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


Sen. Antonio Muñoz

Filed: 5/26/2015





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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