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| Public Act 099-0200 | ||||
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AN ACT concerning regulation.
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Be it enacted by the People of the State of Illinois, | ||||
represented in the General Assembly:
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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. | ||