ASHP Member Compounding Resources
ASHP is the leading provider of sterile compounding, nonsterile compounding, and hazardous drugs resources. We are dedicated to providing timely and important information to our members and customers. Below you will find news, updates, guidance documents, and resources to help you and your staff prepare and implement the new compounding standards and best practices for handling hazardous drugs.
2023 USP Chapter <797> and <795> Revisions
ASHP has compiled the following resources and documents to help inform pharmacies on the USP <797> and <795> changes and as assets to be used during implementation of the new standards to ensure compliance prior to the November 1, 2023 deadline.
Policies, Best Practices, and Guidelines for Sterile Compounding
- USP on Compounding: A Guide for the Compounding Practitioner (Paid subscription required)
- ASHP Guidelines on Outsourcing Sterile Compounding Services
- ASHP Guidelines on Quality Assurance for Pharmacy Prepared Sterile Products
- ASHP Guidelines on Handling Hazardous Drugs
- ASHP Guidelines for Selecting Pharmaceutical Manufacturers and Suppliers
- ASHP Policy 1406: Federal and State Regulation of Compounding
- ASHP Guidelines on the Safe Use of Automated Compounding Devices for the Preparation of Parenteral Nutrition Admixtures
- ASHP Crosswalk of Guidances and Standards for Managing Single (SDV) and Multi-Dose Vials (MDV)
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Presentations and FAQs
- 2020 Q&A From ASHP Midyear Session: NIOSH, USP <800>, and EPA - Update on All Things Hazardous [PDF]
- 2015 Pharmaceutical Compounding Roundtable: How Can Outsourcing Facilities Meet Provider Needs? [PDF]
- Pharmacy Sterile Compounding Summit Summary of Proceedings [PDF]
- Compounding C-Suite Discussion Guide [PDF]
Tools for Sterile Compounding
- 2022 IV Workflow Management Systems (IVWMS) Implementation Checklist [PDF]
- 2021 The Pharmacist Guide to Assigning a Beyond Use Date to a Compounded Sterile or Nonsterile Preparation [PDF]
- 2021 Pharmacy Environmental Monitoring (EM) Implementation Toolkit [PDF]
- Outsourcing Sterile Products Preparation – ASHP Vendor Assessment Tool
USP Chapter <800> Assessment of Risk Toolkit
The United States Pharmacopeia (USP) released Chapter <800> Hazardous Drugs: Handling in Healthcare Settings in February 2016, and all facilities must be in compliance by December, 1 2019. To provide expert guidance and practical advice to pharmacists, technicians and other health professionals involved in the compounding and handling of hazardous drugs, ASHP has published the Chapter <800> Answer Book. In addition to these resources, a toolkit has been generated to assist with difficult to address or implement areas of USP Chapter <800>. As these toolkits for different areas are developed, they will be added to the resource center to help support pharmacists and other health care professionals in the implementation of USP Chapter <800>.
External Resources
- CDC Updates on Multistate Fungal Meningitis Outbreak Investigation
- Resources on Sterile Pharmacy Compounding from the Institute for Safe Medication Practices
- 2022 A 10-Step Blueprint for Managing Pharmaceutical Waste in US Healthcare Facilities [PDF]
- FDA links to State licensing authorities for license verification
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