Showing posts with label Arizona Compounding Task Force. Show all posts
Showing posts with label Arizona Compounding Task Force. Show all posts

Sunday, April 14, 2013

Arizona Board of Pharmacy Compounding Task Force to Meet April 17, 2013


Agenda Includes discussion of office use, accredition, and line-by-line review of current rules on good compounding practices and sterile product compounding.  To read entire agenda click here

Tuesday, March 5, 2013

Arizona State Board of Pharmacy Minutes for Compounding Task Force Meeting February 22, 2013; discuss 5% office use rule


Arizona State Board of Pharmacy
1616 W. Adams, Suite 120
Phoenix, AZ 85007
Telephone (602) 771-2727 Fax (602) 771-2749
THE ARIZONA STATE BOARD OF PHARMACY
HELD A COMPOUNDING TASK FORCE MEETING ON FEBRUARY 22, 2013
MINUTES FOR COMPOUNDING TASK FORCE MEETING
Call to Order – February 22, 2013
Chairman John Musil convened the meeting at 9:00 A.M. and welcomed the audience to the
meeting.
Roll Call and Introduction of Task Force Members
The following Task Force Members were present: Chairman John Musil, Tom Van Hassel, Rich
Monty, Eric Bauer, Dana Reed-Kane, Linda Carboni, Dennis Waggoner, Danielle Evans, and
Sandra Sutcliffe.
Dr. Musil stated that the Task Force had several items to review to see if the Task Force would
like to make recommendations for changes and/or additions to the Pharmacy Compounding
Rules. Dr. Musil stated that the Task Force could also recommended new proposed rules to the
Board.
Topics
1. Require PCAB accreditation
Dr. Musil opened the discussion by asking if the Task Force should require compounding
pharmacies to become PCAB accredited.
Ms. Reed- Kane stated that her pharmacy is PCAB accredited. She stated that it is a very
rigorous process. Ms. Reed-Kane stated that the accreditation is conducted by a private
organization and there is inspector bias. Ms. Reed-Kane stated that one inspector would tell
a pharmacy to do something one way and another inspector would tell a different pharmacy to
do the same thing a different way.
Ms. Reed-Kane stated that there should be a standardized accreditation process. Ms. Reed-Kane
stated that there are very confusing requirements for different processes.
State of Arizona 2 Compounding Task Force
Board of Pharmacy February 22, 2013
Ms. Reed-Kane stated that most of the accreditation process follows USP 797 and 795
requirements.
Mr. Van Hassel stated that maybe the task force should look at the different standards and
define the standards that need to be enforced instead of requiring accreditation by an outside
entity.
Mr. Bauer indicated that he has found that various inspectors view things differently.
Dr. Musil stated that PCAB had originally written the standards so that they were not
prescriptive. Dr. Musil stated that the standards were written so that the pharmacy determined
how the standards were met and did not state that the pharmacy had to do each process in a
specific fashion.
Dr. Musil stated that the task force could develop a list of standards that mirror the standards of
the accrediting bodies.
Mr. Waggoner stated that in manufacturing the FDA inspectors check to see if the manufacturer
is following the procedures that they have put in place according to the FDA regulations.
Separate licensure as compounders
Dr. Musil opened the discussion by asking if there should be a separate class for compounding
pharmacies.
Ms. Carboni stated that she believes that there are both patient and employee safety issues to
consider when compounding medications.
Mr. Van Hassel suggested that there could be a sterile compounding training program such as the
program required for giving immunizations.
Rules for Non – Resident Compounders
Mr. Van Hassel stated that California is planning to have different requirements for out of state
pharmacies.
Ms. Reed-Kane asked if there could be different guidelines for non-resident pharmacies.
Ms. Sutcliffe stated that the regulations do not allow for different guidelines.
Dr. Musil stated that maybe the Board could require that all products that come into Arizona
from non-resident permittees would be patient specific.
State of Arizona 3 Board Meeting
Board of Pharmacy February 22, 2013
Mr. Bauer stated that some products are being sent such as sterile products for home use from
non-resident pharmacies due to insurance requirements.
Ms. Reed-Kane stated that she has concerns about small facilities not having the appropriate
equipment to prepare certain medications.
Mr. Van Hassel stated that if the Board places too many restrictions on the compounding
pharmacies that it may encourage the doctor to compound the medications in their offices.
Ms. Evans stated that if the inspection reports are kept in the centralized database by NABP then
the Board would be able to look at the inspection reports for non-resident permittees.
Compounding during Drug Shortages
Dr. Musil stated that sometimes there are few options if a drug is needed. Dr. Musil noted that
some of the shortages are due to hoarding.
Ms. Carboni stated that when shortages occur at the hospital setting they are forced to require a
formulary change or restrict the use of the supply on hand.
Mr. Van Hassel stated that some of the current standards help create shortages because they are
forced to discard good product because of time frames for use.
The task force members discussed the outsourcing of compounding when the product is not
available.
Patient-Specific vs. Office Use
Dr. Musil opened the discussion by stating the only 5% of the total sales could be sent to
physician offices.
Mr. Van Hassel asked about the use of non- patient specific compounded products.
Ms. Evans stated that it is often difficult to make patient-specific products for veterinary use.
Dr. Musil stated that different types of compounding can be done at each site.
Mr. Bauer stated that due to USP 797 many hospitals did not want to stock all the products
that they may need and have outside pharmacies prepare the products for them.
Requiring Competencies that must be demonstrated before initiating compounding
Ms. Carboni stated that the task force would have to consider that pharmacies may compound
sterile products, non-sterile products, or both.
State of Arizona 4 Board Meeting
Board of Pharmacy February 22, 2013
Mr. Van Hassel stated that the Board must do what is best for the protection of the public. Mr.
Van Hassel noted that the job of the Board is not to protect the pharmacy or the manufacturer.
The task force members briefly discussed the requirement of having training programs in place
The task force members were reminded that items such as accreditation and additional licensure
would require a statutory change.
Call to the Public
Chairman Musil announced that interested parties have the opportunity at this time to address
issues of concern to the task force; however the task force may not discuss or resolve any issues
because the issues were not posted on the meeting agenda.
Rebecca Sheehan, a pharmacist, that works for a veterinary pharmacy came forth to address the
rule concerning the selling of 5% for office use. Ms. Sheehan stated that veterinary pharmacies
provide medications that are not available commercially and often the medications are made in
smaller doses for exotic animals. Ms. Sheehan stated that the veterinarian often needs to have
the medication on hand and 5% is hard to follow when the medication is used for multiple
animals.
The Task Force decided to hold their next meeting on March 21, 2013 from 2:00 P.M. to 4:00
P.M.
The meeting adjourned at 11:35.

Friday, February 15, 2013

Arizona Board of Pharmacy Compounding Task Force Agenda for Feb. 22, 2013 Meeting


AGENDA
The Agenda for the meeting is as follows:
Call to Order – John Musil, Pharm.D.,
Chairman
1 Roll Call of Task Force Members
2. Introduction of Members
(roundtable)
3. Review of items to be reviewed (charge of the task force)
Discussion and possible action regarding the Task Force’s review and recommendations for changes
and additions to the Pharmacy Compounding Rules and possible recommendation of new proposed
rules to the Board
A. Require PCAB accreditation? – Discussion/Action
B. Adopting USP <795> and <797> as the required standards – Discussion/Action
C. Rules for non-resident compounders – Discussion/Action
D. Patient specific compounding versus office supplies – Discussion/Action
E. Compounding during drug shortages – Discussion/Action
F. Separate (distinct) licensure as compounders? - Discussion/Action
G. Required competencies that must be demonstrated before initiating
compounding? - Discussion/Action
4. Call to the Public
The Task Force may make an open call to the public during the meeting, subject to
reasonable time, place, and manner restrictions, to allow individuals to address the Task
Force on any issue within its jurisdiction.
Pursuant to A.R.S. § 38-431.01 (G), members of the Task Force are not allowed to discuss
or take legal action on matters raised during an open call to the public unless the matters are
properly noticed for discussion and legal action. However, the Task Force may ask staff to
review a matter or may ask that a matter be placed on a future agenda.
5. Set next meeting date(s) – Discussion/Action
6. Adjournment
Source found here

Wednesday, February 6, 2013

Agenda for Arizona Compounding Task Force Committee Meeting on Feb. 22, 2013


AGENDA
The Agenda for the meeting is as follows:
Call to Order – John Musil, Pharm.D.,
Chairman
1 Roll Call of Task Force Members
2. Introduction of Members
(roundtable)
3. Review of items to be reviewed (charge of the task force)
Discussion and possible action regarding the Task Force’s review and recommendations for changes
and additions to the Pharmacy Compounding Rules and possible recommendation of new proposed
rules to the Board
A. Require PCAB accreditation? – Discussion/Action
B. Adopting USP <795> and <797> as the required standards – Discussion/Action
C. Rules for non-resident compounders – Discussion/Action
D. Patient specific compounding versus office supplies – Discussion/Action
E. Compounding during drug shortages – Discussion/Action
F. Separate (distinct) licensure as compounders? - Discussion/Action
G. Required competencies that must be demonstrated before initiating
compounding? - Discussion/Action
4. Call to the Public
The Task Force may make an open call to the public during the meeting, subject to
reasonable time, place, and manner restrictions, to allow individuals to address the Task
Force on any issue within its jurisdiction.
Pursuant to A.R.S. § 38-431.01 (G), members of the Task Force are not allowed to discuss
or take legal action on matters raised during an open call to the public unless the matters are
properly noticed for discussion and legal action. However, the Task Force may ask staff to
review a matter or may ask that a matter be placed on a future agenda.
5. Set next meeting date(s) – Discussion/Action
6. Adjournment
Prepared and posted by: hw 02/15/2013

Source found here

Monday, January 7, 2013

Arizona Board of Pharmacy Looking At Task Force To Review Compounding Regulations

AGENDA ITEM 14 – Definition of Compounding and Regulation of Compounding
Pharmacies
President Milovich asked Mr. Wand to address this agenda item.
Mr. Wand stated that in the Board book the following information was included: the definition of
compounding, the NABP model rules, NABP update of legislation affecting compounding, and
PCAB accredidation.[sic]
Mr. Wand stated that the Board could establish a task force to review the regulations.
Dr. Foy stated that he has concerns about recent complaints with questionable compounding and
proper training. Mr. McAllister stated that Texas has recently revised their rules.  Dr. Musil stated that the Texas
Board has regulations concerning testing but has not been able to fulfill their obligations in that
respect.
Dr. Musil stated that he is in favor of a task force to review the laws.   Dr. Musil stated that the
Board may want to look at accreditation.
Mr. McAllister stated that it is the Board’s responsibility to also protect our residents form
non-resident compounders.
Mr. Wand stated that he could research compounding regulations and that he could bring
back names of individuals willing to serve on a task force at the next meeting.

Source found here