Showing posts with label Arizona. Show all posts
Showing posts with label Arizona. Show all posts

Friday, January 31, 2014

Arizona Board of Pharmacy update to Diamondback Inspection where possible misbrading or alteration of drug/ one sample sub-potent and certificate analysis for wrong drug is to issue an advisory letter to Diamondback Drug "encouraging them to purchase high quality compenents from reputable places and to validate the chemcials that they purchase."

Agenda Item 17 – Diamondback Drug Follow-Up Inspection

President Van Hassel asked Mr. Haiber and Mr. Waggoner to address this agenda item.

Mr. Haiber stated at the last Board Meeting the Board asked them to do a follow-up inspection.

Mr. Haiber stated that there was a possible misbranding or alteration of a drug. Mr. Haiber stated that they observed that one sample was sub-potent but was not contaminated.

Mr. Haiber stated that they have fixed issues found on the first inspection.

Mr. Van Hassel asked if there have been significant improvements. Mr. Waggoner stated that they are making the improvements suggested in the first inspection.

Dr. Musil asked about the Sodium Sulfate. Mr. Waggoner stated that the certificate analysis was for the wrong drug.

On motion by Dr. Musil and seconded by Mr. Francis, the Board unanimously agreed to



issue an advisory letter to Diamondback Drug encouraging them to purchase high quality components from reputable places and to validate the chemicals that they purchase.

quoted from here
 

Arizona Board of Pharmacy Approves Weatherford Compounding Pharmacies' Out-of-State License Request Notwithstanding Recent Complaints in Horse Racing World; Arizona Board also approves a numver of other out-of-state compounding pharmacies

4. (2) Non-Resident Pharmacy Permits – Schedule B



NON-RESIDENT PHARMACY PERMITS (Out of State) Pharmacy Location Owner
PharmBlue LLC 40 Pennwood Pl. #300, Warrendale, PA 15086 PharmBlue Holdings, LLC
Rx Remedies Suite Q, 500 Highway 51, Ridgeland, MS 39157 Safemeds Solutions, LLC
BioScrip Infusion Services, Inc 199 Technology Dr. Ste. #140 & #150, Irvine, CA 92618 BioScrip Infusion Services, Inc
BioScrip Infusion Services, Inc 102 The American Road, Morris Plains, NJ 07950 BioScrip Infusion Services, Inc
Synergy Pharmacy Services, Inc. 31201 US Highway 19 N, Suite 2, Palm Harbor, FL 34864 Synergy Pharmacy Services, Inc
Diabetes Total Care 2480 Delta Lane, Elk Grove Village, IL 60007 Total Care Rx, Inc.
Anovorx Group, LLC 1710 N. Shelby Oaks Dr.. Memphis, TN 38134 Anovorx Group, LLC
Inverness Apothecary-Trinty LLC 24333 Gordon Terry Parkway, Suite B, Trinity, AL 35673 Inverness Apothecary – Trinity LLC
One Stop Pharmacy Inc 3193 Tech Dr., Suite B, St. Petersburg, FL 33716 One Stop Pharmacy Inc.
Assured Rx 13555 Automobile Blvd, Suite 230, Clearwater, FL 33762 Assured Rx
Transition Pharmacy 4 Neshaminy Interplex Dr., Ste. 111, Trevose, PA 19053 Transition Pharmacy
Maple Pharmacy 61 Spectrum Blvd., Las Vegas, NV 89101 Maple Pharmacy Inc
Boca Town Pharmacy 7400 N. Federal Hwy., Boca Raton, FL 33487 Rx Advisory and Solutions, Inc.
Rx To You Pharmacy, Inc. 3202 SE Federal Hwy., Stuart, FL. 34997 Rx To You Pharmacy, Inc.
Express Plus Pharmacy, LLC 6692 Stirling Rd., Davie, FL 33024 Express Plus Pharmacy, LLC
Weatherford Compounding Pharmacy 2005 Ft. Worth Highway #100, Weatherford, TX 76086 Joe Landers
Magnolia Specialty Pharmacy, Inc 208 S. 27th Ave, Ste, #4, Hattiesburg, MS 39401 Magnolia Specialty Pharmacy, Inc
Physician Preferred Medical, LLC 3300 NW 56th, Suite 101, Oklahoma City, OK 73112 Physician Preferred Medical, LLC
Spence Pharmacy 4821 River Oaks Blvd., Fort Worth, TX 76114 A-1 Drug Mart Inc.
Missoula Pharmacy Inc. 1211 South Reserve St., Suite 102, Missoula, MT 59801 Missoula Pharmacy Inc.
Central Compounding 125 E. Thomas St., Hammond, LA 70401 Central Rexall Drugs, Inc.
Complete Medical Homecare Inc 14309 West 95th St., Lenexa, KS 66215 Concordia Healthcare USA
Canyon Creek Pharmacy, Inc. 2235 Thousand Oaks Dr., San Antonio, TX 78232 Canyon Creek Pharmacy, Inc.
Cornerstone Compounding Pharmacy 1131 N. Pacific Ave. , Glendale, CA 91202 Cornerstone Compounding Pharmacy, Inc.
quoted here here

Tuesday, December 24, 2013

Revised Arizona Statutes Relating to Pharmacies and Compounding

Chapter 18PHARMACY
Article 1Board of Pharmacy
32-1901Definitions
32-1901.01Definition of unethical and unprofessional conduct; permittees; licensees
32-1902Arizona state board of pharmacy; immunity
32-1903Organization; meetings; quorum; compensation of board; executive director; compensation; powers and duties
32-1904Powers and duties of board; immunity
32-1905Meetings; time and place; annual report
32-1906Membership in national associations; official attendance at professional meetings
32-1907Arizona state board of pharmacy fund
32-1908Scope of chapter
32-1909Prescription medication donation program; distribution; immunity; rules
32-1910Emergencies; continued provision of services
Article 2Licensure and Permits
32-1921Exempted acts; exemption from registration fees; definition
32-1922Qualifications of applicant; reciprocity; preliminary equivalency examination; honorary certificate; fee
32-1923Interns and intern preceptors; qualifications; licensure; purpose of internship
32-1923.01Pharmacy technicians; pharmacy technician trainees; qualifications
32-1924Licenses; fees; signatures
32-1925Renewal of license of pharmacists, interns and pharmacy technicians; fees; expiration dates; penalty for failure to renew; continuing education
32-1926Notice of change of employer or home address; termination of responsibility
32-1926.01Change in residency status; duty to report
32-1927Pharmacists; pharmacy interns; graduate interns; disciplinary action
32-1927.01Pharmacy technicians; pharmacy technician trainees; disciplinary action
32-1927.02Permittees; disciplinary action
32-1928Hearings; restraining order; judicial review
32-1929Biennial registration of pharmacies, wholesalers, manufacturers and similar places; application
32-1930Types of permits; restrictions on permits; discontinuance of pharmacy permit
32-1931Permit fees; issuance; expiration; renewals
32-1932.01Substance abuse treatment and rehabilitation program; private contract; funding
32-1933Display of license or permit
32-1934Pharmacy operated by hospital
32-1935Approval of schools and colleges of pharmacy
32-1936Mandatory continuing professional pharmacy education
32-1937Exceptions to continuing education requirements
32-1939Condition of probation; repayment of inspection costs
32-1940Investigations; hearings; conferences; records; confidentiality
Article 3Regulation
32-1961Limitation on dispensing, compounding and sale of drugs
32-1962New drug; compliance with federal act; exception
32-1963Liability of manager, proprietor or pharmacist in charge of a pharmacy; variances in quality of drugs or devices prohibited
32-1963.01Substitution for prescription drugs; requirements; label; definitions
32-1964Record of prescription orders; inspections; confidentiality
32-1965Prohibited acts
32-1966Acts constituting adulteration of a drug or device
32-1967Acts constituting misbranding of a drug or device; exceptions; interpretation of misleading label
32-1968Dispensing prescription‑only drug; prescription orders; refills; labels; misbranding; dispensing soft contact lenses
32-1969Filling Mexican and Canadian prescription orders; records; exception
32-1970Implementing, monitoring and modifying drug therapy and use; conditions; definitions
32-1971Single active ingredient pseudoephedrine products; location
32-1972Poison or hazardous substances; misbranding and labeling; prohibitions; exemption
32-1973Pharmacies; quality assurance
32-1974Pharmacists; administration of immunizations, vaccines and emergency medications; certification; reporting requirements; advisory committee; definition
32-1975Legend drug products; listing; code identification; exemption; definitions
32-1976Dispensing replacement soft contact lenses; prescription
32-1977Sale of methamphetamine precursors; electronic sales tracking system; violation; classification; state preemption
Article 3.1Regulation of Full Service Wholesale Permittees
32-1981Definitions
32-1982Full service wholesale permittees; bonds; designated representatives; application
32-1983Restrictions on transactions
32-1984Pedigrees; electronic files
32-1985Injunctive relief
Article 4Enforcement of Chapter; Penalties
32-1991Enforcement of chapter
32-1992Provisions of marijuana, prescription‑only drugs, narcotics, dangerous drugs or controlled substances laws not invalidated by this chapter; medicated feed not included
32-1993Authorization to seize certain drugs, counterfeit drugs and equipment; disposition of seized equipment
32-1994Authorization to embargo adulterated or misbranded drugs or devices; condemnation; destruction; costs
32-1995Injunctions; restraining orders
32-1996Violations; classification
found here

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

Sunday, April 7, 2013

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

Wednesday, March 20, 2013

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 

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 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

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

Tuesday, January 29, 2013

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


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