In 2014, United States Pharmacopeia (USP) proposed the Hazardous Drugs – Handling in Healthcare settings chapter, also known as USP <800> to supplement USP <795> and USP <797>, which outline the safe handling and compounding of non-sterile and sterile compounds. In its current form, USP <800> is informational only and not compendially enforceable, unless an entity with legal authority over a hospital or practice decides to enforce the regulations.

While final adoption of USP <800> is still pending, this standard is meant to provide for safe handling of hazardous drugs so the risk of contamination to healthcare personnel, patients, and the environment is minimized. It’s important to recognize this is intended to regulate employee protection.

Gillson Testing is dedicated to empowering our partners to maintain a safe environment for both patients and employees. To that end, Gillson Testing offers a simple testing kit for collecting samples of a variety of hazardous drugs often handled in specialty pharmacies, including those that are hardest to test for and most difficult to clean.
 

Available Sampling and Testing

To enable our clients to meet the requirements of USP <800> Gillson Testing has completed a robust validation in accordance with ICHQ2 of swab sampling followed by analytical testing of several Group 1 hazardous drugs. The validation was completed on the most common material found in cleanroom environments (stainless steel). This validation meets USP requirements for the recovery of these hazardous drugs from stainless steel.

Sampling kits are available for you to purchase and subsequently use to collect samples of these hazardous drugs. Step by step instructions are included in the sampling kits to aid in the sampling process.

  • Group 1 Drugs: cyclophosphamide, methotrexate, irinotecan, daunorubicin, doxorubicin, paclitaxel (all tested within one sample)

  • Group 1 Platinum Drugs: carboplatin, cisplatin, and oxaliplatin (all tested within one sample)

Gillson Testing will continue to add additional drugs to our hazardous drug service offering as we develop validated methods. If you have a need to test for a specific hazardous drug that is not included in this list above, please contact us. We will work with you to develop a plan to address your unmet needs.

Timing

Available now.

Process

Sampling kits can either be ordered and delivered with step-by-step sampling guidance, or Gillson Testing staff can visit and sample on site. The kits are then returned to Gillson Testing where they are analyzed using ICP-MS (platinum drugs: carboplatin, cisplatin, and oxaliplatin) or LC-MS/MS (cyclophosphamide, methotrexate, irinotecan, daunorubicin, doxorubicin, paclitaxel).

Gillson Testing will report the results obtained to the client. It is the client’s responsibility to interpret and apply the data provided for their specific operation.

If you have not ordered supplies from Gillson Testing before, please click here to set up an account.