“ WW ) STATE OF FLORIDA DEPARTMENT OF HEALTH DEPARTMENT OF HEALTH, Petitioner, ADVANCED PHARMACY SERVICES, Respondent. / ADMINISTRATIVE COMPLAINT cole [ vs. Case No. 97-1412] Petitioner, DEPARTMENT OF HEALTH, hereinafter referred to as “Petitioner,” files this Administrative Complaint before the Board of Pharmacy against ADWANCED PHARMACY SERVICES, hereinafter referred to as “Respondent,” and alleges: 1. Effective July , 1997, Petitioner is the state agency charged with regulating the practice of pharmacy pursuant to Section 20.43, Florida Statutes (Supp. 1996); Chapter 455, Florida Statutes; and Chapter 465, Florida Statutes. , » 2. Pursuant to the authority of Section 20.43(3)(f), Florida Statutes (Supp. 1996), the Petitioner has contracted with the Agency for Health Care Administration! to provide consumer complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils, or boards, as appropriate, including the issuance of emergency orders of suspension or restriction. 3. Respondent is, and has been at all times material hereto, a licensed pharmacy, having been issued permit number PH13755. U | UU 4. Respondent’s last known address is 200 SW 8 Street, Suite C, Ocala, Florida 34473. — 5. GA stated he had been a driver for Respondent. GA made| deliveries and picked up unuséd, full or partially full, medications from numerous nursing homes and Assisted Living Facilities (ALF’s). 6. GA stated he was also utilized by Respondent in other capacities such as reviewing records, filling medication orders in medicine on time cards, bubble packs, opus cassettes and bottles. 7. GA also stated he was assigned by Respondent to open the returned on time pack. After opening the packs he removed the medication and returned the iten| to stock.—Verification — of lot number or expiration date was not done. 8. GA stated he had been asked by Respondent to work on Saturday mornin; placing returned medications to stock without a pharmacist present. 9. GA is not a licensed pharmacist. igs 10. | GA stated that if there was no container for a particular medication on the shelf, then an empty prescription bottle was used and a blank label was applied identifying the —_— medication. GA was instructed by Respondent to make up a lot number expiration date of March 1999. COUNT I | with an approximate 11. Petitioner realleges and incorporates by reference the allegations contained in the | foregoing paragraphs as if fully stated herein. GO, OY 12. Based on the foregoing, the Respondent’s license to practice pharmacy in the State of Florida is subject to discipline pursuant to Section 465.016(1)(1)| Florida Statutes, by placing in stock of any pharmacy any part of any prescription compounded or dispensed which is returned by a patient. Each pharmacist shall maintain appropriate record returned medicinal drugs. COUNT II s for any unused or 13. Petitioner realleges and incorporates by reference the allegations contained in the foregoing paragraphs as if fully stated herein. 14. _ Based on the foregoing, the Respondent’s license to practice pharmacy in the State of Florida is subject to discipline pursuant to Section 465.016(1)(n , Florida Statutes, by violating Rule 64B16-28.118(1), Florida Administrative Code, which states that in a closed drug delivery system in which unit dose medication is dispensed to in-patients, the unused unit dose of medication may be returned to the pharmacy for redispensing only if each dose is individually sealed and if each unit dose or the unit dose system of which it is clearly name of the drug, dosage strength, manufacturer’s contro] number, and eé COUNT HI a part is labeled with the xpiration date, if any. 15. Petitioner realleges and incorporates by reference the allegations contained in the foregoing paragraphs as if fully stated herein. 16. Based on the foregoing, the Respondent’s license to practice pharmacy in the State of Florida is subject to discipline pursuant to Section 465.016(1)(e) Florida Statutes, by violating 499.005(1) Florida Statutes, for the manufacture, repackaging or offering for sale of any drug, device, or cosmetic that is adulterated J otherwise been rendered unfit for human or animal use. sale, delivery, or holding misbranded or has Go UU COUNT IV 17. Petitioner realleges and incorporates by reference the allegations contained in the foregoing paragraphs as if fully stated herein. 18. Based on the foregoing, the Respondent’s license to practice pharmacy in the State of Florida is subject to discipline pursuant to Section 465.023(1)(c), Florida Statutes, by violating Rule 64B16-27.410, Florida Administrative Code, by failing to have a pharmacy technician under the direct and immediate personal supervision of a Florida licensed pharmacist. WHEREFORE, Petitioner respectfully requests the Board of Pharmacy enter an Order imposing one or more of the following penalties: imposition of an administrative fine not to exceed $1,000 for each offense, issuance of a reprimand, placement of the Respondent on probation, and/or any other relief that the Board deems appropriate. SIGNED this day ottoman , 1997, Douglas M. Cook Director y: Nancy M. Snurkowski Chief Attorney On Behalf of the Agency for Health Care Administration DEPARTMENT OF H et DEPUTY cuenR ‘ CLERK Mm. b DATE —HA3/7B COUNSEL FOR AGENCY: — Susan B. Bodell yh? Senior Attorney Florida Bar Number 0987859 Agency for Health Care Administration General Counsel’s Office - MQA Allied Health P.O. Box 14229 Tallahassee, FL 32317-4229 (850) 487-9697 SBB:ser pcp: ZN [OF DOM |-24-%

Docket for Case No: 00-001161