FDA Combats National Fungal Meningitis Facility Contamination
The FDA has issued the Guidance for Industry, a new regulation requesting voluntary registration of all outsourcing facilities on the FDA website. This new process will require compounding facilities to declare all of the compounds they work with, including information regarding their strength, unit amount, National Drug Code (NDC) of active ingredients, as well as pharmaceutical info for the finished product.
Compounding centers will be required to report the information for products they’ve handled in the previous six months, which are used in human drugs. According to the report, the FDA will expect semi-annual reports each June and December from all registered facilities.
The FDA will also be implementing a Compounding Quality Act which will limit the ingredients that are considered safe to use in compounding. Reporting will be monitored by the FDA in alliance with the National Association of Boards of Pharmacy, who will be communicating directly with each state pharmacy board. These state boards will be receiving word if there are any compounding facilities that aren’t up to FDA specifications. The FDA will be announcing the members of a newly created Pharmacy Compounding Advisory Committee. Additionally, compounding facilities can expect more frequent and rigorous inspections by the FDA.
Those facilities that are able to register prior to June 2nd, 2014, will be given a two month deadline for reporting on their compounds. As regulations currently stand, there will be no fee to register until October 1, 2014;thereafter, an annual fee from all registered facilities will likely be assessed.
The catalyst for this legislation was the fungal meningitis contamination found in a compounding facility in Framingham, Massachusetts which contaminated pain medication that was distributed around the country. The highest case numbers were in Michigan, Tennessee and Indiana, where over 700 cases of contamination were reported and 64 fatalities. On December 30th, 2013, a preliminary settlement was reached in the amount of $100 million. Complaintants have until January 15, 2014 to file additional claims.
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