I was speaking to a nurse last week about how her drug shortage problems do not seem to be letting up. As she thanked me for being able to supply her facility with some critical medications (ketorolac, metoclopramide, and two different strengths of lidocaine), I was thinking about the process that we go through to research new compounds and determine if a particular drug is a good candidate to be compounded at JCB Laboratories. There are specific criteria that must be met in order for JCB to begin compounding a medication. I thought I would share them with you to help you understand the process and enable you to ask the appropriate questions when seeking compounded solutions to your drug shortage problems.
- Sourcing the raw chemical
- JCB only purchases chemicals from FDA registered suppliers. But, our diligence does not stop there. We review the Certificates of Analysis for every chemical we receive to ensure they meet or exceed USP (United States Pharmacopeia) guidelines. We also check the country of origin. JCB Laboratories will not accept chemicals from countries that have a history of supplying substandard products.
- Researching the formulation
- JCB researches all aspects associated with producing the medication in question. How stable is the raw material? How soluble is it? How is the commercial product made?
- The clinical staff at JCB also looks at peer reviewed journal articles and consults with the nation’s leading compounding suppliers to learn all we can about the medication.
- Stability of the finished product
- Should it be stored at room temperature or refrigerated?
- How long is the drug still potent at these storage temps?
- Does the compound need to be protected from light?
- Does the stability of the medication change if it is stored in a syringe instead of a vial?
- Testing of the finished product.
- Our job is not done once we compound the medication. We utilize an independent third-party testing laboratory and send the finished product in for sterility, fungal, endotoxin and potency testing.
- The final product is not released from quarantine until these microbiology and chemistry tests are complete and meet the USP monograph standards for the drug in question.
Even with all the criteria that must be met for JCB to compound a new product for a customer, we can typically deliver medications that are in short supply in less than 2 weeks. This is a function of our dedicated and experienced staff. Sometimes our strict quality and safety criteria means JCB cannot compound a particular product. We stand firmly behind our pledge to not compromise your patient’s safety or our company values when it comes to supplying compounded sterile products to our valued clients. We know you wouldn’t want it any other way.