When does Chapter 795 of the USP change?
This article ws updated on January 14,2022. On September 1, 2021, the United States Pharmacopeia (USP) prepublished their latest proposed revisions to General Chapter 795, Pharmaceutical Compounding — Nonsterile Preparations. These proposed changes are not in effect now and have several steps to go before they will become official.
When will general chapters 797 and 797 be available?
USP published new versions of General Chapters <795> and <797> on June 1, 2019, which you can download for free here. The chapters are not enforceable until they become official within USP on December 1, 2019.
What is the latest version of USP 797?
First published in 2004, USP <797> has been revised once in 2008, and that is the current official version. The proposed revision, for the second time, was published in September 2021 and is still under review by the committee.
Is the general chapter <795> pharmaceutical compounding—nonsterile preparations being revised?
In accordance with the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that the Compounding Expert Committee intends to revise General Chapter <795> Pharmaceutical Compounding—Nonsterile Preparations. The revisions proposed are based on numerous stakeholder engagement activities and intended to improve clarity.
What is the current version of USP 795?
USP General Chapter <795> provides standards for compounding quality nonsterile preparations. Important Note: The currently official version of General Chapter <795> (last revised in 2014) remains official.
When was USP 797 last updated?
USP 797 2019 Revision Remanded On March 12, 2020, USP published that the 2019 revision of USP 797 was remanded as a result of a final appeal hearing.
What is the difference between USP Section 797 and USP Section 795?
Chapter 795 focuses on applying good compounding practices to the process of preparing nonsterile compounded formulations, while Chapter 797 provides procedures and requirements for compounding sterile preparations.
When did USP 797 go into effect?
On January 1, 2004, the first version of USP Chapter <797>, Pharmaceutical Compound- ing: Sterile Preparations became official,1 which details the procedures and requirements for compounding sterile preparations and sets standards that are applicable to all prac- tice settings in which sterile preparations are ...
When was USP 800 last updated?
December 1, 2019An Overview of USP 800 The U.S. Pharmacopeia Convention (USP) updated the General Chapter USP 800 on December 1, 2019 to set standards of handling hazardous drugs, specifically in clinical pharmacy settings.
What are the major differences between USP 795 797 and 800?
USP 797 provides standards for compounding of sterile preparations while USP 800 provides standards for the safe handling of HDs to minimize exposure risks. USP 797 promotes the protection of the sterility of the drug, while USP 800 is focused on the safety of personnel who come in contact with the HDs.
Is USP 795 finalized?
The currently official <795>, last revised in 2014, remains official. On June 1, 2019, USP published revisions to General Chapter <795> for nonsterile compounding and General Chapter <797> for sterile compounding, as well as a new General Chapter <825> for radiopharmaceuticals.
When was USP 795 established?
2000Since it was originally issued in 2000 and most recently updated in 2011, USP 795 has governed non-sterile compounding of both hazardous and nonhazardous drugs.
Does USP 800 replace USP 797?
Difference Between USP 797 and USP 800 Cleanrooms USP 800 expands controls for the protection of workers and environments against hazardous drug compounds. In contrast to USP 797, which only remedies sterile compounding activities, USP 800 takes a 360-degree approach for processing hazardous drugs.
When did USP 800 go into effect?
December 1, 2019Chapter 800 became official on December 1, 2019; however, as noted above, it remains informational and not compendially applicable until the revisions to Chapters 795 and 797 are fully resolved. The standards within Chapter 800 address the following matters: Identification of HDs.
Did USP 797 evolve from 1206?
On January 1, 2004, USP chapter 797, Pharmaceutical Compounding—Sterile Preparations,15 became official, re- placing USP chapter 1206, Sterile Drug Products for Home Use. 20 The change from a chapter numbered above 1000 to a chapter below 1000 marked a change from an advisory stan- dard to an enforceable one.
Is USP 797 mandatory?
The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (eg, a state Board of Pharmacy, state Board of Medicine, or Occupational Safety department) chooses to make ...
Has USP 800 been implemented?
On December 1, 2019, USP's standard on the safe handling of hazardous drugs, General Chapter <800>, became official.
Is USP 797 mandatory?
The US Pharmacopeia (USP) chapters on Sterile Compounding (USP 797) and Safe Handling of Hazardous Drugs (USP 800) are only legally enforceable when an entity with authority over the medical practice or hospital (eg, a state Board of Pharmacy, state Board of Medicine, or Occupational Safety department) chooses to make ...
Is USP 797 enforceable?
USP 797 is considered a standard of practice and as such can be adopted and enforced by the FDA, local state boards of pharmacy, and accreditation organizations.
What is the difference in BUDs between Category I and Category II?
Category 1: CSPs are typically prepared in an unclassified Segregated Compounding Area (SCA) and have shorter BUDs. Category 2: CSPs are prepared in a cleanroom suite and have longer BUDs.
Training
In the proposed changes to USP 795, there are some themes that stand out when compared to the current version of the chapter. There is a significant expansion and emphasis on training, including knowledge in and demonstration of core competencies.
Cleaning and Sanitizing
Table 1 of the proposed changes to USP 795 also defines minimum schedules for cleaning and sanitizing nonsterile compounding areas. While this chapter is addressing nonsterile compounding, it is also important to consider that USP has multiple chapters on microbial limits for nonsterile preparations, including USP 61 and USP 62.
Beyond-Use Dates
Beyond-use dates (BUDs) are always of significant interest to compounders because they affect patient care opportunities. In considering BUDs, it is common to consider the chemical and physical properties of the active pharmaceutical ingredient (API) in the formulation.
The Designated Person (s)
Responsibility for the performance of the compounding operation is another new theme in the proposed revisions to Chapter 795.
What Comes Next
After the March 17, 2022, comment deadline, the USP Compounding Expert Committee will have to review the comments and determine if further changes to the proposed chapter will be made.
What are the SOPs for CNSPs?
SOPs must describe packaging of CNSPs. Personnel should select and use packaging materials that will maintain the physicaland chemical integrity and stability of the CNSPs. Packaging materials must protect CNSPs from damage, leakage,contamination, and degradation, while simultaneously protecting personnel from exposure.
What is a CNSP inspection?
At the completion of compounding and before release and dispensing, the CNSP must be visually inspected to determinewhether the physical appearance is as expected. Inspections must also confirm that the CNSP and its labeling match theCompounding Record and the prescription or medication order. Some CNSPs, as noted in their Master Formulation Record,also must be visually checked for certain characteristics (e.g., emulsions must be checked for phase separation). All checks andinspections, and if required, any other tests necessary to ensure the quality of the CNSP must be detailed in the facility’s MasterFormulation Records. Checks and inspections must be documented. Additional quality assurance (QA) and quality controlactivities are described in 12. Quality Assurance and Quality Control. Pre-release inspection also must include a visual inspectionof container–closure integrity (e.g., checking for leakage, cracks in the container, or improper seals). CNSPs with observeddefects must be immediately discarded, or marked and segregated from acceptable units in a manner that prevents them frombeing released or dispensed.
When will the USP release new chapters?
USP published new versions of General Chapters <795> and <797> on June 1, 2019, which you can download for free here. The chapters are not enforceable until they become official within USP on December 1, 2019.
What is the difference between "should" and "must" in USP?
Reading USP chapters requires paying special attention to the words “should,” “shall” and “must.” “Shall” and “must” are requirements for compliance with the chapter, while “should” is a recommendation. A number of topics are prescriptive in telling you how to comply, but there are aspects of the chapter that are left up to you to determine ...
What is the effect of excipients on the critical quality attributes of a drug product?
However, the effects of excipient properties on the critical quality attributes (CQAs) of a drug product are unique for each formulation and process and may depend on properties of excipients that are not evaluated in USP or NF monographs.” 4
How long does aqueous meds last?
Preserved aqueous dosage forms: 35 days at control led room temperature or in refrigerator. Nonaqueous dosage forms: 90 days at controlled room temperature or in refrigerator. Solid dosage forms: 180 days at controlled room temperature or in refrigerator.
Is aqueous preparation divided by route of administration?
In the current <795>, aqueous preparations are divided between oral and topical. In the new system, aqueous preparations are no longer divided by route of administration, but rather by whether or not they have a preservative. Refrigeration is key in unpreserved preparations to prevent or reduce microbial growth.
Do you need a stability study for USP?
While USP formulation monographs exist for some medications, many are not addressed. If there is not a USP formulation monograph, you will need a stability study with a stability-indicating assay that includes the specific container-closure used for the formulation.
