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State of Florida

Department of Business and Professional Regulation

Division of Drugs, Devices, and Cosmetics

Application for a Cosmetic Manufacturer

Form No.: DBPR-DDC-206

APPLICATION CHECKLIST – IMPORTANT – Submit all items on the checklist below with your application to ensure faster processing.


APPLICATION	APPLICATION REQUIREMENTS
		Submit fee of $950.00, which includes $800.00 application fee and

	$150.00 initial application/on-site inspection fee. If 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.
Application for		Make cashier’s check or money order payable to the Florida Department
Application for
Permit as a Cosmetic	of Business and Professional Regulation.
Manufacturer
		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.
		Sign and date the Affidavit section of the application.

		Submit the completed application with enclosures to:
		Department of Business and Professional Regulation
		1940 North Monroe Street
		Tallahassee, FL 32399

DBPR-DDC-206 - Application for Licensure as a Cosmetic Manufacturer	Eff. Date: August 2012
Incorporated by Rule: 61N-1

Page 1 of 7

State of Florida

Department of Business and Professional Regulation

Division of Drugs, Devices, and Cosmetics

Application for Cosmetic Manufacturer

Form No.: DBPR-DDC-206

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 [3306/1020]

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). [3306/1020]

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:

City:

State:

Zip Code (+4 optional):

PHYSICAL ADDRESS OF ESTABLISHMENT TO BE PERMITTED

Street Address:

City:		State:		Zip Code (+4 optional):

County (if located in Florida):	Country:

E-Mail Address:	Phone Number:			Fax Number:

DBPR-DDC-206 - Application for Licensure as a Cosmetic 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 Address (must be different than establishment physical address):

City:		State:	Zip Code (+4 optional):

Resicence 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
Tue
Tue		:	am/pm	to	:		am/pm
Wed
Wed		:	am/pm to			:	am/pm
Thu	:		am/pm	to	:		am/pm

Fri

am/pm to

am/pm

Sat

am/pm

Sun

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:

DBPR-DDC-206 - Application for Licensure as a Cosmetic 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 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-206 - Application for Licensure as a Cosmetic Manufacturer	Eff. Date: August 2012
Incorporated by Rule: 61N-1
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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

DBPR-DDC-206 - Application for Licensure as a Cosmetic Manufacturer	Eff. Date: August 2012
Incorporated by Rule: 61N-1

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Section VI – Other Permits or Licenses

PERMITS OR LICENSES

	Are there any other permits or licenses issued by any agency of the State of
1.	Florida that authorize the purchase or possession of prescription drugs at the			Yes	No
	applicant’s establishment or address? (If yes, provide the name in which the
	permit is issued, the permit type, & permit number.)
1a.	Permit/License Name	Permit/License Type	Permit/License Number

Section VII – Cosmetic Manufacturing Activity

MANUFACTURING ACTIVITIES

Identify type of operation.

Mixing		Repackaging			Final Labeling for
				Distribution
Provide your Federal Food and Drug Administration (FDA) establishment registration number.

FDA Establishment Registration Number:______________________

1.	Are products distributed under this permit intended for export?						Yes	No

2.	Are all required records stored and maintained at applicant’s physical						Yes	No
	address? (If no, provide the establishments address where all required
	records will be stored and maintained below.)
2.a	Physical address where required records are stored
	Street Address:

	City:		State:			Zip Code (+4 optional):

3.	Are the required records computerized, automated or stored electronically?						Yes	No
	If yes, do you have a back-up procedure to be able to provide required
	records?						Yes	No
4.	Are you submitting a product registration application and labels of your						Yes	No
	products with this application? (If no, explain on a separate sheet providing
	accurate details.)
5.	Do you have labels of your products ready for inspection?						Yes	No

6.	Do you manufacture a product that has a sunscreen (SPF)? (If yes, and						Yes	No
	Over-the-Counter Drug Manufacturer permit is required.)
7.	Do you intend to comply with all Federal and State “Current Good						Yes	No
	Manufacturing Practices”?
8.	Does the applicant have written policies and procedures to include: storage,
	distribution/disposition, record maintenance/retrieval/retention, recalls and						Yes	No
	withdrawals?
9.	Provide the date the establishment will be ready and available for inspection.						___/___/20___
							This is the earliest
							date the application
							may be deemed
							complete.

DBPR-DDC-206 - Application for Licensure as a Cosmetic Manufacturer	Eff. Date: August 2012
Incorporated by Rule: 61N-1
Page 6 of 7

Section VIII – Affidavit

AFFIDAVIT

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 owner or corporate officer of the applicant without the need for witnesses unless otherwise required by law.

I certify that I am empowered to execute this application as required by Section 559.79, Florida Statutes. I understand that my signature on this application has the same legal effect as if made under oath. 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.

Signature of Owner or Officer:*

Date:

Print Name:

Title:

*If signed by someone other than an owner or officer, you must submit a letter from an owner or officer authorizing the signer to bind the applicant.

Mail completed application to:

Department of Business and Professional Regulation

1940 North Monroe Street

Tallahassee, FL 32399

DBPR-DDC-206 - Application for Licensure as a Cosmetic Manufacturer	Eff. Date: August 2012
Incorporated by Rule: 61N-1

Page 7 of 7

Question	Answer
Form Name	Form Dbpr Ddc 206
Form Length	7 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	1 min 45 sec
Other names	CosmeticManufac turer dbpr ddc 206 form

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