Kansas Board of Pharmacy
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Applications are available for all facility types on the Forms page.
Applications are processed on a first-come, first-serve basis and are only considered for approval when marked complete by licensing staff (all fees and application documents have been received). Pre-opening inspections are only scheduled after the application is complete.
The Board has published additional guidance for facility applicants: Guidance for Facility Applications
Copies of blank Board inspection forms can be found on the Forms page.
Blank inspection forms are provided for general guidance to assist facilities in ensuring compliance with Board requirements. They are not intended to be an exhaustive list of all items that can or will be reviewed during a Board inspection.
The Board does not accept self-inspections.
Non-Resident Facilities
Kansas law 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.
All other non-resident facilities are required to provide the Board with proof of a satisfactory inspection within the previous 36-month period.
The Board has adopted Guidance for Nonresident Inspection Types
Completed Board Inspections
Kansas facilities can access completed inspection reports through the eLicense Renewal Portal.
2024 Pharmacy and Facility Renewals
Pharmacy and other facility permits are eligible for renewal from mid-May through June 30, 2024. Use the eLicense portal to renew each permit through an automated process and pay using the secure portal.
- Manufacturers (4-) and Outsourcing Facilities (20-) should allow 15 business days for Board review and approval. Once approved, the facility can log back in and print/download a copy of the renewed permit.
- All other facilities may immediately print the 2024-2025 renewal permit. If additional copies are needed, the facility can log back in and print/download a copy of the renewed permit.
- Self-inspections are for personal use unless specifically requested by the Board. As of January 1, 2023, self-inspections are no longer accepted with initial and renewal applications.
The Board has also published Guidance for Facility Renewals without Inspections
Frequently Asked Questions
Continuous Quality Improvement (CQI)
CQI meetings must be held quarterly (every 90 days).
- K.A.R. 68-19-1
- Date of meeting
- Who attended
- Review and list all incident reports generated since last quarterly meeting
- What progressive preventative steps will be implemented to prevent future errors
- List of Board newsletter(s) reviewed since last CQI meeting
- Best practice is to utilize prescription numbers when identifying incident reports reviewed.
- CQI meeting reports must be made available to the Board for inspection.
K.S.A. 65-1695 and KAR 68-19-1
Any form may be used provided it includes all requirements of the statute and/or regulation. You may use the CQI Form provided by the Board and found under “Forms” on the Board website.
Incident Reports
A sample Incident Report Form can be found on the Board website. Its use is not required, and pharmacies may use their own forms provided the requirements of K.A.R. 68-7-12b are met.
There are six (6) reportable incidents.
- The patient receiving the wrong drug
- The patient receiving an incorrect drug strength
- The patient receiving an incorrect dosage form
- The drug being received by the wrong patient
- Inadequate or incorrect packaging, labeling, or directions
- The dispensing of a drug to a patient in a situation that results in or has the potential to result in serious harm to the patient
K.A.R. 68-7-12b(c)
Yes. All pharmacy employees involved in the incident must sign the report and document registration or license number.
- K.A.R. 68-7-12b(c)(6)
Five (5) years.
- K.A.R. 68-7-12b(c)
Inventory
- Yearly (no later than 375 days after the date of the previous inventory) and with Pharmacist in Charge (PIC) changes (outgoing and incoming PIC)
- All controlled substances and drugs of concern shall be inventoried on the same calendar date
- K.A.R. 68-20-16(b), K.A.R. 68-1-9(h)(2) & (3), and 21 C.F.R. 1304.11
- All on hand schedule II-V drugs and drugs of concern listed in K.A.R. 68-21-7.
- Each of the following shall be classified as a drug of concern:
- Any product containing all three of these drugs: butalbital, acetaminophen, and caffeine;
- any compound, mixture, or preparation that contains any detectable quantity of ephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;
- any compound, mixture, or preparation that contains any detectable quantity of pseudoephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;
- promethazine with codeine; and
- any product, compound, mixture, or preparation that contains gabapentin.
- Each of the following shall be classified as a drug of concern:
- Do not forget to count and document any out of date (expired) controlled substances on the inventory.
- For retail pharmacies: This inventory must include will call bins, outdated drugs, C-V OTC drugs, and non-automated LTCF e-kits.
- For medical care facilities: This inventory must include automated drug dispensing systems, crash carts, med carts, emergency rooms, operating rooms, etc.
- Each required inventory of schedule II controlled substances and nonliquid dosage forms of other controlled substances and drugs of concern shall be taken by exact count.
- K.A.R. 68-20-16, 21 C.F.R. 1304.04(h), and 21 C.F.R. 1304.11
- All on hand schedule II-V drugs and drugs of concern listed in K.A.R. 68-21-7.
- It shall be maintained in legible, hard-copy format
- It shall include the following:
- The date the inventory was conducted
- The name, license or registration number, and signature of each individual participating in the inventory
- Documentation of whether the inventory was taken before the opening of business or after the close of business. If pharmacy is open 24 hours, the time that the count was taken shall be documented.
- K.A.R. 68-20-16(e)
Licenses, Registrations, and Name Tags
Yes. They shall be conspicuously displayed in the place for which the registration or permit was granted.
- K.S.A. 65-1645(f)
Yes. The original license and renewal card of a pharmacist must be displayed in full view of the public at the pharmacist’s primary place of employment. The current registration card of a technician must be displayed in the area in which the technician works at their primary place of employment.
- K.S.A. 65-1641 and K.S.A. 65-1663(j)
May the pharmacy black out or cover the addresses of the technicians before posting the registrations?
Yes. The addresses may be covered so they are not visible to the public.
All pharmacists, interns, or technicians shall wear a visible nametag stating the wearer’s name and position while performing those functions. This applies to all pharmacy settings.
- K.A.R. 68-2-15
Whose responsibility is it to ensure posting of licenses, registrations, and the wearing of name tags?
Each pharmacist, intern, and technician is responsible for complying with the regulations regarding the posting of their license or registration and wearing their name tag.
- K.S.A. 65-1641, KSA 65-1676(h), K.A.R. 65-1663(j), and K.A.R. 68-2-15
Pharmacist-in-Charge (PIC)
K.A.R. 68-7-13 states “no pharmacist shall be a PIC of more than one full-time pharmacy which is defined as being one where the on-premises pharmacist services total 30 hours or more weekly.” A pharmacist could be a PIC at more than one pharmacy provided the required pharmacists’ services are less than 30 hours per week. A pharmacist may be a PIC at the same location where the facility has multiple registrations. For example, a pharmacist may be PIC at a non-resident pharmacy that is also applying for registration as an outsourcing facility.
The outgoing PIC must notify the Board no later than five (5) days after ceasing to be PIC. The notification must be made by either submitting section A of the PIC Change Form BA-50 to the Board office or completing the online PIC resignation option after logging into the pharmacist’s Board of Pharmacy eLicense account. The outgoing PIC must also inventory all controlled substances and drugs of concern, listed in K.A.R. 68-21-7(a) no more than two days prior to ceasing to be a PIC and no later than the day ceasing to serve as PIC.
- K.A.R. 68-2-5, K.A.R. 68-1-9
The PIC Change Form BA-50 may be mailed, emailed, or faxed to the Board office. Any mailed Form BA-50 must be postmarked no later than 5 days after the pharmacist’s last day as PIC.
If the outgoing PIC is unable to complete the final inventory or is terminated for a suspected or known violation of the Kansas pharmacy act, the pharmacy or facility owner shall request approval from the board to designate another pharmacist to conduct the inventory.
- K.A.R. 68-1-9(h)(4)
The pharmacy owner must obtain a new PIC with 30 days. If additional time is needed, the owner or authorized agent can complete section C of the PIC Change Form BA-50 and submit to the Board before the 30 days expires.
- K.A.R. 68-1-2a(c)(d)
- See K.A.R. 68-1-9 for responsibilities of ALL PICs
- For medical care facility specific responsibilities see K.A.R 68-7-11
- For a facility other than a medical care facility specific responsibilities see K.A.R 68-7-12
- Each pharmacist-in-charge shall be responsible for reviewing each published board newsletter and posting the newsletter in a conspicuous area within the pharmacy until publication of the next board newsletter.
- It needs to be posted in an area where the staff can read it. It does not need to be posted for the public to read.
- K.A.R. 68-1-9(g)
- It needs to be posted in an area where the staff can read it. It does not need to be posted for the public to read.
No. The PIC shall supervise the pharmacy on a full-time or part-time basis and shall be personally available to the extent required to ensure comprehensive pharmaceutical services within the pharmacy.
- K.S.A. 65-1626(xx) and K.A.R. 68-7-12(b)
- Yes, the designated representative and the PIC may be the same person. If the PIC is already licensed in Kansas for the non-resident pharmacy, no further action is required for that licensee. The background check process is already complete. Please let us know if you have additional questions.
- Yes, all pharmacies and outsourcing facilities must designate a Kansas-licensed PIC for the facility. The PIC does not need to be the same pharmacist that is designated as the PIC for the home state registration.
- If the PIC is already licensed in Kansas, all they must do is sign the application and provide their Kansas license information.
The incoming PIC shall take a beginning inventory of ALL controlled substances and drugs of concern no more than two days after beginning to serve as the PIC and submit the completed PIC Change Form BA-50 to the Board.
The inventory may be taken simultaneously with the previous PIC on the last day of the previous PIC if both pharmacists are present in the pharmacy, actively participating in the inventory, and sign the inventory.
- K.A.R. 68-1-9
Each prospective PIC shall, at the time of assuming these duties, sign an acknowledgment that states the pharmacist has reviewed the pharmacy act and board’s regulations and is aware of the responsibilities of a pharmacist-in-charge and provide this acknowledgement to the board within 30 days of assuming the duties of PIC.
- K.A.R. 68-1-2a(b)
Pharmacy Reporting
All controlled substance prescriptions in schedules II-IV plus five drugs of concern defined in K.A.R. 68-21-7 are required to be reported to K-TRACS. K.S.A. 65-1683 outlines the 16 data elements required to be reported for each prescription.
A “dispenser” is defined in K.S.A. 65-1682 as a “practitioner, pharmacy or pharmacist who delivers a scheduled substance or drug of concern to an ultimate user, but does not include:
- A licensed hospital pharmacy that distributes such substances for the purpose of inpatient hospital care;
- A medical care facility as defined in K.S.A. 65-425, and amendments thereto, practitioner or other authorized person who administers such a substance;
- A registered wholesale distributor of such substances;
- A veterinarian licensed by the Kansas board of veterinary examiners who dispenses or prescribes a scheduled substance or drug of concern; or
- A practitioner who has been exempted from the reporting requirements of this act in rules and regulations promulgated by the board.
An exemption request process is in place for dispensers who do not meet these requirements but also do not dispense controlled substances or drugs of concern in Kansas.
K.A.R. 68-21-7 defines drugs of concern as:
- Any product containing all three of these drugs: butalbital, acetaminophen and caffeine;
- Any compound, mixture or preparation that contains any detectable quantity of ephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors;
- Any compound, mixture or preparation that contains any detectable quantity of pseudoephedrine, its salts or optical isomers, or salts of optical isomers and is exempt from being reported to the statewide electronic logging system for the sale of methamphetamine precursors; Promethazine with codeine; and
- Any product, compound, mixture or preparation that contains gabapentin.
Yes, a zero report is required to be submitted by the end of the next business day following a day in which no dispensations occur.
I am trying to correct errors for my pharmacy but am unable to view the errors. How do I see the errors?
Only pharmacists-in-charge are permitted to correct errors within their K-TRACS account. If you are not a PIC, you will not be able to see the error list. If you are a PIC and are unable to see the errors for your pharmacy, contact K-TRACS to update your account information to receive the correct permissions.
Errors occur in prescriptions reported when missing or incorrect information is submitted. Pharmacists-in-charge (PICs) have access to correct errors by logging into their K-TRACS account, navigating to the Menu, then to Rx Management. Each prescription that contains errors is listed. Missing or incorrect information is highlighted within each prescription and can be corrected and re-submitted by the PIC.
Read: How to Correct Errors
No. A patient's physical address is required to be reported with the dispensation. PO boxes are not acceptable. You can obtain a patient's physical address from their driver's license, state ID or insurance card.
For veterinarians without NPI or DEA numbers, pharmacies should use the veterinarian's four-digit state license number in the state license number field. The DEA and NPI fields should be left blank.
For other types of prescribers without a DEA number, the NPI number should be used.
All controlled substance prescriptions must include a DEA number.
Animal prescriptions filled in pharmacies should be entered in pharmacy dispensing systems in the following manner:
- Use the animal's name as the patient name
- Use the human/owner's date of birth and address
- Select the patient type or species code as animal or non-human (required as of November 1, 2023)
Data entry at the pharmacy remains unchanged for these prescriptions. However, K-TRACS recommends pharmacy system vendors report the human/owner's information in the patient (PAT) fields in addition to the species code and animal name.
The distinction between human and non-human prescriptions is important for healthcare providers looking up human prescription history to use in their clinical decision-making, as well as in reporting prescription data in aggregate.
Surety Bond
- The surety bond must meet the requirements of 21 U.S.C. 360eee-2, which says:
(3)The furnishing of a bond or other equivalent means of security, as follows:
(A)(i)For the issuance or renewal of a wholesale distributor license, an applicant that is not a government owned and operated wholesale distributor shall submit a surety bond of $100,000 or other equivalent means of security acceptable to the State.
(ii)For purposes of clause (i), the State or other applicable authority may accept a surety bond in the amount of $25,000 if the annual gross receipts of the previous tax year for the wholesaler is $10,000,000 or less.
(B)If a wholesale distributor can provide evidence that it possesses the required bond in a State, the requirement for a bond in another State shall be waived. - If a wholesale distributor can provide evidence that it possesses the required bond in another state, the requirement for a bond will be waived.
- Yes. Veterinary wholesale distributors are exempt from the surety bond requirement in Kansas.
- Yes. At their meeting on June 4, 2020, the Board decided to exempt non-prescription drug/device distributors from the surety bond requirement in Kansas.
Is there an exemption for manufacturers, distributors, or repackagers of active pharmaceutical ingredients (API), or for medical gas distributors?
Yes. Any manufacturer, distributor, or repackager of API are exempt from the surety bond requirement in Kansas. Medical gas distributors are also exempt from this requirement.- Each registered facility will need its own surety bond.
- The Board will accept a letter of credit that meets the same requirements as the surety bond.
- Yes, the Board has created the S-340 $25,000 Surety Bond Form and the S-345 $100,000 Surety Bond Form. Neither of these forms are required but may be used by wholesale distributors to meet the surety bond requirements.
Theft or Loss
Any employee becoming aware of diversion should report it immediately.
- 21 C.F.R. 1301.91
DEA Form 106. The report must be submitted to the DEA and to the Board of Pharmacy.
- K.A.R. 68-20-15b and 21 C.F.R. 1301.76(b)
Either the pharmacist in charge (PIC) or the pharmacy owner shall notify the Board in writing within one day of any suspected diversion, theft, or loss of any controlled substance and, upon completion, shall provide the Board with a copy of the completed DEA Form 106.
- K.A.R. 68-20-15b
Virtual Manufacturers and Non-Resident Manufacturers
A Virtual Manufacturer is an entity that engages in the manufacture of drug or device products for which it:
- Owns the NDA or ANDA number, if a prescription drug;
- Owns the UDI number, as available, for a prescription device;
- Contracts with a contract manufacturing organization for the physical manufacture of the drug or device product;
- Is not involved in the physical manufacture of the drug or device product; and
- At no time takes physical possession of, or stores, the drug or device product.
If a virtual manufacturer does not have an FDA registration number but lists the labeler code, is the BA-04 form required?
Yes. The FDA registration number fields should be left blank. The facility is still required to complete the BA-04 because it owns the NDA, ANDA, or UDI.If the facility is only shipping products into Kansas that are manufactured at that specific facility into Kansas, register as a manufacturer.
If the facility is shipping products into Kansas manufactured at other facilities/locations, register as a distributor or a third party logistics provider (depending on whether or not the facility takes ownership).
If the facility is shipping products manufactured at that specific location into Kansas and products manufactured at other facilities into Kansas, register as both a manufacturer and a distributor/3PL.- A list of drug or device products it distributes;
- A list of the NDA or ANDA numbers associated with each drug it distributes;
- A list of the UDI numbers, as available, associated with each device it distributes;
- The name and facility address of the contract manufacturer for each drug or device product it distributes;
- Verification of current FDA registration for each contract manufacturing facility listed;
- If the contract manufacturer distributes into Kansas, the wholesale distributor permit number for the contract manufacturer;
- If the contract manufacturer does not distribute into Kansas, the name and Kansas wholesale distributor registration number for the entity that physically distributes the product into this State