ࡱ> _ bjbj 8 bbl  jjjjj~~~8:~u$($$$%)^+jllllll$iQj*-%%*-*-jj$$4L111*-j$j$j1*-j11z,$gÂ->V-HuZ.H|,,jl F,"h,1,,F,F,F,/F,F,F,u*-*-*-*-F,F,F,F,F,F,F,F,F, 0: State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for Permit as a Prescription Drug Repackager Form No.: DBPR-DDC-203 APPLICATION CHECKLIST IMPORTANT Submit all items on the checklist below with your application to ensure faster processing. APPLICATIONAPPLICATION REQUIREMENTSApplication for Permit as a Prescription Drug Repackager  FORMCHECKBOX  Enclose the fee of $1,650.00, which includes a $1,500.00 nonrefundable biennial application fee and $150.00 initial application/on-site inspection fee. If the establishment is applying for multiple manufacturing permits in the applicant s name and at applicant s address, you are only required to pay for the permit with the highest fee.  FORMCHECKBOX  Make cashier s check, corporate check, or money order payable to the Florida Department of Business and Professional Regulation.  FORMCHECKBOX  If you answered  Yes to any question in Section IV, enclose a detailed explanation along with any relevant documentation.  FORMCHECKBOX  Sign and date the Affidavit section of the application. Submit the completed application with enclosures to: Department of Business and Professional Regulation 2601 Blair Stone Road Tallahassee, FL 32399-1047  PLEASE NOTE: Telephone, email, and fax contact information is used to quickly resolve questions with applications. If such information is not provided, questions regarding applications will be mailed to the application contacts mailing address and may take longer to resolve. The disclosure of Social Security numbers is mandatory on all professional and occupational license applications, is solicited by the authority granted by 42 U.S.C. 653 and 654, and will be used by the Department of Business and Professional Regulation pursuant to 409.2577, 409.2598, 499.012(4)(a)f, 499.012(8)(o), 499.63(2), and 559.79(3), Florida Statutes, for the efficient screening of applicant and licensees by a Title IV-D child support agency to assure compliance with child support obligations. It is also required by 559.79(1), Florida Statutes, for determining eligibility for licensure and mandated by the authority granted by 42 U.S.C. 405(c)(2)(C)(i), to be used by the Department of Business and Professional Regulation to identify licensees for tax administration purposes. State of Florida Department of Business and Professional Regulation Division of Drugs, Devices, and Cosmetics Application for Permit as a Prescription Drug Repackager Form No.: DBPR-DDC-203 If you have any questions or need assistance in completing this application, please contact the Department of Business and Professional Regulation, Division of Drugs, Devices and Cosmetics, at 850.717.1800. For additional information see the instructions at the beginning of this application. Section I- Application Type CHECK ONE OF THE APPLICATION TYPES FORMCHECKBOX  New Application [3328/1020]  FORMCHECKBOX  New Application due to change in ownership. If checked, provide legal documentation for the change of ownership (i.e. Bill of Sale, stock transfer, merger). [3347/1020] Permit Number under previous ownership: ___________________________  Section II Applicant Information APPLICANT INFORMATIONTAXPAYER IDENTIFICATION NUMBER OR FEDERAL EMPLOYER IDENTIFICATION NUMBER This is a unique nine-digit number assigned by the Internal Revenue Service (IRS) to business entities operating in the United States for the purposes of identification. When the number is used for identification rather than employment tax reporting, it is usually referred to as a Taxpayer Identification Number (TIN), and when used for the purposes of reporting employment taxes, it is usually referred to as the Federal Employer Identification Number (FEIN).Applicants TIN/FEIN: FULL LEGAL NAME The full legal name is the complete name of the business entity that will be operating the establishment. This is generally the name that is on the documents that establish the existence or formation of the business entity. For example, a corporations full legal name would normally be the name that is found in the corporations articles of incorporation.Applicants Full Legal Name: FICTITIOUS, TRADE, OR BUSINESS NAME If the applicant intends to operate the permitted establishment under a name that is different from the Applicants Full Legal Name listed above e.g. fictitious, trade, or business name (also commonly referred to as a dba, D/B/A, or doing business as name this name must be registered with the Florida Department of State, Division of Corporations). This is the name that will appear on the permit issued to the applicant by the department and must be the name that the applicant uses on operational documents for permitted activities.   FORMCHECKBOX  The applicant WILL NOT operate the permitted establishment under a name that is different from the Applicants Full Legal Name listed above.  FORMCHECKBOX  The applicant WILL operate the permitted establishment under the following fictitious, trade, or business name: __________________________________________________________________ The fictitious, trade, or business name listed directly above, is registered with the Florida Department of State, Division of Corporations and the applicant has been issued the following registration number: ______________________________. APPLICANT MAILING ADDRESSStreet Address or P.O. Box:City:State:Zip Code (+4 optional):Email Address:Telephone Number:Fax Number: PHYSICAL ADDRESS OF ESTABLISHMENT TO BE PERMITTED (only if different from mailing address) Check  FORMCHECKBOX  if not applicableStreet Address:City:State:Zip Code (+4 optional):Email Address:Telephone Number:Fax Number:APPLICATION CONTACTThe application contact is the person that the department will contact if there are questions regarding the responses provided on, or the documentation submitted with, the application. The application contact is also the person that will receive all official communication from the department regarding the application.Last/Surname: First: Middle: Suffix:Address:City:State:Zip Code (+4 optional):Email Address:Telephone Number:Fax Number: EMERGENCY CONTACT INFORMATIONThe emergency contact is the person that the department will contact in the case of an emergency. During an emergency, the department will contact this person at times outside of the regular business hours listed below. The contact information provided should be sufficient for the department to actually reach and communicate with the person listed in the event of an emergency.Last/Surname: First: Middle: Suffix: Position/Title:Street Address:City:State:Zip Code (+4 optional):Email Address:Telephone Number::Fax Number: OPERATING HOURSList the establishments daily hours of operation in terms of Eastern Time. REMEMBER to circle a.m. or p.m. for each time indicated below.Mon : a.m./p.m. to : a.m./p.m. Tue : a.m./p.m. to : a.m./p.m. Wed : a.m./p.m. to : a.m./p.m. Thu : a.m./p.m. to : a.m./p.m. Fri : a.m./p.m. to : a.m./p.m. Sat : a.m./p.m. to : a.m./p.m. Sun : a.m./p.m. to : a.m./p.m. Section III Ownership Information TYPE OF OWNERSHIP  FORMCHECKBOX  Publicly Held Corporation  FORMCHECKBOX  Closely Held Corporation  FORMCHECKBOX  Limited Liability Company  FORMCHECKBOX  Charitable Organization501(c)(3) FORMCHECKBOX  Sole Proprietorship FORMCHECKBOX  Government FORMCHECKBOX  Partnership General  FORMCHECKBOX  Professional Corporation or Association FORMCHECKBOX  Professional Limited Liability Company  FORMCHECKBOX  Partnership Other, Including Limited Liability Partnership and Limited Partnership  FORMCHECKBOX  Other:__________________List the state of incorporation or state of organization (except Partnership General or Sole Proprietorship). Business entities organized under non-U.S. laws list the country of organization.  FORMCHECKBOX  N/A (Partnership General or Sole Proprietorship)State:List name and address of the applicants registered agent for service of process in Florida (except Sole Proprietorship or Partnership General) and provide documentation, such as a print out from the Florida Department of State, Division of Corporations webpage, that the applicants registered agent is registered with the Florida Department of State, Division of Corporations.  FORMCHECKBOX  N/A (Partnership General or Sole Proprietorship)Name: Address: City:State:Zip Code (+4 optional):List the name, position/title, social security number, date of birth and address of each owner, partner, member, manager, officer, director, chief executive, or other person who directly or indirectly controls the operation of the business entity, as applicable. For example, corporations would list officers and directors, limited liability companies would list members and managers, etc.1. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 2. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 3. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 4. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 5. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 6. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 7. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code: 8. Name & Title: Social Security #: Date of Birth: % of Ownership: Street Address: City: State: Zip Code:  List the name, social security number, date of birth and address of each person who owns 10 percent or more of the outstanding stock or equity interest in the business entity. If such person is a business entity, list the business entity name, TIN/FEIN and percentage of ownership and check the box labeled N/A for date of birth.1. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 2. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 3. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 4. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 5. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 6. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 7. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: 8. Name: SSN/TIN/FEIN# Date of Birth:  FORMCHECKBOX  N/A % of Ownership: Street Address: City: State: Zip Code: List all trade or business names used by the applicant. Use additional sheet(s) if necessary. If the applicant does not use other trade or business names check this box  FORMCHECKBOX  and write N/A on the lines below. Is the applicant a subsidiary of another company? (If yes, provide a listing of all parent companies with percentages of ownership, using additional sheet(s) if necessary). Note: A permit issued pursuant to this application is only valid for the applicant, and the applicants name and address. (If no, please check this box  FORMCHECKBOX  and write N/A in the lines below). FORMCHECKBOX  Yes  FORMCHECKBOX  No Parent Company Name% of Ownership  Is diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care services provided at the address of the establishment that is the subject of this permit application? If so, please list the name of the company/companies providing such services below and provide the corresponding license or permit number(s) issued by your residing states regulatory authority. (Use additional sheet(s) if necessary). FORMCHECKBOX  Yes  FORMCHECKBOX  NoName:Permit/License No.:Issuing Agency: Section IV Background Questions BACKGROUND QUESTIONS The term affiliated party means: (a) a director, officer, trustee, partner, or committee member of a permittee or applicant or a subsidiary or service corporation of the permittee or applicant; (b) a person who, directly or indirectly, manages, controls, or oversees the operation of a permittee or applicant, regardless of whether such person is a partner, shareholder, manager, member, officer, director, independent contractor, or employee of the permittee or applicant; (c) a person who has filed or is required to file a personal information statement pursuant to s. 499.012(9) or is required to be identified in an application for a permit or to renew a permit pursuant to s. 499.012(8); or (d) the five largest natural shareholders that own at least 5 percent of the permittee or applicant. If you answer YES to any questions in Section IV, you must provide detailed explanations in Section V, including requirements for submitting supporting legal documents. If needed, explain on separate sheet(s). 1. FORMCHECKBOX  Yes If yes, explain in detail in Section V FORMCHECKBOX  NoHas the applicant or any affiliated party (defined above) been found guilty of (regardless of adjudication), or pled nolo contendere to, in any jurisdiction, a violation of law that directly relates to a drug, device, or cosmetic?2. FORMCHECKBOX  Yes If yes, explain in detail in Section V FORMCHECKBOX  No Has the applicant or any affiliated party (defined above) 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.  FORMCHECKBOX Yes If yes, explain in detail in Section V FORMCHECKBOX  NoHas the applicant or any affiliated party (defined above) been convicted (regardless of adjudication) of any felony under a federal, state (including Florida), or local law?4.  FORMCHECKBOX Yes If yes, explain in detail in Section V FORMCHECKBOX  No Has the applicant or any affiliated party (defined above) been denied a permit or license in any state (including Florida) related to an activity regulated under Chapters 456, 465, 499, or 893, F.S.?5.  FORMCHECKBOX Yes If yes, explain in detail in Section V FORMCHECKBOX  NoHas the applicant or any affiliated party (defined above) 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? 6.  FORMCHECKBOX  Yes If yes, explain in detail in Section V FORMCHECKBOX  NoHas the applicant or any affiliated party (defined above) ever held a permit issued under Chapter 499, F.S., in a different name than the applicants name? (If yes, provide the names in which each permit was issued and at what address). Section V Explanation(s) for Yes response(s) to background question(s) EXPLANATION Section VI Other Permits or Licenses PERMITS OR LICENSES1.Are there any permits or licenses issued by any agency of the State of Florida that authorize the purchase or possession of prescription drugs at the applicants establishment or address? (If yes, please provide a list of all such permits including the issuing agency, the permit/license type, the permit/license number and the expiration date. If not, check the box indicating no other permits or licenses.).  FORMCHECKBOX  Permit/licensure list provided.  FORMCHECKBOX  No permits/licenses.  FORMCHECKBOX  Yes  FORMCHECKBOX  No2.Is the applicant licensed in any other state as a manufacturer, repackager, distributor or wholesaler of prescription drugs? (If yes, please provide a list all such permits including the state, the permit/license type, the permit/license number and the expiration date. If not, check the box indicating no other permits or licenses.).  FORMCHECKBOX  Permit/licensure list provided.  FORMCHECKBOX  No permits/licenses.   FORMCHECKBOX  Yes  FORMCHECKBOX  No Section VII Prescription Drug Repackaging Activity REPACKAGING ACTIVITIESGenerally identify the applicants intended customers, the persons and entities that will purchase or receive repackaged prescription drugs from the applicant after permit issuance.  FORMCHECKBOX  Manufacturers  FORMCHECKBOX  Wholesalers  FORMCHECKBOX  Pharmacies  FORMCHECKBOX  Hospitals  FORMCHECKBOX  Practitioners  FORMCHECKBOX  Health Care Clinics  FORMCHECKBOX  Veterinarians  FORMCHECKBOX  Other (explain) ___________________________________________ Identify the types of prescription drugs the applicant will repackage or distribute under this permit. Check all that apply.  FORMCHECKBOX  Human Prescription Drugs  FORMCHECKBOX  Solid Dose  FORMCHECKBOX  Liquids (Oral)  FORMCHECKBOX  Injectables  FORMCHECKBOX  Topical  FORMCHECKBOX  Dental  FORMCHECKBOX  Ophthalmic  FORMCHECKBOX  Compressed Medical Gases  FORMCHECKBOX  Veterinary Prescription Drugs  FORMCHECKBOX  Repackage From Bulk  FORMCHECKBOX  Repackage From Stock  FORMCHECKBOX  Refrigerated (Human, Veterinary, API or Otherwise)  FORMCHECKBOX  Frozen (Human, Veterinary, API or Otherwise) FORMCHECKBOX  Active Pharmaceutical Ingredients (If yes, check the applicable box(es) for your customers):  FORMCHECKBOX  Manufacturers  FORMCHECKBOX  Pharmacies for Compounding  FORMCHECKBOX  Other explain_____________ Controlled Substances: Provide your DEA Number: _________________ or check  FORMCHECKBOX  No DEA Number Check Schedules:  FORMCHECKBOX  Sch II  FORMCHECKBOX  Sch III  FORMCHECKBOX  Sch IV  FORMCHECKBOX  Sch V Identify type of operation. FORMCHECKBOX  Contract Repackager does not take title to drugs that are repackaged.  FORMCHECKBOX  Own Label Repackager - takes title to drugs that are repackaged. Provide your Federal Food and Drug Administration (FDA) drug establishment registration number. Please note, an FDA drug establish registration is not the same as an FDA 503B Outsourcing Facility registration.  FORMCHECKBOX  FDA Drug Establishment Registration Number:____________________________ or  FORMCHECKBOX  No FDA Drug Establishment Number AND a written explanation is attached  FORMCHECKBOX . 1.Are prescription drugs to be distributed under this permit intended for export? (Note: A permit may be required for Florida recipients that are freight forwarders handling prescription drugs in Florida.) FORMCHECKBOX  Yes  FORMCHECKBOX  No2.Will all required records be stored and maintained at applicants physical address? (If no, provide the name and address of the establishments where all required records will be stored and maintained under question #2a.) Please use additional sheets if necessary. FORMCHECKBOX  Yes  FORMCHECKBOX  No2a.Name and physical address where required records are stored Establishment name: Street Address: City:State:Zip Code (+4 optional):  3.Will the required records be computerized, automated or stored electronically? If yes, will you have a back-up procedure to be able to provide required records? If electronically stored and maintained as a scanned image, is the electronic data maintained unchanged from the time of creation, receipt, purchase or distribution, depending on the document type?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No4.Is there a quarantine area at the applicants establishment? (If no, complete below and provide a written explanation on a separate sheet.) Explanation included?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No5.Is the applicants establishment equipped with adequate climate controls (including refrigerated and freezing storage if appropriate for the applicants repackaged and distributed prescription drugs) to ensure safe storage? Does the applicant establishment have adequate temperature and humidity monitoring recording devices or logs to document proper storage of prescription drugs?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  Yes  FORMCHECKBOX  No6.Are you submitting a product registration application and labels of your products with this application? (If no, explain on a separate sheet providing accurate details). Note: You CAN NOT SELL a product that you repackage at the establishment until that product has been registered with the department. Selling a product before it is registered with the division is the basis for application permit denial and enforcement action by the division. Explanation included?  FORMCHECKBOX  Yes  FORMCHECKBOX  No  FORMCHECKBOX  N/A FORMCHECKBOX  Yes  FORMCHECKBOX  No7.Section 499.0121(2), F.S., requires establishments to be equipped with a) an alarm system to detect entry after hours and b) a security system that provides protection against theft or diversion that is facilitated or hidden by tampering with computers or electronic records. Please provide a written description of the alarm and security systems that includes both the type of systems used and how the systems are monitored. Alarm system description included?  FORMCHECKBOX  Yes  FORMCHECKBOX  No Security system description included?  FORMCHECKBOX  Yes  FORMCHECKBOX  No8.Sections 499.01(2)(a)1. and 499.0121(8), F.S., requires repackagers to establish, maintain, and adhere to written policies and procedures, which must be followed for the receipt, security, storage, inventory, and distribution of prescription drugs. Please provide the applicants written policies and procedures on: the receipt, security, storage, inventory, distribution/disposition of prescription drugs; distributing oldest approved stock first (FIFO); identifying, recording and reporting prescription drug losses and thefts; maintenance, retrieval and retention of required records; prescription drug recalls and withdrawals; natural disasters and other emergencies; segregation and destruction documentation of outdated prescription drugs; temperature and humidity monitoring; and product tracing and other requirements under the federal Drug Supply Chain Security Act (DSCSA) or 21 USC 360eee-1. Label each policy and procedure specifically identifying the subject matter in the list above that is covered by the policy or procedure. For example, the policy and procedure for recalls could be labeled or identified as Recall Policy and Procedure or in another manner similar to this example. Policy Attached? Receipt, security, storage, inventory, distribution/disposition of prescription drugs  FORMCHECKBOX  Yes  FORMCHECKBOX  No Distributing oldest approved stock first (FIFO)  FORMCHECKBOX  Yes  FORMCHECKBOX  No Identifying, recording and reporting prescription drug losses and thefts  FORMCHECKBOX  Yes  FORMCHECKBOX  No Maintenance, retrieval and retention of required records  FORMCHECKBOX  Yes  FORMCHECKBOX  No Prescription drug recalls and withdrawals  FORMCHECKBOX  Yes  FORMCHECKBOX  No Natural disasters and other emergencies  FORMCHECKBOX  Yes  FORMCHECKBOX  No Segregation and destruction of outdated prescription drugs  FORMCHECKBOX  Yes  FORMCHECKBOX  No Temperature and humidity monitoring  FORMCHECKBOX  Yes  FORMCHECKBOX  No Product tracing and other DSCSA requirements  FORMCHECKBOX  Yes  FORMCHECKBOX  No 9.Do you intend to repackage and or distribute (directly or indirectly through your agents, employees or independent contractors) prescription drug samples? (If yes, a Complimentary Drug Distributor permit is required.)  FORMCHECKBOX  Yes  FORMCHECKBOX  No10.Does the applicant establishment intend to sell or distribute into Florida prescription drugs that the establishment does not repackage? (If yes, you will need an Out-of-State Prescription Drug Wholesale Distributor permit or other applicable permit under section 499.01, F.S. depending on your activities.)  FORMCHECKBOX  Yes  FORMCHECKBOX  No11.Provide the date the establishment will be ready and available for inspection. This is the earliest date the application may be deemed complete.__/___/20__  Section VIII Affidavit AFFIDAVITPursuant to s. 559.79, F.S., each application for a license or renewal of a license issued by the Department of Business and Professional Regulation shall be signed under oath or affirmation by the applicant, or owner or chief executive of the applicant without the need for witnesses unless otherwise required by law. Pursuant to s. 559.791, F.S., any license issued by the Department of Business and Professional Regulation which is issued or renewed in response to an application upon which the person signing under oath or affirmation has falsely sworn to a material statement, including, but not limited to, the names and addresses of the owners or managers of the licensee or applicant, shall be subject to denial of the application or suspension or revocation of the license, and the person falsely swearing shall be subject to any other penalties provided by law. I UNDERSTAND THAT THE ISSUANCE OF A PERMIT BY THE DEPARTMENT ONLY AUTHORIZES THE APPLICANT TO CONDUCT REGULATED ACTIVITIES IN THE STATE OF FLORIDA UNDER THE NAME IN WHICH THE PERMIT IS ISSUED. IF THE PERMIT IS ISSUED IN THE NAME OF A DBA OR D/B/A THE APPLICANT MAY ONLY CONDUCT BUSINESS IN FLORIDA IN THE NAME OF THE DBA OR D/B/A. 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To the best of my knowledge, all information contained on this application is true and correct. I understand the falsification of any information on this application may result in administrative action, including a fine, suspension, or revocation of the license. 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