Final Order No. DOH-08-1647- o A FILED DATE - ‘ partment of Poe STATE OF FLORIDA on KC DOK: DEPARTMENT OF HEALTH Deputy Agency Clerk Family Medical Equipment & Supply, Inc., Petitioner, vs. Department of Health, Drugs, Devices, & Cosmetics Program; Respondent. / FINAL ORDER This proceeding was initiated by a petition requesting an administrative hearing to challenge the Department of Health’s intent to deny the Petitioner’s application for a permit to operate as a medical oxygen retail establishment pursuant to the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. The Petitioner was notified of the Department’s intent by letter dated May 20, 2008; which is identified as Exhibit A and incorporated by reference. Subsequently, the parties resolved this matter in a “Settlement Agreement” executed July 8, 2008; which is identified as Exhibit B and incorporated by reference. Counsel for both parties request that this case be closed based on the “Settlement Agreement”. Based on the foregoing, the “Settlement Agreement” is approved, and the parties are directed to comply with it. DONE and ORDERED this [6 a day of July 2008 in Tallahassee, Florida. Ana M. Viamonte Ros, M.D., M.P.H. State Surgeon General AN SHS Paul E. Metts, C.P.A., M.H.A. Deputy Secretary By: Family Medical Equipment and Supply, Inc. p.2 of 2, Final Order, DOAH no.: 08-2934 Copy furnished to each of the following: Jay Adams, Esquire Jennifer Condon, Esquire Broad and Cassel Department of Health Post Office Box 11,300 4052 Bald Cypress Way, bin A-02 Tallahassee, Florida 32302 Tallahassee, Florida 32399-1703 Rebecca R. Poston T.K. Wetherell, II; ALJ Department of Health Division of Administrative Hearings Drugs, Devices, & Cosmetics Program Desoto Building 4052 Bald Cypress Way, bin C-19 1230 Apalachee Parkway Tallahassee, Florida 32399-1739 Tallahassee, Florida 32301-3060 CERTIFICATE OF SERVICE I CERTIFY that a copy of the foregoing Final Order has been served by ordinary mail via the United States Postal Service, hand delivery, or by, ipter-office mail to each of the above named persons this | day of July 2008. JA D#puty Agency Clerk Department of Health 4052 Bald Cypress Way, bin C-01 Tallahassee, Florida 32399-3251 phone: (850)245-4121 : PAGE 82/85 G6/63/ 2888 16:46 85641 @ BD OF ca Chartie « srist Ana M. Viamonte Ros, M4.D., ¥ Pld Sovernc * State Surgiin Ge wrail CERTIFIED MAIL/RETURN RECEIPT REQUESTED May 20, 2008 Family Vledical Equipment & Supp y, Inc. fttn: A sby Roque 1310 Li ngan Avenue Celtone FL 32738 RE: Me fical Oxygen Retail Establishment Permit Application Dear M:. Roque: O71or al out February 28, 2008, the Department of Health (department) received a chance of acldress application for Family Medical Equipment & Supply, Inc., to operate a Medica! Ovygen °etail Establishment at 1060 East Industrial Drive, Suite N, Orange City, Florids. Upc céreful r view, the department intends to deny the application based upon the following facts, gf sunds and considerations: Tt e perr iitting requirements for a medical oxygen retail establishment permit are set out in Sections 499.01, 499.01 22, and 499.041, Florida Statutes (F.S.), and Rule 64F-12.015(::1, 64F - 12 015(8 Xh), Florida Administrative Code (F.A.C.). Section < 99.067(1)(a), F.S., authorizes the department to deny an application for permit if then: has been a substantial failure to comply with Chapter 499, Part I, F.S., or the rules adopted thereund :r. The failure to meet the criteria for obtaining a permit is a substantial failure ti col nply w th the provisions of Chapter 499, Part |, F.S. Section 499.067(1)(b), F.S., furthe authorize i the department to deny an application for a permit if the department finds that it: wo ild be a danger or would not be in the best interest of the public health, safety, and wellare i? the applic ant were issued a permit or certification; if the applicant has not met the requireiients for the pe mit or certification; or, if the applicant demonstrates any of the conditions enume ratec! in £ ection 499.01 or Section 499.012(5), F.s. . The depai tment has adopted through the rulemaking process the application form for obt nining a medical oxygen retailer permit, and passage of an inspection is required. Facts upon which denial is based On |March 7, 2008, an agent for the department conducted an inspection of the above refe encec establishment and upon a review of the application submitted, and recommends of { denial of tii ensure based on the foliowing facts that were demonstrated at the inspection. 1. The establishment was not free of insect infestation. 2. The oldest stock of oxygen cylinders were not being distributed in a first in, ¢rst out method. This was and is contrary to Applicant's policies and procedures, D 4052 Bald q rogram hassee, FL 32399 B50) 413-6982 ry PAGE 3/85 G6/03/2608 16:45 25041 3ggg2 ED OF nn | Vamily Vedical Equipment 4: Supe. y, Ine, May 2C 2008 Flage 2 3. The Applicant did not Pass the March 7, 2008, inspection of the establisi meni. Other Facts Supporting Denial Of the Permit 4, On March 7, 2008, the agent for the department inspected the applicar t's permitted facility at 2290 South Volusia Avenue, Suite F2, Orange City, florid, wT o a ® nN 5 3 = a a ® a a @ a 5 3 2 8 a ® a = 5 a 2 2 > ® oO g B Ss 2 > a 5 Fal = a Applicant could not Produce batch records or inventory records for oxygen tar ks i The Firm did not have a Federal Food and Drug Administration (FDA) Registration for the establishment. By filling the oxygen containers at the establishment the Applicant was engaging in manufacturing or Processing of prescription medical oxygen. it the establishment. é. The firm was unable to Produce any documentation with regard to a transfer and sale of medical oxygen from All Oxygen Refills, Inc. an Issuing a permit would be a danger or wouid not be in the best interest o! the public health, safety and welfare. : Conclusions of Law 1. Tt 3 department has considered the criteria in Section 499.01(5\(d), F.S. and finds che Apjilicant s deficient under: A. Section 499.01(5)(d)9, F. S. The department finds that the facts Stated above, and based on the resuits of the on-site inspection, are other factors or qualifications the department considers relevant to and consistent with the iublic health and safety. B. Section 499.01 (5)(d)7, F. S. The Applicant’s compliance with permitting requirements under previously granted permits by failing to adhere to recon keeping requirements and Operating without a required FDA establishment registration permit for the filling of oxygen containers. 2. Ap; licant was in violation of Section 499.0121(4 \(e), F.S. and section 64F-1 2.014 (4), F.A.>., by: ailing to maintain the establishment in a clean manner and free from infestatior: by inse.:ts. . 3. Sec ion 499.0121(7)(a), F.S., requires the oldest stock of a Prescription drug be distri outed ‘irst. Section 499.0121(7), F.S., mandates distributors to establish, maintain ani adhe to written policies and procedures, which must be followed for the receipt, storage, inver tory ai d distribution of drugs. The Applicant has violated this provision by not adherin; to a pol cy anc procedure which requires the oldest stock of oxygen product be distributed firs: PAGE 64/85 ACY B6/63/2088 16:45 ice, BD OF PHARM @ Family Medical Equipment & Sup nly, Inc. May 2}, 2008 age |. 1. Section 64F-12.007(1), F.A.C., requires medical oxygen retailer establishments who nanuf icture or refill compressed medical gases to comply with the current good man.tlactu inc) yractic 2 regulations (GMP Guidelines). The GMP Guidelines require FDA registration sind Mmainta ning of batch Production records. The Firm has violated section 64F-12.007(11, FA. , yy fail ig to obtain FDA registration and failing to maintain transfilling operations consisient \ th {l0od n anufacturing practices by not maintaining batch production records. b Section 64F-12.01 5(6)(c)5, F.A.C., requires a manufacturer to have an FDA € stabli: hment registration number. The firm is in violation of this rule by failing to have: an FIDN € stabi: hment registration number while engaging in manufacturing activities. €. Section 499.0121(6), F.S., and section 64F-12.012, F.A.C., mandates records [3:2 € stablis 1ed and maintained with regard to the distribution and receipt of prescription druvys. F ecord ; must be available for inspection pursuant to Section 499.0121(6)(b), F.S. The tirm was in violation of Section 499.0121(6)(b), F.S., by failing to produce records regarding x transfer and sale of medical oxygen upon request. : This is ¢ so a failure to meet the minimum permit requirements. The permit is denied pursuan to Secticn 499.067(1)(b)2, F.S. 8. Pursi ant to Section 499.067(1)(b)1., F.S., based on the findings made at the iNspecticn, ths de partm :nt finds that it would be a danger or not in the best interest of the public health, safet ; ar d welf ire if the applicant were issued a permit to operate as a medical oxygen retail establist nent. 9. The di ficiencies and violations described above, or any one of them is a substantial faiure (2 Co nply vith the provisions of Chapter 499, Part |, F.S., or rules adopted thereunder. The-refore the perm tis denied Pursuant to Section 499.067(1)(a), F.S. H wing considered the above factors, the department hereby intends to deny the chiinge a ‘address application of Family Medical Equipment & Supply, Inc.’s Medical unyger: retail este blishment. NOTICE OF RIGHTS TO HEARING AND APPEAL ee Ss TO HEARING AND APPEAL Yc 4 have the right to request an administrative hearing pursuant to Sections 12 ).569 and 120.57, F.S., if you wish to challenge the intended agency action to de ty your application for permit. Such Proceedings are governed by Sections Yoi have the right to be represented by counsel or other qualified rep esentative, at your expense; to present evidence and argument; to call and 06/83/2088 16:45 85041 Sage? ED OF an ) l‘amily Medical Equipment é Supr ly, Inc. Ifay 2€, 2008 Page 4 REP 2foss-examine witnesses; and to have subpoena and subpoena duces tecum ssued on your behalf if a hearing is requested. \ petition for administrative hearing must be in writing and must be received by: he Agency Clerk for the Department, within twenty-one (21) days from the ‘eceipt of this Notice. The address of the Agency Clerk is 4052 Bald Cypress Nay, BIN # A02, Tallahassee FL 32399-1703. The Agency Clerk’s facsimile umber is 850-410-1448. dediation is not available as an alternative remedy. “our failure to submit a petition for hearing within twenty-one (21) days from eceipt of this notice will constitute a waiver of your right to an administrative learing, under section 28-106.111 F.A.C. and this notice shall become a "final oder". ‘ihould this notice become a final order, a party who is adversely affected by it is (ntitled to judicial review pursuant to Section 120.68, F.S. Review proceedings i f@ governed by the Florida Rules of Appellate Procedure. Such proceedings ' vay be commenced by filing one copy of a Notice of Appeal with the Agency Clerk of the Department of Health and a second copy, accompanied by the filing f es required by law, with the Court of Appeal in the appropriate Florida / ppeilate District. The notice must be filed within thirty (30) days of rendition of t te final order. Sincerely, “ fer Rebecca R. Poston,’R.Ph. Executive Director Drugs, Devices, & Cosmetics Program PAGE 65/05 STATE OF FLORIDA DEPARTMENT OF HEALTH aga yn . 2008 WL ~9 AN G: 24 FAMILY MEDICAL EQUIPMENT GFFICE Gr THE CLERK & SUPPLY, INC., Petitioner, Vv. DOH permit file: 10140 DEPARTMENT OF HEALTH, Respondent. / SETTLEMENT AGREEMENT ped Eee SEE ee Comes now the Respondent, Florida Department of Health and Petitioner, Family Medical Equipment & Supply, Inc., (hereinafter the parties) and enter into the following Settlement Agreement: 1. The Department filed a Notice of Intent to deny dated May 20, 2008, in connection with a change of address application for a medical oxygen retail establishment at 1060 East Industrial Drive, Suite N, Orange City, Florida. 2. All Florida Medical Supplies, Inc. timely filed a Petition for Hearing Involving Disputed Issues of Fact on June 2, 2008. 3. Further more, Petitioner has two (2) investigative cases pending against Petitioner identified and assigned case numbers 2008-08462 and 2008-08728. 4. The parties agree that the purpose of this agreement and entry of a final order is to avoid further administrative action as it relates to the permit denial proceeding and all matters identified in paragraphs 2 and 3 above. Further, the parties agree that this is a fair, appropriate and reasonable solution to these matters. TAL 451464836v1 4/22/2008 5. This Settlement Agreement is subject to the approval of the State Surgeon General or her designee. Upon her approval, and without further notice, the State Surgeon General or her designee may issue a Final Order providing for the following: a. Incorporation by reference of all the terms and conditions of this Settlement Agreement for Final Order. b. Respondent will issue a medical oxygen retail establishment permit to Petitioner, for the establishment address at 1060 East Industrial Drive, Suite N, Orange City, Florida. c. Petitioner agrees to withdraw its Petition for Formal Hearing filed with Respondent’s agency clerk concerning the denial of the medical oxygen retailer permit. d. Family Medical Equipment & Supply, Inc. agrees to pay a fine of $2,500.00 to Respondent by cashiers check or money order and made payable to the Florida Drugs, Devices and Cosmetics Trust Fund. This fine is unrelated to the usual and customary fees for application and inspection to obtain a Medical Oxygen Retail Establishment permit. The Parties agree that the fine to be paid under this Settlement Agreement encompasses any and all alleged violations described in the Notice of Intent, or contained in any inspection report generated as a result of paragraph 3. This Settlement Agreement will be incorporated into a Final Order that will be filed with the agency clerk for Respondent. The order will be the final disposition in this permit denial proceeding and shall constitute final agency action. e. Petitioner agrees to refrain from the re-filling of medical oxygen at its establishment for a period of two (2) years. The two years shall commence upon rendition of the Final Order. f. Petitioner agrees to undergo an inspection prior to recommencing refilling activities and agrees not to refill until it successfully passes inspection. TAL 451464836v1 4/22/2008 2 6. Other Terms of the Agreement: A. The parties hereby waive any and all claims to attorney fees and costs arising out of this proceeding and waive all rights to an appeal. B. The parties hereby waive any and all claims to attorney fees and costs arising out of this intent to deny proceeding and the investigative cases and waive all rights to an appeal of a Final Order incorporating this Agreement as final agency action. C. Petitioner affirms that it shall comply with all provisions of the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes, and the rules adopted there under. D. The Petitioner agrees that Petitioner, upon being permitted, will not through its agents or employees, unless the agent or employee is otherwise authorized by law to do so, including but not limit to any extent authorized by home medical equipment provider licensure, engage in any activities itemized at Section 468.352(7),(10) Florida Statutes (2007) unless the agent or employee is licensed pursuant to Part V, Ch. 468, Florida Statutes (2007). E. This Agreement fully and completely resolves all matters set forth in the Department’s permit denial notice dated May 20, 2008 and the petition for formal administrative hearing thereon. F. The parties stipulate and agree that this Settlement Agreement is a legal and binding document and is fully enforceable against all parties in any court of competent jurisdiction. The signatories hereto are vested with the authority to execute this Settlement Agreement on behalf of their respective principals, and as duly designated representatives, to fully bind such principals. [Remainder of page intentionally left blank] TAL 451464836v1 4/22/2008 3 ——— . Signature of parties this 8 day of DS. w ky , 2008. Family Medical Equipment & Florida Department of Health Supply, Inc. Eth fov- Rebecca R. Poston, R.Ph Executive Director Drugs, Devices and Cosmetics Program TAL 451464836v1 4/22/2008 4

Docket for Case No: 08-002934