A Fresh, Affordable Pathway to Compliance and Quality
Experienced Auditors > Commitment to Excellence > Far Lower Cost
Stop by our booth at the
APC Owner Summit
March 19-21
AT&T Hotel and Conference Center
Austin, TX
APC and CCE Announce New Accreditation Partnership
Press Release: Jan. 26, 2026: Read the release here.
Our Mission:
-
Objectively assess and assist 503A pharmacies
-
Prepare pharmacies for any other regulatory agency that might walk in the door
-
Improve your pharmacy's efficiency and effectiveness through ideas, information, and consultative assistance
-
Perform all of this at a reasonable price
We Provide:
-
A realistic assessment of your compliance with relevant regulatory standards
-
Recommendations and information that allow you to improve your internal efficiency and external patient care
-
The opportunity to participate in ongoing compliance programs and a first-ever 503A benchmarking project
Key Attributes:
503A Experts
Audits are conducted by true 503A experts with proven auditing skills. They must have worked in, owned, or have deep auditing experience with compounding pharmacies.
Risk-Based Approach
Follows FDA's Q9(R1) Quality Risk Management approach versus a stricly checklist methodology.
Client Centered Approach
We actively provide pharmacies with information and suggestions that will improve their efficiency and effectiveness.
Our Process:
1. Intake and onboarding
2. Preliminary review of submitted evidence
3. On-site audit
4. Accreditation
5. Ongoing interactions and assistance
Low Cost / High Quality
Our low overhead costs allow us to drastically undercut competitor pricing.
About CCE
The Coalition for Compounding Excellence (CCE) specializes in supporting 503A compounding pharmacies with comprehensive accreditation, compliance, and inspection preparation services. Our expert team guides pharmacies through either CCE, ACHC, PCAB, or NABP accreditation, providing hands-on support for sterile and nonsterile compounding, regulatory readiness, and ongoing quality compliance. CCE also assists with nonresident pharmacy licensing, helping organizations navigate complex regulatory requirements with confidence. With a practical, risk-focused approach, we help compounding pharmacies achieve accreditation efficiently, reduce compliance risk, and maintain the highest standards of patient safety and operational excellence.
See a listing of our Auditors and Advisory Council Members below.
Our Auditors
David Miller, RPh., PhD., FAPC, FACA, Chief Formulation Scientist & Co-Owner, Keystone Pharmacy
David Miller earned his baccalaureate in Pharmacy from Ferris State University in 1990 and his master's and doctorate in pharmaceutics from the University of Michigan in 1994 and 1996, respectively. For seven years, David conducted drug delivery research involving both transdermal and trans-scleral drug delivery. In 2003, David and several partners founded Keystone Pharmacy, a traditional and compounding pharmacy located in Grand Rapids, MI. David has served for eleven years as a member of the Alliance for Pharmacy Compounding (APC) board of directors, including a term as chairman of the board in 2023. He is a fellow of the Alliance for Pharmacy Compounding, a fellow of the American College of Apothecaries (ACA), and an associate professor for pharmaceutics at Ferris State University. He has inspected hundreds of 503A pharmacies for a national accrediting organization.
Wendy Hagwood, PharmD., Pharmacy Operations Manager, Triangle Compounding Pharmacy
Wendy Hagwood was born and raised just outside of Daytona Beach, and is a proud alumnus of the University of Florida. She relocated to North Carolina to pursue her Doctor of Pharmacy degree at Campbell University, which she earned in 2005. As Pharmacy Manager and USP 795/800 Designated Person at Triangle Compounding Pharmacy, Wendy uses her 25 years of compounding experience to lead a dedicated team of pharmacists and technicians, working collaboratively with prescribers to solve complex patient challenges. In addition to her managerial role, Wendy contributes to the broader compounding community via private consultation activities. Areas of expertise include veterinary compounding, BHRT, nutritional support, USP standards, 503A and 503B regulations, writing policies and procedures, and how to meet and exceed accreditation standards in a compounding pharmacy.
Gary McCrory RPh., FACA, CCN, Consultant pharmacist
Involved in pharmacy compounding since 1977, Gary brings a wealth of experience to CCE. This includes his time as a compounding pharmacy owner, Past President and Executive Director of the Alliance for Pharmacy Compounding (APC), and Director of Pharmacy Compliance for PCCA (2015-2019). Gary was over compliance for a. Network of approximately 200 pharmacies while with PCCA. He also served as an ACHC / PCAB surveyor until January 2023
Joseph P. Navarra, RPh., FACA, FAPC, Owner, Town Total Compounding Center
Joe is the owner of Town Total Compounding Center located in Woodbury, New York, an accredited compounding pharmacy providing sterile and nonsterile patient-specific prescriptions. He has been very involved in professional organizations promoting and enhancing the practice of pharmacy at a high level. He is a past President and past Chairman of the Pharmacists Society of the State of New York, and of the Italian-American Pharmacists Society, and is a current board member of the New York City Pharmacists Society, and a Past Chairman of the Alliance for Pharmacy Compounding (APC), with which he is still very active.
Austin Lucht, PharmD., MBA, Director of Pharmacy, Nationwide Compounding Rx
Austin is an experienced Director of Pharmacy with over a decade specializing in sterile and non-sterile compounding. He and his high-performing team ensure full compliance with USP standards as well as state board regulations at a large 503A pharmacy in Scottsdale, AZ. Austin collaborates on FDA drug studies with major universities, contributing to clinical research and advancing patient care. He is skilled in quality assurance, regulatory preparedness, and operational optimization. Austin’s unique combination of clinical insight and business acumen allows him to balance patient-centered care with scalable, compliant operations. Austin is committed to innovation, safety, and excellence in pharmacy practice.
Barbara Petroff MS, RPh., FASHP, BCSCP, FNHIA, CAC, CSPP IgCP, Principal, Shawler Petroff LLC
Barbara is a consultant pharmacist working with organizations entering the home infusion and compounding businesses. She also prepares organizations for accreditation. She started her pharmacy career as a research pharmacist for a pharma company in the product development of sterile products. She subsequently spent over thirty years in the home infusion industry. She was also ACHC's first pharmacist surveyor, a role she continued for many years. Barbara served as the chair of the home infusion section advisory group of ASHP, and was a member of the group that petitioned BPS to provide the BCSCP certification for sterile compounding. She also has served on the standards committee for NHIA, and currently chairs the Sterile Compounding Practice Committee and is on the faculty for the Sterile Compounding Clinic held at the NHIA yearly meeting. She recently assisted a company with setting up a non-sterile compounding program.
Samantha Tricarico, CPhT, CSPTCo-Owner, National Sterile Compounding Institute
Samantha leverages her 30 years of pharmacy technician experience to create and deliver compounding training nationwide. Her time as a technician spanned various settings, including community, hospital, long-term care, outsourcing, and home infusion. Her diverse roles included sterile compounding, cleanroom supervision, prescription dispensing, inventory management, workflow design, and personnel training. Samantha is very active with the National Home Infusion Association (NHIA) where she serves on the Sterile Compounding Practice Committee and is a faculty member in the annual Sterile Compounding Clinic.
L. Rad Dillon, RPh., M.A., ASQ SSGB, GMPro, Founder, Coalition for Compounding Excellence
Rad spent most of his early career in the home infusion and specialty pharmacy industry, holding administrative and management positions for a variety of national and regional organizations. During these years he acquired a variety of certifications from the American Society for Quality (AQS), including as a Certified Manager of Quality and Organizational Excellence (CMQ/OE) and Certified Quality Auditor (CQA). In 2013 he transitioned to the role as a surveyor of a wide variety of alternate site pharmacies for a national accrediting organization, including many 503A pharmacies. Since 2023 he has served with several consulting organizations while laying the groundwork for CCE. He is also active with the National Home Infusion Association (NHIA) and the American College of Apothecaries (ACA).
Brenda Gray, PharmD., Owner and Senior Consultant, Clinical Pharmacy Partners
As a 25 year plus veteran of pharmacy practice, Brenda is a consultant pharmacist who works with compounding organizations (sterile and nonsterile) as well as a variety of other pharmacy practices. She has board certifications in sterile compounding, nutrition support and vascular access in the US and abroad. Well known for challenging companies to pursue excellence, she served as an ACHC/PCAB surveyor and consultant for over 12 years focusing on quality, compliance and efficiencies. She is a well respected speaker at multiple national and international meetings and has served on the faculty of Sterile Compounding Clinic at NHIA since its inception. She has a special interest in disaster preparation and response as well as being a nationally recognized advocate for disabled patient access.
Anne Harthman, PharmD., Consultant Pharmacist
Anne is a proud alumna of Pacific University and owner of a regional Compounding Pharmacy. Her desire to help people led to a fulfilling and evolving career in pharmacy. She is an avid developer of standard-setting efficiency and quality assurance practices in compounding. Her experience lends itself to compounding with specific knowledge of state regulations and non-sterile compounding. She holds multiple state pharmacy licensures and has expertise in various regulatory standards.
Austin Castle, PharmD., Regulatory Compliance Consultant
After a stint in retail pharmacy, Austin moved to providing care for those in a prison facility similar to an LTACH for five years, applying USP <797> standards to the noncompliant pharmacy. After being the Lab Director at a local accredited sterile and nonsterile compounding community pharmacy, he now serves as the Regulatory Compliance Consultant for this pharmacy, where his duties include SOP maintenance, inspection readiness and quality management.
Advisory Council
L. Rad Dillon, R.Ph., M.A., ASQ SSGB, GMPro, ASQ CQA
Founder, Coalition for Compounding Excellence
Joseph Navarra, R.Ph., FACA, FAPC
Owner, Town Total Compounding Center
David Miller, RPh, PhD, FAPC, FACA
Chief Formulation Scientist & Owner, Keystone Pharmacy
Scott Popyk, RPh, MBA
CEO of Healing Dose Compounding Pharmacy
Danny Barnes PharmD BCSCP RPh
Chief Pharmacy Officer/President
Triangle Compounding Pharmacy Inc.
Jerry Eubanks, RPh
President, Pestle - Pharmacy Compliance System
Gary McCrory, RPh, FACA, CCN
Consultant pharmacist
Rick Ferris, PharmD, ND, MBA, MPH
Consultant pharmacist, functional medicine practitioner
Ralph McBride, RPh, MBA, BCSCP
Strategic Sourcing Manager, AuthoraCare Collective
Lawrence Curtis, RPh
Owner, Center for Pharmaceutical Compounding
Barbara Petroff, MS, RPh, FASHP, BCSCP, FNHIA, CAC, CSPP, IgCP
Principal Shawler Petroff LLC
Anthony Grzib, RPh
Vice President of RegulatoryAffairs, Revelation Pharma
Brenda Gray, PharmD
Consultant pharmacist
Mike Rigas, Pharm.D
Chief Clinical Officer, Emeritus, KabaFusion
Samantha Tricarico, CPhT, CSPT
Compounding Pharmacy and Education Specialist
Edie Gigot, RN, MS, MBA
Founder and CEO, AdvisorWoRx
Stanley Chamallas, RPh, FASHP, FNHIA
Director of Process Improvement for Home Care, Pneuma Systems Inc
Emily Durham, MS, CPhT
Director of Business Development, Covetrus
Sky Countryman
Chief Executive Officer at QCRxUSA Pharmacy
Richard B Moon, PharmD, FAPC
Founder, Pharmacy Innovations Group
Timothy Safley, MBA
Owner, Safley Health Care Consulting
Michael Magee, RPh, ASQ CPGP
Owner and Principal Consultant, Kenformete Solutions, LLC
Amy H. Snow, MHS, CIH, CSP
Senior Managing Industrial Hygienist, Trinity Consultants | Life Sciences
CONTACT US