Form DBPR-DDC-235 "Application for Permit as a Prescription Drug Manufacturer - Virtual" - Florida

What Is Form DBPR-DDC-235?

This is a legal form that was released by the Florida Department of Business & Professional Regulation - a government authority operating within Florida. As of today, no separate filing guidelines for the form are provided by the issuing department.

Form Details:

  • Released on July 1, 2016;
  • The latest edition provided by the Florida Department of Business & Professional Regulation;
  • Easy to use and ready to print;
  • Quick to customize;
  • Compatible with most PDF-viewing applications;
  • Fill out the form in our online filing application.

Download a printable version of Form DBPR-DDC-235 by clicking the link below or browse more documents and templates provided by the Florida Department of Business & Professional Regulation.

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State of Florida
Department of Business and Professional Regulation
Division of Drugs, Devices, and Cosmetics
Application for Permit as a Prescription Drug Manufacturer – Virtual
Form No.: DBPR-DDC-235
APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your
application to ensure faster processing.
APPLICATION
APPLICATION REQUIREMENTS
Fee of $1,650, which includes a $1,500 nonrefundable biennial
application fee and $150.00 initial application /on-site inspection fee. If the
applicant is applying for multiple manufacturing permits in the applicant’s name
and at the applicant’s address the applicant is only required to pay for the
permit that has the highest fee.
Application for
Permit as a
Make cashier’s check, corporate check, or money order payable to the
Prescription Drug
Florida Department of Business and Professional Regulation.
Manufacturer -
Virtual
If you answer ―Yes‖ to any question in Section IV, be sure to provide a
detailed explanation along with any relevant documentation.
Sign and date the Affidavit section of the application.
Mail completed application to:
Department of Business and Professional Regulation
2601 Blair Stone Road
Tallahassee, FL 32399-1047
PLEASE NOTE:
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
contact’s 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.
DBPR-DDC-235 - Application for Permit as a Prescription Drug Manufacturer – Virtual
Incorporated by rules: 61N-2.0141, F.A.C.
Eff. Date: July 2016
Page 1 of 14
State of Florida
Department of Business and Professional Regulation
Division of Drugs, Devices, and Cosmetics
Application for Permit as a Prescription Drug Manufacturer – Virtual
Form No.: DBPR-DDC-235
APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your
application to ensure faster processing.
APPLICATION
APPLICATION REQUIREMENTS
Fee of $1,650, which includes a $1,500 nonrefundable biennial
application fee and $150.00 initial application /on-site inspection fee. If the
applicant is applying for multiple manufacturing permits in the applicant’s name
and at the applicant’s address the applicant is only required to pay for the
permit that has the highest fee.
Application for
Permit as a
Make cashier’s check, corporate check, or money order payable to the
Prescription Drug
Florida Department of Business and Professional Regulation.
Manufacturer -
Virtual
If you answer ―Yes‖ to any question in Section IV, be sure to provide a
detailed explanation along with any relevant documentation.
Sign and date the Affidavit section of the application.
Mail completed application to:
Department of Business and Professional Regulation
2601 Blair Stone Road
Tallahassee, FL 32399-1047
PLEASE NOTE:
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
contact’s 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.
DBPR-DDC-235 - Application for Permit as a Prescription Drug Manufacturer – Virtual
Incorporated by rules: 61N-2.0141, F.A.C.
Eff. Date: July 2016
Page 1 of 14
State of Florida
Department of Business and Professional Regulation
Division of Drugs, Devices, and Cosmetics
Application for Permit as a Prescription Drug Manufacturer – Virtual
Form No.: DBPR-DDC-235
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
New Application [3345/1020]
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). [3345/1020]
Current Permit Number: ___________________________
Section II – Applicant Information
APPLICANT INFORMATION
TAXPAYER 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).
Applicant’s 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 corporation’s full legal name would normally be the name that is found in
the corporation’s articles of incorporation.
Applicant’s 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
Applicant’s 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.
The applicant WILL NOT operate the permitted establishment under a name that is different from the
Applicant’s Full Legal Name listed above.
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:
______________________________.
DBPR-DDC-235 - Application for Permit as a Prescription Drug Manufacturer – Virtual
Incorporated by rules: 61N-2.0141, F.A.C.
Eff. Date: July 2016
Page 2 of 14
APPLICANT MAILING ADDRESS
Street Address or P.O. Box:
City:
State:
Zip Code (+4 optional):
County:
Phone Number:
Fax Number:
PHYSICAL ADDRESS OF ESTABLISHMENT TO BE PERMITTED
(only if different from mailing address) Check
if not applicable
Street Address:
City:
State:
Zip Code (+4 optional):
County:
Phone Number:
Fax Number:
Email Address:
APPLICATION CONTACT
The 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):
Telephone Number:
Fax Number:
E-Mail Address:
EMERGENCY CONTACT INFORMATION
The 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):
Phone Number:
E-Mail Address:
DBPR-DDC-235 - Application for Permit as a Prescription Drug Manufacturer – Virtual
Incorporated by rules: 61N-2.0141, F.A.C.
Eff. Date: July 2016
Page 3 of 14
OPERATING HOURS
List the establishment’s 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.
Fri
:
a.m./p.m. to
:
a.m./p.m.
Tue
:
a.m./p.m. to
:
a.m./p.m.
Sat
:
a.m./p.m. to
:
a.m./p.m.
Wed
:
a.m./p.m. to
:
a.m./p.m.
Sun
:
a.m./p.m. to
:
a.m./p.m.
Thu
:
a.m./p.m. to
:
a.m./p.m.
Section III – Ownership Information
TYPE OF OWNERSHIP
Publicly Held Corporation
Closely Held Corporation
Limited Liability Company
Charitable Organization—501(c)(3)
Sole Proprietorship
Government
Partnership – General
Professional Corporation
Professional Limited
or Association
Liability Company
Partnership – Other, Including
Limited Liability Partnership and
Other:__________________
Limited Partnership
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.
N/A (Partnership – General or Sole Proprietorship)
State:
List name and address of the applicant’s 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 applicant’s registered agent is
registered with the Florida Department of State, Division of Corporations.
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:
DBPR-DDC-235 - Application for Permit as a Prescription Drug Manufacturer – Virtual
Incorporated by rules: 61N-2.0141, F.A.C.
Eff. Date: July 2016
Page 4 of 14
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, FEID/FEIN and percentage of ownership and check the box labeled ―N/A‖
for date of birth.
1.
Name:
SSN/FEID/FEIN#
Date of Birth:
% of Ownership:
N/A
Street Address:
City:
State:
Zip Code:
2.
Name:
SSN/FEID/FEIN#
Date of Birth:
% of Ownership:
N/A
Street Address:
City:
State:
Zip Code:
DBPR-DDC-235 - Application for Permit as a Prescription Drug Manufacturer – Virtual
Incorporated by rules: 61N-2.0141, F.A.C.
Eff. Date: July 2016
Page 5 of 14