WEDNESDAY, DECEMBER 12, 2012
NECC Compounding Issue
Thanks for tuning in! On December 27th, I had the opportunity to attend the Board of Pharmacy meeting focused on addressing the New England Compounding Center (NECC) issue, as well as participate in a webinar hosted by the National Association of Board of Pharmacy (NABP). After talking with the Attorney General’s Office and referencing the Data Practices Act, the Board has determined that all inactive investigational data and reports against a pharmacy are considered public documents, unless the material states that it is private and privileged. The media requested the release of this information, but the Board is concerned that the documents, although public, will not be accurately interpreted and potentially falsely reported. The Board fears that its relationship with the compounding pharmacies and pharmacists will be adversely impacted if data are made available to the media without proper communication. In addition, the Board has devised a working group consisting of two Board members and two or more staff members with the charge of updating the format of the surveyor form to clearly define areas where action is required, while separating the summary of information generally discussed and recommended where action is not required. This was a concern of compounding pharmacists, as it was difficult to differentiate between the two.
In response to the NECC compounding issue, all Boards of Pharmacy have been contacted by Congress and required to answer specific questions inquired by the Senate and House of Representatives. NABP is contracting with the Iowa Board of Pharmacy to conduct inspections at high-risk compounding pharmacies in Minnesota and other states that are licensed by the Iowa Board. Training on USP 797 will be completed by NABP representatives conducting the investigations, as well as offered to all Board surveyors. The first wave of investigations will occur between December 2012 and February 2013 to identify traditional versus non-traditional compounding pharmacies. The Board is challenging NABP’s definition ‘non-traditional’ compounding, which includes bulk and sterile compounding, and argues that only two practices exist: compounding and manufacturing. A second wave of investigations will be conducted between March 2013 and June 2013 to discover if the traditional compounding pharmacies identified are practicing sterile versus non-sterile compounding. Throughout this process, NABP will be ensuring that the pharmacies are abiding by the rules and regulations established in Iowa and their resident state. Any potential violations found will be confirmed with the resident Board of Pharmacy before charging disciplinary action to be completed. The Board is not in agreement with NABP conducting the investigations, and would rather report information after having our surveyors visit the indicated pharmacies. Ultimately, NABP will be collating the data and documents gathered from the investigations to create e-Profiles for each of the high-risk compounding pharmacies, which will be made available to all Boards of Pharmacy and the public, if the latter is requested. On December 19, state Board of Pharmacy executives and the FDA are invited to attend an inter-government meeting to discuss the recent NECC compounding issue and explore the best way to provide oversight moving forward. Change is in progress!
Melissa Katzenberger
Pharm.D. Candidate
University of Minnesota College of Pharmacy
Class of 2013
In response to the NECC compounding issue, all Boards of Pharmacy have been contacted by Congress and required to answer specific questions inquired by the Senate and House of Representatives. NABP is contracting with the Iowa Board of Pharmacy to conduct inspections at high-risk compounding pharmacies in Minnesota and other states that are licensed by the Iowa Board. Training on USP 797 will be completed by NABP representatives conducting the investigations, as well as offered to all Board surveyors. The first wave of investigations will occur between December 2012 and February 2013 to identify traditional versus non-traditional compounding pharmacies. The Board is challenging NABP’s definition ‘non-traditional’ compounding, which includes bulk and sterile compounding, and argues that only two practices exist: compounding and manufacturing. A second wave of investigations will be conducted between March 2013 and June 2013 to discover if the traditional compounding pharmacies identified are practicing sterile versus non-sterile compounding. Throughout this process, NABP will be ensuring that the pharmacies are abiding by the rules and regulations established in Iowa and their resident state. Any potential violations found will be confirmed with the resident Board of Pharmacy before charging disciplinary action to be completed. The Board is not in agreement with NABP conducting the investigations, and would rather report information after having our surveyors visit the indicated pharmacies. Ultimately, NABP will be collating the data and documents gathered from the investigations to create e-Profiles for each of the high-risk compounding pharmacies, which will be made available to all Boards of Pharmacy and the public, if the latter is requested. On December 19, state Board of Pharmacy executives and the FDA are invited to attend an inter-government meeting to discuss the recent NECC compounding issue and explore the best way to provide oversight moving forward. Change is in progress!
Melissa Katzenberger
Pharm.D. Candidate
University of Minnesota College of Pharmacy
Class of 2013
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