Indiana 2022 Regular Session

Indiana House Bill HB1158 Compare Versions

OldNewDifferences
1-*HB1158.2*
2-Reprinted
3-January 28, 2022
1+*HB1158.1*
2+January 20, 2022
43 HOUSE BILL No. 1158
54 _____
6-DIGEST OF HB 1158 (Updated January 27, 2022 4:04 pm - DI 77)
5+DIGEST OF HB 1158 (Updated January 19, 2022 5:09 pm - DI 77)
76 Citations Affected: IC 5-10; IC 12-8; IC 12-9; IC 12-11; IC 12-28;
8-IC 16-18; IC 16-41; IC 21-38; IC 25-26; IC 27-8; IC 34-30; IC 34-46;
9-IC 35-52; noncode.
7+IC 16-18; IC 16-41; IC 21-38; IC 25-1; IC 25-26; IC 27-8; IC 34-30;
8+IC 34-46; IC 35-52; noncode.
109 Synopsis: Health and human services matters. Allows an advanced
1110 practice registered nurse or physician assistant to sign certain
1211 individualized family service plans. Changes the composition and
13-duties of the division of disability and rehabilitative services advisory
14-council. Requires the services for individuals with intellectual and
15-other developmental disabilities task force to establish a subcommittee
16-to make certain recommendations to the task force. Modifies provisions
17-concerning records and information about the human
18-immunodeficiency virus (HIV) and acquired immune deficiency
12+duties of the division of the disability and rehabilitative services
13+advisory council. Requires the services for individuals with intellectual
14+and other developmental disabilities task force to establish a
15+subcommittee to make certain recommendations to the task force.
16+Modifies provisions concerning records and information about the
17+human immunodeficiency virus (HIV) and acquired immune deficiency
1918 syndrome. Repeals provisions concerning the following: (1) Reports to
2019 a health officer about a person who is believed to be a serious and
2120 present risk to the health of others. (2) Physician notification to: (A) a
2221 patient with a serious communicable disease; (B) a health officer; and
23-(C) a person at risk. Changes the membership on the Indiana board of
24-pharmacy. Removes the requirement that a qualifying pharmacist is
25-responsible for the legal operations of a pharmacy. Specifies
26-responsibilities of pharmacists concerning duties previously
2722 (Continued next page)
2823 Effective: Upon passage; July 1, 2022.
2924 Clere, Olthoff, Davisson J.,
3025 Shackleford
3126 January 6, 2022, read first time and referred to Committee on Public Health.
3227 January 20, 2022, amended, reported — Do Pass.
33-January 27, 2022, read second time, amended, ordered engrossed.
3428 HB 1158—LS 7067/DI 137 Digest Continued
29+(C) a person at risk. Provides that for purposes of enforcing the health
30+professions standards of practice, a practitioner includes an individual
31+who holds or has held a license. Changes the membership on the
32+Indiana board of pharmacy. Removes the requirement that a qualifying
33+pharmacist is responsible for the legal operations of a pharmacy.
34+Specifies responsibilities of pharmacists concerning duties previously
3535 responsible by a qualifying pharmacist. Allows a qualified pharmacy
3636 technician to administer immunizations delegated by the pharmacist.
3737 (Current law allows pharmacy technicians to administer influenza and
3838 coronavirus disease immunizations.) Amends requirements for remote
39-pharmacies. Adds an exception to the definition of "wholesale
40-distribution" for prescription drugs. Repeals certain offenses
41-concerning: (1) notification, reporting, and investigation related to
42-communicable diseases; and (2) the donation, sale, or transfer of semen
43-that contains antibodies for HIV. Makes technical and conforming
44-changes.
45-HB 1158—LS 7067/DI 137HB 1158—LS 7067/DI 137 Reprinted
46-January 28, 2022
39+pharmacies. Adds exception to definition of "wholesale distribution"
40+for prescription drugs. Repeals certain offenses concerning: (1)
41+notification, reporting, and investigation related to communicable
42+diseases; and (2) the donation, sale, or transfer of semen that contains
43+antibodies for HIV. Makes technical and conforming changes.
44+HB 1158—LS 7067/DI 137HB 1158—LS 7067/DI 137 January 20, 2022
4745 Second Regular Session of the 122nd General Assembly (2022)
4846 PRINTING CODE. Amendments: Whenever an existing statute (or a section of the Indiana
4947 Constitution) is being amended, the text of the existing provision will appear in this style type,
5048 additions will appear in this style type, and deletions will appear in this style type.
5149 Additions: Whenever a new statutory provision is being enacted (or a new constitutional
5250 provision adopted), the text of the new provision will appear in this style type. Also, the
5351 word NEW will appear in that style type in the introductory clause of each SECTION that adds
5452 a new provision to the Indiana Code or the Indiana Constitution.
5553 Conflict reconciliation: Text in a statute in this style type or this style type reconciles conflicts
5654 between statutes enacted by the 2021 Regular Session of the General Assembly.
5755 HOUSE BILL No. 1158
5856 A BILL FOR AN ACT to amend the Indiana Code concerning
5957 health.
6058 Be it enacted by the General Assembly of the State of Indiana:
6159 1 SECTION 1. IC 5-10-8-7.3, AS AMENDED BY P.L.133-2020,
6260 2 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
6361 3 JULY 1, 2022]: Sec. 7.3. (a) As used in this section, "covered
6462 4 individual" means an individual who is:
6563 5 (1) covered under a self-insurance program established under
6664 6 section 7(b) of this chapter to provide group health coverage; or
6765 7 (2) entitled to services under a contract with a prepaid health care
6866 8 delivery plan that is entered into or renewed under section 7(c) of
6967 9 this chapter.
7068 10 (b) As used in this section, "early intervention services" means
7169 11 services provided to a first steps child under IC 12-12.7-2 and 20
7270 12 U.S.C. 1432(4).
7371 13 (c) As used in this section, "first steps child" means an infant or
7472 14 toddler from birth through two (2) years of age who is enrolled in the
7573 15 Indiana first steps program and is a covered individual.
7674 16 (d) As used in this section, "first steps program" refers to the
7775 17 program established under IC 12-12.7-2 and 20 U.S.C. 1431 et seq. to
7876 HB 1158—LS 7067/DI 137 2
7977 1 meet the needs of:
8078 2 (1) children who are eligible for early intervention services; and
8179 3 (2) their families.
8280 4 The term includes the coordination of all available federal, state, local,
8381 5 and private resources available to provide early intervention services
8482 6 within Indiana.
8583 7 (e) As used in this section, "health benefits plan" means a:
8684 8 (1) self-insurance program established under section 7(b) of this
8785 9 chapter to provide group health coverage; or
8886 10 (2) contract with a prepaid health care delivery plan that is
8987 11 entered into or renewed under section 7(c) of this chapter.
9088 12 (f) A health benefits plan that provides coverage for early
9189 13 intervention services shall reimburse the first steps program a monthly
9290 14 fee established by the division of disability and rehabilitative services
9391 15 established by IC 12-9-1-1. Except when the monthly fee is less than
9492 16 the product determined under IC 12-12.7-2-23(b), the monthly fee shall
9593 17 be provided instead of claims processing of individual claims.
9694 18 (g) The reimbursement required under subsection (f) may not be
9795 19 applied to any annual or aggregate lifetime limit on the first steps
9896 20 child's coverage under the health benefits plan.
9997 21 (h) The first steps program may pay required deductibles,
10098 22 copayments, or other out-of-pocket expenses for a first steps child
10199 23 directly to a provider. A health benefits plan shall apply any payments
102100 24 made by the first steps program to the health benefits plan's
103101 25 deductibles, copayments, or other out-of-pocket expenses according to
104102 26 the terms and conditions of the health benefits plan.
105103 27 (i) A health benefits plan may not require authorization for services
106104 28 specified in the covered individual's individualized family service plan,
107105 29 if those services are a covered benefit under the plan, once the
108106 30 individualized family service plan is signed by a physician, a physician
109107 31 assistant, or an advanced practice registered nurse.
110108 32 (j) The department of insurance shall adopt rules under IC 4-22-2
111109 33 to ensure compliance with this section.
112110 34 SECTION 2. IC 12-8-2.5-3, AS ADDED BY P.L.160-2012,
113111 35 SECTION 17, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
114112 36 JULY 1, 2022]: Sec. 3. Unless Except as provided in IC 12-9-4-7, or
115113 37 otherwise provided by a another statute, this chapter applies to the
116114 38 following:
117115 39 (1) The following advisory councils:
118116 40 (A) The division of disability and rehabilitative services
119117 41 advisory council.
120118 42 (B) The division of family resources advisory council.
121119 HB 1158—LS 7067/DI 137 3
122120 1 (C) The division of mental health and addiction advisory
123121 2 council.
124122 3 (2) A body:
125123 4 (A) established by statute for a division; and
126124 5 (B) whose enabling statute makes this chapter applicable to
127125 6 the body.
128126 7 SECTION 3. IC 12-9-4-2, AS AMENDED BY P.L.141-2006,
129127 8 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
130128 9 JULY 1, 2022]: Sec. 2. The division of disability and rehabilitative
131129 10 services advisory council is established to advise and assist the
132130 11 division of disability and rehabilitative services in its effort to
133131 12 develop and sustain a system of supports and services for people
134132 13 with intellectual and developmental disabilities. The council will
135133 14 provide technical expertise and lived experiences and advise on
136134 15 specific areas such as:
137135 16 (1) technology;
138136 17 (2) health;
139137 18 (3) policy;
140138 19 (4) law;
141139 20 (5) marketing;
142140 21 (6) public relations;
143141 22 (7) provider services; and
144142 23 (8) advocacy.
145143 24 SECTION 4. IC 12-9-4-3 IS AMENDED TO READ AS FOLLOWS
146144 25 [EFFECTIVE JULY 1, 2022]: Sec. 3. The council consists of the
147145 26 following eleven (11) sixteen (16) members:
148146 27 (1) The director.
149147 28 (2) Ten (10) individuals:
150148 29 (A) appointed by the secretary; and
151149 30 (B) who have a recognized knowledge of or interest in the
152150 31 programs administered by the division.
153151 32 (2) An individual representing The Arc of Indiana, appointed
154152 33 by The Arc of Indiana.
155153 34 (3) An individual representing the Indiana Association of
156154 35 Rehabilitation Facilities (INARF), appointed by INARF.
157155 36 (4) An individual representing the Self-Advocates of Indiana,
158156 37 appointed by the Self-Advocates of Indiana.
159157 38 (5) A representative of the governor's council for people with
160158 39 disabilities established by IC 4-23-29-7, appointed by the
161159 40 director.
162160 41 (6) A representative of a case management provider
163161 42 contracting with the bureau of developmental disabilities
164162 HB 1158—LS 7067/DI 137 4
165163 1 services established by IC 12-11-1.1-1 to provide family
166164 2 supports Medicaid waiver and community integration
167165 3 habilitation Medicaid waiver case management services,
168166 4 appointed by the director.
169167 5 (7) An individual representing the Indiana Association of
170168 6 Behavior Consultants, appointed by the Indiana Association
171169 7 of Behavior Consultants.
172170 8 (8) An individual representing the Indiana Institute on
173171 9 Disability and Community, appointed by the Indiana Institute
174172 10 on Disability and Community.
175173 11 (9) An individual representing the Indiana Resource Center
176174 12 for Families with Special Needs (INSOURCE), appointed by
177175 13 INSOURCE.
178176 14 (10) An individual representing Indiana Disability Rights,
179177 15 appointed by Indiana Disability Rights.
180178 16 (11) An individual representing Indiana Family to Family,
181179 17 appointed by Indiana Family to Family.
182180 18 (12) Two (2) members, appointed by the director, each of
183181 19 whom is an individual with an intellectual or other
184182 20 developmental disability.
185183 21 (13) Two (2) members, appointed by the director, each of
186184 22 whom is an immediate or extended family member of an
187185 23 individual with an intellectual or other developmental
188186 24 disability.
189187 25 (14) One (1) member, appointed by the director, who is
190188 26 employed by an agency that provides services to people with
191189 27 intellectual or other developmental disabilities.
192190 28 SECTION 5. IC 12-9-4-4, AS AMENDED BY P.L.160-2012,
193191 29 SECTION 23, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
194192 30 JULY 1, 2022]: Sec. 4. Each member of the council appointed under
195193 31 section 3(2) through 3(14) of this chapter has a fixed term as provided
196194 32 in IC 12-8-2.5-4. serves at the will of the appointing authority.
197195 33 SECTION 6. IC 12-9-4-6 IS AMENDED TO READ AS FOLLOWS
198196 34 [EFFECTIVE JULY 1, 2022]: Sec. 6. The council shall meet at least
199197 35 monthly six (6) times annually and is subject to special meetings at the
200198 36 call of its presiding officer.
201199 37 SECTION 7. IC 12-9-4-6.5 IS ADDED TO THE INDIANA CODE
202200 38 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
203201 39 1, 2022]: Sec. 6.5. (a) The division shall provide the council with a
204202 40 quarterly report containing the following information relating to
205203 41 Medicaid waivers:
206204 42 (1) The number of current applications for an emergency
207205 HB 1158—LS 7067/DI 137 5
208206 1 placement priority waiver.
209207 2 (2) The number of individuals served on a particular
210208 3 Medicaid waiver.
211209 4 (3) The number of individuals who are currently on a wait list
212210 5 to be included in a Medicaid waiver.
213211 6 (b) The division shall provide the council with a quarterly
214212 7 report containing the following information relating to vocational
215213 8 rehabilitation services:
216214 9 (1) A status report of the division's effort to fill vocational
217215 10 counselor vacancies.
218216 11 (2) A status report of the order of selection.
219217 12 (3) The number of individuals who submitted applications for
220218 13 vocational rehabilitation services.
221219 14 (4) The number of individuals who are currently on a wait list
222220 15 to obtain vocational rehabilitation services.
223221 16 (5) The number of individuals who are currently receiving
224222 17 vocational rehabilitation services.
225223 18 (c) The division shall provide the council with an annual report
226224 19 summarizing any rate analysis, study, or review conducted by the
227225 20 division.
228226 21 (d) The division shall report to the council prior to any
229227 22 submission of a Medicaid waiver amendment regarding the
230228 23 changes being sought and an explanation of purpose.
231229 24 (e) The division shall report to the council prior to any
232230 25 submission for a renewal of a Medicaid waiver:
233231 26 (1) any changes being proposed to the Medicaid waiver;
234232 27 (2) the current and projected needs of each geographic area
235233 28 of Indiana for residential services for individuals with
236234 29 intellectual or developmental disabilities; and
237235 30 (3) the availability of developmental or vocational services to
238236 31 individuals with an intellectual or developmental disability
239237 32 living in their own home.
240238 33 SECTION 8. IC 12-9-4-7, AS AMENDED BY P.L.160-2012,
241239 34 SECTION 24, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
242240 35 JULY 1, 2022]: Sec. 7. IC 12-8-2.5 applies IC 12-8-2.5-9 through
243241 36 IC 12-8-2.5-11.5 apply to the council.
244242 37 SECTION 9. IC 12-11-15.5-4.5 IS ADDED TO THE INDIANA
245243 38 CODE AS A NEW SECTION TO READ AS FOLLOWS
246244 39 [EFFECTIVE UPON PASSAGE]: Sec. 4.5. (a) The task force shall
247245 40 establish a subcommittee to make recommendations to the task
248246 41 force regarding the:
249247 42 (1) establishment of a statewide training curriculum for
250248 HB 1158—LS 7067/DI 137 6
251249 1 individuals who provide services to individuals with an
252250 2 intellectual or other developmental disability;
253251 3 (2) feasibility of establishing training certification;
254252 4 (3) establishment of a statewide training registry; and
255253 5 (4) feasibility of a pilot project to implement any
256254 6 recommendations made under this section.
257255 7 (b) Not later than September 1, 2022, the subcommittee shall
258256 8 prepare and submit to the task force recommendations made by
259257 9 the subcommittee.
260258 10 (c) This section expires January 1, 2024.
261259 11 SECTION 10. IC 12-11-15.5-4.6 IS ADDED TO THE INDIANA
262260 12 CODE AS A NEW SECTION TO READ AS FOLLOWS
263261 13 [EFFECTIVE UPON PASSAGE]: Sec. 4.6. (a) The task force shall
264262 14 establish a subcommittee to make recommendations to the task
265263 15 force regarding:
266264 16 (1) current trends related to health and safety requests for the
267265 17 community integration habilitation Medicaid waiver or any
268266 18 other service; and
269267 19 (2) the feasibility of the division establishing a pilot program
270268 20 to create special service review teams to assist families or
271269 21 individuals in a crisis situation to identify available resources
272270 22 and sources of assistance.
273271 23 (b) Not later than September 1, 2022, the subcommittee shall
274272 24 prepare and submit to the task force recommendations made by
275273 25 the subcommittee.
276274 26 (c) This section expires January 1, 2024.
277275 27 SECTION 11. IC 12-28-5-10, AS AMENDED BY P.L.210-2015,
278276 28 SECTION 62, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
279277 29 JULY 1, 2022]: Sec. 10. The division of disability and rehabilitative
280278 30 services shall do the following:
281279 31 (1) Determine the current and projected needs of each geographic
282280 32 area of Indiana for residential services for individuals with a
283281 33 developmental disability and, beginning July 1, 2012, annually
284282 34 report the findings to the division of disability and rehabilitative
285283 35 services advisory council established by IC 12-9-4-2.
286284 36 (2) Determine how the provision of developmental or vocational
287285 37 services for residents in these geographic areas affects the
288286 38 availability of developmental or vocational services to individuals
289287 39 with a developmental disability living in their own homes and,
290288 40 beginning July 1, 2012, report the findings to the division of
291289 41 disability and rehabilitative services advisory council established
292290 42 by IC 12-9-4-2.
293291 HB 1158—LS 7067/DI 137 7
294292 1 (3) (1) Develop standards for licensure of supervised group living
295293 2 facilities regarding the following:
296294 3 (A) A sanitary and safe environment for residents and
297295 4 employees.
298296 5 (B) Classification of supervised group living facilities.
299297 6 (C) Any other matters that will ensure that the residents will
300298 7 receive a residential environment.
301299 8 (4) (2) Develop standards for the approval of entities providing
302300 9 supported living services.
303301 10 SECTION 12. IC 12-28-5-12, AS AMENDED BY P.L.210-2015,
304302 11 SECTION 63, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
305303 12 JULY 1, 2022]: Sec. 12. (a) The division may license only those
306304 13 supervised group living facilities that:
307305 14 (1) meet the standards established under section 10 of this
308306 15 chapter; and
309307 16 (2) are necessary to provide adequate services to individuals with
310308 17 a developmental disability in that geographic area.
311309 18 (b) Notwithstanding 460 IAC 9-3-7(c) and 460 IAC 9-3-7(d), the
312310 19 division shall license one (1) supervised group living facility that is
313311 20 located less than one thousand (1,000) feet from another supervised
314312 21 group living facility or a sheltered workshop under the following
315313 22 conditions:
316314 23 (1) Both of the supervised group living facilities meet all
317315 24 standards for licensure as provided in section 10(3) 10(1) of this
318316 25 chapter.
319317 26 (2) Both of the supervised group living facilities are built on land
320318 27 that is owned by one (1) private entity.
321319 28 (3) The supervised group living facilities provides job
322320 29 opportunities for residents of the supervised group living
323321 30 facilities, as appropriate.
324322 31 (c) The division may approve an entity to provide supported living
325323 32 services only if the entity meets the standards established under section
326324 33 10 of this chapter.
327325 34 SECTION 13. IC 16-18-2-275 IS AMENDED TO READ AS
328326 35 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 275. (a) "Person at
329327 36 risk", for purposes of IC 16-41-7-4, has the meaning set forth in
330328 37 IC 16-41-7-4(a).
331329 38 (b) "Person at risk", for purposes of IC 16-41-7-1, and IC 16-41-7-3,
332330 39 has the meaning set forth in IC 16-41-7-1(c).
333331 40 SECTION 14. IC 16-18-2-328, AS AMENDED BY P.L.112-2020,
334332 41 SECTION 10, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
335333 42 JULY 1, 2022]: Sec. 328. "Serious and present risk to the health of
336334 HB 1158—LS 7067/DI 137 8
337335 1 others", for purposes of IC 16-41-7 and IC 16-41-9, has the meaning set
338336 2 forth in IC 16-41-7-2. means an individual with a communicable
339337 3 disease who meets the following conditions:
340338 4 (1) The individual with a communicable disease engages
341339 5 repeatedly in a behavior that has been demonstrated
342340 6 epidemiologically (as defined by rules adopted by the state
343341 7 department under IC 4-22-2) to transmit a serious
344342 8 communicable disease or that indicates a careless disregard
345343 9 for the transmission of the disease to others.
346344 10 (2) The individual with a communicable disease's past
347345 11 behavior or statements indicate an imminent risk that the
348346 12 individual with a communicable disease will engage in
349347 13 behavior that transmits a serious communicable disease to
350348 14 others.
351349 15 (3) The individual with a communicable disease has failed or
352350 16 refused to carry out the individual with a communicable
353351 17 disease's duty to inform under IC 16-41-7-1.
354352 18 SECTION 15. IC 16-41-1-5 IS ADDED TO THE INDIANA CODE
355353 19 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
356354 20 1, 2022]: Sec. 5. Local health officers may submit advisory
357355 21 guidelines to the state department to implement this chapter. The
358356 22 state department shall fully consider such advisory guidelines
359357 23 before adopting a rule under IC 4-22-2-29 implementing this
360358 24 chapter.
361359 25 SECTION 16. IC 16-41-2-3 IS AMENDED TO READ AS
362360 26 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The following
363361 27 persons shall report to the state department each case of human
364362 28 immunodeficiency virus (HIV) infection, including each confirmed
365363 29 case of acquired immune deficiency syndrome (AIDS):
366364 30 (1) A licensed physician.
367365 31 (2) A hospital licensed under IC 16-21.
368366 32 (3) A medical laboratory.
369367 33 (4) The department of correction.
370368 34 The report must comply with rules adopted by the state department.
371369 35 (b) The records of the state department must indicate, if known:
372370 36 (1) whether the individual had undergone any blood transfusions
373371 37 before being diagnosed as having AIDS or HIV or AIDS
374372 38 infection;
375373 39 (2) the place the transfusions took place;
376374 40 (3) the blood center that furnished the blood; and
377375 41 (4) any other known risk factors.
378376 42 (c) A case report concerning HIV infection that does not involve a
379377 HB 1158—LS 7067/DI 137 9
380378 1 confirmed case of AIDS submitted to the state department under this
381379 2 section that involves an individual:
382380 3 (1) enrolled in a formal research project for which a written study
383381 4 protocol has been filed with the state department;
384382 5 (2) who is tested anonymously at a designated counseling or
385383 6 testing site; or
386384 7 (3) who is tested by a health care provider permitted by rule by
387385 8 the state department to use a number identifier code;
388386 9 may not include the name or other identifying characteristics of the
389387 10 individual tested.
390388 11 SECTION 17. IC 16-41-2-5 IS AMENDED TO READ AS
391389 12 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 5. A person who
392390 13 reports information as required by this chapter does not satisfy the
393391 14 duties that exist under IC 16-41-7-3 or in other laws to provide
394392 15 notification to persons identified as being at significant risk of being
395393 16 infected by the individual who is the subject of the report.
396394 17 SECTION 18. IC 16-41-3-1, AS AMENDED BY P.L.112-2020,
397395 18 SECTION 14, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
398396 19 JULY 1, 2022]: Sec. 1. (a) The state department may adopt rules under
399397 20 IC 4-22-2 concerning the compilation for statistical purposes of
400398 21 information collected under IC 16-41-2.
401399 22 (b) The state department shall adopt procedures to gather, monitor,
402400 23 and tabulate case reports of incidents involving serious communicable
403401 24 diseases or unnatural outbreaks of diseases known or suspected to be
404402 25 used as weapons. The state department shall specifically engage in
405403 26 medical surveillance, tabulation, and reporting of confirmed or
406404 27 suspected cases set forth by the Centers for Disease Control and
407405 28 Prevention of the United States Department of Health and Human
408406 29 Services and the United States Public Health Service of the United
409407 30 States Department of Health and Human Services.
410408 31 (c) The state department shall notify the:
411409 32 (1) department of homeland security;
412410 33 (2) Indiana State Police; and
413411 34 (3) county health department and local law enforcement agency
414412 35 having jurisdiction of each unnatural outbreak or reported case
415413 36 described in subsection (b);
416414 37 as soon as possible after the state department receives a report under
417415 38 subsection (b). Notification under this subsection must be made not
418416 39 more than twenty-four (24) hours after receiving a report.
419417 40 (d) Local health officers may submit advisory guidelines to the
420418 41 state department to implement this chapter. The state department
421419 42 shall fully consider such advisory guidelines before adopting a rule
422420 HB 1158—LS 7067/DI 137 10
423421 1 under IC 4-22-2-29 implementing this chapter.
424422 2 SECTION 19. IC 16-41-5-4 IS ADDED TO THE INDIANA CODE
425423 3 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
426424 4 1, 2022]: Sec. 4. Local health officers may submit advisory
427425 5 guidelines to the state department to implement this chapter. The
428426 6 state department shall fully consider such advisory guidelines
429427 7 before adopting a rule under IC 4-22-2-29 implementing this
430428 8 chapter.
431429 9 SECTION 20. IC 16-41-6-11, AS AMENDED BY P.L.112-2020,
432430 10 SECTION 21, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
433431 11 JULY 1, 2022]: Sec. 11. (a) The state department shall adopt rules
434432 12 under IC 4-22-2 that include procedures:
435433 13 (1) to inform the woman of the test results under this chapter,
436434 14 whether they are positive or negative;
437435 15 (2) for explaining the side effects of any treatment for HIV if the
438436 16 test results under this chapter are positive; and
439437 17 (3) to establish a process for a woman who tests positive under
440438 18 this chapter to appeal the woman's status on a waiting list on a
441439 19 treatment program for which the woman is eligible. The rule
442440 20 must:
443441 21 (A) include a requirement that the state department make a
444442 22 determination in the process described in this subdivision not
445443 23 later than seventy-two (72) hours after the state department
446444 24 receives all the requested medical information; and
447445 25 (B) set forth the necessary medical information that must be
448446 26 provided to the state department and reviewed by the state
449447 27 department in the process described in this subdivision.
450448 28 (b) The state department shall maintain rules under IC 4-22-2 that
451449 29 set forth standards to provide to women who are pregnant, before
452450 30 delivery, at delivery, and after delivery, information concerning HIV.
453451 31 The rules must include:
454452 32 (1) an explanation of the nature of AIDS and HIV;
455453 33 (2) information concerning discrimination and legal protections;
456454 34 (3) information concerning the duty to notify persons at risk as
457455 35 described in IC 16-41-7-1;
458456 36 (4) information about risk behaviors for HIV transmission;
459457 37 (5) information about the risk of transmission through breast
460458 38 feeding;
461459 39 (6) notification that if the woman chooses not to be tested for HIV
462460 40 before delivery, at delivery the child will be tested subject to
463461 41 section 4 of this chapter;
464462 42 (7) procedures for obtaining informed, written consent for testing
465463 HB 1158—LS 7067/DI 137 11
466464 1 under this chapter;
467465 2 (8) procedures for post-test counseling by a health care provider
468466 3 when the test results are communicated to the woman, whether
469467 4 the results are positive or negative;
470468 5 (9) procedures for referral for physical and emotional services if
471469 6 the test results are positive;
472470 7 (10) procedures for explaining the importance of immediate entry
473471 8 into medical care if the test results are positive; and
474472 9 (11) procedures for explaining that the use of antiretroviral drugs
475473 10 and other medical interventions lessen the likelihood of
476474 11 transmitting HIV to the child during childbirth.
477475 12 SECTION 21. IC 16-41-7-2 IS REPEALED [EFFECTIVE JULY 1,
478476 13 2022]. Sec. 2. (a) An individual with a communicable disease is a
479477 14 "serious and present risk to the health of others" under the following
480478 15 conditions:
481479 16 (1) The individual with a communicable disease engages
482480 17 repeatedly in a behavior that has been demonstrated
483481 18 epidemiologically (as defined by rules adopted by the state
484482 19 department under IC 4-22-2) to transmit a serious communicable
485483 20 disease or that indicates a careless disregard for the transmission
486484 21 of the disease to others.
487485 22 (2) The individual with a communicable disease's past behavior
488486 23 or statements indicate an imminent risk that the individual with
489487 24 a communicable disease will engage in behavior that transmits a
490488 25 serious communicable disease to others.
491489 26 (3) The individual with a communicable disease has failed or
492490 27 refused to carry out the individual with a communicable disease's
493491 28 duty to inform under section 1 of this chapter.
494492 29 (b) A person who has reasonable cause to believe that a person:
495493 30 (1) is a serious and present risk to the health of others as
496494 31 described in subsection (a);
497495 32 (2) has engaged in noncompliant behavior; or
498496 33 (3) is suspected of being a person at risk (as described in section
499497 34 1 of this chapter);
500498 35 may report that information to a health officer.
501499 36 (c) A person who makes a report under subsection (b) in good faith
502500 37 is not subject to liability in a civil, an administrative, a disciplinary, or
503501 38 a criminal action.
504502 39 (d) A person who knowingly or recklessly makes a false report
505503 40 under subsection (b) is civilly liable for actual damages suffered by a
506504 41 person reported on and for punitive damages.
507505 42 SECTION 22. IC 16-41-7-3 IS REPEALED [EFFECTIVE JULY 1,
508506 HB 1158—LS 7067/DI 137 12
509507 1 2022]. Sec. 3. (a) A licensed physician who diagnoses, treats, or
510508 2 counsels a patient with a serious communicable disease shall inform
511509 3 the patient of the patient's duty under section 1 of this chapter.
512510 4 (b) A physician described in subsection (a) may notify the
513511 5 following:
514512 6 (1) A health officer if the physician has reasonable cause to
515513 7 believe that a patient:
516514 8 (A) is a serious and present risk to the health of others as
517515 9 described in section 2(a) of this chapter;
518516 10 (B) has engaged in noncompliant behavior; or
519517 11 (C) is suspected of being a person at risk (as defined in section
520518 12 1 of this chapter).
521519 13 (2) A person at risk (as defined in section 1 of this chapter) or a
522520 14 person legally responsible for the patient if the physician:
523521 15 (A) has medical verification that the patient is an individual
524522 16 with a communicable disease;
525523 17 (B) knows the identity of the person at risk;
526524 18 (C) has a reasonable belief of a significant risk of harm to the
527525 19 identified person at risk;
528526 20 (D) has reason to believe the identified person at risk has not
529527 21 been informed and will not be informed of the risk by the
530528 22 patient or another person; and
531529 23 (E) has made reasonable efforts to inform the individual with
532530 24 a communicable disease of the physician's intent to make or
533531 25 cause the state department of health to make a disclosure to
534532 26 the person at risk.
535533 27 (c) A physician who notifies a person at risk under this section shall
536534 28 do the following:
537535 29 (1) Identify the serious communicable disease.
538536 30 (2) Inform the person of available health care measures such as
539537 31 counseling and testing.
540538 32 (d) A physician who in good faith provides notification under this
541539 33 section is not subject to liability in a civil, an administrative, a
542540 34 disciplinary, or a criminal action.
543541 35 (e) A patient's privilege with respect to a physician under
544542 36 IC 34-46-3-1 is waived regarding:
545543 37 (1) notification under subsection (b); and
546544 38 (2) information provided about a patient's noncompliant behavior
547545 39 in an investigation or action under this chapter, IC 16-41-2,
548546 40 IC 16-41-3, IC 16-41-5, IC 16-41-6, IC 16-41-8, IC 16-41-9,
549547 41 IC 16-41-13, IC 16-41-14, and IC 16-41-16.
550548 42 (f) A physician's immunity from liability under subsection (d)
551549 HB 1158—LS 7067/DI 137 13
552550 1 applies only to the provision of information reasonably calculated to
553551 2 protect an identified person who is at epidemiological risk of infection.
554552 3 (g) A physician who notifies a person under this section is also
555553 4 required to satisfy the reporting requirements under IC 16-41-2-2
556554 5 through IC 16-41-2-8.
557555 6 SECTION 23. IC 16-41-7-4 IS REPEALED [EFFECTIVE JULY 1,
558556 7 2022]. Sec. 4. (a) As used in this section, "person at risk" means an
559557 8 individual who in the best judgment of a licensed physician:
560558 9 (1) has engaged in high risk activity (as defined in section 1 of
561559 10 this chapter); or
562560 11 (2) is in imminent risk of engaging in high risk activity (as
563561 12 defined in section 1 of this chapter).
564562 13 (b) If a health officer is notified in writing by a physician under
565563 14 section 3(b)(1)(A) of this chapter of a patient:
566564 15 (1) for whom the physician has medical verification that the
567565 16 patient is an individual with a communicable disease; and
568566 17 (2) who, in the best judgment of the physician, is a serious and
569567 18 present risk to the health of others;
570568 19 the health officer shall make an investigation of the individual with a
571569 20 communicable disease as authorized in IC 16-41-5-2 to determine
572570 21 whether the environmental conditions surrounding the individual with
573571 22 a communicable disease or the conduct of the individual with a
574572 23 communicable disease requires the intervention by the health officer or
575573 24 designated health official to prevent the transmission of disease to
576574 25 others.
577575 26 (c) If the state department is requested in writing by a physician who
578576 27 has complied with the requirements of section 3(b)(2) of this chapter
579577 28 to notify a person at risk, the state department shall notify the person
580578 29 at risk unless, in the opinion of the state department, the person at risk:
581579 30 (1) has already been notified;
582580 31 (2) will be notified; or
583581 32 (3) will otherwise be made aware that the person is a person at
584582 33 risk.
585583 34 (d) The state department shall establish a confidential registry of all
586584 35 persons submitting written requests under subsection (c).
587585 36 (e) The state department shall adopt rules under IC 4-22-2 to
588586 37 implement this section. Local health officers may submit advisory
589587 38 guidelines to the state department to implement this chapter,
590588 39 IC 16-41-1, IC 16-41-3, IC 16-41-5, IC 16-41-8, or IC 16-41-9. The
591589 40 state department shall fully consider such advisory guidelines before
592590 41 adopting a rule under IC 4-22-2-29 implementing this chapter,
593591 42 IC 16-41-1, IC 16-41-3, IC 16-41-5, IC 16-41-8, or IC 16-41-9.
594592 HB 1158—LS 7067/DI 137 14
595593 1 SECTION 24. IC 16-41-7-5 IS REPEALED [EFFECTIVE JULY 1,
596594 2 2022]. Sec. 5. (a) Except as provided in IC 35-45-21-3, a person who
597595 3 recklessly violates or fails to comply with this chapter commits a Class
598596 4 B misdemeanor.
599597 5 (b) Each day a violation continues constitutes a separate offense.
600598 6 SECTION 25. IC 16-41-8-7 IS ADDED TO THE INDIANA CODE
601599 7 AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY
602600 8 1, 2022]: Sec. 7. Local health officers may submit advisory
603601 9 guidelines to the state department to implement this chapter. The
604602 10 state department shall fully consider such advisory guidelines
605603 11 before adopting a rule under IC 4-22-2-29 implementing this
606604 12 chapter.
607605 13 SECTION 26. IC 16-41-9-7, AS AMENDED BY P.L.112-2020,
608606 14 SECTION 36, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
609607 15 JULY 1, 2022]: Sec. 7. (a) An individual with a communicable disease
610608 16 who:
611609 17 (1) poses a serious and present risk to the health of others;
612610 18 (2) has been voluntarily admitted to a hospital or other facility for
613611 19 the treatment of tuberculosis or another serious communicable
614612 20 disease; and
615613 21 (3) who leaves the facility without authorized leave or against
616614 22 medical advice or who fails to return from authorized leave;
617615 23 shall be reported to a health officer by the facility not more than
618616 24 twenty-four (24) hours after discovery of the individual with a
619617 25 communicable disease's absence.
620618 26 (b) If a health officer fails or refuses to institute or complete
621619 27 necessary legal measures to prevent a health threat (as defined in
622620 28 IC 16-41-7-2) by the individual with a communicable disease, the case
623621 29 shall be referred to a designated health official for appropriate action
624622 30 under this article.
625623 31 SECTION 27. IC 16-41-9-16 IS ADDED TO THE INDIANA
626624 32 CODE AS A NEW SECTION TO READ AS FOLLOWS
627625 33 [EFFECTIVE JULY 1, 2022]: Sec. 16. Local health officers may
628626 34 submit advisory guidelines to the state department to implement
629627 35 this chapter. The state department shall fully consider such
630628 36 advisory guidelines before adopting a rule under IC 4-22-2-29
631629 37 implementing this chapter.
632630 38 SECTION 28. IC 16-41-14-17 IS REPEALED [EFFECTIVE JULY
633631 39 1, 2022]. Sec. 17. (a) This section does not apply to a person who
634632 40 transfers for research purposes semen that contains antibodies for the
635633 41 human immunodeficiency virus (HIV).
636634 42 (b) A person who, for the purpose of artificial insemination,
637635 HB 1158—LS 7067/DI 137 15
638636 1 recklessly, knowingly, or intentionally donates, sells, or transfers semen
639637 2 that contains antibodies for the human immunodeficiency virus (HIV)
640638 3 commits transferring contaminated semen, a Level 5 felony. The
641639 4 offense is a Level 4 felony if the offense results in the transmission of
642640 5 the virus to another person.
643641 6 SECTION 29. IC 21-38-6-1, AS AMENDED BY P.L.133-2020,
644642 7 SECTION 18, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
645643 8 JULY 1, 2022]: Sec. 1. (a) An employee health plan that provides
646644 9 coverage for early intervention services shall reimburse the first steps
647645 10 program a monthly fee established by the division of disability and
648646 11 rehabilitative services. Except when the monthly fee is less than the
649647 12 product determined under IC 12-12.7-2-23(b), the monthly fee shall be
650648 13 provided instead of claims processing of individual claims.
651649 14 (b) An employee health plan may not require authorization for
652650 15 services specified in the covered individual's individualized family
653651 16 service plan, if those services are a covered benefit under the plan,
654652 17 once the individualized family service plan is signed by a physician, a
655653 18 physician assistant, or an advanced practice registered nurse.
656654 19 (c) The department of insurance shall adopt rules under IC 4-22-2
657655 20 to ensure compliance with this section.
658-21 SECTION 30. IC 25-26-13-2, AS AMENDED BY P.L.207-2021,
659-22 SECTION 30, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
660-23 UPON PASSAGE]: Sec. 2. As used in this chapter:
661-24 "Administering" means the direct application of a drug to the body
662-25 of a person by injection, inhalation, ingestion, or any other means.
663-26 "Board" means the Indiana board of pharmacy.
664-27 "Controlled drugs" are those drugs on schedules I through V of the
665-28 federal Controlled Substances Act or on schedules I through V of
666-29 IC 35-48-2.
667-30 "Coronavirus disease" means the disease caused by the severe acute
668-31 respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
669-32 "Counseling" means effective communication between a pharmacist
670-33 and a patient concerning the contents, drug to drug interactions, route,
671-34 dosage, form, directions for use, precautions, and effective use of a
672-35 drug or device to improve the therapeutic outcome of the patient
673-36 through the effective use of the drug or device.
674-37 "Dispensing" means issuing one (1) or more doses of a drug in a
675-38 suitable container with appropriate labeling for subsequent
676-39 administration to or use by a patient.
677-40 "Drug" means:
678-41 (1) articles or substances recognized in the official United States
679-42 Pharmacopoeia, official National Formulary, official
656+21 SECTION 30. IC 25-1-9-2 IS AMENDED TO READ AS
657+22 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 2. (a) As used in this
658+23 chapter, "practitioner" means an individual who holds:
659+24 (1) an unlimited license, certificate, or registration;
660+25 (2) a limited or probationary license, certificate, or registration;
661+26 (3) a temporary license, certificate, registration, or permit;
662+27 (4) an intern permit; or
663+28 (5) a provisional license;
664+29 issued by the board regulating the profession in question, including a
665+30 certificate of registration issued under IC 25-20.
666+31 (b) The term includes all license statuses, including "active",
667+32 "expired", "retired", "inactive", and any other status that a
668+33 license may be held in.
669+34 SECTION 31. IC 25-26-13-2, AS AMENDED BY P.L.207-2021,
670+35 SECTION 30, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
671+36 UPON PASSAGE]: Sec. 2. As used in this chapter:
672+37 "Administering" means the direct application of a drug to the body
673+38 of a person by injection, inhalation, ingestion, or any other means.
674+39 "Board" means the Indiana board of pharmacy.
675+40 "Controlled drugs" are those drugs on schedules I through V of the
676+41 federal Controlled Substances Act or on schedules I through V of
677+42 IC 35-48-2.
680678 HB 1158—LS 7067/DI 137 16
681-1 Homeopathic Pharmacopoeia of the United States, or any
682-2 supplement to any of them;
683-3 (2) articles or substances intended for use in the diagnosis, cure,
684-4 mitigation, treatment, or prevention of disease in man or animals;
685-5 (3) articles other than food intended to affect the structure or any
686-6 function of the body of man or animals; or
687-7 (4) articles intended for use as a component of any article
688-8 specified in subdivisions (1) through (3) and devices.
689-9 "Drug order" means a written order in a hospital or other health care
690-10 institution for an ultimate user for any drug or device, issued and
691-11 signed by a practitioner, or an order transmitted by other means of
692-12 communication from a practitioner, which is immediately reduced to
693-13 writing by the pharmacist, registered nurse, or other licensed health
694-14 care practitioner authorized by the hospital or institution. The order
695-15 shall contain the name and bed number of the patient; the name and
696-16 strength or size of the drug or device; unless specified by individual
697-17 institution policy or guideline, the amount to be dispensed either in
698-18 quantity or days; adequate directions for the proper use of the drug or
699-19 device when it is administered to the patient; and the name of the
700-20 prescriber.
701-21 "Drug regimen review" means the retrospective, concurrent, and
702-22 prospective review by a pharmacist of a patient's drug related history
703-23 that includes the following areas:
704-24 (1) Evaluation of prescriptions or drug orders and patient records
705-25 for drug allergies, rational therapy contradictions, appropriate
706-26 dose and route of administration, appropriate directions for use,
707-27 or duplicative therapies.
708-28 (2) Evaluation of prescriptions or drug orders and patient records
709-29 for drug-drug, drug-food, drug-disease, and drug-clinical
710-30 laboratory interactions.
711-31 (3) Evaluation of prescriptions or drug orders and patient records
712-32 for adverse drug reactions.
713-33 (4) Evaluation of prescriptions or drug orders and patient records
714-34 for proper utilization and optimal therapeutic outcomes.
715-35 "Drug utilization review" means a program designed to measure and
716-36 assess on a retrospective and prospective basis the proper use of drugs.
717-37 "Device" means an instrument, apparatus, implement, machine,
718-38 contrivance, implant, in vitro reagent, or other similar or related article
719-39 including any component part or accessory, which is:
720-40 (1) recognized in the official United States Pharmacopoeia,
721-41 official National Formulary, or any supplement to them;
722-42 (2) intended for use in the diagnosis of disease or other conditions
679+1 "Coronavirus disease" means the disease caused by the severe acute
680+2 respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
681+3 "Counseling" means effective communication between a pharmacist
682+4 and a patient concerning the contents, drug to drug interactions, route,
683+5 dosage, form, directions for use, precautions, and effective use of a
684+6 drug or device to improve the therapeutic outcome of the patient
685+7 through the effective use of the drug or device.
686+8 "Dispensing" means issuing one (1) or more doses of a drug in a
687+9 suitable container with appropriate labeling for subsequent
688+10 administration to or use by a patient.
689+11 "Drug" means:
690+12 (1) articles or substances recognized in the official United States
691+13 Pharmacopoeia, official National Formulary, official
692+14 Homeopathic Pharmacopoeia of the United States, or any
693+15 supplement to any of them;
694+16 (2) articles or substances intended for use in the diagnosis, cure,
695+17 mitigation, treatment, or prevention of disease in man or animals;
696+18 (3) articles other than food intended to affect the structure or any
697+19 function of the body of man or animals; or
698+20 (4) articles intended for use as a component of any article
699+21 specified in subdivisions (1) through (3) and devices.
700+22 "Drug order" means a written order in a hospital or other health care
701+23 institution for an ultimate user for any drug or device, issued and
702+24 signed by a practitioner, or an order transmitted by other means of
703+25 communication from a practitioner, which is immediately reduced to
704+26 writing by the pharmacist, registered nurse, or other licensed health
705+27 care practitioner authorized by the hospital or institution. The order
706+28 shall contain the name and bed number of the patient; the name and
707+29 strength or size of the drug or device; unless specified by individual
708+30 institution policy or guideline, the amount to be dispensed either in
709+31 quantity or days; adequate directions for the proper use of the drug or
710+32 device when it is administered to the patient; and the name of the
711+33 prescriber.
712+34 "Drug regimen review" means the retrospective, concurrent, and
713+35 prospective review by a pharmacist of a patient's drug related history
714+36 that includes the following areas:
715+37 (1) Evaluation of prescriptions or drug orders and patient records
716+38 for drug allergies, rational therapy contradictions, appropriate
717+39 dose and route of administration, appropriate directions for use,
718+40 or duplicative therapies.
719+41 (2) Evaluation of prescriptions or drug orders and patient records
720+42 for drug-drug, drug-food, drug-disease, and drug-clinical
723721 HB 1158—LS 7067/DI 137 17
724-1 or the cure, mitigation, treatment, or prevention of disease in man
725-2 or other animals; or
726-3 (3) intended to affect the structure or any function of the body of
727-4 man or other animals and which does not achieve any of its
728-5 principal intended purposes through chemical action within or on
729-6 the body of man or other animals and which is not dependent
730-7 upon being metabolized for the achievement of any of its
731-8 principal intended purposes.
732-9 "Electronic data intermediary" means an entity that provides the
733-10 infrastructure that connects a computer system or another electronic
734-11 device used by a prescribing practitioner with a computer system or
735-12 another electronic device used by a pharmacy to facilitate the secure
736-13 transmission of:
737-14 (1) an electronic prescription order;
738-15 (2) a refill authorization request;
739-16 (3) a communication; and
740-17 (4) other patient care information;
741-18 between a practitioner and a pharmacy.
742-19 "Electronic signature" means an electronic sound, symbol, or
743-20 process:
744-21 (1) attached to or logically associated with a record; and
745-22 (2) executed or adopted by a person;
746-23 with the intent to sign the record.
747-24 "Electronically transmitted" or "electronic transmission" means the
748-25 transmission of a prescription in electronic form. The term does not
749-26 include the transmission of a prescription by facsimile.
750-27 "Investigational or new drug" means any drug which is limited by
751-28 state or federal law to use under professional supervision of a
752-29 practitioner authorized by law to prescribe or administer such drug.
753-30 "Legend drug" has the meaning set forth in IC 16-18-2-199.
754-31 "License" and "permit" are interchangeable and mean a written
755-32 certificate from the Indiana board of pharmacy for the practice of
756-33 pharmacy or the operation of a pharmacy.
757-34 "Medication therapy management" means a distinct service or group
758-35 of services that optimize therapeutic outcomes for individuals that are
759-36 independent of, but may occur in conjunction with, the provision of a
760-37 medication or medical device. The term includes the following
761-38 services:
762-39 (1) Performing or obtaining assessments of an individual's health
763-40 status.
764-41 (2) Formulating a medication treatment plan.
765-42 (3) Selecting, initiating, modifying, or administering medication
722+1 laboratory interactions.
723+2 (3) Evaluation of prescriptions or drug orders and patient records
724+3 for adverse drug reactions.
725+4 (4) Evaluation of prescriptions or drug orders and patient records
726+5 for proper utilization and optimal therapeutic outcomes.
727+6 "Drug utilization review" means a program designed to measure and
728+7 assess on a retrospective and prospective basis the proper use of drugs.
729+8 "Device" means an instrument, apparatus, implement, machine,
730+9 contrivance, implant, in vitro reagent, or other similar or related article
731+10 including any component part or accessory, which is:
732+11 (1) recognized in the official United States Pharmacopoeia,
733+12 official National Formulary, or any supplement to them;
734+13 (2) intended for use in the diagnosis of disease or other conditions
735+14 or the cure, mitigation, treatment, or prevention of disease in man
736+15 or other animals; or
737+16 (3) intended to affect the structure or any function of the body of
738+17 man or other animals and which does not achieve any of its
739+18 principal intended purposes through chemical action within or on
740+19 the body of man or other animals and which is not dependent
741+20 upon being metabolized for the achievement of any of its
742+21 principal intended purposes.
743+22 "Electronic data intermediary" means an entity that provides the
744+23 infrastructure that connects a computer system or another electronic
745+24 device used by a prescribing practitioner with a computer system or
746+25 another electronic device used by a pharmacy to facilitate the secure
747+26 transmission of:
748+27 (1) an electronic prescription order;
749+28 (2) a refill authorization request;
750+29 (3) a communication; and
751+30 (4) other patient care information;
752+31 between a practitioner and a pharmacy.
753+32 "Electronic signature" means an electronic sound, symbol, or
754+33 process:
755+34 (1) attached to or logically associated with a record; and
756+35 (2) executed or adopted by a person;
757+36 with the intent to sign the record.
758+37 "Electronically transmitted" or "electronic transmission" means the
759+38 transmission of a prescription in electronic form. The term does not
760+39 include the transmission of a prescription by facsimile.
761+40 "Investigational or new drug" means any drug which is limited by
762+41 state or federal law to use under professional supervision of a
763+42 practitioner authorized by law to prescribe or administer such drug.
766764 HB 1158—LS 7067/DI 137 18
767-1 therapy.
768-2 (4) Monitoring and evaluating an individual's response to therapy,
769-3 including safety and effectiveness.
770-4 (5) Performing a comprehensive medication review to identify,
771-5 resolve, and prevent medication related problems, including
772-6 adverse drug events.
773-7 (6) Documenting the care delivered and communicating essential
774-8 information to the patient's other health care providers.
775-9 (7) Providing education and training designed to enhance patient
776-10 understanding and appropriate use of the individual's medications.
777-11 (8) Providing information and support services and resources
778-12 designed to enhance patient adherence with the individual's
779-13 therapeutic regimens, including medication synchronization.
780-14 (9) Coordinating and integrating medication therapy management
781-15 services within the broader health care services being provided to
782-16 an individual.
783-17 (10) Providing other patient care services allowable by law.
784-18 "Nonprescription drug" means a drug that may be sold without a
785-19 prescription and that is labeled for use by a patient in accordance with
786-20 state and federal laws.
787-21 "Person" means any individual, partnership, copartnership, firm,
788-22 company, corporation, association, joint stock company, trust, estate,
789-23 or municipality, or a legal representative or agent, unless this chapter
790-24 expressly provides otherwise.
791-25 "Practitioner" has the meaning set forth in IC 16-42-19-5.
792-26 "Pharmacist" means a person licensed under this chapter.
793-27 "Pharmacist intern" means a person who is:
794-28 (1) permitted by the board to engage in the practice of pharmacy
795-29 while under the personal supervision of a pharmacist and who is
796-30 satisfactorily progressing toward meeting the requirements for
797-31 licensure as a pharmacist;
798-32 (2) a graduate of an approved college of pharmacy or a graduate
799-33 who has established educational equivalency by obtaining a
800-34 Foreign Pharmacy Graduate Examination Committee Certificate
801-35 and who is permitted by the board to obtain practical experience
802-36 as a requirement for licensure as a pharmacist;
803-37 (3) a qualified applicant awaiting examination for licensure; or
804-38 (4) an individual participating in a residency or fellowship
805-39 program.
806-40 "Pharmacy" means any facility, department, or other place where
807-41 prescriptions are filled or compounded and are sold, dispensed, offered,
808-42 or displayed for sale and which has as its principal purpose the
765+1 "Legend drug" has the meaning set forth in IC 16-18-2-199.
766+2 "License" and "permit" are interchangeable and mean a written
767+3 certificate from the Indiana board of pharmacy for the practice of
768+4 pharmacy or the operation of a pharmacy.
769+5 "Medication therapy management" means a distinct service or group
770+6 of services that optimize therapeutic outcomes for individuals that are
771+7 independent of, but may occur in conjunction with, the provision of a
772+8 medication or medical device. The term includes the following
773+9 services:
774+10 (1) Performing or obtaining assessments of an individual's health
775+11 status.
776+12 (2) Formulating a medication treatment plan.
777+13 (3) Selecting, initiating, modifying, or administering medication
778+14 therapy.
779+15 (4) Monitoring and evaluating an individual's response to therapy,
780+16 including safety and effectiveness.
781+17 (5) Performing a comprehensive medication review to identify,
782+18 resolve, and prevent medication related problems, including
783+19 adverse drug events.
784+20 (6) Documenting the care delivered and communicating essential
785+21 information to the patient's other health care providers.
786+22 (7) Providing education and training designed to enhance patient
787+23 understanding and appropriate use of the individual's medications.
788+24 (8) Providing information and support services and resources
789+25 designed to enhance patient adherence with the individual's
790+26 therapeutic regimens, including medication synchronization.
791+27 (9) Coordinating and integrating medication therapy management
792+28 services within the broader health care services being provided to
793+29 an individual.
794+30 (10) Providing other patient care services allowable by law.
795+31 "Nonprescription drug" means a drug that may be sold without a
796+32 prescription and that is labeled for use by a patient in accordance with
797+33 state and federal laws.
798+34 "Person" means any individual, partnership, copartnership, firm,
799+35 company, corporation, association, joint stock company, trust, estate,
800+36 or municipality, or a legal representative or agent, unless this chapter
801+37 expressly provides otherwise.
802+38 "Practitioner" has the meaning set forth in IC 16-42-19-5.
803+39 "Pharmacist" means a person licensed under this chapter.
804+40 "Pharmacist intern" means a person who is:
805+41 (1) permitted by the board to engage in the practice of pharmacy
806+42 while under the personal supervision of a pharmacist and who is
809807 HB 1158—LS 7067/DI 137 19
810-1 dispensing of drug and health supplies intended for the general health,
811-2 welfare, and safety of the public, without placing any other activity on
812-3 a more important level than the practice of pharmacy.
813-4 "The practice of pharmacy" or "the practice of the profession of
814-5 pharmacy" means a patient oriented health care profession in which
815-6 pharmacists interact with and counsel patients and with other health
816-7 care professionals concerning drugs and devices used to enhance
817-8 patients' wellness, prevent illness, and optimize the outcome of a drug
818-9 or device, by accepting responsibility for performing or supervising a
819-10 pharmacist intern or an unlicensed person under section 18.5 of this
820-11 chapter to do the following acts, services, and operations:
821-12 (1) The offering of or performing of those acts, service operations,
822-13 or transactions incidental to the interpretation, evaluation, and
823-14 implementation of prescriptions or drug orders.
824-15 (2) The compounding, labeling, administering, dispensing, or
825-16 selling of drugs and devices, including radioactive substances,
826-17 whether dispensed under a practitioner's prescription or drug
827-18 order or sold or given directly to the ultimate consumer.
828-19 (3) The proper and safe storage and distribution of drugs and
829-20 devices.
830-21 (4) The maintenance of proper records of the receipt, storage,
831-22 sale, and dispensing of drugs and devices.
832-23 (5) Counseling, advising, and educating patients, patients'
833-24 caregivers, and health care providers and professionals, as
834-25 necessary, as to the contents, therapeutic values, uses, significant
835-26 problems, risks, and appropriate manner of use of drugs and
836-27 devices.
837-28 (6) Assessing, recording, and reporting events related to the use
838-29 of drugs or devices.
839-30 (7) Provision of the professional acts, professional decisions, and
840-31 professional services necessary to maintain all areas of a patient's
841-32 pharmacy related care as specifically authorized to a pharmacist
842-33 under this article.
843-34 (8) Provision of medication therapy management.
844-35 "Prescription" means a written order or an order transmitted by other
845-36 means of communication from a practitioner to or for an ultimate user
846-37 for any drug or device containing:
847-38 (1) the name and address of the patient;
848-39 (2) the date of issue;
849-40 (3) the name and strength or size (if applicable) of the drug or
850-41 device;
851-42 (4) the amount to be dispensed (unless indicated by directions and
808+1 satisfactorily progressing toward meeting the requirements for
809+2 licensure as a pharmacist;
810+3 (2) a graduate of an approved college of pharmacy or a graduate
811+4 who has established educational equivalency by obtaining a
812+5 Foreign Pharmacy Graduate Examination Committee Certificate
813+6 and who is permitted by the board to obtain practical experience
814+7 as a requirement for licensure as a pharmacist;
815+8 (3) a qualified applicant awaiting examination for licensure; or
816+9 (4) an individual participating in a residency or fellowship
817+10 program.
818+11 "Pharmacy" means any facility, department, or other place where
819+12 prescriptions are filled or compounded and are sold, dispensed, offered,
820+13 or displayed for sale and which has as its principal purpose the
821+14 dispensing of drug and health supplies intended for the general health,
822+15 welfare, and safety of the public, without placing any other activity on
823+16 a more important level than the practice of pharmacy.
824+17 "The practice of pharmacy" or "the practice of the profession of
825+18 pharmacy" means a patient oriented health care profession in which
826+19 pharmacists interact with and counsel patients and with other health
827+20 care professionals concerning drugs and devices used to enhance
828+21 patients' wellness, prevent illness, and optimize the outcome of a drug
829+22 or device, by accepting responsibility for performing or supervising a
830+23 pharmacist intern or an unlicensed person under section 18.5 of this
831+24 chapter to do the following acts, services, and operations:
832+25 (1) The offering of or performing of those acts, service operations,
833+26 or transactions incidental to the interpretation, evaluation, and
834+27 implementation of prescriptions or drug orders.
835+28 (2) The compounding, labeling, administering, dispensing, or
836+29 selling of drugs and devices, including radioactive substances,
837+30 whether dispensed under a practitioner's prescription or drug
838+31 order or sold or given directly to the ultimate consumer.
839+32 (3) The proper and safe storage and distribution of drugs and
840+33 devices.
841+34 (4) The maintenance of proper records of the receipt, storage,
842+35 sale, and dispensing of drugs and devices.
843+36 (5) Counseling, advising, and educating patients, patients'
844+37 caregivers, and health care providers and professionals, as
845+38 necessary, as to the contents, therapeutic values, uses, significant
846+39 problems, risks, and appropriate manner of use of drugs and
847+40 devices.
848+41 (6) Assessing, recording, and reporting events related to the use
849+42 of drugs or devices.
852850 HB 1158—LS 7067/DI 137 20
853-1 duration of therapy);
854-2 (5) adequate directions for the proper use of the drug or device by
855-3 the patient;
856-4 (6) the name of the practitioner; and
857-5 (7) if the prescription:
858-6 (A) is in written form, the signature of the practitioner; or
859-7 (B) is in electronic form, the electronic signature of the
860-8 practitioner.
861-9 "Qualifying pharmacist" means the pharmacist who will qualify the
862-10 pharmacy by being responsible to the board for the legal operations of
863-11 the pharmacy under the permit.
864-12 "Record" means all papers, letters, memoranda, notes, prescriptions,
865-13 drug orders, invoices, statements, patient medication charts or files,
866-14 computerized records, or other written indicia, documents, or objects
867-15 which are used in any way in connection with the purchase, sale, or
868-16 handling of any drug or device.
869-17 "Sale" means every sale and includes:
870-18 (1) manufacturing, processing, transporting, handling, packaging,
871-19 or any other production, preparation, or repackaging;
872-20 (2) exposure, offer, or any other proffer;
873-21 (3) holding, storing, or any other possession;
874-22 (4) dispensing, giving, delivering, or any other supplying; and
875-23 (5) applying, administering, or any other using.
876-24 SECTION 31. IC 25-26-13-3, AS AMENDED BY P.L.249-2019,
877-25 SECTION 113, IS AMENDED TO READ AS FOLLOWS
878-26 [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of
879-27 pharmacy is created. The board consists of seven (7) members
880-28 appointed by the governor for terms under IC 25-1-6.5.
881-29 (b) Subject to IC 25-1-6.5-3, the board consists of the following:
882-30 (1) One (1) member of the board, to represent the general public,
883-31 who is a resident of this state who has never been associated with
884-32 pharmacy in any way other than as a consumer.
885-33 (2) Six (6) Five (5) members who are pharmacists in good
886-34 standing of recognized experience and ability from varied practice
887-35 settings who hold a current license to practice pharmacy in
888-36 Indiana, including one (1) member of the board who must be a
889-37 practicing hospital pharmacist.
890-38 (3) One (1) member who is a pharmacy technician in good
891-39 standing, engaged in active practice as a pharmacy technician,
892-40 and holds a current certification from the Pharmacy
893-41 Technician Certification Board.
894-42 (c) A member may be removed under IC 25-1-6.5-4.
851+1 (7) Provision of the professional acts, professional decisions, and
852+2 professional services necessary to maintain all areas of a patient's
853+3 pharmacy related care as specifically authorized to a pharmacist
854+4 under this article.
855+5 (8) Provision of medication therapy management.
856+6 "Prescription" means a written order or an order transmitted by other
857+7 means of communication from a practitioner to or for an ultimate user
858+8 for any drug or device containing:
859+9 (1) the name and address of the patient;
860+10 (2) the date of issue;
861+11 (3) the name and strength or size (if applicable) of the drug or
862+12 device;
863+13 (4) the amount to be dispensed (unless indicated by directions and
864+14 duration of therapy);
865+15 (5) adequate directions for the proper use of the drug or device by
866+16 the patient;
867+17 (6) the name of the practitioner; and
868+18 (7) if the prescription:
869+19 (A) is in written form, the signature of the practitioner; or
870+20 (B) is in electronic form, the electronic signature of the
871+21 practitioner.
872+22 "Qualifying pharmacist" means the pharmacist who will qualify the
873+23 pharmacy by being responsible to the board for the legal operations of
874+24 the pharmacy under the permit.
875+25 "Record" means all papers, letters, memoranda, notes, prescriptions,
876+26 drug orders, invoices, statements, patient medication charts or files,
877+27 computerized records, or other written indicia, documents, or objects
878+28 which are used in any way in connection with the purchase, sale, or
879+29 handling of any drug or device.
880+30 "Sale" means every sale and includes:
881+31 (1) manufacturing, processing, transporting, handling, packaging,
882+32 or any other production, preparation, or repackaging;
883+33 (2) exposure, offer, or any other proffer;
884+34 (3) holding, storing, or any other possession;
885+35 (4) dispensing, giving, delivering, or any other supplying; and
886+36 (5) applying, administering, or any other using.
887+37 SECTION 32. IC 25-26-13-3, AS AMENDED BY P.L.249-2019,
888+38 SECTION 113, IS AMENDED TO READ AS FOLLOWS
889+39 [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of
890+40 pharmacy is created. The board consists of seven (7) members
891+41 appointed by the governor for terms under IC 25-1-6.5.
892+42 (b) Subject to IC 25-1-6.5-3, the board consists of the following:
895893 HB 1158—LS 7067/DI 137 21
896-1 (d) Not later than ten (10) days after a member's appointment, the
897-2 member must subscribe by oath or affirmation to faithfully uphold the
898-3 duties of the member's office. If a member fails to qualify as provided,
899-4 a new member shall be appointed in the member's place.
900-5 (e) At the first meeting of each year the board shall elect from
901-6 among its members a president and vice president who shall perform
902-7 duties and have powers as the board prescribes.
903-8 (f) The board shall meet at least eight (8) times per year at such
904-9 times and places as the board selects. At each meeting the board shall
905-10 continue in session from day to day, for not more than five (5) days,
906-11 until the business of the meeting is complete. Four (4) members of the
907-12 board shall constitute a quorum.
908-13 (g) Each member of the board is entitled to compensation as
909-14 determined by the rules of the budget agency for each day the member
910-15 is actually engaged in business of the board, together with necessary
911-16 travel and other expenses incurred in the performance of the member's
912-17 duties.
913-18 (h) Approval by a majority of the quorum is required for any action
914-19 to be taken by the board.
915-20 SECTION 32. IC 25-26-13-10, AS AMENDED BY P.L.101-2020,
916-21 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
917-22 JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a
918-23 pharmacist intern must furnish proof satisfactory to the board that the
919-24 applicant:
920-25 (1) is actively enrolled in a school of pharmacy accredited by the
921-26 American Council of Pharmaceutical for Pharmacy Education;
922-27 (2) has obtained the Foreign Pharmacy Graduate Examination
923-28 Committee Certificate; or
924-29 (3) is a qualified applicant awaiting the examination for licensure
925-30 as a pharmacist.
926-31 (b) A registration issued under subsection (a) is valid for one (1)
927-32 year and may be renewed by the board in accordance with subsection
928-33 (c) until the expiration date established by the Indiana professional
929-34 licensing agency under IC 25-1-5-4.
930-35 (c) An application for registration or renewal must be accompanied
931-36 by the appropriate fee and one (1) of the following:
932-37 (1) Proof of having obtained the Foreign Pharmacy Graduate
933-38 Examination Committee Certificate.
934-39 (2) Proof of active enrollment in a school of pharmacy accredited
935-40 by the American Council of Pharmaceutical for Pharmacy
936-41 Education.
937-42 SECTION 33. IC 25-26-13-11, AS AMENDED BY P.L.98-2006,
894+1 (1) One (1) member of the board, to represent the general public,
895+2 who is a resident of this state who has never been associated with
896+3 pharmacy in any way other than as a consumer.
897+4 (2) Six (6) Five (5) members who are pharmacists in good
898+5 standing of recognized experience and ability from varied practice
899+6 settings who hold a current license to practice pharmacy in
900+7 Indiana, including one (1) member of the board who must be a
901+8 practicing hospital pharmacist.
902+9 (3) One (1) member who is a pharmacy technician in good
903+10 standing, engaged in active practice as a pharmacy technician,
904+11 and holds a current certification from the Pharmacy
905+12 Technician Certification Board.
906+13 (c) A member may be removed under IC 25-1-6.5-4.
907+14 (d) Not later than ten (10) days after a member's appointment, the
908+15 member must subscribe by oath or affirmation to faithfully uphold the
909+16 duties of the member's office. If a member fails to qualify as provided,
910+17 a new member shall be appointed in the member's place.
911+18 (e) At the first meeting of each year the board shall elect from
912+19 among its members a president and vice president who shall perform
913+20 duties and have powers as the board prescribes.
914+21 (f) The board shall meet at least eight (8) times per year at such
915+22 times and places as the board selects. At each meeting the board shall
916+23 continue in session from day to day, for not more than five (5) days,
917+24 until the business of the meeting is complete. Four (4) members of the
918+25 board shall constitute a quorum.
919+26 (g) Each member of the board is entitled to compensation as
920+27 determined by the rules of the budget agency for each day the member
921+28 is actually engaged in business of the board, together with necessary
922+29 travel and other expenses incurred in the performance of the member's
923+30 duties.
924+31 (h) Approval by a majority of the quorum is required for any action
925+32 to be taken by the board.
926+33 SECTION 33. IC 25-26-13-10, AS AMENDED BY P.L.101-2020,
927+34 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
928+35 JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a
929+36 pharmacist intern must furnish proof satisfactory to the board that the
930+37 applicant:
931+38 (1) is actively enrolled in a school of pharmacy accredited by the
932+39 American Council of Pharmaceutical for Pharmacy Education;
933+40 (2) has obtained the Foreign Pharmacy Graduate Examination
934+41 Committee Certificate; or
935+42 (3) is a qualified applicant awaiting the examination for licensure
938936 HB 1158—LS 7067/DI 137 22
939-1 SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
940-2 JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a
941-3 pharmacist, an individual must file such evidence as is required by the
942-4 board that:
943-5 (1) the individual is at least eighteen (18) years of age;
944-6 (2) the individual does not have a conviction for a crime that has
945-7 a direct bearing on the individual's ability to practice competently;
946-8 (3) the individual:
947-9 (A) has graduated with a professional degree from a school of
948-10 pharmacy accredited by the American Council of
949-11 Pharmaceutical for Pharmacy Education or the Canadian
950-12 Council on Pharmacy Accreditation for Accreditation of
951-13 Pharmacy Programs and approved by the board; or
952-14 (B) has:
953-15 (i) graduated with a professional degree from a school of
954-16 pharmacy located outside the United States and Canada; and
955-17 (ii) met the requirements under subsection (c); and
956-18 (4) the individual has satisfactorily completed a pharmacist intern
957-19 program approved by the board.
958-20 (b) An applicant who has graduated with a professional degree from
959-21 a school of pharmacy accredited by the Canadian Council on Pharmacy
960-22 Accreditation for Accreditation of Pharmacy Programs and
961-23 approved by the board must obtain the Foreign Pharmacy Graduate
962-24 Examination Committee Certificate administered by the National
963-25 Association of Boards of Pharmacy before taking the examination
964-26 required under subsection (d).
965-27 (c) An applicant who has graduated with a professional degree from
966-28 a school of pharmacy located outside the United States and Canada
967-29 must do the following:
968-30 (1) Provide the board with verification of the applicant's academic
969-31 record and graduation.
970-32 (2) Obtain the Foreign Pharmacy Graduate Examination
971-33 Committee Certificate administered by the National Association
972-34 of Boards of Pharmacy.
973-35 (d) After filing an application on a form provided by the board,
974-36 submitting the information required in subsection (a), and successfully
975-37 completing the examination administered by the board, the applicant
976-38 may be licensed as a pharmacist.
977-39 SECTION 34. IC 25-26-13-12, AS AMENDED BY P.L.98-2006,
978-40 SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
979-41 JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a
980-42 pharmacist in another state where the requirements for licensure were
937+1 as a pharmacist.
938+2 (b) A registration issued under subsection (a) is valid for one (1)
939+3 year and may be renewed by the board in accordance with subsection
940+4 (c) until the expiration date established by the Indiana professional
941+5 licensing agency under IC 25-1-5-4.
942+6 (c) An application for registration or renewal must be accompanied
943+7 by the appropriate fee and one (1) of the following:
944+8 (1) Proof of having obtained the Foreign Pharmacy Graduate
945+9 Examination Committee Certificate.
946+10 (2) Proof of active enrollment in a school of pharmacy accredited
947+11 by the American Council of Pharmaceutical for Pharmacy
948+12 Education.
949+13 SECTION 34. IC 25-26-13-11, AS AMENDED BY P.L.98-2006,
950+14 SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
951+15 JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a
952+16 pharmacist, an individual must file such evidence as is required by the
953+17 board that:
954+18 (1) the individual is at least eighteen (18) years of age;
955+19 (2) the individual does not have a conviction for a crime that has
956+20 a direct bearing on the individual's ability to practice competently;
957+21 (3) the individual:
958+22 (A) has graduated with a professional degree from a school of
959+23 pharmacy accredited by the American Council of
960+24 Pharmaceutical for Pharmacy Education or the Canadian
961+25 Council on Pharmacy Accreditation for Accreditation of
962+26 Pharmacy Programs and approved by the board; or
963+27 (B) has:
964+28 (i) graduated with a professional degree from a school of
965+29 pharmacy located outside the United States and Canada; and
966+30 (ii) met the requirements under subsection (c); and
967+31 (4) the individual has satisfactorily completed a pharmacist intern
968+32 program approved by the board.
969+33 (b) An applicant who has graduated with a professional degree from
970+34 a school of pharmacy accredited by the Canadian Council on Pharmacy
971+35 Accreditation for Accreditation of Pharmacy Programs and
972+36 approved by the board must obtain the Foreign Pharmacy Graduate
973+37 Examination Committee Certificate administered by the National
974+38 Association of Boards of Pharmacy before taking the examination
975+39 required under subsection (d).
976+40 (c) An applicant who has graduated with a professional degree from
977+41 a school of pharmacy located outside the United States and Canada
978+42 must do the following:
981979 HB 1158—LS 7067/DI 137 23
982-1 not less than those required in this state at the time of original licensure
983-2 may be issued a license in this state if:
984-3 (1) the individual has registered with and been approved by the
985-4 National Association of Boards of Pharmacy;
986-5 (2) the individual has graduated with a professional degree in
987-6 pharmacy from a school of pharmacy accredited by the American
988-7 Council of Pharmaceutical for Pharmacy Education or the
989-8 Canadian Council on Pharmacy Accreditation for Accreditation
990-9 of Pharmacy Programs and approved by the board; and
991-10 (3) the individual has successfully completed an examination
992-11 administered by the board concerning the federal statutes and
993-12 regulations and the Indiana statutes and rules governing the
994-13 practice of pharmacy.
995-14 (b) An individual who has a professional pharmacy degree from a
996-15 school of pharmacy located outside the United States and Canada and
997-16 who is licensed in another state where the requirements for licensure
998-17 are substantially the same as those in this state may be issued a license
999-18 under this chapter if:
1000-19 (1) the individual has registered with and been approved by the
1001-20 National Association of Boards of Pharmacy;
1002-21 (2) the individual has provided the board with proof of the
1003-22 applicant's:
1004-23 (A) academic record and graduation with a professional degree
1005-24 from a school of pharmacy; and
1006-25 (B) completion of the requirements for obtaining a Foreign
1007-26 Pharmacy Graduate Examination Committee Certificate
1008-27 administered by the National Association of Boards of
1009-28 Pharmacy; and
1010-29 (3) the individual has successfully completed an examination
1011-30 administered by the board concerning the federal statutes and
1012-31 regulations and the Indiana statutes and rules governing the
1013-32 practice of pharmacy.
1014-33 SECTION 35. IC 25-26-13-20, AS AMENDED BY P.L.207-2021,
1015-34 SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1016-35 JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish,
1017-36 operate, or maintain a pharmacy shall apply to the board for a
1018-37 pharmacy permit on a form provided by the board. The applicant shall
1019-38 set forth:
1020-39 (1) the name and occupation of the persons desiring the permit;
1021-40 (2) the location, including street address and city, of the
980+1 (1) Provide the board with verification of the applicant's academic
981+2 record and graduation.
982+3 (2) Obtain the Foreign Pharmacy Graduate Examination
983+4 Committee Certificate administered by the National Association
984+5 of Boards of Pharmacy.
985+6 (d) After filing an application on a form provided by the board,
986+7 submitting the information required in subsection (a), and successfully
987+8 completing the examination administered by the board, the applicant
988+9 may be licensed as a pharmacist.
989+10 SECTION 35. IC 25-26-13-12, AS AMENDED BY P.L.98-2006,
990+11 SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
991+12 JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a
992+13 pharmacist in another state where the requirements for licensure were
993+14 not less than those required in this state at the time of original licensure
994+15 may be issued a license in this state if:
995+16 (1) the individual has registered with and been approved by the
996+17 National Association of Boards of Pharmacy;
997+18 (2) the individual has graduated with a professional degree in
998+19 pharmacy from a school of pharmacy accredited by the American
999+20 Council of Pharmaceutical for Pharmacy Education or the
1000+21 Canadian Council on Pharmacy Accreditation for Accreditation
1001+22 of Pharmacy Programs and approved by the board; and
1002+23 (3) the individual has successfully completed an examination
1003+24 administered by the board concerning the federal statutes and
1004+25 regulations and the Indiana statutes and rules governing the
1005+26 practice of pharmacy.
1006+27 (b) An individual who has a professional pharmacy degree from a
1007+28 school of pharmacy located outside the United States and Canada and
1008+29 who is licensed in another state where the requirements for licensure
1009+30 are substantially the same as those in this state may be issued a license
1010+31 under this chapter if:
1011+32 (1) the individual has registered with and been approved by the
1012+33 National Association of Boards of Pharmacy;
1013+34 (2) the individual has provided the board with proof of the
1014+35 applicant's:
1015+36 (A) academic record and graduation with a professional degree
1016+37 from a school of pharmacy; and
1017+38 (B) completion of the requirements for obtaining a Foreign
1018+39 Pharmacy Graduate Examination Committee Certificate
1019+40 administered by the National Association of Boards of
10221020 41 Pharmacy; and
1023-42 (3) the name of the pharmacist who will qualify the pharmacy by
1021+42 (3) the individual has successfully completed an examination
10241022 HB 1158—LS 7067/DI 137 24
1025-1 being responsible to the board for the legal operation of the
1026-2 pharmacy under the permit; and
1027-3 (4) (3) such other information as the board may require.
1028-4 (b) If the applicant desires to open, establish, operate, or maintain
1029-5 more than one (1) pharmacy, the applicant must file a separate
1030-6 application for each. Each pharmacy must be qualified by a different
1031-7 pharmacist.
1032-8 (c) The board shall permit a pharmacist to serve as a qualifying
1033-9 pharmacist for more than one (1) pharmacy holding a Category II
1034-10 pharmacy permit upon the holder of the Category II permit showing
1035-11 circumstances establishing that:
1036-12 (1) the permit holder has made a reasonable effort, without
1037-13 success, to obtain a qualifying pharmacist who is not serving as
1038-14 a qualifying pharmacist at another Category II pharmacy; and
1039-15 (2) the single pharmacist could effectively fulfill all duties and
1040-16 responsibilities of the qualifying pharmacist at both locations.
1041-17 However, the board shall hold the permit holder responsible and may
1042-18 not discipline or otherwise hold the qualifying pharmacist an
1043-19 individual licensed under this chapter responsible for staffing
1044-20 deficiencies of the pharmacy if the qualifying pharmacist individual
1045-21 does not have authority for staffing determinations of the pharmacy.
1046-22 (d) The board shall grant or deny an application for a permit not
1047-23 later than one hundred twenty (120) days after the application and any
1048-24 additional information required by the board are submitted.
1049-25 (e) The board may not issue a pharmacy permit to a person who
1050-26 desires to operate the pharmacy out of a residence.
1051-27 SECTION 36. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021,
1052-28 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1053-29 JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy
1054-30 shall transfer to another pharmacy a prescription for the patient,
1055-31 including a prescription for a schedule II controlled substance, that the
1056-32 pharmacy has received but not filled unless:
1057-33 (1) prohibited in writing on the prescription by the prescriber; or
1058-34 (2) otherwise prohibited by federal law.
1059-35 (b) Unless prohibited by federal law, a prescription for a patient may
1060-36 be transferred electronically or by facsimile by a pharmacy to another
1061-37 pharmacy if the pharmacies do not share a common data base.
1062-38 (c) A licensed pharmacy technician may transfer a prescription,
1063-39 under subsection (b) including making a verbal transfer, as
1064-40 delegated by a pharmacist.
1065-41 SECTION 37. IC 25-26-13-27 IS AMENDED TO READ AS
1066-42 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 27. (a) If a pharmacy
1023+1 administered by the board concerning the federal statutes and
1024+2 regulations and the Indiana statutes and rules governing the
1025+3 practice of pharmacy.
1026+4 SECTION 36. IC 25-26-13-20, AS AMENDED BY P.L.207-2021,
1027+5 SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1028+6 JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish,
1029+7 operate, or maintain a pharmacy shall apply to the board for a
1030+8 pharmacy permit on a form provided by the board. The applicant shall
1031+9 set forth:
1032+10 (1) the name and occupation of the persons desiring the permit;
1033+11 (2) the location, including street address and city, of the
1034+12 pharmacy; and
1035+13 (3) the name of the pharmacist who will qualify the pharmacy by
1036+14 being responsible to the board for the legal operation of the
1037+15 pharmacy under the permit; and
1038+16 (4) (3) such other information as the board may require.
1039+17 (b) If the applicant desires to open, establish, operate, or maintain
1040+18 more than one (1) pharmacy, the applicant must file a separate
1041+19 application for each. Each pharmacy must be qualified by a different
1042+20 pharmacist.
1043+21 (c) The board shall permit a pharmacist to serve as a qualifying
1044+22 pharmacist for more than one (1) pharmacy holding a Category II
1045+23 pharmacy permit upon the holder of the Category II permit showing
1046+24 circumstances establishing that:
1047+25 (1) the permit holder has made a reasonable effort, without
1048+26 success, to obtain a qualifying pharmacist who is not serving as
1049+27 a qualifying pharmacist at another Category II pharmacy; and
1050+28 (2) the single pharmacist could effectively fulfill all duties and
1051+29 responsibilities of the qualifying pharmacist at both locations.
1052+30 However, the board shall hold the permit holder responsible and may
1053+31 not discipline or otherwise hold the qualifying pharmacist an
1054+32 individual licensed under this chapter responsible for staffing
1055+33 deficiencies of the pharmacy if the qualifying pharmacist individual
1056+34 does not have authority for staffing determinations of the pharmacy.
1057+35 (d) The board shall grant or deny an application for a permit not
1058+36 later than one hundred twenty (120) days after the application and any
1059+37 additional information required by the board are submitted.
1060+38 (e) The board may not issue a pharmacy permit to a person who
1061+39 desires to operate the pharmacy out of a residence.
1062+40 SECTION 37. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021,
1063+41 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1064+42 JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy
10671065 HB 1158—LS 7067/DI 137 25
1068-1 will be closed for five (5) consecutive days or more, the permit holder
1069-2 shall notify the board and take such steps to secure the drugs in the
1070-3 pharmacy as the board may direct.
1071-4 (b) If a pharmacy is to be permanently closed for any reason, the
1072-5 owner or qualifying pharmacist shall:
1073-6 (1) notify the board not less than twenty (20) days before the
1074-7 transfer of any controlled substances and submit a copy of the
1075-8 inventory form required by the federal drug enforcement
1076-9 administration together with the name, address, and registration
1077-10 number of the person to whom the drugs will be transferred;
1078-11 (2) remove all legend drugs from stock by:
1079-12 (A) returning them to the wholesaler or manufacturer if he
1080-13 consents;
1081-14 (B) transferring them to another pharmacy; or
1082-15 (C) destroying them in the presence of a representative
1083-16 appointed by the board;
1084-17 (3) before disposing of any other merchandise in the pharmacy,
1085-18 dispose of all controlled drugs and legend drugs as provided in
1086-19 clauses (1) and (2) and submit the licensed premises to an
1087-20 inspection by a representative of the board to certify that all
1088-21 legend and controlled drugs have been removed;
1089-22 (4) remove from inside and outside the licensed area all symbols
1090-23 and signs using the words "drugs", "drugstore", "prescriptions",
1091-24 "pharmacy", "pharmacy department", "apothecary", or
1092-25 "apothecary shop", or any combination of such titles; and
1093-26 (5) return the pharmacy permit for cancellation by the board
1094-27 within ten (10) days after all legend drugs, controlled drugs, drugs
1095-28 and devices are removed from the premises.
1096-29 SECTION 38. IC 25-26-13-31.7, AS AMENDED BY P.L.207-2021,
1097-30 SECTION 38, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1098-31 JULY 1, 2022]: Sec. 31.7. (a) Subject to rules adopted under
1099-32 subsection (c), a pharmacy technician may administer an influenza or
1100-33 coronavirus disease any immunization to an individual under a drug
1101-34 order or prescription, as delegated by the pharmacist.
1102-35 (b) Subject to rules adopted under subsection (c), a pharmacy
1103-36 technician may administer an influenza or coronavirus disease
1104-37 immunization to an individual or a group of individuals under a drug
1105-38 order, under a prescription, or according to a protocol approved by a
1106-39 physician, as delegated by the pharmacist.
1107-40 (c) The board shall adopt rules under IC 4-22-2 to establish
1108-41 requirements applying to a pharmacy technician who administers an
1109-42 influenza or coronavirus disease immunization to an individual or
1066+1 shall transfer to another pharmacy a prescription for the patient,
1067+2 including a prescription for a schedule II controlled substance, that the
1068+3 pharmacy has received but not filled unless:
1069+4 (1) prohibited in writing on the prescription by the prescriber; or
1070+5 (2) otherwise prohibited by federal law.
1071+6 (b) Unless prohibited by federal law, a prescription for a patient may
1072+7 be transferred electronically or by facsimile by a pharmacy to another
1073+8 pharmacy if the pharmacies do not share a common data base.
1074+9 (c) A licensed pharmacy technician may transfer a prescription,
1075+10 under subsection (b) including making a verbal transfer, as
1076+11 delegated by a pharmacist.
1077+12 SECTION 38. IC 25-26-13-27 IS AMENDED TO READ AS
1078+13 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 27. (a) If a pharmacy
1079+14 will be closed for five (5) consecutive days or more, the permit holder
1080+15 shall notify the board and take such steps to secure the drugs in the
1081+16 pharmacy as the board may direct.
1082+17 (b) If a pharmacy is to be permanently closed for any reason, the
1083+18 owner or qualifying pharmacist shall:
1084+19 (1) notify the board not less than twenty (20) days before the
1085+20 transfer of any controlled substances and submit a copy of the
1086+21 inventory form required by the federal drug enforcement
1087+22 administration together with the name, address, and registration
1088+23 number of the person to whom the drugs will be transferred;
1089+24 (2) remove all legend drugs from stock by:
1090+25 (A) returning them to the wholesaler or manufacturer if he
1091+26 consents;
1092+27 (B) transferring them to another pharmacy; or
1093+28 (C) destroying them in the presence of a representative
1094+29 appointed by the board;
1095+30 (3) before disposing of any other merchandise in the pharmacy,
1096+31 dispose of all controlled drugs and legend drugs as provided in
1097+32 clauses (1) and (2) and submit the licensed premises to an
1098+33 inspection by a representative of the board to certify that all
1099+34 legend and controlled drugs have been removed;
1100+35 (4) remove from inside and outside the licensed area all symbols
1101+36 and signs using the words "drugs", "drugstore", "prescriptions",
1102+37 "pharmacy", "pharmacy department", "apothecary", or
1103+38 "apothecary shop", or any combination of such titles; and
1104+39 (5) return the pharmacy permit for cancellation by the board
1105+40 within ten (10) days after all legend drugs, controlled drugs, drugs
1106+41 and devices are removed from the premises.
1107+42 SECTION 39. IC 25-26-13-31.7, AS AMENDED BY P.L.207-2021,
11101108 HB 1158—LS 7067/DI 137 26
1111-1 group of individuals. The rules adopted under this section must provide
1112-2 for the direct supervision of the pharmacy technician by a pharmacist,
1113-3 a physician, a physician assistant, or an advanced practice registered
1114-4 nurse. Before July 1, 2021, the board shall adopt emergency rules
1115-5 under IC 4-22-2-37.1 to establish the requirements described in this
1116-6 subsection. concerning the influenza immunization and the coronavirus
1117-7 disease immunization. Notwithstanding IC 4-22-2-37.1(g), an
1118-8 emergency rule adopted by the board under this subsection and in the
1119-9 manner provided by IC 4-22-2-37.1 expires on the date on which a rule
1120-10 that supersedes the emergency rule is adopted by the board under
1121-11 IC 4-22-2-24 through IC 4-22-2-36.
1122-12 (d) The board must approve all programs that provide training to
1123-13 pharmacy technicians to administer influenza and coronavirus disease
1124-14 immunizations as permitted by this section.
1125-15 SECTION 39. IC 25-26-13.5-6, AS AMENDED BY P.L.207-2021,
1126-16 SECTION 39, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1127-17 JULY 1, 2022]: Sec. 6. (a) Before a remote dispensing facility may do
1128-18 business in Indiana, the remote dispensing facility must be registered
1129-19 with the board under this chapter and in the manner prescribed by the
1130-20 board.
1131-21 (b) Before a pharmacy licensed under this article may operate a
1132-22 remote dispensing facility, the pharmacy must register with the board
1133-23 under this chapter.
1134-24 (c) A facility must meet the following requirements in order to be
1135-25 registered as a remote dispensing facility under this chapter:
1136-26 (1) If the remote dispensing facility is not jointly owned by the
1137-27 pharmacy, operate under a contract with a supervising pharmacy.
1138-28 (2) Be supervised by a qualifying pharmacist who is licensed
1139-29 under this article and who is designated by the supervising
1140-30 pharmacy to be responsible for oversight of the remote dispensing
1141-31 facility.
1142-32 (3) Be located at least ten (10) miles from an existing retail
1143-33 pharmacy unless:
1144-34 (A) the applicant with the proposed remote dispensing facility
1145-35 demonstrates to the board how the proposed remote dispensing
1146-36 facility will promote public health; or
1147-37 (B) the remote dispensing facility exclusively serves the
1148-38 patients of:
1149-39 (i) a community mental health center established under
1150-40 IC 12-29;
1151-41 (ii) a health care facility (as defined in IC 16-28-13-0.5); or
1152-42 (iii) a physician clinic.
1109+1 SECTION 38, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1110+2 JULY 1, 2022]: Sec. 31.7. (a) Subject to rules adopted under
1111+3 subsection (c), a pharmacy technician may administer an influenza or
1112+4 coronavirus disease any immunization to an individual under a drug
1113+5 order or prescription, as delegated by the pharmacist.
1114+6 (b) Subject to rules adopted under subsection (c), a pharmacy
1115+7 technician may administer an influenza or coronavirus disease
1116+8 immunization to an individual or a group of individuals under a drug
1117+9 order, under a prescription, or according to a protocol approved by a
1118+10 physician, as delegated by the pharmacist.
1119+11 (c) The board shall adopt rules under IC 4-22-2 to establish
1120+12 requirements applying to a pharmacy technician who administers an
1121+13 influenza or coronavirus disease immunization to an individual or
1122+14 group of individuals. The rules adopted under this section must provide
1123+15 for the direct supervision of the pharmacy technician by a pharmacist,
1124+16 a physician, a physician assistant, or an advanced practice registered
1125+17 nurse. Before July 1, 2021, the board shall adopt emergency rules
1126+18 under IC 4-22-2-37.1 to establish the requirements described in this
1127+19 subsection. concerning the influenza immunization and the coronavirus
1128+20 disease immunization. Notwithstanding IC 4-22-2-37.1(g), an
1129+21 emergency rule adopted by the board under this subsection and in the
1130+22 manner provided by IC 4-22-2-37.1 expires on the date on which a rule
1131+23 that supersedes the emergency rule is adopted by the board under
1132+24 IC 4-22-2-24 through IC 4-22-2-36.
1133+25 (d) The board must approve all programs that provide training to
1134+26 pharmacy technicians to administer influenza and coronavirus disease
1135+27 immunizations as permitted by this section.
1136+28 SECTION 40. IC 25-26-13.5-6, AS AMENDED BY P.L.207-2021,
1137+29 SECTION 39, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1138+30 JULY 1, 2022]: Sec. 6. (a) Before a remote dispensing facility may do
1139+31 business in Indiana, the remote dispensing facility must be registered
1140+32 with the board under this chapter and in the manner prescribed by the
1141+33 board.
1142+34 (b) Before a pharmacy licensed under this article may operate a
1143+35 remote dispensing facility, the pharmacy must register with the board
1144+36 under this chapter.
1145+37 (c) A facility must meet the following requirements in order to be
1146+38 registered as a remote dispensing facility under this chapter:
1147+39 (1) If the remote dispensing facility is not jointly owned by the
1148+40 pharmacy, operate under a contract with a supervising pharmacy.
1149+41 (2) Be supervised by a qualifying pharmacist who is licensed
1150+42 under this article and who is designated by the supervising
11531151 HB 1158—LS 7067/DI 137 27
1154-1 (4) Maintain a patient counseling area.
1155-2 (5) Display a sign visible to the public indicating that the location
1156-3 is a remote dispensing facility. The sign must include the
1157-4 following information:
1158-5 (A) That the facility provides remote services supervised by a
1159-6 pharmacist located in another pharmacy.
1160-7 (B) The identification and address of the supervising
1161-8 pharmacy.
1162-9 (C) Disclosure that a pharmacist is required to speak to the
1163-10 consumer using audio and video communication systems any
1164-11 time a new drug or device is dispensed at the remote
1165-12 dispensing facility.
1166-13 (D) Whether patient counseling is provided on a prescription
1167-14 drug refill at the remote dispensing facility.
1168-15 (E) That the facility is under continuous video surveillance and
1169-16 that the video is recorded.
1170-17 (d) If the remote dispensing facility is operating under a contract
1171-18 with a supervising pharmacy, the contract must:
1172-19 (1) specify the responsibilities of each party to the contract; and
1173-20 (2) be available for review by the board at the board's request.
1174-21 SECTION 40. IC 25-26-13.5-7, AS ADDED BY P.L.202-2017,
1175-22 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1176-23 JULY 1, 2022]: Sec. 7. A supervising pharmacy shall implement
1177-24 policies and procedures that address each of the following before
1178-25 engaging in the practice of telepharmacy under this chapter:
1179-26 (1) Minimum standards and practices that ensure the safety,
1180-27 accuracy, security, sanitation, record keeping, and patient
1181-28 confidentiality at the remote dispensing facility. The standards
1182-29 and practices must include the following:
1183-30 (A) Identification of personnel authorized to accept delivery of
1184-31 the drugs and to have access to drug storage and dispensing
1185-32 areas at the remote dispensing facility.
1186-33 (B) Procedures for the procurement of drugs and devices at the
1187-34 remote dispensing facility and any automated dispensing
1188-35 machine system used.
1189-36 (C) Criteria for the required inspection of the remote
1190-37 dispensing facility by the qualifying a pharmacist.
1191-38 (2) The adoption of training standards required for personnel
1192-39 employed at a remote dispensing facility to ensure the
1193-40 competence and ability of employees in operating the electronic
1194-41 verification, electronic record keeping, and communication
1195-42 systems.
1152+1 pharmacy to be responsible for oversight of the remote dispensing
1153+2 facility.
1154+3 (3) Be located at least ten (10) miles from an existing retail
1155+4 pharmacy unless:
1156+5 (A) the applicant with the proposed remote dispensing facility
1157+6 demonstrates to the board how the proposed remote dispensing
1158+7 facility will promote public health; or
1159+8 (B) the remote dispensing facility exclusively serves the
1160+9 patients of:
1161+10 (i) a community mental health center established under
1162+11 IC 12-29;
1163+12 (ii) a health care facility (as defined in IC 16-28-13-0.5); or
1164+13 (iii) a physician clinic.
1165+14 (4) Maintain a patient counseling area.
1166+15 (5) Display a sign visible to the public indicating that the location
1167+16 is a remote dispensing facility. The sign must include the
1168+17 following information:
1169+18 (A) That the facility provides remote services supervised by a
1170+19 pharmacist located in another pharmacy.
1171+20 (B) The identification and address of the supervising
1172+21 pharmacy.
1173+22 (C) Disclosure that a pharmacist is required to speak to the
1174+23 consumer using audio and video communication systems any
1175+24 time a new drug or device is dispensed at the remote
1176+25 dispensing facility.
1177+26 (D) Whether patient counseling is provided on a prescription
1178+27 drug refill at the remote dispensing facility.
1179+28 (E) That the facility is under continuous video surveillance and
1180+29 that the video is recorded.
1181+30 (d) If the remote dispensing facility is operating under a contract
1182+31 with a supervising pharmacy, the contract must:
1183+32 (1) specify the responsibilities of each party to the contract; and
1184+33 (2) be available for review by the board at the board's request.
1185+34 SECTION 41. IC 25-26-13.5-7, AS ADDED BY P.L.202-2017,
1186+35 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1187+36 JULY 1, 2022]: Sec. 7. A supervising pharmacy shall implement
1188+37 policies and procedures that address each of the following before
1189+38 engaging in the practice of telepharmacy under this chapter:
1190+39 (1) Minimum standards and practices that ensure the safety,
1191+40 accuracy, security, sanitation, record keeping, and patient
1192+41 confidentiality at the remote dispensing facility. The standards
1193+42 and practices must include the following:
11961194 HB 1158—LS 7067/DI 137 28
1197-1 (3) A written plan for recovery from an event that interrupts or
1198-2 prevents pharmacist supervision of the remote dispensing facility.
1199-3 (4) Policies concerning the dispensing of prescription drugs.
1200-4 SECTION 41. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE JULY
1201-5 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist on
1202-6 duty are responsible for ensuring that the supervising pharmacy and
1203-7 remote dispensing facility are sufficiently staffed to avoid the risk of
1204-8 harm to public health and safety.
1205-9 (b) In order to serve as a qualifying pharmacist, the pharmacist must
1206-10 be in good standing with the board.
1207-11 (c) A qualifying pharmacist may have this designation for only one
1208-12 (1) supervising pharmacy and for one (1) remote dispensing facility at
1209-13 a time.
1210-14 (d) A qualifying pharmacist must be able to be physically at the
1211-15 remote dispensing facility within a certain time set by the board to
1212-16 address emergencies and safety issues that arise. However, in the
1213-17 qualifying pharmacist's absence the qualifying pharmacist may
1214-18 designate another pharmacist to fulfill the qualifying pharmacist's
1215-19 duties at the remote dispensing facility.
1216-20 (e) A qualifying pharmacist shall visit a remote dispensing facility
1217-21 at least as often as required by the board to inspect the facility and
1218-22 address personnel matters. The qualifying pharmacist shall complete
1219-23 any forms required by the board concerning the required inspection and
1220-24 maintain the records in a manner specified by the board.
1221-25 (f) If the remote dispensing facility is located at a hospital or
1222-26 physician clinic and uses an automated dispensing machine, the
1223-27 qualifying pharmacist shall maintain an up to date inventory of any
1224-28 schedule II controlled substances. The qualifying pharmacist shall at
1225-29 least monthly inventory all controlled substances.
1226-30 (g) The qualifying pharmacist shall develop and implement a
1227-31 continuous quality improvement program. The program must include
1228-32 a reporting mechanism for errors that occur concerning the remote
1229-33 dispensing facility. Information concerning the program must be
1230-34 available to the board upon request.
1231-35 SECTION 42. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA
1232-36 CODE AS A NEW SECTION TO READ AS FOLLOWS
1233-37 [EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a
1234-38 remote dispensing facility is responsible for ensuring the following:
1235-39 (1) The remote dispensing facility is sufficiently staffed to
1236-40 avoid the risk of harm to public health and safety.
1237-41 (2) The pharmacist servicing the remote dispensing facility is
1238-42 in good standing with the board.
1195+1 (A) Identification of personnel authorized to accept delivery of
1196+2 the drugs and to have access to drug storage and dispensing
1197+3 areas at the remote dispensing facility.
1198+4 (B) Procedures for the procurement of drugs and devices at the
1199+5 remote dispensing facility and any automated dispensing
1200+6 machine system used.
1201+7 (C) Criteria for the required inspection of the remote
1202+8 dispensing facility by the qualifying a pharmacist.
1203+9 (2) The adoption of training standards required for personnel
1204+10 employed at a remote dispensing facility to ensure the
1205+11 competence and ability of employees in operating the electronic
1206+12 verification, electronic record keeping, and communication
1207+13 systems.
1208+14 (3) A written plan for recovery from an event that interrupts or
1209+15 prevents pharmacist supervision of the remote dispensing facility.
1210+16 (4) Policies concerning the dispensing of prescription drugs.
1211+17 SECTION 42. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE JULY
1212+18 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist on
1213+19 duty are responsible for ensuring that the supervising pharmacy and
1214+20 remote dispensing facility are sufficiently staffed to avoid the risk of
1215+21 harm to public health and safety.
1216+22 (b) In order to serve as a qualifying pharmacist, the pharmacist must
1217+23 be in good standing with the board.
1218+24 (c) A qualifying pharmacist may have this designation for only one
1219+25 (1) supervising pharmacy and for one (1) remote dispensing facility at
1220+26 a time.
1221+27 (d) A qualifying pharmacist must be able to be physically at the
1222+28 remote dispensing facility within a certain time set by the board to
1223+29 address emergencies and safety issues that arise. However, in the
1224+30 qualifying pharmacist's absence the qualifying pharmacist may
1225+31 designate another pharmacist to fulfill the qualifying pharmacist's
1226+32 duties at the remote dispensing facility.
1227+33 (e) A qualifying pharmacist shall visit a remote dispensing facility
1228+34 at least as often as required by the board to inspect the facility and
1229+35 address personnel matters. The qualifying pharmacist shall complete
1230+36 any forms required by the board concerning the required inspection and
1231+37 maintain the records in a manner specified by the board.
1232+38 (f) If the remote dispensing facility is located at a hospital or
1233+39 physician clinic and uses an automated dispensing machine, the
1234+40 qualifying pharmacist shall maintain an up to date inventory of any
1235+41 schedule II controlled substances. The qualifying pharmacist shall at
1236+42 least monthly inventory all controlled substances.
12391237 HB 1158—LS 7067/DI 137 29
1240-1 (3) A pharmacy may not operate more than one (1) remote
1241-2 dispensing facility at a time, unless otherwise approved by the
1242-3 board.
1243-4 (4) A pharmacist must be able to be physically present at the
1244-5 remote dispensing facility within a certain time set by the
1245-6 board to address emergencies and safety issues that arise.
1246-7 (5) A pharmacist shall visit the remote dispensing facility at
1247-8 least as often as required by the board to inspect the facility,
1248-9 address personnel matters, complete any forms required by
1249-10 the board concerning the required inspection, and maintain
1250-11 records in the manner specified by the board.
1251-12 (6) If the remote dispensing facility is located at a hospital or
1252-13 physician clinic and uses an automated dispensing machine,
1253-14 a pharmacist must maintain an up to date inventory of any
1254-15 schedule II controlled substances. An inventory of all
1255-16 controlled substances must be completed at least once a
1256-17 month.
1257-18 (7) The pharmacy must develop a continuous quality
1258-19 improvement program, which must include a reporting
1259-20 mechanism for errors that occur concerning the remote
1260-21 dispensing facility. Information concerning the remote
1261-22 dispensing facility must be made available to the board upon
1262-23 request.
1263-24 SECTION 43. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019,
1264-25 SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1265-26 JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist
1266-27 working at a remote dispensing facility for every six (6) pharmacist
1267-28 interns, licensed pharmacy technicians, and pharmacy technicians in
1268-29 training at the supervising pharmacy and remote dispensing facility.
1269-30 However, an individual whose only duty is to act as the cashier is not
1270-31 included in the number of employees that may work for one (1)
1271-32 pharmacist under this subsection.
1272-33 (b) A remote dispensing facility that is not staffed by a pharmacist
1273-34 must be staffed by at least one (1) pharmacy technician who meets the
1274-35 following requirements:
1275-36 (1) Is licensed under IC 25-26-19.
1276-37 (2) Has at least two thousand (2,000) hours of experience working
1277-38 as a pharmacy technician in a pharmacy licensed under this article
1278-39 and under the direct supervision of a pharmacist.
1279-40 (3) Has successfully passed a certification examination offered by
1280-41 the Pharmacy Technician Certification Board or another
1281-42 nationally recognized certification body approved by the board.
1238+1 (g) The qualifying pharmacist shall develop and implement a
1239+2 continuous quality improvement program. The program must include
1240+3 a reporting mechanism for errors that occur concerning the remote
1241+4 dispensing facility. Information concerning the program must be
1242+5 available to the board upon request.
1243+6 SECTION 43. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA
1244+7 CODE AS A NEW SECTION TO READ AS FOLLOWS
1245+8 [EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a
1246+9 remote dispensing facility is responsible for ensuring the following:
1247+10 (1) The remote dispensing facility is sufficiently staffed to
1248+11 avoid the risk of harm to public health and safety.
1249+12 (2) The pharmacist servicing the remote dispensing facility is
1250+13 in good standing with the board.
1251+14 (3) A pharmacy may not operate more than one (1) remote
1252+15 dispensing facility at a time, unless otherwise approved by the
1253+16 board.
1254+17 (4) A pharmacist must be able to be physically present at the
1255+18 remote dispensing facility within a certain time set by the
1256+19 board to address emergencies and safety issues that arise.
1257+20 (5) A pharmacist shall visit the remote dispensing facility at
1258+21 least as often as required by the board to inspect the facility,
1259+22 address personnel matters, complete any forms required by
1260+23 the board concerning the required inspection, and maintain
1261+24 records in the manner specified by the board.
1262+25 (6) If the remote dispensing facility is located at a hospital or
1263+26 physician clinic and uses an automated dispensing machine,
1264+27 a pharmacist must maintain an up to date inventory of any
1265+28 schedule II controlled substances. An inventory of all
1266+29 controlled substances must be completed at least once a
1267+30 month.
1268+31 (7) The pharmacy must develop a continuous quality
1269+32 improvement program, which must include a reporting
1270+33 mechanism for errors that occur concerning the remote
1271+34 dispensing facility. Information concerning the remote
1272+35 dispensing facility must be made available to the board upon
1273+36 request.
1274+37 SECTION 44. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019,
1275+38 SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1276+39 JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist
1277+40 working at a remote dispensing facility for every six (6) pharmacist
1278+41 interns, licensed pharmacy technicians, and pharmacy technicians in
1279+42 training at the supervising pharmacy and remote dispensing facility.
12821280 HB 1158—LS 7067/DI 137 30
1283-1 (4) If the remote dispensing facility is located in a hospital or
1284-2 physician clinic setting, either:
1285-3 (A) has graduated from a pharmacy technician training
1286-4 program accredited by the American Council of
1287-5 Pharmaceutical for Pharmacy Education or the American
1288-6 Society of Health System Pharmacists; or
1289-7 (B) obtained the hours described in subdivision (2) before July
1290-8 1, 2017.
1291-9 (5) Is supervised by a pharmacist at the supervising pharmacy at
1292-10 all times that the remote dispensing facility is operational. As
1293-11 used in this subdivision, supervision does not require that the
1294-12 pharmacist be physically present at the remote dispensing facility
1295-13 as long as the pharmacist is supervising telepharmacy operations
1296-14 electronically through a computer link, video link, and audio link.
1297-15 (6) Is currently in good standing with the board.
1298-16 (c) A pharmacy technician in training may not work at a remote
1299-17 dispensing facility unless a pharmacist is on site.
1300-18 (d) The board shall adopt rules that require pharmacy technicians
1301-19 working at a remote dispensing facility that is not staffed by a
1302-20 pharmacist to complete continuing education requirements established
1303-21 by the board.
1304-22 SECTION 44. IC 25-26-13.5-11, AS AMENDED BY P.L.207-2021,
1305-23 SECTION 40, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1306-24 JULY 1, 2022]: Sec. 11. (a) A supervising pharmacy of a remote
1307-25 dispensing facility must maintain a video and audio communication
1308-26 system that provides for effective communication between the
1309-27 supervising pharmacy, the remote dispensing facility, and any
1310-28 consumers. The system must do the following:
1311-29 (1) Provide an adequate number of views of the entire remote
1312-30 dispensing facility.
1313-31 (2) Facilitate adequate pharmacist supervision.
1314-32 (3) Allow an appropriate exchange of visual, verbal, and written
1315-33 communications for patient counseling and other matters
1316-34 concerning the lawful transaction of business.
1317-35 (b) The remote dispensing facility must retain a recording of facility
1318-36 surveillance, excluding patient communications, for at least thirty (30)
1319-37 days.
1320-38 (c) A qualifying pharmacist is adequately supervising through the
1321-39 use of video surveillance by maintaining constant visual supervision
1322-40 and auditory communication with the remote dispensing facility and by
1323-41 maintaining full supervisory control of the automated system, if
1324-42 applicable. The auditory communication must be available, as needed,
1281+1 However, an individual whose only duty is to act as the cashier is not
1282+2 included in the number of employees that may work for one (1)
1283+3 pharmacist under this subsection.
1284+4 (b) A remote dispensing facility that is not staffed by a pharmacist
1285+5 must be staffed by at least one (1) pharmacy technician who meets the
1286+6 following requirements:
1287+7 (1) Is licensed under IC 25-26-19.
1288+8 (2) Has at least two thousand (2,000) hours of experience working
1289+9 as a pharmacy technician in a pharmacy licensed under this article
1290+10 and under the direct supervision of a pharmacist.
1291+11 (3) Has successfully passed a certification examination offered by
1292+12 the Pharmacy Technician Certification Board or another
1293+13 nationally recognized certification body approved by the board.
1294+14 (4) If the remote dispensing facility is located in a hospital or
1295+15 physician clinic setting, either:
1296+16 (A) has graduated from a pharmacy technician training
1297+17 program accredited by the American Council of
1298+18 Pharmaceutical for Pharmacy Education or the American
1299+19 Society of Health System Pharmacists; or
1300+20 (B) obtained the hours described in subdivision (2) before July
1301+21 1, 2017.
1302+22 (5) Is supervised by a pharmacist at the supervising pharmacy at
1303+23 all times that the remote dispensing facility is operational. As
1304+24 used in this subdivision, supervision does not require that the
1305+25 pharmacist be physically present at the remote dispensing facility
1306+26 as long as the pharmacist is supervising telepharmacy operations
1307+27 electronically through a computer link, video link, and audio link.
1308+28 (6) Is currently in good standing with the board.
1309+29 (c) A pharmacy technician in training may not work at a remote
1310+30 dispensing facility unless a pharmacist is on site.
1311+31 (d) The board shall adopt rules that require pharmacy technicians
1312+32 working at a remote dispensing facility that is not staffed by a
1313+33 pharmacist to complete continuing education requirements established
1314+34 by the board.
1315+35 SECTION 45. IC 25-26-13.5-11, AS AMENDED BY P.L.207-2021,
1316+36 SECTION 40, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1317+37 JULY 1, 2022]: Sec. 11. (a) A supervising pharmacy of a remote
1318+38 dispensing facility must maintain a video and audio communication
1319+39 system that provides for effective communication between the
1320+40 supervising pharmacy, the remote dispensing facility, and any
1321+41 consumers. The system must do the following:
1322+42 (1) Provide an adequate number of views of the entire remote
13251323 HB 1158—LS 7067/DI 137 31
1326-1 with the remote dispensing facility and the qualifying pharmacist.
1327-2 (d) A video monitor that is being used to properly identify and
1328-3 communicate with consumers must meet the following requirements:
1329-4 (1) Provide both the supervising pharmacy and the remote
1330-5 dispensing facility with direct visual contact between the
1331-6 pharmacist and the consumer.
1332-7 (2) Be secure and compliant with the federal Health Insurance
1333-8 Portability and Accountability Act (HIPAA).
1334-9 (e) If any component of the communication system is not in
1335-10 operating order, the remote dispensing facility shall remain closed until
1336-11 the communication system is fully operational, unless a pharmacist is
1337-12 located at the remote dispensing facility.
1338-13 SECTION 45. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017,
1339-14 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1340-15 JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have
1341-16 adequate security. The security must do the following:
1342-17 (1) Record the entrance and exit of individuals to the facility.
1343-18 (2) Use alarms or other comparable monitoring systems that
1344-19 protect the equipment, records, drug supply, devices, and other
1345-20 items from unauthorized access, acquisition, or use.
1346-21 (3) Use at least two (2) factoring credentials for employee entry
1347-22 to the remote dispensing facility, using two (2) of the following:
1348-23 (A) A knowledge factor, including a password.
1349-24 (B) Biometrics.
1350-25 (C) An inanimate object.
1351-26 (b) The qualifying A pharmacist shall periodically review the record
1352-27 of entries into the remote dispensing facility.
1353-28 (c) The prescription storage area may remain open while a
1354-29 pharmacist or pharmacy technician is on duty.
1355-30 SECTION 46. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017,
1356-31 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1357-32 JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be
1358-33 dispensed at the remote dispensing facility unless:
1359-34 (1) the facility maintains a perpetual inventory of controlled
1360-35 substances; and
1361-36 (2) the supervising pharmacist checks the Indiana scheduled
1362-37 prescription electronic collection and tracking program
1363-38 established by IC 25-1-13-4 or as directed by the board before:
1364-39 (A) verification of the finished controlled substance
1365-40 prescription; and
1366-41 (B) counseling the patient.
1367-42 (b) Drugs may be transported to a remote dispensing facility that
1324+1 dispensing facility.
1325+2 (2) Facilitate adequate pharmacist supervision.
1326+3 (3) Allow an appropriate exchange of visual, verbal, and written
1327+4 communications for patient counseling and other matters
1328+5 concerning the lawful transaction of business.
1329+6 (b) The remote dispensing facility must retain a recording of facility
1330+7 surveillance, excluding patient communications, for at least thirty (30)
1331+8 days.
1332+9 (c) A qualifying pharmacist is adequately supervising through the
1333+10 use of video surveillance by maintaining constant visual supervision
1334+11 and auditory communication with the remote dispensing facility and by
1335+12 maintaining full supervisory control of the automated system, if
1336+13 applicable. The auditory communication must be available, as needed,
1337+14 with the remote dispensing facility and the qualifying pharmacist.
1338+15 (d) A video monitor that is being used to properly identify and
1339+16 communicate with consumers must meet the following requirements:
1340+17 (1) Provide both the supervising pharmacy and the remote
1341+18 dispensing facility with direct visual contact between the
1342+19 pharmacist and the consumer.
1343+20 (2) Be secure and compliant with the federal Health Insurance
1344+21 Portability and Accountability Act (HIPAA).
1345+22 (e) If any component of the communication system is not in
1346+23 operating order, the remote dispensing facility shall remain closed until
1347+24 the communication system is fully operational, unless a pharmacist is
1348+25 located at the remote dispensing facility.
1349+26 SECTION 46. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017,
1350+27 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1351+28 JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have
1352+29 adequate security. The security must do the following:
1353+30 (1) Record the entrance and exit of individuals to the facility.
1354+31 (2) Use alarms or other comparable monitoring systems that
1355+32 protect the equipment, records, drug supply, devices, and other
1356+33 items from unauthorized access, acquisition, or use.
1357+34 (3) Use at least two (2) factoring credentials for employee entry
1358+35 to the remote dispensing facility, using two (2) of the following:
1359+36 (A) A knowledge factor, including a password.
1360+37 (B) Biometrics.
1361+38 (C) An inanimate object.
1362+39 (b) The qualifying A pharmacist shall periodically review the record
1363+40 of entries into the remote dispensing facility.
1364+41 (c) The prescription storage area may remain open while a
1365+42 pharmacist or pharmacy technician is on duty.
13681366 HB 1158—LS 7067/DI 137 32
1369-1 uses an automated dispensing machine only in a sealed container with
1370-2 a list identifying each drug, drug strength, and quantity included in the
1371-3 container.
1372-4 (c) A delivery of drugs may be accepted at the remote dispensing
1373-5 facility only if a pharmacist or a licensed pharmacy technician is
1374-6 present to accept delivery and verify and sign for the receipt of the
1375-7 drugs, unless the drugs are placed in a secured delivery area that
1376-8 complies with federal and state law.
1377-9 (d) If the delivery is received by a pharmacy technician, a
1378-10 pharmacist at the supervising pharmacy shall ensure through the use of
1379-11 the electronic audio and video communication system or bar code
1380-12 technology that the pharmacy technician has accurately restocked the
1381-13 drugs.
1382-14 (e) A remote dispensing facility must store drugs in a manner that:
1383-15 (1) complies with federal and state law;
1384-16 (2) protects the identity, safety, security, and integrity of the drug;
1385-17 and
1386-18 (3) limits access to:
1387-19 (A) a pharmacist employed by the supervising pharmacy; and
1388-20 (B) a pharmacy technician who has written authorization of the
1389-21 qualifying a pharmacist to access the facility.
1390-22 SECTION 47. IC 25-26-14-11, AS AMENDED BY P.L.264-2019,
1391-23 SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1392-24 JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale
1393-25 distribution" means to distribute legend drugs to persons other than a
1394-26 consumer or patient. The term does not include:
1395-27 (1) a sale or transfer between a division, a subsidiary, a parent, an
1396-28 affiliated, or a related company under the common ownership and
1397-29 control of a corporate entity;
1398-30 (2) the purchase or acquisition by a hospital or other health care
1399-31 entity that is a member of a group purchasing organization of a
1400-32 drug for the hospital's or health care entity's own use from the
1401-33 group purchasing organization or from other hospitals or health
1402-34 care entities that are members of the organization;
1403-35 (3) the sale or transfer of a drug by a charitable organization
1404-36 described in Section 501(c)(3) of the Internal Revenue Code, to:
1405-37 (A) a nonprofit affiliate of the organization; or
1406-38 (B) a nonprofit entity described in Section 501(c)(3) of the
1407-39 Internal Revenue Code that is not affiliated with the
1408-40 organization;
1409-41 to the extent otherwise permitted by law;
1410-42 (4) the sale of a drug among hospitals or other health care entities
1367+1 SECTION 47. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017,
1368+2 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1369+3 JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be
1370+4 dispensed at the remote dispensing facility unless:
1371+5 (1) the facility maintains a perpetual inventory of controlled
1372+6 substances; and
1373+7 (2) the supervising pharmacist checks the Indiana scheduled
1374+8 prescription electronic collection and tracking program
1375+9 established by IC 25-1-13-4 or as directed by the board before:
1376+10 (A) verification of the finished controlled substance
1377+11 prescription; and
1378+12 (B) counseling the patient.
1379+13 (b) Drugs may be transported to a remote dispensing facility that
1380+14 uses an automated dispensing machine only in a sealed container with
1381+15 a list identifying each drug, drug strength, and quantity included in the
1382+16 container.
1383+17 (c) A delivery of drugs may be accepted at the remote dispensing
1384+18 facility only if a pharmacist or a licensed pharmacy technician is
1385+19 present to accept delivery and verify and sign for the receipt of the
1386+20 drugs, unless the drugs are placed in a secured delivery area that
1387+21 complies with federal and state law.
1388+22 (d) If the delivery is received by a pharmacy technician, a
1389+23 pharmacist at the supervising pharmacy shall ensure through the use of
1390+24 the electronic audio and video communication system or bar code
1391+25 technology that the pharmacy technician has accurately restocked the
1392+26 drugs.
1393+27 (e) A remote dispensing facility must store drugs in a manner that:
1394+28 (1) complies with federal and state law;
1395+29 (2) protects the identity, safety, security, and integrity of the drug;
1396+30 and
1397+31 (3) limits access to:
1398+32 (A) a pharmacist employed by the supervising pharmacy; and
1399+33 (B) a pharmacy technician who has written authorization of the
1400+34 qualifying a pharmacist to access the facility.
1401+35 SECTION 48. IC 25-26-14-11, AS AMENDED BY P.L.264-2019,
1402+36 SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1403+37 JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale
1404+38 distribution" means to distribute legend drugs to persons other than a
1405+39 consumer or patient. The term does not include:
1406+40 (1) a sale or transfer between a division, a subsidiary, a parent, an
1407+41 affiliated, or a related company under the common ownership and
1408+42 control of a corporate entity;
14111409 HB 1158—LS 7067/DI 137 33
1412-1 that are under common control;
1413-2 (5) the sale of a drug for emergency medical reasons, including
1414-3 transfers of legend drugs by a retail pharmacy to another retail
1415-4 pharmacy to alleviate a temporary shortage, if the gross dollar
1416-5 value of the transfers does not exceed five percent (5%) of the
1417-6 total legend drug sales revenue of either the transferor or
1418-7 transferee pharmacy during any twelve (12) consecutive month
1419-8 period;
1420-9 (6) the sale of a drug or the dispensing of a drug pursuant to a
1421-10 prescription;
1422-11 (7) the distribution of drug samples by manufacturers'
1423-12 representatives or distributors' representatives;
1424-13 (8) the sale of blood and blood components intended for
1425-14 transfusion;
1426-15 (9) the sale of a drug by a retail pharmacy to a practitioner (as
1427-16 defined in IC 25-26-13-2) for office use, if the gross dollar value
1428-17 of the transfers does not exceed five percent (5%) of the retail
1429-18 pharmacy's total legend drug sales during any twelve (12)
1430-19 consecutive months;
1431-20 (10) the sale of a drug by a retail pharmacy that is ending its
1432-21 business and liquidating its inventory to another retail pharmacy;
1433-22 (11) drug returns by a hospital, health care entity, or charitable
1434-23 institution conducted under 21 CFR 203.23;
1435-24 (12) the sale of minimal quantities of drugs by retail pharmacies
1436-25 to licensed practitioners for office use;
1437-26 (13) the distribution of prescription drugs by the original
1438-27 manufacturer of the finished form of the prescription drug or the
1439-28 distribution of the co-licensed products by a partner of the
1440-29 original manufacturer of the finished form of the prescription
1441-30 drug; or
1442-31 (14) drug returns that meet criteria established by rules adopted
1443-32 by the board; or
1444-33 (15) the sale of a drug for research or clinical trial purposes,
1445-34 provided the seller is authorized by the federal Food and Drug
1446-35 Administration to sell the drug for research or clinical trial
1447-36 purposes.
1448-37 SECTION 48. IC 27-8-27-6, AS AMENDED BY P.L.133-2020,
1449-38 SECTION 19, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1450-39 JULY 1, 2022]: Sec. 6. (a) A health insurance plan that provides
1451-40 coverage for early intervention services shall reimburse the first steps
1452-41 program a monthly fee established by the division of disability and
1453-42 rehabilitative services. Except when the monthly fee is less than the
1410+1 (2) the purchase or acquisition by a hospital or other health care
1411+2 entity that is a member of a group purchasing organization of a
1412+3 drug for the hospital's or health care entity's own use from the
1413+4 group purchasing organization or from other hospitals or health
1414+5 care entities that are members of the organization;
1415+6 (3) the sale or transfer of a drug by a charitable organization
1416+7 described in Section 501(c)(3) of the Internal Revenue Code, to:
1417+8 (A) a nonprofit affiliate of the organization; or
1418+9 (B) a nonprofit entity described in Section 501(c)(3) of the
1419+10 Internal Revenue Code that is not affiliated with the
1420+11 organization;
1421+12 to the extent otherwise permitted by law;
1422+13 (4) the sale of a drug among hospitals or other health care entities
1423+14 that are under common control;
1424+15 (5) the sale of a drug for emergency medical reasons, including
1425+16 transfers of legend drugs by a retail pharmacy to another retail
1426+17 pharmacy to alleviate a temporary shortage, if the gross dollar
1427+18 value of the transfers does not exceed five percent (5%) of the
1428+19 total legend drug sales revenue of either the transferor or
1429+20 transferee pharmacy during any twelve (12) consecutive month
1430+21 period;
1431+22 (6) the sale of a drug or the dispensing of a drug pursuant to a
1432+23 prescription;
1433+24 (7) the distribution of drug samples by manufacturers'
1434+25 representatives or distributors' representatives;
1435+26 (8) the sale of blood and blood components intended for
1436+27 transfusion;
1437+28 (9) the sale of a drug by a retail pharmacy to a practitioner (as
1438+29 defined in IC 25-26-13-2) for office use, if the gross dollar value
1439+30 of the transfers does not exceed five percent (5%) of the retail
1440+31 pharmacy's total legend drug sales during any twelve (12)
1441+32 consecutive months;
1442+33 (10) the sale of a drug by a retail pharmacy that is ending its
1443+34 business and liquidating its inventory to another retail pharmacy;
1444+35 (11) drug returns by a hospital, health care entity, or charitable
1445+36 institution conducted under 21 CFR 203.23;
1446+37 (12) the sale of minimal quantities of drugs by retail pharmacies
1447+38 to licensed practitioners for office use;
1448+39 (13) the distribution of prescription drugs by the original
1449+40 manufacturer of the finished form of the prescription drug or the
1450+41 distribution of the co-licensed products by a partner of the
1451+42 original manufacturer of the finished form of the prescription
14541452 HB 1158—LS 7067/DI 137 34
1455-1 product determined under IC 12-12.7-2-23(b), the monthly fee shall be
1456-2 provided instead of claims processing of individual claims.
1457-3 (b) A health insurance plan may not require authorization for
1458-4 services specified in the covered individual's individualized family
1459-5 service plan, if those services are a covered benefit under the plan,
1460-6 once the individualized family service plan is signed by a physician, a
1461-7 physician assistant, or an advanced practice registered nurse.
1462-8 (c) The department of insurance shall adopt rules under IC 4-22-2
1463-9 to ensure compliance with this section.
1464-10 SECTION 49. IC 34-30-2-81 IS REPEALED [EFFECTIVE JULY
1465-11 1, 2022]. Sec. 81. (a) IC 16-41-7-2 (Concerning the good faith
1466-12 reporting to a health officer of an individual thought to present a
1467-13 serious and present risk to the health of others, to have engaged in
1468-14 noncompliant behavior, or to be at risk of carrying a serious
1469-15 communicable disease).
1470-16 (b) IC 16-41-7-3 (Concerning a physician who provides notification
1471-17 to certain individuals regarding a patient's serious communicable
1472-18 disease).
1473-19 SECTION 50. IC 34-46-2-10 IS REPEALED [EFFECTIVE JULY
1474-20 1, 2022]. Sec. 10. IC 16-41-7-3 (Concerning warning by physician of
1475-21 serious communicable disease).
1476-22 SECTION 51. IC 35-52-16-42 IS REPEALED [EFFECTIVE JULY
1477-23 1, 2022]. Sec. 42. IC 16-41-7-5 defines a crime concerning
1478-24 communicable diseases.
1479-25 SECTION 52. IC 35-52-16-58 IS REPEALED [EFFECTIVE JULY
1480-26 1, 2022]. Sec. 58. IC 16-41-14-17 defines a crime concerning
1481-27 communicable diseases.
1482-28 SECTION 53. [EFFECTIVE UPON PASSAGE] (a) The terms of
1483-29 members appointed to the division of disability and rehabilitative
1484-30 services advisory council under IC 12-9-4-3, before its amendment
1485-31 by this act, expire June 30, 2022.
1486-32 (b) This SECTION expires July 1, 2023.
1487-33 SECTION 54. An emergency is declared for this act.
1453+1 drug; or
1454+2 (14) drug returns that meet criteria established by rules adopted
1455+3 by the board; or
1456+4 (15) the sale of a drug for research or clinical trial purposes,
1457+5 provided the seller is authorized by the federal Food and Drug
1458+6 Administration to sell the drug for research or clinical trial
1459+7 purposes.
1460+8 SECTION 49. IC 27-8-27-6, AS AMENDED BY P.L.133-2020,
1461+9 SECTION 19, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
1462+10 JULY 1, 2022]: Sec. 6. (a) A health insurance plan that provides
1463+11 coverage for early intervention services shall reimburse the first steps
1464+12 program a monthly fee established by the division of disability and
1465+13 rehabilitative services. Except when the monthly fee is less than the
1466+14 product determined under IC 12-12.7-2-23(b), the monthly fee shall be
1467+15 provided instead of claims processing of individual claims.
1468+16 (b) A health insurance plan may not require authorization for
1469+17 services specified in the covered individual's individualized family
1470+18 service plan, if those services are a covered benefit under the plan,
1471+19 once the individualized family service plan is signed by a physician, a
1472+20 physician assistant, or an advanced practice registered nurse.
1473+21 (c) The department of insurance shall adopt rules under IC 4-22-2
1474+22 to ensure compliance with this section.
1475+23 SECTION 50. IC 34-30-2-81 IS REPEALED [EFFECTIVE JULY
1476+24 1, 2022]. Sec. 81. (a) IC 16-41-7-2 (Concerning the good faith
1477+25 reporting to a health officer of an individual thought to present a
1478+26 serious and present risk to the health of others, to have engaged in
1479+27 noncompliant behavior, or to be at risk of carrying a serious
1480+28 communicable disease).
1481+29 (b) IC 16-41-7-3 (Concerning a physician who provides notification
1482+30 to certain individuals regarding a patient's serious communicable
1483+31 disease).
1484+32 SECTION 51. IC 34-46-2-10 IS REPEALED [EFFECTIVE JULY
1485+33 1, 2022]. Sec. 10. IC 16-41-7-3 (Concerning warning by physician of
1486+34 serious communicable disease).
1487+35 SECTION 52. IC 35-52-16-42 IS REPEALED [EFFECTIVE JULY
1488+36 1, 2022]. Sec. 42. IC 16-41-7-5 defines a crime concerning
1489+37 communicable diseases.
1490+38 SECTION 53. IC 35-52-16-58 IS REPEALED [EFFECTIVE JULY
1491+39 1, 2022]. Sec. 58. IC 16-41-14-17 defines a crime concerning
1492+40 communicable diseases.
1493+41 SECTION 54. [EFFECTIVE UPON PASSAGE] (a) The terms of
1494+42 members appointed to the division of disability and rehabilitative
14881495 HB 1158—LS 7067/DI 137 35
1496+1 services advisory council under IC 12-9-4-3, before its amendment
1497+2 by this act, expire June 30, 2022.
1498+3 (b) This SECTION expires July 1, 2023.
1499+4 SECTION 55. An emergency is declared for this act.
1500+HB 1158—LS 7067/DI 137 36
14891501 COMMITTEE REPORT
14901502 Mr. Speaker: Your Committee on Public Health, to which was
14911503 referred House Bill 1158, has had the same under consideration and
14921504 begs leave to report the same back to the House with the
14931505 recommendation that said bill be amended as follows:
14941506 Page 2, line 30, after "physician" insert ", a physician assistant,".
14951507 Page 2, delete lines 34 through 38.
14961508 Page 6, delete lines 32 through 42.
14971509 Page 7, delete lines 1 through 31.
14981510 Page 8, delete lines 39 through 42.
14991511 Delete pages 9 through 10.
15001512 Page 11, delete lines 1 through 16.
15011513 Page 18, delete lines 31 through 42.
15021514 Page 19, delete lines 1 through 5.
15031515 Page 19, line 17, after "physician" insert ", a physician assistant,".
15041516 Page 19, delete lines 21 through 42, begin a new paragraph and
15051517 insert:
15061518 "SECTION 28. IC 25-1-9-2 IS AMENDED TO READ AS
15071519 FOLLOWS [EFFECTIVE JULY 1, 2022]: Sec. 2. (a) As used in this
15081520 chapter, "practitioner" means an individual who holds:
15091521 (1) an unlimited license, certificate, or registration;
15101522 (2) a limited or probationary license, certificate, or registration;
15111523 (3) a temporary license, certificate, registration, or permit;
15121524 (4) an intern permit; or
15131525 (5) a provisional license;
15141526 issued by the board regulating the profession in question, including a
15151527 certificate of registration issued under IC 25-20.
15161528 (b) The term includes all license statuses, including "active",
15171529 "expired", "retired", "inactive", and any other status that a
15181530 license may be held in.".
15191531 Delete pages 20 through 21.
15201532 Page 22, delete lines 1 through 36.
15211533 Page 23, delete lines 1 through 9.
15221534 Page 28, delete lines 7 through 42, begin a new paragraph and
15231535 insert:
15241536 "SECTION 30. IC 25-26-13-3, AS AMENDED BY P.L.249-2019,
15251537 SECTION 113, IS AMENDED TO READ AS FOLLOWS
15261538 [EFFECTIVE JULY 1, 2022]: Sec. 3. (a) The Indiana board of
15271539 pharmacy is created. The board consists of seven (7) members
15281540 appointed by the governor for terms under IC 25-1-6.5.
15291541 (b) Subject to IC 25-1-6.5-3, the board consists of the following:
1530-HB 1158—LS 7067/DI 137 36
1542+HB 1158—LS 7067/DI 137 37
15311543 (1) One (1) member of the board, to represent the general public,
15321544 who is a resident of this state who has never been associated with
15331545 pharmacy in any way other than as a consumer.
15341546 (2) Six (6) Five (5) members who are pharmacists in good
15351547 standing of recognized experience and ability from varied practice
15361548 settings who hold a current license to practice pharmacy in
15371549 Indiana, including one (1) member of the board who must be a
15381550 practicing hospital pharmacist.
15391551 (3) One (1) member who is a pharmacy technician in good
15401552 standing, engaged in active practice as a pharmacy technician,
15411553 and holds a current certification from the Pharmacy
15421554 Technician Certification Board.
15431555 (c) A member may be removed under IC 25-1-6.5-4.
15441556 (d) Not later than ten (10) days after a member's appointment, the
15451557 member must subscribe by oath or affirmation to faithfully uphold the
15461558 duties of the member's office. If a member fails to qualify as provided,
15471559 a new member shall be appointed in the member's place.
15481560 (e) At the first meeting of each year the board shall elect from
15491561 among its members a president and vice president who shall perform
15501562 duties and have powers as the board prescribes.
15511563 (f) The board shall meet at least eight (8) times per year at such
15521564 times and places as the board selects. At each meeting the board shall
15531565 continue in session from day to day, for not more than five (5) days,
15541566 until the business of the meeting is complete. Four (4) members of the
15551567 board shall constitute a quorum.
15561568 (g) Each member of the board is entitled to compensation as
15571569 determined by the rules of the budget agency for each day the member
15581570 is actually engaged in business of the board, together with necessary
15591571 travel and other expenses incurred in the performance of the member's
15601572 duties.
15611573 (h) Approval by a majority of the quorum is required for any action
15621574 to be taken by the board.".
15631575 Delete pages 29 through 30.
15641576 Page 31, delete lines 1 through 40, begin a new paragraph and
15651577 insert:
15661578 "SECTION 31. IC 25-26-13-10, AS AMENDED BY P.L.101-2020,
15671579 SECTION 4, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
15681580 JULY 1, 2022]: Sec. 10. (a) An applicant for registration as a
15691581 pharmacist intern must furnish proof satisfactory to the board that the
15701582 applicant:
15711583 (1) is actively enrolled in a school of pharmacy accredited by the
15721584 American Council of Pharmaceutical for Pharmacy Education;
1573-HB 1158—LS 7067/DI 137 37
1585+HB 1158—LS 7067/DI 137 38
15741586 (2) has obtained the Foreign Pharmacy Graduate Examination
15751587 Committee Certificate; or
15761588 (3) is a qualified applicant awaiting the examination for licensure
15771589 as a pharmacist.
15781590 (b) A registration issued under subsection (a) is valid for one (1)
15791591 year and may be renewed by the board in accordance with subsection
15801592 (c) until the expiration date established by the Indiana professional
15811593 licensing agency under IC 25-1-5-4.
15821594 (c) An application for registration or renewal must be accompanied
15831595 by the appropriate fee and one (1) of the following:
15841596 (1) Proof of having obtained the Foreign Pharmacy Graduate
15851597 Examination Committee Certificate.
15861598 (2) Proof of active enrollment in a school of pharmacy accredited
15871599 by the American Council of Pharmaceutical for Pharmacy
15881600 Education.
15891601 SECTION 32. IC 25-26-13-11, AS AMENDED BY P.L.98-2006,
15901602 SECTION 6, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
15911603 JULY 1, 2022]: Sec. 11. (a) To be eligible for licensure as a
15921604 pharmacist, an individual must file such evidence as is required by the
15931605 board that:
15941606 (1) the individual is at least eighteen (18) years of age;
15951607 (2) the individual does not have a conviction for a crime that has
15961608 a direct bearing on the individual's ability to practice competently;
15971609 (3) the individual:
15981610 (A) has graduated with a professional degree from a school of
15991611 pharmacy accredited by the American Council of
16001612 Pharmaceutical for Pharmacy Education or the Canadian
16011613 Council on Pharmacy Accreditation for Accreditation of
16021614 Pharmacy Programs and approved by the board; or
16031615 (B) has:
16041616 (i) graduated with a professional degree from a school of
16051617 pharmacy located outside the United States and Canada; and
16061618 (ii) met the requirements under subsection (c); and
16071619 (4) the individual has satisfactorily completed a pharmacist intern
16081620 program approved by the board.
16091621 (b) An applicant who has graduated with a professional degree from
16101622 a school of pharmacy accredited by the Canadian Council on Pharmacy
16111623 Accreditation for Accreditation of Pharmacy Programs and
16121624 approved by the board must obtain the Foreign Pharmacy Graduate
16131625 Examination Committee Certificate administered by the National
16141626 Association of Boards of Pharmacy before taking the examination
16151627 required under subsection (d).
1616-HB 1158—LS 7067/DI 137 38
1628+HB 1158—LS 7067/DI 137 39
16171629 (c) An applicant who has graduated with a professional degree from
16181630 a school of pharmacy located outside the United States and Canada
16191631 must do the following:
16201632 (1) Provide the board with verification of the applicant's academic
16211633 record and graduation.
16221634 (2) Obtain the Foreign Pharmacy Graduate Examination
16231635 Committee Certificate administered by the National Association
16241636 of Boards of Pharmacy.
16251637 (d) After filing an application on a form provided by the board,
16261638 submitting the information required in subsection (a), and successfully
16271639 completing the examination administered by the board, the applicant
16281640 may be licensed as a pharmacist.
16291641 SECTION 33. IC 25-26-13-12, AS AMENDED BY P.L.98-2006,
16301642 SECTION 7, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
16311643 JULY 1, 2022]: Sec. 12. (a) An individual who is licensed as a
16321644 pharmacist in another state where the requirements for licensure were
16331645 not less than those required in this state at the time of original licensure
16341646 may be issued a license in this state if:
16351647 (1) the individual has registered with and been approved by the
16361648 National Association of Boards of Pharmacy;
16371649 (2) the individual has graduated with a professional degree in
16381650 pharmacy from a school of pharmacy accredited by the American
16391651 Council of Pharmaceutical for Pharmacy Education or the
16401652 Canadian Council on Pharmacy Accreditation for Accreditation
16411653 of Pharmacy Programs and approved by the board; and
16421654 (3) the individual has successfully completed an examination
16431655 administered by the board concerning the federal statutes and
16441656 regulations and the Indiana statutes and rules governing the
16451657 practice of pharmacy.
16461658 (b) An individual who has a professional pharmacy degree from a
16471659 school of pharmacy located outside the United States and Canada and
16481660 who is licensed in another state where the requirements for licensure
16491661 are substantially the same as those in this state may be issued a license
16501662 under this chapter if:
16511663 (1) the individual has registered with and been approved by the
16521664 National Association of Boards of Pharmacy;
16531665 (2) the individual has provided the board with proof of the
16541666 applicant's:
16551667 (A) academic record and graduation with a professional degree
16561668 from a school of pharmacy; and
16571669 (B) completion of the requirements for obtaining a Foreign
16581670 Pharmacy Graduate Examination Committee Certificate
1659-HB 1158—LS 7067/DI 137 39
1671+HB 1158—LS 7067/DI 137 40
16601672 administered by the National Association of Boards of
16611673 Pharmacy; and
16621674 (3) the individual has successfully completed an examination
16631675 administered by the board concerning the federal statutes and
16641676 regulations and the Indiana statutes and rules governing the
16651677 practice of pharmacy.
16661678 SECTION 34. IC 25-26-13-20, AS AMENDED BY P.L.207-2021,
16671679 SECTION 33, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
16681680 JULY 1, 2022]: Sec. 20. (a) A person desiring to open, establish,
16691681 operate, or maintain a pharmacy shall apply to the board for a
16701682 pharmacy permit on a form provided by the board. The applicant shall
16711683 set forth:
16721684 (1) the name and occupation of the persons desiring the permit;
16731685 (2) the location, including street address and city, of the
16741686 pharmacy; and
16751687 (3) the name of the pharmacist who will qualify the pharmacy by
16761688 being responsible to the board for the legal operation of the
16771689 pharmacy under the permit; and
16781690 (4) (3) such other information as the board may require.
16791691 (b) If the applicant desires to open, establish, operate, or maintain
16801692 more than one (1) pharmacy, the applicant must file a separate
16811693 application for each. Each pharmacy must be qualified by a different
16821694 pharmacist.
16831695 (c) The board shall permit a pharmacist to serve as a qualifying
16841696 pharmacist for more than one (1) pharmacy holding a Category II
16851697 pharmacy permit upon the holder of the Category II permit showing
16861698 circumstances establishing that:
16871699 (1) the permit holder has made a reasonable effort, without
16881700 success, to obtain a qualifying pharmacist who is not serving as
16891701 a qualifying pharmacist at another Category II pharmacy; and
16901702 (2) the single pharmacist could effectively fulfill all duties and
16911703 responsibilities of the qualifying pharmacist at both locations.
16921704 However, the board shall hold the permit holder responsible and may
16931705 not discipline or otherwise hold the qualifying pharmacist an
16941706 individual licensed under this chapter responsible for staffing
16951707 deficiencies of the pharmacy if the qualifying pharmacist individual
16961708 does not have authority for staffing determinations of the pharmacy.
16971709 (d) The board shall grant or deny an application for a permit not
16981710 later than one hundred twenty (120) days after the application and any
16991711 additional information required by the board are submitted.
17001712 (e) The board may not issue a pharmacy permit to a person who
17011713 desires to operate the pharmacy out of a residence.
1702-HB 1158—LS 7067/DI 137 40
1714+HB 1158—LS 7067/DI 137 41
17031715 SECTION 35. IC 25-26-13-24.8, AS AMENDED BY P.L.207-2021,
17041716 SECTION 34, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
17051717 JULY 1, 2022]: Sec. 24.8. (a) Upon request of a patient, a pharmacy
17061718 shall transfer to another pharmacy a prescription for the patient,
17071719 including a prescription for a schedule II controlled substance, that the
17081720 pharmacy has received but not filled unless:
17091721 (1) prohibited in writing on the prescription by the prescriber; or
17101722 (2) otherwise prohibited by federal law.
17111723 (b) Unless prohibited by federal law, a prescription for a patient may
17121724 be transferred electronically or by facsimile by a pharmacy to another
17131725 pharmacy if the pharmacies do not share a common data base.
17141726 (c) A licensed pharmacy technician may transfer a prescription,
17151727 under subsection (b) including making a verbal transfer, as
17161728 delegated by a pharmacist.".
17171729 Page 33, delete lines 15 through 42.
17181730 Page 34, delete lines 1 through 10.
17191731 Page 35, line 33, delete "supervising".
17201732 Page 35, delete line 42, begin a new paragraph and insert:
17211733 "SECTION 40. IC 25-26-13.5-8 IS REPEALED [EFFECTIVE
17221734 JULY 1, 2022]. Sec. 8. (a) The qualifying pharmacist and a pharmacist
17231735 on duty are responsible for ensuring that the supervising pharmacy and
17241736 remote dispensing facility are sufficiently staffed to avoid the risk of
17251737 harm to public health and safety.
17261738 (b) In order to serve as a qualifying pharmacist, the pharmacist must
17271739 be in good standing with the board.
17281740 (c) A qualifying pharmacist may have this designation for only one
17291741 (1) supervising pharmacy and for one (1) remote dispensing facility at
17301742 a time.
17311743 (d) A qualifying pharmacist must be able to be physically at the
17321744 remote dispensing facility within a certain time set by the board to
17331745 address emergencies and safety issues that arise. However, in the
17341746 qualifying pharmacist's absence the qualifying pharmacist may
17351747 designate another pharmacist to fulfill the qualifying pharmacist's
17361748 duties at the remote dispensing facility.
17371749 (e) A qualifying pharmacist shall visit a remote dispensing facility
17381750 at least as often as required by the board to inspect the facility and
17391751 address personnel matters. The qualifying pharmacist shall complete
17401752 any forms required by the board concerning the required inspection and
17411753 maintain the records in a manner specified by the board.
17421754 (f) If the remote dispensing facility is located at a hospital or
17431755 physician clinic and uses an automated dispensing machine, the
17441756 qualifying pharmacist shall maintain an up to date inventory of any
1745-HB 1158—LS 7067/DI 137 41
1757+HB 1158—LS 7067/DI 137 42
17461758 schedule II controlled substances. The qualifying pharmacist shall at
17471759 least monthly inventory all controlled substances.
17481760 (g) The qualifying pharmacist shall develop and implement a
17491761 continuous quality improvement program. The program must include
17501762 a reporting mechanism for errors that occur concerning the remote
17511763 dispensing facility. Information concerning the program must be
17521764 available to the board upon request.
17531765 SECTION 41. IC 25-26-13.5-8.5 IS ADDED TO THE INDIANA
17541766 CODE AS A NEW SECTION TO READ AS FOLLOWS
17551767 [EFFECTIVE JULY 1, 2022]: Sec. 8.5. A pharmacy operating a
17561768 remote dispensing facility is responsible for ensuring the following:
17571769 (1) The remote dispensing facility is sufficiently staffed to
17581770 avoid the risk of harm to public health and safety.
17591771 (2) The pharmacist servicing the remote dispensing facility is
17601772 in good standing with the board.
17611773 (3) A pharmacy may not operate more than one (1) remote
17621774 dispensing facility at a time, unless otherwise approved by the
17631775 board.
17641776 (4) A pharmacist must be able to be physically present at the
17651777 remote dispensing facility within a certain time set by the
17661778 board to address emergencies and safety issues that arise.
17671779 (5) A pharmacist shall visit the remote dispensing facility at
17681780 least as often as required by the board to inspect the facility,
17691781 address personnel matters, complete any forms required by
17701782 the board concerning the required inspection, and maintain
17711783 records in the manner specified by the board.
17721784 (6) If the remote dispensing facility is located at a hospital or
17731785 physician clinic and uses an automated dispensing machine,
17741786 a pharmacist must maintain an up to date inventory of any
17751787 schedule II controlled substances. An inventory of all
17761788 controlled substances must be completed at least once a
17771789 month.
17781790 (7) The pharmacy must develop a continuous quality
17791791 improvement program, which must include a reporting
17801792 mechanism for errors that occur concerning the remote
17811793 dispensing facility. Information concerning the remote
17821794 dispensing facility must be made available to the board upon
17831795 request.
17841796 SECTION 42. IC 25-26-13.5-9, AS AMENDED BY P.L.246-2019,
17851797 SECTION 16, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
17861798 JULY 1, 2022]: Sec. 9. (a) There must be at least one (1) pharmacist
17871799 working at a remote dispensing facility for every six (6) pharmacist
1788-HB 1158—LS 7067/DI 137 42
1800+HB 1158—LS 7067/DI 137 43
17891801 interns, licensed pharmacy technicians, and pharmacy technicians in
17901802 training at the supervising pharmacy and remote dispensing facility.
17911803 However, an individual whose only duty is to act as the cashier is not
17921804 included in the number of employees that may work for one (1)
17931805 pharmacist under this subsection.
17941806 (b) A remote dispensing facility that is not staffed by a pharmacist
17951807 must be staffed by at least one (1) pharmacy technician who meets the
17961808 following requirements:
17971809 (1) Is licensed under IC 25-26-19.
17981810 (2) Has at least two thousand (2,000) hours of experience working
17991811 as a pharmacy technician in a pharmacy licensed under this article
18001812 and under the direct supervision of a pharmacist.
18011813 (3) Has successfully passed a certification examination offered by
18021814 the Pharmacy Technician Certification Board or another
18031815 nationally recognized certification body approved by the board.
18041816 (4) If the remote dispensing facility is located in a hospital or
18051817 physician clinic setting, either:
18061818 (A) has graduated from a pharmacy technician training
18071819 program accredited by the American Council of
18081820 Pharmaceutical for Pharmacy Education or the American
18091821 Society of Health System Pharmacists; or
18101822 (B) obtained the hours described in subdivision (2) before July
18111823 1, 2017.
18121824 (5) Is supervised by a pharmacist at the supervising pharmacy at
18131825 all times that the remote dispensing facility is operational. As
18141826 used in this subdivision, supervision does not require that the
18151827 pharmacist be physically present at the remote dispensing facility
18161828 as long as the pharmacist is supervising telepharmacy operations
18171829 electronically through a computer link, video link, and audio link.
18181830 (6) Is currently in good standing with the board.
18191831 (c) A pharmacy technician in training may not work at a remote
18201832 dispensing facility unless a pharmacist is on site.
18211833 (d) The board shall adopt rules that require pharmacy technicians
18221834 working at a remote dispensing facility that is not staffed by a
18231835 pharmacist to complete continuing education requirements established
18241836 by the board.".
18251837 Page 36, delete lines 1 through 34.
18261838 Page 37, delete lines 26 through 42, begin a new paragraph and
18271839 insert:
18281840 "SECTION 44. IC 25-26-13.5-14, AS ADDED BY P.L.202-2017,
18291841 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
18301842 JULY 1, 2022]: Sec. 14. (a) A remote dispensing facility shall have
1831-HB 1158—LS 7067/DI 137 43
1843+HB 1158—LS 7067/DI 137 44
18321844 adequate security. The security must do the following:
18331845 (1) Record the entrance and exit of individuals to the facility.
18341846 (2) Use alarms or other comparable monitoring systems that
18351847 protect the equipment, records, drug supply, devices, and other
18361848 items from unauthorized access, acquisition, or use.
18371849 (3) Use at least two (2) factoring credentials for employee entry
18381850 to the remote dispensing facility, using two (2) of the following:
18391851 (A) A knowledge factor, including a password.
18401852 (B) Biometrics.
18411853 (C) An inanimate object.
18421854 (b) The qualifying A pharmacist shall periodically review the record
18431855 of entries into the remote dispensing facility.
18441856 (c) The prescription storage area may remain open while a
18451857 pharmacist or pharmacy technician is on duty.
18461858 SECTION 45. IC 25-26-13.5-15, AS ADDED BY P.L.202-2017,
18471859 SECTION 12, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
18481860 JULY 1, 2022]: Sec. 15. (a) A controlled substance may not be
18491861 dispensed at the remote dispensing facility unless:
18501862 (1) the facility maintains a perpetual inventory of controlled
18511863 substances; and
18521864 (2) the supervising pharmacist checks the Indiana scheduled
18531865 prescription electronic collection and tracking program
18541866 established by IC 25-1-13-4 or as directed by the board before:
18551867 (A) verification of the finished controlled substance
18561868 prescription; and
18571869 (B) counseling the patient.
18581870 (b) Drugs may be transported to a remote dispensing facility that
18591871 uses an automated dispensing machine only in a sealed container with
18601872 a list identifying each drug, drug strength, and quantity included in the
18611873 container.
18621874 (c) A delivery of drugs may be accepted at the remote dispensing
18631875 facility only if a pharmacist or a licensed pharmacy technician is
18641876 present to accept delivery and verify and sign for the receipt of the
18651877 drugs, unless the drugs are placed in a secured delivery area that
18661878 complies with federal and state law.
18671879 (d) If the delivery is received by a pharmacy technician, a
18681880 pharmacist at the supervising pharmacy shall ensure through the use of
18691881 the electronic audio and video communication system or bar code
18701882 technology that the pharmacy technician has accurately restocked the
18711883 drugs.
18721884 (e) A remote dispensing facility must store drugs in a manner that:
18731885 (1) complies with federal and state law;
1874-HB 1158—LS 7067/DI 137 44
1886+HB 1158—LS 7067/DI 137 45
18751887 (2) protects the identity, safety, security, and integrity of the drug;
18761888 and
18771889 (3) limits access to:
18781890 (A) a pharmacist employed by the supervising pharmacy; and
18791891 (B) a pharmacy technician who has written authorization of the
18801892 qualifying a pharmacist to access the facility.
18811893 SECTION 46. IC 25-26-14-11, AS AMENDED BY P.L.264-2019,
18821894 SECTION 8, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
18831895 JULY 1, 2022]: Sec. 11. As used in this chapter, "wholesale
18841896 distribution" means to distribute legend drugs to persons other than a
18851897 consumer or patient. The term does not include:
18861898 (1) a sale or transfer between a division, a subsidiary, a parent, an
18871899 affiliated, or a related company under the common ownership and
18881900 control of a corporate entity;
18891901 (2) the purchase or acquisition by a hospital or other health care
18901902 entity that is a member of a group purchasing organization of a
18911903 drug for the hospital's or health care entity's own use from the
18921904 group purchasing organization or from other hospitals or health
18931905 care entities that are members of the organization;
18941906 (3) the sale or transfer of a drug by a charitable organization
18951907 described in Section 501(c)(3) of the Internal Revenue Code, to:
18961908 (A) a nonprofit affiliate of the organization; or
18971909 (B) a nonprofit entity described in Section 501(c)(3) of the
18981910 Internal Revenue Code that is not affiliated with the
18991911 organization;
19001912 to the extent otherwise permitted by law;
19011913 (4) the sale of a drug among hospitals or other health care entities
19021914 that are under common control;
19031915 (5) the sale of a drug for emergency medical reasons, including
19041916 transfers of legend drugs by a retail pharmacy to another retail
19051917 pharmacy to alleviate a temporary shortage, if the gross dollar
19061918 value of the transfers does not exceed five percent (5%) of the
19071919 total legend drug sales revenue of either the transferor or
19081920 transferee pharmacy during any twelve (12) consecutive month
19091921 period;
19101922 (6) the sale of a drug or the dispensing of a drug pursuant to a
19111923 prescription;
19121924 (7) the distribution of drug samples by manufacturers'
19131925 representatives or distributors' representatives;
19141926 (8) the sale of blood and blood components intended for
19151927 transfusion;
19161928 (9) the sale of a drug by a retail pharmacy to a practitioner (as
1917-HB 1158—LS 7067/DI 137 45
1929+HB 1158—LS 7067/DI 137 46
19181930 defined in IC 25-26-13-2) for office use, if the gross dollar value
19191931 of the transfers does not exceed five percent (5%) of the retail
19201932 pharmacy's total legend drug sales during any twelve (12)
19211933 consecutive months;
19221934 (10) the sale of a drug by a retail pharmacy that is ending its
19231935 business and liquidating its inventory to another retail pharmacy;
19241936 (11) drug returns by a hospital, health care entity, or charitable
19251937 institution conducted under 21 CFR 203.23;
19261938 (12) the sale of minimal quantities of drugs by retail pharmacies
19271939 to licensed practitioners for office use;
19281940 (13) the distribution of prescription drugs by the original
19291941 manufacturer of the finished form of the prescription drug or the
19301942 distribution of the co-licensed products by a partner of the
19311943 original manufacturer of the finished form of the prescription
19321944 drug; or
19331945 (14) drug returns that meet criteria established by rules adopted
19341946 by the board; or
19351947 (15) the sale of a drug for research or clinical trial purposes,
19361948 provided the seller is authorized by the federal Food and Drug
19371949 Administration to sell the drug for research or clinical trial
19381950 purposes.".
19391951 Delete pages 38 through 39.
19401952 Page 40, delete lines 1 through 23.
19411953 Page 40, line 35, after "physician" insert ", a physician assistant,".
19421954 Page 40, delete lines 39 through 42.
19431955 Delete pages 41 through 43.
19441956 Page 44, delete lines 1 through 27.
19451957 Page 44, delete lines 37 through 42.
19461958 Delete page 45.
19471959 Page 46, delete lines 1 through 17.
19481960 Page 46, delete lines 21 through 27.
19491961 Page 46, delete lines 39 through 42.
19501962 Page 47, delete lines 1 through 7.
19511963 Renumber all SECTIONS consecutively.
19521964 and when so amended that said bill do pass.
19531965 (Reference is to HB 1158 as introduced.)
19541966 BARRETT
19551967 Committee Vote: yeas 11, nays 0.
1956-HB 1158—LS 7067/DI 137 46
1957-HOUSE MOTION
1958-Mr. Speaker: I move that House Bill 1158 be amended to read as
1959-follows:
1960-Page 15, delete lines 21 through 33.
1961-Renumber all SECTIONS consecutively.
1962-(Reference is to HB 1158 as printed January 20, 2022.)
1963-CLERE
19641968 HB 1158—LS 7067/DI 137