Compounded Sterile Preparations Certificate for Pharmacists

   
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 professional certificate is intended for pharmacists who are responsible for sterile compounding operations and/or who are preparing for the BPS® Board Certified Sterile Compounding Pharmacist (BCSCP) exam.

Overview of Standards, Guidelines, Regulations, and Best Practices
ACPE: 0204-0000-26-741-H07-P
Application-based
2.25 contact hours 

Learning Objectives:

• List the standards of practice that apply to sterile compounding in the United States.
• Identify resources with best practices to ensure sterile compounding safety.
• Differentiate between sterile compounding standards, guidelines, and best practices.
• Describe the role of the United States Pharmacopeia (USP) in sterile compounding.
• Explain federal regulations that influence sterile compounding practice including, but not limited to, the Drug Quality and Security Act (including the Drug Supply Chain Security Act and the Compounding Quality Act), the Resource Conservation and Recovery Act (RCRA), and those enforced by the Occupational Safety and Health Administration (OSHA).
• Compare 503A vs. 503B compounding.
• Summarize the roles of the Food and Drug Administration (FDA) and the states, particularly state boards of pharmacy, related to the regulation of sterile compounding.
• Compare United States Pharmacopeia (USP) <797> standards to noncompliance findings from Food and Drug Administration (FDA) Form 483 inspection reports.
• Analyze corrective and preventive action plans.
• Identify the key responsibilities of compounding designated persons, including scenarios that designated persons are expected to address.
• Explain the role of the compounder in assuring the safety of compounded sterile preparations. 

Pharmacy Calculations for Pharmacists
ACPE: 0204-0000-26-742-H07-P
Application-based
2.25 contact hours 

Learning Objectives:

• 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. 

Compounding Facilities and Engineering Controls
ACPE: 0204-0000-26-743-H07-P
Application-based
2.25 contact hours 

Learning Objectives:

• Describe the primary engineering controls used in sterile compounding.
• Explain the principles of generating a laminar airflow environment in the primary engineering control.
• Identify the secondary engineering control elements in a clean room environment.
• Differentiate between a segregated compounding area and a cleanroom.
• Discuss essential design elements for a sterile compounding facility.
• Analyze the advantages and disadvantages of available finish materials.
• Describe 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. 

Cleanroom Personnel Behaviors and Competencies
ACPE: 0204-0000-26-744-H07-P
Application-based
1.5 contact hours 

Learning Objectives:

• Describe sources of contamination in the cleanroom and work behaviors required to prevent the introduction of contaminants into the cleanroom environment.
• Evaluate appropriate hand hygiene technique.
• Describe donning and doffing procedures for personal protective equipment used in cleanroons, including garb and glove requirements and procedures for non-hazardous and hazardous compounding.
• List core competencies that must be mastered by 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. 

Compounding Materials, Equipment, and Resources
ACPE: 0204-0000-26-745-H07-P
Application-based
1.75 contact hours 

Learning Objectives:

• Identify supplies used in sterile compounding processes.
• Differentiate the following:
  • Critical sites vs. non-critical sites on syringes, needles, vials, and bags; and
  • Single-dose vs. multiple-dose vials.
• Differentiate between the types of automated compounder pumps used in compounding sterile preparations.
• Choose the appropriate compounding equipment needed for various situations.
• Interpret several types of patient medication labels.
• Create a master formulation record and a compounding record.
• Use tertiary resources to find necessary drug information. 

Stability and Sterility: Assigning Beyond-Use Dates
ACPE: 0204-0000-26-746-H07-P
Application-based
2.75 contact hours 

Learning Objectives:

• List factors that influence beyond-use date assignments for compounded sterile preparations.
• Describe physical and chemical compatibility criteria for components.
• Apply USP <797> risk categories to assigning a proper beyond-use date for compounded sterile preparations.
• Recommend a beyond-use date for a final compounded sterile preparation using evidence-based information.
• 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. 

Aseptic Techniques for Compounding Sterile Preparations
ACPE: 0204-0000-26-747-H07-P
Application-based
3.25 contact hours 

Learning Objectives:

• Compare airflow in the primary and secondary engineering controls.
• Describe the airflow patterns in a laminar airflow workbench (LAFW), compounding aseptic isolator (CAI), and a biological safety cabinet (BSC).
• Summarize how dynamic airflow visualization studies can be used to determine the location of the direct compounding area (DCA) in a particular primary engineering control (PEC).
• Visualize how first air may be disrupted when compounding a compounded sterile preparation (CSP) in horizontal and vertical airflows.
• Identify the critical sites on compounding components.
• Compare the appropriate placement of materials and components in horizontal and vertical airflow in primary engineering controls.
• Describe the workflow steps when compounding a sterile preparation in a laminar airflow workbench, compounding aseptic isolator, and biological safety cabinet.
• Describe techniques for reconstituting sterile powders including, but not limited to, strategies for preventing coring of vial stoppers.
• Contrast common preservative-free diluents with bacteriostatic diluents.
• Explain how powder displacement volume affects the volume of drug in solution following reconstitution.
• Recommend safe compounding techniques that reduce compounding-related health risks including sharps injuries, exposure to hazardous drugs, and repetitive strain injuries.
• Describe how to address a hazardous drug spill in a containment primary engineering control (C-PEC). 

Sterile Preparations: Dosage Forms, Administration, and Special Compounding Considerations
ACPE: 0204-0000-26-748-H07-P
Application-based
3.25 contact hours 

Learning Objectives:

• 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.
• Explain basic concepts related to parenteral nutrition including the following:
  • Indications
  • Ordering, verification, transcription, and labeling
  • Macro- and micronutrients, and other additives
  • Methods of, and considerations for, compounding and administration
• Assess automated compounding devices for safety, interoperability, and overall functionality.
• 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 situations when sterile filtration and/or preservative-free ingredients must be utilized when compounding preparations for central nervous system administration.
• Describe situations when additional testing and special techniques must be utilized when compounding ophthalmic preparations.
• Describe personnel qualifications, facility requirements, and compounding processes for; and designated person responsibilities related to; preparation of allergenic prescription sets. 

Compounding Nonsterile-to-Sterile Preparations
ACPE: 0204-0000-26-749-H07-P
Application-based
2 contact hours 

Learning Objectives:

• Explain the following regulatory requirements of USP <797> standards as they apply to nonsterile-to-sterile compounding including:
  • Section 503A of the Food, Drug, and Cosmetic Act regarding compounding with bulk active pharmaceutical ingredients;
  • Application of USP <797> standards to nonsterile-to-sterile compounding;
  • Relationship between USP <797> standards, and regulatory and accreditation requirements; and
  • Difference between minimum compounding standards and best practices as they relate to nonsterile-to-sterile compounding.
• Describe requirements for installation, calibration, and maintenance of equipment used in non-sterile-to-sterile compounding, including validation processes for sterilization equipment.
• Compare terminal and aseptic sterilization.
• Explain best practice quality assurance standards for nonsterile-to-sterile compounding including, but not limited to, sterility testing requirements as outlined in USP <71>.
• Calculate endotoxin limits for final nonsterile-to-sterile products. 

Managing and Maintaining the Cleanroom Environment
ACPE: 0204-0000-26-750-H07-P
Application-based
1.75 contact hours 

Learning Objectives:

• Design elements in sterile compounding areas that lead to easily cleanable conditions.
• Recognize insanitary conditions that can impact high quality aseptic compounding practices.
• 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.
• Identify key elements of an effective environmental monitoring program.
• Recommend appropriate action plans based on personnel and environmental monitoring data. 

Hazardous Drugs
ACPE: 0204-0000-26-751-H07-P
Application-based
2 contact hours 

Learning Objectives:

• Define the scope of USP <800>.
• Describe the key requirements of USP <800> Hazardous Drugs – Handling in Healthcare Settings, including limiting risk to personnel, facility design, and safe work practices.
• Categorize the handling of hazardous drugs in one's organization to determine their eligibility for inclusion in your assessment of risk.
• Create an acknowledgement of risk document.
• Evaluate an organization's current compliance with USP <800>.
• Evaluate an organization's storage and compounding areas.
• Identify the three types of containment primary engineering controls used for compounding hazardous drugs, and the two types of containment secondary engineering controls used for storing and compounding hazardous drugs.
• Identify the key elements that must be addressed during training of personnel who handle hazardous drugs (HDs) including, but not limited to, HD compounders.
• Differentiate personal protective equipment used in HD compounding from that used in non-HD compounding.
• Describe hazardous drug work practices from receiving through compounding.
• Describe hazardous drug (HD) work practices from dispensing through disposal, including a procedure for handling HD spills.
• Apply appropriate strategies for ongoing evaluation of hazardous work practices, competency of personnel, facility monitoring, and assessment of risk. 

Managing Compounded Sterile Preparations until Final Check or Disposal
ACPE: 0204-0000-26-752-H07-P
Application-based
2 contact hours 

Learning Objectives:

• Describe methods for verifying source ingredients.
• Explain cold chain requirements for refrigerated and frozen products.
• Explain USP <797> requirements and best practices for introducing materials into a controlled environment.
• Compare cleanroom storage options for hazardous drugs, high-risk medications, controlled substances, investigational drugs, non-sterile bulk ingredients, and bulk chemicals.
• Explain legal requirements and best practices for labeling sterile preparations.
• Apply FDA repackaging guidance to sterile preparations.
• List the pieces of information that should be found in a master formulation record and a compounding record.
• Explain the verification methods for compounded sterile preparations including in-process and final checks, and their advantages and disadvantages.
• Explain the requirements and best practices related to documentation of controlled substances used in sterile compounding.
• Describe requirements and best practices for storage and transport of compounded sterile preparations within and outside of the facility.
• Explain waste practices for supplies and medications used in sterile compounding processes. 

Patient Care
ACPE: 0204-0000-26-753-H07-P
Application-based
1 contact hour 

Learning Objectives:

• Explain patient- and preparation-specific factors that impact outcomes for patients receiving compounded sterile preparations.
• Compare methods of medication administration and delivery systems.
• Explain patient-specific risk factors for adverse drug events.
• Recommend approaches to treat or prevent adverse drug events.
• Analyze adverse drug events utilizing appropriate investigative inquiry and reporting systems.
• Describe the steps of a root cause analysis. 

Quality Management
ACPE: 0204-0000-26-754-H07-P
Application-based
2 contact hours 

Learning Objectives:

• Apply the four pillars of quality management to sterile compounding operations.
• Explain the role of designated persons related to, and best practices for development of, sterile compounding policies and procedures.
• Identify the core competencies that must be addressed in a training program for sterile compounding personnel.
• Summarize the requirements for evaluating personnel involved in compounding each category of sterile preparations (1, 2, and 3), including the frequency of evaluations.
• Explain the role of environmental and personnel monitoring data in a sterile compounding quality management system including, but not limited to, the following:
  • Interpreting monitoring report data;
  • Trending data;
  • Responding to concerning data results, including development of corrective and preventative action plans; and
  • Documentation and maintenance of data.
• Explain results found in certification reports of sterile compounding primary and secondary engineering controls including:
  • Pressure differentials;
  • Integrity of high-efficiency particulate air (HEPA) filters;
  • Air changes per hour (ACPH);
  • Dynamic airflow smoke pattern testing; and
  • Total particle counts.
• Describe the purpose of, and elements of information included in, master formulation records, compounding records, and standard operating procedures.
• Identify requirements that must be completed prior to the release of compounded sterile preparations (CSPs) for dispensing and administration to patients.
• Explain the factors that should be taken into consideration when deciding among insourcing, outsourcing, and self-sourcing CSPs.

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. 

The following persons in control of this activity’s content have relevant financial relationships:

• Lynda Kiliany: Abbvie, Pfizer, Abbott, Johnson & Johnson; equity shareholder 

All other persons in control of content do not have any relevant financial relationships with an ineligible company. 

As defined by the Standards of Integrity and Independence in Accredited Continuing Education definition of ineligible company. All relevant financial relationships have been mitigated prior to the CE activity.

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. 

Important Note – ACPE 60 Day Deadline: 

Per ACPE requirements, CPE credit must be claimed within 60 days of being earned. To verify that you have completed the required steps and to ensure your credits have been reported to CPE Monitor, check your NABP profile account to validate that your credits were transferred successfully before the ACPE 60-day deadline. After the 60-day deadline, ASHP will no longer be able to award credit for this activity.

The ASHP PROFESSIONAL CERTIFICATES℠ educational product line contains learning activities that are ACPE-accredited knowledge and application-based continuing education. This is not an ACPE Certificate Program. Upon successful completion of the activities, the learner will be able to download an ASHP Professional Certificate.