While these standards provide an important reminder of the potential hazards of the chemical compounds used in medications, implementation of these standards will be complicated, and likely costly and time-consuming. We recommend organizations take immediate steps to assess their specific organizational readiness for compliance and develop a plan to make all necessary changes. Protecting health care personnel from harm resulting from occupational exposure to environmental hazards is a top priority for hospitals and health systems, and implementation of these standards will play a critical role in keeping providers and the patients they treat safe. Due to the wide-reaching impact of both chapters, leadership teams for hospitals and health systems will need to discuss the implications for meeting these new requirements. For example, those facilities with in-house compounding services may benefit from having their facility revisit the financial viability of in-house compounding services, which could require large-scale physical environment changes as a result of the new standards. For those facilities intending to continue in-house compounding, ensuring the development of a comprehensive approach for implementation and compliance is critical. In addition to the resources below, this advisory also includes a high-level checklist for hospital leadership to reference.
Usp 797 beyond use dating chart
Designing a Verification and Monitoring Program. Designing a CSP Facility. Designing a Quality Management System. Teaching Adult Learners. Validation Studies.
This month, we will focus on the changes that relate to Scope, Categorization, Beyond Use Dating, Personnel training and competency, and.
The chapter was to have become official on December 1, , but USP-NF announced on September 23, , that appeals were pending on provisions of the chapter regarding beyond-use dating, use of alternative technologies proven equivalent to those described in the chapter, and applicability of the chapter to veterinary practitioners. This notice and content of this program will be updated as events occur.
Compounding has been a fundamental aspect of providing medicines to patients for centuries. Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills.
Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines. Sterile preparations typically include injections, infusions, irrigations, ophthalmic, and inhalation preparations. Nonsterile preparations typically include oral suspensions, topical solutions, topical suspensions, topical gels, powders, ointments, creams, emulsions, and suppositories.
Usp 797 guidelines beyond use dating
General notices and closures. Name according to usp underwent new revisions as of july At mcguff compounding. An updated draft of providing medicines to meet current needs and requirements. New product categories of csps has been laid out in , First published june 1: compounding — sterile preparations.
Some of the changes in the proposed revision of USP are significant and will require major adjustments in pharmacy Beyond-Use-Dating Requirements.
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Usp 797 beyond use dating 2019
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.
USP General Chapter Update: A Guide to Sterile Compounding for chapter regarding beyond-use dating, use of alternative technologies proven.
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. Table 12 from the proposed chapter summarizes these requirements. As indicated in the table above, CSPs that are sterilized in their final container-closure systems terminal sterilization are permitted longer BUDs than CSPs that are sterilized via filtration.
The proposed chapter places a greater emphasis on the requirement for conducting investigations and implementing corrective actions. The proposed chapter, however, identifies a number of specific scenarios that require that a designated person conduct investigations, implement corrective actions, and document such activities, including:.
Three concepts that create a lot of confusion: stability, beyond-use date, expiration
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.
Several state boards of Pharmacy and the proposed USP state that stability indicating methods must be used to extend BUD’s. If an excipient has a.
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Preparing Personnel & Facilities for USP 797 and 800
Beyond-use Date: Establishment and Maintenance. This includes the issue of increased waste and the cost associated with it. Many facilities opined that this would cause irreparable harm to both the care of the patient and the fiscal well-being of the institution.
USP Chapter sets compounding risk levels based on the likelihood of medium or high—according to USP For case-by-case determination of risk level, it has been revised to keep up to date with drug development and evolution.
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Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures
While these standards provide an important reminder of the potential hazards of the chemical compounds used in medications, implementation of these standards will be complicated, and likely costly and time-consuming. We recommend organizations take immediate steps to assess their specific organizational readiness for compliance and develop a plan to make all necessary changes. Protecting health care personnel from harm resulting from occupational exposure to environmental hazards is a top priority for hospitals and health systems, and implementation of these standards will play a critical role in keeping providers and the patients they treat safe.
Breadcrumb Home Advocacy Advisory.
Due to pending appeals, the effective date of USP remains postponed until further notice and USP remains “informational” until.
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.
Four pillars are used to ensure this outcome: When things go wrong with sterile compounding, it is often the results of inadequate attention to policy and procedures. This includes monitoring and documenting daily temperature and pressure, equipment e. The date is determined from the date or time the preparation is compounded. Note that BUDs do not include the infusion time.