usp chapters 797 and 800 new and revised compounding

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USP 800 USP 797 also brings fundamental change to the medication compounding model The previous version of 797 outlined 3 categories of com-pounded sterile products: low- medium- and high-risk The proposed revision to 797 consolidates that into categories 1 and 2 This shift is likely to have the greatest impact on facilities that were formerly classified as low-risk compounders Compounding Requirements Pending USP Appeals In light of USP's September 23 2019 announcement regarding the appeals and postponement of the official dates of the revised Chapters 795 and 797 and the new Chapter 825 the California State Board of Pharmacy (board) wishes to ensure stakeholders have a clear

Regulatory Advisory: USP Chapters 797 and 800 New

The United States Pharmacopeia (USP) in June 2019 released several new and revised pharmacy compounding standards Specifically USP published the final revised version of general chapter 797 (Pharmaceutical Compounding of Sterile Preparations) to accompany the previous released general chapter 800 (Hazardous Drugs Handling in Healthcare Settings)

No Compounding under USP is much broader and includes many more situations than are subject to the FDA definition of compounding The FDA states that Compounding does not include mixing reconstituting or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product's manufacturer and other manufacturer directions consistent with

These USP compounding standards include USP General Chapter 797 Pharmaceutical Compounding - Sterile Preparations ("USP 797") Under USP 797 healthcare facilities may repackage SDVs into smaller doses each intended for use with one patient Among other things these standards currently require that: • The facility doing the repackaging must use qualified trained personnel to do

USP Chapters 797 and 800 New and Revised Compounding Keyword-suggest-tool In June 2019 the United States Pharmacopeia (USP) released several new and revised pharmacy compounding standards Specifically USP published revisions to general chapter 797 (Pharmaceutical Compounding and Sterile Preparations) and published a new general chapter 800 (Hazardous

Requirements for hazardous drug handling have been part of standards for pharmaceutical compounding of sterile preparation in USP 797 since 2004 They now appear separately in General Chapter 800 which was released in 2016 and becomes official on December 1 2019 1 Learn more about the chapters below

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The chapters published include: 795 Pharmaceutical Compounding ‒ Nonsterile Preparations 797 Pharmaceutical Compounding ‒ Sterile Preparations 825 Radiopharmaceuticals – Preparation Compounding Dispensing and Repackaging The new revised standards in addition to General Chapter 800 published in February 2016 go into effect Dec 1

Important Updates May 26 2020 – Update on stakeholder engagement activities related to beyond-use-date (BUD) provisions in General Chapters 795 797 March 12 2020 – Appeals Panel issues decisions on the Appeals to USP 795 797 and 825 (see FAQs on USP Compounding Appeals) September 23 2019 – Revised General Chapter 797 is postponed until further notice

compounding USP Compounding Chapters And State Jurisdiction Chapter 795 "Pharmaceutical Com- pounding—Nonsterile Preparations " was written in 2000 Chapter 797 "Pharmaceutical Compounding—Sterile Preparations" was fi rst written in 2004 and successfully revised in 2008 These chapters were an existing exhaustive attempt to document and detail best practices in compounding

Upcoming Changes to PCCA Formulas per the New USP 795 797 and 800 The new and revised USP chapters affect many aspects of compounding including formulas In this post PCCA Director of Formulation Development Melissa Merrell Rhoads PharmD details the updates we're planning to make to our formulas based on the new USP guidelines Pro tip: Look at the types of updates we're going to

There has been some confusion among stakeholders regarding the effective date for USP 800 On June 1 2019 USP published revisions to USP chapters 795 and 797 as well as a new chapter 825 Radiopharmaceuticals – Preparation Compounding Dispensing and Repackaging

Affiliated Chapters ASHHRA Store Convention to delay by at least 18 months the effective dates for its general chapter 797 pharmaceutical compounding and general chapter 800 hazardous drug handling in health care settings as well as proposed revisions to general chapter 797 "USP guidelines play a critical role in keeping our hospital staffs and the patients they care for safe

USP Chapters 797 and 800 New and Revised Compounding Keyword-suggest-tool In June 2019 the United States Pharmacopeia (USP) released several new and revised pharmacy compounding standards Specifically USP published revisions to general chapter 797 (Pharmaceutical Compounding and Sterile Preparations) and published a new general chapter 800 (Hazardous

USP 797 Cleaning Disinfecting Guidelines Recommended USP 797 Cleaning Disinfecting Decontaminating for Sterile Compounding Chapter outlines minimal cleaning and disinfecting requirements for the typical Sterile Compounding Pharmacy environment Our recommendations are based on a Class 7 Buffer Zone however facilities with Class 5

USP General Chapters 795 797 800 and 825

Therefore USP is postponing the official dates of the revised 795 and 797 and the new general chapter 825 until further notice In the interim the currently official chapters of 795 (last revised in 2014) and 797 (last revised in 2008) including the section

The USP Revised General Chapters 795 797 and 800 will go into effect December 1 2019 The revisions to USP 795 Nonsterile Compounding include expanded guidance for assigning beyond-use dates (BUD) for compounded nonsterile preparations (CNSP) in the absence of stability

In the interim the currently official chapters of 795 (last revised in 2014) and 797 (last revised in 2008) including the section Radiopharmaceuticals as CSPs will remain official In addition due to the pending appeals USP new general chapter 800 (Hazardous Drugs Handling in Healthcare Settings) will remain official

Chapter 800 applies to the handling of hazardous drugs during receipt storage compounding dispensing administration and disposal and affects all healthcare workers who perform these activities USP chapter 800 like chapters 795 and 797 will be an enforceable standard This means that state boards of pharmacy and other regulatory entities can require regulated facilities to comply with

Moreover this includes Chapters 797 sterile compounding 795 non-sterile compounding and 825 radiopharmaceuticals USP Announced 797 Delay USP is conducting an appeal analysis and postponing the official effective date We expect the revised implementation date to take place in the first quarter of 2020 In fact USP Chapter 800 on hazardous

USP Compounding General Chapters are nearing publication (June 1 2019) and implementation (December 1 2019): 795 Pharmaceutical Compounding – Nonsterile Preparations (revised chapter published June 2019) 797 Pharmaceutical Compounding – Sterile Preparations (revised chapter published June 2019) 825 Radiopharmaceuticals – Preparation Compounding Dispensing and Repackaging (new

Moreover this includes Chapters 797 sterile compounding 795 non-sterile compounding and 825 radiopharmaceuticals USP Announced 797 Delay USP is conducting an appeal analysis and postponing the official effective date We expect the revised implementation date to take place in the first quarter of 2020 In fact USP Chapter 800 on hazardous

On December 1 2019 four USP chapters became official: revised 795 on nonsterile compounding revised 797 on sterile compounding 800 as published on February 1 2016 and new 825 on compounding and handling radiopharmaceuticals Pharmacies need to prepare for compliance for all these chapters not only for patient safety but since state boards of pharmacy and accreditation

Purpose: The purpose of the study is to develop and implement a standardized sterile compounding training program in a multihospital system that incorporates sterile compounding best practice recommendations and ensures compliance with United States Pharmacopeia (USP) Chapters 797 and 800 standards Methods: Baseline sterile compounding training data were collected and reviewed for