Quality Assurance, Compliance, and Safety

Quality Assurance

Tailor Made Compounding’s number one priority is patient safety. We fulfill this commitment by sourcing raw materials only from FDA-registered manufacturers and distributors. As a patient-specific 503A compounding pharmacy, we utilize advanced technology and invest heavily in quality control processes to ensure we dispense the right medication, the right concentration, and right route of administration for the right patient.

Facility & Laboratory Environment Safety

Tailor Made continues to expand its quality assurance program through investments in equipment and people. Our 20,000 square foot compounding facility is designed to meet and exceed current USP guidelines. Our Pharmacy is one of only a few 503A compounding pharmacies equipped with a negative pressure hazardous cleanroom in accordance with new USP <800> guidelines. Recent state-of-the-art investments include:

New Class 100 laminar airflow hoods
Biological safety cabinets for hazardous compounding
Industry-leading, cloud-based Quality Management System
Advanced temperature monitoring system
Continuous environmental monitoring system

Sterility Assurance

Tailor Made works with reputable and experienced third-party independent laboratories to perform sterility testing of all compounded sterile batches, including USP <85> (endotoxin testing) and USP <71> (sterility testing).

In addition to leveraging independent laboratories, Tailor Made further ensures the sterility of our compounded preparations with the following:

Raw materials purchased from FDA-registered facilities with supporting certificate of analysis on hand
Five-step order verification process
Images of the contents of every order captured throughout each stage of the order fulfillment process
Sterility reports available upon request for all sterile orders
Real-time monitoring of conditions in all ISO classified sterile compounding
rooms
Robust internal environmental monitoring program exceeding USP guidelines

Pharmacy Team

We recognize patient safety begins with building an experienced and dedicated pharmacy team. Our employees are the foundation of our Pharmacy. Each team member has undergone a rigorous interview process and background analysis. Our hiring process focuses on identifying honest, qualified, and motivated team members who are dedicated to quality, safety, and service. Our Pharmacy is located within 10 miles of University of Kentucky’s College of Pharmacy, which is considered one of the best pharmacy programs in the country. We continue to leverage our geographic location to build a team of talented and experienced pharmacists.

Other ways we advance patient safety through our staff include:

A Dedicated Compliance Committee that meets weekly to discuss internal compliance matters and relevant regulatory trends. The Compliance Committee is comprised of seven team members who possess a wide variety of expertise (e.g., microbiology, legal, USP compliance)
Full-time, on-site microbiologist to manage internal environmental monitoring program
Routine and unannounced assessments of compounding staff
Weekly training sessions for sterile and nonsterile technicians
Weekly personnel assessments, including glove finger-tip testing

Regulatory Compliance

Tailor Made is licensed in 46 states for both sterile and nonsterile compounding. We are subject to regular inspections by state boards of pharmacy (including the Kentucky State Board of Pharmacy and the California State Board of Pharmacy) and third-parties (including the National Association Board of Pharmacy’s Verified Pharmacy Program) to evaluate our compliance with applicable state laws and United States Pharmacopeia guidelines. Tailor Made Compounding is in good standing in all 46 states in which we are licensed.

We are the Proud Partners of Physicians Who Care

At Tailor Made Compounding, we understand that your patients are more than just a name on a chart. They’re the embodiment of the high-quality care you provide, an extension of your practice, and an example of the life-altering power of integrative medicine.

That’s why, in addition to the high-quality, customizable, and sustainable treatment options we offer, we also provide opportunities and support for the health of your clinic. Including free educational resources to help simplify the business needs of your practice, so you can focus on what really matters – your patients.

Together, we’ll help you cultivate long-term wellness for both your patients and your practice.