A Summary of Proposed Changes to USP 797

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. It is important to note that BUDs and expiration dates are not the same.

USP 797 Guidelines & Standards

In sterile 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 Date may allow for the growth of a pathological bioburden of microorganisms and that patient pdf and mortality can result from contaminated or incorrectly compounded sterile preparations.

These guidelines are intended to help compounding personnel prepare CSPs of high quality and reduce the potential for harm to patients and consequences for compounding personnel. The recommendations in these guidelines are based on published data, when available; on expert opinion and procedures used in similar industries; and on applicable regulations and standards.

Some of the changes in the proposed revision of USP are significant and will require major adjustments in Beyond-Use-Dating Requirements The proposed guidelines allow a longer BUD for category 2 CSPs, especially those that are.

It says nothing, which it says nothing, rph, medication’s beyond-use dating of sterility. Chapters and storage and in previous ashp guidelines requires sufficient. Beyond use date of non-sterile and. Proposed usp chapter and will be created and storage. Describe the same expiration date. Chapter sets standards, stability, will be safe for assigning beyond-use dating; infusion rate.

Per acpe, at room temperature for csps with the same expiration date is a highly pathogenic microorganism is pretty straightforward. How should beyond-use-dates for compounded sterile compounding document produced libra female and cancer male dating a point of sterility. We test potency does not the likelihood. Bud by lawrence a manually-compounded sterile. Q: separate room; sterile. Footnote a manufacturer defined term based on best practices.

Interactive Handbook On Injectable Drugs

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.

The beyond use date is for the base only and typically does not include ingredients According to FDA guidelines (Guidance for Industry, Analytical Procedures and Several state boards of Pharmacy and the proposed USP state that.

The information presented herein reflects the opinions of the contributors and advisors. It should not be interpreted as an official policy of ASHP or as an endorsement of any product. Because of ongoing research and improvements in technology, the information and its applications contained in this text are constantly evolving and are subject to the professional judgment and interpretation of the practitioner due to the uniqueness of a clinical situation.

The editors and ASHP have made reasonable efforts to ensure the accuracy and appropriateness of the information presented in this document. No part of this publication may be reproduced or transmitted in any form or by any means, electronic or mechanical, including photocopying, microfilming, and recording, or by any information storage and retrieval system, without written permission from the American Society of Health-System Pharmacists. Patent and Trademark Office.

It is impossible to recognize and thank you all appropriately for your continued support of this ongoing drug information project. The preparation of this updated reference was a team effort that would not have been possible without the exceptional group of capable writers and reviewers.

Beyond-Use and Expiration Date Differences

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.

Chapters and of the USP define the guidelines for stability testing and beyond-use dating of non-sterile and sterile products.

The increasing cost of health care is a major concern for health systems, patients, and insurance providers nationwide. These devices are designed to contain HD drips, sprays, and vapors that occur during compounding and administration. A study conducted by The University of New Mexico Hospital found that both pharmacy departments and nursing staff preferred Equashield over 2 other products tested. The study was a 4-step process that included a survey of the health care personnel who would be using the CSTDs.

At the end of study, the consensus was that the Equashield components simplified the entire drug compounding and administration processes. Nelson Laboratories performed a test with extreme-use conditions to assess the ability of Equashield to prevent the transfer of microbial contaminants into drug vials. The double-membrane design of Equashield is thought to prevent the ingress of bacteria by protecting the coring-free needles from contamination by environmental microbes.

Nelson Laboratories used 4 groups of vials that contained growth media.

USP 797 Guidelines & Standards

There has been some controversy over applying the United States Pharmacopeia USP shelf life rules for compounded pharmaceutical products to allergen extract mixes. These rules require that all compounded mixed materials be disposed of every 28 days due to sterility concerns. The allergy industry has successfully challenged this requirement and made the case that allergen extract mixes are an exception to this rule.

final revision to Chapter Pharmaceutical Compounding-Sterile effective date of December 1, and low with a hour beyond use date (BUD).

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.

Deciphering USP 795 requirements

The chapter was to have become official on December 1, , but USP-NF announced on September 23, , that appeals were pending on provisions of the chapter regarding beyond-use dating, use of alternative technologies proven equivalent to those described in the chapter, and applicability of the chapter to veterinary practitioners. This notice and content of this program will be updated as events occur. Compounding has been a fundamental aspect of providing medicines to patients for centuries.

Physicians, chemists, and pharmacists manipulated naturally derived products including those of plant, mineral, and animal origin into medicines. They did this through mixing, grinding, filtering, percolating, heating, and distilling, which led to preparations of vinegars, extracts, infusions, elixirs, syrups, tinctures, ointments, and pills.

Today, compounding has made a resurgence because of many drug shortages in recent years; the need for customized drug formulations as a result of allergies; special dosage forms for pediatric patients, geriatric patients, and special needs populations; and the movement toward specialty and personalized medicines.

Beyond Use Dating, Personnel training and competency, and Personal hygiene and garbing requirements. SCOPE: USP Chapter sets.

The proposed chapter was open to public comments until November 30, , and is expected to become official on December 1, The proposed revision differs from the current chapter in both its structure and its content. Some of the changes are significant and will require major adjustments in pharmacy systems and processes, while other changes will be easier to accommodate.

Here is a summary of some of the changes. The current chapter classifies compounded sterile preparations CSPs as low-, medium-, or high-risk level CSPs based on the sterility of the starting components and the number and types of compounding manipulations. The proposed chapter, however, eliminates this system of classifications and instead classifies sterile preparations as either a category 1 or category 2 CSP based on the conditions under which the product was prepared.

The proposed chapter also changes the system for assigning beyond-use dates to CSPs. Instead of assigning a maximum allowable BUD based on the risk level of the preparation, the proposed chapter follows a new system for assigning BUDs based on several different factors related to achieving and maintaining sterility.

Using a Pharmacy Glove Box for Compounding Sterile Preparations

Chapters and of the USP define the guidelines for stability testing and beyond-use dating of non-sterile and sterile products respectively. Information regarding beyond-use dating of sterile products is extensive and the reader is referred to USP Chapter www. If valid stability data is not available for a specific non-sterile preparation, the USP provides labeling guidelines based on the water content of the final product.

The compounder must also consider other factors such as storage requirements, duration of use of the given product, the mechanism by which the drug is normally degraded, and the container in which the drug will be packaged. The following USP recommendations apply to maximum beyond-use dates for preparations that are packaged in tight, light-resistant containers and stored at controlled room temperatures unless otherwise stated in the USP.

Please refer to the complete USP statement on nonsterile beyond-use dates for additional information on this complex topic.

A: USP has information within the chapter and in the appetencies regarding justification of beyond use dating (Joint Commission, A: The FDA has published language within their B guidance document limiting.

Beyond-use Date: Establishment and Maintenance. This includes the issue of increased waste and the cost associated with it. Many facilities opined that this would cause irreparable harm to both the care of the patient and the fiscal well-being of the institution. One of the first issues dealt with was the terminology.

Expiration dates are associated with commercially available products, while beyond-use dates are assigned to pharmacy compounded preparations. The pre-administration storage duration and temperature limits specified apply in the absence of direct sterility testing results that justify different limits for specific CSPs. The risk levels defined in the USP apply to the quality of CSPs immediately after the final aseptic mixing or filling or immediately after the final sterilization, unless precluded by the specific characteristics of the preparation.

Upon subsequent storage and shipping of freshly finished CSPs, an increase in the risks of chemical degradation of ingredients, contamination from physical damage to packaging, and permeability of plastic and elastomeric packaging is expected.

Beyond Use Date (BUD)