Rep. David Harris
Filed: 3/11/2015
 
 

 

 

 
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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    "Prescription", with respect to a biological product, 
4means a product that is subject to Section 503(b) of the 
5Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
6    (b) A pharmacist may substitute a prescription biological 
7product for a prescribed biological product only if:
8        (1) the substituted product has been determined by the 
9    United States Food and Drug Administration to be 
10    interchangeable, as defined in subsection (a) of this 
11    Section, with  the prescribed biological product;
12        (2) the prescribing physician does not designate 
13    orally, in writing, or electronically that substitution is 
14    prohibited in a manner consistent with Section 25 of this 
15    Act;
16        (3) the pharmacy informs the patient of the 
17    substitution; and
18        (4) the cost of the substituted biological product is 
19    less than the cost of the prescribed biological product or, 
20    if the cost of the substituted  biological product is more 
21    than cost of the prescribed biological product, the patient 
22    is informed and has agreed to accept the higher cost 
23    substituted biological product. 
24    (c) Within a reasonable time following the dispensing of a 
25biological product, the dispensing pharmacist or the 
26pharmacist's designee shall communicate to the prescriber the 
 
 
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1specific product provided to the patient, including the name of 
2the product and the manufacturer. The communication shall be 
3conveyed by making an entry into an interoperable electronic 
4medical records system or through electronic prescribing 
5technology or a pharmacy record that is electronically 
6accessible by the prescriber. Otherwise, the pharmacist shall 
7communicate the biologic product dispensed to the prescriber 
8using facsimile, telephone, electronic transmission, or other 
9prevailing means, provided that communication shall not be 
10required where:
11        (1) there is no FDA-approved interchangeable 
12    biological product for the product prescribed; or
13        (2) 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 Board shall maintain a link on the Department's 
18Internet website 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 Board shall adopt rules for compliance with this 
22Section.
 
 
23    Section 99. Effective date. This Act takes effect July 1, 
242016.".