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OHIO STATE BOARD OF PHARMACY77 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: 614/752-4836TTYITDD: Use the Ohio Relay Service: 1-800/750-0750 URL: http://www.pharmacy.ohio.gov

NOTICEOFOPPORTUNITY FOR HEARING

July 10, 2013

Royal Palm Specialty PharmacyC/O Katie L. Fafalla, R.Ph.118 Main St.Webster, MA 01 570

Re: Ohio Terminal DistributorLicense No. 02-2149350Dear Ms. Fafalla:YOU ARE HEREBY NOTIFIED that, in accordance wi th the provisions of Chapters 119. and 4729.of the Ohio Revised Code, the Ohio State Board of Pharmacy will determine whether or not totake action against Royal Palm Specialty Pharmacy's l icense. Prior to any such act ion, RoyalPalm Specialty Pharmacy is entitled to a hearing before the State Board of Pharmacy on thebasis 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. Recordsfurther reflect during the relevant time periods stated herein, Agnes Bergeron, R.Ph. wasthe Responsible Pharmacist pursuant to Rule 4729-5-11 of the Ohio Administrative Codeand Sections 4729.27 and 4729.55 of the Ohio Revised Code.

(2) Royal Palm Specialty Pharmacy did, on or about April 9, 2012, violate OhioAdministrative Code Rule 4729-5-10 by shipping dangerous drugs to an unlicensed clinicwithout obtaining the proper pick-up station waiver. Specifically, vials and syringes wereobtained from an unlicensed clinic bearing the label of Royal Palm Specialty Pharmacy.Such drugs were obtained directly from the pharmacy without obtaining permission fromthe Ohio State Board of Pharmacy pursuant to Rule 4729-5-10 of the Ohio AdministrativeCode. If proven, such indicates that Royal Palm Specialty Pharmacy violated a rule of theboard and/or violated a provision of Chapter 4729 of the Ohio Revised Code therebyceasing to satisfy the qualif ications of a terminal distributor within the meaning ofSection 4729.57 of the Ohio Revised Code.

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

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

YOU ARE HEREBY ADVISED that Section 4729.57 of the Ohio Revised Code provides inpertinent part:(A) The State Board of Pharmacy may suspend, revoke, or refuse to renew any licenseissued to a terminal distributor of dangerous drugs pursuant to section 4729.54 of

the Revised Code, or may impose a monetary penalty or for feiture not to exceed inseverity any fine designated under the Ohio Revised Code for a similar offense or onethousand dollars i f the acts committed have not been classified as an offense by theRevised Code, for any of the following causes:(1) Making any false material statements in an application fo r a licenseas a terminal distributor of dangerous drugs;(2) Violating any rule of the board;(3) Violating any provision of this chapter;(4) Violating any provision of the "Federal Food, Drug, and CosmeticAct," 52 Stat. 1040 (1938),21 U.S.c.A. 301, or Chapter 3715. of theRevised Code;(5) Violating any provision of the federal drug abuse control laws orChapter 2925. or 3719. of the Revised Code;(6) Falsely or fraudulently promoting to the public a dangerous drug,

except that nothing in this division prohibits a terminal distributor ofdangerous drugs from furnishing in formation concerning adangerous drug to a health care provider or another licensedterminal distributor;

(7) Ceasing to satisfy the quali fications of a terminal distributor ofdangerous drugs set forth in Section 4729.55 of the Revised Code.(8) Except as provided in division (B) of this section:

(a) Waiving the payment of all or any part of a deductible orcopayment that an individual, pursuant to a health insuranceor health care policy, contract, or plan that covers theservices provided by a terminal distributor of dangerousdrugs, would otherwise be required to pay fo r the services ifthe waiver is used as an enticement to a patient or group ofpatients to receive pharmacy services from that terminaldistributor;

(b) Advertising that the terminal distributor will waive thepayment of all or any part of a deductible or copayment thatan individual, pursuant to a health insurance or health care

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

policy, contract, or plan that covers the pharmaceuticalservices would otherwise be required to pay fo r the services.YOU ARE FURTHER NOTIFIED that "Revoke", as used in Chapters 3719. and 4729. of theRevised Code, means to take action against a license rendering such license void and suchlicense may not be reissued. "Revoke" is an act ion that is permanent against the l icense andlicensee. Ohio Administrative Code, 4729-9-01 (E)YOU ARE FURTHER NOTIFIED, in accordance with the provisions of Chapters 119. and 4729. ofthe Ohio Revised Code, that you are entitled to a hearing before the Ohio State Board ofPharmacy, if you request such a hearing within thirty (30) days of the time of the mai ling ofthis notice.IF YOUR FACILITY DESIRES A HEARING, such request shall be mailed to the State Board ofPharmacy, 77 South High Street, Room 1702, Columbus, Ohio 43215-6126. YOUR REQUESTMUST BE IN WRITING, AND MUST BE RECEIVED IN THE OFFICE OF THE OHIO STATE BOARD OFPHARMACY ON OR PRIOR TO THE THIRTIETH (30TH) DAY FOLLOWING THE MAILING DATE OFTHIS NOTICE. You may appear at such hearing in person, by or with your attorney, or you maypresent the facility's position, arguments or contentions in writing; and, at this hearing, youmay also present evidence and examine any witnesses appearing fo r and against the facility.YOU ARE FURTHER ADVISED that if there is no request for such a hearing received by theBoard on or prior to the thirtieth (30 th) day following the mailing of this notice, the Ohio StateBoard of Pharmacy, upon consideration of the aforement ioned allegations against yourfacil ity, may take action without such a hearing.

KWP/bte (Case No. 2012-1429)Registered Mail/Return ReceiptRE 946 606 604 USc: Charissa D. Payer,Assistant Attorney General