Illinois General Assembly - Full Text of Public Act 099-0200
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Public Act 099-0200




Public Act 099-0200
SB0455 EnrolledLRB099 03211 HAF 23219 b

    AN ACT concerning regulation.
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
    Section 5. The Pharmacy Practice Act is amended by adding
Section 19.5 as follows:
    (225 ILCS 85/19.5 new)
    Sec. 19.5. Biological products.
    (a) For the purposes of this Section:
    "Biological product" has the meaning given to that term in
42 U.S.C. 262.
    "Interchangeable biological product" means a biological
product that the United States Food and Drug Administration:
        (1) has (A) licensed and (B) determined it to meet the
    standards for interchangeability pursuant to 42 U.S.C.
    262(k)(4); or
        (2) has determined is therapeutically equivalent as
    set forth in the latest edition of or supplement to the
    United States Food and Drug Administration's Approved Drug
    Products with Therapeutic Equivalence Evaluations (Orange
    (b) A pharmacist may substitute an interchangeable
biological product for a prescribed biological product only if
all of the following conditions in this subsection (b) are met:
        (1) the substituted product has been determined by the
    United States Food and Drug Administration to be
    interchangeable, as defined in subsection (a) of this
    Section, with the prescribed biological product;
        (2) the prescribing physician does not designate
    orally, in writing, or electronically that substitution is
    prohibited in a manner consistent with Section 25 of this
    Act; and
        (3) the pharmacy informs the patient of the
    (c) Within 5 business days following the dispensing of a
biological product, the dispensing pharmacist or the
pharmacist's designee shall make an entry of the specific
product provided to the patient, including the name of the
product and the manufacturer. The communication shall be
conveyed by making an entry that can be electronically accessed
by the prescriber through:
        (1) an interoperable electronic medical records
        (2) an electronic prescribing technology;
        (3) a pharmacy benefit management system; or
        (4) a pharmacy record.
    Entry into an electronic records system as described in
this subsection (c) is presumed to provide notice in accordance
with this subsection (c). Otherwise, the pharmacist shall
communicate the biological product dispensed to the prescriber
using facsimile, telephone, electronic transmission, or other
prevailing means, except that communication shall not be
required where:
        (A) there is no United States Food and Drug
    Administration-approved interchangeable biological product
    for the product prescribed; or
        (B) a refill prescription is not changed from the
    product dispensed on the prior filling of the prescription.
    (d) The pharmacy shall retain a record of the biological
product dispensed for a period of 5 years.
    (e) The Department shall maintain a link on its Internet
website to the current list of all biological products
determined by the United States Food and Drug Administration to
be interchangeable with a specific biological product.
    (f) The Department may adopt rules for compliance with this

Effective Date: 1/1/2016