CASE STUDY:

Rapid Deployment of Critical Services Proves Instrumental in Helping Secure MedPrep’s Approval to Resume Operations

THE CLIENT: MedPrep Consulting

MedPrep is a specialty intravenous (I.V.) pharmacy licensed by the State of New Jersey offering compounding services.

THE SITUATION:

MedPrep Consulting contracted Gibraltar Labs in late February of 2013 to help improve their quality standards, testing and compounding practices. The action was taken in advance of new and stricter regulations governing compounding pharmacies, forthcoming at both the Federal and State levels.

In Mid-March, as Gibraltar was assisting MedPrep, an incident occurred at Yale-New Haven Hospital. It involved the discovery of mold contamination in I.V. bags of magnesium sulfate that MedPrep had prepared and supplied to the hospital.

THE REACTION:

Upon learning that the contaminated bags were sourced from its facility, MedPrep promptly issued a recall of all its compounded preparations, ceased operations as directed by the NJ Board of Pharmacy, and requested Gibraltar Labs immediate support in managing the crisis.

THE GIBRALTAR LABS RESPONSE:

Gibraltar Labs rapidly mobilized a response team to begin environmental monitoring. After determining that no mold was present in the cleanroom complex, but finding mold in the warehouse area, Gibraltar was able to determine the likely source of the mold and the possible factors contributing to the contaminated I.V. bags. Shortly thereafter, Gibraltar issued a critical evaluation of the MedPrep facility and its quality procedures, which included comprehensive guidelines for improvements and best practices.

In support of MedPrep’s request to reopen, Gibraltar Labs also authored a position paper on their behalf for submission to the FDA and NJ Board of Pharmacy that documented the steps MedPrep had taken to ensure that it would operate in a safe, compliant manner in the future, and why company should be granted approval to resume operations.

THE RESULTS:

Thanks in part to the timely support and comprehensive services provided by Gibraltar Labs, the New Jersey State Board of Pharmacy officially notified MedPrep on May 2, 2013 that it could resume operations.

“We’re extremely satisfied with the service and responsiveness of Gibraltar Laboratories and look forward to continuing the relationship into the foreseeable future.”  

Gerry Tighe, President of Med Prep.