Quality & Compliance Standards
Quality and Compliance Our Standard of Excellence
At FarmaKeio, quality is built through qualified personnel, controlled processes, appropriate testing, documented oversight, and continuous improvement. Our 503A pharmacies and 503B outsourcing facility are distinct operations governed by different regulatory requirements. Our state-licensed 503A pharmacies prepare medications pursuant to patient-specific prescriptions under applicable state law, USP standards, and Section 503A. FarmaKeio Outsourcing is separately registered with FDA and produces compounded medications in batches under applicable current Good Manufacturing Practice requirements and Section 503B. Each operation maintains quality controls appropriate to its regulatory pathway and the patients and healthcare providers it serves.
The FarmaKeio Quality Framework
Our commitment to quality is built upon three core pillars: sourcing, standardized protocols, and expert oversight.
Sourcing Integrity
The quality of a compounded medication begins with its raw materials. We utilize active pharmaceutical ingredients (APIs) sourced exclusively from FDA-registered manufacturers. Every ingredient is accompanied by a Certificate of Analysis (COA) to verify its identity, purity, and strength before it enters our formulation process.
Rigorous Standard Operating Procedures (SOPs)
Precision requires consistency. Our team follows documented SOPs for every step of the compounding process, from initial formula development and mixing to final packaging and labeling. These protocols ensure that whether we are preparing a single patient-specific cream or a large batch of sterile pellets, the result is consistent and reliable.
Expert Oversight
Our operations are led by highly trained industry professionals who specialize in complex compounding. Our team maintains a culture of continuous improvement, regularly reviewing our processes to incorporate the latest advancements in pharmaceutical science and safety.
Dual-Pathway Compliance
FarmaKeio is uniquely structured to provide different levels of service based on distinct regulatory frameworks.
503A: Traditional Compounding Excellence
Our 503A pharmacy focuses on individualized, patient-specific medications.
- Regulatory Body: Primarily overseen by state pharmacy boards.
- Standards: Full compliance with United States Pharmacopeia (USP) standards, including USP <795> for non-sterile compounding and USP <797> for sterile compounding.
- Patient Focus: Each medication is prepared pursuant to a valid prescription for an individual patient.
503B: FDA-Registered Outsourcing Facility
Our 503B facility is designed for scalable, sterile compounding to support hospital and clinic office use.
- Regulatory Body: Registered with the FDA and subject to regular federal inspections.
- Standards: Adherence to current Good Manufacturing Practice (cGMP) requirements, the same high standards applied to pharmaceutical manufacturers.
- Clinical Focus: Batches are tested for sterility, potency, and endotoxins to ensure the highest level of safety for procedural and in-office use.
Transparency and Testing
We believe in transparency. Our quality assurance program includes regular third-party testing to validate the potency and sterility of our preparations.
- Sterility Testing: Our sterile preparations undergo rigorous testing to ensure they are free of contaminants.
- Potency Verification: We perform regular assays to confirm that the concentration of active ingredients meet defined release specifications.
- Environmental Monitoring: Our cleanrooms are regularly monitored using viable air/surface sampling, non-viable particulate testing as well as temperature and relative humidity sensors to ensure we maintain an optimal environment for sterile compounding.
A Trusted Partner for Your Practice
When you partner with FarmaKeio, you are choosing a facility that invests in the technology, the people, and the processes necessary to protect patient safety. Our mission is to provide clinicians with the peace of mind that comes from knowing their patients are receiving medications prepared with their unique needs in mind.