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(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 |
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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. |