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

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

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

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