:: AZBOP Online Applications ::

Instructions

Attention Virtual Manufacturer Applicants
Before a virtual manufacturer application can be considered by the Board, the following must be attained:
1. Third-party logistics (3PL) providers used by the business must hold valid Arizona 3PL permits; and
2. With the exception of device manufacturers, domestic contract manufacturers used by the business must hold valid Arizona manufacturer permits.

Physical Location

Resident

Non-Resident

Secondary Type

Virtual

503B Outsourcing Facility

Repackager

None

Resident Manufacturers/Repackagers/Outsourcers :

A list of drugs/devices to be manufactured/repackaged
Plans or construction drawings showing facility size and security for the proposed business
Designated Representative’s résumé indicating educational or experiential qualifications related to drug manufacturer operation
Documentation of compliance with local zoning laws (Lease/Zoning Statement from the appropriate zoning authority)
A list of domestic contract manufacturers used, including the business name, address, FDA registration number, and Arizona permit number, if applicable
A list of foreign contract manufacturers used, including the business name, address, and FDA registration number, if applicable
A list of 3PLs used, including the business name, address and Arizona permit number, if applicable
A list of officers or partners, if applicable.
A list of similar businesses, if applicable.
Disciplinary Orders, if applicable
Denial Letters, if applicable
Copies of FDA 483s, responses to FDA 483s, Warning Letters and Close-Out Letters, for each contract manufacturer, if applicable
A list of narcotics or other controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals distributed at the direction of this business, from this location, within the last four years and
Application fee (this fee is nonrefundable)

Non-Resident Manufacturers/Repackagers/Outsourcers :

A copy of the facility’s home state permit
Verification of the business’ valid home-state permit. (A copy of an online verification is acceptable. The verification must include the physical address of the business. Verifications dated more than 90 days in advance of the submission of the application will not be accepted)
A list of drugs/devices to be manufactured/repackaged
A list of domestic contract manufacturers used, including the business name, address, FDA registration number, and Arizona permit number, if applicable
A list of foreign contract manufacturers used, including the business name, address, and FDA registration number, if applicable
A list of 3PLs used, including the business name, address and Arizona permit number, if applicable
A list of officers or partners, if applicable.
A list of similar businesses, if applicable.
Disciplinary Orders, if applicable
Denial Letters, if applicable
Copies of FDA 483s, responses to FDA 483s, Warning Letters and Close-Out Letters, for each contract manufacturer, if applicable
List of narcotics or other controlled substances, prescription-only drugs or devices, nonprescription drugs, precursor chemicals, or regulated chemicals distributed into Arizona at the direction of this business, from this location, during the last four years and
Application fee (this fee is nonrefundable)

Applicable Statutes and Rules

Please familiarize yourself with the statutes and rules listed below.

Statutes

Rules

A.R.S. § 32-1927.02, 1929, 1930, 1931, 1933

A.A.C R4-23-601, 602, 604 (resident)

A.A.C R4-23-607 (non-resident)

The Board of Pharmacy’s statutes and rules are located at https://pharmacy.az.gov under the ‘Resources’ tab”

I have read and understand the statutes and rules.

Business Information

Business Name

FEIN

Physical Street Address

Physical Suite # (Please use appropriate prefix (Example: Suite 101, Apt. 101, #101, etc.))

Physical Zip Code

Physical City

Physical State

Physical County

Phone

Ext

Fax

Email [email protected]

Website

Check if mailing address is the same as above.

Street Address

Suite # (Please use appropriate prefix (Example: Suite 101, Apt. 101, #101, etc.))

Zip Code

City

State

County

Ownership Information

Name of owner(s)

Phone

Ext

Fax

Is this entity a corporation or partnership with officers or partners? If yes, provide the name, title and address of each officer or partner. You may enter this information here or attach a list later in the application process.

Yes

Is this application being submitted because of a change in ownership?

Yes

If yes, indicate the former owner's name, AZ permit number, and permit name.

Other Business Information

Indicate the date your business opened or will open

Has this entity ever operated under any other trade or business names? If yes, indicate the trade or business names used.

Yes

Has this entity ever operated a similar business (e.g. pharmacy, manufacturer, wholesaler, 3PL) in any other state or jurisdiction? If yes, provide the name and location of each similar business sharing common ownership. You may enter this information here or attach a list later in the application process.

Yes

FDA registration number/Labeler code

FDA registration expiration date

Pharmacist-in-Charge Information (503Bs Only)

Has the Pharmacist-in-Charge been designated?If yes, please provide the following information. (Non-resident applicants must designate a PIC.)

Yes

Does this business use:

a.Domestic contract manufacturers to make its products? If yes, provide a list of all domestic contract manufacturers to include the business name, address and Arizona permit number. (Arizona permits are not required for contract manufacturers of virtual device manufacturers.)

Yes

b.Foreign contract manufacturers to make its products? If yes, provide a list of all foreign contract manufacturers to include the business name and address.

Yes

c.A third-party logistics (3PL) company to warehouse and distribute products? If yes, provide a list of all 3PLs to include the business name, address and Arizona permit number.

Yes

Regulatory Questions

Designated Representative Information

Name of Manager Or Responsible Person

Email Address

Emergency Phone Number

Ext

Address

Zip Code

City

State

County

Attachments

Plans or construction drawings showing facility size and security for the proposed business

Drug(s)/Device(s) list

Designated Representative’s Resume

Documentation of compliance with local zoning laws (Lease/Zoning Statement)

A list of officers or partners, if applicable

A list of similar businesses, if applicable

Disciplinary Orders, if applicable

Denial Letters, if applicable

A copy of the facility’s home state permit

Drug(s)/Device(s) list

A list of officers or partners, if applicable

A list of similar businesses, if applicable

Disciplinary Orders, if applicable

Denial Letters, if applicable

Name and Address of 3PL

Name and Address of Contract Manufacturer

Review Your Information

Affirm And Submit

I declare under penalty of perjury under the laws of the state of Arizona that the information I have provided in this application is true and correct to the best of my knowledge.

E-Signature :

Date :

Please be advised of the following pursuant to Arizona Revised Statutes (A.R.S.) § 41-1030:

A.R.S. § 41-1030 (B)

An agency shall not base a licensing decision in whole or in part on a licensing requirement or condition that is not specifically authorized by statute, rule or state tribal gaming compact. A general grant of authority in statute does not constitute a basis for imposing a licensing requirement or condition unless a rule is made pursuant to that general grant of authority that specifically authorizes the requirement or condition.

A.R.S. § 41-1030 (D)

This section may be enforced in a private civil action and relief may be awarded against the state. The court may award reasonable attorney fees, damages and all fees associated with the license application to a party that prevails in an action against the state for a violation of this section.

A.R.S. § 41-1030 (E)

A state employee may not intentionally or knowingly violate this section. A violation of this section is cause for disciplinary action or dismissal pursuant to the Agency's adopted personnel policy.

A.R.S. § 41-1030 (F)

This section does not abrogate the immunity provided by section 12-820.01 or 12-820.02.

Application for Manufacturer Permit

Instructions

Instructions

Applicable Statutes and Rules

Business Information

Ownership Information

Other Business Information

Does this business use:

Regulatory Questions

Designated Representative Information

Attachments

Review Your Information

Affirm And Submit