SETTLEMENT AGREEMENT WITH THE STATE BOARD OF PHARMACY
(Case No. 2012-1918)
In the Matter of:
PHARMACY CREATIONS
c/o SCOTT KAROLYCHYK, R.Ph.
540 Route 10 West
Randolph, New Jersey 07869
This Settlement Agreement is entered into by and between Pharmacy Creations and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.
Pharmacy Creations enters into this Agreement being fully informed of its rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein, the right to appeal. Pharmacy Creations acknowledges that by entering into this Agreement it has waived its rights under Chapter 119. of the Revised Code.
WHEREAS, the State Board of Pharmacy is empowered by Section 4729.57 of the Ohio Revised Code to suspend, revoke, refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty on the license holder, for violation of any of the enumerated grounds of Section 4729.57 of the Ohio Revised Code.
WHEREAS, on or about October 15, 2013, pursuant to Chapter 119. of the Ohio Revised Code, Pharmacy Creations was notified of the allegations or charges against it, its right to a hearing, its rights in such hearing, and its right to submit contentions in writing. Further, a hearing was scheduled/continued by the Board. The October 15, 2013, Notice of Opportunity for Hearing contains the following allegations or charges:
(1) Records of the Board of Pharmacy indicate that on or about March 1, 2013, Scott Karolchyk was the responsible pharmacist for Pharmacy Creations, 540 Route 10 West, Randolph, New Jersey, and that on said date, Pharmacy Creations submitted an application for registration as a Terminal Distributor of Dangerous Drugs.
(2) The applicant has failed to furnish satisfactory proof to the Board that adequate safeguards are in place to assure that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner. To wit: the applicant did, on or before October 10, 2012, illegally compound and sell dangerous drugs to Valley Surgery Center in Ohio without being licensed as a terminal distributor of dangerous drugs. Specifically, Pharmacy Creations compounded and sold Tropicamide1%/phenylephrine10%/Timolol 0.5% drops and Trimacinolone/moxiflovacin/vancomycin intravitreal powder without valid patient specific prescriptions, nor was there any other permissible reason to legally compound and sell the drugs as required by Chapter 21, Section 353a of the United States Code, Section 4729.01 of the Ohio Revised Code, and Sections 4729-9-21 and 4729-9-25 of the Ohio Administrative Code. Such conditions violate, or allow the violation of, Sections 3715.65(A) and 4729.57 of the Ohio Revised Code, and Sections 4729-9-21 and 4729-9-25 of the Ohio Administrative Code.
(3) The applicant has failed to furnish satisfactory proof to the Board that adequate safeguards are in place to assure that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner. To wit: the applicant did, on or before October 10, 2012, sell compounded drugs to Valley Surgery Center in a quantity exceeding a seventy-two (72) hour supply. To wit: It was admitted to a Board Agent that compounded dangerous drugs were ordered to be placed in office stock for procedures. Quantities of 10 vials tropicamide 1%/phenylephrine10%/timolol 0.5% drops were compounded and 120 vials
of triamcinolone/moxifloxacian/vancomycin intravitreal powder was compounded in violation of Section 4729-9-25 of the Ohio Administrative Code. Such conditions violate, or allow the violation of, Sections 4729-9-25, 4729-9-21 and 4729-9-25 of the Ohio Administrative Code.
Pharmacy Creations neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated October 15, 2013; however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same.
Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Pharmacy Creations knowingly and voluntarily agrees with the State Board of Pharmacy to the following:
(A) Pharmacy Creations agrees to the imposition of a monetary penalty of two thousand dollars ($2,000.00) due and owing within thirty days from the effective date of this Agreement. The monetary penalty should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.
(B) Pharmacy Creations Pharmacy is hereby granted a license as a Terminal Distributor of Dangerous Drugs and that license will be placed on probation for one year from the date the license is issued. The terms of probation are as follows:
(1) Pharmacy Creations Pharmacy must not violate the drug laws of the state of Ohio, any other state, or the federal government.
(2) Pharmacy Creations Pharmacy must abide by the rules of the Ohio State Board of Pharmacy.
(3) Pharmacy Creations Pharmacy must comply with the terms of this Agreement.
Pharmacy Creations acknowledges that it has had an opportunity to ask questions concerning the terms of this agreement and that all questions asked have been answered in a satisfactory manner. Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.
Pharmacy Creations waives any and all claims or causes of action it may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement. Pharmacy Creations waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code. http://www.pharmacy.ohio.gov/Documents/Pubs/minutes/201406%20-%20Minutes%20(Jun%202014).pdf
(Case No. 2012-1918)
In the Matter of:
PHARMACY CREATIONS
c/o SCOTT KAROLYCHYK, R.Ph.
540 Route 10 West
Randolph, New Jersey 07869
This Settlement Agreement is entered into by and between Pharmacy Creations and the Ohio State Board of Pharmacy, a state agency charged with enforcing the Pharmacy Practice Act and Dangerous Drug Distribution Act, Chapter 4729. of the Ohio Revised Code.
Pharmacy Creations enters into this Agreement being fully informed of its rights afforded under Chapter 119. of the Ohio Revised Code, including the right to representation by counsel, the right to a formal adjudication hearing on the issues contained herein, the right to appeal. Pharmacy Creations acknowledges that by entering into this Agreement it has waived its rights under Chapter 119. of the Revised Code.
WHEREAS, the State Board of Pharmacy is empowered by Section 4729.57 of the Ohio Revised Code to suspend, revoke, refuse to renew any license issued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of the Revised Code, or may impose a monetary penalty on the license holder, for violation of any of the enumerated grounds of Section 4729.57 of the Ohio Revised Code.
WHEREAS, on or about October 15, 2013, pursuant to Chapter 119. of the Ohio Revised Code, Pharmacy Creations was notified of the allegations or charges against it, its right to a hearing, its rights in such hearing, and its right to submit contentions in writing. Further, a hearing was scheduled/continued by the Board. The October 15, 2013, Notice of Opportunity for Hearing contains the following allegations or charges:
(1) Records of the Board of Pharmacy indicate that on or about March 1, 2013, Scott Karolchyk was the responsible pharmacist for Pharmacy Creations, 540 Route 10 West, Randolph, New Jersey, and that on said date, Pharmacy Creations submitted an application for registration as a Terminal Distributor of Dangerous Drugs.
(2) The applicant has failed to furnish satisfactory proof to the Board that adequate safeguards are in place to assure that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner. To wit: the applicant did, on or before October 10, 2012, illegally compound and sell dangerous drugs to Valley Surgery Center in Ohio without being licensed as a terminal distributor of dangerous drugs. Specifically, Pharmacy Creations compounded and sold Tropicamide1%/phenylephrine10%/Timolol 0.5% drops and Trimacinolone/moxiflovacin/vancomycin intravitreal powder without valid patient specific prescriptions, nor was there any other permissible reason to legally compound and sell the drugs as required by Chapter 21, Section 353a of the United States Code, Section 4729.01 of the Ohio Revised Code, and Sections 4729-9-21 and 4729-9-25 of the Ohio Administrative Code. Such conditions violate, or allow the violation of, Sections 3715.65(A) and 4729.57 of the Ohio Revised Code, and Sections 4729-9-21 and 4729-9-25 of the Ohio Administrative Code.
(3) The applicant has failed to furnish satisfactory proof to the Board that adequate safeguards are in place to assure that the applicant will carry on the business of a terminal distributor of dangerous drugs in a manner that allows pharmacists and pharmacy interns employed by the terminal distributor to practice pharmacy in a safe and effective manner. To wit: the applicant did, on or before October 10, 2012, sell compounded drugs to Valley Surgery Center in a quantity exceeding a seventy-two (72) hour supply. To wit: It was admitted to a Board Agent that compounded dangerous drugs were ordered to be placed in office stock for procedures. Quantities of 10 vials tropicamide 1%/phenylephrine10%/timolol 0.5% drops were compounded and 120 vials
of triamcinolone/moxifloxacian/vancomycin intravitreal powder was compounded in violation of Section 4729-9-25 of the Ohio Administrative Code. Such conditions violate, or allow the violation of, Sections 4729-9-25, 4729-9-21 and 4729-9-25 of the Ohio Administrative Code.
Pharmacy Creations neither admits nor denies the allegations stated in the Notice of Opportunity for Hearing letter dated October 15, 2013; however, the Board has evidence sufficient to sustain the allegations and hereby adjudicates the same.
Wherefore, in consideration of the foregoing and mutual promises hereinafter set forth, and in lieu of a formal hearing at this time, Pharmacy Creations knowingly and voluntarily agrees with the State Board of Pharmacy to the following:
(A) Pharmacy Creations agrees to the imposition of a monetary penalty of two thousand dollars ($2,000.00) due and owing within thirty days from the effective date of this Agreement. The monetary penalty should be made payable to the "Treasurer, State of Ohio" and mailed with the enclosed form to the State Board of Pharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126.
(B) Pharmacy Creations Pharmacy is hereby granted a license as a Terminal Distributor of Dangerous Drugs and that license will be placed on probation for one year from the date the license is issued. The terms of probation are as follows:
(1) Pharmacy Creations Pharmacy must not violate the drug laws of the state of Ohio, any other state, or the federal government.
(2) Pharmacy Creations Pharmacy must abide by the rules of the Ohio State Board of Pharmacy.
(3) Pharmacy Creations Pharmacy must comply with the terms of this Agreement.
Pharmacy Creations acknowledges that it has had an opportunity to ask questions concerning the terms of this agreement and that all questions asked have been answered in a satisfactory manner. Any action initiated by the Board based on alleged violation of this Agreement shall comply with the Administrative Procedure Act, Chapter 119. of the Ohio Revised Code.
Pharmacy Creations waives any and all claims or causes of action it may have against the State of Ohio or the Board, and members, officers, employees, and/or agents of either, arising out of matters which are the subject of this Agreement. Pharmacy Creations waives any rights of appeal pursuant to Chapter 119. of the Ohio Revised Code. http://www.pharmacy.ohio.gov/Documents/Pubs/minutes/201406%20-%20Minutes%20(Jun%202014).pdf
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