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

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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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: (Passed) 2017-08-18 - Public Act . . . . . . . . . 100-0218 [SB0636 Detail]

Download: Illinois-2017-SB0636-Engrossed.html

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AN ACT concerning regulation.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Pharmacy Practice Act is amended by changing
Section 4 as follows:
(225 ILCS 85/4) (from Ch. 111, par. 4124)
(Section scheduled to be repealed on January 1, 2018)
Sec. 4. Exemptions. Nothing contained in any Section of
this Act shall apply to, or in any manner interfere with:
(a) the lawful practice of any physician licensed to
practice medicine in all of its branches, dentist, podiatric
physician, veterinarian, or therapeutically or diagnostically
certified optometrist within the limits of his or her license,
or prevent him or her from supplying to his or her bona fide
patients such drugs, medicines, or poisons as may seem to him
appropriate;
(b) the sale of compressed gases;
(c) the sale of patent or proprietary medicines and
household remedies when sold in original and unbroken packages
only, if such patent or proprietary medicines and household
remedies be properly and adequately labeled as to content and
usage and generally considered and accepted as harmless and
nonpoisonous when used according to the directions on the

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

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

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

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