Illinois 2023-2024 Regular Session

Illinois House Bill HB3310 Compare Versions

Only one version of the bill is available at this time.

Old	New	Differences
1	1	103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED: New Act Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately. LRB103 30128 CPF 56552 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED: New Act New Act Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately. LRB103 30128 CPF 56552 b LRB103 30128 CPF 56552 b A BILL FOR
2	2	103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED:
3	3	New Act New Act
4	4	New Act
5	5	Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately.
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11	11	1 AN ACT concerning health.
12	12	2 Be it enacted by the People of the State of Illinois,
13	13	3 represented in the General Assembly:
14	14	4 Section 1. Short title. This Act may be cited as the
15	15	5 Canadian Prescription Drug Importation Act.
16	16	6 Section 3. Findings. The General Assembly finds:
17	17	7 (1) United States citizens pay some of the highest
18	18	8 prices for prescription drugs in the world, and the
19	19	9 Canadian government estimates that United States consumers
20	20	10 pay twice as much as Canadians for patented prescription
21	21	11 drugs and 20% more for generics.
22	22	12 (2) Under the United States Food and Drug
23	23	13 Administration's discretion not to enforce the law,
24	24	14 individual patients may import from Canada a 90-day supply
25	25	15 of prescription drugs that are less expensive than drugs
26	26	16 licensed by the Food and Drug Administration in the United
27	27	17 States.
28	28	18 (3) Individual importation via the Internet increases
29	29	19 consumer health and safety risks because many Internet
30	30	20 pharmacies are not licensed in Canada, and it is difficult
31	31	21 to verify the validity, reputation, actual identity, and
32	32	22 pharmacy practices of online pharmacies outside of the
33	33	23 United States.
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37	37	103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3310 Introduced , by Rep. Joe C. Sosnowski SYNOPSIS AS INTRODUCED:
38	38	New Act New Act
39	39	New Act
40	40	Creates the Canadian Prescription Drug Importation Act. Provides that the Department of Public Health shall establish the Canadian Prescription Drug Importation Program for the importation of safe and effective prescription drugs from Canada which have the highest potential for cost savings to the State. Provides that the Department shall contract with a vendor to provide services under the program. Provides that on or before December 1, 2023, and each year thereafter, the vendor shall develop a wholesale prescription drug importation list identifying the prescription drugs that have the highest potential for cost savings to the State. Provides that the vendor shall identify Canadian suppliers that are in full compliance with the provisions of the Act and contract with the Canadian suppliers to import drugs under the program. Provides for: a bond requirement; requirements for eligible prescription drugs; requirements for eligible Canadian suppliers; requirements for eligible importers; distribution requirements; federal approval; prescription drug supply chain documentation; immediate suspension of specified imported drug; requirements of an annual report; notification of federal approval. Provides that the Department shall adopt rules necessary to implement the Act. Effective immediately.
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68	68	1 (4) The United States allows patients to travel to
69	69	2 other countries for surgeries and other high-risk medical
70	70	3 treatments without regulating that activity, and insurers
71	71	4 sometimes facilitate and pay for treatments outside of the
72	72	5 United States.
73	73	6 (5) The United States Food and Drug Administration
74	74	7 estimates that currently 40% of finished prescription drug
75	75	8 products are produced outside of the United States, and
76	76	9 80% of raw products for United States pharmaceutical
77	77	10 manufacturing come from outside the United States.
78	78	11 (6) The United States Food and Drug Administration
79	79	12 recently signed reciprocity agreements with European Union
80	80	13 regulators to accept the results of European Union
81	81	14 inspections of pharmaceutical manufacturing plants. Since
82	82	15 1973, the United States Food and Drug Administration has
83	83	16 had in place a Memorandum of Understanding for regulatory
84	84	17 cooperation around pharmaceuticals with the Canadian
85	85	18 regulatory authorities.
86	86	19 (7) Canada has a rigorous regulatory system to license
87	87	20 prescription drugs that is considered to be on par with
88	88	21 the United States licensing system.
89	89	22 (8) The enactment of Title II of the federal Drug
90	90	23 Quality and Security Act (P.L. 113-54) has resulted in
91	91	24 improvements in drug security and safety by implementing a
92	92	25 pharmaceutical track-and-trace system that could be
93	93	26 leveraged for the safe importation of pharmaceuticals.
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104	104	1 (9) The Secretary of the United States Department of
105	105	2 Health and Human Services may certify a prescription drug
106	106	3 reimportation program that is safe and saves consumers
107	107	4 money.
108	108	5 (10) The State can ensure that wholesale importation
109	109	6 of prescription drugs from Canada into the State will be
110	110	7 safe and cost-effective for State consumers.
111	111	8 Section 5. Program established. The Department of Public
112	112	9 Health shall establish the Canadian Prescription Drug
113	113	10 Importation Program for the importation from Canada of safe
114	114	11 and effective prescription drugs that have the highest
115	115	12 potential for cost savings to the State.
116	116	13 Section 10. Definitions. As used in this Act:
117	117	14 "Canadian supplier" means a manufacturer, wholesale
118	118	15 distributor, or pharmacy appropriately licensed or permitted
119	119	16 under Canadian law to manufacture, distribute, or dispense
120	120	17 prescription drugs.
121	121	18 "County health department" means a health care facility
122	122	19 established under Division 5-25 of the Counties Code.
123	123	20 "Department" means the Department of Public Health.
124	124	21 "Drug" or "prescription drug" has the same meaning as
125	125	22 "drugs" in Section 1 of the Pharmacy Practice Act.
126	126	23 "Federal act" means the Federal Food, Drug, and Cosmetic
127	127	24 Act as amended by the federal Drug Quality and Security Act.
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138	138	1 "Free clinic" means a free medical clinic as defined in
139	139	2 subsection (b) of Section 30 of the Good Samaritan Act.
140	140	3 "Medicaid pharmacy" means a pharmacy licensed under the
141	141	4 Pharmacy Practice Act that has a Medicaid provider agreement
142	142	5 in effect with the State and is in good standing with the
143	143	6 State.
144	144	7 "Pharmacist" means a person who holds an active and
145	145	8 unencumbered license to practice pharmacy under the Pharmacy
146	146	9 Practice Act.
147	147	10 "Program" means the Canadian Prescription Drug Importation
148	148	11 Program created under this Act.
149	149	12 "Track-and-trace" means the product-tracing process for
150	150	13 the components of the pharmaceutical distribution supply chain
151	151	14 as described in Title II of the federal Drug Quality and
152	152	15 Security Act.
153	153	16 "Vendor" means the entity contracted by the Department to
154	154	17 manage specified functions of the program.
155	155	18 Section 15. Importation process.
156	156	19 (a) The Department shall contract with a vendor to provide
157	157	20 services under the program.
158	158	21 (b) On or before December 1, 2023, and on or before
159	159	22 December 1 of each year thereafter, the vendor shall develop a
160	160	23 wholesale prescription drug importation list identifying the
161	161	24 prescription drugs that have the highest potential for cost
162	162	25 savings to the State. In developing the list, the vendor shall
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173	173	1 consider, at a minimum, which prescription drugs will provide
174	174	2 the greatest cost savings to State programs, including
175	175	3 prescription drugs for which there are shortages, specialty
176	176	4 prescription drugs, and high-volume prescription drugs. The
177	177	5 Department, in consultation with the federal department, shall
178	178	6 review the wholesale prescription drug importation list every
179	179	7 3 months to ensure that it continues to meet the requirements
180	180	8 of the programs and may direct the vendor to revise the list as
181	181	9 necessary.
182	182	10 (c) The vendor shall identify Canadian suppliers that are
183	183	11 in full compliance with relevant Canadian federal and
184	184	12 provincial laws and regulations and the federal act and who
185	185	13 have agreed to export drugs identified on the list at prices
186	186	14 that will provide cost savings to the State. The vendor must
187	187	15 verify that such Canadian suppliers meet all of the
188	188	16 requirements of the program while meeting or exceeding the
189	189	17 federal and State track-and-trace laws and regulations.
190	190	18 (d) The vendor shall contract with such eligible Canadian
191	191	19 suppliers, or facilitate contracts between eligible importers
192	192	20 and Canadian suppliers, to import drugs under the program.
193	193	21 (e) The vendor shall maintain a list of all registered
194	194	22 importers that participate in the program.
195	195	23 (f) The vendor shall ensure compliance with Title II of
196	196	24 the federal Drug Quality and Security Act by all suppliers,
197	197	25 importers and other distributors, and participants in the
198	198	26 program.
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209	209	1 (g) The vendor shall assist the Department in the
210	210	2 preparation of the annual report required by Section 60 of
211	211	3 this Act including the timely provision of any information
212	212	4 requested by the Department.
213	213	5 (h) The vendor shall provide an annual financial audit of
214	214	6 its operations to the Department as required by the
215	215	7 Department. The vendor shall also provide quarterly financial
216	216	8 reports specific to the program and shall include information
217	217	9 on the performance of its subcontractors and vendors. The
218	218	10 Department shall determine the format and contents of the
219	219	11 reports.
220	220	12 Section 20. Bond requirement. The Department shall require
221	221	13 a bond from the vendor to mitigate the financial consequences
222	222	14 of potential acts of malfeasance or misfeasance or fraudulent
223	223	15 or dishonest acts committed by the vendor, any employees of
224	224	16 the vendor, or its subcontractors.
225	225	17 Section 25. Eligible prescription drugs. Eligible
226	226	18 importers, as described in Section 35 of this Act, may import a
227	227	19 drug from an eligible Canadian supplier, as described in
228	228	20 Section 30 of this Act, if:
229	229	21 (1) the drug meets the United States Food and Drug
230	230	22 Administration's standards related to safety,
231	231	23 effectiveness, misbranding, and adulteration;
232	232	24 (2) importing the drug would not violate federal
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243	243	1 patent laws;
244	244	2 (3) importing the drug is expected to generate cost
245	245	3 savings; and
246	246	4 (4) the drug is not:
247	247	5 (i) a controlled substance as defined in 21 U.S.C.
248	248	6 802;
249	249	7 (ii) a biological product as defined in 42 U.S.C.
250	250	8 262;
251	251	9 (iii) an infused drug;
252	252	10 (iv) an intravenously injected drug;
253	253	11 (v) a drug that is inhaled during surgery; or
254	254	12 (vi) a drug that is a parenteral drug, the
255	255	13 importation of which is determined by the United
256	256	14 States Secretary of Health and Human Services to pose
257	257	15 a threat to the public health.
258	258	16 Section 30. Eligible Canadian suppliers. A Canadian
259	259	17 supplier may export prescription drugs into this State under
260	260	18 the program if the supplier:
261	261	19 (1) is in full compliance with relevant Canadian
262	262	20 federal and provincial laws and regulations;
263	263	21 (2) is identified by the vendor as eligible to
264	264	22 participate in the program; and
265	265	23 (3) submits an attestation that the supplier has a
266	266	24 registered agent in the United States, including the name
267	267	25 and United States address of the registered agent.
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278	278	1 Section 35. Eligible importers. The following entities may
279	279	2 import prescription drugs from an eligible Canadian supplier
280	280	3 under the program:
281	281	4 (1) a pharmacist or wholesaler employed by or under
282	282	5 contract with the Department's central pharmacy, for
283	283	6 distribution to a county health department or free clinic
284	284	7 for dispensing to clients treated in such department or
285	285	8 clinic;
286	286	9 (2) a pharmacist or wholesaler employed by or under
287	287	10 contract with a Medicaid pharmacy, for dispensing to the
288	288	11 pharmacy's Medicaid recipients;
289	289	12 (3) a pharmacist or wholesaler employed by or under
290	290	13 contract with the Department of Corrections, for
291	291	14 dispensing to inmates in the custody of the Department of
292	292	15 Corrections;
293	293	16 (4) a pharmacist or wholesaler employed by or under
294	294	17 contract with the Department of Juvenile Justice, for
295	295	18 dispensing to inmates in the custody of the Department of
296	296	19 Juvenile Justice;
297	297	20 (5) a pharmacist or wholesaler employed by or under
298	298	21 contract with a developmental disabilities center, as
299	299	22 defined in the Mental Health and Developmental
300	300	23 Disabilities Administrative Act, for dispensing to clients
301	301	24 treated in such center; and
302	302	25 (6) a pharmacist or wholesaler employed by or under
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313	313	1 contract with a residential treatment facility, or
314	314	2 "facility" as defined in the Specialized Mental Health
315	315	3 Rehabilitation Act of 2013 for dispensing to patients
316	316	4 treated in such facility.
317	317	5 Section 40. Distribution requirements. Eligible Canadian
318	318	6 suppliers and eligible importers participating under the
319	319	7 program:
320	320	8 (1) must comply with the tracking and tracing
321	321	9 requirements of 21 U.S.C. 360; and
322	322	10 (2) may not distribute, dispense, or sell prescription
323	323	11 drugs imported under the program outside of the State.
324	324	12 Section 45. Federal approval. On or before July 1, 2023,
325	325	13 the Department shall submit a request to the United States
326	326	14 Secretary of Health and Human Services for approval of the
327	327	15 program under paragraph (1) of 21 U.S.C. 384. The Department
328	328	16 shall begin operating the program within 6 months after
329	329	17 receiving such approval. The request must, at a minimum:
330	330	18 (1) describe the Department's plan for operating the
331	331	19 program;
332	332	20 (2) demonstrate how the prescription drugs imported
333	333	21 into this State under the program will meet the applicable
334	334	22 federal and State standards for safety and effectiveness;
335	335	23 (3) demonstrate how the drugs imported into this State
336	336	24 under the program will comply with federal tracing
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347	347	1 procedures;
348	348	2 (4) include a list of proposed prescription drugs that
349	349	3 have the highest potential for cost savings to the State
350	350	4 through importation at the time that the request is
351	351	5 submitted;
352	352	6 (5) estimate the total cost savings attributable to
353	353	7 the program;
354	354	8 (6) provide the costs of program implementation to the
355	355	9 State; and
356	356	10 (7) include a list of potential Canadian suppliers
357	357	11 from which the State would import drugs and demonstrate
358	358	12 that the suppliers are in full compliance with relevant
359	359	13 Canadian federal and provincial laws and regulations as
360	360	14 well as all applicable federal and State laws and
361	361	15 regulations.
362	362	16 Section 50. Prescription drug supply chain documentation.
363	363	17 (a) The vendor shall ensure the safety and quality of
364	364	18 drugs imported under the program. The vendor shall:
365	365	19 (1) for an initial imported shipment of a specific
366	366	20 drug by an importer, ensure that each batch of the drug in
367	367	21 the shipment is statistically sampled and tested for
368	368	22 authenticity and degradation in a manner consistent with
369	369	23 the federal act;
370	370	24 (2) for every subsequent imported shipment of that
371	371	25 drug by that importer, ensure that a statistically valid
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382	382	1 sample of the shipment is tested for authenticity and
383	383	2 degradation in a manner consistent with the federal act;
384	384	3 (3) certify that the drug:
385	385	4 (i) is approved for marketing in the United States
386	386	5 and is not adulterated or misbranded; and
387	387	6 (ii) meets all of the labeling requirements under
388	388	7 21 U.S.C. 352;
389	389	8 (4) maintain qualified laboratory records, including
390	390	9 complete data derived from all tests necessary to ensure
391	391	10 that the drug is in compliance with the requirements of
392	392	11 this Section.
393	393	12 (5) maintain documentation demonstrating that the
394	394	13 testing required by this Section was conducted at a
395	395	14 qualified laboratory in accordance with the federal act
396	396	15 and any other applicable federal and State laws and
397	397	16 regulations governing laboratory qualifications.
398	398	17 (b) All testing required by this Section must be conducted
399	399	18 in a qualified laboratory that meets the standards under the
400	400	19 federal act and any other applicable federal and State laws
401	401	20 and regulations governing laboratory qualifications for drug
402	402	21 testing.
403	403	22 (c) The vendor shall maintain information and
404	404	23 documentation submitted under this Section for a period of at
405	405	24 least 7 years.
406	406	25 (d) A participating importer must submit all of the
407	407	26 following information to the vendor:
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418	418	1 (1) the name and quantity of the active ingredient of
419	419	2 the drug;
420	420	3 (2) a description of the dosage form of the drug;
421	421	4 (3) the date on which the drug is received;
422	422	5 (4) the quantity of the drug that is received;
423	423	6 (5) the point of origin and destination of the drug;
424	424	7 and
425	425	8 (6) the price paid by the importer for the drug;
426	426	9 (e) A participating Canadian supplier must submit the
427	427	10 following information and documentation to the vendor
428	428	11 specifying all of the following:
429	429	12 (1) the original source of the drug, including:
430	430	13 (i) the name of the manufacturer of the drug;
431	431	14 (ii) the date on which the drug was manufactured;
432	432	15 and
433	433	16 (iii) the location including the country, state or
434	434	17 province, and city, where the drug was manufactured;
435	435	18 (2) the date on which the drug is shipped;
436	436	19 (3) the quantity of the drug that is shipped;
437	437	20 (4) the quantity of each lot of the drug originally
438	438	21 received and the source of the lot; and
439	439	22 (5) the lot or control number and the batch number
440	440	23 assigned to the drug by the manufacturer.
441	441	24 (f) The Department may require that the vendor collect any
442	442	25 other information necessary to ensure the protection of the
443	443	26 public health.
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454	454	1 Section 55. Immediate suspension. The Department shall
455	455	2 immediately suspend the importation of a specific drug or the
456	456	3 importation of drugs by a specific importer if it discovers
457	457	4 that any drug or activity is in violation of this Section or
458	458	5 any federal or State law or regulation. The Department may
459	459	6 revoke the suspension if, after conducting an investigation,
460	460	7 it determines that the public is adequately protected from
461	461	8 counterfeit or unsafe drugs being imported into this State.
462	462	9 Section 60. Annual report. On or before December 1 of each
463	463	10 year, the Department shall submit a report to the Governor,
464	464	11 the President of the Senate, and the Speaker of the House of
465	465	12 Representatives on the operation of the program during the
466	466	13 previous fiscal year. The report must include, at a minimum:
467	467	14 (1) a list of the prescription drugs that were
468	468	15 imported under the program;
469	469	16 (2) the number of participating entities;
470	470	17 (3) the number of prescriptions dispensed through the
471	471	18 program;
472	472	19 (4) the estimated cost savings during the previous
473	473	20 fiscal year and to date attributable to the program;
474	474	21 (5) a description of the methodology used to determine
475	475	22 which drugs should be included on the wholesale
476	476	23 prescription drug importation list; and
477	477	24 (6) documentation as to how the program ensures the
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488	488	1 following that:
489	489	2 (i) Canadian suppliers participating in the
490	490	3 program are of high quality, high performance, and in
491	491	4 full compliance with relevant Canadian federal and
492	492	5 provincial laws and regulations as well as all federal
493	493	6 laws and regulations and State laws and rules;
494	494	7 (ii) prescription drugs imported under the program
495	495	8 are not shipped, sold, or dispensed outside of this
496	496	9 State once in the possession of the importer;
497	497	10 (iii) prescription drugs imported under the
498	498	11 program are pure, unadulterated, potent, and safe;
499	499	12 (iv) the program does not put consumers at a
500	500	13 higher health and safety risk than if the consumer did
501	501	14 not participate; and
502	502	15 (v) the program provides cost savings to the State
503	503	16 on imported prescription drugs.
504	504	17 Section 65. Notification of federal approval. Upon receipt
505	505	18 of federal approval of the program, the Department shall
506	506	19 notify the President of the Senate, the Speaker of the House of
507	507	20 Representatives, and the relevant committees of the Senate and
508	508	21 the House of Representatives. After approval is received and
509	509	22 before the start of the next regular session of the General
510	510	23 Assembly in which the proposal could be funded, the Department
511	511	24 shall submit to all parties a proposal for program
512	512	25 implementation and program funding.
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523	523	1 Section 70. Rulemaking. The Department shall adopt rules
524	524	2 necessary to implement this Act.
525	525	3 Section 99. Effective date. This Act takes effect upon
526	526	4 becoming law.
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