| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
| |||||||||||||||||||||||||
1 | AN ACT concerning regulation.
| ||||||||||||||||||||||||
2 | Be it enacted by the People of the State of Illinois,
| ||||||||||||||||||||||||
3 | represented in the General Assembly:
| ||||||||||||||||||||||||
4 | Section 5. The Pharmacy Practice Act is amended by adding | ||||||||||||||||||||||||
5 | Section 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 | ||||||||||||||||||||||||
10 | in subsection (i) of Section 351 of the federal Public Health | ||||||||||||||||||||||||
11 | Service Act (42 U.S.C. 262(i)). | ||||||||||||||||||||||||
12 | "Interchangeable" means a biological product that is | ||||||||||||||||||||||||
13 | licensed by the United States Food and Drug Administration | ||||||||||||||||||||||||
14 | pursuant to 42 U.S.C. 262(k)(4) or is deemed therapeutically | ||||||||||||||||||||||||
15 | equivalent to another biological product by the United States | ||||||||||||||||||||||||
16 | Food and Drug Administration and appears in the latest edition | ||||||||||||||||||||||||
17 | or supplement of the Approved Drug Products with Therapeutic | ||||||||||||||||||||||||
18 | Equivalence Evaluations (Orange Book). | ||||||||||||||||||||||||
19 | "Prescription", with respect to a biological product, | ||||||||||||||||||||||||
20 | means a product that is subject to Section 503(b) of the | ||||||||||||||||||||||||
21 | Federal Food, Drug, and Cosmetic Act (21 U.S.C. 353(b)). | ||||||||||||||||||||||||
22 | (b) A pharmacist may substitute a prescription biological | ||||||||||||||||||||||||
23 | product for a prescribed biological product only if: |
| |||||||
| |||||||
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 | ||||||
12 | biological product, the dispensing pharmacist or the | ||||||
13 | pharmacist's designee shall communicate to the prescriber the | ||||||
14 | specific product provided to the patient, including the name of | ||||||
15 | the product and the manufacturer. The communication shall be | ||||||
16 | conveyed by making an entry into an interoperable electronic | ||||||
17 | medical records system or through electronic prescribing | ||||||
18 | technology or a pharmacy record that is electronically | ||||||
19 | accessible by the prescriber. Otherwise, the pharmacist shall | ||||||
20 | communicate the biologic product dispensed to the prescriber | ||||||
21 | using facsimile, telephone, electronic transmission, or other | ||||||
22 | prevailing means, provided that communication shall not be | ||||||
23 | required 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 |
| |||||||
| |||||||
1 | product dispensed on the prior filling of the prescription. | ||||||
2 | (d) The pharmacy shall retain a record of the biological | ||||||
3 | product dispensed for a period of 5 years. | ||||||
4 | (e) The Board shall maintain a link on the Department's | ||||||
5 | Internet website to the current list of all biological products | ||||||
6 | determined by the United States Food and Drug Administration to | ||||||
7 | be interchangeable with a specific biological product. | ||||||
8 | (f) The Board shall adopt rules for compliance with this | ||||||
9 | Section.
| ||||||
10 | Section 99. Effective date. This Act takes effect upon | ||||||
11 | becoming law.
|