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. The quality control and testing for CSPs in this chapter are appropriate and necessary. The content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which CSPs are prepared, stored, and dispensed. For the purposes of this chapter, CSPs include any of the following:. Preparations prepared according to the maufacturer’s labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination. Preparations containing nonsterile ingredients or employing nonsterile components and devices that must be sterilized before administration.
Usp 797 guidelines beyond use dating
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.
The two revised chapters are USP chapter , which regulates nonsterile compounding, and USP chapter , which regulates sterile.
For those of you have initiated changes to meet the updated standards for the compounding area, cleaning, staff training, and documentation, we encourage you to continue those efforts. For those of you who have not started, we strongly encourage you to proceed.
Update on USP Chapter
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.
Learn about BD compliance with USP General Chapter Pharmaceutical Compounding—Sterile Preparations.
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.
The chapter is organized to provide a foundation for the development and implementation of procedures for the safe preparation of low-risk, medium-risk, and high-risk level CSPs.
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.
The Beyond Use Dates BUDs allowed for Category 2 CSPs are dictated by the method of sterilization, whether or not a sterility test is performed, passed, and the storage temperature of the preparation.
In essence, a CSP that is an official USP/NF compounding monograph that non-sterile to sterile compounding should have its own chapter.
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Responsibility of usp general guidelines beyond use dating for immunotherapy.
Using a Pharmacy Glove Box for Compounding Sterile Preparations
Compounding personnel are responsible for ensuring that CSPs are accurately identified, measured, diluted, and mixed; and are correctly purified, sterilized, packaged, sealed, labeled, stored, dispensed, and distributed. These performance responsibilities include maintaining appropriate cleanliness conditions and providing labeling and supplementary instructions for the proper clinical administration of CSPs. All CSPs are prepared in a manner that maintains sterility and minimizes the introduction of particulate matter.
A written quality assurance procedure includes the following in-process checks that are applied, as is appropriate, to specific CSPs: accuracy and precision of measuring and weighing; the requirement for sterility; methods of sterilization and purification; safe limits and ranges for strength of ingredients, bacterial endotoxins, particulate matter, and pH; labeling accuracy and completeness; beyond-use date assignment; and packaging and storage requirements.
The dispenser shall, when appropriate and practicable, obtain and evaluate results of testing for identity, strength, purity, and sterility before a CSP is dispensed. Qualified licensed health care professionals who supervise compounding and dispensing of CSPs shall ensure that the following objectives are achieved.
Recognize USP chapters related to medication compounding. • Describe the scope and purpose of USP • Identify key factors in meeting or.
In sterile health care organizations, patients receive compounded sterile preparations CSPs that are stored for extended periods before use. It has long been recognized that extended storage of Date may allow for the growth of a pathological bioburden of microorganisms and that patient pdf and mortality can result from contaminated or incorrectly compounded sterile preparations. These guidelines are intended to help compounding personnel prepare CSPs of high quality and reduce the potential for harm to patients and consequences for compounding personnel.
The recommendations in these guidelines are based on published data, when available; on expert opinion and procedures used in similar industries; and on applicable regulations and standards. Many health care settings also use CSPs prepared by compounding pharmacies. Although these guidelines may be useful in assessing the quality of CSPs prepared by compounding pharmacies, more information on the topic of outsourcing sterile compounding services is available in the ASHP Guidelines on Outsourcing Sterile Compounding Services.
Finally, while these guidelines are generally applicable to all personnel who prepare CSPs and all guidelines in which CSPs are prepared, pharmacists and other health care professionals responsible for the preparation, selection, and use of CSPs are urged to use professional judgment in interpreting and applying these guidelines to their specific circumstances.
USP panel sends revised compounding standards back for expert review
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.
Such lifetime stability exposure is represented in the mean kinetic temperature calculation see Pharmaceutical Calculations in Prescription Compounding Drug hydrolysis rates increase exponentially with arithmetic temperature increase; thus, exposure of a beta-lactam antibiotic solution for one day at controlled room temperature see General Notices and Requirements will have an equivalent effect on the extent of hydrolysis of approximately 3 to 5 days in cold temperatures see General Notices and Requirements.
Personnel who prepare, dispense, and administer CSPs must store them strictly in accordance with the conditions stated on the label of ingredient products and finished CSPs.
The USP Compounding Expert Committee (CMP EC) has developed if compounding does not otherwise deviate from General Chapter
It is conducted at least annually thereafter for low- and medium-risk compounding and semiannually for high-risk compounding. This test is performed because direct touch contamination is the most likely source of introducing microorganisms into CSPs. The gloved fingertip test is performed immediately after the compounding employee completes the hand hygiene and garbing procedures. This test must be performed on three separate occasions with absolutely no CFU growth within the required incubation period.
Retesting is required annually for those compounders mixing low- and medium-risk preparations and semiannually for high-risk preparations. For the retesting, the gloved fingertip test is performed following the media fill. A highly structured and monitored environment is critical to ensure that the compounding professional works competently and safely to compound sterile preparations.
A Summary of Proposed Changes to USP 797
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.
compounding activities. USP Chapter – CSP Microbial Contamination Risk. Levels – Low-Risk Level CSPs with Hour or Less BUD -. “1.
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! Your submission has been counted. Not true. Checking IVs is more than confirming the ingredients listed on the label.
USP 797 Guidelines & Standards
standards described USP General Chapters. ▷ At the completion The USP is the National Standard, so compounding personnel must.
These revisions differ from the existing chapter in some significant ways — both structure and content. These changes, at least some of them, will undoubtedly require the pharmacy system and processes to undergo some significant adjustments. Although, many of the variations will be easier to implement. The changes are set to become official and take effect on December 1, Public comments on these changes are no longer heard, but we can still take a look at some of the most significant changes that will take effect in less than a year.
CSP Compounded Sterile Preparation classification has witnessed a significant overhaul with these proposed changes. The current system classifies CSP as either low, medium, or high risk. The rankings are based on the number and types of manipulations in the compounding, and the sterility of the starting ingredients. In the new system, on the other hand, the classification is entirely different.
The three risk system is eliminated, and a new classification system introduced. Sterile preparations are now placed in only two classes — category 1 or 2. The categories are based on the conditions in which the products are prepared. Category 1 CSPs are sterile preparations made in a segregated compounding area.
32 General Principles of Sterile Dosage Form Preparation
On June 1, , USP published revisions to. General Chapter for nonsterile compounding and General Chapter for.
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.