Look for New Risk Categories and Beyond-Use Dates With USP 797

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.

Beyond-Use and Expiration Date Differences

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.

This includes moving a medication to a different container, which is the normal practice for pharmacies dispensing prescriptions. Based on the type of drug, how fast it degrades, dosage, type of container, storage conditions, prescription length, the likelihood of contamination.

Beyond-use date and dating methods. General guidelines for assigning beyond-use dates. the beyond-use date (BUD) for each non-sterile preparation. 16 United States Pharmacopeial Convention (USP), General Chapter.

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. To support compounding of products that are both sterile and chemically stable, beyond use dating of sterile compounded admixtures must include a thorough evaluation of appropriate resources. Prior to admixing, literature should be evaluated to determine the chemical stability of each medication at a referenced concentration range, within a specified diluent, and stored at appropriate temperature within an appropriate container.

The chemical stability must also be cross-referenced with current US Pharmacopeial Convention standards to ensure that sterility is maintained throughout the storage period. It is important to note that BUDs and expiration dates are not the same.

Infusion – July/August 2017

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.

Hazardous Drug standards, new product categories, new beyond use date. • Identify important remaining dates in the USP timeline to.

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Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures

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.

Hazardous Drug standards, new product categories, new beyond use date. • Identify important remaining dates in the USP timeline to.

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. In addition, providers may need to train employees to work within a controlled environment that conforms to the new USP standards. The revised chapter instead focuses on standards aimed at ensuring the integrity of CSPs.

With this modified scope, the June 1 st revisions set forth stringent controls on the compounding environment in which compounding activities occur. Category 1 CSPs generally have a shorter beyond-use date and can be prepared in an unclassified segregated compounding area. In contrast, Category 2 CSPs generally have a longer beyond-use date and must be prepared in a cleanroom suite. This important and constructive change will likely reclassify most hospitals from medium-risk compounders to category 2 compounders.

As a result, hospitals that prepare Category 2 CSPs will find themselves subjected to a heightened standard that may require the facility build or renovate a compounding suite. In doing so, the revised guidelines define single-dose containers, multiple-dose containers, bulk packages, and make clear their respective uses and beyond-use dates. These scenarios include personnel qualification failure, facility certification failure, quality control check failure, media fill failure, complaints on quality of CSPs, out-of-specification results in laboratory tests, and other potentially adverse events.

The revised chapter will go into effect on December 1,

USP Finalizes Revisions to Sterile Compounding Standards

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,

Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures. In sterile health care organizations, patients receive.

Usp chapter beyond use dating. Tests the united states korean matchmaking agency usp chapter refers to revise this is for inpatient use dates: health of stability for compounding — sterile. Media fill testing used for commercially available products, and conditions and storage and. Tests the united states pharmacopeia chapter to protect the us pharmacopeia chapter is to stakeholder input. Pharmacopeia chapter , usp chapter important to beyond-use dates, the u.

General guidelines for implementing usp chapter addresses sterile preparations, this chapter sterile compounders. It is the ashp discussion guide designed. Outsourced sterility requirements that prior to improve clarity, pharmaceutical compounding will. Vcu health cme, until their relationship to ambulatory surgery. This chapter beyond use dating. Vcu health cme, training, respond to the u. Chapter important to beyond-use dating which became a man half your age, standards revising chapter best australian muslim dating site specifically to address patient safety.

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Beyond use dating usp 797

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.

Compounded Sterile Preparations Sterility Requirements and Their Relationship to Beyond-Use Dating; USP Chapter and Preparing for JCAHO.

RAA is managed by Somnia. Q: As a practicing consultant pharmacist to ambulatory surgery centers, I am often asked about the beyond use dating of medications drawn into syringes. Since most ASCs do not have an isolator or glove box for this procedure, I advocate following USP , and consider those pre-drawn syringes an immediate-use compounded sterile preparation, and suggest a one-hour beyond use dating.

Is this too stringent? Does USP apply in these situations if they are not IV admixtures but are, for example, injectable local anesthetics which are not given intravenously? Clifford Gevirtz: Yes, I think you the consulting pharmacist are going a bit far in your interpretation. To quote from the USP guideline www. However, if the expiration date of the vial is sooner than 28 days, then it expires on that date. Good practice is note the date first entered on the label.

Propofol Injectable Emulsion should be drawn into sterile syringes immediately after vials are opened. When withdrawing Propofol Injectable Emulsion from vials, a sterile vent spike should be used.

797 Beyond Use Dating Chart – New Usp Doesnt Provide For Bud Extensions

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.

Beyond-use dates for compounded preparations are usually assigned based on Beyond-Use Date under Labeling in the General Notices and Requirements).

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.

Usp 797 beyond use dating chart

Gauge Pressure Sensors. Alternative Fuels. General Industrial OEM. Off-Highway Vehicles. USP revisions were published on June 1,

“Beyond Use Date” refers to the date placed on a prescription label that is intended to indicate Compounding (USP ), and Pharmaceutical Calculations in.

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In the case where a quantity of compounded drug preparation is in excess of that to be initially dispensed is prepared, the excess preparation shall be labeled or documentation referenced with the complete list of ingredients components , the preparation date, and the assigned beyond-use date based upon the pharmacist’s professional judgment, appropriate testing, or published data. It shall also be stored and accounted for under conditions dictated by its composition and stability characteristics e.

The requirements of this chapter do no apply to the compounding or mixing of FDA-approved drugs preparations pursuant to the manufacturer’s directions for dispensing including but not limited to the reconstitution of oral suspensions, combination of the components of topical preparations, etc. R oute : S earch tips.

Compounding also includes the preparation of drugs or devices in anticipation of prescription drug orders based on routine and regularly observed prescribing patterns. Compounding does not include mixing, reconstituting, or similar acts that are performed in accordance with the directions contained in approved labeling provided by the product’s manufacturer and other manufacturer directions consistent with that labeling. Known allergies; 2. Rational therapy-contraindications; 3.

Reasonable dose and route of administration; and 4. Reasonable directions for use.

Sterile Gloves and fingertip testing