Rep. David Harris
Filed: 3/23/2015
 
 

 

 

 
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1
AMENDMENT TO HOUSE BILL 3519




2    AMENDMENT NO. ______. Amend House Bill 3519 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" means a biological product as defined 
10in subsection (i) of Section 351 of the federal Public Health 
11Service Act (42 U.S.C. 262(i)).
12    "Interchangeable" means a biological product that is 
13licensed by the United States Food and Drug Administration 
14pursuant to 42 U.S.C. 262(k)(4) or is deemed therapeutically 
15equivalent to another biological product by the United States 
16Food and Drug Administration and appears in the latest edition 
 
 
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1or supplement of the Approved Drug Products with Therapeutic 
2Equivalence Evaluations (Orange Book).
3    (b) A pharmacist may substitute a prescribed biological 
4product only if:
5        (1) the substituted product has been determined by the 
6    United States Food and Drug Administration to be 
7    interchangeable, as defined in subsection (a) of this 
8    Section, with  the prescribed biological product;
9        (2) the prescribing physician does not designate 
10    orally, in writing, or electronically that substitution is 
11    prohibited in a manner consistent with Section 25 of this 
12    Act;
13        (3) the pharmacy informs the patient of the 
14    substitution; and
15        (4) the selected biological product that will be used 
16    as the substitution has a unit price less than the 
17    biological product specified in the prescription or, if the 
18    unit price of the selected biological product is higher 
19    than the unit price of the prescribed biological product, 
20    the patient is informed and has agreed to accept the 
21    selected biological product. 
22    (c) No later than 5 days after the time of dispensing of a 
23biological product, the dispensing pharmacist or the 
24pharmacist's designee shall communicate to the prescriber the 
25specific product provided to the patient, including the name of 
26the product and the manufacturer. The communication shall be 
 
 
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1conveyed by making an entry into an interoperable electronic 
2medical records system or through electronic prescribing 
3technology or a pharmacy record that is electronically 
4accessible by the prescriber. Otherwise, the pharmacist shall 
5communicate the biologic product dispensed to the prescriber 
6using facsimile, telephone, electronic transmission, or other 
7prevailing means, provided that communication shall not be 
8required where:
9        (1) there is no FDA-approved interchangeable 
10    biological product for the product prescribed; or
11        (2) a refill prescription is not changed from the 
12    product dispensed on the prior filling of the prescription.
13    (d) The pharmacy shall retain a record of the biological 
14product dispensed for a period of 5 years.
15    (e) The Board shall maintain a link on the Department's 
16Internet website to the current list of all biological products 
17determined by the United States Food and Drug Administration to 
18be interchangeable with a specific biological product.
19    (f) The Board shall adopt rules for compliance with this 
20Section.
 
 
21    Section 99. Effective date. This Act takes effect July 1, 
222016.".