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| 1 | AN ACT concerning regulation. | |||||||||||||||||||
| 2 | Be it enacted by the People of the State of Illinois, | |||||||||||||||||||
| 3 | represented in the General Assembly: | |||||||||||||||||||
| 4 | Section 5. The Wholesale Drug Distribution Licensing Act | |||||||||||||||||||
| 5 | is amended by changing Section 56 as follows: | |||||||||||||||||||
| 6 | (225 ILCS 120/56) | |||||||||||||||||||
| 7 | (Section scheduled to be repealed on January 1, 2028) | |||||||||||||||||||
| 8 | Sec. 56. Restrictions on transactions. | |||||||||||||||||||
| 9 | (a) A licensee shall receive prescription drug returns or | |||||||||||||||||||
| 10 | exchanges from a pharmacy or other persons authorized to | |||||||||||||||||||
| 11 | administer or dispense drugs or a chain pharmacy warehouse | |||||||||||||||||||
| 12 | pursuant to the terms and conditions of the agreement between | |||||||||||||||||||
| 13 | the wholesale distributor and the pharmacy or chain pharmacy | |||||||||||||||||||
| 14 | warehouse. Returns of expired, damaged, recalled, or otherwise | |||||||||||||||||||
| 15 | non-saleable pharmaceutical products shall be distributed by | |||||||||||||||||||
| 16 | the receiving wholesale distributor only to either the | |||||||||||||||||||
| 17 | original manufacturer or a third party returns processor. | |||||||||||||||||||
| 18 | Returns or exchanges of prescription drugs, saleable or | |||||||||||||||||||
| 19 | otherwise, including any redistribution by a receiving | |||||||||||||||||||
| 20 | wholesaler, shall not be subject to the pedigree requirements | |||||||||||||||||||
| 21 | of Section 57 of this Act, so long as they are exempt from the | |||||||||||||||||||
| 22 | pedigree requirement of the FDA's currently applicable | |||||||||||||||||||
| 23 | Prescription Drug Marketing Act guidance. Both licensees under | |||||||||||||||||||
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| 1 | this Act and pharmacies or other persons authorized to | ||||||
| 2 | administer or dispense drugs shall be accountable for | ||||||
| 3 | administering their returns process and ensuring that the | ||||||
| 4 | aspects of this operation are secure and do not permit the | ||||||
| 5 | entry of adulterated and counterfeit product. | ||||||
| 6 | (b) A manufacturer or wholesale distributor licensed under | ||||||
| 7 | this Act may furnish prescription drugs only to a person | ||||||
| 8 | licensed by the appropriate state licensing authorities. | ||||||
| 9 | Before furnishing prescription drugs to a person not known to | ||||||
| 10 | the manufacturer or wholesale distributor, the manufacturer or | ||||||
| 11 | wholesale distributor must affirmatively verify that the | ||||||
| 12 | person is legally authorized to receive the prescription drugs | ||||||
| 13 | by contacting the appropriate state licensing authorities. | ||||||
| 14 | (c) Prescription drugs furnished by a manufacturer or | ||||||
| 15 | wholesale distributor licensed under this Act may be delivered | ||||||
| 16 | only to the business address of a licensee, to the premises | ||||||
| 17 | listed on a the license, or, if the Department has received | ||||||
| 18 | notice that a licensee has authorized a health care entity to | ||||||
| 19 | receive the prescription drugs, to the address of a health | ||||||
| 20 | care entity, provided that the manufacturer or wholesale | ||||||
| 21 | distributor may furnish prescription drugs to an authorized | ||||||
| 22 | person or agent of that person at the premises of the | ||||||
| 23 | manufacturer or wholesale distributor if: | ||||||
| 24 | (1) the identity and authorization of the recipient is | ||||||
| 25 | properly established; and | ||||||
| 26 | (2) this method of receipt is employed only to meet | ||||||
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| 1 | the immediate needs of a particular patient of the | ||||||
| 2 | authorized person. | ||||||
| 3 | For the purposes of this subsection (c), "health care | ||||||
| 4 | entity" means an entity where medical, dental, or veterinary | ||||||
| 5 | services are provided by a licensed practitioner and where the | ||||||
| 6 | licensed practitioner is responsible for the receipt, storage, | ||||||
| 7 | and use of drugs. | ||||||
| 8 | (d) Prescription drugs may be furnished to a hospital | ||||||
| 9 | pharmacy receiving area, provided that a pharmacist or | ||||||
| 10 | authorized receiving personnel signs, at the time of delivery, | ||||||
| 11 | a receipt showing the type and quantity of the prescription | ||||||
| 12 | drug received. Any discrepancy between the receipt and the | ||||||
| 13 | type and quantity of the prescription drug actually received | ||||||
| 14 | shall be reported to the delivering manufacturer or wholesale | ||||||
| 15 | distributor by the next business day after the delivery to the | ||||||
| 16 | pharmacy receiving area. | ||||||
| 17 | (e) A manufacturer or wholesale distributor licensed under | ||||||
| 18 | this Act may not accept payment for, or allow the use of, a | ||||||
| 19 | person or entity's credit to establish an account for the | ||||||
| 20 | purchase of prescription drugs from any person other than the | ||||||
| 21 | owner of record, the chief executive officer, or the chief | ||||||
| 22 | financial officer listed on the license of a person or entity | ||||||
| 23 | legally authorized to receive the prescription drugs. Any | ||||||
| 24 | account established for the purchase of prescription drugs | ||||||
| 25 | must bear the name of the licensee. This subsection (e) shall | ||||||
| 26 | not be construed to prohibit a pharmacy or chain pharmacy | ||||||
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| 1 | warehouse from receiving prescription drugs if payment for the | ||||||
| 2 | prescription drugs is processed through the pharmacy's or | ||||||
| 3 | chain pharmacy warehouse's contractual drug manufacturer or | ||||||
| 4 | wholesale distributor. | ||||||
| 5 | (Source: P.A. 95-689, eff. 10-29-07.) | ||||||