USP Finalizes Revisions to Sterile Compounding Standards
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. One of the first issues dealt with was the terminology. Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations. The pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs. The risk levels defined in the USP apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation. Upon subsequent storage and shipping of freshly finished CSPs, an increase in the risks of chemical degradation of ingredients, contamination from physical damage to packaging, and permeability of plastic and elastomeric packaging is expected.
Infusion – July/August 2017
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.
USP compliance inspections; State the proper approach to beyond use to USP compliance between cleanrooms and compounding aseptic.
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. When CSPs are known to have been exposed to temperatures warmer than the warmest labeled limit, but not exceeding 40 see General Notices and Requirements for more than 4 hours, such CSPs should be discarded, unless appropriate documentation or direct assay data confirms their continued stability.
Determining Beyond-Use Dates. When CSPs deviate from conditions in the approved labeling of manufactured products contained in CSPs, compounding personnel may consult the manufacturer of particular products for advice on assigning beyond-use dates based on chemical and physical stability parameters. Beyond-use dates for CSPs that are prepared strictly in accordance with manufacturers’ product labeling must be those specified in that labeling, or from appropriate literature sources or direct testing.
In addition, the pharmacist may refer to applicable publications to obtain relevant stability, compatibility, and degradation information regarding the drug or its congeners. When assigning a beyond-use date, pharmacists should consult and apply drug-specific and general stability documentation and literature where available, and they should consider the nature of drug and its degradation mechanism, the container in which it is packaged, the expected storage conditions, and the intended duration of therapy see Expiration Date and Beyond-Use Date under Labeling in the General Notices and Requirements.
Stability information must be carefully interpreted in relation to the actual compounded formulation and conditions for storage and use.
Using a Pharmacy Glove Box for Compounding Sterile Preparations
Alternative Date. General Industrial OEM. Off-Highway Vehicles. USP is the standard in place governing the sterile chart of compounded pharmaceuticals. USP covers the compounding of both hazardous and nonhazardous drugs with a focus on the compounding of sterile compounds and environments from contamination.
Sterile Compounding: USP Chapter Home Study, a knowledge-based course, has been approved for 20 contact hour (2 CEUs) of.
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. The following are sections in the chapter:.
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.
Sterile Compounding. Guidelines. 1 What is the difference between expiration date and. Beyond Use Dating (BUD)?. • What are.
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.
Deciphering USP 795 requirements
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.
Keywords: beyond use dating, BUD, stability, sterile compounding, USP. Beyond use date (BUD) is the date after which a compounded preparation shall.
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
Three concepts that create a lot of confusion: stability, beyond-use date, expiration
It says nothing, which it says nothing, rph, medication’s beyond-use dating of sterility. Chapters and storage and in previous ashp guidelines requires sufficient. Beyond use date of non-sterile and.
BEYOND USE DATING FOR STERILE COMPOUNDING. Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD.
Chapters and of the USP define the guidelines for stability testing and beyond-use dating of non-sterile and sterile products respectively. Information regarding beyond-use dating of sterile products is extensive and the reader is referred to USP Chapter www. If valid stability data is not available for a specific non-sterile preparation, the USP provides labeling guidelines based on the water content of the final product. The compounder must also consider other factors such as storage requirements, duration of use of the given product, the mechanism by which the drug is normally degraded, and the container in which the drug will be packaged.
The following USP recommendations apply to maximum beyond-use dates for preparations that are packaged in tight, light-resistant containers and stored at controlled room temperatures unless otherwise stated in the USP. Please refer to the complete USP statement on nonsterile beyond-use dates for additional information on this complex topic. If the solid preparation is formulated from USP products, a 6 month beyond-use date should be assigned. Non-aqueous liquid preparations made from USP products should bear a beyond-use date of 6 months.
Aqueous Water-Containing Formulations For aqueous water-containing liquid preparations prepared from solid ingredients a beyond-use date of 14 days is acceptable if the product is refrigerated 5 degrees Celsius. If all ingredients are liquids, the BUD is 30 days or the intended duration of therapy, whichever is less. Other Formulations For all non-solid and non liquid dosage forms, the beyond-use date is 30 days or duration of therapy, whichever is less.
References: Allen LV.
USP Issues a Decision on: 795, 797, and 825
A beyond-use date is a date placed on a prescription by a pharmacy for compounded medications they prepare, noting when that prescription should no longer be used. This date is determined by the pharmacy when they prepare a compound prescription based on different factors, including:. The beyond-use date is different than an expiration date of a drug.
Waive USP requirements related to the use of personal protective in that a PPE mask and gown may be reused by staff performing sterile compounding.
Each year, the questions take on common themes and was no exception. Some of the questions were repeated in each of the six minute roundtable slots. In the interest of sharing this experience with all those who could not get to this roundtable there were many other topics and with those colleagues unable to make it to the conference, I have summarized some of the main areas of discussion brought forth by participants. Nowobilski-Vasilios and I both thank the many participants at least 60 over the two days who joined this roundtable, and who took the time to write their questions out on note cards so we could produce this summary.
Here are the most common and key points of the discussion. Risk levels: How does one go about deciding what is appropriate? These three related questions came up more than once during the roundtable sessions at the NHIA Conference, so I will address them all with one rather long commentary and suggested approach. Policies and procedures may not always address every situation, requiring professional judgment.
Risk level determination is up to the individual pharmacist or pharmacy management’s “clinical exception process” when patient needs and practice standards seem to conflict. It can also be a valuable tool to support professional judgment decisions when patient care needs conflict with the overall guidelines for risk levels and BUD. Using this decision tree, let’s evaluate a realistic risk level for an elastomeric device prepared under full compliance with all other low-and medium-risk requirements and quality standards.
Assuming all are sterile source components, when the far-left column is all “yes,” the next general criteria are the number of components and the transfer methods.
Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures
The pharmacy shall make available special handling and packaging materials to maintain container integrity and drug stability of the prepared prescription orders, including antineoplastic or other hazardous sterile preparations, during handling and administration to the patient including:. The dispensed container for any compounded sterile preparation shall include labeling according to Maryland law and regulations, in addition to the following information that is required by federal law:.
A pharmacy compounding sterile infusion preparations shall provide a hour telephone number to allow its patients or other health care providers who may be administering its prescriptions to contact its pharmacists. Expiration or Beyond-Use Dating. In the absence of direct testing evidence, as detailed in the Stability Criteria and Beyond Use Dating section of USP Standards, the pharmacist shall use “beyond-use dating” as determined by USP Standards and reference materials as cited in Regulation.
Compounding personnel are responsible for ensuring that CSPs are limits for USP articles, or within 10% if not specified, until their beyond-use dates.
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Usp 797 beyond use dating chart
The most recent revisions implement new standards and revise existing ones based on recent scientific and technological developments. Significant changes include:. In light of the new standards, pharmacies should evaluate the physical capabilities of their compounding facilities to ensure they can meet the demands of the revised requirements.
With states increasingly requiring that licensees adhere to the USP standards, state Boards of Pharmacy are likely to adopt these or similar changes in the near future.
Will isolators continue to be a viable option for compounding pharmacies? The revision of USP may undermine the CAI exception to building a cleanroom.
This proposed chapter is still in the comment phase. No definite date on final revision or implementation. Here is a summary as it pertains to the MIC line of products. These units will now be defined as RABS restricted access barrier systems. RABS will fall into two categories:. An isolator is generally defined as a RABS with automated decontamination of the compounding chamber VHP with decontamination procedures, unidirectional airflow, and must maintain continuous positive pressure.
View Specifications. RABS will fall into two categories: Category 1 — With this scenario basically you are faced with minimal restrictions as if it were a CAI in the current chapter of. However, your BUD beyond use dating cannot exceed 12 hours at room temp or 24 hours in refrigerator. A clean room adds significant expense to build and to maintain, the clean room must have at least 30 air changes per hour plus added garbing, cleaning, and certification expenses.
An environment 8 room is very easy to achieve and far less expensive than an ISO 7 clean room Going the Isolator route in an environment 8 room is much less expensive, faster to implement, and provides a much higher level of sterility assurance 6 log kill rate versus the RABS solution in an ISO Class 7 clean room MIC Single View Specifications.