Our Commitment to Quality and Safety

Where compounded medications are prepared

Every prescription for a compounded medication starts with a relationship between a patient and an independent, licensed provider. When a provider determines that an individual patient needs a medication that isn’t commercially available, our pharmacists, pursuant to that provider’s determination, prepare a compounded medication based on that prescription and clinical determination. All compounded medications are dispensed by US-based 503A pharmacies, which are permitted and regulated by their state Boards of Pharmacy and must follow FDA's 503A law.

The standards we follow

Different work calls for different standards. Here is what each one is and what it asks of us, in plain terms.‍

• Non-sterile medications (tablets and gummies). We follow two United States Pharmacopeia (USP) standards:
  ‍‍
  
  • USP chapter 795 is the national standard for compounding non-sterile medications. It covers the fundamentals of doing it right: clean, well-maintained facilities and equipment; ingredients of verified quality; trained staff; written procedures; accurate labeling; and setting beyond-use dates, which is how long a medication can be safely used after it's compounded.‍
  • USP chapter 800 covers how to safely handle hazardous drugs, meaning medications or ingredients that could harm people if handled inappropriately. It protects our staff, our customers, and the pharmacy environment through measures like dedicated spaces, specialized containment equipment, protective gear, and careful cleaning and disposal.‍

• Sterile medications(injectables). We follow USP chapter 797, the national standard for sterile compounding, along with an internal compliance standard we hold ourselves to. USP 797 requires cleanrooms with controlled, filtered air, strict aseptic technique and gowning, regular testing of the environment for contamination, and beyond-use dates that match how each product is made and tested. Sterility testing is required for certain products, and we test every final batch before we ship.
• Devices. For the medical devices we offer, we follow Good Manufacturing Practice (GMP) requirements. GMP is FDA's framework for making sure products are made consistently and correctly, every time. In practice, it means written procedures that are actually followed, qualified and trained people, clean facilities and calibrated equipment, testing of materials and finished products, and detailed records so that any product can be traced back through every step of how it was made.
• Diagnostics. We follow CLIA (the Clinical Laboratory Improvement Amendments), the federal rules for laboratories that test human samples to diagnose, prevent, or treat disease, in addition to applicable state laws. CLIA exists so that test results are accurate, reliable, and timely. It requires qualified lab personnel, quality control checks, regular proficiency testing, and careful record keeping.

Quality starts with the ingredients

Every active ingredient we use in compounded medications comes from an FDA-registered facility, meeting United States Pharmacopeia (USP) specifications. USP is an independent, not-for-profit organization that sets quality and safety standards for medicine.

Active ingredients are accompanied by a valid Certificate of Analysis (COA), confirming their identity, potency, and purity. And these ingredients are also tested using validated methods before they're used.

All sterile compounded medications are tested by third-party analytical laboratories, per USP standards. Every batch of compounded products is tested for sterility and endotoxin before it  ever goes out to a customer.

People who are trained to do this right

All pharmacists and technicians go through rigorous, ongoing training in aseptic technique, process validation, hazardous drug handling, and more. We require continuing education and qualification assessments, and we hold our teams to applicable FDA, state, and USP requirements.

Our pharmacies have their own quality assurance and quality control professionals, who provide hands-on environmental monitoring and testing, and who make sure our written procedures are followed and working as they should.

Always getting better

Strong systems keep us improving. We have formal procedures to document, investigate, and resolve customer feedback and complaints, and we monitor and report adverse events, based on state and federal requirements. We run regular internal assessments and use corrective and preventive action (CAPA) processes to find root causes and make our processes stronger. If a recall were ever needed, we have procedures to quickly notify regulators, providers, and patients about the affected lots.

We also build redundancy into our supply chain, so we're not overly reliant on any one supplier. It’s part of ensuring our customers maintain reliable, ongoing access to their prescribed treatments.

What customers can count on

Every compounded medication our pharmacies dispense is made to high standards, by trained teams, from carefully sourced ingredients, before it reaches you. We're proud of that, and we're not done. We'll keep listening to our customers, independent providers, and outside experts, and we'll keep raising the bar. Earning your trust is something we do with every order.