House Study Bill 73 - IntroducedA Bill ForAn Act 1relating to the practice of pharmacy, and providing for
2a repeal.
4   Section 1.  Section 147.107, subsection 2, paragraph d, Code
52021, is amended to read as follows:
   6d.  A pharmacist who dispenses prescription drugs, including
7but not limited to controlled substances, for human use,
8may delegate nonjudgmental dispensing functions only when
9verification of the accuracy and completeness of the dispensing
10is determined by the pharmacist in the pharmacist’s physical
11presence. The pharmacist’s verification of the accuracy of the
12prescription drug dispensed shall not be required when verified
13by a certified pharmacy technician in a technician product
14verification program or a tech-check-tech program as defined
15in section 155A.3. The pharmacist’s physical presence shall
16not be required when the pharmacist is remotely supervising
17pharmacy personnel operating in an approved a licensed
18 telepharmacy site or when utilizing an automated dispensing
19system that utilizes an internal quality control assurance
20plan. When utilizing a technician product verification program
21or tech-check-tech program, or when remotely supervising
22pharmacy personnel operating at an approved a licensed
23 telepharmacy site, the pharmacist shall utilize an internal
24quality control assurance plan, in accordance with rules
25adopted by the board of pharmacy, that ensures accuracy for
26dispensing. Automated dispensing verification, technician
27product verification, and telepharmacy practice accuracy and
28completeness remains the responsibility of the pharmacist and
29shall be determined in accordance with rules adopted by the
30board of pharmacy.
31   Sec. 2.  Section 155A.3, Code 2021, is amended by adding the
32following new subsection:
33   NEW SUBSECTION.  35A.  “Pharmacy support person” means
34a person, other than a licensed pharmacist, a registered
35pharmacist-intern, or a registered pharmacy technician, who
-1-1may perform nontechnical duties assigned by a supervising
2pharmacist under the pharmacist’s responsibility and
4   Sec. 3.  Section 155A.3, subsection 46, Code 2021, is amended
5by striking the subsection.
6   Sec. 4.  Section 155A.6A, subsections 3 and 4, Code 2021, are
7amended to read as follows:
   83.  A person who is in the process of acquiring national
9certification as a pharmacy technician and who is in training
10to become a pharmacy technician shall register with the board
11as a pharmacy technician. The registration shall be issued for
12a period not to exceed one year and shall not be renewable.

   134.  The board shall adopt rules in accordance with
14chapter 17A on matters pertaining to pharmacy technician
15registration, application, forms, renewals, fees, termination
16of registration, tech-check-tech programs, technician product
17verification programs, national certification, training, and
18any other relevant matters.
19   Sec. 5.  Section 155A.33, Code 2021, is amended to read as
   21155A.33  Delegation of technical functions.
   22A pharmacist may delegate any technical dispensing functions
23to pharmacy technicians and any nontechnical functions to
24pharmacy support persons
, but only if the pharmacist is
25physically present available to verify the accuracy and
 provide professional oversight of the patient’s
27prescription prior to the delivery of the prescription to the
28patient or the patient’s representative
 delegated functions
29performed by the pharmacy technician or pharmacy support
. However, the physical presence requirement does not
31apply when a pharmacist is utilizing an automated dispensing
32system or a technician product verification program or when
33a pharmacist is remotely supervising a certified pharmacy
34technician practicing at a telepharmacy site approved by
35the board. When using an automated dispensing system or a
-2-1technician product verification program, or when remotely
2supervising a certified pharmacy technician practicing at
3an approved telepharmacy site, the pharmacist shall utilize
4an internal quality control assurance plan that ensures
5accuracy for dispensing.
Verification of automated dispensing,
6technician product verification, and telepharmacy practice
7accuracy and completeness remains the responsibility of the
8pharmacist and shall be determined in accordance with rules
9adopted by the board.
11Outsourcing facilitY LICENSE
12   Sec. 6.  Section 155A.13C, subsection 1, Code 2021, is
13amended by adding the following new paragraph:
14   NEW PARAGRAPH.  e.  Submit evidence of a satisfactory
15inspection conducted by the home state regulatory authority
16or an entity approved by the board in the two-year period
17immediately preceding the application which demonstrates
18compliance with current good manufacturing practices. In
19addition, the applicant shall submit evidence of correction of
20all deficiencies discovered in such inspections and evidence of
21compliance with all directives from the home state regulatory
22authority or entity approved by the board. The board may
23recover from an outsourcing facility, prior to the issuance
24of a license or license renewal, the costs associated with
25conducting an inspection by or on behalf of the board for
26purposes of satisfying the requirements of this paragraph.
28Information Sharing
29   Sec. 7.  Section 155A.45, Code 2021, is amended to read as
   31155A.45  Inspection reports Reports — disclosure.
   321.  Notwithstanding section 272C.6, subsection 4, paragraph
33“a”, an inspection report in possession of the board, regardless
34of whether the report is based on a routine inspection or an
35inspection prompted by one or more complaints, may be disclosed
-3-1to the national association of boards of pharmacy’s inspection
   32.  Notwithstanding section 272C.6, subsection 4, paragraph
4“a”, any complaints, investigative information, or data
5collected pertaining to compounded human drug products may be
6disclosed to the United States food and drug administration,
7including through the use of an information sharing network, in
8order to comply with any memorandum of understanding with the
9United States food and drug administration.
12   Sec. 8.  NEW SECTION.  155A.47  Pilot or demonstration
13research projects.
   141.  Notwithstanding any provision of section 147.107,
15subsection 2, or section 155A.33 to the contrary, the board may
16approve a pilot or demonstration research project of innovative
17applications in the practice of pharmacy to provide enhanced
18patient care.
   192.  The board shall adopt rules pursuant to chapter 17A for
20application for and approval of such projects. The rules may
21include exceptions to any existing rules under the purview
22of the board as necessary for completion of the project,
23limited to the duration of the project. The board may approve
24a project for no more than eighteen months. The board may
25extend or renew a project in accordance with board rules. All
26projects shall comply with the rules adopted for such projects.
   273.  The board shall not approve any project that expands the
28practice of pharmacy as defined in section 155A.3.
29   Sec. 9.  REPEAL.  2011 Iowa Acts, chapter 63, section 36, is
32The inclusion of this explanation does not constitute agreement with
33the explanation’s substance by the members of the general assembly.
   34This bill relates to pharmacy practice.
   35Division I of the bill eliminates the tech-check-tech
-4-1program. The board of pharmacy (board) adopted administrative
2rules to implement and establish a technician product
3verification program as authorized by 2018 Iowa Acts,
4chapter 1142, enacting Code section 155A.33A. Division I
5eliminates the one-year registration limitation for a person in
6training to become a pharmacy technician and makes conforming
7terminology changes. Division I also amends provisions
8relating to the delegation of technical functions between
9a pharmacist and a pharmacy technician or pharmacy support
   11Division II of the bill requires a drug compounding
12outsourcing facility seeking licensure in the state to
13have been inspected by the facility’s home state regulatory
14authority or other entity approved by the board in the two-year
15period immediately preceding the application, which inspection
16demonstrates compliance with federal current good manufacturing
17practices. Division II also allows the board to recover from
18an outsourcing facility costs associated with conducting an
19inspection to satisfy the inspection requirement.
   20Division III of the bill authorizes the board of pharmacy to
21share information collected relating to compounded human drug
22products with the United States food and drug administration
23(FDA) pursuant to any memorandum of understanding between the
24board of pharmacy and the FDA.
   25Division IV of the bill codifies the provisions of 2011 Iowa
26Acts, chapter 63, section 36, relating to pharmacy pilot or
27demonstration research projects. The language in Division IV
28differs from these provisions by eliminating language limiting
29the projects to those based solely on prescription verification
30and by eliminating the requirement that the board report the
31approval or denial of projects to the chairpersons and ranking
32members of the joint appropriations subcommittee on health and
33human services.