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: exec@bop.state.oh.us FAX: 614/752-4836 TTY/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 Page 2 Notice of Opportunity

compound and sell dangerous drugs to Valley Surgery Center in Ohio without being licensed as a terminal distributor of dangerous drugs. compounded and sold Specifically, Pharmacy Creations 0.5% drops and Tropicamide1%/phenylephrine10%/Timolol

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 47299-25 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. triamzinolone/moxifloxacian/vancomycin intravitreal powder Quantities of 10 vials was compounded in tropicamide 1%/phenylephrine10%/timolol 0.5% drops were compounded and 120 vials of 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 Page 3 Notice of Opportunity

(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 the category 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 found guilty 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 Page 4 Notice of Opportunity

(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 or contentions 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 Page 5 Notice of Opportunity

RE 946 606 697 US c: Charissa D. Payer, Assistant Attorney General