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.
Determining Drug Product Shelf Life
To ensure that compounded preparations are made and used safely, published data and suitable testing must be considered. Navigate our complete database of Beyond-Use Dates BUDs and ensure you are equipped with the accurate information for your products. Through strategic partnerships with renowned institutions, we offer a wide variety of stability data tested in various dispensers and container closures , using both forms of APIs : pure powder and commercial drugs.
(g) Creating master formulation records, with documented pharmacist approval; (h) Creating compounding records; (i) Establishing beyond-use dates (BUDs);.
Pharmacies Compounding Sterile Preparations. Pharmacies compounding sterile preparations, prepackaging pharmaceutical products, and distributing those products shall comply with all requirements for their specific license classification and this section. In addition to the definitions for specific license classifications, the following words and terms, when used in this section, shall have the following meanings, unless the context clearly indicates otherwise.
For example: A ISO Class 5 formerly Class is an atmospheric environment that contains less than 3, particles 0. It is also a transition area that: A provides assurance that pressure relationships are constantly maintained so that air flows from clean to dirty areas; and B reduces the need for the heating, ventilating and air conditioning HVAC control system to respond to large disturbances.
The beyond-use date is determined from the date or time the preparation is compounded. Activities that occur in this area include the preparation and staging of components and supplies used when compounding sterile preparations. Microorganisms in the environment are monitored so that a microbial level for air, surface, and personnel gear are not exceeded for a specified cleanliness class.
It is designed to maintain an aseptic compounding environment within the isolator throughout the compounding and material transfer processes. Air exchange into the isolator from the surrounding environment shall not occur unless it has first passed through a microbial retentive filter HEPA minimum.
Air exchange with the surrounding environment should not occur unless the air is first passed through a microbial retentive filter HEPA minimum system capable of containing airborne concentrations of the physical size and state of the drug being compounded. Where volatile hazardous drugs are prepared, the exhaust air from the isolator should be appropriately removed by properly designed building ventilation. Risk of microbial particulate contamination of the critical site increases with the size of the openings and exposure time.
Formula Beyond-Use Date (BUD) Databanks
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.
Beyond-use dating is a matter for professional judgment, based on guidance in USP 27, Pharmaceutical Compounding: Nonsterile.
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.
Note: certain features of this site have been disabled for the general public to prevent digital piracy. You agree not to use any web crawler, scraper, or other robot or automated program or device to obtain data from the website. You agree that you will not sell or license anything that you download, print, or copy from this website. 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.
Today’s compounding pharmacy practice includes sterile preparations and pH, beyond-use dates (BUD) based on stability studies, and assays (for most.
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.
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Compounding is an integral part of pharmacy practice and is essential to the provision of health care. The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounder’s ability in the compounding facility to extemporaneously compound preparations that are of acceptable strength, quality, and purity.
The pharmacist’s responsibilities in compounding drug preparations are to dispense the finished preparation in accordance with a prescription or a prescriber’s order or intent and to dispense those preparations in compliance with the requirements established by the Boards of Pharmacy and other regulatory agencies. Compounders must be familiar with statutes and regulations that govern compounding because these requirements vary from state to state.
The compounder is responsible for compounding preparations of acceptable strength, quality, and purity with appropriate packaging and labeling in accordance with good compounding practices see Good Compounding Practices , official standards, and relevant scientific data and information. Compounders engaging in compounding should have to continually expand their compounding knowledge by participating in seminars, studying appropriate literature, and consulting colleagues.
Registered Pharmacist / Intern / Tech IMMEDIATE USE COMPOUNDING Beyond-use date does not exceed 28 days for multiple-dose containers after initial.
Occasionally I get asked why a compounded product does not have an expiration date as long as that of a manufactured product. Most expiration dates are expressed in years for commercial products. BUDs are generally days or month long and are determined after careful interpretation of appropriate information sources for the same or similar formulations. The BUDs, for products produced by those pharmacies that do not test drug strength or stability, are strictly limited to USP guidelines resulting in BUDs of as little as 24 hours to a maximum of 45 days.
When pharmacies send their products to a lab for strength and stability testing, like JCB does, BUDs as long as 6 months can be assigned. So, while a compounded product will have a BUD based on sound clinical information and testing, it will not have a BUD equal to that of a manufactured product. Ensure confidence with your staff and patients by performing the necessary due diligence to make sure that your sterile compounding pharmacy uses sound procedures to determine Beyond Use Dates.
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Preparing Personnel & Facilities for USP 797 and 800
Extending pharmacy beyond-use dates can be costly and time consuming. There are a number of factors to consider, including finding a quality trusted lab partner. Omnicell is taking the guesswork out of the sterile compounding IV beyond-use dating process and making it easier for our customers with the Formulary Tool Kit.
Phar Urgent use compounded sterile preparations. Phar Beyond use dating. Phar (8) (8) “Component” means any active pharmaceutical ingredient, or added substances used in the compounding of a drug preparation.
I Agree Learn More. With the current high demand for compounded medication, are there interim guidelines an organization can follow for sterile compounding while remaining compliant with The Joint Commission medication management requirements? Any examples are for illustrative purposes only. Organizations may utilize these guidelines and remain in compliance with Joint Commission standards until the state of emergency has been lifted at the regional, state or national level for the organization.
Beyond-Use and Expiration Date Differences
The compounding of medications is a fundamental part of pharmacy practice. All compounding personnel, mainly pharmacists and pharmacy technicians, are responsible for compounding and dispensing sterile products and preparations of correct ingredient identity, purity freedom from physical contaminants, such as precipitates, 1 and chemical contaminants , strength including stability 2 and compatibility , and sterility and for dispensing them in appropriate containers that are labeled accurately and appropriately for the end user.
In contemporary 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 CSPs may allow for the growth of a pathological bioburden of microorganisms 3 and that patient morbidity and mortality can result from contaminated or incorrectly compounded sterile preparations.
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To meet the operational demands of a pharmacy, institutions employ a Keywords: beyond use dating, BUD, stability, sterile compounding, USP.
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.
Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures
Q I have a patient with encephalopathy and a tracheotomy who is unable to swallow tablets. A Glycopyrrolate is soluble It is available as a shelf-stable aqueous injection. The drug is shelf-stable at pH below 6. This information supports the conclusion that an extemporaneously compounded oral solution could be shelf-stable. Beyond-use dating is a matter for professional judgment, based on guidance in USP 27 , Pharmaceutical Compounding: Nonsterile Preparations.
The pharmacist’s responsibilities in compounding drug preparations are to The beyond-use date is the date after which a compounded preparation is not to be.
Q: What is compounding? A: Simply put, compounding is any manipulation of a drug beyond that stipulated on the drug label. Veterinary drugs should only be compounded based on a licensed veterinarian’s prescription, and to meet the medical needs of a specific patient. Manipulation might include mixing, diluting, concentrating, flavoring, or changing a drug’s dosage form.
Some states allow veterinarians to prescribe compounds for administration to patients in the practice; but depending on state rules, it is typically not legal to dispense medications previously compounded by a pharmacy to leave the veterinary practice with clients, so state rules should be reviewed and followed.
Examples of compounding include:. A: It’s regulated by both the U. The FDA says it generally defers day-to-day regulation of compounding by veterinarians and pharmacists to state authorities. The state boards of pharmacy oversee pharmacy practices within the states, while the state veterinary medical boards oversee the practice of veterinary medicine, including prescribing. Generic drugs are approved by the FDA.
Using a Pharmacy Glove Box for Compounding Sterile Preparations
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BUD (Beyond Use Date) studies provide important information on the stability of a compounded preparation. Explore MEDISCA’s BUDs now.
Designing a Verification and Monitoring Program. Designing a CSP Facility. Designing a Quality Management System. Teaching Adult Learners. Validation Studies. Current Developments.