:: Initial Applications ::

Limited Distributors Instructions

This application is not to be used to make changes to the name, address, owner, or facility manager on your existing Limited Distributor license. You must complete and submit the appropriate paper application available on the Board’s website at https://pharmacy.iowa.gov/application-forms

You are applying for a New Limited Distributor License. A Limited Distributor license is required for the following distributions in or into Iowa:
a. Distribution of a medical gas or device at wholesale or to a patient pursuant to a prescription drug order.
b. Wholesale distribution of a prescription animal drug.
c. Wholesale distribution of a prescription drug, or brokering the distribution of a prescription drug at wholesale, by a manufacturer, a manufacturer's co-licensed partner, or a repackager.
d. Intracompany distribution of a prescription drug, including pharmacy chain distribution centers.
e. Distribution at wholesale of a combination product as defined by the United States Food and Drug Administration, medical convenience kit, intravenous fluid or electrolyte, dialysis solution, radioactive drug, or irrigation or sterile water solution to be dispensed by prescription only.
f. Distribution of a dialysis solution by the manufacturer or the manufacturer's agent to a patient pursuant to a prescription drug order, provided that a licensed pharmacy processes the prescription drug order.

A limited distributor license is optional for the following distributions in or into Iowa:
a. Distribution of nonprescription drugs or devices with or without a patient-specific prescription.
b. Distribution of medical devices exclusively to a health care practitioner for use in the normal course of professional practice ("professional use").
c. Distribution of blood and blood products that are not subject to the federal Drug Supply Chain Security Act (DSCSA).

Iowa Regulations

657 Iowa Administrative Code Chapter 42 governs the practice of limited drug and device distribution in or into the state of Iowa.

Have you reviewed and do you understand the Iowa regulations pertaining to limited distributors?

Yes

Required Documents

The following documents to be uploaded with your application:

1.Most Recent Self-Inspection Report (Iowa Self-Inspection Template)

2.The Facility Manager’s Government-Issued Photo Identification

3.The Facility Manager’s Resume

Additional Documents

The following documents may be required to be uploaded with your application:

1.Home State License Verification

2.DEA Certificate

3.Proof of Accreditations

4.FDA 483s, Warning Letters, and Responses

5.FDA Inspection Reports

6.Home State or other Third Party Inspection Report

7.Documentation of the conviction(s) for any criminal history not previously provided to the Board

8.Documentation of the final disciplinary order(s) for any disciplinary history not previously provided to the Board

9.Documentation of the final denial order(s) by a licensing authority not previously provided to the Board

Facility

Has your facility ever been licensed with the Iowa Board of Pharmacy, in any capacity, at the facility’s current physical location?

Yes

Business name

Street Address

C S Z

License #

License Sub-Type Identification

Please select the license sub-type which most accurately describes the majority of your business practice. (Must select one)

Business Information

Business Name (dba)

Legal Name

FEIN

NABP E-Profile

If you do not have an NABP e-profile number, you may create one by clicking here

Type of Ownership

State of Incorporation or Governance

Date Established

Physical Address

Address Line 1

Address Line 2

Address Line 3

Country

Zip

City

State

County

Home State License Verification (only if located outside the state of Iowa)

If your home state does not require you to be licensed, please attach a document indicating a license is not required

Mailing Address

Check if mailing address is the same as physical address.

Address Line 1

Address Line 2

Address Line 3

Country

Zip

City

State

County

Limited Distributor Contact Information

Note : The facility phone number must be a direct number to the proposed licensed facility

Phone Type

Facility Phone #

Accept Text Message

Yes

Phone Type

Alternate Phone # for Facility

Accept Text Message

Yes

E-mail

Fax #

Website

Ownership Information

Name of Legal Owner

Address of Legal Owner

Zip

City

State

Phone #

Fax #

E-mail

Type of Customers-Select all that Apply

Wholesale Distributors	Intracompany Distribution (e.g. Pharmacy Distribution Centers)	Hospitals	Pharmacies	Practitioners (Human)
Veterinarians	Patients (pursuant to prescription orders)	Patients (without prescription order)	Other

Hours of Operation

* (Open and Close times for each day must be completed or “Closed” check box must be marked)

If facility is not open on any day, check the “Closed” box. If facility is open any day, record the times the facility opens and closes by entering the hour:minute and indicating ‘am’ or ‘pm’.

1.Sunday

Open

Closed

2.Monday

Open

Closed

3.Tuesday

Open

Closed

4.Wednesday

Open

Closed

5.Thursday

Open

Closed

6.Friday

Open

Closed

7.Saturday

Open

Closed

Registered Agent

In the event that legal documents or correspondences must be served, they will be served to your Registered Agent. Your Registered Agent must be physically located in Iowa.

Name

Address1

Address2

Address3

Zip

City

State

Controlled Substances

Do you distribute, dispense, manufacture, or prepare for administration any controlled substances in or into Iowa?

Yes

Controlled Substances Handled

Select the schedules of controlled substances you intend to handle in or into Iowa

Federal Drug Enforcement Administration (DEA)

Federal DEA Registration#

Federal DEA Registration Expiration Date

DEA Certificate

Self-Inspection

Limited Distributors are required to complete and submit a self-inspection on forms provided by the Board. The self-inspection form may be found here

Date of last self-inspection

Most Recent Self-Inspection Report

Inspection

Have you ever been inspected by a state licensing authority or other third-party?

Yes

Food and Drug Administration (FDA)

Has your facility been inspected by the FDA?

Yes

Food and Drug Administration (FDA)

Has your facility ever been issued an FDA Warning Letter?

Yes

Other State Licenses

Do you hold licenses in any other states?

Yes

Other State Licenses

Please identify all other state licenses:

State

Licensing Body

License number

License Status

License issue date

License expiration date

Other State License

Facility Manager

Provide full legal name

First name

Middle name

Last name

Other names used

Address1

Address2

Address3

Zip

City

State

Social Security #

Date of Birth

Phone Type

Phone Number

Accept Text Message

Yes

Phone Type

Alternate Phone Number

Accept Text Message

Yes

E-mail

Government Issued Identification

Facility Manager Attestation

As Facility Manager, I, First Name Last Name, attest that I have adequate experience in prescription drug and device distribution, manufacturing, and dispensing, as applicable, and am actively involved in the daily operation of the limited distribution facility. I have and will maintain a functional understanding of federal and state laws, rules, and regulations pertaining to drug and device distribution, manufacturing, and dispensing, as applicable.

I hereby swear or affirm that I, First Name Last Name, have no felony convictions or convictions related to prescription drug and device distribution including distribution of controlled substances.

Signature

Facility Manager Resume

Criminal History

Has the limited distributor, any owner, or Facility Manager been convicted of or entered a plea of guilty, nolo contendere, or no contest to any crime related to prescription drugs, controlled substances, healthcare, or the practice of pharmacy in any jurisdiction? You must include all misdemeanors and felonies, even if adjudication was withheld by the court so that you would not have a record of conviction.

Yes

All convictions, except for minor traffic offenses, must be disclosed. Conviction means a finding, plea, or verdict of guilt made or returned in a criminal proceeding, even if the adjudication of guilt is deferred, withheld, or not entered. Conviction includes Alford pleas and pleas of nolo contendere. You must submit the complaint and judgment of conviction for each offense and a personal statement regarding whether each conviction directly relates to the practice of the profession. Your application will not be considered complete until the entirety of this information is received by the Board.

Disciplinary Actions

Has the Limited Distributor, any owner, or Facility Manager been disciplined by any licensing authority? Discipline includes, but is not limited to, citations, reprimands, fines, and license/registration restrictions, probation, suspension, revocation or surrender.

IBOP Discipline

Yes

Discipline – Not Iowa / Outside Iowa

Yes

License Denials

Has the Limited Distributor ever been denied a license or registration by any licensing authority?

Yes

Pending Investigations

Do you have any knowledge of any investigations, complaints, or charges pending before any licensing authority?

Yes

Preview

Confirm and Submit

I hereby swear or affirm under the penalty of perjury that the information provided in this application is true and correct. I understand that failure to provide complete and truthful information may constitute grounds for denial, revocation, or other disciplinary sanctions against my license.

Signature

Title

Date

Please note that after you click the Submit button, you cannot make changes to your application.

License/Registration Type

State Licensing Body

License/Registration number

License/Registration Status

License/Registration issue date

License/Registration expire date

Proof of Accreditations

Manufacture (not virtual)	Repackage	Brokerage of Sales
Virtual Manufacture	Medical Gas Distribution	Durable Medical Equipment Supply
Medical Device Distribution to Patients	Veterinary Drug Distribution	Intracompany Distribution
Active Pharmaceutical Ingredient (API) Distribution	Other DSCSA-Exempt Wholesale Distribution of Human Prescription Drugs	Non-prescription Drug Distribution
Non-prescription Device Distribution	Medical Device Distribution Exclusively to Health Care Practitioner for Professional Use	Blood and Blood Product Distribution (DSCSA-Exempt)
Returns Processor	Other

Human Prescription Drugs	Human Controlled Substances	Human Nonprescription Drugs
Veterinary-Companion Animal Prescription Drugs	Veterinary-Companion Animal Nonprescription Drugs	Veterinary-Companion Animal Controlled Substances
Veterinary-Food Producing Animal Prescription Drugs	Veterinary-Food Producing Animal Nonprescription Drugs	Veterinary-Food Producing Animal Controlled Substances
Active Pharmaceutical Ingredients	Patient Use Prescription Medical Devices	Professional Use Prescription Medical Devices
Non-prescription Medical Devices	Prescription Combination Products Medical Convenience Kits IV Fluids/electrolyte Radioactive drugs Irrigation/sterile Water Solution	Dialysis Solution
Blood and/or Blood Products	Medical Gases	Other

VAWD	Board-Approved Waiver of VAWD	DMEPOS	CHAP	ACHC
Joint Commission	Other	None