Bill Amendment: IL SB2849 | 2017-2018 | 100th General Assembly

NOTE: For additional amemendments please see the Bill Drafting List

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Bill Title: IDPH-PRESCRIPT DRUG REPOSITORY

Status: 2019-01-09 - Session Sine Die [SB2849 Detail]

Download: Illinois-2017-SB2849-Senate_Amendment_001.html

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Sen. Patricia Van Pelt

Filed: 3/13/2018

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AMENDMENT TO SENATE BILL 2849
AMENDMENT NO. ______. Amend Senate Bill 2849 by replacing
everything after the enacting clause with the following:
"Section 1. Short title. This Act may be cited as the
Prescription Drug Repository Program Act.
Section 5. Definitions. In this Act:
"Controlled substance" means a drug, substance, or
immediate precursor in Schedules I through V of 21 CFR 1308.
"Covered entity" means a long-term care facility licensed
under the Nursing Home Care Act, an assisted living facility
licensed under the Assisted Living and Shared Housing Act, a
shared housing establishment licensed under the Assisted
Living and Shared Housing Act, a pharmacy, a wholesaler, or a
manufacturer, located inside or outside of the State.
"Department" means the Department of Public Health.
"Dispense" has the meaning given to that term in the

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Pharmacy Practice Act.
"Pharmacist" means an individual licensed to engage in the
practice of pharmacy under the Pharmacy Practice Act.
"Pharmacy" means a pharmacy registered in this State under
the Pharmacy Practice Act.
"Practitioner" means a person licensed in this State to
prescribe and administer drugs or licensed in another state and
recognized by this State as a person authorized to prescribe
and administer drugs.
"Prescription drug" means any prescribed drug that may be
legally dispensed by a pharmacy. "Prescription drug" does not
include drugs for the treatment of cancer that can only be
dispensed to a patient registered with the drug manufacturer in
accordance with federal Food and Drug Administration
requirements.
"Program" means the prescription drug repository program
established under this Act.
Section 10. Prescription drug repository program. The
Department shall, by rule, establish and maintain a
prescription drug repository program, under which a covered
entity may donate a prescription drug or supplies needed to
administer a prescription drug for use by an individual who
meets appropriate eligibility criteria. The Department shall
adopt the rules within one year after the effective date of
this Act. Donations may be made on the premises of a pharmacy

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that elects to participate in the program and meets appropriate
requirements. The pharmacy may charge an individual who
receives a prescription drug or supplies needed to administer a
prescription drug under this Act a handling fee that may not
exceed an appropriate amount. A pharmacy that receives a
donated prescription drug or supplies needed to administer a
prescription drug under this Act may distribute the
prescription drug or supplies to another eligible pharmacy for
use under the program.
Section 15. Priority. Uninsured and underinsured
individuals shall be given priority for drugs and supplies
donated under this Act over other eligible persons.
Section 20. Requirements for accepting and dispensing
prescription drugs and supplies. A prescription drug or
supplies needed to administer a prescription drug may be
accepted and dispensed under the program only if all of the
following requirements are met:
(1) The prescription drug or supplies needed to
administer a prescription drug are in their original,
unopened, sealed, and tamper-evident packaging or, if
packaged in single-unit doses, the single-unit-dose
packaging is unopened. Medicine and supplies originally
packaged by a pharmacy are acceptable for donation.
(2) The prescription drug bears an expiration date that

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is later than an amount of time determined by the
Department after the date that the drug was donated.
(3) The prescription drug or supplies needed to
administer a prescription drug are not adulterated or
misbranded, as determined by a pharmacist employed by, or
under contract with, the pharmacy where the drug or
supplies are accepted or dispensed. The pharmacist must
inspect the drug or supplies before the drug or supplies
are dispensed.
(4) The prescription drug or supplies needed to
administer a prescription drug are prescribed by a
practitioner for use by an eligible individual.
(5) The prescription drug is not a controlled
substance.
(6) Drugs that can be dispensed only to a patient
registered with the drug's manufacturer in accordance with
federal Food and Drug Administration requirements may not
be accepted or distributed under the provisions of the
program.
(7) A pharmacy shall maintain a written or electronic
record of a donation under this Act consisting of the name,
strength, and quantity of each accepted drug, and the name,
address, and telephone number of the donor. No other record
of a donation shall be required.
Section 25. Resale of donated drugs or supplies prohibited.

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No prescription drug or supplies needed to administer a
prescription drug that are donated for use under this Act may
be resold.
Section 30. Participation in program not required. Nothing
in this Act requires that a pharmacy or pharmacist participate
in the prescription drug repository program.
Section 90. 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, 2020)
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

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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 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

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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 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;
(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
registered nurse in accordance with a written
collaborative agreement under Sections 65-35 and 65-40 of
the Nurse Practice Act; and
(g-5) the donation or acceptance, or the packaging,
repackaging, or labeling, of prescription drugs to the

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extent permitted or required under the Prescription Drug
Repository Program 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
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

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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. 100-218, eff. 8-18-17; 100-513, eff. 1-1-18;
revised 9-29-17.)
Section 95. The Wholesale Drug Distribution Licensing Act
is amended by changing Section 15 as follows:
(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
(Section scheduled to be repealed on January 1, 2023)
Sec. 15. Definitions. As used in this Act:
"Authentication" means the affirmative verification,
before any wholesale distribution of a prescription drug
occurs, that each transaction listed on the pedigree has
occurred.

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"Authorized distributor of record" means a wholesale
distributor with whom a manufacturer has established an ongoing
relationship to distribute the manufacturer's prescription
drug. An ongoing relationship is deemed to exist between a
wholesale distributor and a manufacturer when the wholesale
distributor, including any affiliated group of the wholesale
distributor, as defined in Section 1504 of the Internal Revenue
Code, complies with the following:
(1) The wholesale distributor has a written agreement
currently in effect with the manufacturer evidencing the
ongoing relationship; and
(2) The wholesale distributor is listed on the
manufacturer's current list of authorized distributors of
record, which is updated by the manufacturer on no less
than a monthly basis.
"Blood" means whole blood collected from a single donor and
processed either for transfusion or further manufacturing.
"Blood component" means that part of blood separated by
physical or mechanical means.
"Board" means the State Board of Pharmacy of the Department
of Professional Regulation.
"Chain pharmacy warehouse" means a physical location for
prescription drugs that acts as a central warehouse and
performs intracompany sales or transfers of the drugs to a
group of chain or mail order pharmacies that have the same
common ownership and control. Notwithstanding any other

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provision of this Act, a chain pharmacy warehouse shall be
considered part of the normal distribution channel.
"Co-licensed partner or product" means an instance where
one or more parties have the right to engage in the
manufacturing or marketing of a prescription drug, consistent
with the FDA's implementation of the Prescription Drug
Marketing Act.
"Department" means the Department of Financial and
Professional Regulation.
"Drop shipment" means the sale of a prescription drug to a
wholesale distributor by the manufacturer of the prescription
drug or that manufacturer's co-licensed product partner, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or by an authorized
distributor of record that purchased the product directly from
the manufacturer or one of these entities whereby the wholesale
distributor or chain pharmacy warehouse takes title but not
physical possession of such prescription drug and the wholesale
distributor invoices the pharmacy, chain pharmacy warehouse,
or other person authorized by law to dispense or administer
such drug to a patient and the pharmacy, chain pharmacy
warehouse, or other authorized person receives delivery of the
prescription drug directly from the manufacturer, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or from an authorized
distributor of record that purchased the product directly from

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the manufacturer or one of these entities.
"Drug sample" means a unit of a prescription drug that is
not intended to be sold and is intended to promote the sale of
the drug.
"Facility" means a facility of a wholesale distributor
where prescription drugs are stored, handled, repackaged, or
offered for sale.
"FDA" means the United States Food and Drug Administration.
"Manufacturer" means a person licensed or approved by the
FDA to engage in the manufacture of drugs or devices,
consistent with the definition of "manufacturer" set forth in
the FDA's regulations and guidances implementing the
Prescription Drug Marketing Act. "Manufacturer" does not
include anyone who is engaged in the packaging, repackaging, or
labeling of prescription drugs only to the extent required
under the Prescription Drug Repository Program Act.
"Manufacturer's exclusive distributor" means anyone who
contracts with a manufacturer to provide or coordinate
warehousing, distribution, or other services on behalf of a
manufacturer and who takes title to that manufacturer's
prescription drug, but who does not have general responsibility
to direct the sale or disposition of the manufacturer's
prescription drug. A manufacturer's exclusive distributor must
be licensed as a wholesale distributor under this Act and, in
order to be considered part of the normal distribution channel,
must also be an authorized distributor of record.

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"Normal distribution channel" means a chain of custody for
a prescription drug that goes, directly or by drop shipment,
from (i) a manufacturer of the prescription drug, (ii) that
manufacturer to that manufacturer's co-licensed partner, (iii)
that manufacturer to that manufacturer's third party logistics
provider, or (iv) that manufacturer to that manufacturer's
exclusive distributor to:
(1) a pharmacy or to other designated persons
authorized by law to dispense or administer the drug to a
patient;
(2) a wholesale distributor to a pharmacy or other
designated persons authorized by law to dispense or
administer the drug to a patient;
(3) a wholesale distributor to a chain pharmacy
warehouse to that chain pharmacy warehouse's intracompany
pharmacy to a patient or other designated persons
authorized by law to dispense or administer the drug to a
patient;
(4) a chain pharmacy warehouse to the chain pharmacy
warehouse's intracompany pharmacy or other designated
persons authorized by law to dispense or administer the
drug to the patient;
(5) an authorized distributor of record to one other
authorized distributor of record to an office-based health
care practitioner authorized by law to dispense or
administer the drug to the patient; or

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(6) an authorized distributor to a pharmacy or other
persons licensed to dispense or administer the drug.
"Pedigree" means a document or electronic file containing
information that records each wholesale distribution of any
given prescription drug from the point of origin to the final
wholesale distribution point of any given prescription drug.
"Person" means and includes a natural person, partnership,
association, corporation, or any other legal business entity.
"Pharmacy distributor" means any pharmacy licensed in this
State or hospital pharmacy that is engaged in the delivery or
distribution of prescription drugs either to any other pharmacy
licensed in this State or to any other person or entity
including, but not limited to, a wholesale drug distributor
engaged in the delivery or distribution of prescription drugs
who is involved in the actual, constructive, or attempted
transfer of a drug in this State to other than the ultimate
consumer except as otherwise provided for by law.
"Prescription drug" means any human drug, including any
biological product (except for blood and blood components
intended for transfusion or biological products that are also
medical devices), required by federal law or regulation to be
dispensed only by a prescription, including finished dosage
forms and bulk drug substances subject to Section 503 of the
Federal Food, Drug and Cosmetic Act.
"Repackage" means repackaging or otherwise changing the
container, wrapper, or labeling to further the distribution of

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a prescription drug, excluding that completed by the pharmacist
responsible for dispensing the product to a patient.
"Secretary" means the Secretary of Financial and
Professional Regulation.
"Third party logistics provider" means anyone who
contracts with a prescription drug manufacturer to provide or
coordinate warehousing, distribution, or other services on
behalf of a manufacturer, but does not take title to the
prescription drug or have general responsibility to direct the
prescription drug's sale or disposition. A third party
logistics provider must be licensed as a wholesale distributor
under this Act and, in order to be considered part of the
normal distribution channel, must also be an authorized
distributor of record.
"Wholesale distribution" means the distribution of
prescription drugs to persons other than a consumer or patient,
but does not include any of the following:
(1) Intracompany sales of prescription drugs, meaning
(i) any transaction or transfer between any division,
subsidiary, parent, or affiliated or related company under
the common ownership and control of a corporate entity or
(ii) any transaction or transfer between co-licensees of a
co-licensed product.
(2) The sale, purchase, distribution, trade, or
transfer of a prescription drug or offer to sell, purchase,
distribute, trade, or transfer a prescription drug for

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emergency medical reasons.
(3) The distribution of prescription drug samples by
manufacturers' representatives.
(4) Drug returns, when conducted by a hospital, health
care entity, or charitable institution in accordance with
federal regulation.
(5) The sale of minimal quantities of prescription
drugs by licensed pharmacies to licensed practitioners for
office use or other licensed pharmacies.
(6) The sale, purchase, or trade of a drug, an offer to
sell, purchase, or trade a drug, or the dispensing of a
drug pursuant to a prescription.
(7) The sale, transfer, merger, or consolidation of all
or part of the business of a pharmacy or pharmacies from or
with another pharmacy or pharmacies, whether accomplished
as a purchase and sale of stock or business assets.
(8) The sale, purchase, distribution, trade, or
transfer of a prescription drug from one authorized
distributor of record to one additional authorized
distributor of record when the manufacturer has stated in
writing to the receiving authorized distributor of record
that the manufacturer is unable to supply the prescription
drug and the supplying authorized distributor of record
states in writing that the prescription drug being supplied
had until that time been exclusively in the normal
distribution channel.

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(9) The delivery of or the offer to deliver a
prescription drug by a common carrier solely in the common
carrier's usual course of business of transporting
prescription drugs when the common carrier does not store,
warehouse, or take legal ownership of the prescription
drug.
(10) The sale or transfer from a retail pharmacy, mail
order pharmacy, or chain pharmacy warehouse of expired,
damaged, returned, or recalled prescription drugs to the
original manufacturer, the originating wholesale
distributor, or a third party returns processor.
(11) The donation of prescription drugs to the extent
permitted under the Prescription Drug Repository Program
Act.
"Wholesale drug distributor" means anyone engaged in the
wholesale distribution of prescription drugs into, out of, or
within the State, including without limitation manufacturers;
repackers; own label distributors; jobbers; private label
distributors; brokers; warehouses, including manufacturers'
and distributors' warehouses; manufacturer's exclusive
distributors; and authorized distributors of record; drug
wholesalers or distributors; independent wholesale drug
traders; specialty wholesale distributors; third party
logistics providers; and retail pharmacies that conduct
wholesale distribution; and chain pharmacy warehouses that
conduct wholesale distribution. In order to be considered part

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of the normal distribution channel, a wholesale distributor
must also be an authorized distributor of record.
(Source: P.A. 97-804, eff. 1-1-13.)
Section 100. The Senior Pharmaceutical Assistance Act is
amended by changing Section 10 as follows:
(320 ILCS 50/10)
Sec. 10. Definitions. In this Act:
"Manufacturer" includes:
(1) An entity that is engaged in (a) the production,
preparation, propagation, compounding, conversion, or
processing of prescription drug products (i) directly or
indirectly by extraction from substances of natural
origin, (ii) independently by means of chemical synthesis,
or (iii) by combination of extraction and chemical
synthesis; or (b) the packaging, repackaging, labeling or
re-labeling, or distribution of prescription drug
products.
(2) The entity holding legal title to or possession of
the national drug code number for the covered prescription
drug.
The term does not include a wholesale distributor of drugs,
drugstore chain organization, or retail pharmacy licensed by
the State. The term also does not include anyone who is engaged
in the packaging, repackaging, or labeling of prescription

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drugs only to the extent required under the Prescription Drug
Repository Program Act.
"Prescription drug" means a drug that may be dispensed only
upon prescription by an authorized prescriber and that is
approved for safety and effectiveness as a prescription drug
under Section 505 or 507 of the Federal Food, Drug and Cosmetic
Act.
"Senior citizen" or "senior" means a person 65 years of age
or older.
(Source: P.A. 92-594, eff. 6-27-02.)
Section 105. The Illinois Food, Drug and Cosmetic Act is
amended by changing Section 16 as follows:
(410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
Sec. 16. (a) The Director is hereby authorized to
promulgate regulations exempting from any labeling or
packaging requirement of this Act drugs and devices which are
(i) , in accordance with the practice of the trade, to be
processed, labeled or repacked in substantial quantities at
establishments other than those where originally processed or
packaged on condition that such drugs and devices are not
adulterated or misbranded under the provisions of this Act upon
removal from such processing, labeling or repacking
establishment or (ii) packaged, repackaged, or labeled to the
extent required under the Prescription Drug Repository Program

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Act.
(b) Drugs and device labeling or packaging exemptions
adopted under the Federal Act and supplements thereto or
revisions thereof shall apply to drugs and devices in Illinois
except insofar as modified or rejected by regulations
promulgated by the Director.
(c) A drug intended for use by man which (A) is a
habit-forming drug to which Section 15 (d) applies; or (B)
because of its toxicity or other potentiality for harmful
effect or the method of its use or the collateral measures
necessary to its use is not safe for use except under the
supervision of a practitioner licensed by law to administer
such drug; or (C) is limited by an approved application under
Section 505 of the Federal Act or Section 17 of this Act to use
under the professional supervision of a practitioner licensed
by law to administer such drug, shall be dispensed only in
accordance with the provisions of the "Illinois Controlled
Substances Act". The act of dispensing a drug contrary to the
provisions of this paragraph shall be deemed to be an act which
results in a drug being misbranded while held for sale.
(d) Any drug dispensed by filling or refilling a written or
oral prescription of a practitioner licensed by law to
administer such drug shall be exempt from the requirements of
Section 15, except subsections (a), (k) and (l) and clauses (2)
and (3) of subsection (i), and the packaging requirements of
subsections (g), (h) and (q), if the drug bears a label

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containing the proprietary name or names, or if there is none,
the established name or names of the drugs, the dosage and
quantity, unless the prescribing practitioner, in the interest
of the health of the patient, directs otherwise in writing, the
name and address of the dispenser, the serial number and date
of the prescription or of its filling, the name of the
prescriber and, if stated in the prescription, the name of the
patient, and the directions for use and the cautionary
statements, if any, contained in such prescription. This
exemption shall not apply to any drug dispensed in the course
of the conduct of business of dispensing drugs pursuant to
diagnosis by mail, or to a drug dispensed in violation of
subsection (a) of this Section.
(e) The Director may by regulation remove drugs subject to
Section 15 (d) and Section 17 from the requirements of
subsection (c) of this Section when such requirements are not
necessary for the protection of the public health.
(f) A drug which is subject to subsection (c) of this
Section shall be deemed to be misbranded if at any time before
dispensing its label fails to bear the statement "Caution:
Federal Law Prohibits Dispensing Without Prescription" or
"Caution: State Law Prohibits Dispensing Without
Prescription". A drug to which subsection (c) of this Section
does not apply shall be deemed to be misbranded if at any time
prior to dispensing its label bears the caution statement
quoted in the preceding sentence.

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(g) Nothing in this Section shall be construed to relieve
any person from any requirement prescribed by or under
authority of law with respect to controlled substances now
included or which may hereafter be included within the
classifications of controlled substances cannabis as defined
in applicable Federal laws relating to controlled substances or
cannabis or the Cannabis Control Act.
(Source: P.A. 84-1308.)".