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 May 6, 2010 Mark R. Fantauzzi, D.O., O.D. 1219 Findley Street Portsmouth, Ohio 45662

Re: Application for Registration as a Terminal Distributor of Dangerous Drugs

Dear Dr. Fantauzzi: 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 State Board of Pharmacy indicate that you have signed an application for licensure indicating that you are the sole proprietor at the address indicated above and thereby the responsible person pursuant to Sections 4729.27 and 4729.55 of the Ohio Revised Code. You did, on or about March 18, 2010, knowingly make a false statement when made with purpose to secure the issuance by the Ohio State Board of Pharmacy of a license, to wit: you submitted an application for licensure as a Terminal Distributor of Dangerous Drugs which contained false and/or misleading statements. Your application indicates that you are a "sole proprietor" when in fact the site to be licensed is owned by another unlicensed individual who employs you by contract; the building in which you intend to operate bears a sign saying "Southern Ohio Complete Pain Management." Such conduct is in violation of Section 2921.13(A)(5) of the Ohio Revised Code, and if proven indicates that you are not of good moral character and habits within the meaning of Rule 4729-9-19 of the Ohio Administrative Code and thereby do not meet the qualifications for a Terminal Distributor of Dangerous Drugs as set forth in Section 4729.55 of the Ohio Revised Code. You have not furnished satisfactory proof to the Board that a pharmacist or licensed health professional authorized to prescribe drugs will maintain supervision and control over the possession and custody of dangerous drugs that may be acquired by you or on your behalf, to wit: you have designated unlicensed persons to be a

(2)

(3)

"pharmacy technician." You have indicated that persons other than a pharmacist or licensed health professional will have keys to, and unfettered access to, the drug stock. Such indicates that you do not meet the qualifications for a Terminal Distributor of Dangerous Drugs as set forth in Section 4729.55(B) of the Ohio Revised Code. (4) You have not furnished satisfactory proof to the Board that adequate safeguards are assured to prevent the sale or the distribution of dangerous drugs by any person other than a pharmacist or licensed health professional authorized to prescribe drugs. Specifically, you have indicated that unlicensed persons will have keys and unfettered access to the drug stock and drug safe. Additionally, you are the only licensed person at the facility, and though you list this as your site of practice, you maintain your residence in Portland, Maine. You, the sole physician and only licensed health professional at the practice, infer that you will not check medications that leave the facility with patients, and that you will only "initial" Schedule II Controlled Substance prescriptions/orders at the end of the business day. Such indicates that you do not meet the qualifications for a Terminal Distributor of Dangerous Drugs as set forth in Section 4729.55(C) of the Ohio Revised Code. You have not furnished satisfactory proof to the Board that, since an agent or employee of yours has been found guilty violating provisions of the federal drug abuse control laws and/or Chapter 2925. of the Ohio Revised Code (or its Indiana equivalent), adequate safeguards are assured to prevent the recurrence of the violation. Specifically, the building's owner, and a contractual participant with you, Tracy Bias, has been convicted of Possession of Marijuana, a class D felony in the State of Indiana, and you have offered no satisfactory proof of any safeguards to assure preventing their recurrence. In fact, Tracy Bias was arrested leaving the facility on July 9, 2009, while in possession of patient sign-in sheets and prescriptions, also in possession of and using marijuana. Such indicates that you do not meet the qualifications for a Terminal Distributor of Dangerous Drugs as set forth in Section 4729.55(E) of the Ohio Revised Code.

(5)

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: (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) 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; (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

William T. Winsley, M.S., R.Ph. Executive Director

DLR: vf (D-100506-117) Registered Mail / Return Receipt RE 663 137 117 US c: Tracy M. Greuel, Assistant Attorney General