Usp chapter 797 beyond use dating chart
ASHP Guidelines on Compounding Sterile Preparations
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Usp chapter 797 beyond use dating
primary engineering controls are used and generally include horizontal flow clean benches, vertical flow clean benches, biological safety cabinets, and barrier isolators. lafws or barrier isolators are used as the iso class 5 air quality environment (see table 1), their blowers must be operated continuously during compounding activity, including during interruptions of less than 8 hours. selected for csps is appropriate to preserve the sterility and strength until the beyond-use date. supervisors shall ensure through either direct measurement or appropriate information sources that specific csps maintain their labeled strength within monograph limits for usp articles, or within 10% if not specified, until their beyond-use dates. the pharmacist consults weights and balances 41 for acceptable tolerances of the weights used. chapter emphasizes the need to maintain high standards for the quality and control of processes, components, and environments; and for the skill and knowledge of personnel who prepare csps. is necessary that equipment, apparatus, and devices used to compound a csp are consistently capable of operating properly and within acceptable tolerance limits.-use dates are assigned based on direct testing or extrapolation from reliable literature sources and other documentation (see stability criteria and beyond-use dating under pharmaceutical compounding—nonsterile preparations 795). 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 quality control and testing for csps in this chapter are appropriate and necessary. inspect all drug products, devices, and other items the patient or caregiver is required to use immediately prior to administration in a manner to ensure that all items are acceptable for use. if the pharmacy uses a continuous temperature recording device, pharmacy personnel should verify at least once daily that the recording device itself is functioning properly. intent of this chapter is to prevent harm and fatality to patients that could result from microbial contamination (nonsterility), excessive bacterial endotoxins, large content errors in the strength of correct ingredients, and incorrect ingredients in csps. available sterile drug products, sterile ready-to-use containers and devices are examples of sterile components. a written procedure for unit-by-unit physical inspection preparatory to use is followed to ensure that these components are sterile, free from defects, and otherwise suitable for their intended use. receipt of each lot of the bulk drug substance or excipient used for csps, the individual compounding the preparation performs a visual inspection of the lot for evidence of deterioration, other types of unacceptable quality, and wrong identification.
Usp chapter 797 beyond use dating guidelines
through high-efficiency particulate air (hepa) filters is unidirectional or columnar, and because of the pore size of the filter the “first air” at the face of the filter is, for the purposes of aseptic compounding, free from airborne particulate contamination. this includes storage in environments inferior to iso class 5 of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives. the in-home preparation area, scrub hands, use proper aseptic technique, and manipulate all containers, equipment, apparatus, devices, and supplies used in conjunction with administration. 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. inspections must confirm compliance with appropriate storage conditions, separation of drugs and food, proper use of multiple-dose containers, and the avoidance of using single-dose products as multiple-dose containers. patient or other recipient is able to store the csps properly, including the use of a properly functioning refrigerator and freezer if csps are labeled for such storage. ascertain from appropriate information sources that the sterile microporous membrane filter used to sterilize csp solutions, either during compounding or administration, is chemically and physically compatible with the csp. pharmacy must have the sole authority for determining whether a csp not administered as originally intended can be used for an alternate patient or under alternate conditions. the standard operating procedures manual of the compounding facility and each specific csp formula record must describe the general basis used to assign the beyond-use date and storage conditions. for sterile compounding areas used for low- and medium-risk preparations, a minimum of monthly evaluation is appropriate. available sterile filters must be approved for human-use applications in sterilizing pharmaceutical fluids. personnel who assign beyond-use dates to csps when lacking direct chemical assay results must critically interpret and evaluate the most appropriate available information sources to decide a conservative and safe beyond-use date. 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 the absence of a bacterial endotoxins limit in the official monograph or other csp formula source, the csp must not exceed the amount of usp endotoxin units (eu per hour per kg of body weight or m2 of body surface area) specified in the above chapter for the appropriate route of administration. or partially used packages of ingredients for subsequent use in csps are properly stored under restricted access conditions in the compounding facility. ensure consistent practices in determining and assigning beyond-use dates, the pharmacy should have written policies and procedures governing the determination of the beyond-use dates for all compounded products.
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Usp chapter 797 beyond use dating chart personnel is prepared through an appropriate combination of specific training and experience to operate or manipulate any piece of equipment, apparatus, or device they may use when preparing csps. additionally, csps must not be redispensed if redispensing cannot be supported by the originally assigned beyond-use time. electric air samplers that actively collect volumes of air for evaluation, the instructions for verification and use of these devices must be followed. potential sources of contamination include, but are not limited to, solid and liquid matter from compounding personnel and objects; nonsterile components employed and incorporated before terminal sterilization; inappropriate conditions within the restricted compounding environment; prolonged presterilization procedures with aqueous preparations; and nonsterile dosage forms used to compound csps. should be recognized that the truly valid evidence of stability for predicting beyond-use dating can be obtained only through product-specific experimental studies. foam padding or inserts are particularly useful where csps are transported by pneumatic tube systems. multiple-dose parenteral medication vials (mdvs) are used, refrigerate the mdvs after they are opened unless otherwise specified by the manufacturer. outdated and unused csps must be returned to the pharmacy for disposal or possible reuse. sections in this chapter are organized to facilitate practitioners’ understanding of the fundamental accuracy and quality practices of csps. the chapter is divided into the following main sections:Responsibilities of all compounding personnel. filter devices are assembled from separate nonsterile components by compounding personnel, such devices shall be identified to be sterile and ascertained to be effective under relevant conditions before they are used to sterilize csps. the following may provide such assurance: the csp was maintained under continuous refrigeration and protected from light, if required; no evidence of tampering or any readying for use outside the pharmacy exists; and there is sufficient time remaining until the originally assigned beyond-use time and date will be reached. in addition, operations using nonsterile components require the use of a method of preparation designed to produce a sterile product. regardless of the methods used, the pharmacy has to evaluate their effectiveness and the reliability of the intended protection. this includes storage in environments inferior to iso class 5 of opened or partially used packages of manufactured sterile products that lack antimicrobial preservatives. beyond-use dates for csps that lack justification from either appropriate literature sources or by direct testing evidence must be assigned as described in the section stability criteria and beyond-use dating in the general test chapter pharmaceutical compounding—nonsterile preparations 795.
Guidelines for Compounding Practices
nonsterile measuring, mixing, and purifying devices are rinsed thoroughly with sterile, pyrogen-free water, and then thoroughly drained or dried immediately before use for high-risk compounding. written procedures outlining required equipment calibration, annual maintenance, monitoring for proper function, controlled procedures for use of the equipment and specified time frames for these activities are established and followed., commercially available sterilizing filter devices for use on handheld syringes may be checked by feeling for greater resistance on the plunger when filtering air after an aqueous fluid has been filtered. procedures are completed, used syringes, bottles, vials, and other supplies are removed, but with a minimum of exit and re-entry into the dcca to minimize the risk of introducing contamination into the aseptic workspace. therefore, ipa used in aseptic areas should always be filtered through a 0. post-training verbal counseling can also be used periodically, as appropriate, to reinforce training and to ensure continuing correct and complete fulfillment of responsibilities.-use dates for compounded preparations are usually assigned based on professional experience, which should include careful interpretation of appropriate information sources for the same or similar formulations (see stability criteria and beyond-use dating in the general test chapter pharmaceutical compounding—nonsterile preparations 795). all csps that are not used as originally intended must be returned to the pharmacy for appropriate disposition, which may include redispensing, but only if adequate continuing quality can be fully ensured. section pertains to the responsibilities of the pharmacy for maintaining product quality and control after the csp leaves the pharmacy for distribution and use within the organized health care system to which the pharmacy belongs. a method not described in the usp may be used if verification results demonstrate that the alternative is at least as effective and reliable as the usp membrane filtration method or the usp direct inoculation of the culture medium method where the membrane filtration method is not feasible. compounding personnel must be capable of accessing the buffer area without use of their hands. the six containers are then arranged as three pairs, and a sterile 10-ml syringe and 18-gauge needle combination is used to exchange two 5-ml aliquots of medium from one container to the other container in the pair. a well-designed positive pressure barrier isolator, supported by adequate procedures for its maintenance, monitoring, and control, may offer an acceptable alternative to the use of conventional lafws in clean rooms for aseptic processing. theoretically predicted beyond-use dating periods should be carefully considered for csps prepared from nonsterile bulk active ingredients having therapeutic activity, especially where these csps are expected to be compounded routinely. 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). the use of tamper-proof closures and seals on csp ports can add an additional measure of security to ensure product integrity regardless of transport method used.
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ASHP Discussion Guide on USP Chapter 797: Compounding Sterile their schedules of use and methods of application are in accord with written procedures. predictions based on other evidence, such as publications, charts, tables, and so forth would result in theoretical beyond-use dates. compounding devices (acds) for the preparation of parenteral nutrition admixtures are widely used by pharmacists in hospitals and other health care settings. programs include a hands-on demonstration and practice with actual items that the patient or caregiver is expected to use, such as csp containers, devices, and equipment. examples include csps with a narrow therapeutic index, where close monitoring or dose titration is required to ensure therapeutic effectiveness and to avoid toxicity; where a theoretically established beyond-use dating period is supported by only marginal evidence; or where a significant margin of safety cannot be verified for the proposed beyond-use dating period. used to bring supplies from the storeroom cannot be rolled beyond the demarcation line in the anteroom area, and carts used in the buffer or clean area cannot be rolled outward beyond the demarcation line unless cleaned and sanitized before returning. 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 prescription orders, written compounding procedure, preparation records, and expended materials used to make csps in all contamination risk levels are inspected for accuracy of correct identities and amounts of ingredients, aseptic mixing and sterilization, packaging, labeling, and expected physical appearance before they are administered or dispensed. filter units used to sterilize csps can also be subjected to the manufacturer's recommended integrity test, such as the bubble point test. individual pouched supplies need not be wiped because the pouches can be removed as these supplies are introduced into the buffer or clean area. theoretically predicted beyond-use dating introduces varying degrees of assumptions, and hence a likelihood of error or at least inaccuracy. commercially available sterile disposable filter devices are used, the compounding personnel may accept the written certification from suppliers that the filters retain at least 107 cfu, of brevundimonas (pseudomonas) diminuta on each cm2 of filter surface. only approved cleaning and sanitizing agents are used with careful consideration of compatibilities, effectiveness, and inappropriate or toxic residues. the double check system should meet state regulations and include label accuracy and accuracy of the addition of all drug products or ingredients used to prepare the finished product and their volumes or quantities. action may be warranted when an increasing trend to 50% above the baseline for areas used for high- and medium- risk preparations or to 100% above baseline for areas used for low-risk preparations is found. pharmacists should consult the general information chapter under pharmaceutical stability 1150 for the appropriate stability parameters to be considered when initiating or evaluating a product-specific stability study.
Beyond use dating for sterile compounding any nonsterile components, including containers, devices, and ingredients are used to make a csp, such csps must be compounded at a high-risk level. facilities must have at least the following written procedures for verifying the correct identity and quality of csps before they are dispensed and administered:That labels of csps bear correct names and amounts or concentrations of ingredients; the total volume; the beyond-use date; the appropriate route(s) of administration; the storage conditions; and other information for safe use. for the purposes of this chapter, csps include any of the following:Preparations prepared according to the maufacturer's labeled instructions and other manipulations when manufacturing sterile products that expose the original contents to potential contamination. the greater the doubt of the accuracy of theoretically predicted beyond-use dating, the greater the need to determine dating periods experimentally. the immediate labeling of the csp container will display prominently and understandably the requirements for proper storage and expiration dating. stability information must be carefully interpreted in relation to the actual compounded formulation and conditions for storage and use. expiration dating not specifically referenced in the package insert should not exceed 30 days once the vial has been opened. after receipt by the compounding facility, packages of ingredients that lack a supplier's expiration date cannot be used after one year, unless either appropriate inspection or testing indicates that the ingredient has retained its purity and quality for use in csps. whenever possible, equipment and other items used in the buffer area should not be taken from the room except for calibration, servicing, or other activity associated with the proper maintenance of the item. in such cases, compounding personnel consider the potential additional risks to the integrity of csps when assigning beyond-use dates. when nonsterile gloves, chosen for their chemically protective composition, are used, they are disinfected with sterile 70% isopropyl alcohol or an antimicrobial agent that is allowed to evaporate before beginning compounding procedures. for gravimetric accuracy, the balance used in conjunction with the acd is tested using various weight sizes that represent the amounts typically used to deliver the various additives. for example, if 40 ml of water was used in the volumetric assessment, its corresponding weight should be about 40 g (assuming the relative density of water is 1., mixing, sterilizing, and purifying devices are clean, appropriately accurate, and effective for their intended uses.-µm nominal porosities will not remove bacterial endotoxins and viruses by physical retention. when csps will be distributed to and administered in residential locations other than health care facilities, the effect of potentially uncontrolled and unmonitored temperature conditions must be considered when assigning beyond-use dates.
General Chapters: <797> PHARMACEUTICAL COMPOUNDING large deviations from usual or expected chemical and physical properties of csps may cause undetectable damage to filter integrity and shrinkage of microorganisms to sizes smaller than filter porosity. the critical point is the use of usp references and possible laboratory procedural differences., without appropriate evidence or direct determination, that packages of bulk ingredients contain at least 95% by weight of their active chemical moiety and have not been contaminated or adulterated between uses. the used additive containers and, for those additives for which the entire container was not expended, the syringes used to measure the additive, should be quarantined with the final products until the final product check is completed. media-fill testing is used to assess the quality of the aseptic skill of compounding personnel. facilities that ship csps to patients and other recipients outside their own premises must ascertain or provide, whichever is the appropriate case, the following assurances:Labels and accessory labeling for csps include clearly readable beyond-use dates, storage instructions, and disposal instructions for out-of-date units. the use of alternative systems in clean rooms that have been verified to achieve the same or better level of environmental quality as that achieved by properly operated lafws may also be utilized. examples of special requirements of these agents also include exposure-reducing strategies such as the use of luer lock syringes and connections, syringe caps, the capping of container ports, sealed plastic bags, impact-resistant containers, and cautionary labeling. standard operating procedures manuals of compounding facilities must describe specific instructions for receiving, acknowledging, and dating receipts; and for recording, or filing, and evaluating reports of adverse events and of the quality of preparation claimed to be associated with csps. for example, an ampul should not be opened unnecessarily in advance of use. pharmacists should consult the general information chapter validation of compendial methods 1225 for verification parameters to be considered when evaluating an acd. such packages cannot be used when visual inspection detects unauthorized breaks in the container, closure, and seal; when the contents do not possess the expected appearance, aroma, and texture; when the contents do not pass identification tests specified by the compounding facility; and when either the beyond-use or expiration date has been exceeded. the content of this chapter applies to health care institutions, pharmacies, physician practice facilities, and other facilities in which csps are prepared, stored, and dispensed. powder-free protective gloves are sterile or, if nonsterile, are sanitized with an appropriate antimicrobial cleaner such as 70% alcohol before use. all cleaning tools, such as wipers, sponges, and mops, are nonshedding and dedicated to use in the buffer or clean area. an air dryer or disposable nonshedding towels are used to dry hands and arms after washing.
Questions about Multi-dose vials | Injection Safety | CDC greater care is required for aqueous injections that are compounded sterile preparations (csps)—the most common csps used in therapy. such items are either used immediately or stored until use in an environment suitable for compounding low- and medium-risk csps. such evaluations are performed as a regular and ongoing process at least monthly for sterile compounding areas used for low- and medium-risk preparations and at least weekly for areas used for high-risk preparations. use of additional resources, such as the accreditation manual for home care from the joint commission on accreditation of healthcare organizations, may prove helpful in the development of a qa plan. if cleaning tools are reused, their cleanliness is maintained by thorough rinsing and sanitization after use and by storing in a clean environment between uses. in addition, the same volume of sterile water for injection used to assess volumetric accuracy is then weighed on the balance used in conjunction with the acd. supervising health care professional must ensure, directly or from appropriate documentation, that the filters are chemically and physically stable at the pressure and temperature conditions to be used, and that the filters will achieve sterility and maintain prefiltration pharmaceutical quality of the specific csp. in addition, during the use of the acd, certain additives, such as potassium chloride (corrected for density differences) can also be tested in the same manner as an in-process test. floor mops may be used in both the buffer or clean area and anteroom area, but only in that order. sterile and sanitized gloves do not remain sterile and clean during compounding activities because they come in contact with nonsterile surfaces and air. provider of csps must have in place a formal quality assurance (qa) program4 intended to provide a mechanism for monitoring, evaluating, correcting, and improving the activities and processes described in this chapter. of all aspects of the preparation and dispensing of products as described in this chapter, including environmental testing, validation results, etc. in short, because beyond-use dating periods established from product-specific data acquired from the appropriate instrumental analyses are clearly more reliable than those predicted theoretically, the former approach is strongly urged to support dating periods exceeding 30 days. for sterile compounding areas used for high-risk preparations, at least weekly evaluation is appropriate. being used, the compounding environment maintains the sterility or the presterilization purity, whichever is appropriate, of the csp. when nonofficial ingredients are used, they must be accompanied by certificates of analysis from their suppliers to aid compounding personnel in judging the identity, quality, and purity in relation to the intended use in a particular csp.
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