Form DBPR-DDC-234 "Application for Restricted Prescription Drug Distributor - Blood Establishment" - Florida

What Is Form DBPR-DDC-234?

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, 2012;
  • 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-234 by clicking the link below or browse more documents and templates provided by the Florida Department of Business & Professional Regulation.

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Download Form DBPR-DDC-234 "Application for Restricted Prescription Drug Distributor - Blood Establishment" - Florida

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State of Florida
Department of Business and Professional Regulation
Drugs, Devices, and Cosmetics Program
Application for a Restricted Prescription Drug Distributor – Blood Establishment
Form No.: DBPR-DDC-234
APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your
application to ensure faster processing.
APPLICATION
APPLICATION REQUIREMENTS
Enclose the fee of $750.00, which includes $600.00 application fee and
$150.00 initial application/on-site inspection fee.
Application for
Permit as a
Make cashier’s check or money order payable to the Florida Department
Restricted
of Business and Professional Regulation.
Prescription Drug
Distributor – Blood
If the applicant answered “Yes” to any question in Section IV, enclose a
Establishment
detailed explanation along with any relevant documentation.
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
DBPR-DDC-234 - Application for Licensure as a Restricted Prescription Drug Distributor – Blood Establishment
Eff. Date 07/01/2012
Incorporated by Rule: 61N-1
Page 1 of 10
State of Florida
Department of Business and Professional Regulation
Drugs, Devices, and Cosmetics Program
Application for a Restricted Prescription Drug Distributor – Blood Establishment
Form No.: DBPR-DDC-234
APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your
application to ensure faster processing.
APPLICATION
APPLICATION REQUIREMENTS
Enclose the fee of $750.00, which includes $600.00 application fee and
$150.00 initial application/on-site inspection fee.
Application for
Permit as a
Make cashier’s check or money order payable to the Florida Department
Restricted
of Business and Professional Regulation.
Prescription Drug
Distributor – Blood
If the applicant answered “Yes” to any question in Section IV, enclose a
Establishment
detailed explanation along with any relevant documentation.
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
DBPR-DDC-234 - Application for Licensure as a Restricted Prescription Drug Distributor – Blood Establishment
Eff. Date 07/01/2012
Incorporated by Rule: 61N-1
Page 1 of 10
State of Florida
Department of Business and Professional Regulation
Drugs, Devices, and Cosmetics Program
Application for Restricted Prescription Drug Distributor – Blood Establishment
Form No.: DBPR-DDC-234
If you have any questions or need assistance in completing this application, please contact the
Department of Business and Professional Regulation, Drugs, Devices and Cosmetics Program, 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 [3357/1020]
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). [3357/1020]
Current Permit Number ___________________________
Section II – Applicant Information
APPLICANT INFORMATION
Federal Tax Identification Number:
FULL LEGAL NAME
Applicant’s Full Legal Name:
FICTITIOUS, TRADE OR BUSINESS NAME
(only if applicant intends to operate under the permit under a name different from full legal name)
Full Fictitious, Trade or Business Name (sometimes “d/b/a” or “dba”):
_______________________________________________________
Note: This name will appear on the permit and must be used on the applicant’s operational documents
for permitting activities.
If the applicant intends to operate under a fictitious, trade or business name, provide the corresponding
registration number for the Florida Secretary of State, Division of Corporations:___________________
APPLICANT’S MAILING ADDRESS
Street Address or P.O. Box:
City:
State:
Zip Code (+4 optional):
PHYSICAL ADDRESS OF ESTABLISHMENT TO BE PERMITTED
Street Address:
City:
State:
Zip Code (+4 optional):
County (if Florida address):
Country:
E-Mail Address:
Phone Number:
Fax Number:
DBPR-DDC-234 - Application for Licensure as a Restricted Prescription Drug Distributor – Blood Establishment
Eff. Date 07/01/2012
Incorporated by Rule: 61N-1
Page 2 of 10
APPLICATION CONTACT
Whom should the department contact with questions regarding this application?
Last/Surname
First
Middle
Suffix
Address
City
State
Zip Code (+4 optional)
Telephone Number
Fax Number:
E-Mail Address:
EMERGENCY CONTACT - RESIDENCE INFORMATION
Last/Surname
First
Middle
Suffix
Position/Title
Residence Street Address (must be different than establishment physical address)
City
State
Zip Code (+4 optional)
Residence Phone Number
E-Mail Address
OPERATING HOURS
List Operating Hours – minimum 10 total per week (M-F) between 8:00 a.m. and 5:00 p.m. Eastern
Standard Time, and at least 2 consecutive hours on at least 1 day:
Mon
:
am/pm to
:
am/pm
Fri
:
am/pm to
:
am/pm
Tue
:
am/pm to
:
am/pm
Sat
:
am/pm to
:
am/pm
Wed
:
am/pm to
:
am/pm
Sun
:
am/pm to
:
am/pm
Thu
:
am/pm to
:
am/pm
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.
State or Country:
DBPR-DDC-234 - Application for Licensure as a Restricted Prescription Drug Distributor – Blood Establishment
Eff. Date 07/01/2012
Incorporated by Rule: 61N-1
Page 3 of 10
List name and address of the applicant’s registered agent for service of process in Florida (except Sole
Proprietorship or Partnership – General).
Name:
Address:
City:
State:
Zip Code (+4 optional)
List the name, position/title, date of birth and percentage of ownership, if applicable, for the applicant’s
owners, partners, members, managers, and corporate officers/directors.
Name
Position/Title
Date of Birth
% of Ownership
List all trade or business names used by the applicant. Use additional sheet(s) if necessary.
Is the applicant a subsidiary of another company? (If yes, provide a listing of all
Yes
No
parent companies with percentages of ownership, using additional sheet(s) if
necessary. Note: A permit issued pursuant to this applicant is only valid for the
applicant, and the applicant’s name and address.)
Parent Company Name
% of Ownership
Section IV – Background Questions
BACKGROUND QUESTIONS
1.
Yes
No
Has the applicant or any “affiliated party” (defined below) been found
If yes, explain
guilty (regardless of adjudication) or pled nolo contendere in any
in detail in
jurisdiction of a violation of law that directly relates to a drug, device or
Section V
cosmetic?
2.
Yes
No
Has the applicant or any affiliated party been fined or disciplined by a
If yes, explain
regulatory agency in any state (including Florida) for any offense that
in detail in
would constitute a violation of Chapter 499, F.S.?
Section V
3.
Yes
No
Has the applicant or any affiliated party been convicted (regardless of
If yes, explain
adjudication) of any felony under a federal, state (including Florida), or
in detail in
local law?
Section V
4
Yes
No
Has the applicant or any affiliated party been denied a permit or license in
If yes, explain
any state (including Florida) related to an activity regulated under
in detail in
Chapters 456, 465, 499, 893, F.S.?
Section V
DBPR-DDC-234 - Application for Licensure as a Restricted Prescription Drug Distributor – Blood Establishment
Eff. Date 07/01/2012
Incorporated by Rule: 61N-1
Page 4 of 10
5
Yes
No
Has the applicant or any affiliated party had any current or previous
If yes, explain
permit or license suspended or revoked which was issued by a federal,
in detail in
state or local governmental agency relating to the manufacture or
Section V
distribution of drugs, devices, or cosmetics?
6
Yes
No
Has the applicant or any affiliated party ever held a permit issued under
If yes, explain
Chapter 499, F.S. in a different name than the applicant’s name? If yes,
in detail in
provide the names in which each permit was issued and at what address?
Section V
The term “affiliated party” includes all of the following that may apply: the applicant’s (i) directors, officers, trustees,
partners, or committee members; (ii) any person who manages, controls or oversees the applicant’s operations (does
not have to be an employee), including the establishment manager and the next four (4) highest ranking employees
responsible for prescription drug wholesale operations; and (iii) the five (5) individuals (natural persons) who own at
least 5% of the applicant’s stock ownership interest.
If you answered “YES” to any questions in Section IV, provide detailed explanations in Section V, including
requirements for submitting supporting legal documents. If needed, explain on separate sheet(s).
Section V – Explanation(s) for “Yes” response(s) to background question(s)
EXPLANATION
Section VI – Other Permits or Licenses
PERMITS OR LICENSES
Are there any other permits or licenses issued by any agency of the state of
Florida that authorize the purchase or possession of prescription drugs at the
applicant’s establishment or address? (If yes, provide the name in which the
Yes
No
1.
permit is issued, the permit type, & permit number in the spaces provided
below.)
DBPR-DDC-234 - Application for Licensure as a Restricted Prescription Drug Distributor – Blood Establishment
Eff. Date 07/01/2012
Incorporated by Rule: 61N-1
Page 5 of 10