Bill Text: IL SB0636 | 2017-2018 | 100th General Assembly | Enrolled

Bill Title: Amends the Pharmacy Practice Act. Provides that the Act shall not apply to, or in any manner interfere with, the sale or distribution of dialysate, drugs, or devices necessary to perform home renal dialysis for patients with chronic kidney failure, provided that certain conditions are met. Effective immediately.

Spectrum: Bipartisan Bill

Status: (Enrolled) 2017-05-26 - Passed Both Houses [SB0636 Detail]

Download: Illinois-2017-SB0636-Enrolled.html

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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 changing
5Section 4 as follows:
6 (225 ILCS 85/4) (from Ch. 111, par. 4124)
7 (Section scheduled to be repealed on January 1, 2018)
8 Sec. 4. Exemptions. Nothing contained in any Section of
9this Act shall apply to, or in any manner interfere with:
10 (a) the lawful practice of any physician licensed to
11practice medicine in all of its branches, dentist, podiatric
12physician, veterinarian, or therapeutically or diagnostically
13certified optometrist within the limits of his or her license,
14or prevent him or her from supplying to his or her bona fide
15patients such drugs, medicines, or poisons as may seem to him
17 (b) the sale of compressed gases;
18 (c) the sale of patent or proprietary medicines and
19household remedies when sold in original and unbroken packages
20only, if such patent or proprietary medicines and household
21remedies be properly and adequately labeled as to content and
22usage and generally considered and accepted as harmless and
23nonpoisonous when used according to the directions on the

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1label, and also do not contain opium or coca leaves, or any
2compound, salt or derivative thereof, or any drug which,
3according to the latest editions of the following authoritative
4pharmaceutical treatises and standards, namely, The United
5States Pharmacopoeia/National Formulary (USP/NF), the United
6States Dispensatory, and the Accepted Dental Remedies of the
7Council of Dental Therapeutics of the American Dental
8Association or any or either of them, in use on the effective
9date of this Act, or according to the existing provisions of
10the Federal Food, Drug, and Cosmetic Act and Regulations of the
11Department of Health and Human Services, Food and Drug
12Administration, promulgated thereunder now in effect, is
13designated, described or considered as a narcotic, hypnotic,
14habit forming, dangerous, or poisonous drug;
15 (d) the sale of poultry and livestock remedies in original
16and unbroken packages only, labeled for poultry and livestock
18 (e) the sale of poisonous substances or mixture of
19poisonous substances, in unbroken packages, for nonmedicinal
20use in the arts or industries or for insecticide purposes;
21provided, they are properly and adequately labeled as to
22content and such nonmedicinal usage, in conformity with the
23provisions of all applicable federal, state and local laws and
24regulations promulgated thereunder now in effect relating
25thereto and governing the same, and those which are required
26under such applicable laws and regulations to be labeled with

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1the word "Poison", are also labeled with the word "Poison"
2printed thereon in prominent type and the name of a readily
3obtainable antidote with directions for its administration;
4 (f) the delegation of limited prescriptive authority by a
5physician licensed to practice medicine in all its branches to
6a physician assistant under Section 7.5 of the Physician
7Assistant Practice Act of 1987. This delegated authority under
8Section 7.5 of the Physician Assistant Practice Act of 1987
9may, but is not required to, include prescription of controlled
10substances, as defined in Article II of the Illinois Controlled
11Substances Act, in accordance with a written supervision
12agreement; and
13 (g) the delegation of prescriptive authority by a physician
14licensed to practice medicine in all its branches or a licensed
15podiatric physician to an advanced practice nurse in accordance
16with a written collaborative agreement under Sections 65-35 and
1765-40 of the Nurse Practice Act; and .
18 (h) the sale or distribution of dialysate or devices
19necessary to perform home peritoneal renal dialysis for
20patients with end-stage renal disease, provided that all of the
21following conditions are met:
22 (1) the dialysate, comprised of dextrose or
23 icodextrin, or devices are approved or cleared by the
24 federal Food and Drug Administration, as required by
25 federal law;
26 (2) the dialysate or devices are lawfully held by a

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1 manufacturer or the manufacturer's agent, which is
2 properly registered with the Board as a manufacturer or
3 wholesaler;
4 (3) the dialysate or devices are held and delivered to
5 the manufacturer or the manufacturer's agent in the
6 original, sealed packaging from the manufacturing
7 facility;
8 (4) the dialysate or devices are delivered only upon
9 receipt of a physician's prescription by a licensed
10 pharmacy in which the prescription is processed in
11 accordance with provisions set forth in this Act, and the
12 transmittal of an order from the licensed pharmacy to the
13 manufacturer or the manufacturer's agent; and
14 (5) the manufacturer or the manufacturer's agent
15 delivers the dialysate or devices directly to: (i) a
16 patient with end-stage renal disease, or his or her
17 designee, for the patient's self-administration of the
18 dialysis therapy or (ii) a health care provider or
19 institution for administration or delivery of the dialysis
20 therapy to a patient with end-stage renal disease.
21 This paragraph (h) does not include any other drugs for
22peritoneal dialysis, except dialysate, as described in item (1)
23of this paragraph (h). All records of sales and distribution of
24dialysate to patients made pursuant to this paragraph (h) must
25be retained in accordance with Section 18 of this Act.
26(Source: P.A. 98-214, eff. 8-9-13.)

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1 Section 99. Effective date. This Act takes effect upon
2becoming law.