Immediate Notification of Compounding Status and Inspections

Posted in Latest News on June 12, 2013.

Notice of Emergency Rule

DEPARTMENT OF HEALTH
Board of Pharmacy
64B16ER12-1: Immediate Notification of Compounding Status and Inspections

SPECIFIC REASONS FOR FINDING AN IMMEDIATE DANGER TO THE PUBLIC HEALTH, SAFETY OR WELFARE:

The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) are currently investigating a multi-state fungal meningitis and other infectious outbreak. The investigation involves collaboration with multiple local and state health departments. The investigation revealed that the outbreak resulted from a compounded drug – a contaminated (adulterated) steroid injection. The New England Compounding Center (NECC) located in Framingham, Massachusetts, compounded and distributed the contaminated, injectable product. As of November 19, 2012, the investigation has confirmed 490 infections and 34 deaths related to the adulterated steroid injection. The CDC has confirmed, in Florida alone, 24 cases of infections and 3 patient deaths. The investigation has further revealed that the NECC compounding facility lacked proper sanitary conditions.

As of November 8, 2012, there were 7,879 Florida licensed pharmacies authorized to compound. Pharmacies may compound either sterile or non-sterile products, excluding nuclear pharmaceuticals, without any additional permit or licensure requirements. However, the board has set standards for compounding sterile products. All permitted pharmacies are subject to inspection to determine compliance with the laws and rules regulating pharmacies. A non-resident pharmacy is a pharmacy physically located outside of Florida that is registered with the board which allows the delivery of a dispensed medicinal drug into this state. As of November 8, 2012, Florida had 725 non-resident pharmacies. NECC is an example of a non-resident pharmacy. Non-resident pharmacies are only subject to inspections based on the laws and rules of the state in which they are physically located and in which they are licensed. Non-resident pharmacies are not required to produce inspection reports to the board.



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