Fillable Form 2022: Complete pages 1-3 for all applications. (Information Technology Services)

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Form 2022: Complete pages 1-3 for all applications. (Information Technology Services)

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INSTRUCTIONS
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Drug Program Information:
Telephone: 919-733-7366 Drug Laws and Regulations:
www.ncagr.gov/fooddrug/drug/
Email: Jeremy.Evans@ncagr.gov
Shannon.Redd@ncagr.gov
**************************************************************************************************
**************************************************************************************************
Application Instructions:
Complete pages 1-3 for all applications. Complete ONE additional Form that corresponds to the ‘License Type’ applying
for and include with pages 1-3 (choose the form according to the ‘Further Requirements Instructions’ on the bottom of
page 3). Type or print answers to all questions. Enter required information on all blanks and use ‘Not Applicable’ or
‘N/A’ where appropriate. Mark all areas with a ‘√’ where indicated. If more space is required, attach supplemental
sheet(s) identifying each item corresponding to the license application. Include all required supplemental documentation
as indicated.
Pay non-refundable fee by check or money order payable to “North Carolina Department of Agriculture & Consumer
Services.” The fee amount is indicated next to the License Type on page 1. DO NOT SEND CASH.
Mail the completed application to the address indicated below for regular mail or overnight delivery.
A COMPLETED APPLICATION INCLUDES:
(1) pages 1-3 of the application,
(2) additional form that corresponds to the specific ‘License Type’ applying for,
(3) supplemental documentation as instructed,
(4) non-refundable fee by check or money order.
It is not necessary to send the ‘Instructions’ page with the application or any ‘Forms’ that do not correspond to the
specific ‘License Type’ applying for.
st
Each license expires December 31 of each year.
Changes in information supplied in this application must be submitted within 90 days of the change.
If you plan to compound and/or distribute Controlled Substances in North Carolina, registration is also required with the
North Carolina Department of Health and Human Services. Please call 919-733-1765 or visit https://www.ncdhhs.gov/
divisions/mhddsas/ncdcu/nc-controlled-substances-regulatory for more information.
*************************************************************************************************
Mailing Address for Application Submission:
Regular Mail:
NCDA & CS
Food & Drug Protection Division
1070 Mail Service Center
Raleigh, N.C. 27699-1070
Attn: Shannon Redd
Overnight Mail (FedEx or UPS):
NCDA & CS
Food & Drug Protection Division
4400 Reedy Creek Road
Raleigh, N.C. 27607
Attn: Shannon Redd
**************************************************************************************************
Drug Program Information:
Telephone: Drug Laws and Regulations:
www.ncagr.gov/fooddrug/drug/
Email:
919-733-7366
Jeremy.Evans@ncagr.gov
Shannon.Redd@ncagr.gov
PAGE 1
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
STATE USE ONLY
Purpose of Application:
LICENSE TYPE / APPLICATION FEE:
(Choose selection with a ‘√’)
- $1000
- $1000
- $1000
- $1000
- $ 700
- $ 700
- $ 700
- $ 700
- $ 700
- $1000
- $ 700
Manufacturer
Virtual Manufacturer
Re-packager
Outsourcing Facility (Sterile 503B)
Distributor (in-state)
Wholesaler (out-of-state)
Reverse Distributor Only
Pseudoephedrine Only
Third Party Logistic Provider Only
Medical Gases Manufacturer
Medical Gas Distributor (in-state)
Medical Gas Supplier (out-of-state)
- $ 700
APPLICATION TYPE
(Choose selection with a ‘√’)
New Registration
Renewal
Change of Ownership
Change In Location
__________________________
CURRENT NC
LICENSE/CERTIFICATE NO.
(Enter number from top right corner
of NC license/registration)
**************************************************************************************************
Location of Facility:
(Choose selection with a ‘√’)
INSIDE NORTH CAROLINA
OUTSIDE NORTH CAROLINA
Supplemental Documentation Required: Supplemental Documentation Required:
*Attach Printout of Current NC Business Registration *Attach Printout of On-line Home State License Verification
(Current NC Secretary of State Registration) *Attach Copy of Current Home State License
TYPE OF OWNERSHIP:
(Choose selection with a ‘√’)
Individual Partnership LLC Corporation _______________
(Enter State of Inc.)
AFFILIATION:
Name or title under which business is conducted: ________________________________________________________________
(Please list legal name and d.b.a. name if applicable)
Tax ID #: ____________________________________________
(Federal Employer Identification Number – EIN)
_____________________
___________________ , ___________
______________________________
City State Zip
Mailing Address: ___
________________________________________________________________________________________
(if different) Number and Street, City, State, Zip
Telephone Number: _________________________ ________ Fax Number: _________________________________
Email contact: ________________________________________
(Renewal
notification in October based on e-mail address submitted on application; please notify us if this changes)
*************************************************************************************************
LICENSE NO.
RECEIVED:
Supplemental Documentation Required:
*Attach Printout of Current NC Business Registration
(Current NC Secretary of State Registration)
Supplemental Documentation Required:
*Attach Printout of On-line Home State License Verification
*Attach Copy of Current Home State License
Physical Address: ____________________________________________________________________________________________________
(P.O. Box not acceptable) Number and Street
PAGE 2
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Company Information:
NAMES OF OFFICERS/PARTNERS/MANAGERS:
(If more space is required, attach supplemental sheet(s) with identifying information.)
______________________________________________ _________________________________________
(President’s Name) (Address)
______________________________________________ _________________________________________
(Vice President’s Name) (Address)
______________________________________________ _________________________________________
(Secretary/Treasurer’s Name) (Address)
FACILITY INFORMATION, IF APPLICABLE:
Please include name and address of all domestic and foreign facility affiliates, the name, phone number, and e-mail address for a
responsible point of contact for each affiliate.
(If more space is required, attach supplemental sheet(s) with identifying information.)
Address: __________________________________ Name: ________________________________________
Phone Number: _________________________________
E-mail address: ____________________________
EMPLOYEE TRAINING:
What education, training, experience, or combination of these are required of employees to assure assigned functions are performed in
a manner that ensures that prescription drug quality, safety, and security will be maintained at all times as required by law?
(If more space is required, attach supplemental sheet(s) with identifying information.)
____________________________________________________________________________________________________________
____________________________________________________________________________________________________________
LICENSURE / REGISTRATION QUESTIONS:
(Choose selection with a ‘√’)
Has drug registration or license under any local, state, or federal law ever been suspended or revoked?
Yes No (If yes, please attach an explanation and certified copies of all documents and records.)
Have you ever been denied issuance of, or pursuant to disciplinary proceedings, refused renewal of a license by any board or agency
in North Carolina or any other state?
Yes No (If yes, please attach an explanation and certified copies of all documents and records.)
Have any of the owners, partners of the firm, or officers of the corporation ever been convicted of any crime under the laws of the
United States, North Carolina, or any other state pertaining to the manufacturing, distribution, sale or dispensing of drugs or narcotics?
Yes No (If yes, please attach an explanation and certified copies of all documents and records.)
Do you compound and/or distribute Controlled Substances in North Carolina?
Yes No (If yes, please list current DEA and NC-DHHS Registration Numbers)
DEA Registration NC-DHHS Registration
Number: _________________________ Number: ________________________
**************************************************************************************************
PAGE 3
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Applicant and On-Site Designated Representative:
I, the undersigned, do hereby certify that all the information contained in this application is complete, true, and correct. In
addition, I agree that the business will be operated in compliance with all applicable Federal and State laws and
regulations.
Date _____________________ Applicant Name______________________________________
Owner, Partner, or Officer of Corporation
Title ________________________________________________
Applicant Signature ____________________________________
Date _____________________ On-Site Designated Rep. Name: __________________________
- FORM A - Manufacturer
- FORM B - Virtual Manufacturer
- FORM C - Re-packager
- FORM D - Outsourcing Facility (Sterile 503B)
- FORM E - Medical Gases Manufacturer
- FORM F - Distributor (in-state);
Wholesaler (out-of-state);
Reverse Distributor Only;
Pseudoephedrine Only;
Third Party Logistic Provider Only;
Medical Gas Distributor (in-state);
Medical Gas Supplier (out-of-state)
Designated Rep. Signature _______________________________
**************************************************************************************************
Further Requirements Instructions:
Choose the form from the list below that corresponds to the ‘License Type’ you are applying for. COMPLETE ONE
FORM ONLY per application and submit the completed form with pages 1-3 as indicated in the instructions. Type or
print answers to all questions. Enter required information on all blanks and use ‘Not Applicable’ or ‘N/A’ where
appropriate. Mark all areas with an ‘√’ where indicated. If more space is required, attach supplemental sheet(s)
identifying each item corresponding to the license application.
INCLUDE ALL REQUIRED SUPPLEMENTAL DOCUMENTATION AS INDICATED.
Choose only one form according to the list below that corresponds with the type of application you are applying
for. EACH APPLICATION WILL SUBMIT ONLY ONE FORM PER APPLICATION.
FORM - LICENSE TYPE:
click to sign
signature
click to edit
click to sign
signature
click to edit
- FORM A -
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Manufacturer:
TYPE OF MANUFACTURER:
(Choose selection with a ‘√’)
Title Holder – NDA(s) and/or ANDA(s) and/or BLA(s)
Contract Manufacturer
Other _____________________________________
(Enter Description for ‘Other’)
FDA Registration:
Firm Name: _________________________________________________________
FDA Establishment Identifier (FEI#): ___________________________________
DUNS #: ____________________________________________________________
Expiration Date: _____________________________________________________
NDC Labeler Code:
Firm Name: _________________________________________________________
Labeler Code: _______________________________________________________
National Drug Code listing:
NDA Number(s): _____________________________________________________
ANDA Number(s):
____________________________________________________
BLA Number(s): ______________________________________________________
**************************************************************************************************
Supplemental Documentation Required:
1. Proof of Registration with the FDA
*Attach Printout of Current Registration from the ‘Drug Establishments Current Registration Site’ on FDA
website (https://www.accessdata.fda.gov/scripts/cder/drls)
2. Proof of listed NDA(s) and/or ANDA (s) and/or BLA (s)
*Attach Printout of Current Registration from the ‘National Drug Code Directory’ on FDA website of human
prescription drug(s) listed under Firm Labeler Name and Code
(https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)
- FORM B -
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Virtual Manufacturer:
TYPE OF VIRTUAL MANUFACTURER:
(Choose selection with a ‘√’)
Title Holder – NDA(s) and/or ANDA(s) and/or BLA(s)
Other Agreement
_____________________________________
(Enter Description; i.e. ‘Co-licensing Agreement’, etc)
Home State License:
Yes License
Type: _________________________ License Number: _______________
No (Attach supporting documentation if Home State license not required)
NDC Labeler Code:
Firm Name: _________________________________________________________
Labeler Code: _______________________________________________________
National Drug Code listing:
NDA Number(s): _____________________________________________________
AND
A Number(s): ___________________________________________________
BLA Number (s): _____________________________________________________
**************************************************************************************************
Supplemental Documentation Required:
1. Proof of listed NDA(s) and/or ANDA (s) and/or BLA (s)
*Attach Printout of Current Registration from the ‘National Drug Code Directory’ on FDA website of human
prescription drug(s) listed under Firm Labeler Name and Code
(
https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)
2. Proof of Other Agreement
(If Applicable)
*Attach supporting documentation for type of Agreement Firm holds (as entered on ‘Other Agreement’ for
Type of Virtual Manufacturer above), if Current Listing(s) from the ‘National Drug Code Directory’ on FDA
website of human prescription drug(s) are listed under other Firm Name and Labeler Code in which
Agreement is held.
- FORM C -
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Re-Packager:
FDA Registration:
Firm Name: _________________________________________________________
FDA Establishment Identifier (FEI#): ___________________________________
DUNS #: ____________________________________________________________
Expiration Date: _____________________________________________________
NDC Labeler Code:
(Enter if applicable)
Firm Name: _________________________________________________________
Labeler Code: _______________________________________________________
National Drug Code listing:
(Enter if applicable)
NDA Number(s): _____________________________________________________
ANDA Number(s): ____________________________________________________
BLA Number (s): _____________________________________________________
**************************************************************************************************
Supplemental Documentation Required:
1. Proof of Registration with the FDA
*Attach Printout of Current Registration from the ‘Drug Establishments Current Registration Site’ on FDA
website (https://www.accessdata.fda.gov/scripts/cder/drls)
2. Proof of listed NDA(s) and/or ANDA (s) and/or BLA (s)
(If Applicable)
*Attach Printout of Current Registration from the ‘National Drug Code Directory’ on FDA website of human
prescription drug(s) listed under Firm Labeler Name and Code
(https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory)
- FORM D -
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Outsourcing Facility (Sterile 503B):
(Choose selection with a ‘√’)
Yes
No
Indicate whether the facility intends to compound products on FDA’s drug shortage
For drugs compounded by registered outsourcing facilities that are on the FDA Shortage List, the
drug must be compounded after the drug is placed on the drug shortage list and may not be
dispensed or administered to a patient after it has been removed from the drug shortage list.
Yes No Indicate whether the facility compounds from bulk drug substances
If any ingredients are used in compounding the drug, such ingredients comply with the standards
of the applicable United States Pharmacopeia or National Formulary monograph, if such
monograph exists, or of another compendium or pharmacopeia recognized by the Secretary for
purposes of paragraph (3) of 353b, if any.
Yes No Licensed/registered in home state
Home State License:
License Type: ____________________________________________________
License Number: _________________________________________________
Pharmacist(s) in direct supervision of drug compounding operation:
Name (s): ___________________________________________________________
License/Registration Number(s): _______________________________________
Supplemental Documentation Required:
1. Proof of Registration with the FDA
*Attach Printout of Current Registration from the ‘Registered Outsourcing Facilities Site’ on FDA website
(https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities)
2. Most recent Inspection Report(s) and Observations
*Attach copy of most recent inspection report by appropriate regulatory agency (federal or state) including any
findings, observations, and/or corrective actions.
*Attach copies of Form FDA483 or warning letter issued relative to inspection, if applicable
3. Response to Inspection Report(s)
*Attach copies of corrective actions provided in response to Form FDA 483, warning letter, or findings.
4. Proof of valid license/registration to operate as a pharmacy
(If Applicable)
**************************************************************************************************
Supplemental Documentation Required:
1. Proof of Registration with the FDA
*Attach Printout of Current Registration from the ‘Registered Outsourcing Facilities Site’ on FDA website
(https://www.fda.gov/drugs/human-drug-compounding/registered-outsourcing-facilities)
2. Most recent Inspection Report(s) and Observations
*Attach copy of most recent inspection report by appropriate regulatory agency (federal or state) including any
findings, observations, and/or corrective actions.
*Attach copies of Form FDA483 or warning letter issued relative to inspection, if applicable
3. Response to Inspection Report(s)
*Attach copies of corrective actions provided in response to Form FDA 483, warning letter, or findings.
4. Proof of valid license/registration to operate as a pharmacy
(If Applicable)
- FORM E -
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Medical Gases Manufacturer:
FDA Registration:
Firm Name: _________________________________________________________
FDA Establishment Identifier (FEI#): ___________________________________
DUNS #: ____________________________________________________________
Expiration Date: _____________________________________________________
Supplemental Documentation Required:
1. Proof of Registration with the FDA
*Attach Printout of Current Registration from the ‘Drug Establishments Current Registration Site’ on FDA
website (https://www.accessdata.fda.gov/scripts/cder/drls)
**************************************************************************************************
Supplemental Documentation Required:
1. Proof of Registration with the FDA
*Attach Printout of Current Registration from the ‘Drug Establishments Current Registration Site’ on FDA
website (https://www.accessdata.fda.gov/scripts/cder/drls)
- FORM F -
North Carolina Department of Agriculture and Consumer Services
Food & Drug Protection Division
Steve Troxler, Commissioner
Anita MacMullan, Director
Jeremy Evans, Drug Administrator
2022
**************************************************************************************************
Distributor (in-state) / Wholesaler (out-of-state) / Reverse Distributor Only/
Pseudoephedrine Only / Third Party Logistic Provider Only / Medical
Gas Distributor (in-state) / Medical Gas Supplier (out-of-state):
Federal Background Check:
Federal Background Checks Must Be Less Than Two Years Old.
New Applications must submit a completed Federal Background Check for both the Applicant and On-Site Designated
Representative from page 3 of the application (Instructions listed below).
Renewal Applications must submit a completed Federal Background Check for both the Applicant and On-Site
Designated Representative from page 3 of the application ONLY IF the signatories are different personnel from the last
application submitted or if the Designated Representatives are being updated (Instructions listed below). The
background check is not required if the signatories remain the same.
Supplemental Documentation Required:
1. Valid, Signed Driver License
*Attach a Copy of a valid, signed Driver License of the Applicant and On-Site Designated Representative from
page 3 of the application.
2. Completed Federal Background Check
*Attach Copy of each Federal Background Check received from the Applicant and On-Site Designated
Representative from page 3 of the application after following the instructions below.
Supplemental Documentation Required:
1. Valid, Signed Driver License
*Attach a Copy of a valid, signed Driver License of the Applicant and On-Site Designated Representative from
page 3 of the application.
2. Completed Federal Background Check
*Attach Copy of each Federal Background Check received from the Applicant and On-Site Designated
Representative from page 3 of the application after following the instructions below.
FEDERAL BACKGROUND CHECK INSTRUCTIONS:
Go to the www.fbi.gov/checks website, complete the Available Now: EDO process (the blue box) by first going to
Option 1 HOW TO SUBMIT YOUR REQUEST ELECTRONICALLY – click on that link.
When you click on the link, a new page will open. When the page opens, it will say enter your email in the blue box.
When you do that, we will send you an email with a PIN number on it – please write this down.
Then, you will click on the part that says “click here”. This will take you to start the paperwork online – your
registration. Fill out step by step. At the end, we will send you an email.
You will print the email and mail it to FBI CJIS Division – Summary Request, 1000 Custer Hollow Road, Clarksburg, WV
26306 unless otherwise noted with your fingerprint card. I would pay the post office to put tracking on your
envelope. After we receive it, it will take approximately 7 business days to send it to you via email. If you would also
like the hard copy response, please check the "preferences box" on the application to state that you would like the hard
copy response in the mail/post.
o Submit the report along with the completed license application to our department
o No license will be granted until all of this information is collected and reviewed.
**************************************************************************************************
Notice of Federal Background Check Required
The North Carolina Department of Agriculture and Consumer Services, Food and Drug Protection Division, requires applicants of Wholesale Prescription Drug
Distributors to obtain and submit a federal background check report with the license application. The Food and Drug Protection Division will consider the following
factors when reviewing any criminal convictions:
(1) The level and seriousness of the crime;
(2) The date of the crime;
(3) The age of the applicant at the time of the crime;
(4) The circumstances surrounding the commission of the crime, if known;
(5) The nexus between the criminal conduct and the prospective duties of the applicant as a licensee;
(6) The prison, jail, probation, parole, rehabilitation, and employment records of the applicant since the date the crime was committed;
(6a) The completion of, or active participation in, rehabilitative drug or alcohol treatment;
(6b) A Certificate of Relief granted pursuant to N.C. Gen. Stat. § 15A-173.2;
(7) The subsequent commission of a crime by the applicant; and
(8) Any affidavits or other written documents, including character references.
If the Food and Drug Protection Division denies a license application based on a criminal conviction, the applicant may appeal the denial in accordance with the North
Carolina Administrative Procedures Act, N.C. Gen. Stat. § 150B-1 et seq. The applicant may commence the denial by filing a petition for a contested case hearing with
the North Carolina Office of Administrative Hearings (OAH) within sixty (60) days at:
Office of Administrative Hearings
6714 Mail Service Center
Raleigh, NC 27699-6700
The petition must be in writing and in the form prescribed by N.C. Gen. Stat. § 150B-23 and accompanied by a filing fee established by OAH. The applicant must also
serve a copy of the petition for a contested case hearing to:
Ms. Tina L. Hlabse
North Carolina Department of Agriculture and Consumer Services
Registered Agent and General Counsel
1001 Mail Service Center
Raleigh, NC 27699-1001
Any questions about filing a petition may be directed to the North Carolina Office of Administrative Hearings by telephone at (919) 431-3000. Information may also
be obtained online at https://www.oah.nc.gov/hearings-division.
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