Rep. David Harris

Filed: 3/11/2015

 

 


 

 


 
09900HB3519ham001LRB099 09712 AMC 32139 a

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.".