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.
Using a Pharmacy Glove Box for Compounding Sterile Preparations
This proposed rulemaking will be effective upon final-form publication in the Pennsylvania Bulletin. This rulemaking is proposed under the authority of sections 4 j and 6 k 1 and 9 of the Pharmacy Act act 63 P. Since at least , the Board has been considering promulgating regulations setting standards for the compounding of drug products by pharmacists. In October , National headlines reported a meningitis outbreak of epidemic proportions.
that a pharmaceutical company assumes for its approved drugs. Beyond Use Date: A beyond use date is the date after which a compounded preparation.
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.
A glove box provides an additional level of protection, as the sterile product is never exposed to the room environment or to compounding personnel directly. When using a glovebox, materials are passed into the main working chamber through an enclosed pass-thru chamber, and accessed through glove ports to perform aseptic manipulations. Clean air is supplied to the work area through a HEPA filter, providing better than ISO Class 5 conditions under positive pressure within the glovebox.
Gloveboxes offer the same or better air quality as a clean bench or biosafety cabinet located within a clean room, plus their design offers some significant advantages in both initial investment and ongoing operating expenses. USP Chapter speaks to aseptic conditions for compounded sterile preparations; however the chapter does not cover in detail the risks to pharmacy personnel associated with handling cytotoxic or other hazardous drugs.
For these special cases of CSPs, a negative pressure glovebox should be used to provide ISO Class 5 conditions while also protecting personnel from exposure. The Baker Company has also created an online library of links to articles and studies relevant to current trends and standards in pharmacy compounding.
Beyond-Use and Expiration Date Differences
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.
Ensuring appropriate Beyond-Use-Dating (BUD) is used. Please see section 2 of the Guidance Document for Pharmacy Compounding of Non-Sterile.
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.
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Determining Drug Product Shelf Life
Compounding is an integral part of pharmacy practice and is essential to the provision of health care. 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.
USP Pharmaceutical BUDs in USP Pharmaceutical Compounding —. Nonsterile Preparations What are Beyond-Use Dates?
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. Sign up for our e-mail updates to get the latest in product releases, customer notifications, and company news. FSS US is a solution you can rely on for all your outsourced pharmaceutical compounding needs.
Extending the Beyond-Use Dates for Sterile Preparations
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.
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 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 monograph stipulates that, in the absence of applicable stability and beyond-use information for a specific drug and preparation, water-containing compounds from ingredients in solid form may be assigned a beyond-use date not later than 14 days from the date of compounding when stored at cold temperatures.
Here is a suggestion for your compound: Dilute the glycopyrrolate powder in water, or use the injectable form, and combine it with flavored syrup. For a nasogastric, gastrostomy, or jejunostomy tube, the aqueous, unflavored form would suffice. Adjust to pH 6 with sodium hydroxide or hydrochloric acid. Continuing Education.
USP Finalizes Revisions to Sterile Compounding Standards
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
Q: As a practicing consultant pharmacist to ambulatory surgery centers, I am often Rules for Beyond Use Dating of Medications Drawn Into Syringes: Q&A With those pre-drawn syringes an immediate-use compounded sterile preparation.
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. Most users should sign in with their email address. If you originally registered with a username please use that to sign in.
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