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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

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  • 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

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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 thorough Risk-Based audit 

4. Accreditation

5. Ongoing interactions, assistance, and support

Low Cost / High Quality

Our low overhead costs allow us to drastically undercut competitor pricing.

See the "Our Method" page for an explanation of "risk-based" auditing and accreditation, and why it is a superior method for protecting your patients, your employees, and your pharmacy.
 

Coalition Members

L. Rad Dillon, R.Ph., M.A., ASQ SSGB, GMPro, ASQ CQA​​

Founder, Coalition for Compounding Excellence

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​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

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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

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Lawrence Curtis, RPh

Owner, Center for Pharmaceutical Compounding

 

Barbara Petroff, MS, RPh, FASHP, BCSCP, FNHIA, CAC, CSPP, IgCP 

Principal Shawler Petroff LLC

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Thomas Kupiec, Ph.D., Pharmaceutical Sciences

President and Managing Editor, International Journal of Pharmaceutical Compounding

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​Anthony Grzib, RPh

Vice President of RegulatoryAffairs, Revelation Pharma

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Brenda Gray, PharmD

Consultant pharmacist

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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

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Stanley Chamallas, RPh, FASHP, FNHIA

Director of Process Improvement for Home Care, Pneuma Systems Inc   ​

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Emily Durham, MS, CPhT

Director of Business Development, Covetrus

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Sky Countryman, B.S., Chemistry

Chief Executive Officer at HeliosRx Pharmacy

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Richard B Moon, PharmD, FAPC

Founder, Pharmacy Innovations Group

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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 Manager Industrial Hygiene, Trinity Life Sciences

 

Michael R. Alexander, J.D.

Shareholder, Brown & Fortunato

CONTACT US

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