Illinois General Assembly - Full Text of SB0455
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Full Text of SB0455  99th General Assembly



SB0455 EnrolledLRB099 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:



SB0455 Enrolled- 2 -LRB099 03211 HAF 23219 b

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