*NOTIFY THE DEPARTMENT IN WRITING OF ANY UPDATES

Transcription

1 APPLICATION FOR A PERMIT UNDER CHAPTER 499, FLORIDA STATUTES Florida Department of Business and Professional Regulation Drugs, Devices, and Cosmetics Program 1940 North Monroe Street, Tallahassee FL Phone This application form provides information as required by the Florida Drug and Cosmetic Act, Chapter 499, Florida Statutes. Only a completed application signed by the authorized representative of the applicant will be processed. Additional information may be required for an application to be considered complete. APPLICATION TO BE TYPED OR PRINTED WITH INK Type of permit(s) requested (mark all that apply). The applicant can apply for multiple permits under one application if each permit requested is at the same physical location and the same permit name. This application cannot be used to apply for a Prescription Drug Wholesaler, Prescription Drug Wholesaler/Broker Only, or OutofState Prescription Drug Wholesaler permit. MANUFACTURERS Prescription Drug Manufacturer NonResident Prescription Drug Manufacturer OvertheCounter Drug Manufacturer Compressed Medical Gases Manufacturer Prescription Drug Repackager RESTRICTED PERMITS Restricted Prescription Drug Distributor Health Care Entity Restricted Prescription Drug Distributor Charitable Organization Restricted Prescription Drug Distributor Reverse Distributor Restricted Prescription Drug Distributor Destruction Restricted Prescription Drug Distributor Government Programs Device Manufacturer Cosmetic Manufacturer WHOLESALERS DISTRIBUTORS Veterinary Prescription Drug Wholesale Distributor Compressed Medical Gases Wholesale Distributor Retail Pharmacy Drug Wholesale Distributor Limited Veterinary Prescription Drug Wholesaler Distributor Restricted Prescription Drug Distributor Institutional Research OTHER DISTRIBUTORS Complimentary Drug Distributor Veterinary Prescription Drug Retail Establishment Medical Oxygen Retail Establishment Freight Forwarder Third Party Logistics Provider (3PL) SEE PAGE 4 FOR APPLICATION FEES 1 NE OF APPLICANT (name in which company is doing business; this is the name in which the permit will be issued; limit to 41 characters) 2 APPLICANT ADDRESS (physical location of establishment this address should be reflected on all sales invoices and shipping documentation) 3 SUITE NUMBER 4 CITY 5 STATE 6 ZIP 7 COUNTY 8 AREA CODE & TELEPHONE NUMBER 9 *NORMAL OPERATING HOURS 10 *PROVIDE AN ADDRESS WHERE REGULATORY UPDATES CAN BE SENT M : TU : W : TH : F : 11 *FACSIMILE NUMBER WHERE REGULATORY UPDATES CAN BE SENT *NOTIFY THE DEPARTMENT IN WRITING OF ANY UPDATES 12 MAILING ADDRESS (if different from physical location; this is where the renewal application and other official information will be sent by the department) 13 SUITE NUMBER 14 CITY 15 STATE 16 ZIP 17 EMERGENCY CONTACT PERSON (an individual with your company that the department can contact, if necessary, after normal business hours) NE (Last, First, MI) RESIDENCE PHONE (Area Code & Number) RESIDENCE ADDRESS POSITION/TITLE CITY STATE ZIP CODE OFFICE USE ONLY DEPOSIT INSPECTION APPLICATION REVIEW PERMIT ISSUED Entity Number Cash Code No. Inspected By: Approved by Permit No. Deposit Date Date Date Receipt Code Deposit No. Denied by Expiration Date Check Amount Is follow up required? Date 64F F.A.C. Page 1 of 6

2 OWNERSHIP SECTION 18 FEDERAL TAX IDENTIFICATION NUMBER (FEID#) If you do not have an FEID#, call CORPORATE NE OR LEGAL NE IF DIFFERENT FROM APPLICANT NE: 20 TYPE OF OWNERSHIP (check only one box in this section [shaded areas], and provide all necessary information as requested): SOLE PROPRIETORSHIP OWNER'S NE (Last, First, MI) DATE OF BIRTH (mm/dd/yy) / / PARTNERSHIP LIST ALL PARTNERS (use additional sheet if necessary) % OF OWNERSHIP NE (Last, First, MI) DATE OF BIRTH (mm/dd/yy) TITLE (if applicable) (must total to 100%) PUBLICLY HELD CORPORATION CLOSELY HELD CORPORATION Provide a listing of each individual, other than the officers listed below, (traded on a stock exchange) (if applicable) holding 5% or more of the corporation's voting stock. Include names, dates of birth and percentage of ownership. STATE OF INCORPORATION state abbreviation LIST THE FIVE MOST SENIOR CORPORATE OFFICERS (i.e., CEO/COO, President, V.P., Sec., Treas.): (use additional sheet if necessary) NE (Last, First, MI) DATE OF BIRTH (mm/dd/yy) POSITION/TITLE % OF OWNERSHIP if applicable if applicable if applicable if applicable if applicable ARE ALL CORPORATE OFFICERS EIGHTEEN (18) YEARS OF AGE OR OLDER? YES NO IS THE APPLICANT A SUBSIDIARY OF ANOTHER COMPANY? YES NO If yes, provide a listing of all parent companies with percentages of ownership. Please note that a permit issued pursuant to this application is only valid for the applicant's name and address. LIMITED LIABILITY COMPANY (LLC) You must provide the following information on an attached sheet (this is a requirement). THE NE AND ADDRESS OF EACH MEMBER/MANAGER THE NE AND ADDRESS OF THE LLC, THE RESIDENT AGENT OF THE LLC, AND THE NE OF THE STATE IN WHICH THE LLC WAS ORGANIZED OTHER (Explain): GOVERNMENT 21 HAS THE APPLICANT, OWNER(S), MANAGER(S)INCHARGE, ANY OFFICER(S) AND/OR EMPLOYEES: YES NO ANY YES RESPONSE MUST BE DISCUSSED ON AN ATTACHED SHEET IN AS MUCH DETAIL AS POSSIBLE. 1. BEEN FOUND GUILTY (REGARDLESS OF ADJUDICATION) OR PLED NOLO CONTENDERE IN A COURT IN FLORIDA OR ANY OTHER JURISDICTION OF A VIOLATION OF LAW THAT DIRECTLY RELATES TO A DRUG, DEVICE, OR COSMETIC? 2. BEEN FINED OR DISCIPLINED BY A REGULATORY AGENCY IN ANY STATE (INCLUDING FLORIDA) FOR ANY OFFENSE THAT WOULD CONSTITUTE A VIOLATION OF CHAPTER 499, F.S.? 3. BEEN CONVICTED OF ANY FELONY UNDER A FEDERAL, STATE (INCLUDING FLORIDA), OR LOCAL LAW? 4. HAD ANY CURRENT OR PREVIOUS PERMIT OR LICENSE SUSPENDED OR REVOKED WHICH WAS ISSUED BY A FEDERAL, STATE OR LOCAL GOVERNMENTAL AGENCY RELATING TO THE MANUFACTURE OR DISTRIBUTION OF DRUGS, DEVICES, OR COSMETICS? 5. BEEN DENIED A PERMIT OR LICENSE RELATED TO AN ACTIVITY REGULATED UNDER CHAPTER 499, F.S., IN ANY STATE? 6. EVER HELD A PERMIT ISSUED UNDER CHAPTER 499, F.S., IN A DIFFERENT NE THAN THE APPLICANT'S NE? IF YES, PROVIDE THE NES IN WHICH EACH PERMIT WAS ISSUED AND AT WHAT ADDRESS. 64F F.A.C. Page 2 of 6

3 22 ARE THERE ANY OTHER PERMITS (OR LICENSES FOR PHARMACIES OR PRACTITIONERS) ISSUED BY ANY AGENCY IN THE STATE OF FLORIDA THAT AUTHORIZE THE PURCHASE OR POSSESSION OF PRESCRIPTION DRUGS AT THE APPLICANT'S ADDRESS? YES NO If yes, provide the name in which the permit is issued, the permit type and permit number. 23 CHECK THE APPROPRIATE BOX(ES) FOR THE TYPE OF PRODUCTS YOU WILL HANDLE: Human Rx Veterinary Rx OTC Drugs Oxygen Other Gases Cosmetics Medical Devices Controlled Substances (mark all that apply) SCH II SCH III SCH IV SCH V provide your DEA# 24 TO WHOM DO YOU INTEND TO DISTRIBUTE YOUR PRODUCT(s) UNDER THE PERMITS FOR WHICH YOU ARE APPLYING? Manufacturers Wholesalers Practitioners Pharmacies Hospitals Clinics Public Patients With a Prescription Veterinarians Other 25 TYPE OF SALES: Domestic (USA) Export 26 WHERE WILL THE REQUIRED RECORDS BE STORED AND MAINTAINED? Applicant Address Other (Explain): 27 ARE YOUR RECORDS AUTOMATED? YES NO If yes, do you have a backup procedure to be able to provide required records? YES NO DO YOU UNDERSTAND ELECTRONICALLY MAINTAINED RECORDS MUST REFLECT THE EXACT TRANSACTION WITHOUT UPDATES? YES NO 28 DO YOU AGREE TO COMPLY WITH CHAPTER 499, FLORIDA STATUTES, AND RULE CHAPTER 64F12, F.A.C.? YES NO 29 DO YOU UNDERSTAND THAT YOU CANNOT BEGIN OPERATIONS IN OR INTO FLORIDA UNTIL A PERMIT HAS BEEN ISSUED? YES NO 30 DID YOU PROVIDE A LIST OF ALL COMPANIES YOU CURRENTLY OR AT ANYTIME HAD OWNERSHIP INTEREST? YES NO 31 IS THIS NEW APPLICATION RELATED TO A CHANGE OF OWNERSHIP? If yes, please include the permit number of the current holder. 32 WHO SHOULD THE DEPARTMENT CONTACT WITH QUESTIONS REGARDING THIS APPLICATION? NE (Last, First, MI) AREA CODE & TELEPHONE NUMBER POSITION/TITLE ADDRESS CITY STATE ZIP CODE ADDRESS FACSIMILE NUMBER (fax) COMPLETE THE QUESTIONS ON THE ATTACHMENTS RELATED TO THE SPECIFIC PERMITS FOR WHICH YOU ARE APPLYING. ATTACHMENTS FREIGHT FORWARDER LIMITED VETERINARY PRESCRIPTION DRUG WHOLESALE DISTRIBUTOR MANUFACTURER (RX, OTC, DEVICE, COSMETIC, PRESCRIPTION DRUG REPACKAGER) MEDICAL GASES (MANUFACTURER, WHOLESALER, MEDICAL O2 RETAILER) RESTRICTED HCE / CHARITABLE ORG. / GOV'T PGMS / INST. RESEARCH RESTRICTED REVERSE DISTRIBUTOR / DESTRUCTION RETAIL PHARMACY DRUG WHOLESALE DISTRIBUTOR VETERINARY PRESCRIPTION DRUG RETAIL ESTABLISHMENT VETERINARY PRESCRIPTION DRUG WHOLESALE DISTRIBUTOR THIRD PARTY LOGISTICS AFFIDAVIT: (must be completed) I DO SOLEMNLY SWEAR OR AFFIRM THAT THE INFORMATION SUBMITTED TO THE DEPARTMENT ON THIS APPLICATION AND ANY ATTACHMENTS THERETO ARE TRUE AND CORRECT. Signature of Owner or Corporate Officer Title Date If signed by someone other than an owner or officer identified, you must submit a letter of delegation for the signer to bind the applicant. 64F F.A.C. Page 3 of 6

4 CALCULATING YOUR APPLICATION FEE Below you will find the permit(s) for which you are applying along with the associated application fee(s). Fill in the appropriate box(es) under "Amount" then add the boxes to calculate your "Total Due". Make checks payable to the Florida Department of Business and Professional Regulation. PERMIT TYPE APPLICATION FEE OUNT Prescription Drug Manufacturer $1, * Prescription Drug Repackager $1, * Device Manufacturer $1, * Cosmetic Manufacturer $ * Compressed Medical Gases Manufacturer $1, * OvertheCounter Drug Manufacturer $ * Product Registration $30.00 X (number of products) = NonResident Prescription Drug Manufacturer (see below) Veterinary Prescription Drug Wholesale Distributor (In Florida) $1, Limited Prescription Drug Veterinary Wholesale Distributor (In Florida) $1, Compressed Medical Gas Wholesale Distributor (In Florida) $ Restricted Drug Distributor Health Care Entity $ Restricted Drug Distributor Reverse Distributor $ Restricted Drug Distributor Destruction $ Complimentary Drug Distributor (In Florida) $ Veterinary Prescription Drug Retail Establishment $ Medical Oxygen Retail Establishment $ Third Party Logistics Provider (In Florida) $ Freight Forwarder $ $15.00 X (number of identical products) = *If applying for multiple MANUFACTURING permits, you are only required to pay for the one with the highest fee. In addition, all manufacturers, except Device Manufacturers and NonResident Prescription Drug Manufacturers, are required to register. Initial Application/Inspection Fee $ Total Due APPLICATIONS NOT REQUIRING AN INITIAL APPLICATION/INSPECTION FEE Veterinary Prescription Drug Wholesale Distributor (OutofState) $1, Limited Prescription Drug Veterinary Wholesale Distributor (OutofState) $1, Complimentary Drug Distributor (OutofState) $ NonResident Prescription Drug Manufacturer $1, Retail Pharmacy Drug Wholesale Distributor $ Restricted Drug Distributor Charitable Organization $ Restricted Drug Distributor Government Programs $ Restricted Drug Distributor Institutional Research $ Third Party Logistics Provider (OutofState) $ Total Due 64F F.A.C. Page 4 of 6

5 MANUFACTURER IF THE APPLICANT IS APPLYING FOR A: PRESCRIPTION DRUG MANUFACTURER; OVERTHECOUNTER DRUG MANUFACTURER; DEVICE MANUFACTURER; COSMETIC MANUFACTURER OR REPACKAGER PERMIT, YOU MUST COMPLETE ALL SECTIONS ON THIS PAGE THAT ARE APPLICABLE TO YOUR ACTIVITIES AND SUBMIT AS A PART OF THE APPLICATION FOR A PERMIT UNDER CHAPTER 499, F.S. GENERAL QUESTIONS (all manufacturers and repackagers must answer these questions) A. DO YOU INTEND TO COMPLY WITH ALL FEDERAL AND STATE "CURRENT GOOD MANUFACTURING PRACTICES," AND/OR QUALITY SYSTEM REGULATIONS (DEVICES)? YES NO B. WHAT IS YOUR FDA ESTABLISHMENT NUMBER? You must provide the FDA establishment number or a copy of the application you submitted to the FDA. (Not required for Cosmetic Manufacturers.) C. IS THE APPLICANT LICENSED IN ANY OTHER STATE AS A MANUFACTURER, REPACKAGER, OR WHOLESALER OF PRESCRIPTION DRUGS? YES NO If yes, provide a listing of all states where licensed, including the license numbers and expiration dates. D. TYPE OF OPERATION: CONTRACT MANUFACTURER OWN LABEL MANUFACTURER LIMITED MANUFACTURING OPERATIONS (Sterilizing, Encapsulating, etc.) E. DO YOU UNDERSTAND THE PRODUCTS YOU MANUFACTURE OR REPACKAGE MUST BE REGISTERED WITH THE DEPARTMENT PRIOR TO SALE? YES NO Does not apply to Device Manufacturers. F. ARE YOU SUBMITTING A PRODUCT REGISTRATION APPLICATION WITH THE PERMIT APPLICATION? YES NO If not, please explain: G. DO YOU HAVE LABELS OF YOUR PRODUCTS READY FOR INSPECTION? YES NO PRESCRIPTION DRUG MANUFACTURERS ONLY A. DO YOU INTEND TO MANUFACTURE OR DISTRIBUTE PRESCRIPTION DRUG SPLES? YES* NO *If yes, you must also obtain a Complimentary Drug Distributor permit. B. DO YOU MANUFACTURE A PRESCRIPTION DRUG AS A FINISHED PRODUCT? YES NO C. TYPE OF DRUGS YOU MANUFACTURE (check all that apply): Solid Dose Injectables Veterinary Ophthalmic Repackage From Stock Liquids (oral) Topical Dental Bulk Chemicals Repackage From Bulk D. DO YOU CURRENTLY HAVE THE FOLLOWING IN PLACE? IF NOT, THEY MUST BE IN PLACE PRIOR TO THE ONSITE INSPECTION. For help on writing Policies & Procedures, review the form entitled Guidance on Drafting Policies & Procedures, or s (7), F.S. Security/Alarm System Type: Climate Control The Receipt of Rx Drugs Record Maintenance/Retrieval/Retention Quarantine Area Storage Recalls and Withdrawals Temperature/Humidity Monitoring REPACKAGERS ONLY A. DO YOU INTEND TO DISTRIBUTE PRESCRIPTION DRUG SPLES? YES* NO *If yes, you must also obtain a Complimentary Drug Distributor permit. B. DO YOU CURRENTLY HAVE THE FOLLOWING IN PLACE? IF NOT, THEY MUST BE IN PLACE PRIOR TO THE ONSITE INSPECTION. For help on writing Policies & Procedures, review the form entitled Guidance on Drafting Policies & Procedures, or s (7), F.S. Security/Alarm System Type: Climate Control The Receipt of Rx Drugs Record Maintenance/Retrieval/Retention Quarantine Area Storage Recalls and Withdrawals Temperature/Humidity Monitoring 64F F.A.C. Page 5 of 6

6 DEVICE MANUFACTURERS ONLY A. DO YOU REFURBISH MEDICAL DEVICES? YES NO B. DO YOU MANUFACTURE CUSTOM DEVICES? YES NO C. DO YOU MANUFACTURE A COMPONENT OF ANOTHER DEVICE? YES NO D. DO ANY OF THE DEVICES YOU MANUFACTURE INCLUDE A PRESCRIPTION DRUG? YES NO If yes, a Prescription Drug Manufacturer permit is required. E. WHAT IS THE CLASSIFICATION OF DEVICES YOU MANUFACTURE? CLASS I CLASS II (Submit a premarket notification letter (510K) for each class II device you manufacture.) CLASS III (Submit the name of the product and FDA premarket approval number for each class III device you manufacture.) F. DO YOU CURRENTLY HAVE THE FOLLOWING IN PLACE? IF NOT, THEY MUST BE IN PLACE PRIOR TO THE ONSITE INSPECTION. For help on writing Policies & Procedures, review the form entitled Guidance on Drafting Policies & Procedures, or s (7), F.S. Climate Control Quarantine Area Storage Record Maintenance/Retrieval/Retention Recalls and Withdrawals OVERTHECOUNTER DRUG MANUFACTURERS ONLY A. TYPE OF DRUGS YOU MANUFACTURE (check all that apply): Solid Dose Veterinary Relabel Ophthalmic Repackage From Bulk Liquids (oral) Topical Repackage From Stock Other Explain: B. DO YOU START WITH A PRESCRIPTION DRUG TO MAKE ANY OF YOUR OTC DRUGS? YES NO If yes, a Prescription Drug Manufacturer permit is required. C. DO YOU CURRENTLY HAVE THE FOLLOWING IN PLACE? IF NOT, THEY MUST BE IN PLACE PRIOR TO THE ONSITE INSPECTION. For help on writing Policies & Procedures, review the form entitled Guidance on Drafting Policies & Procedures, or s (7), F.S. Climate Control Quarantine Area Storage Record Maintenance/Retrieval/Retention Recalls and Withdrawals COSMETIC MANUFACTURERS ONLY A. TYPE OF OPERATION: MIXING REPACKAGING FINAL LABELING FOR DISTRIBUTION OTHER B. DO YOU MANUFACTURE A PRODUCT THAT HAS A SUNSCREEN (SPF)? YES NO If yes, an OvertheCounter Drug Manufacturer permit is required. C. DO YOU CURRENTLY HAVE THE FOLLOWING IN PLACE? IF NOT, THEY MUST BE IN PLACE PRIOR TO THE ONSITE INSPECTION. For help on writing Policies & Procedures, review the form entitled Guidance on Drafting Policies & Procedures, or s (7), F.S. Storage Record Maintenance/Retrieval/Retention Recalls and Withdrawals DATE SIGNATURE OF OWNER OR CORPORATE OFFICER 64F F.A.C. Page 6 of 6