Nonsterile compounding for pharmacy technicians covers all the concepts and processes necessary to prepare the student, novice, or seasoned pharmacy technician with the tools to enter this growing pharmacy sector, or enhance their skills in order to be successful in any nonsterile compounding practice environment. Between the monograph references and the index is a pair of appendixes that provide benchmarks based on usp guidance for determining beyonduse time points for sterile and nonsterile preparations to be referred to when adequate stability data is unavailable. Detail current requirements of master formulation and compounding records. Value a clinical case scenario flow chart that helps the compounder navigate decisionmaking requirements, leading to a compounded medication. In pharmacology, compounding done in compounding pharmacies is the creation of a particular pharmaceutical product to fit the unique need of a patient. Healthsystem pharmacists routinely compound medications in response to patient needs. Applied pharmaceutics in contemporary compounding, 4e, and its accompanying website have been carefully developed for pharmacists, pharmacy educators, pharmacy students, and pharmacy technician students. Previous edition was extemporaneous formulary moh 2012. Documented training of all pharmacists performing andor supervising nonsterile compounding, signed by trainer. Model standards for pharmacy compounding of nonsterile. This may be done for medically necessary reasons, such as to change the form of the medication from a solid pill to a liquid, to.
The pharmacy technician 4e chapter 9 compounding slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Millions of medications are compounded each year in the us to meet the unique needs of patient, including vulnerable populations such as seniors and children. Getting started in nonsterile compounding workbook and dvd. Usp compounded preparation monographs contain formulations used in human and animal patients. Jan 01, 2005 administration admixtures agents airflow allergen american society ampuls antineoplastic appropriate aseptic technique ashp guidelines automated compounding devices beyonduse dating biological safety cabinets cabinet chapter chemical clean cleanroom components compounded sterile preparations containers contract pharmacy controlled area. Mixing powders using a spatula in a mortar, an ointment slab, or a plastic bag. Trissels stability of compounded formulations, 5th edition provides a single compilation of all. Each step of the compounding process should be documented. She has specialty training in nonsterile compounding, pharmaceutical technology, cosmetology, and veterinary compounding. List important elements on a certificate of analysis 4. Pharmacy compounding of nonsterile preparations, and the accompanying guidance document for pharmacy compounding of nonsterile preparations. It should be kept in a 3ring binder and stored with other operational pharmacy binders. Formulas in this section are contemporary and have been available since this website was initiated.
Since its first publication, extemporaneous formulations, by rita jew, winson soohoo, sarah erush, and elham amiri, has been the goto guide for treating patients who require any of the 80% of medications not commercially available in appropriate forms or dosages for pediatric, geriatric, or special needs. Non sterile compounding is mostly topical and enteral. Usp standardsgeneral chapters and monographscontained in the united states pharmacopeia and the national formulary uspnf are recognized in. This book covers all elements of compounding, sterile and nonsterile, with preparations ranging from iv products to powders, solutions, and suspensions. All rights reserved no part of this publication may be reproduced, stored or transmitted in any form or by any means. Guidance document for pharmacy compounding of nonsterile. In addition, napra would like to thank the members of the national advisory committee on pharmacy practice for their continued diligence in the development of these documents. Reflective assessment objectives integration of concepts and ideas apply and adapt standards of practice to best suit your compounding practice. Consistency and compliance to meet the increasing demand for. This comprehensive program combines the concepts foundation of a textbook with the skills practice of a training manual. The actual practical and handson preparation of dosage forms bridges the gap between theory and practice. Based on data published over the past 60 years, the reference summarizes specific formulations and stability studies. A comprehensive literature search was carried out to identify new drugs with extemporaneous formulations and new formulations of drugs that appeared in the previous edition of the book. Sterile and nonsterile compounding online practice exam.
These formulations can sometimes be very important in meeting a patients needs, such as when a person is allergic to an inactive ingredient found in commercially available forms of the. This is not a recipe book it isnt going to tell you the processes to create individual recipes. The master formulation record is the general information that will be used each time a particular cnsp is compounded, a recipe to follow. Frequently asked questions about pharmaceutical compounding. These monographs provide quality standards for specific preparations to assist practitioners in compounding formulations for which there is no suitable commercially available product. It provides compounders with guidance on applying good compounding practices for the preparation of nonsterile compounded formulations for dispensing andor administration. Trissels stability of compounded formulations bd education center. This book is designed to convey a fundamental understanding of the practices involved in developing and preparing compounded dosage forms utilizing. Pinheiro was a surveyor and standards committee member of brazils national association of compounding pharmacy, a nonprofit organization that oversees customized pharmaceutical preparations. Nonsterile compounding techniques in action to help your trainees get started right view the getting started video training series demo. Extemporaneous formulations for pediatric, geriatric, and.
Extemporaneous formulation, moh 2015 pharmaceutical services division, ministry of health malaysia lot 36, jalan universiti, 46350 petaling jaya, selangor. If you continue browsing the site, you agree to the use of cookies on this website. Ashp has a couple of books available for purchase about compounding for peds and geriatrics. If you can get your hands on an old martindale book, that would be good for older drugs. We strongly encourage you to have a copy of the workbook for each trainee. Usp compounded monographs provide quality standards for specific preparations to assist practitioners in compounding formulations for which there is no. One common conundrum solved by compounding is the provision of a liquid formulation of a medication made from a tablet or capsule for a pediatric patient who cant swallow solid dosage forms. Start studying compounding and processing nonsterile preparations 209100. Frequently asked questions about pharmaceutical compounding compounding is the creation of a pharmaceutical preparationa drugby a licensed pharmacist to meet the unique needs of an individual patient either human or animal when a commercially available drug does not. Addition of a new requirement for master formulation records for csps prepared for more than one patient and for csps prepared from nonsterile ingredient s and compounding records for all csps. Pharmaceutical compounding is performed or supervised by a pharmacist licensed by a state board of pharmacy see question below on legal oversight of compounding versus. Official or assigned name, strength, and dosage form of the cnsp 2. Nonsterile preparations, and chapter 797, pharmaceutical compoundingsterile prepara tions, when these standards are addressed by the individual state board of pharmacy.
A practical guide to contemporary pharmacy practice and. Two appendicesbeyonduse dating for nonsterile compounded. What is the purpose of lactose in the following master formulation record. Formulation sheets with information on how to compound specific oral liquids may be accessed by clicking on the drug. Developed in collaboration with skilled technician educators who are also experienced certified technicians, the getting started in nonsterile video training program brings you the most practical. For use in sterile and nonsterile compounding areas, hospitals, nursing homes, medical and dental offices and clinics, operating r ooms, isolation wards, and medical research facilities. Available in dvd, each video is designed to be used with a companion workbook that has plenty of exercises and selfassessment questions to ensure your students and staff get the most out of their training time. For purposes of this chapter, nonsterile compounding is defined as combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturers labeling, or otherwise altering a drug or bulk drug.
Trissels stability of compounded formulations by lawrence. Compounding records usp chapter 795 requires pharmacies to maintain formulation record master formula compounding record for each compounded preparation formulation recordan individual record like a recipe filed alphabetically listing of the ingredients compounding equipment instructions for preparing formula. Identify challenges pharmacists an support staff may encounter when. Their primary advantages include enhanced solubility and bioavailability for lipophilic drugs that provide formulation challenges. Discuss approaches to ensure personnel safety, and the quality and safety of nonsterile preparations. Usp general chapters for compounding establish procedures, methods and practices that are utilized by practitioners to help ensure the quality of compounded preparations. Basic compounding documentation the compounding record usp 2019 8. These formulas include both contemporary, informational, and some historical formulas. Jul 27, 2015 chapter 3 sterile and nonsterile compounding 123 sifting. The books and references may be in electronic format andor available via the internet. The most common compounding you are likely to do is preparation of intravenous iv solutions. Chapters also cover pharmaceutical calculations and the basics of prescription processing.
Book or notebook in which data are recorded or compiled to. The usp and compounding nonsterile medications lisa d. When compounding nonsterile preparations cnsp, documentation is necessary in order to be able to systematically trace, evaluate and replicate the steps throughout the compounding process. Traditional compounding is the preparation of a medication to meet the prescribers exact specifications and to be dispensed directly to the patient, pursuant to a valid prescription for that patient. The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounders ability in the compounding facility to extemporaneously compound preparations that are of. Nonsterile compounding and repackaging basicmedical key. In addition, uspchapter 795, pharmaceutical compoundingnonsterile preparations. Ingredients used for nonsterile compounding quality and storage. Drug compounding is a service provided by some pharmacies and is a process in which medications are prepared in unique formulations for a specific patient.
A date assigned to compounded prescription telling the patient when the. Documented training of all technicians performing nonsterile compounding, signed by trainer. Selfemulsifying drug delivery systems can be orally administered in hardgelatin capsules so they can be appropriate for compounding after the formulation has been developed. Trissel s stability of compounded formulations is the only book in print that compiles all currently available stability information on drugs in compounded oral, enteral, topical, ophthalmic, and other specialized preparations. When the cnsp is compounded according to manufacturers labeling instructions, no further documentation is required. A technique to either blend or combine powders spatulation. The book uses an outline, bulleted format with examples and graphics interspersed throughout. They are continually being updated and new formulas added. At the completion of this activity, the participant will be able to explain the trends contributing to the growing need for compounding services, and apply compounding regulations and guidelines outlined in section 503a and usp 795. This ashp resource center is a compilation of tools and resources to help pharmacists ensure the quality of compounded sterile products.
Usp provides three types of public quality standards for compounding. Initiative to standardize compounding of oral liquids. The compounding log must be filled out for each and every compound made. A prescription, medication order, or label may serve as the compounding record provided that it contains all of the information specified in the chapter. Explain risk management strategies fo r handling hazardous drugs, including those in u. The nonsterile compounding standard, usp general chapter pharmaceutical compounding nonsterile preparations categorizes nonsterile compounds as simple, moderate, or complex dosage forms. Concepts training and assessment for pharmacy technicians. The newest addition to our pharmacy technicians product group is sterile compounding and aseptic technique. Chapter 3 sterile and nonsterile compounding quizlet. Start studying chapter 3 sterile and nonsterile compounding.
Usp chapter 795 requires pharmacies to maintain a formulation record, also known as the master formula, and a compounding record for each compounded preparation. Compounded preparations monographs cpms usp compounded preparation monographs contain formulations used in human and animal patients. Implementing united states pharmacopeia chapter 795 pharmaceutical compounding nonsterile preparations, part 3. Ashworth, bs pharm, rph, faca compounding specialist and clinical pharmacist.
Training is appropriate to category of compounding, simple, moderate andor complex. Participants will perform preformulation calculations, prepare an array of current and popular dosage forms, and adhere to a series of standard operating procedures while formulating in the lab environment. Pharmacy tech chapter 9 on compounding proprofs quiz. This is not a recipe book it isn t going to tell you the processes to create individual recipes. A regulation from uspnf pertaining to the nonsterile compounding of formulations. Some differences between standards for sterile compounding in this chapter and those for nonsterile compounding in. Compounding is an integral part of pharmacy practice and is essential to the provision of health care. Applied pharmaceutics in contemporary compounding, 4e.
These standards are developed by the usp compounding expert committee to help ensure the quality of compounded medicines. Veterinary compounding a customized approach lp3 network. With a number of different sample formulas to choose from, you can benefit from our extensive formula database to help with your daytoday compounding needs. Since 1820, a nongovernmental organization, the united states pharmacopeial con. A book or reference containing formulas with directions for compounding. Usp details requirements for nonsterile compounding activi ties. Pharmaceutical compoundingnonsterile preparations pharmaceutical compoundingsterile preparations. Do you know how it compares to allens compounded formulations. Pharmacists who compound medicines will find this formulations. Looking for published articles is a good option too. Pharmacy technicians letter includes 12 issues every year, with brief articles about new meds and hot topics.
Pharmaceutical compoundingnonsterile preparations official january 1, 2014 osha hazard communication labels see osha. The purpose of this chapter and applicable monographs on formulation is to help define what constitutes good compounding practices and to provide general information to enhance the compounders ability in the compounding facility to extemporaneously compound preparations. This chapter andor processing of a drug or device, either directly or indiapplicable monographs on formulation help define good rectly, by extraction of the drug from substances of natural. The compounding record is the specific information for a specific cnsp.
Calculations used when compounding medications pharmacists and pharmacy technicians all compound medications in one way or another, at least at some point in their careers, and you will try your hand at it soon, if you have not already. To do this, compounding pharmacists combine or process appropriate ingredients using various tools. Description of categories gov, and material safety data sheets msdss are available to compounding personnel for all drugs and chemicals used in compounding. Non sterile compounding flashcards from mike ferenzs temple university school of pharmacy class online, or in brainscapes iphone or android app. There has been no commercial support for this activity. Pharmaceutical compounding nonsterile preparations. This program will focus on providing guidance for pharmacy technicians involved in non sterile compounding in a variety of pharmacy practice settings. Best book to use for nonsterile compounding recipes. When compounding is done on bulk production of a given formulation rather than patientspecific production, it is known as non traditional compounding which, as discussed below, is arguably not compounding but rather manufacturing. Multiple published formulations of medicines with the same concentration, as well as formulations with differing concentrations, are offered to enable pharmacists to select the most appropriate formulation for their patients. Ashworth, bs pharm, rph, faca compounding specialist and clinical pharmacist, childrens health system of texas. The framework of this book will help readers determine whether formulated.
This is much more than a book of drug formulation recipes. Learn vocabulary, terms, and more with flashcards, games, and other study tools. Trissels stability of compounded formulations is the only book in print that compiles all currently available stability information on drugs in compounded oral, enteral, topical, ophthalmic, and other specialized preparations. The formulation record is an individual record like a recipe that is stored in a file with other formulas. Compounding and processing nonsterile preparations 209100. Support the transition from process development, to master formulation record, to compounding record through the use of a template designed to incorporate the parameters for all three formulation stages. There are just over 170 usp compounding monographs.
Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases. There are several essential compounding general chapters. Guidelines for compounding practices american pharmacists. Pharmaceutical and formulation considerations 4 section ii drug dosage form and drug delivery system design after reading this chapter, the student will be able to. In rare occurrences, an alternate concentration may be available in addition to the standard. Sometimes these formulas may have a name associated with them. It includes clear stepbystep instructions and brief. Basic compounding documentation the master formula form usp 2019 8. Compounding is an integral part of pharmacy practice andmanufacturingthe production, propagation, conversion, is essential to the provision of healthcare.
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