infectious disease topics: urinary tract infections, meningitis, catheter related infections, bacteremia, and infective endocarditis:

• Interpret laboratory and diagnostic tests.
• Recommend the most appropriate treatment and monitoring plans based on patient-specific information and current guidelines.

Select Neurology Topics in Critical Care Patients
ACPE #: 0204-0000-20-990-H01-P

• For the following specific critical care topics: status epilepticus, traumatic brain injury, ischemic stroke, subarachnoid hemorrhage:
  • Interpret laboratory and diagnostic tests.
  • Evaluate benefits and risks of drug therapy considering other medication, and other patient-specific factors.
  • Recommend the most appropriate treatment and monitoring plans based on patient-specific information and current guidelines.

Alterations in Pharmacokinetics and Pharmacodynamics in Critical Care
ACPE #: 0204-0000-21-611-H01-P

• Identify pharmacokinetic and pharmacodynamic (PK/PD) changes that occur in critical illness, and the impact on commonly administered medications in this setting.
• Apply knowledge of general PK/PD changes in critical illness to the following patient-specific factors that further complicate drug dosing:
  • Burns
  • Obesity
  • Pregnancy
  • Continuous renal replacement therapy (CRRT)
  • Extracorporeal membrane oxygenation (ECMO)

• Develop a therapeutic strategy to optimize PK/PK for commonly used medications in the intensive care unit. "

Select Topics in Prevention and Supportive Care in Critical Care Patients
ACPE #: 0204-0000-20-991-H01-P

For the following specific critical care topics─stress ulcer prophylaxis (SUP), venous thromboembolism (VTE) prophylaxis, bowel regimens, and ventilator associated pneumonia (VAP) prevention:

• Interpret laboratory and diagnostic tests.
• Recommend the most appropriate treatment and monitoring plans based on patient-specific information and current guidelines.

Select Topics in Toxicology
ACPE #: 0204-0000-21-612-H01-P

For the following specific toxicology topics: acetaminophen, toxic alcohols, calcium channel blockers, beta blockers, opioids, and ecstasy:

• Interpret laboratory and diagnostic tests
• Recommend the most appropriate treatment and monitoring plans based on patient-specific information and current guidelines.

Select Topics in Pulmonary Disorders
ACPE #: 0204-0000-22-644-H01-P

For the following specific pulmonary disease topics: asthma exacerbation, acute exacerbation of chronic obstructive pulmonary disease, pulmonary embolism, and pulmonary arterial hypertension:

• Interpret laboratory and diagnostic tests.
• Recommend the most appropriate treatment and monitoring plans based on patient-specific information and current guidelines.

Cardiac Arrhythmias and Advanced Cardiac Life Support
ACPE #: 0204-0000-20-992-H01-P

• Interpret signs, symptoms and diagnostic tests for cardiac arrhythmias.
• Identify drug-related problems, including drug interactions and adverse effects, associated with pharmacotherapy of cardiac arrhythmias.
• Identify strategies to prevent drug-induced arrhythmias.
• Recommend therapy and monitoring for cardiac arrhythmias based on patient-specific information, current guidelines and Advanced Cardiac Life Support guided therapies.

Pharmacotherapy Considerations in the Management of Shock
ACPE #: 0204-0000-20-993-H01-P

• Interpret diagnostic and/or laboratory tests, vital signs, and clinical presentation in order to differentiate types of shock (hypovolemic, distributive, cardiogenic)
• Compare and contrast the pharmacologic agents utilized in shock
• Recommend therapy and monitoring based on patient-specific information and current guidelines for the treatment of shock

Fluid, Electrolytes, and Nutrition
ACPE #: 0204-0000-22-617-H01-P

• Interpret laboratory and diagnostic tests for fluid, electrolyte, and nutrition status.
• Recommend the most appropriate therapy and monitoring in patients with fluid, electrolyte, and nutritional disorders based on patient-specific information and current guidelines.
• Apply strategies to manage drug-related electrolyte interactions and nutrient interactions.

Cindy Brasher, PharmD, MS, BCSCP
Manager of Compounding
St. Jude Children's Research Hospital
Memphis, Tennessee

Ashley Duty, PharmD, MS, BCSCP *
Director of Inpatient Pharmacy Operations
Nationwide Children's Hospital
Columbus, Ohio 

Kevin Hansen, PharmD, MS, BCPS, BCSCP *
Director Pharmacy, Compounding Services
Moses H. Cone Memorial Hospital
Greensboro, North Carolina 

Cindy Huber, PharmD
Pharmacy Operations Manager
Providence Infusion and Pharmacy
Tukwila, Washington 

Jackie Jaskowiak, PharmD, BCPS, BCSCP
Inpatient Pharmacist Specialist, Compounding Compliance and Operations
University of California San Diego Health
La Jolla, California 

Patricia C. Kienle, BSPharm, MPA, BCSCP, FASHP *
Director, Accreditation and Medication Safety
Cardinal Health Innovative Delivery Solutions
Wilkes-Barre, Pennsylvania 

Kristen Kruszewski, PharmD, MBA, BCSCP
Director of Pharmacy Strategy and Services Consulting
Geisinger
Durham, North Carolina 

Stephen Milstead, PharmD, MS, BS, BCSCP, CFT, CNC
Pharmacist, Parenteral Operations & Hazardous Drug CoordinatorGra
ndview Medical Center
Birmingham, Alabama 

Angela Yaniv, PharmD, BCSCP
Director, Sterile Products
Cleveland Clinic
Cleveland, Ohio

*Content Matter Experts

Angela Cassano, PharmD, BCPS, FASHP

Anita Abata, BCSCP, BCCCP, BCPS
Summer Abduqadir, PharmD, BCSCP
Ghassan Agha, MAT, PharmD, RPh, BCNP, BCSCP
Jeff Arquiette, BS, BCSCP
Amisha Arya, PharmD, BCSCP, CJCP
Paul Baker, PharmD, BCSCP
Karen Bertch, PharmD, BCSCP, FCCP
Gina Bliss, PharmD, BCSCP
Allison Braden, PharmD, BCSCP
David Braverman, PharmD, BCSCP
Tara Breuer, RPh, BCSCP, BCPS
Michelle Buse, PharmD, BCSCP
Ashlyn Carter, PharmD, BCSCP
Leroy Carter, PharmD, BCSCP
Michael Christensen, BSPharm, BCSCP
Letitia Cooper, PharmD, CPh, BCSCP
Jenny Dellapietro, BS, PharmD, BCPS, BCSCP
Heather DeSanto, PharmD, BCSCP
Bonnie Estrada, PharmD, BCSCP
Pammi Farren, RPh, PhD, BCSCP
Timothy Fine, PharmD, BCSCP
Angela Forcucci, PharmD, BCSCP
Michael Freudiger, PharmD, APh, BCPS, BCSCP
Julianna Gachoya, PharmD, BCPS, BCSCP, MBA-MHA, PLA
Varsha Gaitonde, PharmD, PhD, BCPS, BCSCP, FACHE
Lori Garcia, PharmD, BCSCP
Erica Garris, PharmD, BCSCP
Steven Getz, PharmD, BCSCP
Zoe Glaras, PharmD, BCSCP
Joanne Glatz, PharmD, BCSCP
Sarah Greif, PharmD, BCSCP
Craig Greszler, PharmD, MBA, BCSCP
Ralph Grillo, PharmD, BCSCP
Tareq Haddad, RPh, BCSCP
Alesia Hanson, RPh, BCSCP
Amanda Harding, PharmD, BCSCP
Katherine Harmston, PharmD, BCSCP
Kimberly Haverstick, PharmD, MBA, BCSCP
Shawn Hegner, PharmD, BCSCP
Eileen Hendrickson, PharmD, BCSCP, MBA
William Ho, PharmD, BCSCP
Allison Hoff, BCSCP
Suet Huang, PharmD, BCSCP
Kim Hunt, BCSCP
Joshua Jaussi, BCSCP
Maisha Khan, PharmD, BCSCP
Lynda Kiliany, BSPharm, PharmD, BCSCP
Kyle Klawon, PharmD, BCSCP
Tracy Kosinski, PharmD, BCSCP, CPPS
Maria Kraj, RPh, BCSCP
Bernard Lau, PharmD, BCSCP
Daisy Leong, PharmD, BCPS
Meghan Libby, PharmD, BCSCP
Valerie Lindeborg, PharmD, BCOP, BCSCP
Ruth Link, PharmD, BCSCP
Melissa Marshall, PharmD, BCPS, BCSCP
Richard Martin, PharmD, BCSCP
Ryan Martinez, PharmD, BCSCP
James Mason, PharmD, MS, BCSCP, CPGP
Fred Massoomi, Pharm.D., BCSCP, FASHP
Koshy Mathew, PharmD, MBA, BCSCP
Pamela Mathis, PharmD, BCSCP
Aura Matyjas, PharmD, BCSCP
Kristen McCloy, PharmD, BCSCP, IgCP
Vicki McConnell, BSPharm, PharmD, BCSCP
Mary McGarry, PharmD
Conor McGladrigan, PharmD, JD, BCOP, BCSCP
Linda McKee, PharmD, BCPS, BCSCP
Helen McKnight, PharmD, MBA, BCSCP
Kathleen McTernan, PharmD, BCSCP
Melissa Messick, PharmD, BCNSP, BCSCP
Andrew Meyer, PharmD, BCPS, BCSCP
Pamela Meysenburg, PharmD, BCSCP
Ann Miller, PharmD, BCSCP
Benjamin Myatt, PharmD, BCSCP
Mary Nazzal, PharmD
Ioana Necs, PharmD, BCSCP
Kembral Nelson, PharmD, MS, BCSCP, CMQOE
Trang Nguyen, PharmD, BCSCP
Edmond Nunes, PharmD, RPh, BCSCP
Susan Oji, BSPharm, BCSCP
Lindsay Oliveira, PharmD, BCSCP
Sean O'Rourke, PharmD, BCSCP
Barbara Petroff, MS, RPh, BCSCP, FASHP, FNHIA
Amanda Phillips, PharmD, BCSCP
Lauren Piccoli, PharmD, BCSCP
Alyssa Powell, PharmD, BCPS, BCSCP
Jagwant Rai, BPharm, BCSCP
Jocelyn Reynoso, PharmD, BCPS, BCGP, BCSCP
Christine Riat, PharmD, BCSCP
Joanna Robinson, PharmD, MS, BCSCP
Gina Rosito, PharmD, BCSCP, APP
Charnae Ross, PharmD, MSHA, BCSCP
Elizabeth Schar, BCSCP
Andrew Schwierjohn, PharmD, BCSCP
Julie Selfridge, BSPharm, RPh, BCSCP
Jill Smitherman, BSPharm, BCSCP
Ileana C Soto, PharmD, BCSCP
Erin Stanley, PharmD, BCPS, BCSCP
Kathy Stone, PharmD, BCSCP
Elaine Strauss, PharmD, MS, BCSCP
Wai Tak Sung, PharmD, BCOP, BCSCP
Vincent Toto, PharmD, BCSCP
Shunsuke Toyoda, PharmD, BCPS, CPHQ, BCNSP, BCSCP
Dennis Trautman, PharmD, BCSCP
Meredith Vafeas, PharmD, BCSCP
Wai Tak Vince, PharmD, BCOP, BCSCP
Kara Watts, PharmD, BCSCP
Laurence Weiss, PharmD, BCPS, BCCCP, CPPS, BCSCP
Stacy Wong, PharmD, MSHS, BCSCP
Suha Zein, RPh, BCSCP

In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with an ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company. 

An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience. 

No one in control of the content of this activity has a relevant financial relationship (RFR) with an ineligible company. 

As required by the Standards of Integrity and Independence in Accredited Continuing Education, all relevant financial relationships have been mitigated prior to the CPE activity.

Activities can be completed in any order. Each activity consists of audio, video, and/or PDFs and evaluations. Learners must review all content and complete the evaluations to receive continuing pharmacy education credit for each activity. 

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.