155A.13 Pharmacy license.

1. A person shall not establish, conduct, or maintain a pharmacy in this state without a license. The license shall be identified as a pharmacy license. A pharmacy license issued pursuant to subsection 4 may be further identified as a hospital pharmacy license.

2. The board shall specify by rule the licensing procedures to be followed, including specifications of forms for use in applying for a pharmacy license and fees for filing an application.

3. a. The board may issue a special or limited-use pharmacy license based upon special conditions of use imposed pursuant to rules adopted by the board for cases in which the board determines that certain requirements may be waived.

b. The board shall adopt rules for the issuance of a special or limited-use pharmacy license to a telepharmacy site. The rules shall address:

(1) Requirements for establishment and operation of a telepharmacy site, including but not limited to physical requirements and required policies and procedures.

(2) Requirements for being a managing pharmacy.

(3) Requirements governing operating agreements between telepharmacy sites and managing pharmacies.

(4) Training and experience required for certified pharmacy technicians working at a telepharmacy site.

(5) Requirements for a pharmacist providing services to and supervising a telepharmacy site.

(6) Any other health and safety concerns associated with a telepharmacy site.

c. The board shall not issue a special or limited-use pharmacy license to a proposed telepharmacy site if a licensed pharmacy that dispenses prescription drugs to outpatients is located within ten miles by the shortest driving distance of the proposed telepharmacy site unless the proposed telepharmacy site is located on property owned, operated, or leased by the state or unless the proposed telepharmacy site is located within a hospital campus and is limited to inpatient dispensing. The mileage requirement does not apply to a telepharmacy site that has been approved by the board and is operating as a telepharmacy prior to July 1, 2016.

d. An applicant seeking a special or limited-use pharmacy license for a proposed telepharmacy site that does not meet the mileage requirement established in paragraph “c” and is not statutorily exempt from the mileage requirement may apply to the board for a waiver of the mileage requirement. A waiver request shall only be granted if the applicant can demonstrate to the board that the proposed telepharmacy site is located in an area where there is limited access to pharmacy services and can establish the existence of compelling circumstances that justify waiving the mileage requirement. The board’s decision to grant or deny a waiver request shall be a proposed decision subject to mandatory review by the director of public health. The director shall review a proposed decision and shall have the power to approve, modify, or veto a proposed decision. The director’s decision on a waiver request shall be considered final agency action subject to judicial review under chapter 17A.

e. The board shall issue a special or limited-use pharmacy license to a telepharmacy site that meets the minimum requirements established by the board by rule.

4. a. The board shall adopt rules for the issuance of a hospital pharmacy license to a hospital which provides pharmacy services for its own use. The rules shall:

(1) Recognize the special needs and circumstances of hospital pharmacies.

(2) Give due consideration to the scope of pharmacy services that the hospital’s medical staff and governing board elect to provide for the hospital’s own use.

(3) Consider the size, location, personnel, and financial needs of the hospital.

(4) Give recognition to the standards of the joint commission on the accreditation of health care organizations and the American osteopathic association and to the conditions of participation under Medicare.

b. To the maximum extent possible, the board shall coordinate the rules with the standards and conditions described in paragraph “a”, subparagraph (4), and shall coordinate its inspections of hospital pharmacies with the Medicare surveys of the department of inspections and appeals and with the board’s inspections with respect to controlled substances conducted under contract with the federal government.

c. A hospital which provides pharmacy services by contracting with a licensed pharmacy is not required to obtain a hospital pharmacy license or a general pharmacy license.

5. A hospital which elects to operate a pharmacy for other than its own use is subject to the requirements for a general pharmacy license. If the hospital’s pharmacy services for other than its own use are special or limited, the board may issue a special or limited-use pharmacy license pursuant to subsection 3.

6. To qualify for a pharmacy license, the applicant shall submit to the board a license fee as determined by the board and a completed application on a form prescribed by the board. The application shall include the following and such other information as required by rules of the board and shall be given under oath:

a. Ownership.

b. Location.

c. The license number of each pharmacist employed by the pharmacy at the time of application.

d. The trade or corporate name of the pharmacy.

e. The name of the pharmacist in charge, who has the authority and responsibility for the pharmacy’s compliance with laws and rules pertaining to the practice of pharmacy.

7. A person who falsely makes the affidavit prescribed in subsection 6 is subject to all penalties prescribed for making a false affidavit.

8. A pharmacy license issued by the board under this chapter shall be issued in the name of the pharmacist in charge and is not transferable or assignable.

9. The board shall specify by rule minimum standards for professional responsibility in the conduct of a pharmacy.

10. A separate license is required for each principal place of practice.

11. The license of the pharmacy shall be displayed.

87 Acts, ch 215, §13; 98 Acts, ch 1100, §20; 2005 Acts, ch 179, §179; 2009 Acts, ch 41, §195; 2016 Acts, ch 1093, §3; 2016 Acts, ch 1138, §22

Referred to in §155A.15

Practice of pharmacy pilot or demonstration research projects relating to authority of prescription verification and the ability of a pharmacist to provide enhanced patient care;

2011 Acts, ch 63, §36

;

2012 Acts, ch 1113, §31

;

2013 Acts, ch 138, §128