STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, We CASE NO. 2013-01125 LAS MERCEDES DRUG STORE, INC., PH, RESPONDENT. / ADMINISTRATIVE COMPLAINT COMES NOW, Petitioner, Department of Health, by and through its undersigned counsel, and files this Administrative Complaint before the Board of Pharmacy against Respondent, Las Mercedes Drug Store, Inc., PH, and in support thereof alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 456, Florida Statutes; and Chapter 465, Florida Statutes. 2. At all _times material to this Administrative Complaint, Respondent was a permitted community pharmacy within the state of Florida, having been issued permit number PH 25947. 3. Respondent's address of record is 7209 SW Coral Way, Miami, Florida 33155. 4, On or about January 9, 2013, a Department of Health (Department) inspector conducted an inspection of Respondent at 7209 SW Coral Way, Miami, Florida 33155, and observed the following deficiency: | a. Pedigrees not retrievable as required by Rule 64F- 12.012(3)(a)2., (d), Florida Administrative Code, 5. On or about February 27, 2013, the Department inspector conducted an inspection of Respondent at 7209 SW Coral Way, Miami, Florida 33155, and observed the following deficiency: a. Pedigrees not retrievable as required by Rule 64F- 12.012(3)(a)2., (4), Florida Administrative Code. 6. As part of the inspection on or about January 9, 2013, the Department inspector conducted an audit of the drugs Lidoderm, Abilify, and Advair. 7. Lidaderm is a brand name of lidocaine topical. Lidoderm is a local anesthetic prescribed to relieve post-shingles pain. Department af Health v. Las Mercedes Drug Store, Inc, PH Case Number 2013-01125 8. Abilify is a brand name of aripiprazole. Abilify is an antipsychotic medication prescribed to treat the symptoms of various psychotic conditions. 9. Advair is a brand name of fluticasone and salmeterol. Advair contains a steroid and a bronchodilator, and is prescribed to prevent asthma attacks. 10. According to Respondent's purchasing records, to include invoices and receipts, from on or about October 1, 2012 through on or about December 31, 2012, Respondent purchased the following quantities of the audited drugs: Lidoderm 5% patch, 30 count. Respondent was unable to produce any purchasing records for Abilify, all strengths, or Advair, all strengths. 11. According to Respondent's dispensing records, from on or about October 1, 2012 through on or about December 31, 2012, Respondent dispensed the following quantities of the audited drugs: 720 count of Lidaderm 5% patch, 180 tablets of Abilify, all strengths, and.960 tablets.of Advair, all strengths. 12. From on or about October 1, 2012 through on or about December 31, 2012, Respondent cannot provide documentation to account Department of Health v. Las Mercedes Drug Store, Inc., PH 3 Case Number 2013-01125 for the receipt of 690 count of Lidoderm 5% patch, and/or 180 tablets of Abilify, all strengths, and/or 960 tablets of Advair, all strengths, , 13. As part of the inspection on or about February 27, 2013, the Department inspector conducted an audit of the drug Crestor. 14. Crestor is a brand name of rosuvastatin. Crestor is a statin prescribed to lower cholesteral in the blood. 15. According to Respondent's purchasing records, to include invoices and receipts, from on or about January 1, 2013 through on or about February 27, 2013, Respondent purchased 90 tablets of Crestor, 20 milligrams. . 16. According to Respondent’s dispensing records, from on or about January 1, 2013 through on or about February 27, 2013, Respondent dispensed 390 tablets of Crestor, 20 milligrams. 17, From on or about January 1, 2013 through on or about February 27, 2013, Respondent cannot provide documentation to account for the receipt of approximately 300 tablets of Crestor, 20 milligrams. 18. Section 465.023(1)(c), Florida Statutes (2012), provides that the board may revoke or suspend the permit of any pharmacy permittee, and may fine, place on probation, or otherwise discipline any pharmacy Department of Health v. Las Mercedes Drug Store, Inc, PH 4 Case Number 2013-01125 permittee who has violated any of the requirements of Chapter 499, Florida Statutes (2012), or any of the rules of the Board of Pharmacy. 19. Section 499.005(18}, Florida Statutes (2012), states that it is unlawful if there is a failure to maintain records as required by this part and rules adopted under this part. 20, Rule 61N-1.012(1)(a), Florida Administrative Code, (formerly Rule 64F-12.012(1}(a), FA.C.), provides that records to document the movement of drugs, devices or cosmetics must provide a complete audit trail from a person's receipt or acquisition to sale or other disposition of the product or component. 21. As set forth in paragraph twelve, on or about January 9, 2013, the Department inspector found Respondent unable to retrieve the pedigree records or invoices for 690 count of Lidoderm 5% patch, and/or 180 tablets of Abilify, all strengths, and/or 960 tablets of Advair, all strengths. 22. As set forth in paragraph seventeen, on or about February 27, 2013, the Department inspector found Respondent unable to retrieve the pedigree records or invoices for 300 tablets of Crestor, 20 milligrams. Department of Health v, Las Mercedes Drug Store, Inc., PH 5 Case Number 2013-01125 23. Based on the foregoing, Respondent has violated Section 465.023(1)(c), Florida Statutes (2012), by violating Section 499.005(18), Florida Statutes (2012), by violating Rule G1N-1.012(1){a), Florida Administrative Code, which requires that records to document the movement of drugs, devices or cosmetics must provide a complete audit trall from a person’s receipt or acquisition to sale or other disposition of the product or component. WHEREFORE, the Petitioner respectfully requests that the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of Respondent’s license, restriction of practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. SIGNED this _20* day of DUNE 2013. John H. Armstrong, MD, FACS State Surgeon General and Secretary of Health Department of Health v, Las Mercedes Drug Store, Inc., PH 6 Case Number 2013-01125 Chelan. A _fessite CHRISTOPHER A.J CH Assistant General Counsel Fla. Bar No. 0099014 FILED Florida Department of Health DEPARTMENT OFHEALTH Office of the General Counsel CLERK Angel sannnn 4052 Bald Cypress Way, Bin #C65 pare JUN S 3G Tallahassee, FL 32399-3265 “ Telephone: (850) 245-4444 ext. 8174 Facsimile: (850) 245-4683 Email: christopher_jurich@doh. state. fl.us {CAJ PCP: June 20,0015 PCP Members: Mesaros, J. + Risch) L. Department of Health v. Las Mercedes Drug Store, Inc, PH Case Number 2013-01125 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 126.569 and 120.57, Florida Statutes, to be represented by counsel or other qualified representative, to present evidence and argument, to call and cross-examine witnesses and to have subpoena and subpoena duces tecum issued on his or her behalf if a hearing is requested. NOTICE REGARDING ASSESSMENT OF COSTS Respondent is placed on notice that Petitioner has incurred costs related to the investigation and prosecution of this matter. Pursuant to Section 456.072(4), Florida Statutes, the Board shall assess costs related to the investigation and prosecution of a disciplinary matter, which may include attorney hours and costs, on the Respondent in addition to any other discipline imposed. Department of Health v. Las Mercedes Drug Store, Inc., PH 8 Cease Number 2013-01125

Docket for Case No: 13-003258