WHOLESALE DISTRIBUTOR APPLICATION INSTRUCTIONS

1 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 , 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.

2 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.

3 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.

4 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 .

5 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 .

6 NOTE: The APPLICATION fee is a non-refundable administrative fee. APPLICATION FEE New APPLICATION Name Change Renewal Relocation CSA Registration Fee $ Fee $ Fee $ Fee $ Fee $ BACKGROUND CHECK FEE (NEW APPLICANTS ONLY) $ PENALTY FEE (AMOUNTS IN ADDITION TO THE APPLICATION FEE) After January 1: $ After February 1: $ After March 1: $ After April 1: $ 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)

7 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.

8 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 5 Rev: 09/12/2017 C.

9 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.

10 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.