NONSTERILE COMPOUNDING: BEYOND USE DATES and LABELING. BEYOND USE DATES: USP Chapter 795 defines Beyond Use Date (BUD) as e date after which a compounded nonsterile preparation (CNSP) should not be used. e BUD is determined from e date e CNSP is compounded. When determining BUD, e pharmacist must take into account stability information . Compounding of Sterile Preparations) to accompany e previous released In e , e United States Pharmacopeia (USP) released several new and revised pharmacy compounding standards. Specifically, USP published revisions to general chapter environmental monitoring and beyond-use dates.File Size: 538KB. 29, · When e bag and vials are docked for future activation and administration, e docking process is considered compounding and e docking process must occur wi in an ISO Class 5 environment and e Beyond Use Dating assignment must not exceed e manufacturer’s labeling. PERSONNEL TRAINING AND COMPETENCY. 22, · Compliance—Postponement In accordance wi e Rules and Procedures of e – Council of Experts, USP is postponing e official date of Pharmaceutical Compounding—Nonsterile Preparations. After publication of e revised on e 1, USP received appeals on certain provisions. 5.4.2 Equipment for non-sterile compounding 22 6. PRODUCT AND PREPARATION REQUIREMENTS 23 6.1 Beyond-use date and dating me ods 23 6.1.1 General guidelines for assigning beyond-use dates 23 6.2 Master Formulation Record 24 6.2.1 Template for a Master Formulation Record 25 6.3 Ingredients used for non-sterile compounding — quality and storage 27. When is is not possible, a pharmacist ideally consults wi e manufacturer to establish a beyond use date. e USP/NF Section. 1206 Sterile Drug Products for Home Use, Storage and Beyond Use Dating directs at: Most pharmacies have e name, address, and phone number of e pharmacy pre-printed on eir prescription labels. In addition, federal and state (NC) regulations require at e . Beyond Use Date (BUD) is very different from expiration date. USP Chapter 797 defines BUD as e date or time after which a compounded sterile preparation (CSP) not be stored or transported and is calculated from e date or time of compounding. Expiration date is a manufacturer defined term based on very specific testing used for commercially available products. A CSP cannot be labeled File Size: 124KB. 15, · USP develops standards for compounding nonsterile medications to help ensure patient benefit and reduce risks such as contamination, infection or incorrect dosing. USP General Chapter provides standards for compounding quality nonsterile preparations. Do e compounding guidance documents apply only to sterile compounding? No. All current compounding guidances apply to bo sterile and non-sterile compounding.Missing: dating. e beyond-use date is determined from e date of compounding by applying drug-specific and general stability resources, when available. ese resources should consider e nature of e drug, degradation, packaging containers, storage conditions, and e duration of erapy. USP states at when a manufactured product is used as an active ingredient in a compounded preparation, e product expiry date cannot be used . 22, · Posting Date 22– – Official Date 01– – Expert Committee Compounding Reason for Revision Compliance—Postponement In accordance wi e Rules and Procedures of e – Council of Experts, USP is postponing e official date of Pharmaceutical Compounding—Sterile Preparations. After publication of e. Still, C-SCAs are segregated, maintain negative pressure, and have appropriate air exchange. A C-SCA can replace a C-SEC during sterile compounding only for low- and medium-risk drugs wi beyond-use dating limited to 12 hours. Overall, a C-SCA is a less-expensive option, providing a benefit to clinics at do not have e required. 23, · e chapter was to have become official on ember 1, but USP-NF announced on 23, at appeals were pending on provisions of e chapter regarding beyond-use dating, use of alternative technologies proven equivalent to ose described in e chapter, and applicability of e chapter to veterinary practitioners. 24, · High-risk compounding would include making a solution at 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. References: ASHP Guidelines on Compounding Sterile Missing: dating. Non-Sterile Compounding. Regular Pharmacy Compounding. 1997 Food and Drug Administration Modernization. Clarify e status of pharmacy compounding. USP Chapter Non-sterile compounding. USP Chapter Sterile compounding. Beyond-Use-Dating. Expiration date for compounded materials. PCAB. Pharmacy Compounding Accreditation Board. Where a USP or NF Substance is e Source of Active Ingredient— e beyond-use date is not later an 6 mon s. For Water-Containing Formulations (prepared from ingredients in solid form)— e beyond-use date is not later an 14 days for liquid preparations . durations to non-ISO classified air, personnel garbing and gloving, and o er a tic precautions by which sterile products are to be prepared for administration). Beyond-use exposure and storage dates or times (see. General Notices and Requirements.. Pharmaceutical Compounding . e publication of e USP in 2004 represents e first official enforceable standard for sterile compounding in e United States. Beyond use dating: Room Temperature: . Compounding area is arated from non-compounding area: 12 hours: 12 hours: Medium-risk. Multiple additives and/or small volumes. Batch preparations. USP sets e standards for all of e folllowing dosage forms except: medications. Which of e following statements is(are) true concerning beyond-use dating of compounded non-sterile products? All of e above statements are true. Which organization establishes e standards for a non-sterile compounding area? United States. 08, · ese chapters, along wi USP General Chapter (Hazardous Drugs – Handling in Heal care Settings) will become effective ember 1, . In is article we will review e substantive changes to USP Nonsterile Compounding. Future articles will address USP Sterile Compounding and USP General Chapter. e Beyond Use Dates (BUDs) allowed for Category 2 CSPs are dictated by e me od of sterilization, whe er or not a sterility test is performed, passed, and e storage temperature of e preparation. Table 11 of e new Chapter 7971provides e following maximum BUDs. , · Take, for example, e beyond-use date (BUD) for tablets taken from a manufacturer's large container and repackaged into smaller containers. According to e guidance, FDA wants e BUD for ose repackaged tablets to be e earliest of 6 mon s from e first time e large container is . 17, · is is true for e practice of pharmacy compounding, wi e latest addition being new guidelines for bo sterile and nonsterile compounding from e United States Pharmacopeia. USP published new versions of General Chapters. 795 and 797 on e 1, which you can download for free here. e chapters are not enforceable until ey. For ose practitioners not familiar wi USP’s nonsterile compounding content, e chapter should be reviewed in its entirety. Beyond at, e sections of most urgent interest to practitioners are ose covering compounding documentation, beyond-use dating, and stability criteria. 02, · In accordance wi e ch 12, USP Appeals Panel isions on e appeals to General Chapters USP, and, e Compounding Expert Committee held an open forum on 15, for e Beyond-Use Date . 12, · e United States Pharmacopeia Appeals Panel today remanded e revised USP General Chapter standards for nonsterile compounding and for sterile compounding to an expert committee for fur er engagement on e issues raised concerning e beyond-use date provisions. USP last year postponed e effective dates for ese standards and for e new General . Assignment of Beyond-Use Date for Non-Sterile Compounded Preparations: 8.011 u: Assignment of Beyond-Use Date Non-Sterile Compounded Preparations (USP ) 8.012: Compounding Sterile Solutions: 8.013: Compounding Sterile Suspensions: 8.014: Extemporaneous Compounding (No Master Formula Record) 8.018: Handling Drugs in e Dry State: 8.019. Apr 29, · Beyond-Use Dates (BUD) BUDs be assigned if compounding does not o erwise deviate from USP General Chapter standards: For low and medium-risk level compounded sterile preparations (CSPs) prepared in a segregated compounding area, apply BUDs conservatively, not to exceed: 12 hours at controlled room temperature. 24 hours in a refrigerator. Types of Compounding • Sterile versus non-sterile compounding • Sterile compounding • USP chapter • Non-sterile compounding • USP chapter Areas used for sterile preparations are to be arated and distinct from e non-sterile compounding area. From: USP General Chapter 6/14/12. 4. sterile preparation compounders should meet or exceed e e need for a quality assurance system is well docu- standards set for in 〈797〉. mented in United States Pharmacopeia (USP) chapters for compounded preparations (see Quality Control under Phar-maceutical Compounding—Nonsterile Preparations 〈795〉 and STANDARD OPERATING PROCEDURES. Standards for Pharmacy Compounding of Non-hazardous Sterile Preparations. Standards for Pharmacy Compounding of Hazardous Sterile Preparations. Additional Resources: Beyond Use Dating: e Nor York General Hospital Experience (Pharmacy Connection, Fall ) College Contact: Pharmacy Practice. Introduction. 1. Any use of non-sterile ingredients, including manufactured products not intended for sterile routes of administration (e.g. oral), are incorporated or a non-sterile device is employed before terminal sterilization. 2. Any of e following are exposed to air quality worse . 6.1 Beyond-use date and dating me ods 36 6.2 Compounded sterile preparation protocols 40 6.3 Compounded sterile preparation log 41 6.4 Patient file 43 6.5 Conduct of personnel in areas reserved for e compounding of sterile preparations 43 6.6 A tic compounding of non-hazardous sterile preparations 44 6.7 Packaging 51 6.8 Storage 52. List Price: $ 4.00 Member Price: $83.00 Page Count: 0 e Nonsterile Compounding Answer Book: A Guide to Contemporary Best Practices outlines quality of practice standards for nonsterile compounding by following a nonsterile product from receipt to preparation in a heal care facility, addressing core elements of USP Chapter. e Q & A approach to is book provides a . ere is sooner an 795 days for implementing usp, compounding sterile compounding sterile calculator. Several state boards of pharmacy and additions non be valid. Adoption of beyond use date and most how e beyond-use dating principles, and additions to do at mean e extension and New definitions and is silent chart: Route of. USP Guidance: •For nonsterile solid and liquid dosage forms at are packaged in single-unit and unit-dose containers, e beyond use date shall be one year from e date packaged or e expiration date on e manufacturer’s container, whichever is earlier. . • Beyond Use Dates (BUDs) for STERILE drugs: – if approved product has an in use time, BUD is in accordance wi in use time or expiration date, whichever shorter. Feb 04, · As part of PCAB accreditation our facility must meet standards set for in e United States Pharmacopeia Chapter 797, considered e most stringent set of guidelines involving sterile compounding. Product Testing – United Pharmacy keeps routine testing of bo sterile and non-sterile . 3. Written policies and procedures are required to document e me od by which Beyond Use Dates (BUD) are established for each sterile drug product. Default BUD information is found in chapter 535:15- -61 and is also available in e chart in Appendix A USP Beyond Use Date Limits Chart located at e end of chapter 525. Sterile and Non-Sterile Compounding Guidelines (USP and NAPRA) Beyond Use Dating BUD) Storage Requirements. At CPM- e Compounding Pharmacy of Manitoba, we utilize e latest technology available for e preparation of each product. We follow a collection of Standard Operating Procedures specific to our facility and every compound is prepared. BEYOND-USE DATE (BUD): e date after which a compounded preparation should not to be used. determined from e date e preparation is compounded. STABILITY: e extent to which a preparation retains, wi in specified limits and roughout its period of storage and use, e same properties and characteristics at it possessed at e time of compounding (see Stability Considerations. Beyond-Use Dating By Lou Diorio, RPh, and Dave omas, RPh, MBA Assigning Beyond-Use Dates for Compounded Sterile Preparations: Evaluating Stability Data Photo courtesy of Baxa Compounded preparation-specific, experimentally determined stability data evaluation protocols are always preferable to published stability information. Approach to assigning beyond-use dates. e goals of e Sterile Compounding Answer Book are to clarify common questions, address special situations, streamline e nature of e information included in e USP chapter, and provide wording clarity. e book provides expert guidance and practical advice to pharmacists, technicians, and o er. is ensures medication is at e labeled streng wi in e beyond-use date assigned it and complies wi USP. Facilities – Columbia Compounding utilizes an ISO 7 class cleanroom for preparation of sterile medications. In a cleanroom, all air is pulled in rough HEPA-filters, creating an environment at is much lower. You can, what would e usp cur- rently defines beyond use date. bud by type of a beyond use date' bud, bud, sterile, ismp, stability. Beyond-Use dates. Usp chapter 797, based on usp. ere is e conditions which a batch of. Due to usp 797, inc. Preparations and proposed changes. Preparations be done. e exact one hour beyond use date Related Products from MCN: Compounded Sterile Preparation – USP 797 Compliance Manual. MCN HEAL CARE. Regulatory Compliance Solutions for Heal care Organizations, Including Policy Management Softe, Policy Library Templates, StayAlert! – Regulatory Alert System, and Learning Management System. Non-Member $260.00 List e Beyond-use Dates (BUD) for low-, medium-, and high- risk CSPs Sterile Compounding Exam Review Webinar: USP Sterile Preparations is an online educational activity for pharmacists developed by e American Pharmacists Association and e U.S. Pharmacopeia.