Usp 797 beyond use dating chart
The proposed chapter was open to public comments until November 30, , and is expected to become official on December 1, The proposed revision differs from the current chapter in both its structure and its content. Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate. Here is a summary of some of the changes. The current chapter classifies compounded sterile preparations CSPs as low-, medium-, or high-risk level CSPs based on the sterility of the starting components and the number and types of compounding manipulations. The proposed chapter, however, eliminates this system of classifications and instead classifies sterile preparations as either a category 1 or category 2 CSP based on the conditions under which the product was prepared. The proposed chapter also changes the system for assigning beyond-use dates to CSPs. Instead of assigning a maximum allowable BUD based on the risk level of the preparation, the proposed chapter follows a new system for assigning BUDs based on several different factors related to achieving and maintaining sterility. The proposed guidelines allow a longer BUD for category 2 CSPs, especially those that are terminally sterilized, prepared using only sterile components, tested for sterility, or stored in refrigerated or frozen storage conditions.
A Summary of Proposed Changes to USP 797
This chapter provides procedures and requirements for compounding sterile preparations. Sterile compounding also requires cleaner facilities; specific training and testing of personnel in principles and practices of aseptic manipulations; air quality evaluation and maintenance; and sound knowledge of sterilization and solution stability principles and practices.
Aqueous injections for administration into the vascular and central nervous systems pose the greatest risk of harm to patients if there are issues of nonsterility and large errors in ingredients. The intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination nonsterility , excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in CSPs.
BEYOND USE DATING FOR STERILE COMPOUNDING. Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD.
One definition of sterile preparations is that they are anything that is not a nonsterile preparation. Although the statement may be true, it is not very helpful. A sterile preparation is one that does not have any microbial contamination. However, the only absolute method to prove that a preparation has no microbial contamination is to submit the entire preparation to a sterility test, thereby consuming it.
Sterility in a practical sense must provide a means to statistically ascertain that the preparation is not likely to carry enough of a microbial burden to cause patient harm. These guidelines were difficult to formulate and slow to be accepted. In a national survey conducted in , only 5. The first revision was available in , but between January 2, , and January 1, , the USP identified components that needed revision based on external stakeholders’ feedback and internal review.
32 General Principles of Sterile Dosage Form Preparation
Consequently, the Board amended rule —8. On September 23, USP announced that the effective date of the published revisions to USP Chapters and would be delayed, and would no longer become effective on December 1, USP is considering the following appeal topics for USP Chapters and 1 beyond-use date BUD provisions in both chapters, 2 removal of the alternative technology provision from USP Chapter , and 3 the applicability of both chapters to veterinary practitioners. In accordance with rules — On October 3, the Board convened and made the following decisions regarding enforcement:.
All pharmacies are expected to be fully compliant with USP Chapter beginning on December 1,
The general guidelines for assigning beyond use dates have been laid out in USP chapter and will be changed with the revision that is.
Featured Issue Featured Supplements. Subscribe Jobs. The USP Chapter was introduced in to provide regulation to pharmacies on quality standards for compounding sterile products CSPs. USP was subsequently introduced in , with an implementation date of December The purpose of this chapter is to describe practice and quality standards for handling hazardous drugs. Both USP and have the intent to promote safety and prevent patient harm by warranting sterility and accuracy of all CSPs.
Failure to comply with these recommendations and standards may result in the greatest risk of contamination, leading to potential patient harm. With the focus on sterile-compounding training in these USP chapters, sterile-compounding facilities are required to develop and implement training processes in order to ensure safe and adequate training of compounding personnel. A recent study in Hospital Pharmacy sought to develop and implement a standardized sterile-compounding training program in a multihospital system to incorporate sterile-compounding best practices and recommendations in compliance with USP Chapters and standards.
The multihospital system included 16 hospitals in eastern Wisconsin. Previously, each facility developed and implemented its own sterile-compounding training at each site, but this led to inconsistencies, with varying skills and knowledge levels across sites. In order to begin the standardization process, each facility identified site-specific super-users who attended a live, 1-day refresher course to review key concepts and aseptic techniques from USP Chapters and
Iowa Board of Pharmacy Enforcement of USP Chapters 795, 797, and 800
The chapter is not yet enforceable as it will become official in USP on December 1st, In the current and soon to be former Chapter sterile preparations were divided into Low, Medium, and High Risk Preparations. Category 1 CSPs do not require sterility testing while Category 2 CSPs may require a sterility test depending on the beyond use date assigned.
USP General Chapter Pharmaceutical Compounding – Sterile Preparations provides official standards for compounding quality sterile.
The system that most pharmacies use to assign a date beyond which it should no longer be used seems to be a point of confusion. We, myself included, historically have given day beyond use dating to our products without a second thought and no real scientific data to back up that claim. Seems the revised BUD guidance gives some credence to preservatives, sterilization methods, etc, but with a maximum BUD of 45 days. Email address:. That being said, the only TRUE way to extend dating is to do a stability study.
Polyethelyne Glycol degrades to Diethylene glycol which is a great solvent but basically starts shutting down biological systems liver kidney in humans. I try to take a common sense approach on all of this and come to logical conclusions. Does it really make sense for us to have this kind of dating without any REAL data behind it?
Does that actually make any sense? Is the probability of contamination lower? It only takes a single bacterial cell or fungi to get into 1 bottle of 1 compound to have very detrimental effect on a patient. Are these studies and tests expensive?
USP Pharmaceutical Compounding – Sterile Preparations for Compounding Professionals
Beyond-use dates for CSPs are rarely based on preparation-specific chemical assay results, which are used with the Arrhenius equation to determine expiration dates see General Notices and Requirements for manufactured products. The majority of CSPs are aqueous solutions in which hydrolysis of dissolved ingredients is the most common chemical degradation reaction. The extent of hydrolysis and other heat-catalyzed degradation reactions at any particular time point in the life of a CSP represents the thermodynamic sum of exposure temperatures and durations.
On June 1, , the revised USP chapters and on nonsterile and sterile compounding, respectively, were published. We all went.
Patricia C. Kienle, B. Webb Lecture Award. With over invited presentations and 50 publications, she has special interests in medication safety, compounding sterile preparations, accreditation, and regulatory issues. Do you have a designated person assigned to oversee compounding? Is that person a pharmacist or a technician? Thank you!
USP Finalizes Revisions to Sterile Compounding Standards
To support compounding of products that are sterile and chemically stable, beyond use dating of admixtures must include a thorough evaluation of appropriate resources. In most instances, resources provide documentation of a specific compounded admixture, at a specific concentration and storage parameters, that does not coincide with current operations or patient-specific requirements.
To meet the operational demands of a pharmacy, institutions employ a referenced guideline approach to guide decision making for safe sterile admixing. Often these guidelines are established and maintained at individual practicing locations with varying levels of detail and accuracy. In an effort to improve sterile compounding across a multihospital system, we developed and implemented beyond use dating guidelines to improve consistency and patient safety while meeting regulatory concerns.
Beyond use date BUD is the date after which a compounded preparation shall not be used, and it is set based on the date on which the preparation was compounded.
Dylan Herr, RA/QA Development Manager at Eagle, understands that the revised USP chapter for sterile compounding makes significant.
D uring the s, the practice of pharmacy began growing and evolving. In response to an increasing number of patient injuries due to medication delivery and sterile compounding, the industry began calling attention to safety. For the next 30 years, various pharmacy organizations published documents in an effort to establish a standard for the practice of compounding sterile preparations CSPs.
However, none of the documents were successful in providing a professional mandate and the handling of sterile product preparation by licensed pharmacies varied nationally through the s. In , The U. The law introduced limits on pharmacy compounding and attempted to protect patients from unnecessary use of compounded drugs.
USP panel sends revised compounding standards back for expert review
Eric S. Kastango, M. Guidelines for adopting and successfully implementing the requirements of the United States Pharmacopeia USP chapter for compounding sterile preparations are presented. The quality of a compounded sterile preparation CSP is directly related to the methods used to ensure that the CSP achieves the desired goal of purity, potency, and sterility.
Quality-Control Analytical Methods: USP Chapter Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating.
Chapter in Pharmaceutical Compounding — Sterile Preparations issued by the US Pharmacopeia describes the guidelines, procedures and compliance requirements for compounding sterile preparations and sets the standards that apply to all settings in which sterile preparations are compounded. The clean room must include an attached anteroom at the same air quality level ISO Class 8 for movement of personnel and materials in and out of the clean room. Building and operating a clean room can be an expensive and time-consuming proposition.
Fortunately, pharmacies can also comply with requirements using a barrier isolator, also known as a glovebox. A glovebox isolator or barrier isolator provides a physical barrier between pharmacy personnel and the compounding activity. Traditional clean benches and biosafety cabinets have an open front access area, where there is the possibility that disruptions in the room airflow or poor aseptic technique by the operator will introduce contaminants to the work area.