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Gibraltar Labs’ Efforts Instrumental In Helping MedPrep Secure Approval To Resume Operations

(Fairfield, NJ – May 13, 2013) NJ-based Gibraltar Laboratories, a leading provider of contract testing consulting services and moist heat steam sterilization services for the pharmaceutical and related industries was contracted by compounding pharmacy MedPrep Consulting in late February 2013. The reason: to help MedPrep improve its quality standards, testing and compounding practices in anticipation of new and stricter regulations governing compounding pharmacies, forthcoming at both the Federal and State levels. On March 13, 2013, an incident occurred involving MedPrep that would test the resources, expertise and responsiveness of Gibraltar Labs.

A Yale-New Haven Hospital nurse noticed that one bag of magnesium sulfate received from MedPrep Consulting contained floating particles, possibly mold. The Hospital reported the incident to the Connecticut Department of Health, who immediately shared it with the FDA, and subsequently the NJ Board of Pharmacies.

Gibraltar Labs CEO, Dr. Daniel Prince, stated, “MedPrep was attempting to be proactive in preparing its facility, personnel and processes to meet the new regulations. Unfortunately, in this particular instance, these enhancements to Med Prep’s QA process that may have prevented this from occurring had yet to be initiated.”

Upon learning that the contaminated bags were sourced from its facility, MedPrep Consulting immediately issued a recall of its 83 compounded preparations and called in Gibraltar Labs for support in managing the crisis. Gibraltar Labs was as a key part of the (medication safety pharmacists and consultants) team tasked to evaluate the situation.

Upon being apprised of the situation by MedPrep, Gibraltar Labs quickly mobilized a response team to begin environmental monitoring to determine if any mold could be detected in the facility, and if the root cause of the problem could be identified. Gibraltar received and tested the contaminated IV bags, and verified that the particles found were mold. They identified the type of mold and then shared their findings with the Centers for Disease Control (CDC) for independent confirmation.

After determining that no mold was present in the cleanroom complex, but finding mold in the warehouse area, Gibraltar was able to arrive at a conclusion as to the likely source of the mold, and issued a report on the possible factors contributing to the contaminated IV bags. Following a critical evaluation of its facility and quality procedures, which included guidelines for improvements and best practices, MedPrep adopted Gibraltar Labs’ recommendations and was also able to address the conditions that may have compromised its ability to safely compound the contaminated doses in question.

MedPrep came to Gibraltar because it is an established laboratory that operates under current good manufacturing practices. It has many years of experience in helping its customers meet FDA requirements.  “This has been the most high profile project that we have been a part of with respect to the involvement of multiple government agencies, at both the federal and state levels,” commented Dr. Prince.  

As part of the process, Gibraltar Labs wrote a position paper on MedPrep’s behalf for submission to the NJ Board of Pharmacy, documenting the steps taken to ensure that MedPrep will continue to operate in a safe, compliant manner, and why MedPrep should be allowed to resume operations. Thanks in part to the comprehensive services provided by Gibraltar Labs, MedPrep was officially notified by the New Jersey State Board of Pharmacy: “The committee has approved MedPrep’s resumption of operation with the conditions and limitations in the Order filed on May 2, 2013.” To date, MedPrep customers have been supportive, recognizing and respecting its responsiveness to the incident as well as the steps taken to prevent future occurrences.

In the span of roughly four weeks, MedPrep recalled all of its compounded preparations, ceased its compounding operations, examined all of its practices and preparations, and was placed under the close scrutiny of the FDA and NJ Board of Pharmacy as a condition to being permitted to resume operations on a limited basis. During its April 24, 2013 meeting  the Board  agreed that MedPrep could be allowed to resume operations on a limited basis and under strict supervision, and after documented proof that the pharmacy had extensively retrained its staff and undertaken significant changes required by the Board to protect the public’s health and safety. The Board last week determined that MedPrep met those requirements.

Although pharmacy compounders are not subject to the same quality standards and oversight as their larger drug manufacturer counterparts, they are beginning to operate in a similar manner, as they produce higher volumes of preparations, and distribute across state lines. With increased scrutiny from the FDA, State Pharmacy Boards, and new regulatory guidelines to better regulate the growing compounding pharmacy practice, this situation is rapidly changing.

This sense of urgency comes in the wake of a fungal meningitis outbreak in 2012 that resulted in 53 deaths and more than 733 illnesses[1] – the result of contaminated steroids distributed by the New England Compounding Center. Following this tragedy, the FDA launched an investigation of 31 compounding pharmacies that produce sterile preparations. To date, FDA inspectors have identified numerous safety violations at all but one of the compounding pharmacies that were part of this investigation. Gibraltar Laboratories stands ready to be part of the solution to help protect and assure patient safety.

As these new operational procedures are put in place, MedPrep looks to become a model that other pharmacy compounders will look to in achieving operational standards for regulatory compliance. “Not only was MedPrep very cooperative with Gibraltar Labs, but also very grateful and thankful for our responsiveness, expertise and thoroughness of support.” stated Dr. Prince. “Med Prep is extremely satisfied with the service and responsiveness of Gibraltar Laboratories and looks forward to continuing the relationship into the foreseeable future.[2]” stated Gerry Tighe, President of Med Prep.

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About Gibraltar Laboratories, Inc.

With over 43 years of service, Gibraltar Laboratories is a leading provider of microbiology and analytical chemistry services in stability and quality control to the pharmaceutical, medical device, biotech industries. It provides media fill validation support, supplies sterile TSB and Moist heat steam sterilization services of prefilled syringes, ampules, vials etc. Areas of expertise include analytical chemistry, microbiology, virology, validations and calibrations, biopharmaceuticals, environmental monitoring and steam sterilization services. Gibraltar Laboratories headquarters and facilities are located in Fairfield, NJ.

For more information about Gibraltar Labs’ research, testing, and scientific consulting services, please visit: www.gibraltarlabs.com or contact:

Name:  Kristah Kohan, Sales Manager

Gibraltar Labs

T: 973-227-6882 x534

E: kkohan@gibraltarlabsinc.com

For more press information, please contact:

Ed Delia

Delia Associates

T: 908-534-9044

E: edelia@delianet.com

[1] As of 4.8.13 per CDC data (www.cdc.gov)

[2] Gerry Tighe, president of Med Prep.