STATE OF FLORIDA 0 . DEPARTMENT OF HEALTH / OK . YP ne DEPARTMENT OF HEALTH, Vg S13 eo fey 17, Go Petitioner, v. CASE NO. 2001-10154 = MARCIA R. GIRO, R.PH., Respondent. / ONE td ¢1 04420 Wat: ADMINISTRATIVE COMPLAINT. COMES NOW the Department of Health (Petitioner) and files this Administrative Complaint before the Board of Pharmacy (the Board) against Marcia R. Giro, RPh. (Respondent) and alleges: 1. Petitioner is the state agency charged with regulating the practice of pharmacy under Section 20.43 and Chapters 456 and 465, Fla. Stat. Under Section 20.43(3)(g), Fla. Stat. (2001), Petitioner has contracted with the Agency for Health Care Administration (the Agency) to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards, as appropmiate. 2. Respondent is and has been at all times material hereto a licensed pharmacist in the state of Florida having been issued license number PS 17338. Respondent’s last known address is PO Box 134, Hialeah, Florida 33011. 3. On or-about July 31, 2001, a routine inspection was conducted of the premises of the Advance Equipment Supplies and Pharmacy, Inc. (the pharmacy), a community pharmacy where Respondent is the pharmacy manager, during normal business hours. 4. The routine inspection showed the following deficiencies and observations: a) b) c) 5. Fla. Stat., following: a) b) c) 6. The pharmacy possessed boxes of compounded Ibuterol that were not properly labéfed as required by Rule 64B16-27.101, Fla. Admin. Code; The pharmacy did not properly maintain compounding records regarding the compounded Ibuterol as required by Rule 64B16-28.140(3)(g), Fla. Admin. Code, in that the records did not contain the date of compounding, control or lot numbers, or complete formulas as required by Rule 64B16-28.140(1)(a), (b) and (c), Fla, Admin. Code; Boxes of compounded Ibutero! did not contain Jot numbers of expiration dates as required by Rule 64B16-28.402(1)(h), Fla. Admin. Code. Respondent violated a rule of the Board, or a rule adopted pursuant to Chapter 465, in that on or about July 18, 2001, Respondent failed to do one or more of the Properly label boxes of compounded Ibuterol as required by Rule 64B16-27.101, Fla. Admin. Code; Properly maintain compounding records regarding the compounded Ibuterol as required by Rule 64B16-28.140(3)(g), Fla. Admin. Code, by maintaining records that contain the date of compounding, control or lot numbers, or complete formulas as required by Rule 64B16-28.140(1)(a), (b) and (c), Fla. Admin. Code; Properly place lot numbers and expiration dates on boxes of compounded Ibuterol as required by Rule 64B16-28.402(1)(h), Fla. Admin. Code. Based on the foregoing, Respondent violated Section 465.016(1)(n) & (r), Florida Statutes (2001), by violating a mule of the Board, or a mule adopted pursuant to Chapter 465, Fla. Stat. WHEREFORE, the Petitioner respectfully requests the Board of Pharmacy enter an order imposing one or more of the following penalties: permanent revocation or suspension of the Respondent’s license, restriction of the Respondent's practice, imposition of an administrative fine, issuance of a reprimand, placement of the Respondent on probation, the assessment of costs related to the investigation and prosecution of this case as provided for in Section 456.072(4), Florida Statutes (2001), and/or any other relief that the Board deems appropriate. SIGNED this _ SW). day of Ato ,200.> John O. A: obi, M.D., M.B.A., Secretary Naficy M. Snurkowski Chief Attorney—Practitioner Regulation COUNSEL FOR DEPARTMENT: Danni Vogt, Senior Attorney Florida Bar 40437158 Agency for Health Care Administration DEP Building 3, Room 3135B DEMENT OF HEAL 2727 Mahan Drive , K P.O. Box 14229, Mail Stop #39 CLERK Yahi, Ee Tallahassee, Florida 32317-4229 DATE 2 i low PCP: 243/02- PCP Members: Barack ¢ Smete)

Docket for Case No: 02-001982PL