Pharmacy Creations (PD TDDD)
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Transcript of Pharmacy Creations (PD TDDD)
7/27/2019 Pharmacy Creations (PD TDDD)
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OHIO STATE BOARD OF PHARMACY 77 South High Street, Room 1702; Columbus, OH 43215-6126
-Equal Opportunity Employer and Service Provider-
TEL: 614/466-4143 E-MAIL: [email protected] FAX: 614/752-4836TTY/TDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http://www.pharmacy.ohio.gov
PROPOSAL TO DENY/NOTICE OF OPPORTUNITY FOR HEARING
October 15, 2013
Pharmacy Creations
John Scott Karolchyk, R.Ph.
540 Route 10 West
Randolph, New Jersey 07869 Re: Application for Registration as a
Terminal Distributor of Dangerous
Drugs
Dear Mr. Karolchyk:
YOU ARE HEREBY NOTIFIED, in accordance with the provisions of Section 119.07 of the Revised
Code, that your application for registration as a Terminal Distributor of Dangerous Drugs
pursuant to Section 4729.54 of the Revised Code, has been proposed to be denied.
The reason for this proposal is that the Board has evidence which leads it to believe that you
do not qualify for registration under Section 4729.55 of the Revised Code. Specifically, you
have not furnished satisfactory proof to the Board that you meet the qualifications of a
terminal distributor of dangerous drugs. The specific evidence in support of this action is as
follows:
(1) Records of the Board of Pharmacy indicate that on or about March 1, 2013, you were 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
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compound and sell dangerous drugs to Valley Surgery Center in Ohio without being
licensed as a terminal distributor of dangerous drugs. Specifically, Pharmacy Creationscompounded 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, and if proven constitute an unsafe and/or
ineffective manner of practicing pharmacy.
(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 vialstropicamide 1%/phenylephrine10%/timolol 0.5% drops were compounded and 120 vials of
triamzinolone/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, and if proven constitute an unsafe and/or ineffective manner of
practicing pharmacy.
YOU ARE HEREBY ADVISED that Section 4729.55 of the Ohio Revised Code provides in pertinent
part that:
No license shall be issued to an applicant for licensure as a terminal distributor of
dangerous drugs unless the applicant has furnished satisfactory proof to the board of
pharmacy that:
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(A) The applicant is equipped as to land, buildings, and equipment to properly
carry on the business of a terminal distributor of dangerous drugs within thecategory of licensure approved by the board.
(B) A pharmacist, licensed health professional authorized to prescribe drugs,
animal shelter licensed with the state board of pharmacy under section 4729.531 of
the Revised Code, or a laboratory as defined in section 3719.01 of the Revised Code
will maintain supervision and control over the possession and custody of dangerous
drugs that may be acquired by or on behalf of the applicant.
(C) Adequate safeguards are assured to prevent the sale or other distribution of dangerous drugs by any person other than a pharmacist or licensed health
professional authorized to prescribe drugs.
(D) Adequate safeguards are assured 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.
(E) If the applicant, or any agent or employee of the applicant, has been foundguilty of violating section 4729.51 of the Revised Code, the "Federal Food, Drug, and
Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, the federal drug abuse control
laws, Chapter 2925., 3715., 3719., or 4729. of the Revised Code, or any rule of the
board, adequate safeguards are assured to prevent the recurrence of the violation
. . .
Rule 4729-9-19 of the Ohio Administrative Code states:
(A) The state board of pharmacy may consider as evidence of a person not meeting
the requirements provided in sections 4729.53 and 4729.55 of the Revised
Code, and may deny a person registration as a wholesale distributor of
dangerous drugs or licensure as a terminal distributor of dangerous drugs in
Ohio if such person:
(1) Has been convicted of a felony;
(2) Has been convicted of violating any state or federal pharmacy or drug law;
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(3) Is not of good moral character and habits;
(4) Is addicted to or abusing liquor or drugs;
(5) Has been disciplined by the Ohio state board of pharmacy pursuant to
section 4729.16 of the Revised Code; or
(6) Has been disciplined by any board of pharmacy.
YOU ARE FURTHER NOTIFIED, in accordance with the provisions of Chapters 119. and 4729. of
the Ohio Revised Code, that you are entitled to a hearing before the Ohio State Board of Pharmacy, if you request such a hearing within thirty (30) days of the time of the mailing of
this notice.
IF YOU DESIRE A HEARING, such request shall be mailed to the State Board of Pharmacy, 77
South High Street, Room 1702, Columbus, Ohio 43215-6126. YOUR REQUEST MUST BE IN
WRITING, AND MUST BE RECEIVED IN THE OFFICE OF THE OHIO STATE BOARD OF PHARMACY
ON OR PRIOR TO THE THIRTIETH (30TH) DAY FOLLOWING THE MAILING DATE OF THIS NOTICE.
You may appear at such hearing in person, by your attorney, or by such other representative as
is permitted to practice before the agency, or you may present your position, arguments orcontentions in writing; and, at this hearing, you may also present evidence and examine any
witnesses appearing for and against you.
YOU ARE FURTHER ADVISED that if there is no request for such a hearing received by the Board
on or prior to the thirtieth (30th) day following the mailing of this notice, the Ohio State Board
of Pharmacy, upon consideration of the aforementioned allegations against you, may take
action without such a hearing.
BY ORDER OF THE STATE BOARD OF PHARMACY
Kyle W. Parker, M.B.A., R.Ph.
Executive Director
KWP/2012-1918 (Case Number)
Registered Mail / Return Receipt
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RE 946 606 697 US
c: Charissa D. Payer, Assistant Attorney General