GFI #256: How it affects compounding for veterinary patients – 2023 / 0.5 CE
This webinar will help veterinary compounders understand the requirements of GFI-256 and why such a document is necessary in the current federal landscape. Pharmacists and technicians will learn when FDA intends to use enforcement discretion regarding the compounding of animal drugs using bulk drug substances and how to comply with these requirements. They will also learn how they can nominate drugs to the list for compounding office stock drugs used for nonfood-producing animals.
Understanding the revision to USP <795> Pharmaceutical Compounding – Nonsterile Preparations – 2023 / 0.5 CE
This webinar will help pharmacists and technicians understand and prepare for changes to USP <795> Pharmaceutical Compounding – Nonsterile Preparations that will go into effect on November 1, 2023. The webinar will include differentiating dosage forms that may be compounded as nonsterile preparations and how to assign beyond-use dates as well as reviewing changes to facility, personnel, and documentation requirements.
Preparing for change: Key aspects of revised USP <797> Pharmaceutical Compounding – Sterile Preparations / 1 CE
This webinar will help pharmacists and technicians understand and prepare for changes to USP <797> Pharmaceutical Compounding – Sterile Preparations that will take effect on November 1, 2023. The webinar will include an overview of requirements including the transition to Category 1, Category 2, and Category 3 compounded sterile preparations and what each of these entails. Topics covered include requirements for facility and equipment, environmental monitoring, personnel training, and competency, documentation, and quality management.
Interpreting and Applying USP Compounded Preparation Monographs in Pharmacy Practice: Recipes for Quality / 1 CE
Since 1820, USP has published Compounded Preparation Monographs (CPMs) with the goal of standardizing quality-assured formulas for the most commonly used compounded preparations for humans and animals. While most pharmacy professionals are aware of these monographs, many do not understand the significance and utility of each of the sections of a monograph. Join this webinar to learn where to find and how to interpret the meaning and intent of these unique “recipes” and how to apply them to your veterinary pharmacy practice.
Gigi Davidson, RPh, DICVP, FACVP, FSVHP is the former Director of Clinical Pharmacy at the NC State University College of Veterinary Medicine where she practiced veterinary pharmacy for 35 years. Ms. Davidson received a pharmacy degree from UNC-Chapel Hill in 1983 and earned Diplomate status in the International College of Veterinary Pharmacy in 2001. She was inducted into the Phi Zeta Honor Society in 2006 as an honorary member for distinguished advancement of veterinary science. Gigi is a past President of the Society of Veterinary Hospital Pharmacists and of the American College of Veterinary Pharmacists. Ms. Davidson is the ACVP delegate to the American Pharmacists Association House of Delegates. Ms. Davidson was the Chair of the United States Pharmacopeia Compounding Expert Committee from 2010-2020 and continues to serve as a member. Gigi is the recipient of USP’s Beal Award when in 2015 she became the first female and first veterinary recipient of that award. She has many publications in peer-reviewed scientific journals, and her primary area of research interest is the stability, safety, and efficacy of compounded therapies in non-human species. Her research interests in retirement include drug disposition in honey bees and the pharmacological action of plant pollens and nectars on honey bee colonies.
Brenda Jensen CPhT, CNMT, MBA owns Compounding Consultants, LLC in Sioux Falls, SD. She has helped hundreds of compounding facilities across the country improve compounding quality and safety. Brenda is currently president-elect of the American College of Veterinary Pharmacists, serves on the Board of Directors for the American College of Apothecaries Research and Education Foundation, is a peer reviewer for Pharmacy Technician’s Letter, is a member of the APhA House of Delegates, and also teaches compounding courses for the American College of Apothecaries. She was previously the coordinator for the APhA Compounding Special Interest Group and served on the Board of Directors for the International Academy of Compounding Pharmacists and the Pharmacy Compounding Foundation. Brenda began volunteering for USP in 2013 and is currently Chair of the 2020–2025 Compounding Expert Committee.
USP has proposed revisions to chapter <795> which creates minimum standards for compounding of nonsterile dosage forms for both human and animal patients. Attendees will learn about the changes from the current version of USP <795>, highlight key themes in the proposed changes, and prepare themselves to meet or exceed these new standards. In addition, attendees will learn how some the concepts coincide with the FDA’s Insanitary Conditions Guidance document and the role this currently plays in pharmacy practice.
Tuesday, October 11, 2022 12 Noon Eastern / 11:00 am Central / 10:00 am Mountain / 9:00 am Pacific
ACA & ACVP Members: FREE Non-Members: $20
Define the changes in the proposed USP <795> compared to the current USP <795>
Illustrate the role that personnel and appropriate facilities play in limiting potential contamination of nonsterile compounds.
Analyze the key themes of the proposed USP <795> and how they coincide with the FDA’s Insanitary Conditions Guidance
Plan to implement any changes needed for compliance and quality of nonsterile compounds.
This webinar does not offer CE.
Register below. After you register, you will be directed to Zoom to complete your sign up and receive your Zoom webinar links via email.
Matt Martin, PharmD, BCSCP, joined the PCCA Clinical Services team in September 2014 and now serves as Director of Clinical Services. He graduated from Morehead State University with a BS in Chemistry in 2002 and received his PharmD from the University of Kentucky College of Pharmacy in 2006. In 2020, Matt became board certified in Compounded Sterile Preparations through the Board of Pharmacy Specialties. Prior to joining the PCCA team, Matt worked in compounding pharmacy for more than eight years and has experience with both sterile and non-sterile preparations.
On September 23, 2019, ACA received notification that due to ongoing appeals, implementation of proposed changes to USP Chapters 795 and 797 will not occur on December 1, 2019. This is good news for compounding pharmacy: the scope of the revisions to USP Chapters 795 and 797 – and the impact that the current revisions as written would have on maintaining patients’ access to compounded medications and on the preservation of local, independent community pharmacies’ ability to continue to compound—were too great.
ACA is committed to providing compounding training that reflects the USP Chapter Standards. We are in the process of updating the curricula for our 2020 live and online courses to reflect the proposed changes as they are currently written. Once USP makes a decision to deny or remand the ongoing appeals to Chapters 795 and 797, and communicates a new implementation schedule, we will adjust our revisions and training updates accordingly on our website.
If you have any questions about ACA compounding training or the inclusion of USP Chapter Standards in our curricula, please contact us at email@example.com. Click here to read the notice from USP.
Susan Bartlemay, RPh, FACA, FAPhA
Executive Director | CEO
American College of Apothecaries
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