Aug 11 2006 3:06 Aug 11 2006 98:04 P.O3 _ STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, PETITIONER, v. , , CASE NO, 2003-06550 YOUR DRUGGIST, RESPONDENT. a ADMINISTRATIVE COMPLAINT Petitioner, Department of Health, by and through undersigned counsel, files this Administrative Complaint before’ the Board of Pharmacy against Respondent, Your Druggist, and in support thereof alleges: 4. Petitioner is the state department 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 Complaint, Respondent was a permitted community pharmacy within the state of Florida, having been issued permit number PH 8106. 3. Respondent’s address of record is 8091 W. Sample Road, Coral . Springs, Florida 33065. Aug 11 2006 8:07 fug 11 2006 8:04 P. O04 4. On or about February 17, 2003, Department of Health (DOH) investigators conducted.a routine inspection of Respondent. 5. On or about june 9, 2003, DOH investigators conducted a re- inspection of Respondent. 6. Section 465.023(1)(c), Florida Statutes (2002), provides that the Board of Pharmacy may revoke or suspend, fine, place on probation, or otherwise discipline any pharmacy permittee who has violated. any of the requirements of Chapter 465, Florida Statutes; any of the rules of the Board of Pharmacy; of Chapter 499, Florida Statutes; of 21 U.S.C. ss, 301- 392, known as the “Federal Food, Drug, and Cosmetic Act”; of 21 U.S.C, ss. 821 et seq., known as the Comprehensive Drug Abuse Prevention and Control Act; or of Chapter 893, Florida Statutes. COUNT ONE ‘7, Petitioner realleges and incorporates paragraphs one (1) through six (6)-as if fully set forth in this count. 8. Rule 64B16-28.110, Florida Administrative Code, provides that persons qualified to do so shall examine the stock of the prescription department at a minimum interval of four months and remove all deteriorated pharmaceuticals or pharmaceuticals that bear upon the container an expiration date which date has been reached. 2 Aug 11 2006 8:07 fug 11 2006 8:05 P.O5 9. During the February .17, 2003, inspection, the DOH investigators found outdated medications in the Your Druggist prescription department. , «10. The outdated medications found during the February 17, 2003, inspection, included: a. Prozac liquid, lot number 4NF57M, expiration 1/03; b. Hydroxyzine HCl, lot number 23651C, expiration 12/02; | c, Quad Jann Ped. Suspension, lot number 70920, expiration 9/02: d. Donnagel Liquid, lot number 0000028, expiration 5/02; e. Dura Dal HD Plus Liquid, lot number 00912, expiration 9/02; f. Cimetidine 200mg tablets, lot number 2660-702, expiration 10/01; g. Calcionate Syrup, lot number 067921, expiration 6/02; h. Chlorpheniramine 4mg tablets, lot number 20551; expiration 5/02; i. Generlac Solution 10g/15ml, jot number 23801A, expiration 11/02; Aug 11 2006 8:07 fug 11 2006 8:05 P. O06 j. Furosemide Oral Solution 10mg/ml, lot number 23342C, expiration 7/02; | k, Coumadin 7-1/2 mg tablets, lot number ENE240A, expiration 4/02; |, Metoclopramide Oral Solution 5mg/ml, lot number 235944, expiration 11/02: m. Naproxen Sodium tablets 550mg, jot number 567244, expiration 5/02; . | n. Vincristine Sulfate Injection, lot number 1037139, expiration 8/02; | 0. , Sterile’ pacitracin 50,000 units, lot number 37DMW, expiration 4/02; p. Darvocet-N 100 tablets, lot number 3AK83M, expiration 10/02; q. . Novolin R Pen Fill Insulin, lot number 1M27004, expiration 12/02; r Humulin N Pen U-100 Insulin, lot number FFON90A, expiration 6/02; s. | Humulin 70/30 Pen U-100 Insulin, lot number FFOL23A, expiration 5/02; Aug 11 2006 8:07 fug 11 2006 8:06 P.O? t. Chlorhexidine Digiuconate 20%, lot number 59199, expiration 11/99; u. ‘Bubble Gum Flavor Concentrate, lot number 89626, expiration 2/03; y, Promethazine HCI, lot number 50314, expiration 3/01; w. Butylated Hydroxytoluene FCC, lot number 44057, expiration 9/99; x. . Betahistine Dihydrochlorite, lot: number 81515, expiration 12/01; y. Vitamin D-2, lot number 86938, expiration 7/02; z. Alupent Aerosol, lot number 000253W, expiration 5/02; aa. Promethazine DM Syrup, lot number 0990460, expiration 10/02; bb. Raspberry Flavor Concentrate, lot number 82386, expiration 4/02; | cc, orange Flavor Concentrate, lot number 83744, expiration 5/02; dd. Strawberry Flavor Concentrate, lot number 70821, expiration 12/00; ee, Benzocaine Powder, lot number 40879, expiration 5/99; Aug 11 2006 8:07 fug 11 2006 8:05 P. 08 ff. Phenylephrine HCl Powder, lot number 56573, expiration 5/99; gg. Belladonna Tincture, lot number 12124, expiration 4/01/91; hh, Peppermint Oil, lot number 147684, expiration 6/01; and ii. Betamethasone Dipropionate Powder, lot number BDMO79, expiration 10/00. 11. During the June 9, 2003, inspection, the DOH investigators found outdated medications in the prescription department. 12. The outdated medications found during the June 9, 2003, inspection included: . . a, Dilaudid Cough Syrup, lot number 33300018, expiration 1/2002; b. Cimetidine HCL Oral Solution, lot number RK1688, expiration 4/03; c. Sodium Polystyrene Sulfonate Powder, lot number RB 1243, expiration 11/30/02; d. Buspirone Smg tablets, lot number 3015092, expiration 11/2002; e. Per-lax capsules, lot number 0286AB, expiration 11/02; Aug 11 2006 3:08 fug 11 2006 8:05 P.09 f, Buspirone 10mg tablets, lot number 3013004, expiration 10/2002; | gq. Epoetin Alfa-Procrit, lot number D002713, expiration 4/03; h. Humulin R inj, lot number FFOM73A, expiration 5/02, L. Neosporin G.U. Irrigant, lot number OA1296, expiration j. Miconazole Nitrate, lot number 63289, expiration 5/03; k. Bethanechol Chloride, lot number 78183, expiration 9/01; I. Reserpine Powder, lot numbers 58618 and 67567, expiration 11/02; : _m.’ Nystatin USP, lot number 81213, expiration 3/03; and n. , Acetylcysteine Inj., lot number 1072-15, expiration 5/03. 13. Based on the foregoing, Respondent has violated Section 465.023(1)(c), Florida Statutes (2002), violating a rule of the board, through a violation of Rule 64B16-28.110, Florida Administrative Code, by failing to remove outdated pharmaceuticals from the active stock of the prescription department. Aug 11 2006 8:08 fug 11 2006 98:06 P.10 UNT TWO 14. Petitioner realleges and incorporates paragraphs one (1) through six (6) as if fully set forth in this count. 15. Rule 64B16-27.300(3)(a), Florida Administrative Code, provides that each pharmacy establish a Continuous Quality Improvement Program (COD with the CQI being described in the pharmacy’s policy and procedures manual, At a minimum, the CQI shall contain: provisions for a COI committee: provisions for the prescription department manager to ensure that the committee conducts a review of Quality Related events at least every three months; a planned process to record, measure, assess, and improve the quality of patient care; and the procedure for reviewing Quality Related events. 16. Rule 64B16-27.300(5), Florida Administrative Code, provides that the records maintained as a component of the pharmacy CQI are confidential; however, to determine compliance, the Department may review the policy and procedures and a Summarization of Quality Related Events. 17. During the February 17, 2003, inspection and the June 9, 2003, inspection, the DOH investigator requested to review Respondent's policy and procedures and summarization of Quality Related Events. Aug 11 2006 3:08 fug 11 2006 8:06 P.11 18. No CQI or ‘Summarization of Quality Related Events was presented to the DOH investigator during the February 17, 2003, inspection. : 19. No CQI or “summatization of Quality Related Events was presented to the DOH investigator during the June 9, 2003, inspection. 20, Based on the foregoing, Respondent has violated Section 465.023(1)(c), Florida Statutes (2002), violating a rule of the board, ‘through a- violation of Rule 64B16-27.300(5), Florida Administrative Code, by failing to make the pharmacy’s policy and procedures, including CQI and a Summarization of Quality Related Events, available to. the Department investigator for review. WHEREFORE, 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 Respondent on. probation, corrective action, refund of fees billed or collected, remedial education and/or any other relief that the Board deems appropriate. Aug 11 2006 3:08 fug 11 2006 8:06 P.12 bab SIGNED this__ 344 day of __feuz _— , 2004, John O. Agwunobi, M.D, M.B.A., M.P.H. Secretary, Department of Health Deborah B, Loucks Assistant General Counsel DEPARTMENT OF HEALTH DOH Prosecution Services Unit DEPUTY CLERK 4052 Bald Cypress Way, Bin C-65 ouenk N ocbhue Colman Tallahassee, FL 32399-3265 pare 28105 : Florida Bar # 0169889 ; (850) 414-8126 (850) 488-1855 FAX Reviewed and approved by: DKA (initials) _/o/+7 /27(date) PCP: Vautlos Your Druggist, Case Number 2003-06550 NOTICE OF RIGHTS Respondent has the right to request a hearing to be conducted in accordance with Section 120.569 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. 10

Docket for Case No: 06-002882