PPT-PARENTERALS: COMPOUNDING STERILE FORMULATIONS

CHAPTER 9 CHAPTER OUTLINE Compounding Sterile Formulations Special Considerations Regulatory Oversight LVP Solutions SVP Solutions Special Solutions Administration Devices Laminar Flow Hoods. Background on STERILE PREPARATION COMPOUNDING Safety General information Stakeholder Collaboration Goals for the summit Disclosure Hemant N. Joshi, Ph.D., MBA. Tara Innovations LLC. www.tarainnovations.com. . October 17, 2011. Quality by Design. QbD. is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management.. Proposed USP Chapter <800>. on Hazardous Drugs. Bill Peters. NuAire, Inc.. Safe Compounding Act of 2013. Gives FDA authority for compounding. Over 80 483s and warning letters issued to what will be considered FDA outsourcing facilities. parenterals. , Total Parenteral. Nutrition and Intravenous additives.. Injections . These are the preparations which are given other than oral routes. . Injections are sterile, pyrogen-free preparations intended to be administered . Frederick M. Frankhauser, JD, MBA. Adjunct Assistant Professor. MCPHS University. Objectives. 1. Provide an brief overview in the recent changes in pharmacy compounding regulations. 2. Describe the Drug Quality and Security Act and its impact on pharmacy. Stephanie Montoya, CPhT. Coryann. . Senteno. , CPhT. Objectives:. At the completion of this application-based presentation, the Pharmacist participant will be able to: . 1) Accurately calculate the correct amounts of ingredients for a compounded product. . Danielle Fagnan, . pharmacist. ,M. Sc.. . Director. of . professional. services. Ordre des pharmaciens du Québec. NAPRA March 13. ,. 2014. Standards for pharmacy compounded sterile preparations. Jessica Tagerman, . PharmD. , . RPh. Compounding is like cooking!. “What are we making?”. Medication- . “What are we making?”. i.e. “medication preparations”. “What are we making?”. Dosage Forms. What is the name of the . document with approved agents . to be used in an institution or reimbursable by an insurance plan?. a. database. b. policy. c. legend. d. formulary. formulary. When checking in an order from the wholesaler, against which of the following documents should the order be checked?. CompoundingSterile Preparations detailed in Pharmaceutical Compoundingibe practices to provide a reasonable assurance of maintaining patient safety associated with the administration of 34 Committee s A.I. Fraguas-Sánchez . 1. , A. Fernández-Carballido. 1. , and A.I. Torres-Suárez . 1,. *. 1. Department of Pharmaceutics and Food Technology, Faculty of Pharmacy, . Complutense. University. . *. Pharmacy . Technician Education. ASHP Section Advisory Group on Advancing Pharmacy Practice with Technicians 2018-2019. Table of Contents . Didactic overview of types of hazardous drugs (HD) and their risks. Yousef Ahmed . Alomi. , Fatimah . Fouad. Al . Doughan. ,. . Faiz. A. . Bahadig. , . Malika. . Alhadab. , Mona . Lubbad. , . Ebtesam. . Nazal. ABSTRACT: . Objectives: . The primary objective of this study was to explore cost analysis of pediatric formulations in Riyadh city, Saudi Arabia. . Yousef Ahmed . Alomi. , . Malika. . Alhadab. , . Faiz. A. . Bahadig. , . Mona . Lubbad. , . Ebtesam. . Nazal. , . Khulud. . Khalid . Alnami. ABSTRACT: . Objective: . The aim of this study is to explore the cost analysis of pediatrics anticonvulsant formulations in Saudi Arabia.