Sen. Antonio Muņoz
Filed: 5/26/2015
 
 

 

 

 
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1
AMENDMENT TO SENATE BILL 455




2    AMENDMENT NO. ______. Amend Senate Bill 455 by replacing 
3everything after the enacting clause with the following:


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