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However, administration and preparation per approved labeling are out of the scope of the chapter as described in 1. The intent of the chapter is to establish minimum standards to help ensure quality of CSPs, whether the CSP is for human or animal patients. USP has no role in the enforcement of compounding chapters. Pursuant to General Notices, 2. Generally, requirements in a General Chapter are conveyed by use of the terms "must" or "shall". Recommendations are conveyed by use of the terms "should" and "may". The USP "official date" indicates the date by which affected users are expected to meet the requirements of a particular standard.
Usp 797 beyond use dating chart
We developed several assumptions before researching the available literature on chemical stability. This assumption applied to the reconstituted vial and the compounding of the admixture.
ing the ASHP guidelines with United States Pharmacopeia. (USP) chapter , Pharmaceutical Compounding—Sterile. Preparations To help achieve that. USP sterility times, or if you are making high-risk preparations. Sterility tests Q: What are some basic guidelines for determining the beyond-use dates for the different A: The first printing of USP > limited multi-dose. Beyond Use Date (BUD) is very different from expiration date. USP Chapter defines BUD as the date or time after which a compounded sterile preparation.
The beyond use dating would only be applicable under the assumption that the admixture was compounded for a single patient and not for anticipated batch compounding. The associated beyond use dating for batch compounding would be adjusted for compounding risk level and assigned through an automated system for capturing batch-specific information. These guidelines were not intended for proprietary bag systems, as manufacturer-specific guidance would be sought for those systems.
In addition, nonreferenced manufacturer medication information may differ in stability data.
If limited chemical stability was a factor, this was indicated for applicable admixtures within the guideline by an associated expiration date. For each medication listed, information was provided that was vital to safe, accurate, and consistent compounding throughout the organization.
Separate columns were developed within the guidelines for medication vial specifics and secondary admixture specifics. The chart template was completed for each medication, starting with the most recent manufacturer package insert information for which vial reconstitution and stability were indicated. The diluent information, if applicable, was then entered from the same package insert, along with any concentration specifics indicated by the manufacturer.
Published reference standards were consulted for information that was not found within the package insert.
The primary goal of the beyond use dating guideline was to provide a comprehensive information source for safe and consistent admixing.
Published references were used to find extended chemical stability at reference ranges, which were indicated within the chart.
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An upper and lower concentration reference range was needed to establish a range of stability concentrations at the indicated BUD. Necessary temperature, diluent, and container information was also found to ensure that admixing was in accordance with the study referenced.
After the guideline was developed, it was reviewed for accuracy by the second author N. 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.
Stability information must be carefully interpreted in relation to the actual compounded formulation and conditions for storage and use.
Predictions based on other evidence, such as publications, charts, tables, and so forth would result in theoretical beyond-use dates. Theoretically predicted beyond-use dating introduces varying degrees of assumptions, and hence a likelihood of error or at least inaccuracy.
STORAGE AND BEYOND-USE DATING. Beyond-use dates for compounded preparations are usually assigned based on professional evidence, such as publications, charts, tables, and so forth would result in theoretical beyond-use dates. Keywords: beyond use dating, BUD, stability, sterile compounding, USP >. Beyond use date (BUD) is the date after which a compounded preparation shall. ?? Pharmaceutical Compounding—Sterile Preparations 1. Change to read: quality standards for CSPs of drugs and nutrients based on current scientific.
The degree of error or inaccuracy would be dependent on the extent of differences between the CSP's characteristics such as composition, concentration of ingredients, fill volume, or container type and material and the characteristics of the products from which stability data or information are to be extrapolated.
The greater the doubt of the accuracy of theoretically predicted beyond-use dating, the greater the need to determine dating periods experimentally.Beyond-Use Dates for Compounded, Non-Sterile Preparations
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 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.
It must be ascertained that CSPs will not be exposed to warm temperatures see General Notices and Requirements unless the compounding facility has evidence to justify stability of CSPs during such exposure.
It should be recognized that the truly valid evidence of stability for predicting beyond-use dating can be obtained only through product-specific experimental studies. However, quantitative stability-indicating assays, such as high performance liquid chromatographic HPLC assays, would be more appropriate for certain CSPs.
Responsibility of the person completing the compounding A Blueprint for Implementing USP Chapter >, Pharmaceutical Compounding: Sterile . May use more general guidelines when specific information is. USP Chapter sets compounding risk levels based on the likelihood of under each level of risk--low, medium or high--according to USP For >ASHP Guidelines on Compounding Sterile Preparations (). Where can I find FAQs and other information on USP Compounding Standards To whom do the standards in General Chapter > apply?.
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. 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.
Guidelines for the Establishment of Appropriate Beyond Use Dating of Sterile Compounded Admixtures
To 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. Exposing sterile ingredients and devices to air quality below ISO Class 5 will create a high-risk compounding situation, as will the prolonged storage of opened or partially-used products that lack antimicrobial preservatives in an environment in les than ISO Class 5 conditions.
In addition, assuming rather than verifying directly or by examining the labeling and documentation that the chemical purity and strength of bulk ingredients meet their specifications establishes a high-risk condition. In the absence of passing a sterility test, high risk compounded sterile products cannot be stored for more than 24 hours at controlled room temperature, more than three days in cold temperatures or for more than 45 days if frozen solid and held at degrees Fahrenheit or less.
Special care must be taken in high-risk compounding. Please refer to Chapter for more details. High-risk compounding would include making a solution that will be terminally sterilized from non-sterile bulk drug or nutrient powders or measuring or mixing sterile ingredients in a non-sterile device prior to sterilization.
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