Saturday, November 29, 2014

Check out all the Cases against Compounding Pharmacies in September 2014 before the Colorado Board of Pharmacy

COLORADO STATE BOARD OF PHARMACY
September 18, 2014
Minutes
The Colorado State Board of Pharmacy meeting was convened by President Jeannine 
Dickerhofe, RPh, at approximately 8:31 a.m. on Thursday, September 18, 2014, at 1560 
Broadway, Conference Room 110 D, Denver, CO 80202. Notice of this meeting was given in 
accordance with Division of Professions and Occupations Policy Number 80-17.
Board members attending were: Jeannine Dickerhofe, RPh; Wesley Hunter, RPh; Donald 
Johnson, RPh; Ginny Orndorff, MBA, Armand Potestio, RPh, and Luis Rivera-Lleras, RPh.
Staff members attending were: Chris Gassen, RPh, Program Director; Mark O’Neill, RPh,
Board Inspector; and Jean Rowcliffe, Complaint and Licensing Specialist. Also present was
Jo Kaye, Assistant Attorney General, to advise the Board.
APPROVAL OF THE MINUTES
The Board approved the minutes from its July 17, 2014 and August 21, 2014 meetings as 
amended.
REPORTS 
President’s Remarks
Ms. Dickerhofe reported that she will be attending the National Association of Boards of 
Pharmacy Annual District 6, 7, and 8 meeting immediately following this Board meeting in 
Whitefish, Montana.
Program Director’s Report
Mr. Gassen presented a proposed amendment to Board Rule 4.06.00 regarding licensee 
identification as directed by the Board. After careful consideration of the available 
information, the Board voted unanimously to move the proposed rule amendment to a 
future public rulemaking hearing following stakeholder feedback as required by law. 
Mr. Gassen discussed reorganizational changes to the Board’s staff as mandated by the 
Division of Professions and Occupations. There is no longer a Chief Inspector in the office, 
as this position is now working in the field by handling all cases and audits. Other 
pharmacy inspectors will assume the remaining duties of the Chief Inspector position, as 
they will no longer be investigating cases.
Mr. Gassen discussed procedural changes to registration and license certificates. The 
Division of Professions and Occupations is no longer printing wallet size license or
registration certificates (cards), as they are now available for each licensee and registrant
online for the purpose of printing and posting. There is still available, for a fee, wallet and 
wall certificate licenses, and additional information regarding the ordering of such is 
available on the Board’s website.
Colorado Pharmacists Society (“CPS”) – Donald Johnson, RPh
No report was provided.Pharmacy Board Minutes
September 18, 2014
2
Governor’s Expert Emergency Epidemic Response Committee (“GEEERC”) – Jeannine 
Dickerhofe, RPh
Ms. Dickerhofe gave an update regarding two presentations from the GEEERC’s August 14, 
2014 meeting. The first was regarding the Human Plague, which can be a threat in 
Colorado as earlier this year, a family had contracted it from the family’s dog, which is 
believed to have been contracted from playing with area prairie dogs. The second 
presentation involved the Ebola virus. While Colorado is believed to be ready for an 
outbreak, chances are low of such an outbreak occurring in Colorado. 
 
Intern & School Relations – Jeannine Dickerhofe, RPh
Gina Moore, Professor for the University of Colorado Denver Skaggs School of Pharmacy, 
welcomed 160 students to their program this year, and is already preparing for the early 
admissions interviews for the next term. Ms. Moore again thanked the Board for all their 
help and support - which includes Board inspectors and Board members helping teach the
school’s pharmacy law course. 
Rod Carter, Dean of the Regis University School of Pharmacy, welcomed 82 students to 
their program this year, which includes a father and his daughter. Mr. Carter announced
that the school’s Practice Chair, Dave Clark, will be stepping down in December, and the 
search for his replacement has already begun.
Legislation - Jeannine Dickerhofe, RPh
Ms. Dickerhofe reported that the Colorado Pharmacy Coalition will begin meeting in 
October in preparation of the next legislative session. Anticipated bills affecting pharmacy 
include topics covering Naloxone, Physician-Assisted Suicide, Specialty Drugs, Provider 
Status, and Biosimilars. 
Inspectors’ Reports
City Market Pharmacy #451, PDO 812
The Board reviewed an Agenda Memorandum from Inspector Lisa A. Cornett, regarding a 
routine inspection at City Market Pharmacy #451. After careful consideration of the 
available information, the Board voted unanimously to initiate a case against City Market 
Pharmacy #451. 
Express Plus Pharmacy, LLC, OSP 6117
The Board reviewed an Agenda Memorandum from Inspector Cornett regarding discipline 
Express Plus Pharmacy received in another state. After careful consideration of the 
available information, the Board voted unanimously to refer the matter to Executive 
Session for legal advice.
After Executive Session, the Board voted unanimously to initiate a case against Express 
Plus Pharmacy’s nonresident pharmacy registration, and then to dismiss the case. The 
Board found that there was no reasonable cause to warrant further action at this time. Pharmacy Board Minutes
September 18, 2014
3
Walgreen Pharmacy #3500, PDO 405
Mr. Johnson recused.
The Board reviewed an Agenda Memorandum from Inspector Cornett regarding a recent 
inspection of Walgreen Pharmacy #3500. After careful consideration of the available 
information, the Board voted unanimously to table further consideration of the matter for 
six months because the pharmacy just recently began working with a practice monitor as a 
condition of a Stipulation and Final Agency Order the pharmacy entered into with the 
Board in February 2014. 
OLD BUSINESS
Complaints
Brunson, Roy D., RPH 17457 & Case 2013-3387
The Board reviewed a request from the Complainant to re-open this case based on new 
information not available at the Board’s March 20, 2014 meeting when the case was 
dismissed.
While the Board voted unanimously not to reconsider its prior decision regarding Case 
2013-3387 against Mr. Brunson, the Board voted unanimously to initiate a separate case 
against Sav-On Pharmacy # 858 (PDO 24-2) based on the additional information.
Brown’s Compounding Center, PDO 589 & Cases 2014-1462 & 2014-2476
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
Sackey, George, RPH 15584 & Case 2014-1040
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Stipulations / Board Orders
Baker, Susan H., RPH 12734 & Case 2013-3658
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
CJ Pharmacy II, PDO 807 & Case 2011-2747
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding CJ Pharmacy 
II’s request to be released from their Stipulation and Final Agency Order the pharmacy 
entered into with the Board. After careful consideration of the available information, the 
Board voted unanimously to release CJ Pharmacy II from the Stipulation and Final Agency 
Order and to restore their prescription drug outlet registration to an active and 
unencumbered status. Pharmacy Board Minutes
September 18, 2014
4
Emmonds, Todd A., RPH 16591 & Case 2012-4771
Mr. Johnson recused.
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding Mr. Emmonds
request to be released from the terms of the Stipulation and Final Agency Order he entered 
into with the Board. The Board voted unanimously to release Mr. Emmonds from his 
Stipulation and Final Agency Order and to restore his pharmacist license to an active and 
unencumbered status. 
Hornby, Teresa B., RPH 17826 & Case 2008-3744
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding Ms. Hornby’s
request to be released from the terms of the Stipulation and Final Agency Order she 
entered into with the Board. The Board voted unanimously to refer the case to Executive 
Session for legal advice. 
After Executive Session, the Board voted unanimously to release Ms. Hornby from her
Stipulation and Final Agency Order and to restore her pharmacist license to an active and 
unencumbered status. 
Rhine, Heather A., RPH 16640 & Case 2014-1736
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case as being without 
merit.
Walgreen Pharmacy #1769, PDO 243 & Case 2009-4013
Mr. Johnson recused.
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding Walgreen 
Pharmacy #1769’s request to be released from their Stipulation and Final Agency Order it 
entered into with the Board. After careful consideration of the available information, the 
Board voted unanimously to release Walgreen Pharmacy #1769 from their Stipulation and 
Final Agency Order and to restore their prescription drug outlet registration to an active 
and unencumbered status. 
Walgreen Pharmacy #4596, PDO 24-77 & Case 2010-0978
Mr. Johnson recused. 
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding a request from 
Walgreen Pharmacy #4596 to be released from a Stipulation and Final Agency Order it 
entered into with the Board. After careful consideration of the available information, the 
Board voted unanimously to release Walgreen Pharmacy #4596 from their Stipulation and 
Final Agency Order and to restore their prescription drug outlet registration to an active 
and unencumbered status. Pharmacy Board Minutes
September 18, 2014
5
Miscellaneous
SAS Research & OK Compounding (OSP 6225)
The Board reviewed an Agenda Memorandum from Inspector Cornett regarding additional
information pertaining to a complaint against SAS Research the Board tabled at its March 
20, 2014 meeting. The investigation found that it was related to the OK Compounding 
matter also reviewed at the Board’s March 20, 2014 meeting. After careful consideration of 
the available information, the Board voted unanimously to refer the matter to Executive 
Session for legal advice. 
After Executive Session, the Board noted the information regarding SAS Research, and 
voted unanimously to initiate a case against OK Compounding (OSP 6225), and then to 
refer the case for discipline. 
NEW BUSINESS
Complaints 
A & R Pharmacy, OSP 6202 2014-1345
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
Beacon Hill Medical Pharmacy, OSP 6107 2014-1703
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Boulder Community Hospital, PDO 9-3 2014-1916
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Brown’s Compounding Center, PDO 589 2014-1863
The Board voted unanimously to table further consideration of this case pending receipt of 
additional information.
Christensen, Jennifer L., RPH 19880 2014-2607
The Board voted unanimously to issue a Stipulated Letter of Admonition for violations of 
the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act, which will require Ms. 
Christensen to complete four (4) hours of Accreditation Counsel for Pharmacy Education 
(ACPE) – approved continuing education relating to the prevention of dispensing errors.Pharmacy Board Minutes
September 18, 2014
6
The Board also voted unanimously to initiate a case against the prescription drug outlet 
registration of King Soopers Pharmacy #80 (PDO 8-30) for alleged record-keeping 
deficiencies as it directly pertains to investigating Case 2014-2607. 
Civic Center Pharmacy, OSP 6057 2014-2393
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
Crowley County Correctional Facility, OO 405 2014-2466
The Board voted unanimously to issue a Letter of Admonition for violations of the 
Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act.
Crown Point Pharmacy, PDO 590 2014-2483
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Green Valley Drugs Home Health, OSP 5872 2014-1704
The Board voted unanimously to dismiss the case as being without merit. 
Gregoire, Lee M., RPH 11546 2014-2205
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Hopkins, Wesley, RPH 15749 2014-2115
The Board voted unanimously to issue a Letter of Admonition for violations of the 
Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act.
Hopkinton Drug, Inc., OSP 6206 2014-2115
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
Jung, Madelyn, RPH 15046 2014-1999
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. Pharmacy Board Minutes
September 18, 2014
7
Kotulock, Paula, RPH 12637 2014-1816
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to issue a Letter of Admonition for 
violations of the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act.
KVP Pharmacy, Inc., OSP 6235 2014-1343
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
Leiter’s Pharmacy, OSP 5267 2014-1706
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Luyk, Lori S., RPH 16752 2014-2481
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline. 
Matthews, Terry, RPH 10961 2014-1865
The Board voted unanimously to issue a Stipulated Letter of Admonition for violations of 
the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act, which will require Mr. 
Matthews to complete four (4) hours of Accreditation Counsel for Pharmacy Education 
(ACPE) – approved continuing education relating to the prevention of dispensing errors. 
Medaus Pharmacy, OSP 5284 2014-1708
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
NuVision Pharmacy Inc., OSP 6011 2014-1709
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Olympia Pharmacy, OSP 5968 2014-1707
The Board voted unanimously to refer the case to Executive Session for legal advice.Pharmacy Board Minutes
September 18, 2014
8
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Omnicare of Grand Junction, PDO 53-5 2014-2551
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Owen, Kenneth, RPH 10054 2014-1762
The Board voted unanimously to dismiss the case as being without merit. 
Paramount Pharmacy, OSP 6295 2014-2495
The Board voted unanimously to dismiss the case as being without merit.
The Board also voted unanimously to initiate a case against non-resident prescription drug 
outlet registration of Fusion Specialty Pharmacy, Inc. (OSP 6181). 
Pharmaca Integrative Pharmacy, PDO 670 2014-2402
Mr. Potestio recused. 
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Prescription Alternatives, Inc., PDO 48-5 2014-2468
The Board voted unanimously to dismiss the case as being without merit. 
Rite Aid #6269, PDO 73-101 2014-1719
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Safeway Pharmacy #0920, PDO 39-10 2014-1737
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Transition Pharmacy, OSP 6239 2014-1344
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.Pharmacy Board Minutes
September 18, 2014
9
Uhnavy, David, RPH 14039 2014-1743
The Board voted unanimously to dismiss the case as being without merit. 
The also voted unanimously to initiate a separate case against Amy G. Schmidt, RPH 
17552. 
University Pharmacy, Inc., OSP 5469 2014-1713
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
Walgreen Pharmacy #11101, PDO 262 2014-1790
Mr. Johnson recused. 
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Walgreen Pharmacy #2843, PDO 199 2014-1955
Mr. Johnson recused. 
The Board voted unanimously to dismiss the case as being without merit.
Walgreen Pharmacy #10370, PDO 668 2014-2074
Mr. Johnson recused. 
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted to initiate a separate case against Walgreen 
Pharmacy #10370 for allegedly not timely submitting an application and fee detailing a 
change in pharmacist manager, and the Board voted unanimously to table case 2014-2074 
pending review of the new case. 
Walgreen Pharmacy #7022, PDO 511 2014-2275
Mr. Johnson recused. 
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Walgreen Pharmacy #3207, PDO 119-19 2014-2398
Mr. Johnson recused. Pharmacy Board Minutes
September 18, 2014
10
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline.
Watenpaugh, Mark, RPH 9580 2014-1724
The Board voted unanimously to dismiss the case as being without merit.
Webster, Eileen, RPH 14785 2014-2057
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to refer the case for discipline and, 
because sufficient evidence existed that led the Board to believe that the health, safety and 
welfare imperatively required immediate action, to summarily suspend Ms. Webster’s 
pharmacist license if she fails to submit an application to the Board to reinstate her 
pharmacist license (as the pharmacist manager of Fairplay Pharmacy) by 3 p.m. on 
September 26, 2014.
After Executive Session, the Board also voted unanimously to initiate a case against 
prescription drug outlet registration of Fairplay Pharmacy (PDO 157-1), and to refer the 
case for discipline. In addition, because sufficient evidence existed that led the Board to 
believe that the health, safety and welfare imperatively required immediate action, the 
Board voted unanimously to summarily suspend Fairplay Pharmacy’s prescription drug 
outlet registration if it fails to submit a change of pharmacist manager application to the 
Board by 3 p.m. on September 26, 2014. 
Wedgewood Village Pharmacy, Inc., OSP 5464 2014-1715
Mr. Hunter recused. 
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.
WelldyneRX, PDO 37-50 2014-1864
The Board voted unanimously to dismiss the case as being without merit.
Wells Pharmacy Network, LLC., OSP 6079 2014-1716
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to dismiss the case. The Board 
found that there was no reasonable cause to warrant further action at this time.Pharmacy Board Minutes
September 18, 2014
11
Licensing/Registration Issues
Lang, Johnny T., RPH 15136 – Pharmacist Reinstatement Applicant
The Board voted unanimously to refer the case to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to table further consideration of this 
application pending receipt of additional information.
Paine, Alex T., Pharmacist Applicant
Mr. Johnson recused. 
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding Mr. Paine’s
application for a pharmacist license. After careful consideration of the available 
information, the Board voted unanimously to refer the matter to Executive Session for legal 
advice.
After Executive Session, the Board voted unanimously to deny Mr. Paine’s pharmacist 
application. Grounds for denial were noted to include, but were not limited to, CRS 12-
42.5-123(1) (d) and (e). As part of this denial, the Board also voted unanimously to offer 
Mr. Paine a conditional pharmacist license and, should he wish to pursue this option, the 
Board provided settlement parameters for a conditional license. 
MISCELLANEOUS
Correspondence, etc.
2013/2014 – 4th Quarter Peer Assistance Services’ Report
The Board noted the information.
E-Prescription copies
The Board reviewed a request from Wal-Mart to modify the Board’s requirements in order to 
electronically maintain prescription orders to match various other states’ requirements. 
After careful consideration of the available information, the Board voted unanimously to 
table the matter pending receipt and review of additional research by Board staff. 
Fisher Scientific Company, LLC and William H. Blessing
The Board reviewed an Agenda Memorandum from inspector Cornett regarding Fisher 
Scientific Company LLC’s application for an in-state prescription drug wholesaler 
registration. After careful consideration of the available information, the Board voted 
unanimously to refer the matter to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to note the information and to 
proceed with the customary steps to issue a registration.Pharmacy Board Minutes
September 18, 2014
12
Nuclear Pharmacy Regulations
The Board reviewed proposed amendments from Cardinal Health to Board Rules 12.00.00 
and 21.00.00 as they specifically pertain to compounding practices that occur within a 
nuclear pharmacy setting. After careful review of all the available information, the Board 
voted unanimously to move the proposed rule amendments to a future public rulemaking 
hearing following stakeholder feedback as required by law.
Pharmacy Technician Supervision with Refill Wizard
Ms. Dickerhofe recused.
The Board reviewed a question regarding delegating to pharmacy technicians to work 
within Refill Wizard to manage refill authorization requests by approving refill requests
under a protocol with a physician or group of physicians. After careful consideration of the 
available information, the Board voted unanimously to refer the matter to Executive 
Session for legal advice.
After Executive Session, the Board voted unanimously to send a letter explaining why refill 
authorization requests may not be approved by pharmacy technicians under a protocol. 
Proving Shortages
The Board reviewed an inquiry regarding obtaining proof when there is a shortage of a drug 
and therefore making it available to be compounded. The Board voted unanimously to refer 
the matter to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to send a letter recommending that 
one check the websites of American Society of Health System Pharmacists, the Federal 
Food & Drug Administration, and those of corresponding manufacturers’ for up-to-date 
information regarding drug shortages and to attach documentation from these sources to 
the affected compounding records. 
Referral from Colorado Medical Board
The Board reviewed an Agenda Memorandum from Mr. Gassen regarding a matter referred
by the Colorado Medical Board. 
The Board voted unanimously to initiate a case against the prescription drug registration of 
Jack’s Market Pharmacy (PDO 546).
Rio Grande Pharmacy, LLC, PDO 28-1
The Board reviewed an Agenda Memorandum from Ms. Rowcliffe regarding information the 
pharmacy reported pertaining to controlled substance losses as required pursuant to Board 
statute and rule, and voted unanimously to initiate a case against the prescription drug 
registration of Rio Grande Pharmacy, LLC. Pharmacy Board Minutes
September 18, 2014
13
Troy Pharmacy, OSP 5936
The Board reviewed an Agenda Memorandum from Inspector Cornett regarding disciplinary 
action Troy Pharmacy received in another state, and voted unanimously to refer the matter 
to Executive Session for legal advice.
After Executive Session, the Board voted unanimously to initiate a case against Troy 
Pharmacy, and then to dismiss the case. The Board found that there was no reasonable 
cause to warrant further action at this time. 
EXECUTIVE SESSION
At 12:08 a.m., Board President Jeannine Dickerhofe, R.Ph. moved that the Board enter into 
Executive Session. The motion was seconded. The vote was unanimous with five votes 
approving the motion to go into Executive Session and none opposing. The Board exited 
Executive Session at 3:40 p.m.
Case 2014-0170
The Board voted unanimously to rescind its prior referral for discipline, and to dismiss the 
case. The Board found that there was no reasonable cause to warrant further action at this 
time.
Case 2014-0171
The Board voted unanimously to rescind its prior referral for discipline, and to dismiss the 
case. The Board found that there was no reasonable cause to warrant further action at this 
time.
Case 2014-1417
Mr. Johnson recused.
The Board voted unanimously to dismiss the case. The Board found that there was no 
reasonable cause to warrant further action at this time.
Case 2014-1589
Mr. Johnson recused.
The Board voted unanimously to issue a Stipulated Letter of Admonition for violations of 
the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act.
Case 2014-1814
Mr. Johnson recused.
The Board voted unanimously to dismiss the case as being without merit.
The Board also voted unanimously to initiate a case against prescription drug outlet 
Walgreen Pharmacy # 5261.Pharmacy Board Minutes
September 18, 2014
14
Case 2014-1815
Mr. Johnson recused.
The Board voted unanimously to issue a Stipulated Letter of Admonition for violations of 
the Pharmacists, Pharmacy Businesses, and Pharmaceuticals Act.
The Board voted unanimously to initiate a case against prescription drug outlet Walgreen 
Pharmacy # 9568.
Case 2014-1884
The Board voted unanimously to dismiss the case. The Board found that there was no 
reasonable cause to warrant further action at this time.
Case 2012-6859
The Board voted unanimously to rescind its prior referral for discipline, and to dismiss the 
case. The Board found that there was no reasonable cause to warrant further action at this 
time.
Case 2012-6732
The Board voted unanimously to rescind its prior referral for discipline, and to dismiss the 
case. The Board found that there was no reasonable cause to warrant further action at this 
time.
ADJOURNMENT
The Board adjourned at 3:58 p.m.
___________________________________________ _____ ____________________________
Jeannine Dickerhofe, R.Ph. Approval Date
Board Presiden

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We Need More Pharmacists Doing This Type of Work; We need more State Boards of Pharmacy Publishing this Type of Information: Frequently Asked Questions for Pharmacists on Compounding Itraconazole (brand name - Sporonox) Q: Should I compound Itraconazole? (Answered by Gigi Davidson, BSPH, RPH, DICVP)

Pharmacist FAQs

Frequently Asked Questions for Pharmacists on Compounding Itraconazole (brand name - Sporonox)
Q: Should I compound Itraconazole?
A: Pharmacists should note the following important information regarding compounding of itraconazole products from the bulk chemical:
Itraconazole bulk powder (brand name - Sporonox) is NOT bioavailable in mammalian species. All of the commercially available Itraconazole products (capsules, oral solution and injectable) are complexed onto a cyclodextran molecule to increase solubility and systemic bioavailability. Unless compounding pharmacists are also utilizing this cyclodextran technology, the Itraconazole products from bulk chemical are not being absorbed and are therapeutically worthless. Dr. Mark Papich, our clinical pharmacologist, has studied the bioavailability of Itraconazole (both FDA-approved and compounded from bulk) in animal patients, and the bulk chemical is simply not bioavailable. We have had MULTIPLE therapeutic failures (and some resulting deaths in dogs suffering from blastomycosis) in the veterinary community from Itraconazole capsules and suspension compounded from the bulk chemical. We had another therapeutic failure today that resulted from the compounding pharmacist offering to compound Itraconazole suspension because the commercially available products are "too expensive". As most of the systemic fungal infections that animals suffer from are life-threatening, we must do everything we can to educate compounding pharmacists to stop compounding with Itraconazole bulk chemical. Thank you for any intervention that you might be able to provide.
Gigi Davidson, BSPh, RPh, DICVP
Director of Clinical Pharmacy Services
North Carolina State University College of Veterinary Medicine 4700 Hillsborough Street Raleigh, NC 27606
email: gigi_davidson@ncsu.edu
phone: 919-513-6575
fax: 919-513-6571
quoted from here

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Question of the Day November 27, 2014 What is the biggest issue in the compounding industry today that is being overlooked by state boards of pharmacies? How would the compounding pharmacy world improve if the state boards of pharmacy would address the issues relating to traditional compounding?

1 comment:

Anonymous said...
A few thoughts:

**Chemicals are recipes are SOLD for compounding but not warrantied for this use

**Boards need to to acknowledge financial incentives and conflicts of interest for recommending substitution of compounded drugs at individual and population levels under the guise of pharmacy professionalism (steering patients to compounds in lieu of regulated finished products to make more money)

**While boards are exceptionally well qualified and suited to regulate the licensing and professional practice of pharmacists and doctors, they are not well suited to regulating the safety, effectiveness and security of drug supplies

**There are no surveillance procedures for safety, quality, adverse event reporting and counterfeiting/bioterrorism chemical security for most states

**Pharmaceutical Care Models are useful at state levels for determining if and when a patient cannot be treated with an FDA-approved product, which carry product liability insurance, and what disclosures should be made regarding financial interests surrounding recommendations

**Having the often-claimed "right" to compound medications does not mean you should

**Compounded drugs may be compulsory for patients in certain settings (they are used based on contracts with health clinics, nursing homes) are a breach of professionalism and unethical if patients or their caregivers are not given an option to chose an FDA-approved, GMP-produced formulation

California State Board of Pharmacy Permanently Revokes One Pharmacist’s License and His Pharmacy’s Permit



The California State Board of Pharmacy has acted as a stern example for pharmacists and pharmacies across the Golden State, and the Fourth Appellate District court agrees with the Board’s decision.
Pharmacist Tue Hoang was in charge of Orange Pharmacy when the pharmacy refused an on-site fraud prevention review. The review was mandatory for pharmacies that wanted to submit claims for certain prescriptions under Medi-Cal, so Orange was excluded from the program.
Hoang was not thwarted for long, however, as he cooked up the scheme that would eventually land him in hot water with the Board. Hoang arranged for Orange Pharmacy to dispense Medi-Cal prescriptions, but would forward the information to another local pharmacy, Pacific Pharmacy. Pacific would then submit the claims as their own, and would return the payments to Orange.
When the California State Board of Pharmacy learned of the arrangement, Hoang was brought before an administrative law judge (ALJ), who recommended that Hoang’s pharmacist license and Orange Pharmacy’s permits essentially be placed on probation for five years. The Board opted to ignore the judge’s recommendation, and instead opted to permanently revoke Orange Pharmacy’s permit and Hoang’s license.
continue to read here

Question of the Day November 29, 2014 Why hasn't or doesn't physicans/doctors object to pharmacists crossing over into the "practice of medicine" especially with the surveys and questionaires and advising patients that they need compounded medications, when in fact they may need no medication at all?


Medication Mistakes Made by Maine Pharmacists

  1. 13 investigates medication mistakes by Maine pharmacists ...

    www.wgme.com/.../13-investigates-medication-mistakes-mai...
    WGME‑TV
    Nov 5, 2014 - In one case, the Maine Board of Pharmacy reports instead of getting a drug to treat seizures, the patient got an antibiotic to treat anthrax. According to the report,  ...

Very interesting comments regarding Texas State Board of Pharmacy Rejecting Proposal to Create a class of pharmacy for dispensing doctors especially since pharmacists have very much crossed over into what has traditional been doctor's roles without much objection from the medical community

  1. Texas State Board of Pharmacy just rejected a proposal to ...  

    www.reddit.com/.../pharmacy/.../texas_state_board_of_pharmacy_j...
    reddit
    Nov 4, 2014 - Texas State Board of Pharmacy just rejected a proposal to create a class of pharmacy for ... submitted 2 days ago by azwethinkweizmKing of Pharmacy (ΦΔΧ).

Recent Issues & Updates - Texas Pharmacy Association

Recent Issues & Updates - Texas Pharmacy Association

SOUTH DAKOTA BOARD OF PHARMACY WHOLESALE DISTRIBUTOR LICENSES; ACTIVE IN GOOD STANDING AS OF 11/19/14

SOUTH DAKOTA BOARD OF PHARMACY WHOLESALE ...  

https://doh.sd.gov/.../boards/pharmacy/DistributorVerificati...
South Dakota
Nov 19, 2014 - SOUTH DAKOTA BOARD OF PHARMACY. WHOLESALE DISTRIBUTOR LICENSES; ACTIVE IN GOOD STANDING AS OF 11/19/14. 

Utah Board of Pharmacy Audio and Handouts Available for the November 18, 2014 Meeting (disciplinary action against compounding pharmacies, compounding task force report and rule changes)




Pharmacy_2014-11-18_Audio pt 3.mp3Audio RecordingAdded: 2014/11/19 09:50 AMPharmacy_2014-11-18_Audio pt 1.mp3Audio RecordingAdded: 2014/11/19 09:50 AMPharmacy_2014-11-18_Audio pt 2.mp3Audio RecordingAdded: 2014/11/19 09:50 AMPharmacy_2014-11-18_handouts pt 1.pdfPublic Information HandoutAdded: 2014/11/19 09:50 AMPharmacy_2014-11-18_agenda update 2.pdfOtherAdded: 2014/11/14 11:19 AMPharmacy_2014-11-18_agenda.pdfOtherAdded: 2014/11/06 12:05 PMPharmacy_2014-11-18_agenda.pdfOtherAdded: 2014/11/12 09:39 AM

Arizonia Board of Pharmacy October 2014 Meeting Minutes and Video Now Available

The minutes and video from the October board meeting are now available.

NM Mexico Board of Pharmacy Regulation Changes - New Mexico Veterinary Medical Association--office use for non-sterile compounds allowed

NM Mexico Board of Pharmacy Regulation Changes - New Mexico Veterinary Medical Association

Louisiana Board of Pharmacy Application for Renewal of Non-Resident Pharmacy Permit Contains a Survey Regarding Compounding and ask Pertient Disciplinary History Questions

Application for Renewal of Non-Resident Pharmacy Permit ...  

www.pharmacy.la.gov/assets/docs/.../057_AppRenPHY-NR_2015-F.pdf
Nov 1, 2014 - (Complete this application for pharmacies located OUTSIDE the state.) ... date and sign this application; send with fee, payable to “Louisiana Board of Pharmacy”,.


Friday, November 28, 2014

DEA and Medical Boards Target Weight Loss Clinics

  1. DEA and Medical Boards Target Weight Loss Clinics and ...

    greenandassociates.blogspot.com/.../dea-and-medical-boards-target-weig...
    Nov 2, 2014 - We have seen more investigations of physicians or advanced practitioners (physician assistants and nurse practitioners) prescribing phentermine to patients.

Essendon supplements saga: Hearing to discuss evidence

Essendon supplements saga: Hearing to discuss evidence ...  

www.northweststar.com.au/.../essendon-supplements-saga-hearing-to-discus...
21 hours ago - A dispute over crucial anti-doping evidence which the 34 past and present Essendon players facing bans say has been denied to them by ASADA is expected to ..

Essential Read: FDA Panel Warns Against Certain Back Pain Injections

  1. FDA Panel Warns Against Certain Back Pain Injections

    Medscape-6 hours ago
    Originally, the question put to the panel was, "Do you recommend FDA add a contraindication to the labeling of injectable corticosteroids for the use of these ...

Review Shows that Licensing Boards Voted Improperly: For instance, after initially voting at a legal board meeting to shut down a Webster compounding pharmacy that gave a teenager medicine that was 1,000 times too potent, triggering a heart attack, a handful of board members voted to reverse the action at a meeting a week later without a legal quorum. The pharmacy has since closed on its own, and DPH is continuing to investigate the matter

read entire article here

Reminder: There are more than just the state and federal pharmacies rules to comply with; Here is an example of what veterinarians in Texas must also comply with relating to labels, use, controlled substances, extra and off-label use and compounded drugs--Make sure your legal counsel is advising you on the full umbrella of laws that may impact your specific practice

Texas Administrative Code

TITLE 22EXAMINING BOARDS
PART 24TEXAS BOARD OF VETERINARY MEDICAL EXAMINERS
CHAPTER 573RULES OF PROFESSIONAL CONDUCT
SUBCHAPTER EPRESCRIBING AND/OR DISPENSING MEDICATION
Rules
§573.40Labeling of Medications Dispensed
§573.41Use of Prescription Drugs
§573.42Use of Scheduled Drugs in Training and/or Racing
§573.43Controlled Substances Registration
§573.44Compounding Drugs
§573.45Extra-Label or Off-Label Use of Drugs

Veterinarians in Texas: Are you ready for an inspection? Texas Board Notes there are still issues with controlled substances and prescription labels; Great Compliance Inspection List to help you get ready for no-notice inspections in Texas

We continue to document chronic problems that exist in the areas of Continuing Education (CE), controlled substances, and Prescription Labels. Licensees are subject to no-notice inspections at anytime. Veterinarians are strongly encouraged to keep their CE records in the facility where they are practicing. Under rule 573.64, CE records must be maintained for the last 3 renewal cycles and be provided to the Board investigators for inspection upon request. When practicing veterinary medicine, relief and mobile veterinarians are requested to keep with them copies of their CE records, current renewal certificate and DEA/DPS Controlled Substances Registrations Certificates Controlled substances logs must maintain balance on hand at all times. The log book must also contain the proper information concerning the purchase, identification and use of controlled substances. For more information on controlled substances and record keeping, please review rule 573.50. Prescription labels must contain the species being treated. For further information on labeling, please review rule 573.40.
Click here to view a Compliance Inspection List.

Clinic Postings

Compliance visits have revealed that some licensees are not posting the required Complaint Information Notice " . . . in an effective way to inform his/her consumers . . . about how to file complaints . . ." as required by rule 573.29.
Also, many practitioners are under the impression that DEA and DPS Drug registration Certificates must be posted. These notices do not need to be posted and in fact we discourage posting them. The registrant's drug license number is shown on these certificates and if the wrong client got these numbers, drugs could be ordered under the practitioner's registration number.

Patient Record Keeping

Rule 573.52 of the Rules of Professional Conduct, addresses patient records and what should be included in each record. Section (a)(12) of this rule states ". . . Each entry in the patient record shall identify the veterinarian who performed or supervised the procedure recorded." When reviewing the patient records involved in consumer complaints, we continue to have difficulty identifying the DVM that performed a given procedure. Please remember each entry on the record should include at least the initials of the licensee that performed the procedure.

quoted from Texas State Board of Veterinary Medical Examiners

Look at this DEA fact sheet on Ketamine

Significant Guidance Documents of DEA office of Diversion Control that Pharmacist and their Legal Counsel Should be Aware of

List of Significant Guidance Documents of the Drug Enforcement Administration Office of Diversion Control

Second Question of the Day November 28, 2014 How many are aware that it is a federal criminal offense to make a threat toward a federal employee? You may want to read 18 U.S.C. 115(a)(2) before you speak words with intent to impeded, intimidate or interfere with a federal employees job whether it be FDA, DEA, FBI, etc.

Section 115(a)(2) of Title 18 covers threats against all Federal employees, including those covered by § 351, when such threat is done "with intent to impede, intimidate, or interfere with" such Federal employee "while engaged in the performance of official duties, or with intent to retaliate against" such Federal employee.

Overview of Texas Employees Group Benefits Program for Fiscal Year 2015: HealthSelect of Texas Benefits for Compounded Medication Coverage

Pharmacy Benefit Management Update
Compound Prescription Drugs
 Compound drugs products refers to a prescription medication product that requires
compounding by a pharmacist.
 Compound Drugs consist of two or more solid, semi-solid or liquid ingredients, at least one
of which is a Prescription Drug.
 Effective July 1, 2014, the coverage of compound drugs under the HealthSelect plan
administered by Caremark and the HealthSelect Medicare Rx plan administered by
SilverScript will entail a 2-step process.
 All Compound Medications with a cost greater than $300 will require a pre-authorization to
insure that it is being prescribed for a “medically accepted indication”; and
 Compounded prescription drug product may be covered if it contains at least one FDA
approved drug component, although reimbursement is limited to the compounding fees and
FDA approved component(s) only. Bulk chemicals are not FDA approved drug products.
Agenda item 5g - Meeting book dated May 20,2014

Defense Health Agency Webcast/Powerpoint on Pharmacy

DHA Webcast September, 2014 - The Defense Health ...  

pec.ha.osd.mil/.../DHA%20Pharmacy%20September%20DCO_9-17-201...
Sep 17, 2014 - Documentation  Training (PowerPoint slides &User Guide), Implementation ..... (i.e. FDA approved) and current patient care needs (i.e. paying forcompound  .

Pharmacy Purchasing and Product November 2014 Magazine has Articles on DQSA and 503B Outsourcing Facilities

  1. Home - Pharmacy Purchasing & Products Magazine  

    www.pppmag.com/
    Nov 20, 2014 - November 2014 ... FDA Expectations for 503B Outsourcing Facilities. Although the 2012 compounding tragedy at the New England Compounding Center ...

Powerpoint: FDA Progress, Trends and Compliance at the AFDO in Denver

FDA – Progress, Trends, and Compliance - Denver - AFDO

denver.afdo.org/uploads/1/5/9/4/15948626/830-fda-morrison.ppt
June 24, 2014 ... FDA continues to increase the number of foreign inspections; FDA has global offices. 3 ... Designed to improve the safety of drug compounding and further protect the drug supply by building an electronic, interoperable system  ...

FiercePharma's Top Ten List

FDA Product Safety Information Adverse Drug Experience (ADE) Reports Animal Drug Reports Available through 2013

How many are doing this for unapproved animal compounded medications? Report a Problem Veterinary Adverse Event Voluntary Reporting

Report a Problem Veterinary Adverse Event Voluntary Reporting

FDA’s Has Serious Concerns about Unapproved Animal Drugs