“ STATE OF FLORIDA - eos DEPARTMENT-OF HEALTH ~ 00 MAY -3 PM. 321. DIVE DEPARTMENT OF HEALTH, AONE ik Mel Petitioner, O 0 Vs. CASENO. 99-0127 ” IRA SAUL STERN, R.PH., Respondent. ~ ADMINISTRATIVE COMPLAINT COMES NOW the Petitioner, Department of Health, and files this Administrative Complaint before the Board of Pharmacy against the Respondent, IRA SAUL STERN, ’ R.PH. and in support thereof would state: ve 1. Petitioner is the state agency charged with regulating the practice of Pharmacy pursuant to Section 20.43, Florida Statutes; Chapter 455, Florida Statutes; and Chapter 465, Florida Statutes. “9” Pursuant to the authority of Section 20.43(3)(g), Florida Statutes, the Petitioner has contracted with the Agency for Health Care Administration, hereinafter referred to as the "Agency, to provide consumer ‘complaint, investigative, and prosecutorial services required by the Division of Medical Quality Assurance, councils or board, as appropriate, ve including the i issuan of emergency orders of suspension or restriction. 3. Respondent has been at all times pertinent hereto, a duly licensed pharmacist pursuant to Chapter 465, Florida Statutes, having been issued license number PS cee eee poe rey v Yy 0015262. In addition, the Respondent was employed z as : the pharmacy manager for Palm - Beach Pharmacy D/B/A A Tay’ s Drugs, 1498 Northwest tsa Street, Miami, Florida 33142. 4. Respondent's last known address is 9130 Southwest 92"! Court, Miami, Florida 33176. 5. On February 10, 1999 an employee of the Pharmacy, met with an investigator for HRS Services and advised that the Respondent was selling Viagra via the internet, dispensing the Viagra and shipping the medication throughout the United States via the United States Postal Service. ” 6. From what was ascertained, the pharmacy where the Respondent was employed as the pharmacy manager, placed an advertisement on the internet that listed a 1-800 number for customers to place an order for Viagra. The 1-800 number was . answered in the state of Maryland. A questionnaire would be filled out for the customer over the phone, and then sent to a doctor in Arizona. The doctor in Arizona would then fax a request to another doctor in Mexico for a prescription. The doctor in Mexico would then fax a prescription batk to the doctor in Arizona. The prescription would then be faxed to the pharmacy in Miami, and filled by the Respondent. None of the patients received the proper verbal and written counseling at the time the medication was dispensed, nor was a therapeutic review done of the patient's records to determine — therapeutic appropriateness of the medication dispensed. In addition, there was no final check made of the dis ensed medication by the > Respondent. 7 The final preparations of the medication were checked by an unlicensed and a courier of the pharmacy, who was dispensing the medication from his home. 8. The Respondent kept the medications stored in an employee’s home, to be packaged by the employee for shipping throughout the United States via the U.S. Postal Service. That employee was hota licensed pharmacist, nor was he supervised by a wok. a Lv U : licensed pharmacist. Rather, the Respondent delegated or contracted for the performance of professional responsibilities by a person the licensee knew or had reason to know, was not qualified by training, experience and authorization to perform such duties. 9. Atno time did the pharmacy, where the Respondent was employed as the pharmacy manager, have a permit for a special pharmacy which is required to ship medications outside of the pharmacy via the U.S. Postal Service. 10. The conduct of the Respondent as aforesaid is contrary to the provisions contained in: Sections 465.016(1)(e) and Rule 64B16-28.112, Florida Administrative Code, by owning, operating, or maintaining a pharmacy wherein that sale, possession, or transfer of possession, either with or without a prescription, of any medicinal drug is done in violation of the laws of the State of Florida or any federal laws; Section 465.015(2)(c), Florida Statutes, by dispensing medications without a prescription; Rule 64B16-28.120, Florida Administrative Code, by failing to keep all legend drugs within the confines of the prescription department, Section 455.624(2)(p), Florida Statutes, by delegating or contracting for the performance of professional responsibilities by a person when the licensee delegating or contracting for performance of such responsibilities knows or has reason to know, such person is not qualified by training, experience, and authorization when required to perform them; Rule 64B16-27.430, Florida Administrative Code, by the delegation of duties, tasks or functions without the continuing review and ultimate supervision of a Florida licensed pharmacist who instigated the specific task, so that the “continuity of supervised activity is present; and Section 465.01 5(1)(b), Florida Statutes, by operating a pharmacy where an unlicensed unsupervised person practices the profession of pharmacy. YY . y WHEREFORE, Petitioner respectfully requests the Board of Pharmacy to enter an Order imposing one or more ‘of the penalties proscribed by law, together with any other and further relief deemed just wrider the circumstances. SIGNED Elle of raat. 2000. Robert G. Brooks, M.D. _ Secretary, Department of Heal h FILED 2 DEPARTMENT OF HEAL By: Nancy M. Snurkowski DEPUTY CLERK : fj . . Chief Attorney CLERK Nichi R-Dlaor On Behalf of the Agency for “B-|O-ALv©2o2 Health Care Administration pATE_ 7 /eT ae COUNSEL FOR AGENCY: Lawrence F. Kranert, Jr) Senior Attorney Florida Bar No. 0171063 Agency for Health Care ‘Administration General Counsel's Office - MQA ~ Practitioner Regulation P.O. Box 14229 Tallahassee, Florida 32317-4229 (850) 487- 2225 | ms ie om CoS

Docket for Case No: 00-001886