Illinois 2023-2024 Regular Session

Illinois House Bill HB3490 Compare Versions

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11 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3490 Introduced , by Rep. Hoan Huynh 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 by 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. LRB103 27325 CPF 53696 b A BILL FOR 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3490 Introduced , by Rep. Hoan Huynh 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 by 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. LRB103 27325 CPF 53696 b LRB103 27325 CPF 53696 b A BILL FOR
22 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3490 Introduced , by Rep. Hoan Huynh SYNOPSIS AS INTRODUCED:
33 New Act New Act
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55 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 by 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.
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1111 1 AN ACT concerning health.
1212 2 Be it enacted by the People of the State of Illinois,
1313 3 represented in the General Assembly:
1414 4 Section 1. Short title. This Act may be cited as the
1515 5 Canadian Prescription Drug Importation Act.
1616 6 Section 5. Legislative findings. The General Assembly
1717 7 finds:
1818 8 (1) United States consumers pay some of the highest
1919 9 prescription drug prices in the world, and it is estimated
2020 10 that United States consumers pay twice as much as the amount
2121 11 Canadian consumers pay for patented prescription drugs and 20%
2222 12 more for generic drugs.
2323 13 (2) Federal law, as codified in 21 U.S.C. 384, authorizes
2424 14 the Secretary of the United States Department of Health and
2525 15 Human Services to allow wholesale importation of prescription
2626 16 drugs from Canada if such importation is shown to be both safe
2727 17 and less costly for United States consumers.
2828 18 (3) Although importing prescription drugs would be less
2929 19 costly, there may be risks posed to consumer health and safety
3030 20 if the source, quality, and purity of prescription drugs sold
3131 21 by online pharmacies cannot be verified.
3232 22 (4) Canada has a rigorous regulatory system to license
3333 23 prescription drugs, equivalent to the licensing system in the
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3737 103RD GENERAL ASSEMBLY State of Illinois 2023 and 2024 HB3490 Introduced , by Rep. Hoan Huynh SYNOPSIS AS INTRODUCED:
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4040 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 by 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.
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6868 1 United States.
6969 2 (5) In the United States, Title II of the federal Drug
7070 3 Quality and Security Act, referred to as the Drug Supply Chain
7171 4 Security Act, has significantly improved drug security and
7272 5 safety through a system of pharmaceutical product
7373 6 track-and-trace procedures.
7474 7 (6) A wholesale drug importation program for the exclusive
7575 8 benefit of residents of the State should be designed and
7676 9 implemented to provide consumers of the State access to safe
7777 10 and less expensive prescription drugs.
7878 11 Section 10. Definitions. As used in this Act:
7979 12 "Canadian supplier means a manufacturer, wholesale
8080 13 distributor, or pharmacy that is appropriately licensed or
8181 14 permitted under Canadian federal and provincial laws and
8282 15 regulations to manufacturer, distribute, or dispense
8383 16 prescription drugs.
8484 17 "Department" means the Department of Public Health.
8585 18 "Drug" or prescription drug" has has the same meaning as
8686 19 "drugs" in Section 1 of the Pharmacy Practice Act.
8787 20 "Eligible importer" means an importer that is:
8888 21 (1) a pharmacist or wholesaler employed by or under
8989 22 contract with a medicaid pharmacy, for dispensing to the
9090 23 pharmacy's medicaid recipients;
9191 24 (2) a pharmacist or wholesaler employed by or under
9292 25 contract with the Department of Corrections, for
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103103 1 dispensing to inmates in the custody of the Department of
104104 2 Corrections;
105105 3 (3) a commercial plan, as defined by rules adopted by
106106 4 the Department and as approved by the federal government;
107107 5 and
108108 6 (4) a licensed pharmacist under the Pharmacy Practice
109109 7 Act or registered wholesaler approved by the Department.
110110 8 "Federal act" means the federal Food, Drug, and Cosmetic
111111 9 Act.
112112 10 "Medicaid pharmacy means a pharmacy licensed under the
113113 11 Pharmacy Practice Act that has a Medicaid provider agreement
114114 12 in effect with the State and is in good standing with the
115115 13 State.
116116 14 "Pharmacist" means a person who holds and active and
117117 15 unencumbered license to practice pharmacy under the Pharmacy
118118 16 Practice Act.
119119 17 "Program" means the Canadian prescription drug importation
120120 18 program created in this Act.
121121 19 "Vendor" means a vendor with which the State who contracts
122122 20 for the provision of services under the program pursuant to
123123 21 subsection (a) of Section 15.
124124 22 Section 15. Canadian prescription drug importation
125125 23 program; importation process; contract with vendor; vendor
126126 24 duties.
127127 25 (a) The Canadian prescription drug importation program is
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138138 1 created in the Department. Upon receiving approval of the
139139 2 program as described in Section 25, the Department shall
140140 3 contract with one or more vendors to provide services under
141141 4 the program. For 3 years following the effective date of this
142142 5 Act, the selection of any vendor pursuant to this subsection
143143 6 is exempt from the requirements of the Illinois Procurement
144144 7 Code.
145145 8 (b) Each vendor, in consultation with the Department and
146146 9 any other vendors, shall establish a wholesale prescription
147147 10 drug importation list that identifies the prescription drugs
148148 11 that have the highest potential for cost savings to the State.
149149 12 In developing the list, each vendor shall consider, at a
150150 13 minimum, which prescription drugs will provide the greatest
151151 14 cost savings to the State, including prescription drugs for
152152 15 which there are shortages, specialty prescription drugs, and
153153 16 high-volume prescription drugs. Each vendor shall revise the
154154 17 list at least annually and at the direction of the State
155155 18 department pursuant to this subsection. The Department shall
156156 19 review the wholesale prescription drug importation list at
157157 20 least every 3 months to ensure that it continues to meet the
158158 21 requirements of the program. The Department may direct a
159159 22 vendor to revise the list, as necessary. Each vendor, in
160160 23 consultation with the Department, shall identify Canadian
161161 24 suppliers who are in full compliance with relevant Canadian
162162 25 federal and provincial laws and regulations and who have
163163 26 agreed to export prescription drugs identified on the
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174174 1 wholesale prescription drug importation list. Each vendor
175175 2 shall verify that such Canadian suppliers meet all of the
176176 3 requirements of the program and will export prescription drugs
177177 4 at prices that will provide cost savings to the State. Each
178178 5 vendor shall contract with such eligible Canadian suppliers,
179179 6 or facilitate contracts between eligible importers and
180180 7 Canadian suppliers, to import prescription drugs under the
181181 8 program. Each vendor shall assist the Department in developing
182182 9 and administering a distribution program within the program.
183183 10 Each vendor shall assist the Department with the annual report
184184 11 described in this Act and provide any information requested by
185185 12 the Department for the report. Each vendor shall ensure the
186186 13 safety and quality of drugs imported under the program, as
187187 14 follows:
188188 15 (1) for an initial imported shipment, ensure that each
189189 16 batch of the drug in the shipment is statistically sampled
190190 17 and tested for authenticity and degradation in a manner
191191 18 consistent with the federal act, and for any subsequent
192192 19 imported shipment, ensure that a statistically valid
193193 20 sample of the shipment is tested for authenticity and
194194 21 degradation in a manner consistent with the federal act;
195195 22 (2) certify that each drug: (i) is approved for
196196 23 marketing in the United States and is not adulterated or
197197 24 misbranded; and (ii) meets all of the labeling
198198 25 requirements under 21 U.S.C. 352;
199199 26 (3) maintain qualified laboratory records, including
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210210 1 complete data derived from all tests necessary to ensure
211211 2 that the drug is in compliance with the requirements of
212212 3 this Section; and
213213 4 (4) maintain documentation demonstrating that the
214214 5 testing required by this Section was conducted at a
215215 6 qualified laboratory in accordance with the Federal Act
216216 7 and any other applicable federal and State laws and
217217 8 regulations governing laboratory qualifications.
218218 9 (c) All testing required by this section must be conducted
219219 10 in a qualified laboratory that meets the standards under the
220220 11 Federal Act and any other applicable federal and State laws
221221 12 and regulations governing laboratory qualifications for drug
222222 13 testing.
223223 14 (d) Each vendor shall maintain a list of all eligible
224224 15 importers that participate in the program.
225225 16 (e) Each vendor shall ensure compliance with Title II of
226226 17 the federal Drug Quality and Security Act by all Canadian
227227 18 suppliers, eligible importers, distributors, and other
228228 19 participants in the program.
229229 20 (f) Each vendor shall provide an annual financial audit of
230230 21 its operations to the Department. Each vendor shall also
231231 22 provide quarterly financial reports specific to the program
232232 23 and shall include information concerning the performance of
233233 24 its subcontractors and vendors. The Department shall determine
234234 25 the format and contents of the reports.
235235 26 (g) Each vendor shall submit evidence of a surety bond
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246246 1 with any bid or initial contract negotiation documents and
247247 2 shall maintain documentation of evidence of such a bond with
248248 3 the Department throughout the contract term. The surety bond
249249 4 may be from this State or any other State in the United States
250250 5 and must be in an amount of at least $25,000. The surety bond
251251 6 or comparable security arrangement must include the State as a
252252 7 beneficiary. In lieu of the surety bond, a vendor may provide a
253253 8 comparable security agreement, such as an irrevocable letter
254254 9 of credit or a deposit into a trust account or financial
255255 10 institution that includes the State as a beneficiary, payable
256256 11 to the State. The purposes of the bond or other security
257257 12 arrangement are to:
258258 13 (1) ensure participation of the vendor in any civil or
259259 14 criminal legal action by the State department, any other
260260 15 State agency, or private individuals or entities against
261261 16 the vendor because of the vendor's failure to perform
262262 17 under the contract, including, but not limited to, causes
263263 18 of actions for personal injury, negligence, and wrongful
264264 19 death;
265265 20 (2) ensure payment by the vendor through the use of a
266266 21 bond or other comparable security arrangement of any legal
267267 22 judgments and claims that are awarded to the State, other
268268 23 entities acting on behalf of the State, individuals, or
269269 24 organizations if the vendor is assessed a final judgment
270270 25 or other monetary penalty in a court of law for a civil or
271271 26 criminal action under the program. The bond or comparable
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282282 1 security arrangement may be accessed if the vendor fails
283283 2 to pay any judgment or claim within 60 days after final
284284 3 judgment; and
285285 4 (3) allow for civil and criminal litigation claims to
286286 5 be made against the bond or other comparable security
287287 6 arrangements for up to one year after the vendor's
288288 7 contract under the program has ended with the Department,
289289 8 the vendor's license is no longer valid, or the program
290290 9 has ended, whichever occurs last.
291291 10 (8) Each vendor shall maintain information and
292292 11 documentation submitted under this Section for a period of at
293293 12 least 7 years.
294294 13 (9) The Department may require each vendor to collect any
295295 14 other information necessary to ensure the protection of the
296296 15 public health.
297297 16 Section 20. Eligible prescription drugs; eligible Canadian
298298 17 suppliers; eligible importers; distribution requirements.
299299 18 (a) An eligible importer may import a prescription drug
300300 19 from a Canadian supplier if:
301301 20 (1) the drug meets the United States Food and Drug
302302 21 Administration's standards related to safety,
303303 22 effectiveness, misbranding, and adulteration;
304304 23 (2) importing the drug would not violate federal
305305 24 patent laws;
306306 25 (3) importing the drug is expected to generate cost
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317317 1 savings; and
318318 2 (4) the drug is not:
319319 3 (i) a controlled substance as defined in 21 U.S.C.
320320 4 802;
321321 5 (ii) a biological product as defined in 42 U.S.C.
322322 6 262;
323323 7 (iii) an infused drug;
324324 8 (iv) an intravenously injected drug;
325325 9 (v) a drug that is inhaled during surgery; or
326326 10 (vi) a drug that is a parenteral drug, the
327327 11 importation of which is determined by the United
328328 12 States Secretary of Health and Human Services to pose
329329 13 a threat to the public health.
330330 14 (b) A Canadian supplier may export prescription drugs into
331331 15 the State under the program if the supplier:
332332 16 (1) is in full compliance with relevant Canadian
333333 17 federal and provincial laws and regulations;
334334 18 (2) is identified by the vendor as eligible to
335335 19 participate in the program; and
336336 20 (3) submits an attestation that the supplier has a
337337 21 registered agent in the United States, including the name
338338 22 and United States address of the registered agent.
339339 23 (c) The following entities are eligible importers and may
340340 24 obtain imported prescription drugs:
341341 25 (1) a pharmacist or wholesaler employed by or under
342342 26 contract with a Medicaid pharmacy, for dispensing to the
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353353 1 pharmacy's Medicaid recipients;
354354 2 (2) a pharmacist or wholesaler employed by or under
355355 3 contract with the Department of Corrections, for
356356 4 dispensing to inmates in the custody of the Department of
357357 5 Corrections;
358358 6 (3) commercial plans, as defined by rules promulgated
359359 7 by the State Board and as approved by the federal
360360 8 government; and
361361 9 (4) a licensed pharmacist or wholesaler approved by
362362 10 the Department under the Pharmacy Practice Act.
363363 11 (d) The Department shall designate an office or division
364364 12 that must be a licensed pharmaceutical wholesaler or that
365365 13 shall contract with a licensed pharmaceutical wholesaler
366366 14 licensed pursuant to Part 3 of Article 42.5 of Title 12. The
367367 15 office or division designated by the Department shall:
368368 16 (1) set a maximum profit margin so that a wholesaler,
369369 17 distributor, pharmacy, or other licensed provider
370370 18 participating in the program maintains a profit margin
371371 19 that is no greater than the profit margin that the
372372 20 wholesaler, distributor, pharmacy, or other licensed
373373 21 provider whole have earned on the equivalent nonimported
374374 22 drug;
375375 23 (2) exclude generic products if the importation of the
376376 24 products would violate United States patent laws
377377 25 applicable to United States-branded products;
378378 26 (3) comply with the requirements of 21 U.S.C. 360eee
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389389 1 through 360eee-4 as enacted in Title II of the federal
390390 2 Drug Quality and Security Act; and
391391 3 (4) determine a method for covering the administrative
392392 4 costs of the program, which method may include a fee
393393 5 imposed on each prescription pharmaceutical product sold
394394 6 through the program or any other appropriate method as
395395 7 determined by the Department, but the Department shall not
396396 8 require a fee in an amount the Department determines would
397397 9 significantly reduce consumer savings.
398398 10 (e) Canadian suppliers and eligible importers
399399 11 participating under the program:
400400 12 (1) shall comply with the tracking and tracing
401401 13 requirements of 21 U.S.C. 360; and
402402 14 (2) shall not distribute, dispense, or sell
403403 15 prescription drugs imported under the program outside of
404404 16 the State.
405405 17 (f) A participating eligible importer shall submit to the
406406 18 vendor all of the following information about each drug to be
407407 19 acquired by the importer under the program:
408408 20 (1) the name and quantity of the active ingredient of
409409 21 the drug;
410410 22 (2) a description of the dosage form of the drug;
411411 23 (3) the date on which the drug is received;
412412 24 (4) the quantity of the drug that is received;
413413 25 (5) the point of origin and destination of the drug;
414414 26 and
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425425 1 (6) the price paid by the importer for the drug.
426426 2 (g) A participating Canadian supplier shall submit to the
427427 3 vender the following information about each drug to be
428428 4 supplied by the Canadian supplier under the program:
429429 5 (1) the original source of the drug, including:
430430 6 (i) the name of the manufacturer of the drug;
431431 7 (ii) the date on which the drug was manufactured;
432432 8 and
433433 9 (iii) the location including the country, state or
434434 10 province, and city, where the drug was manufactured;
435435 11 (2) the date on which the drug is shipped;
436436 12 (3) the quantity of the drug that is shipped;
437437 13 (4) the quantity of each lot of the drug originally
438438 14 received and the source of the lot; and
439439 15 (5) the lot or control number and the batch number
440440 16 assigned to the drug by the manufacturer.
441441 17 (h) The Department shall immediately suspend the
442442 18 importation of a specific drug or the importation of drugs by a
443443 19 specific eligible importer if it discovers that any drug or
444444 20 activity is in violation of this Section or any federal or
445445 21 State law or regulation. The Department may revoke the
446446 22 suspension if, after conducting an investigation, it
447447 23 determines that the public is adequately protected from
448448 24 counterfeit or unsafe drugs being imported into this State.
449449 25 Section 25. Federal approval.
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460460 1 (a) On or before September 1, 2023, the Department shall
461461 2 submit a request to the United States Secretary of Health and
462462 3 Human Services for approval of the program under 21 U.S.C.
463463 4 384. The Department shall begin operating the program within 6
464464 5 months after receiving such approval. The request must, at a
465465 6 minimum:
466466 7 (1) describe the Department's plan for operating the
467467 8 program;
468468 9 (2) demonstrate how the prescription drugs imported
469469 10 into this State under the program will meet the applicable
470470 11 federal and State standards for safety, effectiveness,
471471 12 misbranding, and adulteration;
472472 13 (3) include a list of proposed prescription drugs that
473473 14 have the highest potential for cost savings to the State
474474 15 through importation at the time that the request is
475475 16 submitted;
476476 17 (4) estimate the total cost savings attributable to
477477 18 the program;
478478 19 (5) include a list of potential Canadian suppliers
479479 20 from which the State would import drugs and demonstrate
480480 21 that the suppliers are in full compliance with relevant
481481 22 Canadian federal and provincial laws and regulations.
482482 23 (b) Notwithstanding any provision of this subsection to
483483 24 the contrary, the Department may expend money for the purpose
484484 25 of requesting approval of the program as described in
485485 26 subsection (a), but the Department shall not spend any other
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496496 1 money to implement the program until the Department receives
497497 2 approval of the program as described in subsection (a).
498498 3 (c) Upon receipt of federal approval of the program, the
499499 4 Department shall notify the President of the Senate and the
500500 5 Speaker of the House of Representatives, as well as the Health
501501 6 and Human Services Committee of the Senate and the Health and
502502 7 Insurance Committee of the House of Representatives, or any
503503 8 successor committees. After approval is received and before
504504 9 the start of the next regular session of the General Assembly
505505 10 in which the proposal could be funded, the Department shall
506506 11 submit to all parties specified in this subsection a proposal
507507 12 for program implementation and program funding.
508508 13 Section 30. Reports. On or before December 1, 2024, and on
509509 14 or before December 1 each year thereafter, the Department
510510 15 shall submit a report to the Governor, the President of the
511511 16 Senate, and the Speaker of the House of Representatives on the
512512 17 operation of the program during the previous fiscal year. The
513513 18 report must include, at a minimum:
514514 19 (1) a list of the prescription drugs that were
515515 20 imported under the program;
516516 21 (2) the number of participating Canadian suppliers and
517517 22 eligible importers;
518518 23 (3) the number of prescriptions dispensed through the
519519 24 program;
520520 25 (4) the estimated cost savings during the previous
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531531 1 fiscal year and to date attributable to the program;
532532 2 (5) a description of the methodology used to determine
533533 3 which drugs should be included on the wholesale
534534 4 prescription drug importation list; and
535535 5 (6) documentation as to how the program ensures the
536536 6 following that:
537537 7 (i) Canadian suppliers participating in the
538538 8 program are in full compliance with relevant Canadian
539539 9 federal and provincial laws;
540540 10 (ii) prescription drugs imported under the program
541541 11 are not shipped, sold, or dispensed outside of this
542542 12 State once in the possession of the eligible importer;
543543 13 (iii) prescription drugs imported under the
544544 14 program are pure, unadulterated, potent, and safe;
545545 15 (iv) the program does not put consumers at a
546546 16 higher health and safety risk than if the program did
547547 17 not exist; and
548548 18 (v) the program provides cost savings to the State
549549 19 on imported prescription drugs.
550550 20 Section 35. Importation program authorized; rulemaking.
551551 21 (a) Upon approval by the Secretary, in accordance with
552552 22 Section 30, the Department shall administer an importation
553553 23 program.
554554 24 (b) The Department shall approve a method of financing and
555555 25 administrative costs of the importation program, which method
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566566 1 may include imposing a fee on each prescription pharmaceutical
567567 2 product sold through the importation program or any other
568568 3 appropriate method determined by the Department to finance
569569 4 administrative costs. The Department shall not require a fee
570570 5 in an amount that the Department determines would
571571 6 significantly reduce consumer savings.
572572 7 (c) The Department shall adopt rules necessary to
573573 8 implement this Act.
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