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



Pharmacy Creations

Notice of Opportunity

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:



Pharmacy Creations


(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;



Pharmacy Creations


(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



Pharmacy Creations


RE 946 606 697 US

c: Charissa D. Payer, Assistant Attorney General

pharmacy creations (pd tddd)

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