Dbpr Ddc 202 Form – Fill Out and Use This PDF

State of Florida

Department of Business and Professional Regulation

Division of Drugs, Devices, and Cosmetics

Application for Non-Resident Prescription Drug Manufacturer

Form No.: DBPR-DDC-202

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 [3326/1020]

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). [3326/1020]

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 (applies only if 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 from the Florida Secretary of State, Division of Corporations:___________________

APPLICANT’S MAILING ADDRESS

Street Address or P.O. Box:

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-202 - Application for Licensure as a Non-Resident Prescription Drug Manufacturer				Eff. Date August 2012
	Incorporated by Rule: 61N-1

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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 -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:

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:

DBPR-DDC-202 - Application for Licensure as a Non-Resident Prescription Drug Manufacturer	Eff. Date August 2012
Incorporated by Rule: 61N-1
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List name and address of the applicant’s registered agent for service of process in Florida (except Sole Proprietorship or Partnership – General).

Name:

Address:

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. Please note: A permit issued
pursuant to this application is only valid for the applicant’s name and applicant’s
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
	DBPR-DDC-202 - Application for Licensure as a Non-Resident Prescription Drug Manufacturer					Eff. Date August 2012
	Incorporated by Rule: 61N-1
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