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 TTYITDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http://www.pharmacy.ohio.gov

NOTICE OF OPPORTUNITY FOR HEARING

July 10, 2013

Royal Palm Specialty Pharmacy C/O Katie L. Fafalla, R.Ph. 118 Main St. Webster, MA 01 570 Re: Ohio Terminal Distributor License No. 02-2149350

Dear Ms. Fafalla: 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 Royal Palm Specialty Pharmacy's license. Prior to any such action, Royal Palm Specialty Pharmacy is entitled to a hearing before the State Board of Pharmacy on the basis of the following allegations:
(l)

Records of the Board of Pharmacy indicate that Royal Palm Specialty Pharmacy is licensed with the State Board of Pharmacy as a Terminal Distributor of Dangerous Drugs. Records further reflect during the relevant time periods stated herein, Agnes Bergeron, R.Ph. was 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. Royal Palm Specialty Pharmacy did, on or about April 9, 2012, violate Ohio Administrative Code Rule 4729-5-10 by shipping dangerous drugs to an unlicensed clinic without obtaining the proper pick-up station waiver. Specifically, vials and syringes were obtained from an unlicensed clinic bearing the label of Royal Palm Specialty Pharmacy. Such drugs were obtained directly from the pharmacy without obtaining permission from the Ohio State Board of Pharmacy pursuant to Rule 4729-5-10 of the Ohio Administrative Code. If proven, such indicates that Royal Palm Specialty Pharmacy violated a rule of the board and/or violated a provision of Chapter 4729 of the Ohio Revised Code thereby ceasing to satisfy the qualifications of a terminal distributor within the meaning of Section 4729.57 of the Ohio Revised Code.

(2)

For these reasons, the State Board of Pharmacy will determine whether to take action pursuant to Section 4729.57 of the Ohio Revised Code.

Royal Palm Specialty Pharmacy C/O Katie L. Fafalla, R.Ph. Page 2 Notice of Opportunity

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) 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

(2) (3) (4)

(5)

(6)

(7)

(8)

(b)

Royal Palm Specialty Pharmacy C/O Katie L. Fafalla, R.Ph. Page 3 Notice of Opportunity

policy, contract, or plan that covers the pharmaceutical services would otherwise be required to pay for the services. YOU ARE FURTHER NOTIFIED that "Revoke", as used in Chapters 3719. and 4729. of the Revised Code, means to take action against a license rendering such license void and such license may not be reissued. "Revoke" is an action that is permanent against the license and licensee. Ohio Administrative Code, 4729-9-01 (E) 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 (30 TH) 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 (30 th) 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.

KWP/bte (Case No. 2012-1429) Registered Mail/Return Receipt RE 946 606 604 US

c: Charissa D. Payer, Assistant Attorney General