Are the technicians required to do media fill and gloved fingertip testing. The information contained in this page is intended for healthcare professionals only. Minibag plus container system infusion solutions, inc. Mini bag plus systems, viaflex containers and vialmate adaptor devices are rx only. Inventory control strategies evaluate supplies on a healthsystemwide basis and redeploy svps to areas of greatest need. Both dates need to be recorded in the compounding log. In other words, follow manufacturers instructions for handling and storing addvantage, mini bag plus, add a vial, addease products, and any others. Describe how usp 797 has impacted preparation of sterile products. Docking and activation in accordance with the manufacturers instructions for immediate administration to an individual patient is not considered compounding.
Usp general chapter indicates that buds for compounded preparations are to be assigned on the basis of the compounders professional experience, starting with the csps risk level low, medium, high and including a careful inter. The plastic packaging systems and their materials of construction revision bulletin will supersede the monograph becoming official in usp 40nf 35. Based on the number and significance of public comments received in response to the revision proposal published in pf 416, the usp compounding expert committee is. In light of these appeals, and in accordance with our bylaws, usp is postponing the official date of 797 until further notice. Usp sterile satpax 670 sterile prewetted 55% cellulose 45% polyester nonwoven cleanroom wiper key attributes 55% cellulose 45% polyester hydroentangled nonwoven blend no chemical binders in base material prewetted with consistent 70% ipa 30% di water to a high saturation level resealable solvent resistant packaging.
Revised usp standards for product dating, packaging, and temperature monitoring. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing. The drugcontaining vial is attached to the bag in the pharmacy but is not activated or mixed until just before administration. A guide for the compounding practitioner, usp 36nf 31. Based on the number and significance of public comments received in response to the revision proposal published in pf 416, the usp compounding expert committee is proposing to revise this chapter. Dextrose injection minibag fda prescribing information. No definite date on final revision or implementation. Can this function be done the coupling of mini bag plus and vialmate are not considered compounding per usp chapter 797 and therefore these pharmacy technicians would not be required to. Iso classification of particulate matthalmic drops and ointments, and tissueter in room air limits are in particles of 0. Sterile compounding is defined as the combining, admixing, diluting, pooling, reconstituting, repackaging or otherwise altering a drug or bulk drug substance to create a sterile medication. Bag drug vial closure vial cover 20 mm mini bag plus container drug vial adaptor foil cover administration port protector breakaway seal inside port tube bag drug vial closure vial cover 20 mm mini bag plus container drug vial adaptor oil cover administration port protector breakaway seal inside port tube bag drug vial closure vial cover 20. Mini bag plus container drug vial adaptor oil cover administration port protector breakaway seal inside port tube bag drug vial closure vial cover 20 mm mini bag plus container drug vial adaptor foil cover administration port protector breakaway seal inside port tube bag. On january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations,15 became official, replacing usp chapter 1206, sterile drug products for home use.
Our pharmacy technicians are only responsible for attaching the vial the coupling of mini bag plus and vialmate are not considered compounding per usp chapter 797 and therefore these. Having a physical plant that is compliant with usp 797 requirements is the most important determinant to reducing the risk of contamination to csps. For the safe and proper use of the devices referenced within, refer to the complete instructions for use or the appropriate manual. Docking and activation of proprietary bag and vial systems e. It is important to note that as long as administration of the preparation to the patient began prior to the bud, the preparation can be used.
Addvantage, minibag plus, addease attachingactivating these not considered compounding acceptable for nursing to attach and activate use manufacturers instructions for storage and stability the cdc advised on a more conservative approach to further safeguard patients. Purchasing from facilities dedicated to higher risk preparations. Usp chapter 797 defines bud as the date or time after which a compounded sterile preparation csp may not be stored or transported and is calculated from the date or time of compounding. Sodium chloride minibag fda prescribing information, side. These procedures are generally viewed as best practices for sterile product preparation and storage. Prior to the enforcement of the usp 797 standard, diverse practices with regard to immediateuse compounding developed at the institutional and professional level. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. Usp chapter 797 sets forth the minimal standards to be followed when preparing compounded sterile products csp. As with all medications, the compounding of radiopharmaceuticals must comply with these standards whether in a hospital nuclear medicine department or by an outsourced.
Make sure all health care professionals administering medications have access to iv push policies and guidelines and have been trained and assessed for competency in administering medications via the iv push route. Outline variables to consider in achieving optimal compliance to usp 797 regulations discuss the pharmacy buyers role in the financial considerations of compliance to usp 797. Minibag plus systems, viaflex containers and vialmate adaptor devices are rx only. The usp chapter 797 standards are not limited in their application to any specific profession or to any specific types of sterile compounding site. Nonsterile multi dose containers manufacturers expiration date unless otherwise specified by manufacturer nonsterile compounded products usp 795, june 20. Point of care systems such as mini bag plus, vial mate, addvantage. It allows for drug admixture after connection to a single dose powdered drug vial having a 20 mm closure. Examples include addvantage, mini bag plus, duplex, and vialmate. Jul 30, 2019 usp chapter 797 sets forth the minimal standards to be followed when preparing compounded sterile products csp. Developing usp general chapter 797 usp is a notforprofit, sciencedriven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.
Identify the key acronyms and state the definition of key terms associated with usp 797. The revision bulletin will be incorporated in usp 41nf 36. Compatibility of avycaz solution for administration with other drugs has not been established. Bud for the nonactivated state according to the manufacturer. A variety of factors may be involved in the decision to use premixed, rtu, and poc iv products. Sterile product preparation for nonpharmacy personnel dennis. Digitizing minibag plus inventory with significant improvements in inventory control support for pharmacists with employee vaccination initiative. Temporary importation of intravenous drug products to addressdrug shortages. Proper identification of compounding risk levels and. Point of care systems such as minibag plus, vial mate, addvantage varies, refer to product package insert for storage and handling example. Sterile product preparation for nonpharmacy personnel.
Jan 15, 2014 on january 1, 2004, usp chapter 797, pharmaceutical compoundingsterile preparations, 15 became official, replacing usp chapter 1206, sterile drug products for home use. Should you have any questions, please contact desmond hunt, ph. The joint commission medication compounding certification. Risk level determination and assignment of beyonduse dates. Nov 22, 2019 in accordance with the rules and procedures of the 20152020 council of experts, usp is postponing the official date of pharmaceutical compoundingsterile preparations.
Baxter offers one of the most comprehensive drug delivery portfolios in the industry. Usp develops standards for preparing compounded sterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. The remainder of this report will discuss agreed upon consensus statements for csps. The mini bag plus container is a standard diluent container with an integral drug vial adaptor. Iso classification of particulate matter in room air limits are in particles of 0.
Proposed revision to usp chapter 797 for sterile compounding will be published for comment on november 2, 2015 and comments will be accepted until january 31, 2016. Provides guidelines for development of policies and procedures for the safe preparation of sterile preparation. There are several reputable manufacturers of premixed, rtu, and poc products, including b. These products may contain fructose as an impurity in the dextrose material. Iso classification of particulate matthalmic drops and ointments, and tissue ter in room air limits are in particles of 0. Monitoring controlled storage areas to ensure that product potency is retained through the manufacturers. Usp is a comprehensive set of standards designed to improve patient safety by reducing the number of transmitted infections due to improperly compounded pharmaceuticals. Proper identification of compounding risk levels and notification to the board. Beyond use date bud is very different from expiration date. Overview of chapter for surveyors and inspectors kate douglass october 9, 20. Pharmaceutical compoundingsterile preparations revision bulletin table 1.
Accurate reporting of this information is crucial for at least two reasons. Describe both the general responsibilities of compounding personnel and those specific to the. Usp 797 cleanroom supplies hardy diagnostics tryptic soy broth, media bag for the general cultivation of microorganisms. Completely reorganizes the chapter and groups like sections together, eliminating redundancies, and clarify requirements. Designed to eliminate aerosolization of chemotherapeutic medications during vial reconstitution and drug preparation process. Aseptic technique, sterile compounding, and iv admixture. Each 100 ml contains 900 mg of sodium chloride, usp nacl. Make sure all health care professionals administering medications have. Evaluation of the maximum beyondusedate stability of. Establishing a practice standard for compounding sterile preparations in pharmacy find, read and cite all the research. Health care practitioners, including nurses and physicians, gained experience compounding products in patient areas without a strong pharmacy presence.
Our goal is to assist you in creating the right blend for your facility with safety, efficiency and compliance in mind. Usp chapter 797, and apply them in a variety of nuclear pharmacy practice settings. Vantage, mini bag plus shall be applied as indicated by the manufacturer. Docking for future activation and administration is considered compounding. Most of the con sensus statements fit with a particular core process, but some span several core processes. Compatible with standard 20 mm closure, singledose, powdereddrug vials. Usp chapter 797 standard applies to sterile compounding without regard to the location or profession of the compounding personnel. Usp chapter is a document published by the united states pharmacopea that provides procedures and requirements for preparing sterile products. Usp chapter 797 is intended to be applicable to any. Caution must be exercised in the administration of parenteral fluids to patients receiving corticosteroids or corticotropin. Pharmaceutical compounding sterile preparations established requirements for the aseptic preparation of sterile dosage forms.
Docking and activation of proprietary bag and 40 vial systems e. September 23, 2019 revised general chapter is postponed until further notice. Pharmacy products usp 797 and 800 pharmacy products securingcapping iva seals blue baxter viaflex mini bags. Impact safety, efficiency, and the bottom line with premixed. Usp chapter 797 is a document published by the united states pharmacopea that provides procedures and requirements for preparing sterile products. In regulations set forth by the united states pharmacopeia chapter 797 usp 797 guidelines, all extemporaneous admixtures must be manufactured in a certified clean room. Pdf on oct 1, 2004, eric s kastango and others published usp chapter 797. In the interim, the currently official version of 797 last revised in 2008. The image displayed may not represent the specific product. Parenteral sterile formulations the iv route of administration is used.
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