1 Rev: 09/12/2017

WHOLESALE DISTRIBUTOR APPLICATION INSTRUCTIONS

• Complete the attached Iowa Board of Pharmacy's Application for Wholesale Distributor License. Be sure to check the box for the relevant application type (New, Renewal, Name Change, or Relocation).

NOTE: Every wholesaler as defined in rule 657—17.1, wherever located, that engages in wholesale distribution into, out of, or within this state must be licensed by the board before engaging in wholesale distribution of prescription drugs. Where operations are conducted at more than one location by a single wholesaler, each such location shall be separately licensed in Iowa. A Third-Party Logistics Provider is not eligible for a wholesale distributor license and is currently not required to be licensed in Iowa.

EFFECTIVE January 1, 2018, EVERY wholesaler, regardless of location, engaged in the distribution of controlled substances in Iowa is required to have a Controlled Substance Act (CSA) registration. If you do not currently have a CSA registration, you must apply for one by checking the box in section 2C and including an additional $90 non-refundable CSA registration application fee.

• Submit the completed application, including the Application Checklist, all attachments, and a check made payable to the Iowa Board of Pharmacy in the appropriate amount to: Iowa Board of Pharmacy, 400 SW 8th St, Ste E, Des Moines, IA 50309

FOR IN-STATE APPLICANTS: If a new wholesale distribution location was not a licensed wholesale distribution location immediately prior to the proposed opening of the new wholesale facility, the location shall require an on-site inspection by a Board compliance officer prior to the issuance of the wholesale distributor license. The purpose of the inspection is to determine compliance with requirements pertaining to space, equipment, drug storage safeguards, and security. The inspection may be scheduled anytime following submission of necessary license and registration applications and prior to beginning wholesale distribution. Prescription drugs, including controlled substances, may not be delivered to a new wholesale distribution facility prior to satisfactory completion of the opening inspection. An application for a wholesale distributor license will become null and void if the applicant fails to complete the licensure process within 6 months of submission of a completed application. The licensure process shall be complete upon the wholesaler’s opening for business at the licensed location following a satisfactory inspection by a Board compliance officer. When an applicant fails to timely complete the licensure process, any fees submitted with the application are forfeited and will not be transferred or refunded. FOR ALL APPLICANTS: An incomplete application for a wholesale distributor license will only be maintained for a maximum period of 6 months. Failure to submit all required information within 6 months of submission of the original application will result in the application becoming null and void and any fees submitted with the application are forfeited and will not be transferred or refunded. FOR NEW APPLICANTS ONLY: Once a completed application is received, a fingerprint packet will be sent to the mailing address indicated on the application. The fingerprint packet is to be completed by the facility manager and returned to the Board for processing.

2 Rev: 09/12/2017

NOTE: Proof of a surety bond or other security of equal value must be submitted by all applicants who are engaged, or intend to engage, in wholesale distribution as defined by the federal Drug Supply Chain Security Act. The bond shall be in the amount of $100,000, unless the applicant’s annual gross receipts from the tax previous year are less than $10,000,000, in which case the bond shall be in the amount of $25,000. The applicant shall possess the bond in the state in which it is physically located.

NOTE: Please allow four to six weeks for the Board to process your completed application.

NOTE: The application fee is a non-refundable administrative fee.

APPLICATION FEE

New Application

Name Change

Renewal

Relocation

CSA Registration

Fee $270.00 Fee $270.00 Fee $270.00 Fee $270.00 Fee $90.00

BACKGROUND CHECK FEE (NEW APPLICANTS ONLY)

$45.00

PENALTY FEE (AMOUNTS IN ADDITION TO THE APPLICATION FEE)

After January 1: $270.00

After February 1: $360.00

After March 1: $450.00

After April 1: $540.00

3 Rev: 09/12/2017

APPLICATION CHECKLIST

Application Fee ($270) ☐YES ☐NO ☐N/A

CSA Registration Fee ($90) ☐YES ☐NO ☐N/A

Background Check Fee ($45) ☐YES ☐NO ☐N/A

Late Fee ($270-$540) ☐YES ☐NO ☐N/A

Most Recent Inspection Report ☐YES ☐NO ☐N/A

Proof of Accreditations ☐YES ☐NO ☐N/A

Copy of DEA Certificate ☐YES ☐NO ☐N/A

Copy of License/Permit from State of Residence ☐YES ☐NO ☐N/A

Copy of Lease or Deed ☐YES ☐NO ☐N/A

Ownership Information (Section 4) ☐YES ☐NO ☐N/A

Surety Bond (or other similar security) ☐YES ☐NO ☐N/A

Proof of Annual Gross Receipts (if claiming $25,000 bond) ☐YES ☐NO ☐N/A

List of Products Distributed (do not send catalogs) ☐YES ☐NO ☐N/A

List of Iowa Customers ☐YES ☐NO ☐N/A

List of each criminal conviction and court records of the conviction(s) (Section 5)

☐YES ☐NO ☐N/A

List of disciplinary actions by any licensing authority and documentation of final disciplinary orders (Section 6)

☐YES ☐NO ☐N/A

List of final denial orders by any licensing authority and documentation of final denial orders (Section 6)

☐YES ☐NO ☐N/A

Attachment 1 – Facility Manager ☐YES ☐NO ☐N/A

Facility Manager’s Resume ☐YES ☐NO ☐N/A

List of disciplinary actions taken against any professional or business license and documentation of final disciplinary orders

☐YES ☐NO ☐N/A

Explanation and documentation of violation(s) of any federal or state law pertaining to the possession, control, or distribution of prescription drugs

☐YES ☐NO ☐N/A

List of each criminal conviction and court records of the conviction(s), and any pending criminal charges

☐YES ☐NO ☐N/A

4 Rev: 09/12/2017

APPLICATION FOR WHOLESALE DISTRIBUTOR LICENSE

Please type or print legibly in ink.

Complete all application sections and sign. Incomplete or illegible forms will delay the issuance of your license.

1. APPLICANT INFORMATION

A. Name of Applicant: (name in which company is doing business)

Iowa License Number (if applicable):

B. Facility Address (physical location of establishment which should be reflected on all sales invoices and shipping documents):

Street Address: Suite #:

City: State: Zip Code:

Telephone #: Fax #:

Web Site: Email Address:

Federal Tax ID #:

Mailing Address (where all correspondence regarding licensure will be sent if other than facility address):

Street Address: Suite #:

City: State: Zip Code:

Emergency Contact Phone at Licensed Facility:

BOARD USE ONLY Received: Paid: Approved/Processed:

Date:

Staff Initials:

Iowa Board of Pharmacy 400 SW 8th St Ste E

Des Moines, IA 50309 515-281-5944

https://pharmacy.iowa.gov/

5 Rev: 09/12/2017

C. Type of Business (check all that apply):

Sole Proprietorship Partnership C Corporation

S Corporation LLC Other (please explain):

Date Established:

D. Legal Name (if different from Applicant Name):

State of Incorporation:

E. Parent Companies

(include any and all companies that have direct or indirect control over the applicant)

F. Registered Agent:

Name: Title:

Street Address: Suite #:

City: State: Zip Code:

Telephone #: Fax #:

2. FACILITY INFORMATION

A. Date of last inspection by a state agency, accreditation program, or FDA: (attach most recent inspection report)

B. Accreditations held (attach proof of accreditation, as applicable):

VAWD ACHC

CHAP Joint Commission

6 Rev: 09/12/2017

C. DEA Registration #: (attach copy of registration certificate)

Expiration Date:

FDA #

(if applicable)

Expiration Date:

IA CSA Registration #

(if applicable)

Expiration Date:

New CSA Registration (check box if you wish to apply)

$90 Registration Fee included

PROPOSED DISTRIBUTION Check schedules of controlled substances that you intend to distribute in Iowa.

Schedule II Narcotic Schedule III Narcotic

Schedule II Nonnarcotic Schedule III Nonnarcotic

Schedule V Schedule IV

D. Facility ownership description (attach copy of lease or deed)

OWN RENT

1. Number of years in current facility:

2. Name of Lessor (if applicable):

E. Facility physical description

1. Square footage:

2. Description of security and alarm systems:

3. Description of temperature and humidity control monitoring:

7 Rev: 09/12/2017

F. State and Federal permit/license/registration numbers (attach additional pages if necessary): (Out-of-state applicants: Include a copy of the permit/license/registration issued by your state of residence)

LICENSING BODY PERMIT / LICENSE / REGISTRATION NUMBER

EXPIRATION DATE

3. OPERATIONS

A. Hours of Operation

Sunday Thursday

Monday Friday

Tuesday Saturday

Wednesday

B. Facility Type

Wholesale Distribution Only Durable Medical Equipment Supplier

Manufacturer Medical Gas Distributor

Repackager Distribution Center

Reverse Distributor Chain Pharmacy Distribution Center

Other (describe):

C. Products distributed (check all applicable boxes) (please send a list of the products distributed--do not send catalogs):

Drugs Devices

Prescription

Non-prescription

Controlled Substances

Prescription/Patient Use

Prescription/Professional Use

OTC

Medical Gases

8 Rev: 09/12/2017

D. Import Activities (list all countries of import for facility listed on application):

If you import controlled substances, please attach DEA Form 357.

E. Customers (attach a list of Iowa customers)

Other Wholesalers Practitioners

Hospitals Patients/End Users

Pharmacies Other:

4. OWNERSHIP

Please include the following on a separate sheet:

1. Full name, title, date of birth, and business address for owner, sole proprietor, each partner, and/or each corporate director or officer;

2. Full name, title, date of birth, and business address for each manager of a LLC;

3. Full name, title, date of birth and business address for each shareholder owning 10% or more of the shares for a non-publicly traded corporation; or

4. Corporate name for a publicly traded corporation.

5. CRIMINAL HISTORY

A. Have any of the applicant(s) and/or facility manager ever been convicted of, or entered a plea of guilty, nolo contendere, or no contest to a crime other than a minor traffic offense, 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. (For example, you must report if your conviction was expunged, you received a deferred judgment, or you received an executive pardon.)

YES NO

B. Include a separate sheet of paper providing a signed and dated explanation of each conviction and attach court records of the conviction(s).

Attachment included: YES NO

9 Rev: 09/12/2017

6. DISCIPLINARY ACTIONS

A. Have the applicant, or any owner, officer, partner, or facility manager ever 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.

YES NO

B. Include a separate sheet listing all disciplinary actions by any licensing authority and include documentation of any final disciplinary orders.

Attachment included: YES NO

C. Has the applicant ever been denied a license by any licensing authority? YES NO

D. Include a separate sheet listing all final denial orders by any licensing authority and include documentation of any final denial orders.

Attachment included: YES NO

7. SURETY BOND Required only for wholesale distributors as defined by the federal Drug Supply Chain Security Act.

Is a surety bond or other equivalent means of security attached? YES NO N/A

Annual gross receipts in Iowa for previous tax year are less than $10,000,000

(please attach appropriate documentation)

Annual gross receipts in Iowa for previous tax year are $10,000,000 or more

8. Facility Manager

Please complete and attach Attachment 1 – Facility Manager

10 Rev: 09/12/2017

9. SIGNATURE (Notarization Required)

I hereby swear under 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 ground for denial, revocation, or other disciplinary sanctions against my license.

Signature of Applicant:

Business Telephone #: Business Fax #:

Name and Title:

10. NOTARY

State of: County of:

I certify that on the date set forth below, the individual named above did appear physically before me and that I did identify this applicant by: (a) comparing his/her appearance with the photograph on the identifying document presented by the applicant and with the photograph affixed hereto, and (b) comparing the applicant’s signature made in my presence on this form with the signature on his/her identifying document.

The statements on this document are subscribed and sworn to before me by the applicant on this day of , 20 .

Notary Public Signature:

My Notary Commission Expires

Notary Stamp or Seal

11 Rev: 09/12/2017

APPLICATION FOR WHOLESALE DISTRIBUTOR LICENSE

FACILITY MANAGER Attachment 1

I certify that this is a photograph of me taken within the previous 180 days of submitting this application.

Signature:

1. IDENTIFICATION First Name: Middle / Maiden Name: Last Name: Street Address:

City: State: Zip:

Work Phone: Date of Birth: Place of Birth: Email Address:

2. PLACES OF RESIDENCE Complete the following table with your places of residence for the previous seven (7) years. Attach additional pages if necessary.

Dates(s) Address City, State, Zip

Place a recent photograph in this space

Attach a photograph showing your face, with a three quarter view. The photograph must be recent and in good condition.

• Please type or print legibly in ink.

• Complete all application sections and sign. Incomplete forms will delay the issuance of your license.

12 Rev: 09/12/2017

3. EMPLOYMENT INFORMATION Complete the following table with your places of employment for the previous seven (7) years. Attach a resume.

Employer Name Job Title Date of Hire End Date Address City, State, Zip

4. PERSONAL ATTESTATION QUESTIONS

Initial each statement to indicate your understanding and agreement to abide by applicable federal and state laws governing wholesale distribution:

____ I have been employed full-time for at least 3 years in a position related to prescription drug distribution.

____ I am employed by the applicant full-time in a managerial level position.

____ I am actively involved in, and aware of, the daily operation of the wholesale distributor.

____ I am physically present, except for an authorized absence such as sick or vacation leave, at the facility of the applicant during regular business hours.

____

I do not have any convictions for a violation of any federal, state or local laws relating to wholesale or retail prescription drug distribution or distribution of controlled substances.

____ I do not have any felony convictions under federal, state, or local laws.

____ I have knowledge and understanding of the federal Drug Supply Chain Security Act.

____

I have knowledge and understanding of Iowa laws and rules pertaining to wholesale distribution, including Iowa Code chapters 124, 126, and 155A, and the Board rules found in 657-Chapters 10, 17, and 36.

13 Rev: 09/12/2017

5. ADDITIONAL QUESTIONS

If you answer “YES” to any question, please provide a detailed explanation (attach additional pages if necessary) and supporting documentation. Failure to provide complete and correct information may result in delay, or denial, of your wholesale distributer application.

1. Have you had disciplinary action taken against any professional or business license you have held?

If yes, provide an explanation and copies of any final disciplinary orders.

YES NO

2. Have you been enjoined, either temporarily or permanently, by a court of competent jurisdiction for violating any federal or state law regulating the possession, control, or distribution of prescription drugs?

If yes, provide the details and any documentation regarding the event.

YES NO

3. Have you ever been convicted of, or entered a plea of guilty, nolo contendere, or no contest to a crime other than a minor traffic offense, 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. (For example, you must report if your conviction was expunged, you received a deferred judgment, or you received an executive pardon.)

If yes, list each criminal conviction and provide court records of the conviction(s).

YES NO

4. Do you have any pending criminal charges?

If yes, provide an explanation and copies of any pending charges.

YES NO

** Nolo contendere- A plea in a criminal case which has a similar legal effect as pleading guilty. The defendant does not admit or deny the charges, but a fine or sentence may be imposed based on this plea.

14 Rev: 09/12/2017

SIGNATURE: Facility Manager (Notarization Required)

By signing this application, I solemnly affirm under the penalties of perjury that the contents of this section of the application are true to the best of my knowledge, information, and belief. I understand that the Iowa wholesale distributor license issued pursuant to this application may be revoked if any assertion made in this application is found to be false.

Name:

Date of Birth: (must be minimum 21 y/o)

Place of Birth:

Telephone #: Fax #:

Signature:

Date:

NOTARY:

State of: County of:

I certify that on the date set forth below, the individual named above did appear physically before me and that I did identify this applicant by: (a) comparing his/her appearance with the photograph on the identifying document presented by the applicant and with the photograph affixed hereto, and (b) comparing the applicant’s signature made in my presence on this form with the signature on his/her identifying document.

The statements on this document are subscribed and sworn to before me by the applicant on this day of , 20 .

Notary Public Signature:

My Notary Commission Expires

Notary Stamp or Seal