Sunday, April 28, 2013

Interesting Discussion At March 2013 Utah State Board of Pharmacy Meeting Regarding Compounding

Mr. Steinagel met with the Board and reviewed the Division’s response to recommendations made by the Compounding Task Force.
The task force recommends that the Division enforce  an inspection moratorium on compounding pharmacies. The Division is uncomfortable with this idea. The Division cannot cease issuing citations and disciplining compounding pharmacies.
The task force recommends that DOPL investigators and inspectors go through training on federal laws that regulate the pharmacy profession. The Division supports this idea and is willing to provide additional training for investigators. Five investigators will go through intensive NABP training in May that was scheduled before the task force met to discuss recommendations.
The task force encourages inspectors to educate licensees when they investigate them and follow-up on inspections. The Division supports this idea.
The task force recommends updating of the compounding self-inspection report. The Division agrees with this idea and will consult with Board members and others in the field as necessary as updates to the report are made. The Division will make updates to the report and submit a revised self- inspection report to the Board for review at the May meeting.
The task force recommends creation of self- inspection reports for Class B and C pharmacies. The Division is working on this.
The task force recommends that the Pharmacy Practice Act be revised. The Division is happy to provide input to Board members, legislators, and associations as they propose amendments to the Act. The Board will be discussing possible amendments to the Act during future Board meetings.
The task force recommends that standards regarding transferring compounds within the same institutional setting be clarified and that language in regard to manufacturing vs. traditional vs. non-traditional compounding be clarified. The Division is willing to work with the Board on these items.
The task force recommends that DOPL send a letter to compounding pharmacies. A letter was sent last year and the Division is willing to consider sending a second one this year.
The task force recommends that network-network- network become compliant with USP standards. This is something the Division agrees that the industry can work on.
Mr. Steinagel advised the Board that DOPL is interested in inviting NABP to come to Utah to make training available to representatives of pharmacies in Utah that engage in compounding. This training is three or four days and is very intensive. Mr. Steinagel advised the Board that it would require legislation to amend the laws upon which the inspection report is based.
The Board expressed concern regarding sending sterilized compounding out of state. Mr. Steinagel noted that currently pharmacies are self reporting to DOPL and encouraged the Board to consider the following options: (1) Creation of licensure for compounding pharmacy; (2) Require pharmacies to declare whether they do sterile compounding; (3) During renewal, have the pharmacy representative affirm whether they are engaging in sterile compounding. The Board will discuss this at a future meeting.

Quoted from Utah Board of Pharmacy March 3, 2013 minutes 

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