Immediate Notification of Compounding Status and Inspections

 

DEPARTMENT OF HEALTH
Board of Pharmacy

RULE NO.: RULE TITLE:
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.
A compounded product that is contaminated or adulterated or a compounding pharmacy which lacks proper sterile and sanitary environments, presents an immediate, clear, present danger to the welfare, health, and safety of the citizens of the state of Florida as manifested by the recent outbreak of infections and resulting deaths. Moreover, The State Surgeon General recently issued the emergency suspension of two Florida compounding pharmacies for improper sanitary and environmental controls. For the protection of the citizens’ health, welfare and safety from continued proliferation of unsanitary or contamination compounding environments and distribution of contaminated products into this state, the board is in immediate need of comprehensive data: the specific compounding activities taking place at all permitted pharmacies and non-resident pharmacies. The rule is specifically designed to target, through inspection reporting requirements of non-resident pharmacies, to identify and minimize the immediate threat of contaminated products. The rule is also critical for identifying the high risk compounding activities in Florida pharmacies, so the department and board can prioritize inspections to minimize the immediate health and safety risks associated with unsanitary and unsterile compounding facilities in Florida.
REASON FOR CONCLUDING THAT THE PROCEDURE IS FAIR UNDER THE CIRCUMSTANCES: On November 14, the Board provided a public notice that the board would be holding a public meeting on November 20, 2012, to address compounding pharmacies. The board published the notice in the Florida Administrative Register. The Florida Administrative Register is available worldwide on the web. The agenda included the topic of requiring mandatory compounding reporting. The board placed the notice on the department website and provided a public notice of the agenda on the same website. On November 20, 2012, the board held a publicly noticed meeting for the purposes of addressing pharmacy compounding that included the necessity of this emergency rule. The board gave all interested parties the opportunity to provide input on pharmacy compounding and the rule. The parties present included counsels for pharmacy companies; state and national pharmacy associations; and individual pharmacy company representatives. Accordingly, the board provided all impacted parties sufficient notice of the intended action and provided a fair procedural opportunity for participation. Additionally, the board has directed that all pharmacies impacted by this emergency rule must be given direct notice of the rule through electronic mail or via correspondence at the the address of record on file with the department.
SUMMARY: The rule requires all permitted and registered pharmacies immediately notify the board of its compounding activities. Based on the data, the board requires prioritizing inspections based on the risk level to the citizens of the state of Florida.
THE PERSON TO BE CONTACTED REGARDING THE EMERGENCY RULE IS: Mark Whitten, Executive Director, Board of Pharmacy, 4052 Bald Cypress Way, Bin C04, Tallahassee, Florida 32399-3254

THE FULL TEXT OF THE EMERGENCY RULE IS:

64B16ER12-1 Immediate Notification of Compounding Status and Inspections.

All permitted and non-resident pharmacies shall, within 14 days of the effective date of this rule, report their compounding activities.

(1) All Pharmacies: The compounding status of all permitted and registered pharmacies shall be reported on form number DH-MQA 1308, Compounding Survey, herein adopted and incorporated by reference. The form is available at http://survey.doh.state.fl.us/survey/entry.jsp?id=1353086689950;

(2) Permitted Pharmacies: Based on the compilation of the data reported, inspections of permitted pharmacies required by Rule 64B16-28.101 shall be prioritized as follows: 1) Those pharmacies which only engage in compounding sterile products; 2) Those pharmacies which engage in the compounding of sterile and non-sterile products; 3)Those pharmacies which only engage in non-sterile compounding and those pharmacies which do not engage in compounding;

(3) Registered Non-Resident Pharmacies: All registered pharmacies must immediately provide a copy of their last two inspection reports that were required by the state in which the pharmacy is physically located and licensed. The board must receive the report within 14 days of the effective date of this rule.

(4) A failure to timely comply with this section shall constitute the basis for disciplinary action.

Rule Making Authority: 465.005; 465.0155; 465.022, F.S. Law Implemented: 465.0155; 465.0156(1)(c) and (2); 465.017; 465.022; 465.023, F.S. History – New.

 

THIS RULE TAKES EFFECT UPON BEING FILED WITH THE DEPARTMENT OF STATE UNLESS A LATER TIME AND DATE IS SPECIFIED IN THE RULE.
EFFECTIVE DATE: November 26, 2012