Oklahoma 2022 Regular Session

Oklahoma Senate Bill SB638 Compare Versions

Version 1 (Old)

Version 2 (New)

Old	New		Differences
1	1
2	2
3		-	SENATE FLOOR VERSION - SB638 SFLR Page 1
4		-	(Bold face denotes Committee Amendments) 1
	3	+	Req. No. 1686 Page 1 1
5	4		2
6	5		3
7	6		4
8	7		5
9	8		6
10	9		7
11	10		8
12	11		9
13	12		10
14	13		11
15	14		12
16	15		13
17	16		14
18	17		15
19	18		16
20	19		17
21	20		18
22	21		19
23	22		20
24	23		21
25	24		22
26	25		23
27	26		24
28	27
29		-	SENATE FLOOR VERSION
30		-	February 22, 2021
	28	+	STATE OF OKLAHOMA
31	29
	30	+	1st Session of the 58th Legislature (2021)
32	31
33	32		COMMITTEE SUBSTITUTE
34	33		FOR
35		-	SENATE BILL ~~NO.~~ 638 By: McCortney
	34	+	SENATE BILL 638 By: McCortney
36	35
37	36
38	37
39	38
	39	+
	40	+	COMMITTEE SUBSTITUTE
40	41
41	42		An Act relating to pharmacy; amending 59 O.S. 2011,
42	43		Section 367.2, which relates to definitions us ed in
43	44		the Utilization of Unused Prescription Medications
44	45		Act; adding definition; amending 59 O.S. 2011,
45	46		Section 367.3, as amended by Secti on 45, Chapter 475,
46	47		O.S.L. 2019 (59 O.S. Supp. 2020 , Section 367.3),
47	48		which relates to program for utilization of unuse d
48	49		prescription drugs; deleting procedure for transfer
49	50		of certain prescription drugs; providing for donation
50	51		or return of unused prescription medications for
51	52		credit or reimbursement; excluding certain drugs;
52	53		amending 59 O.S. 2011, Section 367.4, which relates
53	54		to criteria for accepting unused prescription drugs;
54	55		broadening criteria to apply to returned drugs;
55	56		amending 59 O.S. 2011, Section 367.5, which relates
56	57		to participation in program ; clarifying inclusion of
57	58		certain facilities; specifying ability to refuse
58	59		individual returns; authorizing pharmacy to restock
59	60		and redistribute returned prescription drugs after
60	61		credit or reimbursement; amending 59 O.S. 2011,
61	62		Section 367.6, which relates to l iability of
62	63		participating organizations and manufacturers;
63	64		broadening criteria to apply to returned drugs;
64	65		removing certain pharmacies from program; clarifying
65	66		inclusion of certain facilities; amending 59 O.S.
66	67		2011, Section 367.7, which relates to promulgation of
67	68		rules; directing promulgation of certain rules; and
68	69		providing an effective date.
69	70
70	71
71	72
72	73
73	74		BE IT ENACTED BY THE PEOPLE OF TH E STATE OF OKLAHOMA:
74	75
75		-	SENATE FLOOR VERSION - SB638 SFLR Page 2
76		-	(Bold face denotes Committee Amendments) 1
	76	+	Req. No. 1686 Page 2 1
77	77		2
78	78		3
79	79		4
80	80		5
81	81		6
82	82		7
83	83		8
84	84		9
85	85		10
86	86		11
87	87		12
88	88		13
89	89		14
90	90		15
91	91		16
92	92		17
93	93		18
94	94		19
95	95		20
96	96		21
97	97		22
98	98		23
99	99		24
100	100
101	101		SECTION 1. AMENDATORY 59 O.S. 2011, Section 367.2, is
102	102		amended to read as follows:
103	103		Section 367.2. As used in the Utilization of Unused
104	104		Prescription Medications Act:
105	105		1. “Assisted living center ” has the same meaning as such term
106	106		is defined in Section 1 -890.2 of Title 63 of the Oklahoma Statutes;
107	107		2. “Cancer drugs” means any of several drugs that control or
108	108		kill neoplastic cells, commonly referred to as “cancer-fighting
109	109		drugs”; and includes, but is not limited to, drugs used in
110	110		chemotherapy to destroy cancer cells;
111	111		3. “Charitable clinic” means a charitable nonpro fit corporation
112	112		or a facility organized as a not-for-profit organization pursuant to
113	113		the provisions of the Oklahoma General Corporation Act that:
114	114		a. holds a valid exemption from federal income taxation
115	115		issued pursuant to Section 501(a) of the Internal
116	116		Revenue Code (26 U.S.C., Section 501(a)) ,
117	117		b. is listed as an exempt organization under 501(c) of
118	118		the Internal Revenue Code (26 U.S.C., Section 501(c)),
119	119		c. provides on an outpatient basis for a period of less
120	120		than twenty-four (24) consecutive hours to persons not
121	121		residing or confined at such faci lity advice,
122	122		counseling, diagnosis, treatment, surger y, care or
123	123		services relating to the preservation or maintenance
124	124		of health, and
125	125
126		-	SENATE FLOOR VERSION - SB638 SFLR Page 3
127		-	(Bold face denotes Committee Amendments) 1
	126	+	Req. No. 1686 Page 3 1
128	127		2
129	128		3
130	129		4
131	130		5
132	131		6
133	132		7
134	133		8
135	134		9
136	135		10
137	136		11
138	137		12
139	138		13
140	139		14
141	140		15
142	141		16
143	142		17
144	143		18
145	144		19
146	145		20
147	146		21
148	147		22
149	148		23
150	149		24
151	150
152	151		d. has a licensed outpatient pharmacy;
153	152		4. “Health care professional ” means any of the following
154	153		persons licensed and authorized to prescribe and dispense drugs or
155	154		to provide medical, dental, or other health -related diagnoses, care
156	155		or treatment within the scope of their professional license:
157	156		a. a physician holding a current license to practice
158	157		medicine pursuant to Chapter 11 or Chapter 14 of Title
159	158		59 of the Oklahoma Statutes this title,
160	159		b. an advanced practice nurse licensed pursuant to
161	160		Chapter 12 of Title 59 of the Oklahoma Statutes this
162	161		title,
163	162		c. a physician assistant licensed pursuant to Chapter 11
164	163		of Title 59 of the Oklahoma Statutes this title,
165	164		d. a dentist licensed pursuant to Chapter 7 of Title 59
166	165		of the Oklahoma Statutes this title,
167	166		e. an optometrist licensed pursuant to Chapter 13 of
168	167		Title 59 of the Oklahoma Statutes this title, and
169	168		f. a pharmacist licensed pursuant to Chapter 8 of Title
170	169		59 of the Oklahoma Statutes this title;
171	170		4. 5. “Medically indigent” means a person eligible to receive
172	171		Medicaid or Medicare or a person who has no health insurance and who
173	172		otherwise lacks reasonable means to purchase prescribed medications;
174	173
175		-	SENATE FLOOR VERSION - SB638 SFLR Page 4
176		-	(Bold face denotes Committee Amendments) 1
	174	+	Req. No. 1686 Page 4 1
177	175		2
178	176		3
179	177		4
180	178		5
181	179		6
182	180		7
183	181		8
184	182		9
185	183		10
186	184		11
187	185		12
188	186		13
189	187		14
190	188		15
191	189		16
192	190		17
193	191		18
194	192		19
195	193		20
196	194		21
197	195		22
198	196		23
199	197		24
200	198
201	199		5. “Charitable clinic” means a charitable nonpro fit corporation
202	200		or a facility organized as a not-for-profit pursuant to the
203	201		provisions of the Oklahoma General Corporation Act that:
204	202		a. holds a valid exemption from federal income taxation
205	203		issued pursuant to Secti on 501(a) of the Internal
206	204		Revenue Code (26 U.S.C., Section 501(a)),
207	205		b. is listed as an exempt organization under 501(c) of
208	206		the Internal Revenue Code (26 U.S.C., Section 501(c)),
209	207		c. provides on an outpatient basis for a period of less
210	208		than twenty-four (24) consecutive hours to persons not
211	209		residing or confined at such facility advice,
212	210		counseling, diagnosis, treatment, surgery, care or
213	211		services relating to the preservation or maintenance
214	212		of health, and
215	213		d. has a licensed outpatient pharmacy; and
216	214		6. “Nursing facility” has the same meaning as such term is
217	215		defined in Section 1-1902 of Title 63 of the Oklahoma Statutes ; and
218	216		7. “Prescription drug” means a drug which may be dispense d only
219	217		upon prescription by a health care professional authorized by his or
220	218		her licensing authority and which is approved for saf ety and
221	219		effectiveness as a prescription drug under Section 505 or 507 of the
222	220		Federal Food, Drug and Cosmetic Act (52 Stat. 1040 (1938), 21
223	221		U.S.C.A., Section 301).
224	222
225		-	SENATE FLOOR VERSION - SB638 SFLR Page 5
226		-	(Bold face denotes Committee Amendments) 1
	223	+	Req. No. 1686 Page 5 1
227	224		2
228	225		3
229	226		4
230	227		5
231	228		6
232	229		7
233	230		8
234	231		9
235	232		10
236	233		11
237	234		12
238	235		13
239	236		14
240	237		15
241	238		16
242	239		17
243	240		18
244	241		19
245	242		20
246	243		21
247	244		22
248	245		23
249	246		24
250	247
251	248		SECTION 2. AMENDATORY 59 O.S. 2011, Section 367.3, as
252	249		amended by Section 45, Chapter 475, O.S.L. 2019 (59 O.S. Supp. 2020,
253	250		Section 367.3), is amended to re ad as follows:
254	251		Section 367.3. A. The State Board of Pharmacy shall implement
255	252		statewide a program consistent with public heal th and safety through
256	253		which unused prescription drugs, other than prescription dr ugs
257	254		defined as controlled dangerous substances in Section 2-101 of Title
258	255		63 of the Oklahoma Statutes , may be transferred from residential
259	256		care homes, nursing facilities, assis ted living centers, public
260	257		intermediate care facilities for individuals with inte llectual
261	258		disabilities (ICFs/IID) or pharmaceutica l manufacturers to
262	259		pharmacies operated by a county. If no county pharmacy exists, or
263	260		if a county pharmacy chooses not to part icipate, such unused
264	261		prescription medications may be transferred to a pharmacy op erated
265	262		by a city-county health department or a ph armacy under contract with
266	263		a city-county health department, a pharmacy operated by the
267	264		Department of Mental Health and Substan ce Abuse Services or:
268	265		1. Donated by a residential care home, a nursing facility, an
269	266		assisted living center, an intermediate care facility for
270	267		individuals with intellectual disabilities (ICF/IID) or a
271	268		pharmaceutical manufacturer to a charitable clinic for the purpose
272	269		of distributing the unused pre scription medications to Oklahoma
273	270		residents who are medically indigent ; or
274	271
275		-	SENATE FLOOR VERSION - SB638 SFLR Page 6
276		-	(Bold face denotes Committee Amendments) 1
	272	+	Req. No. 1686 Page 6 1
277	273		2
278	274		3
279	275		4
280	276		5
281	277		6
282	278		7
283	279		8
284	280		9
285	281		10
286	282		11
287	283		12
288	284		13
289	285		14
290	286		15
291	287		16
292	288		17
293	289		18
294	290		19
295	291		20
296	292		21
297	293		22
298	294		23
299	295		24
300	296
301	297		2. Returned by a residential care home, a nursing facility, an
302	298		assisted living center or an intermediate care facility for
303	299		individuals with intellectual disabilities (ICF/IID) to the pharmacy
304	300		where the unused prescription medications were purchased in exchange
305	301		for credit or reimbursement. Returns under this paragraph shall not
306	302		be available for drugs purchased by the state Medicaid program.
307	303		B. The Board of Pharmacy shall promulgate rules and establish
308	304		procedures necessary to implement the program e stablished by the
309	305		Utilization of Unused Prescription Medications Act.
310	306		C. The Board of Pharmacy shall provide technical as sistance to
311	307		entities who may wish to participate in the program.
312	308		SECTION 3. AMENDATORY 59 O.S. 2011, Section 367.4, is
313	309		amended to read as follows:
314	310		Section 367.4. The following criteria shall be used in
315	311		accepting unused prescription drugs for use under t he Utilization of
316	312		Unused Prescription Medi cations Act:
317	313		1. Only prescription drug s in their original sealed unit dose
318	314		packaging or unused injectables shall be accepted and dispensed
319	315		pursuant to the Utilization of Unused Prescription Medications Act;
320	316		2. The packaging must be unopened, except that cancer drugs
321	317		packaged in single-unit doses may be accepted and dispensed when the
322	318		outside packaging is opened if the single -unit-dose packaging has
323	319		not been opened;
324	320		3. Expired prescription drugs shall not be accep ted;
325	321
326		-	SENATE FLOOR VERSION - SB638 SFLR Page 7
327		-	(Bold face denotes Committee Amendments) 1
	322	+	Req. No. 1686 Page 7 1
328	323		2
329	324		3
330	325		4
331	326		5
332	327		6
333	328		7
334	329		8
335	330		9
336	331		10
337	332		11
338	333		12
339	334		13
340	335		14
341	336		15
342	337		16
343	338		17
344	339		18
345	340		19
346	341		20
347	342		21
348	343		22
349	344		23
350	345		24
351	346
352	347		4. A prescription drug shall not be accepted or dispensed if
353	348		the person accepting or dispensing the drug has reason to believe
354	349		that the drug is adulterated;
355	350		5. No controlled dangerous substances shall be accepted; and
356	351		6. Subject to the limitation s pecified in this section, unused
357	352		prescription drugs dispensed for purposes of a m edical assistance
358	353		program or drug product donation progra m, or unused prescription
359	354		drugs returned by a facility listed in Section 367.3 of this title
360	355		in exchange for credit or reimbursement, may be accepted and
361	356		dispensed under the Utilization of Unused Pre scription Medications
362	357		Act.
363	358		SECTION 4. AMENDATORY 59 O.S. 2011, Section 367 .5, is
364	359		amended to read as follows:
365	360		Section 367.5. A. Participation in the Utilization of Unused
366	361		Prescription Medications Act by pharmacies, nursing homes
367	362		facilities, assisted living centers , intermediate care facilities
368	363		for individuals with intellectual disabilities (ICF/IID), charitable
369	364		clinics or prescription dru g manufacturers shall be voluntary.
370	365		Nothing in the Utilization of Unused Prescription Medicat ions Act
371	366		shall require any pharmacy, nursing home facility, assisted living
372	367		center, intermediate care facility for individuals with intellectual
373	368		disabilities (ICF/IID), charitable clinic or prescription drug
374	369		manufacturer to participate in the program . Furthermore, a pharmacy
375	370
376		-	SENATE FLOOR VERSION - SB638 SFLR Page 8
377		-	(Bold face denotes Committee Amendments) 1
	371	+	Req. No. 1686 Page 8 1
378	372		2
379	373		3
380	374		4
381	375		5
382	376		6
383	377		7
384	378		8
385	379		9
386	380		10
387	381		11
388	382		12
389	383		13
390	384		14
391	385		15
392	386		16
393	387		17
394	388		18
395	389		19
396	390		20
397	391		21
398	392		22
399	393		23
400	394		24
401	395
402	396		that participates in the program shall have the right to refuse
403	397		individual returns of unused prescr iption medications.
404	398		B. A pharmacy or charitable clinic which meets the eligibility
405	399		requirements established in the Utilization of Unuse d Prescription
406	400		Medications Act may:
407	401		1. Dispense dispense prescription drugs d onated under the
408	402		Utilization of Unused Prescription Medications Act to persons who
409	403		are medically indigent residents of Oklahoma as establis hed in rules
410	404		by the State Board of Pharmacy; and
411	405		2. Charge. Such drugs shall not be resold . However, the
412	406		charitable clinic may charge persons receiving donated prescription
413	407		drugs a handling fee established by rule by the Board of Pharmacy.
414	408		C. A pharmacy which meets the eligibility requireme nts
415	409		established in the Utilization of Unused Prescription Medications
416	410		Act may restock and redistribute prescription drugs returned to the
417	411		pharmacy after the pharmacy has issue d the credit or reimbursement
418	412		to the facility or entity who purchased the prescription drugs.
419	413		D. A pharmacy or charitable clinic which meets the eligibility
420	414		requirements established and authorized by the Utilization of Unused
421	415		Prescription Medications Act which accepts donated prescription
422	416		drugs shall:
423	417		1. Comply with all applicable federal and state laws related to
424	418		the storage and distribution of dangerous drugs;
425	419
426		-	SENATE FLOOR VERSION - SB638 SFLR Page 9
427		-	(Bold face denotes Committee Amendments) 1
	420	+	Req. No. 1686 Page 9 1
428	421		2
429	422		3
430	423		4
431	424		5
432	425		6
433	426		7
434	427		8
435	428		9
436	429		10
437	430		11
438	431		12
439	432		13
440	433		14
441	434		15
442	435		16
443	436		17
444	437		18
445	438		19
446	439		20
447	440		21
448	441		22
449	442		23
450	443		24
451	444
452	445		2. Inspect all prescription drugs prio r to dispensing the
453	446		prescription drugs to determine that such drugs are not adulterated;
454	447		and
455	448		3. Dispense prescription drugs only pursuant to a prescription
456	449		issued by a health care professional .
457	450		D. Prescription drugs donated under the Utilization of Unuse d
458	451		Prescription Medications Act shall not be resold.
459	452		E. For purposes of the Utilization of Unused Prescription
460	453		Medications Act, reimbursement from governmental agencies to
461	454		charitable clinics shall not be considered resale of prescription
462	455		drugs.
463	456		SECTION 5. AMENDATORY 59 O.S. 2011, Section 367.6, is
464	457		amended to read as follows:
465	458		Section 367.6. A. For matters related only to the lawful
466	459		donation, return, acceptance, or dispensing of prescription drugs
467	460		under the Utilization of Unused Pr escription Medications Act, the
468	461		following persons and e ntities, in compliance with the Utilizatio n
469	462		of Unused Prescription Medications Act, in the absence of bad faith
470	463		or gross negligence, shall not be subject to criminal or civil
471	464		liability for injury other than death, or loss to person or
472	465		property, or professi onal disciplinary action:
473	466		1. The State Board of Pharmacy;
474	467		2. The Department of Mental Health and Substance Abuse
475	468		Services;
476	469
477		-	SENATE FLOOR VERSION - SB638 SFLR Page 10
478		-	(Bold face denotes Committee Amendments) 1
	470	+	Req. No. 1686 Page 10 1
479	471		2
480	472		3
481	473		4
482	474		5
483	475		6
484	476		7
485	477		8
486	478		9
487	479		10
488	480		11
489	481		12
490	482		13
491	483		14
492	484		15
493	485		16
494	486		17
495	487		18
496	488		19
497	489		20
498	490		21
499	491		22
500	492		23
501	493		24
502	494
503	495		3. Any prescription drug manufacturer, governmental entity,
504	496		nursing home facility, or assisted living cent er, intermediate care
505	497		facility for individuals with intellectual disabilities (ICF/IID)
506	498		donating or returning prescription drugs under the Utilization of
507	499		Unused Prescription Medications Act;
508	500		4. Any prescription drug manufact urer or its representative
509	501		that directly donates prescr iption drugs in professional samples to
510	502		a charitable clinic or a pharmacy under the Utilization of Unused
511	503		Prescription Medications Act;
512	504		5. Any pharmacy, charitable clinic or health care professional
513	505		that accepts or dispenses prescription drugs under the Utilization
514	506		of Unused Prescription Medicati ons Act; and
515	507		6. Any pharmacy, or charitable clinic, city-county pharmacy or
516	508		other state-contracted pharmacy that employs a health care
517	509		professional who accept s or can legally dispense prescription drugs
518	510		under the Utilization of Unused Prescription Medicat ions Act and the
519	511		Oklahoma Pharmacy Act.
520	512		B. For matters related to the donation , return, acceptance, or
521	513		dispensing of a prescription drug manufactured by the p rescription
522	514		drug manufacturer that is donated by any en tity under the
523	515		Utilization of Unused Presc ription Medications Act, a prescription
524	516		drug manufacturer shall not, in the absence of bad faith or gross
525	517		negligence, be subject to criminal or civil liability for injury
526	518		other than for death, or loss to person or property including, but
527	519
528		-	SENATE FLOOR VERSION - SB638 SFLR Page 11
529		-	(Bold face denotes Committee Amendments) 1
	520	+	Req. No. 1686 Page 11 1
530	521		2
531	522		3
532	523		4
533	524		5
534	525		6
535	526		7
536	527		8
537	528		9
538	529		10
539	530		11
540	531		12
541	532		13
542	533		14
543	534		15
544	535		16
545	536		17
546	537		18
547	538		19
548	539		20
549	540		21
550	541		22
551	542		23
552	543		24
553	544
554	545		not limited to, liability for failure to transfer or communicate
555	546		product or consumer information or the expiration date of the
556	547		donated prescription drug.
557	548		SECTION 6. AMENDATORY 59 O.S. 2011, Secti on 367.7, is
558	549		amended to read as follows:
559	550		Section 367.7. A. The State Board of Pharmacy shall promulgate
560	551		emergency rules by December 1, 2004, to implement the Utilization of
561	552		Unused Prescription Medications Act. Permanent rules shall be
562	553		promulgated pursuant to the A dministrative Procedures Act. Such
563	554		rules shall include:
564	555		1. Eligibility criteria for pharmacies and charitable clinics
565	556		authorized to receive and dispense donated prescri ption drugs under
566	557		the Utilization of Unused Prescription Medic ations Act;
567	558		2. Establishment of a formulary which shall include a ll
568	559		prescription drugs app roved by the federal Food and Drug
569	560		Administration;
570	561		3. Standards and procedures for transfer, acceptanc e, safe
571	562		storage, security, and dispensing of donated prescript ion drugs;
572	563		4. A process for seeking input from the State Departme nt of
573	564		Health in establishing provisions which affect nursing homes
574	565		facilities and assisted living centers;
575	566		5. A process for seeking input from the Department of Mental
576	567		Health and Substance Abuse Servi ces in establishing provisions which
577	568		affect mental health and substance abuse clients;
578	569
579		-	SENATE FLOOR VERSION - SB638 SFLR Page 12
580		-	(Bold face denotes Committee Amendments) 1
	570	+	Req. No. 1686 Page 12 1
581	571		2
582	572		3
583	573		4
584	574		5
585	575		6
586	576		7
587	577		8
588	578		9
589	579		10
590	580		11
591	581		12
592	582		13
593	583		14
594	584		15
595	585		16
596	586		17
597	587		18
598	588		19
599	589		20
600	590		21
601	591		22
602	592		23
603	593		24
604	594
605	595		6. Standards and procedures for inspecting donated prescription
606	596		drugs to ensure that the drugs are in comp liance with the
607	597		Utilization of Unused Prescription Medications Act and to ensure
608	598		that, in the professi onal judgment of the pharmacist, the
609	599		medications meet all federal and state standards for product
610	600		integrity;
611	601		7. Procedures for destruction of medications that are donated
612	602		which are controlled substances;
613	603		8. Procedures for verifying whether the pharmacy a nd
614	604		responsible pharmacist participating in the prog ram are licensed and
615	605		in good standing with the Board of Pharmacy;
616	606		9. Establishment of standards for ac ceptance of unused
617	607		prescription medications from assisted livi ng centers; and
618	608		10. Procedures for credit and reimbursement for returns of
619	609		unused prescription medications; and
620	610		11. Any other standards and procedures the Board of Pharmacy
621	611		deems appropriate or necessary to imple ment the provisions of the
622	612		Utilization of Unused Prescr iption Medications Act.
623	613		B. In accordance with the rules and procedures of the program
624	614		established pursuant to this section, a resident of a nursing
625	615		facility or assisted living cent er, or the represent ative or
626	616		guardian of a resident may donate unused presc ription medications,
627	617		other than prescription drugs defined as controlled dange rous
628	618
629		-	SENATE FLOOR VERSION - SB638 SFLR Page 13
630		-	(Bold face denotes Committee Amendments) 1
	619	+	Req. No. 1686 Page 13 1
631	620		2
632	621		3
633	622		4
634	623		5
635	624		6
636	625		7
637	626		8
638	627		9
639	628		10
640	629		11
641	630		12
642	631		13
643	632		14
644	633		15
645	634		16
646	635		17
647	636		18
648	637		19
649	638		20
650	639		21
651	640		22
652	641		23
653	642		24
654	643
655	644		substances by Section 2 -101 of Title 63 of the Oklahoma Statutes,
656	645		for dispensation to medically in digent persons.
657	646		SECTION 7. This act shall become effective November 1, 2021.
658		-	~~COMMITTEE REPORT BY: COMMITTEE ON HEALTH AND HUMAN SERVICES~~
659		-	~~February~~ 22, 2021 ~~- DO PASS AS AMENDED~~
	647	+
	648	+	58-1-1686 DC 2/22/2021 3:40:10 PM