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

Apothecary Shop of Phoenix, Inc also Discplined by Arizonia Board of Pharmacy

Y003155	Apothecary Shop of Phoenix, Inc.	03-0015 CONSENT AGREEMENT
	Apothecary Shop of Phoenix, Inc.	03-0015 AMENDED COMPLAINT
	Apothecary Shop of Phoenix, Inc.	03-0015 FINDINGS OF FACT

Arizona's Compounding Survey

Compounding Survey
The following questions were mailed out to all permit
holders on record on March 13, 2013, by the end of the
day’s mail pickup on March 15, 2013. Board staff requests
that all pharmacists-in-charge respond to the survey questions
by returning an e-mail, fax, or paper document to
the Board office by April 30, 2013. In case you have not
received the survey, here are the questions:
Are you compounding prescription or over-thecounter
(OTC) drugs at your pharmacy?
If so,
a. What type(s) of compounding is being done (sterile,
nonsterile, or OTC)?
b. If located in Arizona, does your pharmacy ship compounded
products out of state?
c. Are any of the pharmacists, technicians, or the pharmacy
itself accredited?

d. If accredited by an agency, what is the name of the
accrediting agency?
e. What are the standards and qualifications to become
accredited?
f. Are all compounds dispensed pursuant to a patientspecific
prescription?
g. If compounds are distributed for “office use,” what is
the percentage of prescription volume?
h. If not located in Arizona, do you ship compounds into
other states besides Arizona?
i. If so, please list the name of product shipped and
amount shipped annually?

Source found at April 2013 Arizona Board of Pharmacy Newsletter

Job Opening at Arizona State Board of Pharmacy for Compliance Officer

General Information (244109)

Job title: Arizona State Board of Pharmacy - Compliance Officer Job location: Phoenix, Maricopa County, AZ, AZ 85007 United States Requisition code: Date posted: 02/19/13 Job type: Full-Time Compensation: DOE Job Classification Job Category: Other

Job Description

Job description:

Board Compliance Officer - Recruitment for Vacant Position A vacancy exists in Arizona for a Board Compliance Officer. Arizona pharmacists with a current, unrestricted Arizona pharmacist license are invited to mail a cover letter with current resume to Ms. C. Hunter, secretary to the Board executive staff at P O Box 18520, Phoenix, AZ 85005 OR E-Mail her at chunter@azpharmacy.gov . All resumes should be received by April 15, 2013. Please do not call the Board office regarding the position. Qualified candidates will be contacted by Board staff after written materials have been received, It is the intention of Board staff to interview qualified candidates and fill the vacancy no later than May 15, 2013.

Job Requirements

Education, training, experience:

Education, training, experience: BS or Pharm D in Pharmacy from ACPE accredited institution Excellent communication/computer skills, work experience in a variety of pharmacy specialties and must have been licensed as a pharmacist in Arizona for at least five years. A valid, unrestricted Arizona drivers license is also required and a state vehicle is provided for state business. Work schedule is Monday through Friday only.

Arizona Board of Pharmacy Compounding Task Force Meeting Tomorrow, March 21, 2013

During the meeting the task force will discuss R4-23-410 Current Good Compounding Practices, and it may make recommendations as to new rules regarding compounding.  To see the complete agenda, click here 

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.

Arizona Proposed Legislation--Senate Bill 1188 - Pharmacy Omnibus Bill

To view more information about the bill and the status of this bill, click here

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

Arizona Board of Pharmacy Minutes for January 24-25, 2013 : A lot of discussion on Compounding

AGENDA ITEM 18 – Update concerning the FDA’s Intergovernmental Working Meeting on Compounding on December 19, 2012
President Milovich asked Mr. Wand to address this agenda item.
Mr. Wand stated that the meeting was held in Washington D.C. with the FDA to discuss compounding. Mr. Wand stated that the participants were divided into districts and discussed
what they believed constituted compounding and manufacturing.
Mr. Wand stated that they discussed compounding of medications due to shortages and if some of the larger firms were compounding or manufacturing.
Mr. Wand stated that some states had not inspected facilities in their states for 5 years.
Mr. Wand stated that it was discussed about developing training programs to train the inspectors

Mr. Van Hassel stated that they discussed certifying the inspectors. Mr. Van Hassel stated that
standards would be set for inspections.
Mr. Wand stated that there were concerns about doctors hiring technicians to compound medications since doctor’s offices are not inspected by the Boards.
Mr. Van Hassel stated that it why the Board is forming a task force to review the rules.
AGENDA ITEM 19 – Selection of Compounding Task Force Members
President Milovich opened the discussion by stating that the Board would select a chairman and members of the task force.
Dr. Foy stated that there should be an adequate number of people on the task force and should represent all the different areas of compounding.
Mr. McAllister stated that the selection of a compounding task force would show that the Board is thinking about the changes and not overacting to the problems.
On motion by Mr. McAllister and seconded by Dr. Foy, the Board unanimously approved the following individuals to serve on the task force:
1. John Musil – Chairman
2. Tom Van Hassel – Co-Chairman
3. Danielle Evans
4. Rich Monty
5. Eric Bauer
6. Dennis Waggoner
7. Dana Reed
8. Linda Carboni
9. Sandra Sutcliffe
Mr. McAllister stated that some of the topics that he feels the task force should consider is
PCAB accreditation, non-resident compounders, compounding for office use, and a separate license for sterile compounding

Source found here

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

Bill would ban basic compounds behind synthetic drugs like bath salts, spice

Tuesday, Jan. 29, 2013By MATTHEW LONGDON
Cronkite News

About HB 2327:

• Author: Rep. Eddie Farnsworth, R-Gilbert.

• Key provision: Would expand the state's definition of dangerous drugs to include chemical configurations that typically compose synthetic cannabinoids and bath salts.

• Status: Endorsed by the House Judiciary Committee and headed to the floor by way of the Rules Committee.

PHOENIX – It’s become a pattern as state lawmakers try to address synthetic drugs such as bath salts or spice: Almost as soon as one recipe is outlawed, manufacturers simply change to a mix that isn’t banned.

Hoping to get ahead of that cycle, the chairman of the House Judiciary Committee is out to ban the basic chemical formulas underlying such drugs.

“Imagine a Christmas tree. You can change one of the bulbs on the lights and it’s a little different, but it’s the same tree,” said Rep. Eddie Farnsworth, R-Gilbert. “This bill would just outlaw the Christmas tree.”

Farnsworth said that chemists have identified the most basic formulas used to create synthetic drugs. HB 2327 would ban those basic formulas so the substances are always illegal despite any alteration.

He said he avoided banning any formula that had a legitimate commercial use, such as the recipes for cleaning supplies.

Continue to read here

AZ Prescription Compounding Task Force

Prescription Compounding Task Force
The recent tragedy caused by contaminated compounded
prescription drugs distributed across the country by a pharmacy
in Massachusetts has probably been the “biggest story” in
pharmacy in the last decade. Unfortunately, it is not the kind
of news that pharmacy as a profession is proud of. Any time
a patient suffers a negative outcome is a “failure” both for the
professional involved and for the profession as a whole. In
this extreme case, there were at least 656 cases where patients
were infected by various organisms in the products and 39
deaths in 19 states.
On October 6, NECC [the New England Compounding
Center] expanded its recall to include all products
in circulation that were distributed from its facility in
Framingham, Mass. As part of the ongoing investigation,
FDA [Food and Drug Administration] and CDC
[Centers for Disease Control and Prevention] have
been testing various NECC products for evidence of
contamination. Laboratory testing at CDC and FDA has
found bacterial and/or fungal contamination in unopened
vials of betamethasone, cardioplegia, and triamcinolone

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

Recent Disciplinary Action Against Pharmacists in Arizona

Disciplinary Actions
Notice: Before making a prescription-dispensing or other decision pursuant to information in this issue, you are encouraged to verify the current condition of a license with the appropriate
licensing agency (Board).
Pharmacists
Alnoah, Fahad (S015734) – Placed on probation for two
years; fined $2,000. Required to retake Multistate Pharmacy
Jurisprudence Examination®
. Effective September 21, 2012.
Boel, Eric (S018886) – Probation terminated. Effective November 14, 2012.
Coppola, Thomas (S017161) – License revoked. Effective
September 21, 2012.
Hannibal, Jeffrey (S011674) – Probation terminated. Effective
September 19, 2012.
Hodges, James (S009569) – Fined $500 and required to complete six additional hours of CE within 90 days. Effective
September 27, 2012.
Hunter, Lisa (S013072) – License reinstated; no additional
conditions. Effective September 19, 2012.
Makai, Gerwyn (S016844) – Board agreed at November 14,
2012 meeting to terminate Pharmacists Assisting Pharmacists of Arizona (PAPA) contract. Effective upon signing of
revised consent.
Martinez, David (S015190) – Probation terminated. Effective
November 14, 2012.
Merkel, D. Steven (S009366) – License reinstated with five
years of probation. Effective September 27, 2012.
Oxford, Sherri (S009874) – Suspended for a minimum of six
months, followed by five years of probation and a five-year
PAPA contract.
Tobin, Robert (S016952) – Placed on probation for one year,
fined $6,000, both due within 90 days. Effective September
27, 2012.

Source found here
 

Arizona Board of Pharmacy Prescription Compounding Task Force Comments on NECC

Prescription Compounding Task Force
The recent tragedy caused by contaminated compounded
prescription drugs distributed across the country by a pharmacy
in Massachusetts has probably been the “biggest story” in
pharmacy in the last decade. Unfortunately, it is not the kind
of news that pharmacy as a profession is proud of. Any time
a patient suffers a negative outcome is a “failure” both for the
professional involved and for the profession as a whole. In
this extreme case, there were at least 656 cases where patients
were infected by various organisms in the products and 39
deaths in 19 states.

Continue reading in the Arizona Board of Pharmacy January 2013 Newsletter here