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State of Florida

Department of Business and Professional Regulation

Division of Drugs, Devices, and Cosmetics

Application for a Non-Resident Prescription Drug Manufacturer

Form No.: DBPR-DDC-202

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


APPLICATION	APPLICATION REQUIREMENTS
		Submit fee of $1,000.00, made payable only by cashier’s check or money

	order, to the Florida Department of Business and Professional Regulation.
Application for		If you answer “Yes” to any question in Section IV, be sure to provide a

	detailed explanation along with any relevant documentation.
Permit as a Non-	detailed explanation along with any relevant documentation.
Permit as a Non-
Resident		Submit photocopy of your license/permit issued by your resident state that
Resident
Prescription Drug
Prescription Drug	authorizes the sale and/or distribution of prescription drugs from the applicant’s
Manufacturer
Manufacturer	address.
	address.
		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-202 - Application for Licensure as a Non-Resident Prescription Drug Manufacturer	Eff. Date August 2012
Incorporated by Rule: 61N-1

Page 1 of 10

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:

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-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:

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-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

Does the applicant, the applicant’s parent, sister or subsidiary companies, provide diagnostic, medical, surgical, or dental treatment or care, or chronic or rehabilitative care? If so, please list all company/companies below. (Use additional sheet(s) if necessary).

Yes

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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	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
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-202 - Application for Licensure as a Non-Resident Prescription Drug 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
	Florida that authorize the purchase or possession of prescription drugs at the
1.	applicant’s establishment or address? (If yes, provide the name in which the						Yes	No
	permit is issued, the permit type, & permit number in the spaces provided
	below.)
1a.	Permit/License Name			Permit/License Type		Permit/License Number




2.	Is the applicant licensed in any other state as a manufacturer, repackager, or
	wholesaler of prescription drugs? (If yes, list all states where licensed,						Yes	No
	including the license numbers and expiration date in the spaces provided
	below. Use separate sheet of paper if needed.)
2a.	State		Permit/License		Permit/License		Expiration Date
2a.	State		Number/Type		Number/Type		Expiration Date
			Number/Type		Number/Type



3.	Does the location for which you are applying sell prescription drugs into
	Florida? (If no, provide the name and address from which the drugs are sold						Yes	No
	into Florida in the spaces provided below. Use additional sheets if needed.)
3a.		Name		Physical Address		Florida Permit/License Number



4.	Does the location for which you are applying ship prescription drugs into
	Florida? (If no, provide the name and address of all locations that ship						Yes	No
	prescription drugs into Florida on your behalf in the spaces provided below.
	Use additional sheets if needed.)
4a.		Name		Physical Address		Florida Permit/License Number

Section VII – Prescription Drug Manufacturing Activity

MANUFACTURING ACTIVITIES

Generally identify the applicant’s intended customers, the persons and entities that will purchase or receive products from the applicant after permit issuance.

Manufacturers

Hospitals

Veterinarians

Wholesalers Practitioners

Pharmacies Clinics

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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Other (explain) ___________________________________________

Identify the types of products the applicant will manufacture or distribute under this permit.

Human Prescription Drugs

Solid Dose

Liquids (Oral)

Injectables

Topical

Dental

Ophthalmic

Compressed Medical Gases

Veterinary Prescription Drugs

Repackage – From Bulk

Repackage – From Stock

Refrigerated (Human, Veterinary, API or Otherwise) Frozen (Human, Veterinary, API or Otherwise)

Active Pharmaceutical Ingredients (If yes, check the applicable box(es) for your customers):

Manufacturers	Pharmacies for Compounding	Other explain_____________
Controlled Substances:	Provide your DEA Number: _________________

Check Schedules:

Sch II

Sch III

Sch IV

Sch V

Identify type of operation.

Contract Manufacturer	Own Label Manufacturer	Limited Manufacturing
		Operations (Sterilizing,
		Encapsulating, etc.)
Provide your FDA establishment registration number.

FDA Establishment Registration Number:______________________

Provide all National Drug Codes (NDCs) for all drug listings manufactured or distributed from the establishment. (Provide NDCs and drug listing on a separate sheet.)

NDCs and drug listings:_____________________________

1.Does your company sell and/or distribute only FDA approved drugs? (If no,

explain on a separate sheet of paper.)

Yes

2.Do you manufacture a prescription drug as a finished product? (If no,

	explain on a separate sheet providing accurate details.)	Yes	No
3.	Will you distribute prescription drugs, including any active pharmaceutical	Yes	No
	ingredient (API), used or intended for use in the manufacture of a
	prescription drug from the establishment? (For assistance in determining the
	definition of “distribute” see Section 499.003(17), Florida Statutes.)

4.Do you intend to manufacture or distribute prescription drug samples? (If

	yes, a Complimentary Drug Distributor permit is required.)	Yes	No
5.	Do you understand that a repackager of prescription drugs is not considered	Yes	No
	a manufacturer for the purpose of this permit and that an Out-Of-State
	Prescription Drug Wholesale Distributor permit is required to wholesale
	repackaged drugs into Florida?

6.	Do you repackage prescription drugs?	Yes	No

7.	Do you understand that this permit only authorizes the distribution of	Yes	No
	prescription drugs made by you, or your client, and that if you sell and/or
	distribute a prescription drug made by another, you will be required to obtain

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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an additional permit as an Out-Of-State Prescription Drug Wholesale Distributor?

8.	Are you recognized by the FDA as a manufacturer of prescription drugs?
	(Please select below.)				Yes	No
8.a	___Own Label Manufacturer ___Contract Manufacturer	____ Other: ________________________

9.	Do you comply with all Federal and State “Current Good Manufacturing				Yes	No
	Practices?

10.	Are you located outside the United States? (If yes, provide the name of each
	prescription drug you intend to import into Florida and attach documentation				Yes	No
	(Example: FDA Form 2656) from the United State Food and Drug
	Administration (FDA) giving you approval to do so. Use additional sheets.)
11.	Are products distributed under this permit intended for export?				Yes	No

	(Note: A permit may be required for freight forwarders handling products in
	Florida.)
12.	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.)
13.	Physical address where required records are stored
	Street Address:

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

14.	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
15.	Is the applicant’s establishment equipped with an alarm system to detect				Yes	No
15.	entry after hours and a security system protecting against theft and				Yes	No

	diversion? (If yes, provide the types and descriptions of those systems on a
	separate sheet.)
16.	Is there a quarantine area at the applicant’s establishment? (If not, please				Yes	No
	explain on a separate sheet.)
17.	Is the applicant’s establishment equipped with adequate climate controls
	(including refrigerated and freezing storage if appropriate for the applicant’s				Yes	No
	distributed products) to ensure safe storage? (If not, please explain on a
	separate sheet.)

18.Does the applicant have written policies and procedures to include: the

	receipt, security, storage, inventory, distribution/disposition of prescription	Yes	No
	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 of
	outdated products; temperature and humidity monitoring?
19.	Have you attached a photocopy of your license/permit issued by your	Yes	No
	resident state that authorizes the sale and/or distribution of prescription
	drugs from the applicant address? (Note: If a license/permit is not needed in
	your state, you must comply with Rule 61N-1.015(6)(c), F.A.C.)

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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Section VIII– Qualify as a Manufacturer

QUALIFYING AS A MANUFACTURER

(Check all that apply)

1.	Do you qualify as a “manufacturer” as a person who prepares, derives,	Yes	No
	manufactures, or produces a drug, device, or cosmetic?
2.	Do you qualify as a “manufacturer” as the holder of an FDA-approved	Yes	No
	prescription drug application or biologics license? If yes, list all biologics
	licenses and approved applications by number, and provide copies of no more
	than 5 FDA approval letters.
3.	Do you qualify as a “manufacturer” as a private label distributor?	Yes	No
	If yes, provide all agreements between you and any other manufacturer of a
	given prescription drug for which you are claiming to be a private label
	distributor, and a list of all NDCs and copies of all labeling for such drugs.
4.	Do you qualify as a “manufacturer” pursuant to a co-marketing agreement	Yes	No
	or contract with another manufacturer? If yes, provide a copy of your co-
	marketing agreement/contract.
5.	Do you qualify as a “manufacturer” as an exclusive distributor for	Yes	No
	manufacturers that are members of your affiliated group as defined in
	Section 1504 of the Internal Revenue Code of 1986? If yes, complete and
	provide the information and documents request under items A. – C. below.

A.Submit a copy of Parts I, II, and IV of the most recent Internal Revenue Service Form 851, Affiliations Schedule (Form 851) filed by the affiliated group’s parent corporation, along with a copy of the certification/signature page(s) from the affiliated group’s most recent consolidated tax return. If any of the information in Parts I, II or IV has changed since the Form 851 was filed, please submit a list of all such changes in the same detail required by Form 851.

B.Identify each affiliated group member identified on Form 851 above that qualifies as a “manufacturer” of prescription drugs under Section 499.003(31)(a), (b), (c) or (d), F.S. (a “source member”), and for each source member list the following:

1)Full corporate or entity name.

2)Principal place and address of business (mailing and physical).

3)State of incorporation or organization.

4)Any fictitious or trade name registered in Florida or to be used in connection with the distribution of prescription drugs in or into Florida.

5)Reference how the source member qualifies as a “manufacturer” – Section 499.003(31)(a), (b), (c) and/or (d), F.S.

C.In addition to the source members identified above, identify any other entities for which the applicant intends to distribute prescription under this permit. For each such person or entity, list the following:

1)Full corporate or entity name.

2)Principal place and address of business (mailing and physical).

3)State of incorporation or organization.

4)Any fictitious or trade name registered in Florida or to be used in connection with the distribution of prescription drugs in or into Florida.

If any entity identified in response to items B. or C. above is or was incorporated, organized or otherwise formed under the laws of any jurisdiction other than a state, possession or territory of the United States, including the District of Columbia and the Commonwealth of Puerto Rico, identify the foreign jurisdiction where each such entity was incorporated, organized or formed.

NOTE: You must advise the department in writing within (30) calendar days of any change of any

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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information contained or required to be contained in this source member list. This includes but is not limited to deletions and additions to source members for whom you distribute prescription drugs.

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

Page 10 of 10

Question	Answer
Form Name	Dbpr Ddc 202 Form
Form Length	10 pages
Fillable?	No
Fillable fields	0
Avg. time to fill out	2 min 30 sec
Other names	dbpr condominium, dbpr, form number dbpr ddc 224, dbpr ddc application

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