Monday, October 28
(Sponsored by the International Academy of Compounding Pharmacists with support from PCCA)
Part A: Smaller-Volume Compounding and Compliance: A Value Proposition for Indie Pharmacies
Compounding presents patient care and revenue opportunities for independent pharmacies, but also requires learning a new set of skills – including data collection, quality control/quality assurance, and justifying the quality of the preparations you provide. For those who understand the standards and are able to navigate the regulatory landscape, there’s a competitive advantage to be seized. This session will focus specifically on non-sterile compounding standards and the practical ways independent pharmacies can comply…profitably.
Seth DePasquale, PharmD, co-owner of BET Pharm, LLC (a compounding pharmacy specializing hormone formulations for equine reproduction.) Seth’s pharmacy ships to all 50 states, so he has a deep understanding of standards, rules, and regulations related to pharmaceutical compounding.
Dylan Herr, quality assurance and regulatory affairs manager, Eagle Analytics. Dylan oversees Eagle’s Quality Assurance and Quality Control functions of Eagle’s operations and is a regulatory consultant to 503A compounding pharmacies. Dylan has led pharmacies through NABP, BOP, and FDA inspections and helped them achieve ACHC and PCAB accreditation.
Part B: Everything Smaller-Volume Compounders Need to Know About USP <800> But Haven’t Had Time to Ask
The evolving regulatory environment will have to make changes, from facilities to workflow to SOPs. USP <800> implementation begins December 1, so pharmacies that compound hazardous drugs need to understand the requirements, construction and other associated costs, plus best practices – even if your state has not yet implemented the chapter. In this session, you’ll learn about industry trends, what other independent compounding pharmacies have done to prepare, and strategies to help overcome the related expenses – and you’ll get risk assessment templates and other tools to help you comply!
A.J. Day, PharmD, clinical pharmacist and vice president of clinical services, PCCA. His practice focus areas include veterinary compounding, aseptic compounding, pain management, compounding technique, and regulatory affairs. A.J. serves on the IACP Board of Directors and the National Community Pharmacists Association Compounding Expert Committee.
Bryan Prescott, PharmD, MBA, director of business coaching, PCCA. He works to provide clients financial analysis, marketing, and human resource expertise. Before joining PCCA, Bryan was PIC and operations manager of LTC at Pharmcare in Pearland, Texas. He is a frequent presenter on pain, palliative care, wound, scar, ENT, and marketing.
Pharmacist and Pharmacy Technician Learning Objectives:
- Describe applicable USP Standards related to non-sterile compounding (not only USP <795>.)
- Identify three opportunities for small scale non-sterile compounding operations that are often overlooked and three skills that are necessary for compounding professionals to have.
- Describe the lab design requirements necessary to ensure pharmacies are compliant with USP <800>.
- Explain risk assessment strategies and best practices each pharmacy should follow.
ACPE UAN: 0207-0000-19-319-L07-P | ACPE UAN: 0207-0000-19-319-L07-T | 2.0 contact hours (0.2 CEUs) | Activity Type: Knowledge-Based