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

NOTICE OF OPPORTUNITY FOR HEARING May 6, 2010 Grund Drug Co. c/o Jeffrey Allen Osborne, R.Ph. 227 S. Front Street Fremont, Ohio 43420 Re: Ohio Terminal Distributor License No. 02-0146200 Dear Mr. Osborne: YOU ARE HEREBY NOTIFIED that, in accordance with the provisions of Chapters 119. and 4729. of the Ohio Revised Code, the Ohio State Board of Pharmacy will determine whether or not to take action against its license. Prior to any such action, you are entitled to a hearing before the State Board of Pharmacy on the basis of the following allegations: (1) Records of the Board of Pharmacy indicate that Grund Drug Co. is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drugs and Jeffrey Allen Osborne is the Responsible Pharmacist pursuant to Rule 4729-5-11 of the Ohio Administrative Code and Sections 4729.27 and 4729.55 of the Ohio Revised Code. Grund Drug did, on or about August 22, 2008, misbrand a drug, to wit: when the pharmacy received a request to refill a prescription for Synthroid 0.1 mg, RX #6297421, a pharmacist dispensed warfarin 10 mg, which had not been specifically prescribed by the physician. The patient subsequently was harmed. Such conduct is in violation of Section 3715.52(A)(2) of the Ohio Revised Code, and if proven constitutes violating a provision of Chapter 3715. of the Ohio Revised Code within the meaning of Section 4729.57 of the Ohio Revised Code. Grund Drug did, on or about August 22, 2008, misbrand a drug, to wit: when the pharmacy received a request to refill a prescription for Coumadin 10 mg, RX #6314727, a pharmacist dispensed levothyroxine 0.1 mg, which had not been specifically prescribed by the physician. Such conduct is in violation of Section 3715.52(A)(2) of the Ohio Revised Code, and if proven constitutes violating a provision of Chapter 3715. of the Ohio Revised Code within the meaning of Section 4729.57 of the Ohio Revised Code. Grund Drug did, on or about August 22, 2008, fail to have a system in place to ensure positive identification of the pharmacist or pharmacists responsible for performing all activities relating to the practice of pharmacy including, but not limited to: prescription information entered into the record keeping system; and/or dispensing. Such conduct is in violation of Rule 4729-5-27(A) of the Ohio

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Administrative Code, and if proven constitutes violating a rule of the Board within the meaning of Section 4729.57 of the Ohio Revised Code. For these reasons, the State Board of Pharmacy will determine whether to take action pursuant to Section 4729.57 of the Ohio Revised Code. YOU ARE HEREBY ADVISED that Section 4729.57 of the Ohio Revised Code provides in pertinent part: (A) The State Board of Pharmacy may suspend, revoke, or 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 or forfeiture not to exceed in severity any fine designated under the Ohio Revised Code for a similar offense or one thousand dollars if the acts committed have not been classified as an offense by the Revised Code, for any of the following causes: (1) (2) (3) (4) Making any false material statements in an application for a license as a terminal distributor of dangerous drugs; Violating any rule of the board; Violating any provision of this chapter; Violating any provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A. 301, or Chapter 3715. of the Revised Code; Violating any provision of the federal drug abuse control laws or Chapter 2925. or 3719. of the Revised Code; Falsely or fraudulently promoting to the public a dangerous drug, except that nothing in this division prohibits a terminal distributor of dangerous drugs from furnishing information concerning a dangerous drug to a health care provider or another licensed terminal distributor; Ceasing to satisfy the qualifications of a terminal distributor of dangerous drugs set forth in Section 4729.55 of the Revised Code. Except as provided in division (B) of this section: (a) Waiving the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the services provided by a terminal distributor of dangerous drugs, would otherwise be required to pay for the services if the waiver is used as an enticement to a patient or group of patients to receive pharmacy services from that terminal distributor; Advertising that the terminal distributor will waive the payment of all or any part of a deductible or copayment that an individual, pursuant to a health insurance or health care policy, contract, or plan that covers the

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pharmaceutical services would otherwise be required to pay for the services. 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 YOUR FACILITY DESIRES 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 or with your attorney, or you may present the facility's position, arguments or contentions in writing; and, at this hearing, you may also present evidence and examine any witnesses appearing for and against the facility. 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 your facility, may take action without such a hearing. BY PHARMACY ORDER OF THE STATE BOARD OF

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

WTW:vf (D-100506-112) Registered Mail / Return Receipt RE 663 137 063 US c: Tracy M. Greuel, Assistant Attorney General