New! The Chapter <797> Answer Book, 2nd Edition

The Chapter <797> Answer Book, 2nd Edition provides expert guidance and practical advice to pharmacists, technicians and other health professionals involved in sterile compounding. The book follows a sterile product from receipt to preparation in a healthcare facility, addressing core elements of the revised USP chapter, to answer major questions healthcare systems may have when implementing the new standards.

Key discussion areas of the book include:

• Overview of the major changes between 2008 version of USP <797> and 2023 revision
• Guidelines, procedures, and compliance requirements for compounding sterile preparations
• Work practices to meet requirements and best practices
• Personnel training and core competencies, including suggested approaches for documenting competency
• Requirements for a cleanroom suite, segregated compounding areas, storage areas and areas used for compounding hazardous drugs
• Approach to assigning beyond-use dates

Categories:  Sterile,  Institutional

New! The Chapter <795> Answer Book, 2nd Edition

The Chapter <795> Answer Book, 2nd Edition provides a comprehensive overview and explanation of the requirements and recommendations of USP Chapter <795>, as well as practical advice and consideration in complying with the chapter. This book outlines quality of practice standards for nonsterile compounding by following a nonsterile product from receipt to preparation in a healthcare facility, addressing core elements of the revised USP Chapter <795>.

Key discussion areas of the book include:

• Overview of major changes between 2014 version of USP <795> and 2023 revision
• Facility design specification
• Personnel training and core competencies, including suggested approaches for documenting competency
• Work practices to meet requirements and ensure best practices
• Guidelines, procedures, and compliance requirements for compounding nonsterile preparations
• Compounding quality nonsterile preparations
• Beyond-use dating guidance and training

Categories:  Nonsterile,  Institutional

New! The Chapter <800> Answer Book, 2nd Edition

The Chapter <800> Answer Book, 2nd Edition expands on the first edition and outlines quality-of-practice standards for handling hazardous drugs (HDs) that promote the safety of patients and health care personnel who are exposed daily to HDs.

The Q&A approach of the resource provides a comprehensive overview and explanation of the requirements of USP <800> as well as:

• Hazardous Drug Risk Assessment Form
• Sample Form: Employee Acknowledgement of Hazardous Drug Risk
• List of Policies Required and Recommended in USP <800>
• List of new and updated questions since the first edition
• Sample “Action Plan” for Compliance with USP <800>

Categories:   Hazardous,  Institutional

New! Compounding Sterile Preparations, 5th Edition

From its inception, this reference has served as both a professional reference guide for pharmacists and pharmacy technicians and a student textbook covering the regulation, technique, and quality assurance of compounding sterile preparations. The new fifth edition reflects the latest advancements in the field, providing you with an indispensable resource to navigate the complex landscape of sterile compounding.

The essential sterile compounding reference every pharmacist needs includes:

• All chapters have been expanded to align with the most recent literature and the revised USP standards
• Newly included information on USP Chapter <825>
• Two new chapters covering; Allergenic Extracts, and Corrective and Preventative Action (CAPA) Plans
• Six expanded chapters to provide you with a comprehensive understanding of critical topics

Categories:  Sterile,  Institutional, Hazardous

Extemporaneous Formulations, 4th Edition

The go-to guide for treating patients who require medications that are not commercially available in appropriate forms or dosages for pediatric, geriatric, or special needs. Now even more comprehensive, the fourth edition provides the same evidence-based formulation in easy-to-follow "recipes".

Highlights of the new edition:

• Total of 312 formulations
• 129 new formulations- 47 new drugs and 36 new concentrations of drugs that were in the previous edition
• Content to reflect changes to USP Chapter <795>
• List of standardized concentrations for compounded oral liquids from ASHP’s Standardize 4 Safety initiative

Categories:  Sterile, Nonsterile, Hazardous,  Institutional

ASHP Injectable Drug Information 2023 Edition

The 2023 Edition of the industry’s go-to guide is newly updated with the latest information on compatibility, stability, storage, and preparation of parenteral drugs. Backed by quality, peer-reviewed published literature, ASHP Injectable Drug Information has been one of pharmacy’s most trusted resources for more than four decades. Authored under the editorial authority of AHFS Drug Information and published by ASHP, it is the global gold standard for IV compatibility and stability information.

• 180+ new references
• More than 400 monographs
• Over 24,000 total compatibility pairs
• Full list of the AHFS Pharmacologic-Therapeutic Classification system

Categories:  Sterile, Nonsterile, Hazardous,  Institutional

Extended Stability for Parenteral Drugs, 7th Edition

Get the support you need to safely extend dating of parenteral drugs beyond the usual 24-hour limit—minimizing waste, lowering medication costs, and enabling optimal patient administration schedules at alternate infusion sites. The new seventh edition features the inclusion of monographs expanded beyond home infusion to be inclusive of all clinical settings where parenteral drugs are stored or compounded.

New in this edition:

• All 196 stability monographs completely updated- including 37 new monographs
• Newly published stability information for parenteral nutrition, oncology, specialty, and COVID medications
• An extensive list of medications with temperature excursion data for intact vials
• Each monograph contains updated extended drug stability data specific to: container, drug manufacturer, concentration, and diluent
• Stability timeframes include standardized temperatures for room, refrigerated, frozen, post thaw, and body temperatures
• Inclusion of monographs expanded beyond home infusion to be inclusive of all clinical settings where parenteral drugs are stored or compounded

Categories:  Sterile, Nonsterile, Hazardous,  Institutional

Compounded Sterile Preparations Certificate for Pharmacists 

Refreshed with the latest USP <797> revisions, this certificate is designed as a resource for pharmacists working toward compliance and serves as curriculum for pharmacists preparing to take the Board of Pharmacy Specialties (BPS) Board Certified Sterile Compounding Pharmacist (BCSCP) exam.

• 27.5 CE Hours
• 15 modules
• Content released on May 31, 2023
• Completion required by May 31, 2026

Categories:  Sterile,  Institutional

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Practical Training in Compounding Sterile Preparations Certificate

Refreshed with the latest USP <797> revisions, this certificate is designed for pharmacy technicians and pharmacists who wish to build their knowledge and skills in compounding sterile preparations, and serves as a preparatory resource for the PTCB Certified Compounded Sterile Preparation Technician (CSPT®) certification exam.

• 22.25 CE Hours
• 13 modules
• Content released on May 31, 2023
• Completion required by May 31, 2026

Categories:  Sterile,  Institutional

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BCSCP Intensive Studies

Intensive Studies offer recertification credit through a high-level, interactive discussions on contemporary and emerging issues in compounding sterile preparations. The 2023 Online Intensive Studies package offers up to 6 contact hours of board recertification credit and includes the following topics:

• Challenges Across the Parenteral Nutrition Continuum: Transcription, Compounding, Dispensing, Administration
• Challenges Across the Parenteral Nutrition Continuum: Clinical Assessment, Intervention, and Monitoring
• Monthly Surface Sampling in the Cleanroom: Developing a Viable Plan
• Cleanroom Excursions: Don't Let Issues Compound
• Expires in Aug. 2024

Categories:  Sterile,  Institutional

BCSCP Specialty Selected Readings

The selected readings activity includes relevant, contemporary readings in the field of sterile compounding. The current package offers up to 4 contact hours of recertification credit and covers the following topics:

• Calcium Chloride Compatibility
• Technology-Assisted vs. Manual Compounding
• Centralized Insourcing
• Analysis of FDA Warning Letters Issued Against Compounding Pharmacies
• Expires Nov. 2024

Categories:  Sterile,  Institutional

Pharmacy Competency Assessment Center

Designed for pharmacist and pharmacy technician staff looking to stay current with changes in patient care and achieve high levels of competency in critical areas. Access to 130+ key competencies and skills assessments covering onboarding, technician skills, clinical topics, compounding guidelines, regulatory compliance, and much more. CE Hours: 100+

Popular Competencies:

• Vancomycin Dosing and Monitoring
• Antimicrobial Stewardship
• Anticoagulation Management
• Pain Management and Opioid Stewardship

Categories:  Sterile, Nonsterile, Hazardous,  Institutional

Compounding Competency Assessment Center

The Compounding Competency Assessment Center, formerly ASHP's Compounding Sterile Preparations Competency Library (CSPCL) is a comprehensive training center that institutions can use for staff training to comply with USP standards. More than 25 modules are categorized by nonsterile compounding, sterile compounding, and handling hazardous drugs allowing institutions to customize the training based upon the specific roles and responsibilities of the staff involved in compounding. CE Hours: 6+

Center Highlights:

• Includes updated content for USP <795>, USP <797>, and USP <800>
• 24 educational videos designed to boost learning in a visually engaging format
• Addresses all personnel training key-elements from the standards
• Modules are broken down into 15-minute segments to allow for completion during a busy work day
• Practical training developed by leading compounding experts, Patti Kienle and Kevin Hansen

Categories:  Sterile, Nonsterile, Hazardous,  Institutional

ASHP Consulting Services

With the USP <797> and <795> standards implementation date of November 1, 2023, many facilities will be making needed changes to ensure compliance. ASHP has been at the forefront of the USP revisions including submitting comments to USP on the proposed chapter updates and also participating in the USP Compounding Expert Committee meetings.  Our expert consultants can help with any sterile, nonsterile, or Chapter <800> needs your pharmacy may encounter, big or small.

Service offerings include:

• Sterile and Nonsterile Compounding Processes
• Gap assessment and planning
• Personnel
• Facilities and Engineering Controls
• Environmental Quality
• Protection
• Sterile Product Prescribing, Ordering, Receiving, Preparing, Administering, Transport, and Disposal