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.
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