SB0455 EngrossedLRB099 03211 HAF 23219 b



1    AN ACT concerning regulation.

 
2    Be it enacted by the People of the State of Illinois, 
3represented in the General Assembly: 

 
4    Section 5. The Pharmacy Practice Act is amended  by adding 
5Section 19.5 as follows:
 
6    (225 ILCS 85/19.5 new)
7    Sec. 19.5. Biological products.
8    (a) For the purposes of this Section:
9    "Biological product" has the meaning given to that term in 
1042 U.S.C. 262.
11    "Interchangeable biological product" means a biological 
12product that the United States Food and Drug Administration:
13        (1) has (A) licensed and (B)  determined  it to meet the 
14    standards for interchangeability pursuant to 42 U.S.C. 
15    262(k)(4); or 
16        (2) has determined is therapeutically equivalent as 
17    set forth in the latest edition of or supplement to the 
18    United States Food and Drug Administration's Approved Drug 
19    Products with Therapeutic Equivalence Evaluations (Orange 
20    Book). 
21    (b) A pharmacist may substitute an interchangeable 
22biological product for a prescribed biological product only if 
23all of the following conditions in this subsection (b) are met:
 
 
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1        (1) the substituted product has been determined by the 
2    United States Food and Drug Administration to be 
3    interchangeable, as defined in subsection (a) of this 
4    Section, with  the prescribed biological product;
5        (2) the prescribing physician does not designate 
6    orally, in writing, or electronically that substitution is 
7    prohibited in a manner consistent with Section 25 of this 
8    Act; and
9        (3) the pharmacy informs the patient of the 
10    substitution.
11    (c) Within 5 business days following the dispensing of a 
12biological product, the dispensing pharmacist or the 
13pharmacist's designee shall make an entry of the specific 
14product provided to the patient, including the name of the 
15product and the manufacturer. The communication shall be 
16conveyed by making an entry that can be electronically accessed 
17by the prescriber through:
18        (1) an interoperable electronic medical records 
19    system;
20        (2) an electronic prescribing technology;
21        (3) a pharmacy benefit management system; or 
22        (4) a pharmacy record. 
23    Entry into an electronic records system as described in 
24this subsection (c) is presumed to provide notice in accordance 
25with this subsection (c). Otherwise, the pharmacist shall 
26communicate the biological product dispensed to the prescriber 
 
 
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1using facsimile, telephone, electronic transmission, or other 
2prevailing means, except that communication shall not be 
3required where: 
4        (A) there is no United States Food and Drug 
5    Administration-approved interchangeable biological product 
6    for the product prescribed; or 
7        (B) a refill prescription is not changed from the 
8    product dispensed on the prior filling of the prescription. 
9    (d) The pharmacy shall retain a record of the biological 
10product dispensed for a period of 5 years.
11    (e) The Department shall maintain a link on its Internet 
12website to the current list of all biological products 
13determined by the United States Food and Drug Administration to 
14be interchangeable with a specific biological product.
15    (f) The Department may adopt rules for compliance with this 
16Section.