102ND GENERAL ASSEMBLY
State of Illinois
2021 and 2022
HB3720

 

Introduced 2/22/2021, by Rep. C.D. Davidsmeyer

 

SYNOPSIS AS INTRODUCED:
 
New Act

    Creates the Drug and Sharps Waste Stewardship Act. Directs the Environmental Protection Agency to administer a drug and sharps waste stewardship program. Provides that the State Board of Pharmacy is to guide and advise the Agency in its administration of the program. Requires covered entities to provide lists of covered and not covered products to the State Board and to implement stewardship plans. Requires stewardship plans to be submitted to the Agency for review and acceptance. Requires that all counties have at least one collection site for unused drugs and sharps per 50,000 people, and no fewer than 5 such collection sites. Requires counties that do not have the necessary number of collection sites to establish a mail-back program, or alternative collection program for covered products, or both. Imposes an administrative fee on covered entities. Provides penalties for covered entities that fail to comply with the provisions of the Act. Creates the Drug and Sharps Stewardship Fund and the Drug and Sharps Stewardship Penalty Account within the Fund. Directs the Agency to post lists of compliant covered entities on its website. Exempts stewardship programs already in existence under local ordinances at the time the Act takes effect from the Act's provisions, but provides that those entities with programs that are not within the Act's purview are not to receive any monetary support from the Drug and Sharps Stewardship Fund or the Drug and Sharps Stewardship Penalty Account. Exempts confidential proprietary information from public disclosure by the Agency.


LRB102 13980 CPF 19332 b

FISCAL NOTE ACT MAY APPLY
HOME RULE NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB3720LRB102 13980 CPF 19332 b

1    AN ACT concerning safety.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4
Article 1. Short Title; Definitions

 
5    Section 1-1. Short title. This Act may be cited as the Drug
6and Sharps Waste Stewardship Act.
 
7    Section 1-5. Definitions. In this Act:
8    "Agency" means the Illinois Environmental Protection
9Agency.
10    "Authorized collection site" means a location where an
11authorized collector operates a secure collection receptacle
12for collecting covered products.
13    "Authorized collector" means a person or entity that has
14entered into an agreement with a program operator to collect
15covered drugs, including, but not limited to, any of the
16following:
17        (1) A person or entity that is registered with the
18    United States Drug Enforcement Administration and that
19    qualifies under federal law to modify that registration to
20    collect controlled substances for the purpose of
21    destruction.
22        (2) A law enforcement agency.

 

 

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1        (3) A retail pharmacy that offers drug take-back
2    services in compliance with subpart 205 of part 889 of
3    title 35 of the Illinois Administrative Code.
4    "Controlled substance" means a substance listed under the
5Illinois Controlled Substances Act or Section 812 or 813 of
6Title 21 of the United States Code.
7    "Cosmetic" has the meaning provided in Section 2 of the
8Illinois Food, Drug and Cosmetic Act.
9    "Covered drug" means a drug, including a brand name or
10generic drug, sold, offered for sale, or dispensed in the
11State of Illinois in any form, including, but not limited to,
12any of the following:
13        (1) Prescription and nonprescription drugs approved by
14    the United States Food and Drug Administration under
15    Section 505 of the Federal Food, Drug, and Cosmetic Act
16    (21 U.S.C. 355) or Section 351 of the federal Public
17    Health Service Act (42 U.S.C. 262).
18        (2) A drug marketed pursuant to an over-the-counter
19    drug monograph.
20        (3) A drug in a medical device, or a combination
21    product containing a drug and a medical device.
22    "Covered drug" does not include any of the following:
23        (1) Vitamins or supplements.
24        (2) Herbal-based remedies and homeopathic drugs,
25    products, or remedies.
26        (3) Cosmetics, soap with or without germicidal agents,

 

 

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1    laundry detergent, bleach, household cleaning products,
2    shampoos, sunscreens, toothpaste, lip balm,
3    antiperspirants, or any other personal care product that
4    is regulated as both a cosmetic and a nonprescription drug
5    under the Federal Food, Drug, and Cosmetic Act.
6        (4) A drug for which a pharmaceutical product
7    stewardship program or drug take-back program is provided
8    in the State as part of a United States Food and Drug
9    Administration managed risk evaluation and mitigation
10    strategy under 21 U.S.C. 355-1.
11        (5) Biological drug products, as defined by 42 U.S.C.
12    262(i)(1), including those products currently approved in
13    the State under a new drug application that will be deemed
14    to be licensed under Section 351 of the Public Health
15    Service Act (42 U.S.C. 262) pursuant to Section 7002(e) of
16    the federal Biologics Price Competition and Innovation Act
17    of 2009 (Public Law 111-148).
18        (6) A medical device, or a component part or accessory
19    of a medical device, if it does not contain a covered drug.
20        (7) Drugs that are used for animal medicines,
21    including, but not limited to, parasiticide products for
22    animals.
23        (8) Dialysate drugs or other saline solutions required
24    to perform kidney dialysis.
25    "Covered entity" means:
26        (1) The manufacturer of covered products that are sold

 

 

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1    in or into the State.
2        (2) If no entity that meets the definition in
3    paragraph (1) is located in the State, "covered entity"
4    means the distributor of covered products that are sold in
5    or into the State that is licensed as a wholesale drug
6    distributor, as defined in the Wholesale Drug Distribution
7    Licensing Act, but does not include a warehouse of a
8    retail pharmacy chain that is licensed as a wholesale drug
9    distributor if it engages only in intracompany transfers
10    between any division, affiliate, subsidiary, parent, or
11    other entity under complete common ownership and control.
12        (3) If no entity that meets the definitions in
13    paragraphs (1) or (2) is located in the State, "covered
14    entity" means any person or entity who repackages, as
15    defined in the Wholesale Drug Distribution Licensing Act,
16    covered products that are sold in or into the State.
17        (4) If no entity that meets the definitions in
18    paragraphs (1), (2), or (3) is located in the State,
19    "covered entity" means the owner or licensee of a
20    trademark or brand under which covered products are sold
21    in or into the State, regardless of whether the trademark
22    is registered.
23        (5) If no entity that meets the definitions in
24    paragraphs (1), (2), (3), or (4) is located in the State,
25    "covered entity" means the importer of the covered
26    products that are sold in or into the State.

 

 

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1    The Agency shall adopt regulations on the process for
2determining what entity is a covered entity following the
3priority order set forth in paragraphs (1) through (5).
4    "Covered product" means a covered drug or home-generated
5sharps waste.
6    "Distributor" means a wholesale drug distributor, as that
7term is defined in Wholesale Drug Distribution Licensing Act.
8    "Drug" means any of the following:
9        (1) An article recognized in the United States
10    Pharmacopoeia or the National Formulary published by the
11    United States Pharmacopoeia Convention, or the Homeopathic
12    Pharmacopoeia of the United States published by the
13    Homeopathic Pharmacopoeia Convention of the United States,
14    or any supplement of the Formulary or those
15    Pharmacopoeiae.
16        (2) A substance intended for use in the diagnosis,
17    cure, mitigation, treatment, or prevention of disease in
18    humans or other animals.
19        (3) A substance, other than food, intended to affect
20    the structure or any function of the body of humans or
21    other animals.
22        (4) A substance intended for use as a component of any
23    substance specified in this subsection.
24    "Generic drug" means a drug that is chemically identical
25or bioequivalent to a brand name drug in dosage form, safety,
26strengths, route of administration, quality, performance,

 

 

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1characteristics, and intended use, though inactive ingredients
2may vary.
3    "Home-generated sharps waste" means hypodermic needles,
4pen needles, intravenous needles, lancets, and other devices
5that are used to penetrate the skin for the delivery of
6medications derived from a household, including a multifamily
7residence or household. "Home-generated sharps waste" does not
8include either of the following:
9        (1) Components manufactured for use with external
10    ambulatory insulin pump therapy systems or continuous
11    glucose monitoring systems, including, but not limited to,
12    insulin infusion sets, glucose sensors that are sterile
13    goods indicated for single subcutaneous use, sterile drug
14    delivery channels indicated for single subcutaneous use,
15    and injection ports.
16        (2) A biological product, as defined in Section
17    262(i)(1) of Title 42 of the United States Code, including
18    a combination product, as defined in Section 3.2(e) of
19    Title 21 of the Code of Federal Regulations.
20    "Mail-back program" means a method of collecting covered
21products from ultimate users by using prepaid, preaddressed
22mailing envelopes.
23    "Medical waste generator" means any person whose act or
24process produces medical waste and includes, but is not
25limited to, a provider of health care. All of the following are
26examples of businesses that generate medical waste:

 

 

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1        (1) Medical and dental offices, clinics, hospitals,
2    surgery centers, laboratories, research laboratories,
3    unlicensed health facilities, those facilities required to
4    be licensed, chronic dialysis clinics, and education and
5    research facilities.
6        (2) Veterinary offices, veterinary clinics, and
7    veterinary hospitals.
8        (3) Pet shops.
9        (4) Trauma scene waste management practitioners.
10    "Nonprescription drug" means any drug that may be lawfully
11sold without a prescription.
12    "Pharmacy" has the meaning provided in the Pharmacy
13Practice Act.
14    "Prescription drug" means a drug, including, but not
15limited to, a controlled substance, that is required under
16State or federal law to be dispensed with a prescription, or is
17restricted to use by practitioners only.
18    "Program operator" means a covered entity, or stewardship
19organization on behalf of a group of covered entities, that is
20responsible for operating a stewardship program in accordance
21with this Act.
22    "Proprietary information" means information that is all of
23the following:
24        (1) Submitted under this Act.
25        (2) A trade secret, or commercial or financial
26    information, that is privileged or confidential, and is

 

 

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1    identified as such by the entity providing the information
2    to the Agency.
3        (3) Not required to be disclosed under any other law
4    or any regulation affecting a covered product or covered
5    entity.
6    "Retail pharmacy" has the meaning provided for "pharmacy"
7in the Pharmacy Practice Act.
8    "Retail pharmacy chain" means a retail pharmacy with 5 or
9more stores in the State.
10    "Sharps" means hypodermic needles, pen needles,
11intravenous needles, lancets, and other devices that are used
12to penetrate the skin for the delivery of medications.
13    "State Board" means the Illinois State Board of Pharmacy.
14    "Stewardship organization" means an organization exempt
15from taxation under Section 501(c)(3) of the federal Internal
16Revenue Code of 1986 that is established by a group of covered
17entities in accordance with this Act to develop, implement,
18and administer a stewardship program established under this
19Act.
20    "Stewardship plan," or "plan" means the plan that is
21developed by a covered entity or stewardship organization
22under this Act for collecting and properly managing covered
23products.
24    "Stewardship program" means a stewardship program for the
25collection, transportation, and disposal of covered products.
26    "Ultimate user" means a State resident or other

 

 

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1nonbusiness entity and includes a person who has lawfully
2obtained, and who possesses, a covered product, including a
3controlled substance, for his or her own use or for the use of
4a member of his or her household. "Ultimate user" does not
5include a needle exchange program, or a medical waste
6generator as defined in this Act.
 
7
Article 5. Covered Entities and Stewardship Organizations

 
8    Section 5-1. Covered and noncovered products.
9    (a) No later than 90 days after the effective date of this
10Act, a covered entity shall provide to the State Board a list
11of covered products and a list and description of any drugs or
12sharps that are not covered products that it sells or offers
13for sale in the State.
14    A covered entity, or a stewardship organization on behalf
15of a group of covered entities, shall update the lists
16described in this subsection and provide the updated lists to
17the State Board on or before January 15 of each year or upon
18request by the Agency.
19    (b) No later than 90 days after the effective date of this
20Section, a retail pharmacy that sells a covered product under
21its own label shall provide written notification to the State
22Board identifying the covered entity from which the retail
23pharmacy obtains a covered product that the retail pharmacy
24sells under its store label.

 

 

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1    (c) The State Board shall verify the information received
2under subsections (a) and (b) and make it available to the
3Agency upon request.
4    (d) The State Board may issue a letter of inquiry to any
5covered entity, requesting a list of all drugs and sharps it
6distributes in Illinois, regardless of whether the drugs or
7sharps are covered under this Act, the name of the
8manufacturer of such products, and any additional information
9necessary to carry out this Act. An entity that is issued a
10letter of inquiry under this subsection shall respond in
11writing no later than 60 days after receipt of the letter.
12Responses to those inquiries may be shared with the Agency,
13but are otherwise deemed proprietary and exempt from
14disclosure. If the entity does not believe it is a covered
15entity for purposes of this Act, it shall submit all of the
16following to the State Board in response to the letter of
17inquiry:
18        (1) the basis for the claim that it is not a covered
19    entity;
20        (2) a list of any drugs and sharps it sells,
21    distributes, repackages, or otherwise offers for sale
22    within the State; and
23        (3) if applicable, the name and contact information of
24    the person or entity from which it obtains a drug or sharp
25    identified under paragraph (2).
26    (e) The State Board shall obtain and verify and, within 30

 

 

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1days of receipt or upon request by the Agency, submit to the
2Agency a list of drugs and sharps sold or offered for sale in
3the State excluded from the definition of covered drugs or
4from the definition of home-generated sharps waste.
5    (f) Notwithstanding Section 30-10, information submitted
6by the State Board to the Agency under this Act may include
7proprietary information.
8    (g) The State Board shall notify the Agency if any covered
9entity or stewardship organization is in violation of this
10Section for purposes of enforcement by the Agency.
 
11    Section 5-5. Implementation and administration.
12    (a) The Agency shall adopt regulations for the
13implementation of this Act with an effective date of no later
14than January 1, 2022.
15    (b) The State Board may adopt rules for the administration
16of the portions of this Act for which it has been given
17responsibility.
 
18    Section 5-10. Compliance.
19    (a) Except as specified in subsection (d) of Section 25-1,
20a covered entity is not in compliance with this Act and is
21subject to penalties under Article 25 if, commencing one year
22after the adoption of rules under Section 5-5, a covered
23product sold or offered for sale by the covered entity is not
24subject to an approved stewardship plan, which is submitted by

 

 

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1the covered entity or by a stewardship organization that
2includes the covered entity, that has been approved by the
3Agency under Section 10-1.
4    (b) In order to comply with the requirements of this Act, a
5covered entity may establish and implement a stewardship
6program independently, or as part of a group of covered
7entities through membership in a stewardship organization
8exempt from taxation under Section 501(c)(3) of the federal
9Internal Revenue Code of 1986.
 
10    Section 5-15. Education and outreach program.
11    (a) A program operator shall conduct a comprehensive
12education and outreach program intended to promote
13participation in the stewardship program. At a minimum, the
14education and outreach program shall do all of the following:
15        (1) promote its stewardship program to ultimate users
16    by providing signage for hospitals, pharmacies, and other
17    locations, as necessary;
18        (2) provide educational and outreach materials for
19    persons authorized to prescribe drugs, pharmacies,
20    pharmacists, ultimate users, and others, as necessary;
21        (3) establish a website that publicizes the location
22    of authorized collectors and provides other information
23    intended to promote the use of the stewardship program;
24        (4) prepare and provide additional outreach materials
25    not specified in this Section, as needed, to promote the

 

 

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1    collection and proper management of covered drugs and
2    home-generated sharps waste; and
3        (5) encourage ultimate users to separate products that
4    are not covered products from covered products, when
5    appropriate, before submitting the covered products to an
6    authorized collection site or mail-back program.
7    (b) A program operator shall not, as part of the education
8and outreach program, promote the disposal of a covered
9product in a manner inconsistent with the services offered to
10ultimate users by the stewardship program.
 
11
Article 10. Stewardship Plans

 
12    Section 10-1. Stewardship plan; submission; Agency review.
13    (a) Within 6 months after the adoption of regulations by
14the Agency under Section 5-5, a program operator shall submit
15to the Agency for approval a complete stewardship plan that
16meets the requirements of Section 10-5 for the establishment
17and implementation of a stewardship program, in a format
18determined by the Agency. The Agency shall approve a proposed
19stewardship program if the program operator submits a
20completed plan that meets the requirements of this Section.
21    (b) Before submitting a stewardship plan to the Agency
22under this Section, a program operator shall submit its
23proposed stewardship plan to the State Board for review, and
24to any other applicable State agencies with areas of authority

 

 

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1relative to the stewardship plan. The duration of time that
2the State Board takes to review a stewardship plan under this
3subsection shall not count toward the time limit specified in
4subsection (a).
5    A State agency that receives a plan shall review the plan
6for compliance with State and federal laws and regulations
7related to that agency's respective authority. The agency
8shall determine compliance or noncompliance with those laws
9and regulations, and provide to the program operator that
10determination and an explanation for any finding of
11noncompliance, within 90 days of receipt of the plan.
12    A program operator may submit an updated proposed plan to
13a State agency that issued a determination of noncompliance to
14attempt to obtain a determination of compliance. A program
15operator shall submit any determination received from an
16agency when it submits its stewardship plan to the Agency.
17    If, 90 days after submitting a plan to an applicable State
18agency, a program operator has not received a response from
19the applicable agency, the program operator may submit a
20certification to the Agency that the stewardship plan is
21consistent with all other applicable laws and regulations.
22    (c) The Agency shall determine if a stewardship plan is
23complete, including the determinations required under
24subsection (b), and notify the submitting program operator
25within 30 days of receipt.
26    If the Agency finds that the stewardship plan is complete,

 

 

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1the Agency's 90-day review period for consideration of
2approval of the plan set forth in subsection (d) shall
3commence upon the original date of receipt.
4    If the Agency determines the stewardship plan is
5incomplete, the Agency shall identify for the program operator
6the required additional information, and the program operator
7shall resubmit the plan within 30 days.
8    If the Agency determines upon resubmission that the
9stewardship plan is complete, the Agency's 90-day review
10period for consideration of approval of the plan shall
11commence upon the date of receipt of the resubmitted plan.
12    (d) The Agency shall review a complete submitted
13stewardship plan and shall approve, disapprove, or
14conditionally approve the plan within 90 days of receipt of
15the complete plan. The Agency may consult with, or submit a
16stewardship plan for review to, the State Board or another
17State agency it determines is necessary to determine the
18completeness of the stewardship plan or for making a
19determination on the approval of the stewardship plan or an
20amendment to the stewardship plan. The duration of time that
21the Agency takes to review a stewardship plan shall not count
22toward the 90-day time limit specified in this subsection.
23    (e) A program operator shall submit any significant
24changes to a stewardship plan in writing for approval by the
25Agency, and shall not implement the changes prior to that
26approval.

 

 

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1    (f) If the Agency disapproves a submitted stewardship plan
2under subsection (d), the Agency shall explain, in writing
3within 30 days, how the plan does not comply with this Act, and
4the program operator shall resubmit a revised plan to the
5Agency.
6    If the Agency finds that the revised stewardship plan
7submitted by the program operator does not comply with the
8requirements of this Act and disapproves the plan, the covered
9entity operating its own stewardship program, or the
10stewardship organization and the covered entities that are
11members of the stewardship organization, are not in compliance
12with this Act until the program operator submits a plan that
13the Agency approves.
14    (g) A program operator shall fully implement an approved
15stewardship program no later than 270 days after approval by
16the Agency of the stewardship plan.
17    (h) If a stewardship plan is revoked under subsection (a)
18of Section 25-10 or terminated by the program operator that
19submitted the plan, a covered entity no longer subject to that
20plan may, without being subject to penalties under Article 25,
21sell or offer for sale covered products in the State for a
22period of up to one year after the plan terminated or was
23revoked if the covered entity continues to operate under the
24most recent approved stewardship plan to which the covered
25entity was subject.
26    (i) The Agency shall make all stewardship plans submitted

 

 

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1under this Section available to the public, except proprietary
2information in the plans protected under Section 30-10.
 
3    Section 10-5. Stewardship plan requirements.
4    (a) To be complete, a stewardship plan for covered drugs
5shall do all of the following:
6        (1) Identify and provide contact information for the
7    stewardship organization, if applicable, and each
8    participating covered entity, and identify each covered
9    drug sold or offered for sale by each participating
10    covered entity.
11        (2) Identify and provide contact information for the
12    authorized collectors for the stewardship program, as well
13    as the reasons for excluding any potential authorized
14    collectors from participation in the program.
15        (3) Include any determinations provided by a State
16    agency under subsection (b) of Section 10-1. Any
17    determination of noncompliance shall be accompanied by a
18    superseding determination of compliance.
19        (4) Demonstrate adequate funding for all
20    administrative and operational costs of the stewardship
21    program, to be borne by participating covered entities.
22        (5) Provide for a handling, transport, and disposal
23    system that complies with applicable State and federal
24    laws, including, but not limited to, regulations adopted
25    by the United States Drug Enforcement Administration.

 

 

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1        (6) Provide for a collection system that complies with
2    the requirements of this Act and meets all of the
3    following requirements for authorized collection sites in
4    each county in which the plan will be implemented:
5            (A) Provides for a minimum of 5 authorized
6        collection sites or one authorized collection site per
7        50,000 people, whichever is greater.
8            (B) Provides for a reasonable geographic spread of
9        authorized collection sites and an explanation for the
10        geographic spread.
11            (C) Provides for a mail-back program covering any
12        counties where there is not an authorized retail
13        pharmacy operating as an authorized collection site.
14        (7) Require a program operator to do all of the
15    following:
16            (A) Permit an ultimate user who is a homeless,
17        homebound, or disabled individual to request prepaid,
18        preaddressed mailing envelopes, or an alternative form
19        of a collection and disposal system, as described in
20        paragraph (2) of subsection (c), that would render the
21        covered drug inert. A program operator shall accept
22        that request through a website and toll-free telephone
23        number that it shall maintain to comply with the
24        requests.
25            (B) Provide alternative methods of collection from
26        ultimate users for any covered drugs, other than

 

 

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1        controlled substances, that cannot be accepted or
2        commingled with other covered drugs in secure
3        collection receptacles or through a mail-back program,
4        to the extent technically feasible and permissible
5        under applicable State and federal law, including, but
6        not limited to, United States Drug Enforcement
7        Administration regulations.
8            (C) Provide a service schedule that meets the
9        needs of each authorized collection site to ensure
10        that each secure collection receptacle is serviced as
11        often as necessary to avoid reaching capacity and that
12        collected covered drugs are transported to final
13        disposal in a timely manner. A receipt or collection
14        manifest shall be left with the authorized collection
15        site to support verification of the service. The
16        authorized collection site shall maintain and make
17        available to the Agency this documentation. An
18        authorized collector shall comply with applicable
19        State and federal laws regarding collection and
20        transportation standards, and the handling of covered
21        drugs, including United States Drug Enforcement
22        Administration regulations.
23        (8) Provide the policies and procedures for the safe
24    and secure collection, transportation, and disposal of the
25    covered drug, describe how and where records will be
26    maintained, describe how, at a minimum, instances of

 

 

HB3720- 20 -LRB102 13980 CPF 19332 b

1    security problems that occur will be addressed, and
2    explain the processes that will be taken to change the
3    policies, procedures, and tracking mechanisms to alleviate
4    the problems and to improve safety and security.
5    (b) At least 120 days before submitting a stewardship plan
6to the Agency, the operator of a stewardship program for
7covered drugs shall notify potential authorized collectors in
8the county or counties in which it operates of the opportunity
9to serve as an authorized collector for the proposed
10stewardship program. If a potential authorized collector
11expresses interest in participating in a stewardship program,
12the program operator shall commence good faith negotiations
13with the potential authorized collector within 30 days.
14    A retail pharmacy shall make a reasonable effort to serve
15as an authorized collector as part of a stewardship program in
16the county in which it is located. If the minimum threshold
17described in subparagraph (A) of paragraph (6) of subsection
18(a) is not met in each county in which a retail pharmacy chain
19has store locations, the retail pharmacy chain shall have at
20least one location or 15 percent of its store locations,
21whichever is greater, in that county serve as authorized
22collectors in a stewardship program.
23    A program operator shall include as an authorized
24collector under its stewardship program any entity that meets
25the definition of an authorized collector and offers to
26participate in the stewardship program, in writing and without

 

 

HB3720- 21 -LRB102 13980 CPF 19332 b

1compensation, even if the minimum threshold described in
2subparagraph (A) of paragraph (6) of subsection (a) has been
3achieved. The program operator shall include the offering
4entity as an authorized collector in the program within 90
5days of receiving the written offer to participate. A program
6operator shall not be required to respond to offers under this
7subsection until the program operator's stewardship plan has
8been approved by the Agency.
9    (c) After a stewardship plan for covered drugs has been
10approved, the program operator may supplement service, if
11approved by the Agency, for a county in which it operates that
12does not have the minimum number of authorized collection
13sites due to circumstances beyond the program operator's
14control, by establishing one or both of the following:
15        (1) A mail-back program. The mail-back program may
16    include providing information on where and how to receive
17    mail-back materials or providing the locations at which it
18    distributes prepaid, preaddressed mailing envelopes. The
19    program operator shall propose the locations of those
20    envelope distribution locations as part of the stewardship
21    plan. Prepaid mailing envelopes may be mailed to an
22    ultimate user upon request.
23        (2) An alternative form of collection and disposal of
24    covered drugs that complies with applicable State and
25    federal law, including, but not limited to, United States
26    Drug Enforcement Administration regulations.

 

 

HB3720- 22 -LRB102 13980 CPF 19332 b

1    (d) To be complete, a stewardship plan for home-generated
2sharps waste shall do all of the following:
3        (1) Identify and provide contact information for the
4    stewardship organization, if applicable, and each
5    participating covered entity, and identify each covered
6    product sold or offered for sale by each participating
7    covered entity.
8        (2) Include any determinations provided by a State
9    agency under subsection (b) of Section 10-1. Any
10    determination of noncompliance shall be accompanied by a
11    superseding determination of compliance.
12        (3) Demonstrate adequate funding for all
13    administrative and operational costs of the stewardship
14    program, to be borne by participating covered entities.
15        (4) Provide for a handling, transport, and disposal
16    system, at no cost to the ultimate user, that complies
17    with applicable State and federal laws.
18        (5) Maintain a website and toll-free telephone number
19    for purposes of providing information on the program,
20    including disposal options, and to receive requests for
21    sharps waste containers from ultimate users.
22        (6) Provide that a stewardship program for
23    home-generated sharps waste shall be a mail-back program
24    for home-generated sharps waste that complies with this
25    Act and that meets all the following requirements:
26            (A) The program provides or initiates distribution

 

 

HB3720- 23 -LRB102 13980 CPF 19332 b

1        of a sharps waste container and mail-back materials at
2        the point of sale, to the extent allowable by law.
3        Containers and mail-back materials shall be provided
4        at no cost to the ultimate user. The program operator
5        shall select and distribute a container and mail-back
6        materials sufficient to accommodate the volume of
7        sharps purchased by an ultimate user over a selected
8        time period. Containers and mail-back materials shall
9        include:
10                (i) for any sharps, on the packaging, inserts,
11            instructions, or separate information provided to
12            the ultimate user, information on proper sharps
13            waste disposal;
14                (ii) on a label affixed to the container or
15            packaging or on a separate insert included in the
16            container or packaging, the program operator's
17            website and toll-free telephone number; and
18                (iii) prepaid postage affixed to the container
19            or to the mail-back packaging.
20            (B) Upon request, the program provides for
21        reimbursement to local agencies for disposal costs
22        related to home-generated sharps waste, unless the
23        program operator provides for the removal of the
24        home-generated sharps waste from the local household
25        hazardous waste facility.
26                (i) A local agency shall not knowingly request

 

 

HB3720- 24 -LRB102 13980 CPF 19332 b

1            reimbursement for disposal expenses under this
2            subparagraph for disposal costs resulting from a
3            municipal needle exchange program or a medical
4            waste generator.
5                (ii) Reimbursement costs shall be limited to
6            the actual costs of transportation from the
7            household hazardous waste facility and for the
8            actual costs of disposal.
9                (iii) A request for reimbursement under this
10            subparagraph shall be submitted with a declaration
11            under penalty of perjury that the local agency has
12            not knowingly requested reimbursement for expenses
13            prohibited by this Section.
14                (iv) A cost is eligible for reimbursement
15            under this subparagraph if the cost is incurred
16            270 days or more after the approval of a
17            stewardship plan for home-generated sharps waste.
18    (e) A stewardship plan shall include provisions to expand
19into jurisdictions not included in the stewardship plan under
20Section 30-5, in the event a jurisdiction repeals its local
21stewardship program ordinance.
22    (f) A stewardship plan shall include educational and
23outreach provisions to meet the requirements under Section
245-15.
 
25
Article 15. Budgets, Reports, and Records

 

 

 

HB3720- 25 -LRB102 13980 CPF 19332 b

1    Section 15-1. Stewardship plan program budget. With the
2submission of a stewardship plan, a program operator shall
3submit to the Agency an initial stewardship program budget for
4the first 5 calendar years of operation of its stewardship
5program that includes both of the following:
6    (a) the total anticipated revenues and costs of
7implementing the stewardship program; and
8    (b) a total recommended funding level sufficient to cover
9the plan's budgeted costs and to operate the stewardship
10program over a multiyear period.
 
11    Section 15-5. Program operator reports.
12    (a) On or before March 31, 2023, and each year thereafter,
13a program operator shall prepare and submit to the Agency both
14of the following:
15        (1) a written report describing the stewardship
16    program activities during the previous reporting period of
17    one calendar year; and
18        (2) a written program budget for stewardship program
19    implementation for the upcoming calendar year.
20    (b) An annual report submitted under paragraph (1) of
21subsection (a) shall include, at a minimum, all of the
22following for the prior year:
23        (1) A list of covered entities participating in the
24    stewardship organization.

 

 

HB3720- 26 -LRB102 13980 CPF 19332 b

1        (2) The updated and reverified list provided under
2    subsection (a) of Section 5-1 of covered products that
3    each covered entity subject to the stewardship plan sells
4    or offers for sale.
5        (3) The amount, by weight, of covered products
6    collected from ultimate users at each authorized
7    collection site that is part of the stewardship program.
8        (4) For a stewardship plan for covered drugs, the name
9    and location of authorized collection sites at which
10    covered drugs were collected.
11        (5) For a stewardship plan for home-generated sharps
12    waste, information on the mail-back program.
13        (6) Whether policies and procedures for collecting,
14    transporting, and disposing of covered products, as
15    established in the stewardship plan, were followed during
16    the reporting period and a description of each instance of
17    noncompliance, if any occurred.
18        (7) Whether any safety or security problems occurred
19    during collection, transportation, or disposal of
20    collected covered products during the reporting period
21    and, if so, what changes have been or will be made to
22    policies, procedures, or tracking mechanisms to alleviate
23    the problem and to improve safety and security.
24        (8) How the program operator complied with all
25    elements in its stewardship plan.
26        (9) Any other information the Agency reasonably

 

 

HB3720- 27 -LRB102 13980 CPF 19332 b

1    requires.
2    (c) An annual program budget submitted under paragraph (2)
3of subsection (a) shall include, at a minimum, both of the
4following for the upcoming calendar year:
5        (1) an independent financial audit of the stewardship
6    program, as required under subsection (b) of Section
7    15-10, funded by the stewardship organization from the
8    charge paid from its member covered entities under Section
9    20-1 or by a covered entity if it operates its own
10    stewardship program; and
11        (2) anticipated costs and the recommended funding
12    level necessary to implement the stewardship program,
13    including, but not limited to, costs to cover the
14    stewardship plan's budgeted costs and to operate the
15    stewardship program over a multiyear period in a prudent
16    and responsible manner.
17    (d) The Agency shall determine if a submitted annual
18report and program budget are complete and notify the
19submitting stewardship organization or covered entity within
2030 days.
21    If the Agency finds that an annual report and program
22budget are complete, the Agency's 90-day review period for
23consideration of approval of the annual report and program
24budget, set forth in subsection (e), shall commence upon the
25original date of receipt.
26    If the Agency determines either an annual report or a

 

 

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1program budget is incomplete, the Agency shall identify for
2the program operator within 30 days the required additional
3information, and the program operator shall submit a revised
4annual report or program budget, as applicable, within 30
5days.
6    If the Agency determines upon resubmission that the annual
7report or program budget is complete, the Agency's 90-day
8review period for consideration of approval of the annual
9report or program budget shall commence upon the date of
10receipt of the resubmitted report or program budget.
11    (e) The Agency shall review the annual report and program
12budget required under subsection (a) and within 90 days of
13receipt shall approve, disapprove, or conditionally approve
14the annual report and program budget.
15    If the Agency conditionally approves an annual report or
16program budget, the Agency shall identify the deficiencies in
17the annual report or program budget and the program operator
18shall comply with the conditions of the conditional approval
19within 60 days of the notice date, unless the Director of the
20Agency determines that additional time is needed.
21    If the Agency conditionally approves an annual report or
22program budget and the conditions are not met within 60 days of
23the notice date, unless additional time is granted under this
24subsection, the Agency shall disapprove the annual report or
25program budget.
26    If the Agency disapproves an annual report or program

 

 

HB3720- 29 -LRB102 13980 CPF 19332 b

1budget, the Agency shall identify the deficiencies in the
2annual report or program budget and the program operator shall
3submit a revised annual report or program budget and provide
4any supplemental information requested within 60 days of the
5notice date.
 
6    Section 15-10. Keeping minutes, books, and records;
7audits.
8    (a) A program operator shall keep minutes, books, and
9records that clearly reflect the activities and transactions
10of the program operator's stewardship program.
11    (b) The minutes, books, and records of a program operator
12shall be audited at the program operator's expense by an
13independent certified public accountant retained by the
14program operator at least once each calendar year.
15    A program operator shall arrange for the independent
16certified public accountant audit to be delivered to the
17Agency, along with the annual report and program budget
18submitted under subsection (a) of Section 15-5.
19    The Agency may conduct its own audit of a program
20operator. The Agency shall review the independent certified
21public accountant audit for compliance with this Act and
22consistency with the program operator's stewardship plan,
23annual report, and program budget submitted under this Act.
24The Agency shall notify the program operator of any conduct or
25practice that does not comply with this Act or of any

 

 

HB3720- 30 -LRB102 13980 CPF 19332 b

1inconsistencies identified in the Agency's audit. The program
2operator may obtain copies of the Agency's audit, including
3proprietary information contained in the Agency's audit, upon
4request. The Agency shall not disclose any confidential
5proprietary information protected under Section 30-10 that is
6included in the Agency's audit.
 
7    Section 15-15. Local jurisdiction reimbursement;
8requirements. For a local jurisdiction that requests removal
9of home-generated sharps waste or cost recovery or
10reimbursement for removal under Section 10-5, the local
11jurisdiction shall provide information on home-generated
12sharps waste to the covered entity or program operator, within
13a reasonable time, upon request by the covered entity or
14program operator.
 
15    Section 15-20. Adequate access report. As part of the
16administration of this Act, within 12 months of a program
17operator's submission of 3 consecutive complete annual reports
18submitted under Section 15-5, the Agency shall develop, and
19post on its website, a report analyzing whether the program
20operator's stewardship program provides adequate access to
21safe disposal of home-generated sharps waste or covered drugs,
22as applicable, to the ultimate user.
 
23
Article 20. Financial Provisions

 

 

 

HB3720- 31 -LRB102 13980 CPF 19332 b

1    Section 20-1. Administrative and operational costs. In
2order to further the objective that covered entities establish
3and implement stewardship programs that comply with the
4requirements of this Act, each covered entity, either
5individually or through a stewardship organization, shall pay
6all administrative and operational costs associated with
7establishing and implementing the stewardship program in which
8it participates, including the cost of collecting,
9transporting, and disposing of covered products.
 
10    Section 20-5. Administrative fee.
11    (a) On or before the end of State Fiscal Year 2024, and
12once every 3 months thereafter, a program operator shall pay
13to the Agency an administrative fee. The Agency shall set the
14fee at an amount that, when paid by every covered entity, is
15adequate to cover the Agency's and any other State agency's
16full costs of administering and enforcing this Act. The total
17amount of fees collected shall not exceed the State's actual
18and reasonable regulatory costs to implement and enforce this
19Act. These costs may include the actual and reasonable costs
20associated with regulatory activities under this Act before
21submission of stewardship plans under Section 10-1.
22    For a stewardship organization, the administrative fee
23paid under this subsection shall be funded by the covered
24entities that make up the stewardship organization. This

 

 

HB3720- 32 -LRB102 13980 CPF 19332 b

1administrative fee shall be in addition to the charge paid
2under Section 20-1. A stewardship organization may require its
3participating covered entities to pay the administrative fee
4and the charge paid under Section 20-1 at the same time.
5    (b) The fees received by the Agency under this Section
6shall be deposited into the Drug and Sharps Stewardship Fund,
7which is hereby created as a special fund in the State
8treasury. Upon appropriation by the General Assembly, moneys
9in the fund may be expended by the Agency, the State Board, and
10any other agency that assists in the regulatory activities of
11administering and enforcing this Act. Upon appropriation by
12the General Assembly, moneys in the fund may be used for those
13regulatory activities and to reimburse any outstanding loans
14made from other funds used to finance the startup costs of the
15Agency's activities under this Act. Moneys in the fund shall
16not be expended for any purpose not enumerated in this Act.
17    (c) The penalties received by the Agency under Section
1825-5 shall be deposited into the Pharmaceutical and Sharps
19Stewardship Penalty Account, which is hereby created as an
20account within the Pharmaceutical and Sharps Stewardship Fund.
21Upon appropriation by the General Assembly, moneys in the
22account may be expended by the Agency on activities including,
23but not limited to, the promotion of safe handling and
24disposal of covered products, grants for related purposes, and
25the administration and enforcement this Act.
 

 

 

HB3720- 33 -LRB102 13980 CPF 19332 b

1    Section 20-10. Audits.
2    (a) A stewardship organization may conduct an audit of
3covered entities that are required to remit a charge or
4administrative fee to the stewardship organization under
5Sections 20-1 and 20-5 to verify that the administrative fees
6and charges paid are proper and accurate. A stewardship
7organization may conduct an audit of authorized collectors to
8verify the charges submitted are proper and accurate.
9    The purpose of the audits described in this subsection is
10to ensure parties required by this Act to pay or collect an
11administrative fee or charge are paying or collecting the
12proper amount to implement the program.
13    (b) If a stewardship organization conducts an audit under
14subsection (a), it shall do each of the following:
15        (1) conduct the audit in accordance with generally
16    accepted auditing practices;
17        (2) limit the scope of the audit of covered entities
18    to confirming whether a charge or administrative fee has
19    been properly paid by the covered entities;
20        (3) hire an independent third-party auditor to conduct
21    the audit; and
22        (4) provide a copy of the audit to the Agency.
 
23
Article 25. Enforcement

 
24    Section 25-1. Posting listed stewardship organizations.

 

 

HB3720- 34 -LRB102 13980 CPF 19332 b

1    (a) On or before June 30, 2023, and at least annually
2thereafter, the Agency shall post on its website a list of
3stewardship organizations, including entities with an approved
4stewardship plan, and covered entities, authorized collection
5sites, retail pharmacies, and retail pharmacy chains provided
6in the stewardship plans that are in compliance with this Act.
7    The State Board shall coordinate with the Agency to verify
8that the list posted under this subsection is consistent with
9the information submitted to each agency under Section 5-1.
10    (b) A covered entity or stewardship organization that is
11not listed on the Agency's website under subsection (a), but
12demonstrates compliance with this Act before the Agency is
13required to post the following year's list under subsection
14(a), may request a certification letter from the Agency
15stating that the covered entity or stewardship organization is
16in compliance with this Act. A covered entity or stewardship
17organization that receives a certification letter shall be
18deemed to be in compliance with this Act.
19    (c) A distributor or wholesale drug distributor of covered
20products, and a pharmacy or other retailer that sells or
21offers for sale a covered product, shall monitor the Agency's
22website to determine which covered entities and stewardship
23organizations are in compliance with this Act. The distributor
24or wholesale drug distributor and the pharmacy or other
25retailer shall notify the Agency if it determines that a
26covered product that it sells or offers for sale is from a

 

 

HB3720- 35 -LRB102 13980 CPF 19332 b

1covered entity that is not listed on the Agency's website.
2    (d) The sale, distribution, or offering for sale of any
3inventory that was in stock before the commencement of a
4stewardship program is exempt from this Act and not required
5to be subject to a stewardship plan.
6    (e) If the Act determines a covered entity or stewardship
7organization is not in compliance with this Act, the Agency
8shall remove the entity from the list maintained on the
9Agency's website under subsection (a).
 
10    Section 25-5. Administrative penalties.
11    (a) The Agency may impose an administrative penalty on any
12covered entity, program operator, stewardship organization, or
13authorized collector that sells, offers for sale, or provides
14a covered product in violation of this Act.
15    The amount of the administrative penalty imposed under
16this subsection shall not exceed $10,000 per day per violation
17unless the violation is intentional, knowing, or reckless, in
18which case the administrative penalty shall not exceed $50,000
19per day per violation.
20    (b) The Agency shall not impose a penalty on a program
21operator under this Section for failure to comply with this
22Act if the program operator demonstrates it received false or
23misleading information that contributed to its failure to
24comply, including, for a stewardship organization, from a
25participating covered entity.
 

 

 

HB3720- 36 -LRB102 13980 CPF 19332 b

1    Section 25-10. Additional penalties. Upon a written
2finding that a covered entity, program operator, stewardship
3organization, or authorized collector has not met a material
4requirement of this Act, in addition to any other penalties
5authorized under this Act, the Agency may take one or both of
6the following actions to ensure compliance with the
7requirements of this Act, after affording the covered entity,
8stewardship organization, or authorized collector a reasonable
9opportunity to respond to, or rebut, the finding:
10    (a) Revoke the program operator's stewardship plan
11approval or require the program operator to resubmit the plan.
12    (b) Require additional reporting relating to compliance
13with the material requirement of this Act that was not met.
 
14    Section 25-15. Agency access and records; keeping records.
15    (a) A covered entity, stewardship organization, program
16operator, retail pharmacy, or retail pharmacy chain shall do
17both of the following:
18        (1) Upon request, provide the Agency with reasonable
19    and timely access, as determined by the Agency, to its
20    facilities and operations, as necessary to determine
21    compliance with this Act.
22        (2) Upon request, provide the Agency with relevant
23    records necessary to determine compliance with this Act.
24    (b) A covered entity, stewardship organization, program

 

 

HB3720- 37 -LRB102 13980 CPF 19332 b

1operator, retail pharmacy, or retail pharmacy chain shall
2maintain and keep accessible all records required to be kept
3or submitted under this Section for a minimum of 3 years.
4    (c) All reports and records provided to the Agency under
5this Section shall be provided under penalty of perjury.
6    (d) The Agency may take disciplinary action against a
7covered entity, stewardship organization, program operator,
8pharmacy, retail pharmacy, or retail pharmacy chain that fails
9to provide the Agency with the access to information required
10under this Section, including one or both of the following:
11    (1) Imposing an administrative penalty under Section 25-5.
12    (2) Posting a notice on the Agency's website, in
13association with the list that the Agency maintains under
14subsection (a) of Section 25-1, that the covered entity,
15stewardship organization, program operator, pharmacy, retail
16pharmacy, or retail pharmacy chain is no longer in compliance
17with this Act.
18    (e) The Agency shall not prohibit as a disciplinary action
19a covered entity, stewardship organization, program operator,
20pharmacy, retail pharmacy, or retail pharmacy chain from
21selling a covered product.
 
22    Section 25-20. Handling, transport, and disposal. All
23handling, transport, and disposal undertaken as part of a
24stewardship program under this Act shall comply with
25applicable State and federal laws, including, but not limited

 

 

HB3720- 38 -LRB102 13980 CPF 19332 b

1to, regulations adopted by the United States Drug Enforcement
2Administration.
 
3
Article 30. Miscellaneous Provisions

 
4    Section 30-1. Violation exceptions.
5    (a) Except as provided in subsection (c), an action
6specified in subsection (b) that is taken by a stewardship
7organization or a covered entity under this Act is not a
8violation of the Illinois Antitrust Act.
9    (b) Subsection (a) shall apply to all of the following
10actions taken by a stewardship organization or covered entity:
11        (1) The creation, implementation, or management of a
12    stewardship plan approved by the Agency under Article 10
13    and the determination of the types or quantities of
14    covered products collected or otherwise managed under a
15    stewardship plan.
16        (2) The determination of the cost and structure of an
17    approved stewardship plan.
18        (3) The establishment, administration, collection, or
19    disbursement of the charge or administrative fee imposed
20    under Section 20-1 or 20-5.
21    (c) Subsection (a) shall not apply to an agreement that
22does any of the following:
23        (1) Fixes a price of or for covered products, except
24    for an agreement related to costs, charges, or

 

 

HB3720- 39 -LRB102 13980 CPF 19332 b

1    administrative fees associated with participation in a
2    stewardship plan approved by the Agency and otherwise in
3    accordance with this Act.
4        (2) Fixes the output of production of covered
5    products.
6        (3) Restricts the geographic area in which, or
7    customers to whom, covered products are sold.
 
8    Section 30-5. Ordinances affected; local stewardship
9programs.
10    (a) This Act does not apply to a drug or sharp within a
11jurisdiction that is subject to a local stewardship program
12under an ordinance that took effect before January 1, 2021. If
13that ordinance is repealed, the drug or sharp program shall be
14subject to this Act in that jurisdiction within 270 days after
15the date on which the ordinance is repealed.
16    (b) This Act shall preempt a local stewardship program for
17drugs or sharps enacted by an ordinance with an effective date
18on or after January 1, 2021. The regulation of the collection,
19transportation, and disposal of drugs and sharps as described
20in this Act is an exclusive power and function of the State. A
21home rule unit may not regulate the collection,
22transportation, and disposal of drugs and sharps. This Section
23is a denial and limitation of home rule powers and functions
24under subsection (h) of Section 6 of Article VII of the
25Illinois Constitution.

 

 

HB3720- 40 -LRB102 13980 CPF 19332 b

1    (c) A local stewardship program for covered products
2enacted by an ordinance that has an effective date before
3January 1, 2021, may continue in operation, but the program
4and its participants shall not receive or benefit from moneys
5from the Pharmaceutical and Sharps Stewardship Fund or the
6Pharmaceutical and Sharps Stewardship Penalty Account,
7including, but not limited to, for administrative or
8enforcement costs. Participants of a local stewardship program
9for covered products enacted by an ordinance that has an
10effective date before January 1, 2021, shall be eligible to
11participate in a stewardship program under this Act and
12thereby become eligible to receive funds from the Drug and
13Sharps Stewardship Fund or the Drug and Sharps Stewardship
14Penalty Account only if the local stewardship program is
15dissolved.
 
16    Section 30-10. Confidential proprietary information.
17Proprietary information submitted to the Agency under this Act
18shall be protected by all parties as confidential and shall be
19exempt from public disclosure under the State Records Act and
20the Freedom of Information Act. The Agency and other parties
21may only disclose proprietary information in an aggregated
22form that does not directly or indirectly identify financial,
23production, or sales data of an individual covered entity or
24stewardship organization. Proprietary information may be
25disclosed to the party that submitted the proprietary

 

 

HB3720- 41 -LRB102 13980 CPF 19332 b

1information.