House File 555 - Enrolled
House File 555
AN ACT
RELATING TO THE PRACTICE OF PHARMACY, AND PROVIDING FOR
ADMINISTRATIVE PENALTIES.
3 BE IT ENACTED BY THE GENERAL ASSEMBLY OF THE STATE OF IOWA:
1 Section 1. NEW SECTION. 155A.2B Practice of pharmacy ——
2 general principles.
3 To evaluate whether an act by a licensee or registrant under
4 this chapter violates the appropriate standard of care, a
5 licensee or registrant of the board must consider all of the
6 following:
7 1. Whether performance of the act is expressly prohibited
8 by a provision of this chapter.
9 2. Whether performance of the act is expressly prohibited
10 by a rule adopted by the board.
11 3. Whether performance of the act is consistent with
12 the education, training, and experience of a licensee or
13 registrant.
14 4. Whether performance of the act is within the accepted
15 standard of care that would be provided in a similar setting by
16 a reasonable and prudent licensee or registrant with similar
17 education, training, and experience.
18 Sec. 2. Section 155A.3, subsection 39, Code 2024, is amended
19 to read as follows:
20 39. “Practitioner” means a physician, dentist, podiatric
21 physician, prescribing psychologist, veterinarian, optometrist,
22 pharmacist, physician assistant, advanced registered nurse
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23 practitioner, or other person licensed or registered to
24 prescribe, distribute, or dispense a prescription drug or
25 device in the course of professional practice in this state or
26 a person licensed by another state in a health field in which,
27 under Iowa law, licensees in this state may legally prescribe
28 drugs.
29 Sec. 3. Section 155A.3, Code 2024, is amended by adding the
30 following new subsection:
31 NEW SUBSECTION. 49A. “Therapeutic substitution” means the
32 replacement of a prescribed drug, biological product, or device
33 with an alternative molecule or device with assumed equivalent
34 therapeutic effect. The alternative drug, biological product,
35 or device may be within the same class or from another class
1 with assumed therapeutic equivalence.
2 Sec. 4. Section 155A.7, Code 2024, is amended by striking
3 the section and inserting in lieu thereof the following:
4 155A.7 Pharmacist-intern, pharmacy technician, and pharmacy
5 support person registration.
6 1. Registration programs for pharmacist-interns, pharmacy
7 technicians, and pharmacy support persons are established for
8 the purposes of identification, tracking, and disciplinary
9 action for the violation of federal drug laws or regulations,
10 state drug or pharmacy laws, or rules of the board.
11 2. A person who is or desires to be a pharmacist-intern,
12 pharmacy technician, or pharmacy support person in this state
13 shall apply to the board for registration on a form prescribed
14 by the board.
15 a. A pharmacist-intern shall be registered during internship
16 training and thereafter pursuant to rules adopted by the board.
17 b. An applicant for a new pharmacy technician registration
18 or for a pharmacy technician renewal shall provide proof of
19 current certification by a national technician certification
20 authority approved by the board. A person who is in the
21 process of acquiring national certification as a pharmacy
22 technician and who is in training to become a pharmacy
23 technician shall register with the board as a pharmacy
24 technician.
25 3. The board shall adopt rules pursuant to chapter 17A on
26 matters pertaining to pharmacist-intern, pharmacy technician,
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27 and pharmacy support person registration, renewals, fees,
28 training, national certification for pharmacy technicians,
29 approval of preceptors for pharmacist-interns, and other
30 relevant matters.
31 a. The board shall establish standards for pharmacist-intern
32 registration.
33 b. The board shall not adopt rules pertaining to pharmacy
34 support person registration which include any determination of
35 the competency of the registered person and, notwithstanding
1 section 272C.2, subsection 1, shall not require continuing
2 education for renewal.
3 4. The board may deny, suspend, or revoke the registration
4 of a pharmacist-intern, pharmacy technician, or pharmacy
5 support person, or otherwise impose disciplinary penalties upon
6 the registration of a pharmacy technician or pharmacy support
7 person, for any violation of the laws of this state, another
8 state, or the United States relating to prescription drugs,
9 controlled substances, or nonprescription drugs, or for any
10 violation of this chapter or chapter 124, 124B, 126, 147, 205,
11 or 272C, or any rule of the board. The board may deny, suspend,
12 or revoke a pharmacist-intern registration for failure to meet
13 the standards prescribed by the board pursuant to subsection 3.
14 5. Responsibility for the actions of a pharmacist-intern,
15 pharmacy technician, or pharmacy support person working under
16 a licensed pharmacist’s delegated functions and reasonable
17 professional oversight shall remain with the licensed
18 pharmacist.
19 Sec. 5. Section 155A.8, Code 2024, is amended to read as
20 follows:
21 155A.8 Requirements for pharmacist Pharmacist license.
22 1. A person shall not engage in the practice of pharmacy in
23 this state without a license. The license shall be identified
24 as a pharmacist license.
25 2. A pharmacist may dispense, administer, monitor, and
26 issue prescription drugs, biological products, and medication
27 orders commensurate with the pharmacist’s training and
28 education and in accordance with the appropriate standard of
29 care.
30 3. To qualify for a pharmacist license, an applicant shall
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31 meet the following requirements:
32 1. a. Be a graduate of a school or college of pharmacy
33 or of a department of pharmacy of a university recognized and
34 approved by the board.
35 2. b. File proof, satisfactory to the board, of internship
1 for a period of time fixed by the board.
2 3. c. Pass an examination prescribed by the board.
3 4. The board shall specify by rule procedures and fees to
4 renew a pharmacist license and penalties for late renewal or
5 failure to renew a pharmacist license.
6 Sec. 6. Section 155A.9, subsection 2, Code 2024, is amended
7 to read as follows:
8 2. An applicant who is a graduate of a school or college of
9 pharmacy located outside the United States but who is otherwise
10 qualified to apply for a pharmacist license in this state may
11 be deemed to have satisfied the requirements of section 155A.8,
12 subsection 1 section 155A.8, subsection 3, paragraph “a”, by
13 verification to the board of the applicant’s academic record
14 and graduation and by meeting other requirements established
15 by rule of the board. The board may require the applicant
16 to pass an examination or examinations given or approved by
17 the board to establish proficiency in English and equivalency
18 of education as a prerequisite for taking the licensure
19 examination required in section 155A.8, subsection 3.
20 Sec. 7. Section 155A.12, Code 2024, is amended by adding the
21 following new subsections:
22 NEW SUBSECTION. 11. Engaged in conduct outside the accepted
23 standard of care that would be provided in a similar setting by
24 a reasonable and prudent applicant or licensee.
25 NEW SUBSECTION. 12. Displayed incapacity of a nature
26 preventing engagement in the practice of pharmacy with
27 reasonable skill, competence, and safety to the public.
28 Sec. 8. Section 155A.13, subsection 3, paragraph b, Code
29 2024, is amended by striking the paragraph and inserting in
30 lieu thereof the following:
31 b. The board shall adopt rules for the issuance of a special
32 or limited-use pharmacy license to a telepharmacy site.
33 Sec. 9. Section 155A.13, subsection 3, paragraphs c, d, and
34 e, Code 2024, are amended by striking the paragraphs.
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35 Sec. 10. Section 155A.13, subsection 8, Code 2024, is
1 amended by striking the subsection.
2 Sec. 11. Section 155A.18, Code 2024, is amended to read as
3 follows:
4 155A.18 Penalties.
5 1. The board shall impose penalties as allowed under section
6 272C.3. In addition, civil penalties not to exceed twenty-five
7 thousand dollars, may be imposed.
8 2. The board may impose an administrative penalty of up to
9 five hundred dollars on a licensee or registrant who does any
10 of the following:
11 a. Engages in a practice regulated by this chapter without a
12 current license or registration.
13 b. Employs a person without a current license or
14 registration to engage in a practice regulated by this chapter.
15 c. Fails to complete the continuing education required for
16 renewal of a license or registration.
17 d. Fails any component of a routine inspection conducted by
18 the board.
19 e. The assessment and payment of a penalty imposed pursuant
20 to this subsection shall not be considered a disciplinary
21 action or reported as discipline and shall be confidential.
22 Sec. 12. Section 155A.19, Code 2024, is amended by striking
23 the section and inserting in lieu thereof the following:
24 155A.19 Notifications to board.
25 Individuals and businesses licensed or registered pursuant
26 to this chapter shall notify the board of pertinent changes
27 related to activities performed pursuant to a license or
28 registration issued under this chapter, pursuant to rules of
29 the board.
30 Sec. 13. Section 155A.23, Code 2024, is amended by adding
31 the following new subsection:
32 NEW SUBSECTION. 4. a. A person found in possession of a
33 drug or device limited to dispensation by prescription, unless
34 the drug or device was so lawfully dispensed, commits a serious
35 misdemeanor.
1 b. Paragraph “a” does not apply to a licensed pharmacy,
2 licensed wholesaler, physician, veterinarian, dentist,
3 podiatric physician, optometrist, advanced registered nurse
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4 practitioner, physician assistant, pharmacist, a nurse
5 acting under the direction of a physician, staff acting
6 under the direction of a person licensed to prescribe, or
7 the board of pharmacy, its officers, agents, inspectors,
8 and representatives, or to a common carrier, manufacturer’s
9 representative, or messenger when transporting the drug or
10 device in the same unbroken package in which the drug or device
11 was delivered to that person for transportation.
12 Sec. 14. Section 155A.26, unnumbered paragraph 1, Code
13 2024, is amended to read as follows:
14 The board, its officers, agents, inspectors compliance
15 officers, and representatives, and all peace officers
16 within the state, and all county attorneys shall enforce
17 all provisions of this chapter, except those specifically
18 delegated, and shall cooperate with all agencies charged
19 with the enforcement of the laws of the United States, of
20 this state, and of all other states relating to prescription
21 drugs. Officers, agents, inspectors compliance officers, and
22 representatives of the board shall have the powers and status
23 of peace officers when enforcing the provisions of this chapter
24 and chapters 124, 126, and 205. Officers, agents, inspectors
25 compliance officers, and representatives of the board of
26 pharmacy may:
27 Sec. 15. Section 155A.26, subsection 3, Code 2024, is
28 amended to read as follows:
29 3. Conduct routine and unannounced inspections of
30 pharmacies, drug wholesalers, and the offices or business
31 locations of all individuals and institutions authorized to
32 have possession of prescription drugs including any entity
33 licensed by the board or location authorized to possess
34 controlled substances or prescription devices, regardless of
35 the location of the office or business.
1 Sec. 16. Section 155A.27, subsection 2, paragraph a, Code
2 2024, is amended to read as follows:
3 a. Beginning January 1, 2020, every Every prescription
4 issued for a prescription drug shall be transmitted
5 electronically as an electronic prescription to a pharmacy by a
6 prescriber or the prescriber’s authorized agent unless exempt
7 under paragraph “b”.
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8 Sec. 17. Section 155A.27, subsection 3, unnumbered
9 paragraph 1, Code 2024, is amended to read as follows:
10 For prescriptions issued prior to January 1, 2020, or
11 for prescriptions exempt from the electronic prescription
12 requirement in subsection 2, paragraph “b”, a prescriber or the
13 prescriber’s authorized agent may transmit a prescription for a
14 prescription drug to a pharmacy by any of the following means:
15 Sec. 18. Section 155A.27, Code 2024, is amended by adding
16 the following new subsections:
17 NEW SUBSECTION. 8. Except as specified in subsection 9, a
18 prescription for any prescription drug or device which is not a
19 controlled substance shall not be filled or refilled more than
20 eighteen months after the date on which the prescription was
21 issued and a prescription which is authorized to be refilled
22 shall not be refilled more than twelve times.
23 NEW SUBSECTION. 9. A pharmacist may exercise professional
24 judgment by refilling a prescription drug order without
25 prescriber authorization in accordance with the appropriate
26 standard of care and pursuant to rules established by the
27 board.
28 NEW SUBSECTION. 10. An authorization to refill a
29 prescription drug order shall be transmitted to a pharmacy by
30 a prescriber or the prescriber’s authorized agent pursuant
31 to this section, except that prescription drug orders for
32 controlled substances shall be transmitted pursuant to section
33 124.308, and, if not transmitted directly by the practitioner,
34 shall also include the name and title of the practitioner’s
35 agent completing the transmission.
1 Sec. 19. Section 155A.32, Code 2024, is amended by striking
2 the section and inserting in lieu thereof the following:
3 155A.32 Drug product selection —— restrictions.
4 1. If an authorized practitioner prescribes a drug, the
5 pharmacist may exercise professional judgment in the interest
6 of the patient by providing a therapeutic substitution for
7 dispensing and sale to the patient.
8 2. The pharmacist shall not provide a therapeutic
9 substitution if “dispense as written” is indicated on the
10 prescription.
11 3. The board shall adopt rules on proper recording and
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12 notification when a therapeutic substitution is made under this
13 section.
14 Sec. 20. Section 155A.39, subsection 6, Code 2024, is
15 amended to read as follows:
16 6. Funds and surcharges collected under this section shall
17 be deposited in an account and may be used by the board to
18 administer a program authorized by this section, but shall
19 not be used for costs incurred for a participant’s initial
20 evaluation, referral services, treatment, or rehabilitation
21 subsequent to intervention and to assist licensees and
22 registrants with costs incurred for participation in the
23 program.
24 Sec. 21. Section 155A.40, subsection 1, Code 2024, is
25 amended to read as follows:
26 1. The board may request and obtain, notwithstanding
27 section 692.2, subsection 5, criminal history data for any
28 applicant for an initial or renewal license or registration
29 issued pursuant to this chapter or chapter 147, any applicant
30 for reinstatement of a license or registration issued pursuant
31 to this chapter or chapter 147, or any licensee or registrant
32 who is being monitored as a result of a board order or
33 agreement resolving an administrative disciplinary action,
34 for the purpose of evaluating the applicant’s, licensee’s,
35 or registrant’s eligibility for licensure, registration, or
1 suitability for continued practice of the profession. Criminal
2 history data may be requested for all owners, managers, and
3 principal employees of a pharmacy, third-party logistics
4 provider, or drug wholesaler wholesale distributor licensed
5 pursuant to this chapter. The board shall adopt rules
6 pursuant to chapter 17A to implement this section. The board
7 shall inform the applicant, licensee, or registrant of the
8 criminal history requirement and obtain a signed waiver from
9 the applicant, licensee, or registrant prior to submitting a
10 criminal history data request.
11 Sec. 22. Section 155A.46, Code 2024, is amended by adding
12 the following new subsection:
13 NEW SUBSECTION. 01. A pharmacist may, pursuant to
14 statewide protocols developed and approved by the board in
15 consultation with the department of health and human services,
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16 order and administer prescription drugs, products, tests, or
17 treatments. Each protocol, as established by rule, may define
18 the prescription drugs, products, tests, or treatment