DIVISION OF MEDICAL QUALITY ASSURANCE BOARD OF PHARMACY 4052 BALD CYPRESS WAY, BIN #C-04 TALLAHASSEE, FLORIDA 32399-3254 (850) 245-4292 INTERNET PHARMACY PERMIT APPLICATION AND INFORMATION JANUARY 2011 DH-MQA 1216, 07/10 Rule 64B16-28.XXX, F.A.C. American LegalNet, Inc. www.FormsWorkFlow.com Dear Florida Pharmacy Permit Applicant, Thank you for applying for a pharmacy permit in the State of Florida. The information in this packet has been designed to provide the essential information required to process your application in a timely manner. Your assistance in providing all required information will enable the Florida Board of Pharmacy (the board) staff to process your application as soon as possible. You are encouraged to apply as early as possible, to avoid delays due to a large volume of applicants. Florida Statutes require a completed application and fees before your application can be reviewed. Please read these instructions carefully and fully before submitting the application. You should keep a copy of the completed application and all other materials sent to the board office for your records. When you mail the completed application and fees, use the address noted in the instructions and on the application form. When your application arrives, your fees will be deposited and verified before the staff review can begin. You will receive a letter acknowledging receipt of your application. The staff will notify you within 30 days if any materials are incomplete. If you need to communicate with the board staff, you are encouraged to email the board staff at mqa_pharmacy@doh.state.fl.us, or you may at call us at (850) 245-4292. Phone calls are returned within 24 hours and emails are responded to within 48 hours during normal business hours. Our staff is committed to providing prompt and reliable information to our customers. Many procedures have been streamlined to expedite the processing of applications; we certainly welcome your comments on how our services may be improved. Sincerely, The Board of Pharmacy DH-MQA 1216, 07/10 Rule 64B16-28.XXX, F.A.C. American LegalNet, Inc. www.FormsWorkFlow.com Internet Pharmacy Permit Application Information Whether opening a new establishment, changing locations, or changing owners, a pharmacy permit is required prior to operating in the State of Florida. The permit application must be completed and returned to the Florida Board of Pharmacy with the required fee of $255.00. The application MUST have the original signatures of the owner or officer of the establishment and the Prescription Department Manager (PDM). An Internet Pharmacy as authorized by Section 465.0197, F.S., is required for any location not otherwise licensed or issued a permit under this chapter, within or outside this state that uses the Internet to communicate with or obtain information from consumers and uses the information to fill or refill prescriptions or to dispense, distribute, or otherwise engage in the practice of pharmacy in this state. The Internet Pharmacy Permit is open at least 6 days per week for a minimum of 40 hours per week. A toll-free telephone number shall be provided to facilitate communication between patients in this state and a pharmacist in the pharmacy who has access to the patient’s records. Application Processing Please read all application instructions before completing your application. 1) Please mail the application and the $255.00 application fee (check or money order made payable to the FLORIDA DEPARTMENT OF HEALTH) to the following address: Department of Health Board of Pharmacy P.O. Box 6320 Tallahassee, Florida 32314-6320 OR, use the following address if you are using express mail: Department of Health Board of Pharmacy 4052 Bald Cypress Way, Bin C-04 Tallahassee, FL 32399-3254 Within 30 days of receipt of your application and fees, the board office will notify you of the receipt of your application, any required documents, and your status. If the application is complete, you will be notified that an inspector will contact you to setup an inspection appointment. Please do not contact the board office concerning your inspection date, and allow 30 days for the inspector to contact you. If you have not been contacted by the inspector within 30 days, then notify the board. If your application is incomplete, you will be notified in writing of what is required to make your application complete. 2) Submit a set (two) fingerprint cards and appropriate fee with the application. Section 465.022(3)(a), Florida Statutes requires the applicant to submit a set of fingerprints and $48 from the PDM, all owners/officers who have ownership interest of 5 percent or greater and who, directly or indirectly, manages, oversees, or controls the operation pharmacy unless the corporation has more than $100 million of business taxable assets in this state. If the corporation has more than $100 million of business taxable assets in this state, the department shall only require the PDM and a representative of the corporation to submit a set of fingerprints DH-MQA 1216, 07/10 Rule 64B16-28.XXX, F.A.C. 1 American LegalNet, Inc. www.FormsWorkFlow.com and the $48.00 processing fee (section 465.022(3)(a)(1), Florida Statutes). The applicant must submit proof if claiming more than $100 million in business taxable assets. If the fingerprints of the representative of the corporation are on file with DOH or AHCA, the requirement to submit fingerprints is satisfied if you provide proof that the fingerprints are clear and on file. Failure to submit fingerprint cards will delay your application. You may obtain your fingerprint cards (FD-258) and have them rolled from your local law enforcement agency. When you contact your local law enforcement agency, confirm that they have the FD-258 fingerprint card available. If the FD-258 card is unavailable, you may order blank fingerprint cards for a fee at http://www.fldoh.sofn.net . Please attach a Fingerprint Form to each fingerprint card prior to mailing the card to the Board. The form is located on the website at www.doh.state.fl.us/mqa/pharmacy under Applicant Information, Pharmacy Permit Forms. All applicants are required to log on to the internet site: www.fldoh.sofn.net to enter profile information. Entering your profile information is free. Print out the resulting barcode sheet, and mail the barcode sheet with your completed fingerprint cards to our office address below: Florida Board of Pharmacy 4052 Bald Cypress Way, Bin C-04 Tallahassee, FL 32399-3254 We will scan your fingerprint card to complete your biometric data. If you do not have access to the internet at home or work, you can use a computer at your local public library. Handle your fingerprint card with the utmost care and mail it to our address in a flat envelope. Smudged, folded, or bent cards may result in rejected results making resubmission necessary. 3) Attestation for Business Taxable Assets If the applicant has more than $100 million dollars of business taxable assets in this state, please submit a formal opinion letter from a Certified Public Accountant duly licensed in the state of your principle place of business affirming the corporation has more than $100 million of business taxable assets in this state for the previous tax year. In lieu of submitting a formal opinion letter from a Certified Public Accountant, the applicant may submit its Florida Corporate Income/Franchise and Emergency Excise Tax Return (Form F-1120, Effective 01/09). Licensure Process Once the application is deemed complete, the board staff authorizes an inspection. Upon completion of the inspection, the inspector notifies the board office as to whether the inspection was satisfactory or unsatisfactory. If the inspection is satisfactory, a permit number is issued within 10 days. Please wait 10 days from your satisfactory inspection before checking on the status of your permit. You may lookup your license number on our website at http://www.doh.state.fl.us/mqa under “Lookup Licensee.” Drug Enforcement Administration (DEA) The DEA will not issue a registration until the Florida Board of Pharmacy has issued a pharmacy permit. The Board is responsible for notifying the DEA when the pharmacy permit is issued. If controlled substances will be involved in your pharmacy practice, you must make an Application for Registration under the Controlled Substance Act of 1970 with the DEA. If possible, you are encouraged to use the on-line form system provided by the DEA. Information DH-MQA 1216, 07/10 Rule 64B16-28.XXX, F.A.C. 2 American LegalNet, Inc. www.FormsWorkFlow.com is available by visiting their website at http://www.DEAdiversion.usdoj.gov. DEA Form 224 may be obtained in paper form by writing to: Drug Enforcement Administration Attn: ODR PO Box 2639 Springfield, VA 22152-2639 Mail completed DEA Form 224 via U.S. Postal service to the address listed on the form. DEA applications are not required for a change of location or change of name. However, if your pharmacy does change locations, you are required to have a pharmacy inspection prior to operating in the new location and the inspector will contact the board office and the DEA to notify them of the change. DH-MQA 1216, 07/10 Rule 64B16-28.XXX, F.A.C. 3 American LegalNet, Inc. www.FormsWorkFlow.com PRE-INSPECTION CHECKLIST _____ Is there an adequate sink in workable condition that is easily accessible to the prescription counter that will be available during the hours when the prescription department is normally open for business pursuant to Rule 64B16-28.102, F.A.C.? _____ Is the pharmacy department equipped an area suitable for private patient counseling if applying for a Internet Pharmacy permit pursuant to Rule 64B1628.1035, F.A.C.? _____ Are all required signs displayed? o Daily operating hours pursuant to Rule64B16-28.1081, F.A.C. o “Consult your pharmacist regarding the availability of a less expensive generically equivalent drug and the requirements of Florida law” pursuant to Section 465.025(7), F.S. o Prescription Department Closed pursuant to Rule 64B16-28.109, F.A.C. o Pharmacist meal breaks pursuant to Rule 64B16-27.400(6), F.A.C. o Patient Consultation Area pursuant to Rule 64B16-28.1035, F.A.C. _____ If compounding sterile preparations, is your pharmacy compliant with Standards for Compounding Sterile Preparations pursuant to Rule 64B16-27.797, F.A.C? DH-MQA 1216, 07/10 Rule 64B16-28.XXX, F.A.C. 4 American LegalNet, Inc. www.FormsWorkFlow.com FLORIDA BOARD OF PHARMACY P.O. Box 6320 Tallahassee, FL 32314-6320 Telephone (850) 488-0595 http://www.doh.state.fl.us/mqa/pharmacy INTERNET PHARMACY PERMIT APPLICATION Application Type – Please choose one of the following: ____ New Establishment $255 fee ____ Change of Location $100 fee _______________(existing permit number) ____ Change of Ownership (a new permit number will be issued) $255 ________________(existing permit number) Federal Employer Identification Number: ______________________ 1. Corporate Name Telephone Number 2. Doing Business As (d/b/a) E-Mail Address 3. Mailing Address City State Zip State Zip 4. Physical Address City 5. List the Prescription Department Manager and submit a set of fingerprints and $48 with application. Start Date Name License No. Signature 6. Contact Person Telephone Number 7. DEA Registration Number 8. Date ready for inspection 9. Please provide the name, address, telephone number, and permit number of your prescription drug wholesale distributor. Name Telephone Number Permit Number Street Address City State Zip 10. Pharmacy Technician Ratio 2:1 or 3:1 (Optional) Rule 64B16-27.410, Florida Administrative Code, provides that the prescription department manager be required to submit a request and receive approval from the Board of Pharmacy prior to practicing with either a 2:1 or 3:1 ratio of supervision. If you would like to apply for the Pharmacy Technician 2:1 or 3:1 ratio, you may do so by checking the appropriate selection below. Selecting an option below serves as your official notification to the board office that you are requesting approval to practice with a 2:1 or 3:1 ratio. The board will provide notice of application approval or denial. _____ 2:1 Ratio DH-MQA, 1216, 07/10 Rule 64B16-28.XXX, F.A.C. _____ 3:1 Ratio Page 1 of 5 American LegalNet, Inc. www.FormsWorkFlow.com 11. Operating Hours Prescription Department Hours Provide Toll-Free Telephone Number Monday-Friday: Open ________ Close: ________ ( Saturday: Open: ________ Close: ________ Sunday: ) _______- __________ Open: ________ Close: ________ 12. Ownership Information a. Type of Ownership: _____Individual _____Corporation _____Partnership ______Other: _________________________________________ NOTE: IF CORPORATION OR LIMITED PARTNERSHIP YOU MUST INCLUDE WITH YOUR APPLICATION A COPY OF THE ARTICLES OF INCORPORATION ON FILE WITH THE FLORIDA SECRETARY OF STATE'S OFFICE. b. Are the applicants, officers, directors, shareholders, members and partners over the age of 18? Yes No c. Does the corporation have more than $100 million of business taxable assets in this state? Yes If yes, provide attestation from Certified Public Accountant for previous tax year or Florida Corporate Income/Franchise and Emergency Excise Tax Return (F-1120). If no, continue to 12d. No d. List all the owners and officers of the corporation. Each person listed below having an ownership interest of 5 percent or greater and any person who, directly or indirectly, manages, oversees, or controls the operation of the applicant including officers and members of the board of directors must submit a set of fingerprints and fees unless you answered yes to 12c. If 12c is yes please list the owners below and only submit fingerprint cards for the PDM and the representative who is signing this application. If the representative has prints on file with DOH or AHCA you may provide proof and the requirements to submit prints for this person is met. Attach a separate sheet if necessary. Date of Birth Owner/Officer-Title Mailing Address, City, State, Zip Code % of Ownership / / % / / % / / % / / % / / % / / % Pursuant to Section 456.0635(2), Florida Statutes, questions 13 through 19 are being asked. If you answer yes to any of the following questions, explain on a separate sheet providing accurate details and submit copies of supporting documentation. 13. Has the applicant or any principal, officer, agent, managing employee, or affiliated person of the applicant been convicted of, or entered a plea of guilty or nolo contendere to, regardless of adjudication, a felony under Chapter 409, Chapter 817, or Chapter 893, Florida Statutes; or 21 U.S.C. ss. 801-970 or 42 U.S.C. ss.1395-1396? (If no, do not answer 14.) Yes DH-MQA, 1216, 07/10 Rule 64B16-28.XXX, F.A.C. No (You must include all misdemeanors and felonies, even if adjudication was withheld by the court, so that you would not have a record of conviction. Driving under the influence or driving while impaired is NOT a minor traffic offense for the purposes of this question.) Page 2 of 5 American LegalNet, Inc. www.FormsWorkFlow.com 14. Has it been more than 15 years prior to the date of this application since the sentence and completion of any subsequent period of probation for such conviction? Yes No (If yes, explain on a separate sheet providing accurate details) 15. Has the applicant or any principal, officer, agent, managing employee, or affiliated person of the applicant ever been terminated for cause from the Florida Medicaid Program pursuant to Section 409.913, Florida Statutes? (If no, do not answer 16.) Yes No (If yes, explain on a separate sheet providing accurate details) 16. If the applicant or any principal, officer, agent, managing employee, or affiliated person of the applicant has been terminated, has the applicant been reinstated and in good standing with the Florida Medicaid Program for the most recent five years? Yes No (If yes, explain on a separate sheet providing accurate details) 17. Has the applicant or any principal, officer, agent, managing employee, or affiliated person of the applicant ever been terminated for cause, pursuant to the appeals procedures established by the state or federal government, from any other state Medicaid program or the federal Medicare program? (If no, do not answer 18 and 19) Yes No (If yes, explain on a separate sheet providing accurate details) 18. Has the applicant been in good standing with a state Medicaid program or the federal Medicare program for the most recent five years? Yes No (If yes, explain on a separate sheet providing accurate details) 19. Did the termination occur at least 20 years prior to the date of this application? Yes No (If yes, explain on a separate sheet providing accurate details) 20. Are you currently registered or permitted in any other states? If yes, provide the state, permit type and permit number for each permit. Attach a separate sheet if necessary. Yes No State Permit Type Permit Number 21. Has the applicant, affiliated person, partner, officer, director ever owned a pharmacy? If yes, provide the name of the pharmacy, the state where the pharmacy is located and the status of the pharmacy. Attach a separate sheet if necessary. Yes No Pharmacy Name (If yes, explain on a separate sheet providing accurate details) State Status 22. Has any disciplinary action ever been taken against any license, permit or registration issued to the applicant, affiliated person, partner, officer, director, or prescription department manager? No Yes DH-MQA, 1216, 07/10 Rule 64B16-28.XXX, F.A.C. (If yes, explain on a separate sheet providing accurate details) Page 3 of 5 American LegalNet, Inc. www.FormsWorkFlow.com 23. Is there any other permit issued by the Department Health located at the physical location address on this application? No Yes (If yes, explain on a separate sheet providing accurate details) 24. Has the applicant, or any officer, member or partner ever been convicted of a felony or misdemeanor, excluding minor traffic convictions? No Yes (You must include all misdemeanors and felonies, even if adjudication was withheld by the court, so that you would not have a record of conviction. Driving under the influence or driving while impaired is NOT a minor traffic offense for the purposes of this question.) ALL QUESTIONS MUST BE ANSWERED OR YOUR APPLICATION WILL BE RETURNED ******************************************************************************************************************************** Section 456.013(1), F.S., requires that applicants supplement their applications as needed to reflect any material change in any circumstances or conditions stated in the application, which takes place between the initial filing of the application and the final grant or denial of the license, which might affect the decision of the department. I certify that the statements contained in this application are true, complete, and correct and I agree that said statements shall form the basis of my application and I do authorize the Florida Board of Pharmacy to make any investigations that they deem appropriate and to secure any additional information concerning me, and I further authorize them to furnish any information they may have or have in the future concerning me to any person, corporation, institution, association, board, or any municipal, county, state, or federal governmental agencies or units, and I understand according to the Florida Board of Pharmacy Statutes that a Pharmacy Permit may be revoked or suspended for presenting any false, fraudulent, or forged statement, certificate, diploma, or other thing, in connection with an application for a license or permit, as set forth in Section 465.015(2)(a), F.S. I hereby have sworn that these statements are true and correct and recognize that providing false information may result in disciplinary action against my license or criminal penalties pursuant to sections 465.016, 775.082, 775.083, and 775.084, F.S. SIGNATURE ______________________________________________ DATE_________________________ (Owner or officer of establishment) DH-MQA, 1216, 07/10 Rule 64B16-28.XXX, F.A.C. Page 4 of 5 American LegalNet, Inc. www.FormsWorkFlow.com PHARMACY PERMIT APPLICATION CHECKLIST Keep a copy of the completed application for your records. It is recommended that you use the following checklist to help ensure that your application is complete. Failure to attach any required document, or to have required documentation sent to the Board, will result in an incomplete application. Final approval for inspection can not be granted until the application is complete. Faxed applications will not be accepted. INTERNET PHARMACY PERMIT ______ ______ Application signed ______ Pharmacy Manager or Consultant Listed with Signature ______ $255.00 Fee Attached (Permit fee includes $250 application fee and $5.00 unlicensed activity fee) ______ Certificate of Status for the Corporation from the Secretary of State ______ Attach Finger Print Cards & $48.00 fee for each set of fingerprints for owner/officers who have 5% or greater and any person who directly or indirectly, manages, oversees, or controls the operation of the applicant including members and board of directors. If the corporation has more than $100 million in business taxable assets you only have to send the prints of the corporate representative and the prescription department manager. Please attach the card to the Fingerprint Form located on the website at www.doh.state.fl.us/mqa/pharmacy under Applicant Information, Pharmacy Permit forms. ______ Attach Proof from AHCA that the fingerprints are on file if applicable ______ Attestation for Business Taxable Assets of $100 million if applicable ______ DH-MQA, 1216, 07/10 Rule 64B16-28.XXX, F.A.C. Application Completed (all questions answered) Bill of Sale is required for Change of Ownership Page 5 of 5 American LegalNet, Inc. www.FormsWorkFlow.com