Fagron Sterile Services

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</797>

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.

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 occasionsExample:

  • 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 a 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:

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.

Fagron Sterile Services
A leading DEA & FDA-registered 503B pharmaceutical outsourcing company dedicated to safe, quality sterile preparations.