Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, September 27, 2016
Allergy Shots and Why You Could Be at Risk
Unlike physicians' offices, compounding pharmacies, for example, must comply with the Compounding Quality Act (CQA) that includes meeting current ..
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Upcoming Florida State Board of Pharmacy Meetings for October 2016
October 18, 2016 Rules Committee Meeting
Embassy Suites Lake Buena Vista South
4955 Kyngs Heath Rd Kissimmee FL 34746 Get Directions →(407) 597-4000 |
Materials:
FAR Notice (PDF)
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October 18, 2016 Sterile Compounding Committee Meeting
Embassy Suites Lake Buena Vista South
4955 Kyngs Heath Rd Kissimmee FL 34746 Get Directions →(407) 597-4000 |
Materials:
FAR Notice (PDF)
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October 18 - October 19, 2016 Board Meeting
Embassy Suites Lake Buena Vista South
4955 Kyngs Heath Rd Kissimmee FL 34746 Get Directions →(407) 597-4000 |
Materials:
FAR Notice (PDF
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OSBP vs Martin-Tipton Pharmacy, #99-6012 – Case No. 1405
OSBP vs Martin-Tipton Pharmacy, #99-6012 – Case No. 1405:
The Board was called to order by President Spoon to hear the case of Martin-Tipton. Attorney
Kimberly Stevens was present as representative for the pharmacy.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Respondent was charged with multiple violations of state and federal regulations and rules,
including failing as a non-resident pharmacy to submit on initial licensure the name and license
number of an Oklahoma licensed PIC who is responsible for the non-resident pharmacy’s compliance
with Oklahoma laws; the name of the Oklahoma licensed PIC shall be reported to the Board, in
writing, with each renewal and/or within 10 days of any change of such PIC.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, Martin-Tipton would agree to the following: The Respondent would admit guilt on all four (4)
counts. Respondent would agree to pay $1250.00 per count for a total fine of $5,000.00 which is due
on June 15, 2016. Respondent would agree to not ship into Oklahoma until an Oklahoma licensed
PIC is hired.
Motion was made by Dr. Justin Wilson and seconded by Dr. Greg Adams to accept the Agreed
Order. Motion passed on roll call vote
source Oklahoma Board of Pharmacy June 2016 minutes
source Oklahoma Board of Pharmacy June 2016 minutes
OSBP vs Wellston Clinic Pharmacy, #31-5799 – Case No. 1414
OSBP vs Wellston Clinic Pharmacy, #31-5799 – Case No. 1414:
The Board was called to order by President Spoon to hear the case of Wellston Clinic
Pharmacy. Kathy Dossey, owner and PIC was present as representative of the pharmacy.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Respondent was charged with multiple violations of state and federal regulations and rules,
including failing to ensure that the prescription drug or medication order, regardless of the means of
transmission, has been issued for a legitimate medical purpose by an authorized prescriber acting in
the usual course of the prescriber’s professional practice.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, Wellston Clinic Pharmacy would agree to the following: The Respondent would admit guilt on
Counts 4-3004. Respondent would agree to pay $10.00 per count for a total fine of $10,000.00 which
is due on June 15, 2016.
Motion was made by Dr. Justin Wilson and seconded by Dr. Greg Adams to accept the Agreed
Order. Motion passed on roll call vote.
source Oklahoma Board of Pharmacy June 2016 minutes
source Oklahoma Board of Pharmacy June 2016 minutes
OSBP vs. Qualgen, LLC., #1-M-4255 / #1-B-4469 – Case No. 1408: Respondent agrees to pay a fine of $95.24 per count for a total of $100,000.00
OSBP vs. Qualgen, LLC., #1-M-4255 / #1-B-4469 – Case No. 1408:
The Board was called to order by President Spoon to hear the case of Qualgen, LLC. Shaun
Riney, Managing Director for Qualgen was present along with Attorneys, Beau Patterson and Greg
Frogge.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Respondent was charged with multiple violations of state and federal regulations and rules,
including failing to conform to Federal Food, Drug, and Cosmetic Act Good Manufacturing Practices.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, Qualgen would agree to the following: The Respondent would admit to guilt on Counts 1003,
1090, 1260-1269, 1406 and 1409-1460. The Responded denies guilt on Counts 53-669, 722-1002,
1057-1088, 1144-1175, 1228-1259, 1270-1353, 1407-1408. The Respondent neither admits nor
denies guilt on the remaining counts. The Respondent would be placed on probation for five (5)
years until June 15, 2021 and may appear after one (1) year (after June 15, 2017) to ask the Board
that the probation be lifted. In determining whether to lift the probation, the Board may consider such
matters as the following: (a) Semi-annual reports to the Board by Respondent Qualgen regarding
compliance with applicable laws, regulations and standards; (b) Retention by Respondent of an
independent third-party consultant to review, monthly, to assess Respondent Qualgen’s compliance
with applicable laws, regulations and standards, and make recommendations to promote compliance
and (c) The engaging in mock inspections to monitor and promote Respondent Qualgen’s compliance
with applicable laws, regulations and standards. The Respondent agrees to pay a fine of $95.24 per
count for a total of $100,000.00 which is due and payable in three installments, as follows: $50,000
on June 15, 2016, 25,000 on September 15, 2016 and $25,000 on December 15, 2016. The
Respondent will agree to remedy all observations noted by the FDA in its Form 483. Any application
by any current or future member (owner) of Qualgen for any license issued by the Board filed before
June 15, 2021 shall be made to the Board and decided by the Board. Any application by Shaun
Riney for any license issued by the Board for himself on any business entity in which he owns an
interest filed before June 15, 2021 shall be made to and decided by the Board. The Respondent’s
PIC shall attend a one-day (8 hour) law seminar during the years 2016 and 2017 in addition to the
required fifteen (15) hours of CE.
Motion was made by Dr. Justin Wilson and seconded by Dr. Greg Adams to accept the Agreed
Page 9 of 9
Order. Motion passed on roll call vote.
source Oklahoma Board of Pharmacy June 2016 minutes
source Oklahoma Board of Pharmacy June 2016 minutes
Oklahoma State Board of Pharmacy vs. Physician Preferred Medical, LLC, #1-6190 – Case No. 1407: The Respondent agrees to revocation of its parenteral (sterile compounding) permit. The Respondent would be placed on probation for five (5) years until June 15, 2021. The Respondent agrees to pay a fine of $72.09 per count for a total of $125,000.00
OSBP vs Physician Preferred Medical, LLC, #1-6190 – Case No. 1407:
The Board was called to order by President Spoon to hear the case of Physician Preferred
Medical, LLC (PPM). Ryan Orton, primary owner of PPM, was present along with Attorneys Beau
Patterson and Greg Frogge.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Respondent was charged with multiple violations of state and federal regulations and rules,
including failing to comply with all aspects of minimum current good compounding practices for the
preparation of drug products.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, PPM would agree to the following: The Respondent would admit to guilt on Counts 448-531,
538-994, 1188-1634, 1799-1801, 1803-2090. The Respondent denies guilt on Counts 532-537, 996-
1186, 1636-1795, 1798, 1802, 2091-2094. The Respondent neither admits nor denies guilt on the
remaining counts. The Respondent agrees to revocation of its parenteral (sterile compounding)
permit. The Respondent would be placed on probation for five (5) years until June 15, 2021. The
Respondent agrees to pay a fine of $72.09 per count for a total of $125,000.00 which is due and
payable in three installments, as follows: $50,000 on June 15, 2016, 37,500 on September 15, 2016
and $37,500 on December 15, 2016. Any application by any current or future member (owner) of
PPM for any license issued by the Board filed before June 15, 2021 shall be made to the Board and
decided by the Board. The Respondent’s PIC shall attend a one-day (8 hour) law seminar during the
years 2016 and 2017 in addition to the required fifteen (15) hours of CE.
Motion was made by Dr. Mark St. Cyr and seconded by Dr. Justin Wilson to accept the Agreed
Order. Motion passed on roll call vote.
source Oklahoma State Board of Pharmacy Minutes for June 2016
source Oklahoma State Board of Pharmacy Minutes for June 2016
Oklahoma State Board of Pharmacy vs. Turner Drug--total fine of $75,027.00 which is due the date the pharmacy is sold or at the latest one hundred twenty days from the date of the Agreed Order.
OSBP vs Turner Drug, #47-6211 – Case No. 1418:
The Board was called to order by President Spoon to hear the case of Turner Drug. Bobby
Gee, part owner and PIC of Turner Drug was present along with his wife, Vickie Gee who is also part
owner and office manager and Attorney Charles Mashek.
Assistant Attorney General, Brinda White presented the Board with the Complaint for review.
The Respondent was charged with multiple violations of state and federal regulations and rules,
including failing to have a sterile compounding preparation pharmacy permit as required of all
pharmacies compounding sterile preparations.
Ms. White then presented the Board with an Agreed Order. If the Board accepts the Agreed
Order, Turner Drug would agree to the following: The Respondent would admit guilt on all counts
except Counts 2 and 8501. Respondent would agree to pay $8.82 per count for a total fine of
$75,027.00 which is due the date the pharmacy is sold or at the latest one hundred twenty days from
the date of the Agreed Order.
Motion was made by Dr. Greg Adams and seconded by Dr. Justin Wilson to accept the Agreed
Order. Motion passed on roll call vote.
source Oklahoma Board of Pharmacy June 2016 Minutes
source Oklahoma Board of Pharmacy June 2016 Minutes
Park West Pharmacy, Inc., PHY 46623, Administrative Case AC 5378
Through a disciplinary action of the Board, the license is revoked and canceled and the right to practice or operate has ended.
West Hills, CA
Decision effective 8/29/2016.
View the decision
Through a disciplinary action of the Board, the license is revoked and canceled and the right to practice or operate has ended.
West Hills, CA
Decision effective 8/29/2016.
View the decision
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