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Outsourcing of
Human Drugs (503b Services)

At KRS we provide innovative, effective and safe solutions to some of the greatest challenges in today’s medical environment.

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Our team of professionals is dedicated to delivering the most effective preparations possible to meet patients’ and health care professionals’ needs

In November of 2013, President Barack Obama signed the Compounding Quality Act which forced the compounding industry to follow certain guidelines to ensure the safety and quality of the products they prepare. Far removed from the days of mortar and pestle compounding, we are now known as a 503b Human Outsourcing Facility.

KRS is an industry leading customized FDA-registered and inspected 503b Human Outsourcing Facility that provides sterile compounding service to patients, surgery centers, ophthalmology clinics, hospitals and universities nationwide.

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KRS is an industry-leading customized FDA-registered and inspected 503b Human Outsourcing Facility, that provides sterile compounding service to patients, surgery centers, ophthalmology clinics, hospitals and universities nationwide. For more information about pharmacy outsourcing…

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Capabilities and Services

Our goal at KRS Global is to be the missing link to any
of your supply chain shortfalls.

KRS specializes in sterile, non-sterile and sterile intravenous admixture compounding services performed in a quality controlled, closed-system, automated environment.

Why do customers choose KRS?

  • Competitive Pricing
  • Convenience
  • Availability of Product
  • Customer Service
  • Testing of preparations with in-house, state-of-the-art quality control equipment.
  • Shipping nationwide with next day delivery.
  • Our customers rely on us for our ability to ship for hospital use in states where the law allows specialized drugs for patients which typical pharmacies cannot satisfy.
  • Custom dosages and delivery methods available upon request.
The FDA is encouraging all hospitals, surgical centers, and universities to utilize the services of a registered and inspected 503b outsourcing facility to meet their compounding needs for short medications. As the laws continue to evolve, only 503b facilities will be able to fill your hospital use needs.

Snap Shot of Available Dosage Forms

In-Process Testing

We now have the unique ability to switch once and for all from retrospective to real time microbial control.

Industry trends show that our partners have moved from a mere reliance on finished product testing towards comprehensive “in-process” testing at every crucial stage of production. This shift is especially critical to the Pharmaceutical industry, where microbial contamination is a prime concern. Delays associated with the traditional 14 day growth stage have motivated this shift in emphasis. These delays in microbial testing can directly impact effective consumer protection. With our leading edge equipment, we eliminate these possibilities.

Bioburden Testing

Testing for the amount of CFUs (bacteria) present in a preparation before sterilization via filtration

Dosage Testing to ensure accuracy

Bubble-Point Filter Testing

Testing to ensure filter functionality after sterilization

Safe. Effective. Innovative.

World Class Preparations

The advantages of a 503b FDA Human Outsourcing Facility with unmatched quality
and the advanced technology of a pharmaceutical manufacturer.

At KRS, the quality of the compounds we provide directly affects the care your patients receive. We make no compromise; our compounding processes implement the highest standards of quality control and testing equipment. These processes greatly exceed that of most compounding pharmacies in the United States.

On-site biochemists and microbiologists adhere to the strictest quality control measures, ensuring that your patients receive the highest quality compounds. Moreover, having an in-house, state-of-the-art analytical laboratory allows us to fully certify and conduct “in-process testing” with same-day results on final products.

This is a clear advantage when it comes to assuring the identity, concentration, quality, and purity of compounds. This protocol allows us to complete a certificate of analysis before a compound is made available to our partners, eliminating the possibility of errors and identifying any potential risks.

Our staff includes expert microbiologists, biochemists, chemists and PhDs.

Enhanced Assurances

Biotechnology Expertise

KRS is an outsourcing facility specializing in sterile injectables and other superior preparations. We are compliant with cGMP and held to the same standards as FDA registered manufacturers.

We utilize specific reporting requirements, including source of ingredients.

We offer accountability, traceability, and trackability of all preparations.

We apply validations and closed-system automations that mirror those of pharmaceutical manufacturers.

We follow a double sterilization process: filter and terminal sterilization utilizing autoclave.

We provide quality assurance with a full analytical laboratory.

Our Corporate Vision:

  • To provide the highest quality pharmaceutical medications in a timely manner without compromising patient safety.
  • To set the standard for all other human outsourcing facilities through utilization of manufacturer guidelines.