99TH GENERAL ASSEMBLY
State of Illinois
2015 and 2016
SB1611

 

Introduced 2/20/2015, by Sen. Antonio Muņoz

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/19.5 new

    Amends the Pharmacy Practice Act. Provides that a pharmacist may substitute a prescription biological product for a prescribed biological product only if specified criteria are met. Requires that, within a reasonable time following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the product and the manufacturer. Requires the pharmacy to retain a record of the biological product dispensed for a period of 5 years. Requires the State Board of Pharmacy to maintain a link on the Department's Internet web site 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. Effective immediately.


LRB099 09151 AMC 29348 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

SB1611LRB099 09151 AMC 29348 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" 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
17or supplement of the Approved Drug Products with Therapeutic
18Equivalence Evaluations (Orange Book).
19    "Prescription", with respect to a biological product,
20means a product that is subject to Section 503(b) of the
21Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)).
22    (b) A pharmacist may substitute a prescription biological
23product for a prescribed biological product only if:

 

 

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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 a reasonable time following the dispensing of a
12biological product, the dispensing pharmacist or the
13pharmacist's designee shall communicate to the prescriber the
14specific product provided to the patient, including the name of
15the product and the manufacturer. The communication shall be
16conveyed by making an entry into an interoperable electronic
17medical records system or through electronic prescribing
18technology or a pharmacy record that is electronically
19accessible by the prescriber. Otherwise, the pharmacist shall
20communicate the biologic product dispensed to the prescriber
21using facsimile, telephone, electronic transmission, or other
22prevailing means, provided that communication shall not be
23required where:
24        (1) there is no FDA-approved interchangeable
25    biological product for the product prescribed; or
26        (2) a refill prescription is not changed from the

 

 

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1    product dispensed on the prior filling of the prescription.
2    (d) The pharmacy shall retain a record of the biological
3product dispensed for a period of 5 years.
4    (e) The Board shall maintain a link on the Department's
5Internet website to the current list of all biological products
6determined by the United States Food and Drug Administration to
7be interchangeable with a specific biological product.
8    (f) The Board shall adopt rules for compliance with this
9Section.
 
10    Section 99. Effective date. This Act takes effect upon
11becoming law.