Fill - Free fillable Complete pages 1-3 for all applications. Complete ONE (Information Technology Services) PDF form

INSTRUCTIONS

North Carolina Department of Agriculture and Consumer Services

Food & Drug Protection Division

Steve Troxler, Commissioner

Anita MacMullan, Director

Jeremy Evans, Drug Administrator

2021

**************************************************************************************************

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.

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

2021

**************************************************************************************************

STATE USE ONLY

Purpose of Application:

LICENSE TYPE / APPLICATION FEE:

(Choose selection with a ‘√’)

- $1000

- $ 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

2021

**************************************************************************************************

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

2021

**************************************************************************************************

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

2021

**************************************************************************************************

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

2021

**************************************************************************************************

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: _______________

(Attach supporting documentation if Home State license not required)

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 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

2021

**************************************************************************************************

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

2021

**************************************************************************************************

Outsourcing Facility (Sterile 503B):

(Choose selection with a ‘√’)

Yes

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

2021

**************************************************************************************************

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

2021

**************************************************************************************************

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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