CA Board of Pharmacy to hold special board meeting RE: legislative proposal for compounding pharmacies on December 13, 2012

Special Board of Pharmacy Meeting Announced
November 21, 2012

November 21, 2012

The Board announces the convening of a special, one-day Board Meeting on December 13, 2012 in Sacramento. Two main elements for this meeting will be a regulation hearing on the adoption of two regulations for e-pedigree implementation, and refinement of a legislative proposal for compounding pharmacies. The agenda for this meeting will be released in early December (before December 3, 2012).

Gov. may seek changes in Mass. pharmacy board

November 28, 2012, 11:24 am

BOSTON (AP) — Gov. Deval Patrick says the state board that oversees pharmacies is too heavily dominated by people who are pharmacists themselves and he might seek a change in the panel's makeup.
The state Board of Pharmacy has come under scrutiny in the aftermath of a national fungal meningitis outbreak that has claimed 36 lives and sickened hundreds of others. The outbreak has been linked to a steroid produced by Framingham-based New England Compounding Center, which is regulated by the board.
Patrick said Wednesday he has become concerned that 10-member board is largely made up of pharmacists and he'd like to see a "different blend of talent."
He told the "Ask the Governor" program on WTKK-FM that he expected to file legislation when state lawmakers return to Beacon Hill in January.

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The benefits and risks of compounding pharmacies

• Infectious Disease News, November 2012
  Edward A. Bell, PharmD, BCPS

As of the end of October, 28 deaths resulting from the use of poorly prepared compounded medications by a Massachusetts-based compounding pharmacy have been reported. These deaths have focused increased attention on the role and safety of compounded specialized medicines and dosage forms in the United States.

Pharmaceutical compounding is defined as the combining or mixing of pharmaceutical ingredients to create a customized medication product for a specific patient by a prescriber’s order or prescription. Inherent in this definition is the notion that the final product is not tested for safety and efficacy by data that the FDA normally uses to assess a product. Because pharmacy school curriculums include training in the science and art of compounding, pharmacists are generally well trained in how to compound many medicines. More advanced training is also available for post-graduate pharmacists and pharmacy technicians, by organizations such as the Professional Compounding Centers of America. Although most independently owned and chain pharmacies (eg, Walgreens) do not prepare many compounded products, specialized compounding pharmacies are available that do prepare many compounded products.

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Florida's Mandatory Pharmacy Compounding Survey, FAQ, and Emergency Rule

Mandatory Pharmacy Compounding Survey
FAQs for Pharmacy Compounding Survey - (pdf- 36kb)
Emergency Rule 64B16ER12-1
With the recent nationwide fungal meningitis outbreak caused by contaminated compounded products, the Florida Board of Pharmacy adopted Emergency Rule 64B16ER12-1, Florida Administrative Code This Emergency Rule requires all Florida licensed pharmacy permit holders, including non-residents, to complete a mandatory survey to inform the Board of its compounding activities. The goal of this mandatory survey is to determine the scope of sterile and non-sterile compounding within Florida licensed pharmacies --whether physically located in or out-of-state.

Failure to timely complete the mandatory survey is grounds for disciplinary action; however the goal is not to discipline, only to obtain critical data. Your cooperation in this matter is important to the department’s public protection mission.

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