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 
    Book). 
    (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 
    substitution.
    (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 
    system;
        (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 
Section.

Effective Date:  1/1/2016