Quality assurance is foundational to every step of the process at J Kohll RX Compounding. We prepare sterile and non-sterile medications using validated procedures and in accordance with applicable USP and 503A guidelines. Every prescription is reviewed by a licensed pharmacist and compounded with clinical precision using FDA-registered ingredients.
503A Compliance
J Kohll RX Compounding is a 503A facility under Section 503A of the Federal Food, Drug, and Cosmetic Act. This designation requires that all compounded medications be prepared pursuant to a valid prescription for an individually identified patient.
Unlike 503B outsourcing facilities, 503A pharmacies do not compound for office use or bulk distribution. We focus exclusively on patient-specific medications, prepared under pharmacist supervision and supported by traceability, documentation, and quality assurance at every step.
USP <795> and USP <797> Standards
We operate under the most current USP guidelines for both sterile and non-sterile compounding:
USP <795> – Non-Sterile Compounding
Applies to preparations such as capsules, creams, gels, troches, and oral suspensions. These medications are compounded using validated processes designed to preserve stability and formulation accuracy.
USP <797> – Sterile Compounding
Governs the preparation of sterile medications, including injectables and ophthalmic solutions. Our cleanroom facilities are maintained under controlled environmental conditions, with routine aseptic technique training and microbial monitoring.
Quality Assurance and Safety Protocols
Our internal quality assurance framework is designed to ensure that every compounded medication meets specifications for identity, strength, purity, and uniformity. Key safeguards include:
Regular internal audits and procedural reviews support continuous quality improvement and accountability.
FDA-Registered Ingredient Sourcing
J Kohll RX sources all Active Pharmaceutical Ingredients (APIs) exclusively from FDA-registered manufacturers. Each vendor’s compliance with cGMP standards is verified before sourcing, and all ingredients are logged, inspected, and securely stored prior to use.
Documentation is maintained for every lot used in compounding, supporting traceability and reinforcing our commitment to formulation integrity.
Pharmacist-Led Oversight
All prescriptions at J Kohll RX Compounding are prepared under the direct supervision of licensed pharmacists with experience in clinical, regulatory, and specialty compounding. From formulation development to final dispensing, every step involves pharmacist oversight.
Our leadership is guided by Justin Kohll, R.Ph., a third-generation pharmacist with over 30 years of experience in compounding and pharmacy operations. He is supported by a highly skilled team:
Together, this team ensures each prescription is reviewed for accuracy, prepared in accordance with applicable regulations, and dispensed with provider-aligned clinical intent.
Setting the Standard in Compounding
J Kohll RX Compounding is committed to maintaining the highest standards in pharmacist-guided compounding. We support providers and patients with individualized formulations, strong communication, and fully compliant processes from prescription to dispensing.
If you’re a provider seeking a trusted compounding resource, contact our pharmacy team to learn more about our capabilities and procedures.
Located in Omaha, NE, and licensed in multiple states.
Phone: (402) 408-0015 or (888) 733-0300.