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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, Name Change, Facility Manger, Ownership or Relocation).

NOTE: Every wholesaler as defined in rule 657—17.1, wherever located, that engages in wholesale distribution of human drugs into, out of, or within this state must be licensed by the board before engaging in wholesale distribution of human 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.

EFFECTIVE January 1, 2018, E V E R Y 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 and are engaged in wholesale distribution of controlled substances in or into Iowa, 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 instruction check lists, all attachments, and a check in the appropriate amount made payable to the Iowa Board of Pharmacy to:

Iowa Board of Pharmacy, 400 S.W. 8th

St., Ste. E, Des Moines, IA 50309-4688

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.

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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 ($750.00)

New Application

Name Change

Relocation

Facility Manager

Ownership

CSA REGISTRATION FEE

$90.00

BACKGROUND CHECK FEE (NEW FACILITY MANAGERS ONLY)

$45.00

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APPLICATION CHECKLIST

Most Recent Inspection Report ☐YES ☐NO

Proof of Accreditations (Beginning January 1, 2020, VAWD accreditation will be required of all wholesale distributors.)

☐YES ☐NO

Copy of DEA Certificate ☐YES ☐NO

Copy of License/Permit from State of Residence if outside Iowa ☐YES ☐NO

Surety Bond (or other similar security) ☐YES ☐NO

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

List of each criminal conviction and court records of the conviction(s) not previously reported to the Board

☐YES ☐NO

List of disciplinary actions by any licensing authority and documentation of

final disciplinary orders not previously reported to the Board ☐YES ☐NO

List of final denial orders by any licensing authority and documentation of

final denial orders not previously reported to the Board ☐YES ☐NO

Addendum 1 – Facility Manager ☐YES ☐NO

Facility Manager’s Resume ☐YES ☐NO

List of disciplinary actions taken against any professional or business

license not previously reported to the Board and documentation of final disciplinary orders

☐YES ☐NO

Explanation and documentation of violation(s) of any federal or state law

pertaining to the possession, control, or distribution of prescription drugs not previously reported to the Board

☐YES ☐NO

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

any pending criminal charges not previously reported to the Board ☐YES ☐NO

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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. Facility Type:

Wholesale Distribution – Human Drugs Reverse Distributor

If your business type does not fall into one of these two types this is not the correct application.

2. APPLICANT INFORMATION

A. Name of Applicant:

(name in which company is doing

business)

Legal Name

Federal Tax ID#:

NABP e-Profile ID

Iowa License Number:

Facility Manger:

B. Facility Address (physical location of establishment which should be reflected on all sales

invoices and shipping documents):

Street Address: Suite #:

Address

City: State: Zip Code:

Telephone #: Fax #:

Email Address:

Website:

Emergency Contact Phone at Licensed Facility:

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C. Mailing Address (where all correspondence regarding licensure will be sent if other than

facility address):

Street Address: Suite #:

Address:

City: State: Zip Code:

D. Wholesale Distributor Ownership

Owner Name:

Owner Address:

Owner Phone Number: Email:

Type of Ownership (check all that apply):

Sole Proprietorship Partnership C Corporation

S Corporation LLC Government

Date Established:

State of Incorporation:

3. OPERATIONS

A. Hours of Operation:

Sunday Monday

Tuesday Wednesday

Thursday Friday

Saturday

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

VAWD ACHC CHAP Joint Commission

Effective January 1, 2020, VAWD accreditation will be required of all wholesale distributors

C. Customers:

Other Wholesalers Practitioners

Hospitals Patients/End Users

Pharmacies Other:

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D. Products distributed: (check all applicable boxes) Drugs:

Human Prescription Drugs Human Nonprescription Drugs

Human Controlled Substances 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

Devices:

Prescription/Patient Use Devices Prescription/Professional Use Devices

Nonprescription Devices

Medical Gases Other:

E. Iowa Resident Wholesalers Only Import Activities: (list all countries of import for the facility listed on the application):

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

G. 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

4. INSPECTION INFORMATION

Most Recent Inspection Performed by:

Date of Most Recent Inspection:

Since your last application, has the facility been inspected by the FDA: ☐Yes ☐No If yes, date of most recent FDA inspection:

Since your last application, has the FDA issued a 483 or a Warning Letter: (attach the FDA’s documentation and your response to the FDA)

☐Yes ☐No

Are you registered with the FDA as a 503(b) outsourcing facility? ☐Yes ☐No

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5. CONTROLLED SUBSTANCES

DEA Registration #:

Expiration Date:

FDA # : Expiration Date:

IA CSA Registration #: 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 II Nonnarcotic

Schedule III Narcotic Schedule III Nonnarcotic

Schedule IV Schedule V

RESPONSIBLE INDIVIDUAL: (Whose signature is authorized on Federal Controlled Substances Order

Form 222 or CSOS)

Name: Title:

6. CRIMINAL HISTORY (new applicants must provide a complete history)

A. Since the last application have any of the applicant(s), owners and/or facility manager 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 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

7. DISCIPLINARY ACTIONS (new applicants must disclose all disciplinary actions

described below)

A. Since the last application has the applicant, or any owner, officer, partner, 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.

YES NO

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

Attachment included: YES NO

C. Since the last renewal, has the applicant been denied a license by any licensing authority?

YES NO

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

Attachment included: YES NO

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

YES NO F. Include an explanation for any pending investigations, complaints, or charges.

Attachment included: YES NO

8. SURETY BOND- 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 in Iowa from the previous tax year are less than $10,000,000, in which case the bond shall be in the amount of $25,000.

Is a surety bond or other equivalent means of security attached? ☐YES ☐NO

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

9. Registered Agent (Registered Agents must be registered with the Iowa Secretary of State)

Name: Title:

Street Address: Suite #:

City: State: Zip Code:

Telephone #: Fax #:

10. SIGNATURE

I hereby swear or affirm 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:

Date:

Name and Title:

Business Telephone #: Business Fax

#:

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APPLICATION FOR WHOLESALE DISTRIBUTOR LICENSE

FACILITY MANAGER

Addendum 1

Please type or print legibly in ink.

Complete all application sections and sign.

Incomplete forms will delay the issuance of

your license.

Facility Name:

Iowa License No.:

1. IDENTIFICATION

First Name:

Middle Name: Maiden Name:

Last Name:

Street Address:

City: State: Zip:

Work Phone:

Email Address: Social Security No.:

Date of Birth: Place of Birth:

2. PLACES OF RESIDENCE

Complete the following table with your places of residence for the previous seven (7) years.

Attach additional pages if necessary.

Date(s) Address City, State, Zip

Place a recent photograph in this

space

Attach a clear color photograph of

yourself. The photograph must be

recent and in good condition.

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3. EMPLOYMENT INFORMATION

Complete the following table with your places of employment for the previous seven (7) years.

Attach a resume.

1. Employer Name Address City, State, Zip

Job Title Date of Hire End Date

2. Employer Name Address City, State, Zip

Job Title Date of Hire End Date

3. Employer Name Address City, State, Zip

Job Title Date of Hire End Date

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.

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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-IAC Chapters 10, 17, and 36.

If you are not able to attest to all of the statements provide an explanation on a separate page.

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 distributor 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 receive 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.

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SIGNATURE: Facility Manager

By signing this application, I solemnly swear or affirm under the penalty 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.

Printed Name:

Signature:

Date: