New Jersey Department of Health

Consumer, Environmental and Occupational Health Service

P. O. Box 369

Trenton, NJ 08625-0369

Phone: 609-826-4935 Fax: 609-826-4990

www.nj.gov/health/foodanddrugsafety

FOOD AND DRUG SAFETY PROGRAM

WHOLESALER DRUG APPLICATION INSTRUCTIONS

Please review the application and return all required fees and complete documentation on the enclosed application. NOTE: If the application, ATTACHMENTS, and all rEQUIRED information is not completely signed and enclosed, your application will be returned.

Misrepresentation of any information on the application is a violation of the laws of the State of New Jersey and may result in the denial of your application or the suspension or revocation of your registration.

1.	APPLICATIONS MUST BE TYPED OR PRINTED LEGIBLY.

2.	NOTE: OUT-OF-STATE DISTRIBUTORS – If you are an out-of-state distributor, please attach a copy of the license/permit/registration of your company’s resident state when you submit this application.

3.	As part of the application, the following attachments are required. Send photocopies only; do not send originals:

Federal ID Tax Certificate(s)

If a corporation, Certificate of Incorporation

If a Limited Liability Corporation (LLC), Certificate of Limited Liability Corporation

Federal DEA License, if handling Controlled Dangerous Substances

Resident State Controlled Dangerous Substance License, if handling Controlled Dangerous Substances

Resident State License, if your company is located outside of New Jersey.

For any questions, please contact the Food and Drug Safety Program at (609) 826-4935. Thank you.

New Jersey Department of Health

Consumer, Environmental and Occupational Health Service

PO Box 369

Trenton, NJ 08625-0369

Phone: 609-826-4935 Fax: 609-826-4990

www.nj.gov/health/foodanddrugsafety

REGISTRATION OF DRUG OR MEDICAL DEVICE MANUFACTURING

OR WHOLESALE DRUG OR MEDICAL DEVICE BUSINESS

(N.J.S.A. 24:6B)

FEE:	$200 - Single location in the State or out of State

$500 - 2 or more locations in State or out of State

$50 - for each location in the State if the gross total annual business in drugs does not exceed 3% of the gross total annual volume. (CPA Certification is required.)	FOR STATE USE ONLY
Check MO	#_______________

Date Received	_______________

Amount	_______________

Certificate No.	_______________

Registration No.	_______________

Date Issued	_______________

Check all that apply:

Mfg	Whrse	Repacker

Dist	Broker Only	Relabeler

SCBA Only

Other: ___________________________
A check or money order, payable to "New Jersey Department of Health" must accompany this Registration. Registration must be renewed prior to February 1 of each calendar year.

NOTE: If more space is required, attach supplemental sheets identifying each item corresponding to the number on this Registration form.

SECTION I ‑ IDENTIFICATION
1.	Name of Parent Company

2.	Telephone Number

( )
3.	Mailing Address (Street)

4.	Fax Number

( )
5.	City, State, Zip Code

6.	Federal ID Number

(MUST attach copy of certificate)

7.	Email Address

8.	Web Address

9.	Trade Name (Doing Business As)

10.	Telephone Number

( )
11.	Mailing Address (Street)

12.	Fax Number

( )
13.	City, State, Zip Code

14.	Federal ID Number

(MUST attach copy of certificate)

15.	Email Address

16.	Web Address

17.	List all locations in which your company manufactures, stores and/or distributes for the Drug or Medical Device Manufacturing or Wholesale Drug or Medical Device Business Conducted in ANY State:
Location A:
Street Address:
City, State, Zip Code:
Responsible Person:
Telephone Number:	Residential? Yes No
Activity Conducted:	Manufacturer Warehouse Repacker Distributor Broker Only Relabeler
Reverse Distributor Contract Manufacturer Logistics Provider Company
Other (specify):
Location B:
Street Address:
City, State, Zip Code:
Responsible Person:
Telephone Number:	Residential? Yes No
Activity Conducted:	Manufacturer Warehouse Repacker Distributor Broker Only Relabeler
Reverse Distributor Contract Manufacturer Logistics Provider Company
Other (specify):
Location C:
Street Address:
City, State, Zip Code:
Responsible Person:
Telephone Number:	Residential? Yes No
Activity Conducted:	Manufacturer Warehouse Repacker Distributor Broker Only Relabeler
Reverse Distributor Contract Manufacturer Logistics Provider Company
Other (specify):
Location D:
Street Address:
City, State, Zip Code:
Responsible Person:
Telephone Number:	Residential? Yes No
Activity Conducted:	Manufacturer Warehouse Repacker Distributor Broker Only Relabeler
Reverse Distributor Contract Manufacturer Logistics Provider Company
Other (specify):
Location E:
Street Address:
City, State, Zip Code:
Responsible Person:
Telephone Number:	Residential? Yes No
Activity Conducted:	Manufacturer Warehouse Repacker Distributor Broker Only Relabeler
Reverse Distributor Contract Manufacturer Logistics Provider Company
Other (specify):
Location F:
Street Address:
City, State, Zip Code:
Responsible Person:
Telephone Number:	Residential? Yes No
Activity Conducted:	Manufacturer Warehouse Repacker Distributor Broker Only Relabeler
Reverse Distributor Contract Manufacturer Logistics Provider Company
Other (specify):
18.	Have you ever made application for registration in New Jersey? Yes No
A. If Yes, year of previous application:
19.	Does your company IMPORT? Yes No
A. If Yes, provide information on company(ies):
Name of Company:
Address of Company:
Country:	FDA Reg. No.:
Name of Company:
Address of Company:
Country:	FDA Reg. No.:
Name of Company:
Address of Company:
Country:	FDA Reg. No.:
20.	Does your company EXPORT? Yes No
A. If Yes, provide information on company(ies):
Name of Company:
Address of Company:
Country:	FDA Reg. No.:
Name of Company:
Address of Company:
Country:	FDA Reg. No.:
Name of Company:
Address of Company:
Country:	FDA Reg. No.:
21.	List All of the states with which your company possesses current Registration. Provide License Number and Expiration Date for each.
Lic. No.
Exp.Date
Lic. No.
Exp.Date
Lic. No.
Exp.Date
Lic. No.
Exp.Date
AK
ID
NC
SC
AL
IL
ND
SD
AR
IN
NE
TN
AZ
KS
NH
TX
CA
KY
NJ
UT
CO
LA
NM
VA
CT
MA
NV
VI
DC
MD
NY
VT
DE
ME
OH
WA
FL
MI
OK
WI
GA
MN
OR
WV
GU
MO
PA
WY
HI
MS
PR
IA
MT
RI
22.	If the registrant's business is not conducted from a location within the State, you are required to provide the name of the company appointed as New Jersey Registered Agent:
NJ Registered Agent:
Street Address:
City, State, Zip Code:
Telephone Number:
Locations from which NJ customers are serviced:
Address:
Address:

SECTION II ‑ BUSINESS STRUCTURE
1.	Provide the Names and Residential Addresses of Owners, Partners, Officers and Agents:
A. SOLE OWNERSHIP
Name:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
B. PARTNERSHIP
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
B. PARTNERSHIP, Continued
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
C. INCORPORATION *	(Attach copy of Certificate of Incorporation)
*In case of a corporation with more than one Division, list Division Officers responsible for NJ operation.
Date of Incorporation:
State:
President:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Vice-President:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
C. INCORPORATION (Continued)
Secretary:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Treasurer:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Other Officer/Director:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Other Officer/Director:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:

D. OTHER [Designate the type of business structure, if other than private ownership, partnership or corporation, for example: Limited Liability Corporation (LLC). Attach a copy of Certificate of Limited Liability Corporation.]
Type of Structure:
Name of Partner:
Title:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Title:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Title:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:
Name of Partner:
Title:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
Social Security Number (Last 4 Digits Only):	Date of Birth:
Place of Birth – City, State:	Country:
Percent Owned:
Signature:

SECTION III ‑ RECEIPT OF ORDERS SERVED
1.	List the names and addresses of officers, registered agent, or legal counsel, upon whom orders of the Commissioner may be served:
A. Name:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:
B. Name:
Residence Street Address:
City, State, Zip Code:
Residence Telephone Number:

SECTION IV ‑ DESCRIPTION OF BUSINESS/PRODUCTS
1. Are you engaged in inter-state commerce?	Yes	No

2. Are the following products and/or activities conducted at any of your locations involving prescription drugs and/or prescription veterinary drugs?	Yes	No

3. Indicate which of the following products and/or activities are conducted at each of the locations you listed on Page 1, Section 1, Question 17, by checking the appropriate box:

Location	Location	Location	Location	Location	Location

A	B	C	D	E	F

A.	Prescription drugs which fall under the Federal

Prescription Drug Marketing Act of 1987, 21 U.S.,

C. 351, 353, 371 and 374 and C.F.R. 205

B.	Non-prescription, non-legend or over-the-counter (OTC)

drugs

C.	Medical devices

D.	OTC veterinary drugs

E.	Prescription veterinary drugs

F.	Manufacturing, compounding, processing, wholesaling,

jobbing, or distribution of controlled dangerous

substances as defined by law

G.	Transfilling of scuba oxygen tanks

H.	Medical gases

I.	Repacking

J.	Relabeling

K.	Reverse distribution

L.	Contract manufacturing

M.	Controlled dangerous substances

N.	Medical gases
4. DEA Registration Number:	(Attach a COPY of the Certificate(s) to this application.)
5. CDS State Registration No.:

6.	List the drugs or medical device products manufactured or distributed for sale or wholesaled. The list must be a complete attestation of all drugs and products handled and distributed. The list MUST itemize exact product names, NDC numbers and exact dosages. You may enclose a CD, catalog or printed drug list of your products for this registration.

SECTION V – CORPORATE OFFICERS EMPLOYMENT
1.	Please provide the Corporate Officers’ (all principals in the Business Structure) past and present experience in the manufacturing or distribution of drugs or device manufacturing or distribution. Provide name, location and phone number of previous employers and time of employment. As part of this application, attach a copy of the resume for each employee and complete this section.
A.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
B.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
C.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
D.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
E.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
F.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
G.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer
H.	Name of Employee:
Do you hold any other position with any other company?	Yes No
Name of Company:
Position Held:
City, State, Zip Code:
Telephone No.:	Contact Person:
Period of Employment: Begin Date:	End Date:
Type of Operation:	Manufacturer Primary Dist. Secondary Dist. Broker Repacker Retailer

SECTION VI – CONVICTIONS / SUSPENSIONS
1.	Has the company or any principals or its owners or partners been convicted under any Federal or local laws relating to drug samples, wholesale or retail drug distribution or medical devices?
Yes No
a. If Yes, explain:
2.	Is the registrant’s Federal or State registration for the manufacture or distribution of prescription drugs or controlled substances currently or previously been suspended or revoked?
Federal Registration: Yes No	State Registration: Yes No
a. If Yes, explain:

SECTION VII – CERTIFICATION
To be signed by Individual Owner, Partner, Corporate President or Responsible Principal, whichever is applicable.

I hereby certify that the answers given in this application and attached documentation are true and correct. I understand that any infraction of the laws of the State of New Jersey regulating the operation of a wholesale drug or medical device business may be grounds for the revocation/suspension of this registration.

I have read all questions, answers and statements and know the contents thereof. I hereby certify under penalty of perjury, that the information furnished on this application are true, accurate and correct. I hereby authorize the New Jersey Department of Health, it’s agents, servants and employees to conduct any investigation(s) of my business, professional, social and moral background, qualification and reputation, as it may deem necessary, proper or desirable.

I am aware that if any of the foregoing statements are willingly false, I am subject to punishment.
Name

Title

Signature	Date
Name

Title

Signature	Date

SECTION VIII - NOTARY PUBLIC
State of ______________________________

County of	________________________________________

Subscribed and sworn to before me this

________ day of __________________________,	20_____.

Notary Public of the State of	______________________.

MY COMMISSION EXPIRES:	_______________________.	By_______________________________________________

SECTION IX ‑ CERTIFICATION BY CERTIFIED PUBLIC ACCOUNTANT OR PUBLIC ACCOUNTANT
I hereby certify that the gross total business in drugs of the above-named registrant does not exceed 3% of the gross total annual volume of the registrant's business.
Name of CPA or Public Accountant

Certificate Number

Address

Signature	Telephone Number

( )	Date

F-2

JUL 12

JUL 12	Page 1 of 11 Pages.

REGISTRATION OF DRUG OR MEDICAL DEVICE MANUFACTURING

OR WHOLESALE DRUG OR MEDICAL DEVICE BUSINESS (Continued)

JUL 12	Page 11 of 11 Pages.

F-2, Wholesale Drug Registration Package

F-2, Wholesale Drug Registration, application, food and drug safety, wholesale, drug manufacturer, medical device

EWhite

2007-01-29

NJDOH