Pharmacy

Pharmacy Definitions

Nonresident pharmacy means a pharmacy, including an Internet-based pharmacy, located outside the state of Iowa which delivers, dispenses, or distributes, by any method, prescription drugs or devices to an ultimate user physically located in this state. This includes pharmacies located outside the state of Iowa, which provides routine pharmacy services to ultimate users in this state.

General Pharmacy is a location where a pharmacist provides pharmaceutical services or dispenses pharmaceutical products to patients in accordance with pharmacy laws.

Hospital Pharmacy means and includes a pharmacy licensed by the Board and located within any hospital, health system, institution, or establishment which maintains and operates organized facilities for the diagnosis, care, and treatment of human illnesses to which persons may be admitted for overnight stay at the facility.

Long-Term Care Pharmacy means a hospital pharmacy, a general pharmacy, a limited use pharmacy, in which drugs, chemicals, or poisons are prepared, compounded, dispensed, vended, distributed, or sold on a regular and recurring basis to or for the use of residents of a long-term care facility and from which related pharmacy services are delivered.

Limited Use Pharmacy may be issued based upon special conditions of use proposed by the individual pharmacy site. The board has currently recognized Nuclear Pharmacy and Correctional Facility Pharmacy as qualifying for limited use pharmacy licenses.

Telepharmacy means a licensed pharmacy that is operated by a managing pharmacy and staffed by one or more telepharmacy technicians where pharmaceutical care services, including the storage and dispensing of prescription drugs, drug utilization review, and patient counseling, are provided by a licensed pharmacist through the use of technology.

New Pharmacy Applicants

Please familiarize yourself with the applicable rules and laws regarding the practice of pharmacy in Iowa prior to the submission of any application.

A pharmacy license issued by the Board is required for all sites where prescription drugs are offered for sale or dispensed under the supervision of a pharmacist. The current pharmacy license certificate shall be displayed in a position visible to the public. The Board may issue any of the following types of pharmacy licenses: a general pharmacy license, a hospital pharmacy license, a limited use pharmacy license, or a nonresident pharmacy license. 

Nonresident pharmacy license applicants shall comply with Board rules regarding nonresident pharmacy practice except when a waiver has been granted. 

Applicants for general or hospital pharmacy practice shall comply with Board rules regarding general or hospital pharmacy practice except when a waiver has been granted. 

Any pharmacy that dispenses controlled substances to Iowa residents must also obtain an Iowa Controlled Substances Act registration pursuant to 657 IAC 10

Complete and submit a New/Change Application found under the Pharmacy Applications/Forms and Online Services menu, with the appropriate nonrefundable fees, to the Board office.

DEA registration: The form is now available on the DEA's web site (click on registration, then click on registration applications). DO NOT mail the application to the Pharmacy Board office. The DEA registration will not be issued before the Iowa Controlled Substances Act registration application has been processed.

Licenses are issued to pharmacies under the "doing business as" (DBA) name. Be sure that all applications are completed with this DBA name listed first and that addresses on all applications are identical.

In-state Pharmacies: IMPORTANT: This procedure does NOT authorize the POSSESSION of prescription drugs (including controlled substances) prior to a formal inspection of the premises by a Board Compliance Officer to review requirements pertaining to space, library, equipment, and drug storage safeguards. Prescription drugs delivered to a new licensee prior to formal inspection and approval will be subject to seizure by the Board.

Upon receipt in the Board office of the completed applications and nonrefundable fees for a pharmacy license and an Iowa Controlled Substances Act registration, the Board will notify you of the procedure for scheduling a formal inspection of the premises. PLEASE ALLOW AT LEAST TWO (2) WEEKS' NOTICE FOR INSPECTION. Your pharmacy should be in full compliance of Iowa laws, rules, and regulations at the time of this initial inspection. 

Opening Inspection Checklist 

Telepharmacy Opening Inspection Checklist

Upon submission of a satisfactory inspection report by our compliance staff, the pharmacy license certificate and the Iowa CSA certificate will be mailed to the pharmacy and prescription drugs and controlled substances may be received. 

Please contact the Federal DEA concerning the issuance of your DEA registration and Schedule II controlled substance order forms (DEA Form 222).

Nonresident Pharmacies:

In addition to the licensure requirements identified in 657 IAC 8.35, a nonresident pharmacy must meet the following requirements:

  • The PIC must either hold a current Iowa pharmacist license or a nonresident PIC registration.  The PIC is not required to hold both.  Please see the Pharmacist in Charge menu for more information about those requirements and obtaining a NRP PIC registration, if applicable (657 IAC 657 19.3).
  • The pharmacy must provide toll-free telephone service, the telephone number of which is printed on the label affixed to each prescription dispensed or distributed in Iowa, that allows patients to speak with a pharmacist who has access to patient records at least six days per week for a total of at least forty hours (155A.13A).
  • The pharmacy must provide an inspection report that was conducted by an approved entity of the Board that was completed within two years, was conducted while the pharmacy was in operation, and addresses all services that the pharmacy conducts.  Please see the Inspection Requirements for Nonresident Pharmacies for more information (657 IAC 19.2).
  • The pharmacy must provide the NABP e-profile ID of the pharmacy and PIC (657 IAC 8.35(2)).

Pharmacy License/CSA Registration Renewals

Please familiarize yourself with the applicable rules and laws regarding the practice of pharmacy in Iowa prior to the submission of any application.

Pharmacy licenses expire December 31 of each year. 

CSA registrations are biennial registrations with staggered expiration dates. 

License/registration renewal is the licensee's responsibility. As a courtesy, the Board sends a renewal notice to each licensee at least 60 days prior to license/registration expiration; however, the option to renew will not be available more than 60 days prior to the expiration date. The renewal notice is sent to the primary email address on file with the Board. Failure of the licensee to receive the notice does not relieve the licensee of the responsibility to renew the license or registration prior to its expiration.  A license can be renewed online or by paper application. Refer to the Pharmacy Applications/Forms and Online Services menu below for the most current application. Using the most current application ensures that all necessary information is appropriately captured and/or provided.

Nonresident pharmacies - please review applicable rules found in 657 IAC 19.2 and/or inspection menu for more information concerning the inspection requirements for license renewal. 

Changes to the existing pharmacy license or CSA registration are not permitted during the renewal.  

Penalty fees will be assessed for late submissions.

Pharmacist in Charge (PIC) Changes

Please familiarize yourself with the applicable rules and laws regarding the practice of pharmacy in Iowa prior to the submission of any application.

Each pharmacy shall have one pharmacist in charge (PIC). The primary responsibilities of the PIC are identified in the following rules:

The PIC is ultimately responsible for establishing and implementing policies and procedures for all operations of the pharmacy and for ensuring the pharmacy operations and practices comply with all requirements of federal and state pharmacy and drug laws, rules, and regulations.

A part-time PIC has the same obligations and responsibilities as a full-time PIC.

The PIC shall take a complete inventory of controlled substances on hand at the pharmacy upon assuming the duties of PIC.

A PIC, upon resigning the position of PIC, shall take a complete controlled substances inventory.

If a permanent PIC has been identified by the time of a vacancy of the position, a pharmacy PIC change application identifying the new PIC, along with the nonrefundable fee, is required to be submitted to the Board within ten (10) days of the change.

If a permanent PIC has not been identified by the time of the vacancy of the position, a temporary PIC shall be identified. Notification identifying the temporary PIC, on forms provided by the Board, must be submitted to the Board within ten (10) days of the vacancy. The temporary PIC of a nonresident pharmacy is not required to be an Iowa-licensed pharmacist or nonresident PIC registrant. The pharmacy shall, within 90 days of the vacancy, identify a permanent PIC and submit an application for PIC change and nonresident PIC registration, if needed, along with the nonrefundable fee(s) associated with the pharmacy license change. 

Nonresident pharmacy: A change of permanent PIC for a nonresident pharmacy requires registration of the new permanent PIC if the pharmacist in charge is not currently registered by the Board or licensed to practice pharmacy in Iowa. 

Iowa Code 155A.13A(2) states that the pharmacist who is the pharmacist in charge of the nonresident pharmacy shall be designated as such on the nonresident pharmacy license application or renewal.

Click HERE to access the Iowa Pharmacy Law Boot Camp: Education for Iowa Nonresident Pharmacists.  The course is listed under the Featured section on the front page.  The permanent PIC of a nonresident pharmacy must supply their Statement of Credit from CPE Monitor as proof of course completion. If course credit submission to  CPE Monitor is waived, the system will not generate a certificate (Statement of Credit).

Penalty fees will be assessed for late submissions.  

The old license(s) must be returned to the Board office within ten (10) days of receiving the updated license certificate.

Please refer to the Pharmacy Applications/Forms and Online Services menu below for the most current application. Using the most current application ensures that all necessary information is appropriately captured and/or provided. 

A pharmacy license is issued in the name of the PIC and is not assignable or transferable.

Inspection Requirements for Nonresident Pharmacies

Iowa Code Section 155A.13A requires all pharmacies located outside of the state of Iowa that provide prescription drugs or devices to ultimate users located in Iowa to be licensed with the Iowa Board of Pharmacy as a nonresident pharmacy. 

Inspections: 657 IAC 19.2(1) dictates specific inspection requirements for license eligibility. Inspection requirements must be met to be eligible for licensure - no exceptions will be made.  Nonresident pharmacies must submit an inspection report with initial or renewal application that satisfies requirements of Iowa Code Section 155A.13A. 

If an inspection report that satisfies the requirements in 657 IAC 19.2(1) is not or will not be available prior to the submission of an initial application or when renewing the Iowa nonresident pharmacy license, please contact your home state board of pharmacy to request an inspection be performed. 

The Iowa Board of Pharmacy accepts an inspection report in lieu of a home-state inspection that has been conducted by the following entities:

  1. NABP Verified Pharmacy Program (note that if the pharmacy is a sterile compounder and the inspection is conducted virtually, the inspection must include video review of the compounding facility)
  2. Iowa Board of Pharmacy - Please complete the request form to request an inspection be performed by the Iowa Board of Pharmacy (at your expense)
    1. For initial applicants, a completed application and applicable fees must be submitted prior to requesting an inspection 
  3. Gates Healthcare Associates (note that if the pharmacy is a sterile compounder and the inspection is conducted virtually, the inspection must include video review of the compounding facility)
  4. To discuss alternative entities that may be qualified to perform the inspection please contact the Board's licensing specialist assigned to pharmacy licensing

The Iowa Board of Pharmacy has reviewed and specifically declines an inspection report provided by the following entities:

  • Drug Enforcement Administration
  • Pharmacy Compounding Accreditation Board (PCAB), a subsidiary of the Accreditation Commission for Healthcare (ACHC)
  • Accreditation Commission for Healthcare (ACHC)
  • The Joint Commission

If the pharmacy cannot meet the statutory requirements for licensure, the license cannot be issued or renewed.  Failure to submit an inspection report that complies with these requirements with the application will result in the application being  considered incomplete and a pharmacy license will not be issued or renewed.  If a license is renewed online and an audit finds that the inspection report does not meet the statutory requirements, the license may be rescinded.  Applications that do not meet statutory requirements will be held for a period of six (6) months from the date of receipt.  If a compliant inspection report is not received within that time frame, the application will be voided.  Application fees are nonrefundable and nontransferable.

Pharmacy Location Changes

Please familiarize yourself with the applicable rules and laws regarding the practice of pharmacy in Iowa prior to the submission of any application.

Instate Pharmacy - A change of pharmacy location requires submission of a pharmacy license application and nonrefundable fee. A change of location may require an on-site inspection of the new location.  The pharmacy will be issued a new license number. 

Nonresident Pharmacy - A change of pharmacy location requires the submission of a pharmacy license application, with the exception of the inspection requirement, and nonrefundable fee within ten (10) days after the issuance by the home state regulatory authority of a license bearing the new address. The pharmacy will not be issued a new license number.

A pharmacy undergoing a change in location is required to notify its Iowa patients of the change in accordance with paragraph 657 IAC 8.35(7)“d.” 

If the pharmacy also holds an Iowa CSA registration, then the application must include the nonrefundable fee to update the CSA registration.  

The old license/registration must be returned to the Board office within ten (10) days of receiving the updated license/registration certificate. 

Please refer to the Pharmacy Applications/Forms and Online Services menu below for the most current application. To ensure that all necessary information is appropriately captured and/or provided. 

Penalty fees will be assessed for late submissions. 

Pharmacy Name Changes

Please familiarize yourself with the applicable rules and laws regarding the practice of pharmacy in Iowa prior to the submission of any application.

Instate Pharmacies - A change of the name under which the pharmacy is doing business shall require submission of a pharmacy license application and nonrefundable fee prior to the change of name.

Nonresident Pharmacies - A change of the pharmacy name which is provided to patients requires submission of a pharmacy license application and nonrefundable fee within ten (10) days after issuance by the home state regulatory authority of a license bearing the new name.

If the pharmacy also holds an Iowa CSA registration, then the application must include the nonrefundable fee to change the CSA registration.  

New license numbers will not be issued for instate or nonresident pharmacies. 

The old license/registration must be returned to the Board office within ten (10) days of receiving the updated license certificate. 

Penalty fees will be assessed for late submissions.  

The application can be found in the Pharmacy Applications/Forms and Online Services menu below.

Pharmacy Ownership Changes

Please familiarize yourself with the applicable rules and laws regarding the practice of pharmacy in Iowa prior to the submission of any application.

A change of ownership occurs when the owner listed on the pharmacy’s most recent application changes or when there is a change affecting the majority ownership interest of the owner listed on the pharmacy’s most recent pharmacy application. A pharmacy undergoing a change in ownership is required to notify the pharmacist in charge and patients of the change in accordance with 657 IAC 8.35(7). A change of ownership effectively consists of closing a pharmacy and opening a new pharmacy.

Any restrictions or disciplinary history associated with the previous pharmacy shall remain unchanged. A pharmacy wishing to disassociate itself from the previously licensed pharmacy restrictions or disciplinary history may petition the board for such disassociation. The burden is on the pharmacy to demonstrate that the current pharmacy is not associated with or responsible for the pharmacy as it previously existed. 

Instate Pharmacy - A change of pharmacy ownership requires submission of a pharmacy license application and nonrefundable fee. A change of ownership may require an on-site inspection.  The pharmacy will be issued a new license number. 

Nonresident Pharmacy* - A change of pharmacy ownership requires submission of a pharmacy license application and nonrefundable fee.  The pharmacy will not be issued a new license number.  

*In the instance where the nonresident pharmacy’s name is also changing, please defer to the Name Change instructions. 

If the pharmacy also holds an Iowa CSA registration, then the application must include the nonrefundable fee to change the CSA registration.  

Closed pharmacies must return the pharmacy license(s) to the Board office within ten (10) days of closing.

Penalty fees will be assessed for late submissions.  

The application can be found in the Pharmacy Applications/Forms and Online Services menu below.

 

Closing a Pharmacy/Discontinuing Services in Iowa

Please complete the Pharmacy Closing Notification if the pharmacy is being sold, closing, or discontinuing services in Iowa. 

A closing procedures checklist is available for reference.

At least 40 days prior to closing a pharmacy, the pharmacist in charge (PIC) of the closing pharmacy must be notified of the pending sale or pharmacy closing. The pharmacy owner may require that the PIC keep the information regarding the pending sale confidential until the information is made public. The PIC is responsible for working with the pharmacy owner to ensure that all required notifications are completed in a timely manner and that all closing procedures are followed. The PIC of the purchasing or receiving pharmacy must be notified at least 30 days prior to the pharmacy closing.

Patient Notification: Every patient with records of prescriptions filled by the closing/sold pharmacy within the previous 18 months must be notified by direct mail or personal delivery at least 30 days prior to the pharmacy closing date (657 IAC 8.35(7)"d"). Any new patients filling prescriptions during the 30-day period prior to the pharmacy closing/sale shall receive written notification of the closing/sale.

DEA Notification: Please refer to the DEA website for notification procedures and cancellation of DEA Forms 222 and CSOS authorizations.

Only the pharmacist in charge of the pharmacy discontinuing business shall have access to the prescription drugs until those drugs are transferred to the new owner.  REMEMBER, once the pharmacy is closed and the license has been surrendered to the Board office, the drugs MUST be removed from the premises.  If they are not promptly removed after closing the pharmacy, they may be subject to seizure by the Board.  DO NOT create a situation whereby these drugs can be stolen and diverted to illicit use.

If 30 days’ written notice cannot be provided, contact the Board office as soon as the decision is made to discontinue business. The Board may be able to work with you to ensure an orderly and legal transfer of prescription drugs and records.

Within ten (10) days of closing the pharmacy, all signs identifying the closed location as a pharmacy must be removed or covered.

Instate Pharmacy - If of any of the following items remain in the pharmacy location, please contact Melissa Carstens by email (melissa.carstens@iowa.gov) or phone (515-725-3492) to make arrangements for the items  to be returned to the Iowa Board of Pharmacy:

  • Green "MedDrop" stainless steel medication disposal receptacle
  • Blue "MedDrop" stainless steel medication disposal receptacle
  • 22 gallon cardboard receptacle liner for MedDrop systems
  • 18 gallon Sharps "MedSafe" stainless steel medication disposal receptacle
  • 38 gallon Sharps "MedSafe" stainless steel medication disposal receptacle
  • 18 gallon cardboard inner liner for MedSafe systems
  • 38 gallon cardboard inner liner for MedSafe systems
  • 20 gallon cardboard "TakeAway" Environmental Return System for non-controlled substances

Petition for Waiver

Please see the Petition for Waiver page for more information.

Limited Use Pharmacy

Limited use pharmacy licenses may be issued for pharmacy practice settings including, but not limited to, nuclear pharmacy practice, correctional facility pharmacy practice, or veterinary pharmacy practice. Applications for a limited use pharmacy will be considered on a case-by-case basis. 

For more information concerning the rules for specific pharmacy practice settings, please review the Board’s rules contained in 657 Iowa Administrative Code.

A new applicant seeking a limited use pharmacy license or existing licensee who wishes to change the pharmacy license subtype must complete and submit the New License or Change Application and the Limited Use Pharmacy Application Addendum found in the Pharmacy Applications/Forms and Online Services menu below.

For more information, please contact the Licensure Specialist responsible for pharmacy licenses.

Telepharmacy

Pharmaceutical care services at a telepharmacy site must utilize audiovisual technologies that link the telepharmacy site with the managing pharmacy and one or more verifying pharmacists. 

A telepharmacy site and the managing pharmacy must be located within Iowa.

The managing pharmacy must be within a 200 mile radius of the telepharmacy.

A telepharmacy must be at least ten (10) miles from the nearest licensed pharmacy that dispenses prescription drugs to outpatients or, if telepharmacy is within ten (10) miles from the nearest licensed pharmacy that dispenses prescription drugs to outpatients, a waiver request must be submitted (Iowa Code 155A.13(3)“d”). 

The distance requirement does not apply if: 

  • Telepharmacy site was approved prior to July 1, 2016,
  • Telepharmacy site is located within a hospital campus and services will be limited to in-patient dispensing, or 
  • Telepharmacy site is located on property owned, operated, or leased by the state.

The managing pharmacy and the telepharmacy must execute and maintain a current written agreement between the pharmacies. 

For more information regarding the rules for telepharmacies, please review 657 IAC Chapter 13.

The application can be found in the Pharmacy Applications/Forms and Online Services menu below.

 

Pharmacy Controlled Substance Inventory

Federal and state laws require all controlled substance registrants to inventory all stocks of controlled substances in the possession of the registrant on the date the registrant first engages in the manufacture, distribution, or disposition of controlled substances. In the event the registrant commences business with no controlled substances on hand, that fact shall be recorded as the initial inventory. After the initial inventory, a registrant shall take a new inventory at least annually. The annual inventory may be taken on any date that is within 372 days (one year + 7 days)  of the previous inventory.

A pharmacy located in Iowa that dispenses controlled substances listed in Schedule II of the Controlled Substances Act shall maintain a perpetual inventory system for each of those substances.  Specific requirements for maintenance and periodic reconciliation of the perpetual inventory are found in Board rule 657--10.33(124,155A). See 657 IAC chapter 10.

All inventories shall be taken either as of opening of business or as of the close of business on the inventory date and the inventory record shall identify either “opening” or “close of business and include the signature(s) of the person(s) responsible for taking the inventory”  The inventory record shall be maintained in written, typewritten, or electronically printed form at the registered location two (2) years from the date of the inventory. An inventory record of substances listed in Schedule I or Schedule II of the Controlled Substances Act shall be maintained separately from an inventory of all other controlled substances.

Inventory records of controlled substances shall include the name of the substance, the strength and dosage form of the substance (e.g. 10 mg. tablet), and the quantity of the substance. If the substance is listed in Schedule I or Schedule II of the Controlled Substances Act and for all solid oral and injectable hydrocodone-containing products, an exact count or measure of the contents shall be recorded. For all other substances listed in Schedules III, IV or V of the Controlled Substances Act, if the container has been opened, the registrant may make an estimated count or measure of the substance unless the original unopened container held more than 100 tablets or capsules in which case an exact count shall be recorded.

It is the responsibility of both the current pharmacy owner and the prospective pharmacy owner to take an inventory of all controlled substances whenever there is a change in ownership of a facility licensed by the Board. A pharmacy owner may delegate the actual taking of such inventory.

It is the responsibility of the pharmacy owner to take an inventory of all controlled substances whenever there is a change in the pharmacist in charge of any establishment licensed by the Board.

Additional questions may be directed to  the appropriate compliance officer.

 

Theft/Loss Reports

Any person or business registered to handle controlled substances in Iowa must, in case of any loss or theft of controlled substances under the registrant's control, report such loss or theft to the Board of Pharmacy within 14 days of discovery of the loss or theft. Federal regulations also require reporting to the Drug Enforcement Administration (DEA).

If the theft was committed by a registrant or licensee of the board or if there is reason to believe that the theft was committed by a registrant or licensee of the board, the registrant from which the controlled substances were stolen must notify the Board immediately upon discovery of the theft and identify the registrant or licensee suspected of the theft.

A registrant must complete the online DEA Form 106, print the report, and submit it to the Board. Reports must be filled out completely, including identification of the registrant, the type of loss or theft, the date of the occurrence, and a detailed listing of the substances and quantities lost. The DEA Form 106 online report is located on the DEA's website at the following location: https://www.deadiversion.usdoj.gov/webforms/dtlLogin.jsp.

A registrant, following completion of the report, must maintain a copy of the DEA Form 106 for a minimum two (2) years.

For more information, please contact Amanda Woltz

Technician Product Verification Programs

The Iowa  Board of Pharmacy recently finalized a complete revision of Chapter 40 relating to Technician Verification Programs (TPV), formerly known as “Tech-Check-Tech” Programs, in response to changes to the Iowa Code to allow such programs in the community setting, pursuant to Board rules.

The final rules can be found here and were effective as of June 26, 2019. Please note that existing Tech-Check-Tech programs are not automatically “grandfathered” to be deemed automatically compliant with the newly revised rules. Such programs in existence prior to June 26, 2019 will be expected to be compliant with the rules found above. If a program is not able to be compliant with the minimum standards, the pharmacy will need to seek a waiver from the Board for any rule that the pharmacy determines is not able to be complied with.

If your pharmacy wishes to establish and implement a TPV program, please complete the Technician Product Verification Program Notification form, the form will be automatically submitted to the Board.  Also, update the pharmacy’s services using the pharmacy’s online profile here

Upon implementation of the program, the pharmacy is required to complete quarterly reports of compliance. The Technician Product Verification Quarterly Report shall be completed, retained by the pharmacy, and available for inspection and copying by the board or its authorized agent.

Pharmacy Applications/Forms and Online Services

Applications and Forms

Online Services

A pharmacy can access its online profile at any time during the year to update the pharmacy’s hours, practice/services, compounding practice, accreditations, employees, and general contact information. A pharmacy can also print a copy of the pharmacy and/or CSA certificate within the online profile.

If the pharmacy’s online profile has not previously been accessed, the pharmacy license holder may utilize the “sign up” option to create login credentials.

On November 1 of every year, the renewal period opens for all pharmacy licenses.  Pharmacies can access the online profile to renew the pharmacy license online.  The following items are required to be submitted with the online renewal application.

Nonresident Pharmacy:

  • Inspection Report
  • Prescription Label
  • Home State License Verification
  • Acknowledgement and Attestation Form (completed by PIC)

In-State Pharmacy:

  • Acknowledgement and Attestation form (completed by PIC)

Printed from the Iowa Board of Pharmacy website on December 02, 2021 at 7:43am.