Businesses and Facilities

NEW Distributor, 3PL, and Outsourcing Requirements

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New Frequently Asked Questions updated 4-7-2020

Surety Bond forms are now available on our Forms Page - S-340 ($25,000) and S-345 ($100,000). These forms are available but use is not required.
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Wholesale Distributors:
During the 2020 renewal period (May 4 – June 30, 2020), wholesale distributors will be required to do the following to remain registered in Kansas:
  • Provide a surety bond that meets the requirements of 21 U.S.C. 360eee.

  • Provide a list of all manufacturers, wholesale distributors, third-party logistics providers, outsourcing facilities, and dispensers with which the registrant is transacting business.

  • For non-resident facilities, provide an inspection report conducted at the current physical location within the previous 36-month period (after July 1, 2017) by the resident state Board of Pharmacy or the National Association of Boards of Pharmacy. Self-inspection reports will not be accepted.

Third-Party Logistics Providers:
Kansas law now requires each third-party logistics provider be properly registered in Kansas, provide the Board with proof of a satisfactory inspection conducted by the resident state or NABP, and designate a representative located at the facility responsible for compliance with Kansas law. The Board has granted a waiver through June 30, 2020 to afford facilities currently registered in other categories sufficient time to comply and minimize any economic impact on facility operations. The regulations also create a separate category for non-prescription drug/device third-party logistics providers.

On or before June 30, 2020, 3PLs are required to submit a BA-23 3PL Application Form and fee to the Board. 3PLs that only ship non-prescription drugs/devices should submit a BA-25 Application Form.
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To transfer an existing distributor registration to a 3PL registration, check the “New Application” box and include your current wholesale distributor registration number under the “Change” section. Do not renew the distributor registration online.
    - If the facility wants to add a 3PL registration, check the “New Application” box on the application and renew existing registrations online from May 4 – June 30, 2020.

Outsourcing Facilities:
Kansas law now requires each outsourcing facility be properly registered in Kansas, provide the Board with proof of satisfactory inspections conducted by the resident state and the FDA, and designate a Kansas-licensed pharmacist-in-charge (PIC). The Board has granted a waiver through June 30, 2020 to afford facilities currently registered in other categories sufficient time to comply and minimize any economic impact on facility operations. On or before June 30, 2020, facilities are required to submit a BA-20 Outsourcing Facility Application and fee to the Board.

NOTE: Due to the COVID-19 pandemic, waivers may be requested for PIC and inspection requirements in conjunction with initial and renewal applications made on or before June 30, 2020. Requests will be evaluated by the Board on a case-by-case basis and must demonstrate good cause.

NOTEIf the facility needs to remain registered in another category (i.e., pharmacy, non-resident pharmacy, wholesale distributor, etc.), the facility will also need to renew the existing registration prior to June 30, 2020. If the facility does not need to maintain other registrations, allow the registration to expire with no action.

Non-Resident Pharmacy Requirements

Kansas law now requires each registered non-resident pharmacy to provide the Board with proof of a satisfactory inspection of the pharmacy conducted within the previous 18-month period and designate a Kansas-licensed pharmacist-in-charge (PIC).

Frequently Asked Questions

Does the pharmacist in charge need be licensed in Kansas?
Yes, all non-resident pharmacies must designate a Kansas-licensed PIC for the facility. This does not need to be the same pharmacist that is designated as the PIC for the home state registration.

When does the pharmacy need to be in compliance?
Any currently registered non-resident pharmacy must have a Kansas licensed pharmacist designated at the time of submitting the 2018 renewal (May – June 2018). When the pharmacy renews, they must provide a Kansas license number for their current PIC or change the PIC to a Kansas licensed pharmacist using the BA-50 form. They will also need to provide an inspection report completed within the past 18 months. Instructions for renewals will be sent out prior to the renewal portal opening.

Can a pharmacist be PIC at more than one location?
A pharmacist can only be a PIC at one full-time location. Full-time is defined as having 30 hours or more per week.

We have a pharmacist/PIC who is already licensed in Kansas. What do they need to do?
If your PIC was licensed in Kansas more than two years ago and has never served as PIC at a facility located in Kansas, they will need to take and pass our PIC exam. You can request a PIC exam by emailing pharmacy@ks.gov. Please provide the facility number and the PIC’s name and Kansas license number. 

Inspection Forms