Choosing the Correct Type of Sterile Compounding Pharmacy

As a high risk sterile compounder, I routinely run into confusion over the different types of sterile compounding.  Not all compounders are the same and understanding the differences is an important first step in picking a compounder that can meet your needs.  Do you need a smaller-sized, unit-of use, prefilled syringe of a medicine that is only available in a large volume vial from a manufacturer?  Or, do you need a specialized product that is not available from the manufacturer?   Often times, you will need a couple of different sterile compounding suppliers depending on the type of procedure and the specific needs of your physicians.  

There are three types of Compounded Sterile Products (CSPs) and the United States Pharmacopeia, <797>, designates them by microbial contamination risk levels

1. Low Risk Sterile Compounding

  • This is compounding with aseptic manipulations using only sterile products components or devices.
  • Example:  using sterile needles and syringes to transfer sterile drugs from the manufacturer’s original packaging into another delivery container such as a unit of use syringe of morphine for use in the OR.

2. Medium Risk Sterile Compounding

  • Multiple individual or small doses of sterile products are compounded or pooled to prepare a sterile product that will be administered to multiple patients or to one patient on multiple occasions
  • Example: compounding total parenteral nutrition

There are national companies that specialize in low and medium risk compounding.  Everything they make starts with a commercially available sterile product.  Therefore, they are limited by the availability of manufactured product. These suppliers are also limited by the available strengths of the manufactured product. For example, If a physician wants a 4000 mcg/mL baclofen intrathecal syringe prepared, the low/medium risk pharmacies cannot supply this medication since the highest concentration of commercially available product is 2000 mcg/mL.  These types of compounds must be sent to the third type of compounding pharmacy- a High Risk Sterile Compounder:

3. High Risk Sterile Compounding

  • Non-sterile components (such as raw chemicals) are used to make a sterile product, which is then terminally sterilized.
  • Examples:
    • An intrathecal or epidural injection prepared from the raw drug powders.
    • A fortified antibiotic ophthalmic eye drop
    • Preservative Free versions of corticosteroids (such as triamcinolone and betamethasone) to use in the epidural space.

There are only a handful of sterile compounding pharmacies that exclusively prepare high risk CSPs.  High risk sterile compounding pharmacies are able to respond quickly to requests, such as the record number of drug shortages, because they have access to and need smaller amounts of the active ingredients needed to formulate medications.

JCB Laboratories Sticks With Core Competency

As a trusted sterile compounding pharmacy, we get requests daily to compound all manner of sterile medications. It can be tempting to try and “take all comers”. However, being all things to all people is not the way we have earned our reputation as the go-to high-risk compounder and a trusted resource for our customers. We take pride in JCB’s narrow focus on high-risk sterile compounding for the pain, ophthalmic and dialysis markets.


Written by Newport Beach Compounding Center Staff

As one of the most experienced compounding pharmacies in Newport Beach, We provide a valuable service working together with physicians and patients to create medications tailored to specific requirements. We are specialists in the art and science of pharmacy compounding. Our Team of experts can meet all of your unique pharmaceutical needs.

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