101ST GENERAL ASSEMBLY
State of Illinois
2019 and 2020
HB4888

 

Introduced 2/18/2020, by Rep. Jennifer Gong-Gershowitz - Fred Crespo - Marcus C. Evans, Jr. - Grant Wehrli - Terra Costa Howard, et al.

 

SYNOPSIS AS INTRODUCED:
 
New Act
5 ILCS 140/7  from Ch. 116, par. 207
30 ILCS 105/5.930 new

    Creates the Pharmaceutical Recovery Act. Requires covered manufacturers to, no later than July 1, 2021 or 6 months after becoming a covered manufacturer, whichever is later, participate in an approved drug take-back program or have established and implemented a drug take-back program independently or as part of a group of covered manufacturers. Provides requirements for the drug take-back program and for manufacturer program operators. Requires each manufacturer program operator to submit a proposal for the establishment and implementation of a drug take-back program to the Environmental Protection Agency for review and approval. Contains provisions regarding changes or modifications to drug take-back programs, promotion of drug take-back programs, annual reports, funding, and reimbursement. Requires covered manufacturers and manufacturer program operators to submit an annual $5,000 registration fee. Provides civil penalties. Creates the Pharmaceutical Take-Back Reimbursement Program Fund and makes a conforming change in the State Finance Act. Contains other provisions. Amends the Freedom of Information Act. Provides that proprietary information submitted to the Environmental Protection Agency under the Pharmaceutical Recovery Act is exempt from inspection and copying under the Act. Effective immediately.


LRB101 18479 CPF 67929 b

 

 

A BILL FOR

 

HB4888LRB101 18479 CPF 67929 b

1    AN ACT concerning safety.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 1. Short title. This Act may be cited as the
5Pharmaceutical Recovery Act.
 
6    Section 5. Findings. The General Assembly finds that:
7        (1) A safe system for the collection and disposal of
8    unused, unwanted, and expired medicines is a key element of
9    a comprehensive strategy to prevent prescription drug
10    abuse and pharmaceutical pollution. Home medicine cabinets
11    are full of unused and expired prescription drugs, only a
12    fraction of which get disposed of properly.
13        (2) Storing unused, unwanted, or expired medicines can
14    lead to accidental poisoning, drug abuse, and even drug
15    trafficking, but disposing of medicines by flushing them
16    down the toilet or placing them in the garbage can
17    contaminate groundwater and other bodies of water,
18    contributing to long-term harm to the environment and
19    animal life.
20        (3) Manufacturers of these drugs hold the ultimate
21    responsibility for the lasting impacts of the drugs they
22    produce.
23        (4) The General Assembly therefore finds that it is in

 

 

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1    the interest of public health and environmental protection
2    to establish a single, uniform, statewide system of
3    regulation for safe and secure collection and disposal of
4    medicines through a uniform drug "take-back" program
5    operated and funded by drug manufacturers.
 
6    Section 10. Definitions. In this Act:
7    "Agency" means the Environmental Protection Agency.
8    "Authorized collector" means any of the following who elect
9to collect covered drugs through participation in a
10pharmaceutical drug take-back program:
11        (1) a person who is registered with the United States
12    Drug Enforcement Administration to collect controlled
13    substances for the purpose of destruction; or
14        (2) a law enforcement agency.
15    "Collection site" means the location where an authorized
16collector operates a collection receptacle for the purpose of
17collecting covered drugs as part of a drug take-back program
18under this Act.
19    "Consumer" means a person who possesses a covered drug for
20personal use or for the use of a member of the person's
21household.
22    "Covered drug" means a legend drug, nonlegend drug, brand
23name drug, or generic drug. "Covered drug" does not include:
24        (1) a dietary supplement as defined by 21 U.S.C 321
25    (ff);

 

 

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1        (2) drugs that are defined as Schedule I controlled
2    substances under the Illinois Controlled Substances Act;
3        (3) personal care products, including, but not limited
4    to, cosmetics, shampoos, sunscreens, lip balms,
5    toothpastes, and antiperspirants, that are regulated as
6    both cosmetics and nonprescription drugs under the federal
7    Food, Drug, and Cosmetic Act, 21 U.S.C. 301.
8        (4) drugs for which manufacturers provide a
9    pharmaceutical product stewardship or drug take-back
10    program as part of a federal managed risk evaluation and
11    mitigation strategy under 21 U.S.C. 355-1;
12        (5) biological drug products, as defined by 21 C.F.R.
13    600.3(h), for which manufacturers provide a pharmaceutical
14    product stewardship or drug take-back program;
15        (6) drugs that are administered in a clinical setting;
16        (7) emptied injector products or emptied medical
17    devices and their component parts or accessories;
18        (8) needles or sharps;
19        (9) drugs that are intended for use as animal
20    medicines, including, but not limited to, parasiticide
21    products;
22        (10) pet pesticide products contained in pet collars,
23    powders, shampoos, topical applications, or other forms;
24    or
25        (11) dialysate drugs or other saline solutions
26    required to perform kidney dialysis.

 

 

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1    "Covered manufacturer" means a manufacturer, distributor,
2or licensed wholesale drug distributor, as defined in the
3Wholesale Drug Distribution Licensing Act, of a covered drug
4that is sold or offered for sale in Illinois. "Covered
5manufacturer" does not include:
6        (1) a private label distributor of a covered drug, or a
7    pharmacy that sells a covered drug under the pharmacy's
8    store label, if the manufacturer of the covered drug is
9    identified under Section 20;
10        (2) a pharmacy chain that is licensed as a wholesale
11    drug distributor under the Wholesale Drug Distribution
12    Licensing Act, if it engages in intracompany transfers of
13    covered drugs between any division, affiliate, subsidiary,
14    parent, or other entity under complete common ownership or
15    control, or if the manufacturer of the covered drug
16    distributed at wholesale is identified under Section 20;
17        (3) a repackager of a covered drug, if the manufacturer
18    of the drug is identified under Section 20, or if the
19    repackager is a pharmacy chain that engages in intracompany
20    transfers of the covered drug between any division,
21    affiliate, subsidiary, parent, or other entity under
22    complete common ownership or control; or
23        (4) a health care corporation exempt from taxation
24    under Section 501(c)(3) of the federal Internal Revenue
25    Code of 1986 that repackages covered drugs solely for the
26    purpose of supplying the drugs to facilities or pharmacies

 

 

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1    operated by the corporation or an affiliate of the
2    corporation, if the manufacturer of the drug is identified
3    under Section 20.
4    "Drug" means an article:
5        (1) recognized in the official United States
6    Pharmacopoeia, the National Formulary, the Homeopathic
7    Pharmacopoeia of the United States, Dispensatory of the
8    United States of America, "Remington: The Science and
9    Practice of Pharmacy", or any supplement to any of those
10    sources;
11        (2) intended for use in the diagnosis, cure,
12    mitigation, treatment or prevention of disease in human
13    beings;
14        (3) other than food and that is intended to affect the
15    structure or any function of the body of human beings; or
16        (4) intended for use as a component of any article
17    specified in paragraph (1), (2) or (3), but not devices or
18    their components, parts or accessories.
19    "Drug take-back program" means a program implemented by a
20manufacturer program operator for the collection,
21transportation, and disposal of covered drugs.
22    "Generic drug" means a drug that is chemically identical or
23bioequivalent to a brand name drug in dosage, form, safety,
24strength, route of administration, quality, performance
25characteristics, and intended use. The inactive ingredients in
26a generic drug need not be identical to the inactive

 

 

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1ingredients in the chemically identical or bioequivalent brand
2name drug.
3    "Legend drug" means a drug limited by the federal Food,
4Drug, and Cosmetic Act to being dispensed by or upon a medical
5practitioner's prescription because the drug is:
6        (1) habit forming;
7        (2) toxic or having potential for harm; or
8        (3) limited by the new drug application for the drug to
9    use only under a medical practitioner's supervision.
10    "Manufacturer program operator" means a covered
11manufacturer, or group of covered manufacturers, that
12implements a drug take-back program.
13    "Medical practitioner" means any person licensed to
14practice medicine in all its branches in the State.
15    "Nonlegend drug" means a drug that does not require
16dispensing by prescription and which is not restricted to use
17by practitioners only.
18    "Nonprescription drug" means a drug that may be lawfully
19sold in Illinois without a prescription.
20    "Person" means any individual, partnership,
21co-partnership, firm, company, limited liability company,
22corporation, association, joint stock company, trust, estate,
23political subdivision, State agency, or any other legal entity,
24or their legal representative, agent, or assign.
25    "Pharmaceutical drug take-back reimbursement program"
26means a program identified as part of a drug take-back program

 

 

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1to reimburse all authorized collectors for all costs associated
2with the collection, transportation, and disposal of covered
3drugs.
4    "Pharmaceutical reimbursement program operator" means an
5organization exempt from taxation under Section 501(c)(6) of
6the federal Internal Revenue Code of 1986 that exclusively
7represents retailers in Illinois and implements a
8pharmaceutical drug take-back reimbursement program.
9    "Pharmacy" has the meaning provided in Section 3 of the
10Pharmacy Practice Act.
11    "Prescription drug" means a drug that is required under
12State or federal law to be dispensed with a prescription or
13that is restricted to use by medical practitioners only.
14     "Proprietary information" means information that is:
15        (1) submitted under this Act;
16        (2) a trade secret or commercial or financial
17    information that is privileged or confidential and is
18    identified as such by the person providing the information;
19    or
20        (3) not required to be disclosed under any other law or
21    any regulation affecting a covered product, covered
22    manufacturer, or pharmacy.
 
23    Section 15. Participation in a drug take-back program. Each
24covered manufacturer must, no later than July 1, 2021 or 6
25months after becoming a covered manufacturer, whichever is

 

 

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1later, participate in an approved drug take-back program or
2have established and implemented a drug take-back program that
3complies with the requirements of this Act. A covered
4manufacturer must establish and implement a drug take-back
5program independently or as part of a group of covered
6manufacturers.
 
7    Section 20. Identification of covered manufacturers.
8    (a) No later than April 1, 2021, a covered manufacturer
9that sells or offers for sale in Illinois a covered drug must
10provide a list of covered manufacturers for that covered drug
11to the Agency. A covered manufacturer must provide an updated
12list to the Agency on January 15th of each subsequent year.
13    (b) No later than April 1, 2021, each pharmacy, private
14label distributor, and repackager that sells or offers for sale
15in Illinois, under its own label, a covered drug must provide
16written notification to the Agency identifying the covered
17manufacturer from which the covered drug is obtained.
18    (c) All covered manufacturers of covered drugs sold or
19offered for sale in Illinois must register with the Agency and
20pay to the Agency the annual registration fee set forth under
21Section 65.
 
22    Section 25. Drug take-back program requirements.
23    (a) At least 120 days prior to submitting a proposal under
24Section 35, a manufacturer program operator must notify

 

 

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1potential authorized collectors of the opportunity to serve as
2an authorized collector for the proposed drug take-back
3program. No later than 30 days after the potential authorized
4collector expresses interest in participating in a proposed
5program, the manufacturer program operator must commence good
6faith negotiations with a potential authorized collector
7regarding the collector's participation in the program.
8    (b) A person may serve as an authorized collector for a
9drug take-back program voluntarily, in exchange for
10compensation, or as part of a pharmaceutical take-back
11reimbursement program. Nothing in this Act requires any person
12to serve as an authorized collector for a drug take-back
13program.
14    (c) A pharmacy shall not be required to participate in a
15drug take-back program. A pharmacy that is registered with the
16United States Drug Enforcement Administration to collect
17controlled substances and elects to serve as an authorized
18collector shall participate in a pharmaceutical drug take-back
19reimbursement program.
20    (d) A drug take-back program must include as a collector
21any hospital or clinic with an on site pharmacy, and any law
22enforcement agency that (i) is an authorized collector and (ii)
23offers to participate in the program without compensation. The
24manufacturer program operator must include the hospital,
25clinic, or law enforcement agency in the program as a collector
26no later than 90 days after receiving a written offer to

 

 

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1participate.
2    (e) A drug take-back program must include and reimburse any
3authorized collection site registered with a pharmaceutical
4take-back reimbursement program under subsection (b) of
5Section 60.
6    (f) A drug take-back program collection site must accept
7all covered drugs from ultimate users during the hours that the
8authorized collector is normally open for business to the
9public.
10    (g) A drug take-back program collection site must use
11collection receptacles in compliance with federal law,
12including United States Drug Enforcement Administration
13regulations. The manufacturer program operator must provide a
14service schedule that meets the needs of each collection site
15to ensure that each secure collection receptacle is serviced as
16often as necessary to avoid reaching capacity and that
17collected covered drugs are transported to final disposal in a
18timely, environmentally sound manner, including a process for
19additional prompt collection service upon notification from
20the collection site.
21    (h) Authorized collectors must comply with applicable
22provisions of federal laws and regulations governing the
23handling of covered drugs, including United States Drug
24Enforcement Administration regulations.
25    (i) A drug take-back program's collection system must be
26safe, secure, and convenient on an ongoing, year-round basis

 

 

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1and must provide equitable and reasonably convenient access for
2residents across the State.
3    (j) A drug-take back program shall have a minimum of 3
4collection sites in each county of the State, plus one
5additional collection site per county for every 50,000 county
6residents.
7    Authorized collection sites registered with a
8pharmaceutical take-back reimbursement program shall be
9counted towards meeting the minimum number of collection sites
10within a drug take-back program.
11    If a manufacturer program operator demonstrates to the
12Agency that there are not a sufficient number of authorized
13collection sites in the county, a drug take-back program must
14establish mail-back distribution locations or hold periodic
15collection events to supplement service to any area of the
16State that is underserved by collection sites, as determined by
17the Agency. The manufacturer program operator, in consultation
18with the Agency, local law enforcement, local health
19jurisdiction, and local community, must determine the number
20and locations of mail-back distribution locations and the
21frequency and location of these collection events, to be held
22at least twice each year, unless otherwise determined through
23consultation with the local community. The program must arrange
24any periodic collection events in advance with local law
25enforcement agencies and conduct periodic collection events in
26compliance with United States Drug Enforcement Administration

 

 

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1regulations and protocols and applicable State laws
 
2    Section 30. Manufacturer program operator requirements. A
3manufacturer program operator shall:
4        (1) Adopt policies and procedures to be followed by
5    persons handling covered drugs collected under the program
6    to ensure safety, security, and compliance with
7    regulations adopted by the United States Drug Enforcement
8    Administration, as well as any applicable State laws.
9        (2) Ensure the security of patient information on drug
10    packaging during collection, transportation, recycling,
11    and disposal.
12        (3) Promote the program by providing consumers,
13    pharmacies, and other entities with educational and
14    informational materials as required under Section 45.
15        (4) Demonstrate adequate funding for all
16    administrative and operational costs of the drug take-back
17    program with costs apportioned among participating covered
18    manufacturers.
19        (5) Set long-term and short-term goals with respect to
20    collection amounts and public awareness.
21        (6) Consider:
22            (A) the use of existing providers of
23        pharmaceutical waste transportation and disposal
24        services;
25            (B) separation of covered drugs from packaging to

 

 

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1        reduce transportation and disposal costs; and
2            (C) recycling of drug packaging.
 
3    Section 35. Drug take-back program approval.
4    (a) By July 1, 2021, each manufacturer program operator
5must submit to the Agency for review and approval a proposal
6for the establishment and implementation of a drug take-back
7program.
8    (b) The Agency shall approve a proposed program if the
9manufacturer program operator pays the program operator fee
10established under Section 65, the program fulfills the
11requirements under Section 25, and the manufacturer program
12operator submits the following information on forms prescribed
13by the Agency:
14        (1) The identity and contact information for the
15    manufacturer program operator and each participating
16    covered manufacturer.
17        (2) The identity and contact information for the
18    authorized collectors under a drug take-back program not
19    enrolled in a pharmaceutical drug take-back reimbursement
20    program.
21        (3) The identity of transporters and waste disposal
22    facilities that the program will use to transport and
23    dispose of collected covered drugs.
24        (4) The identity of the pharmaceutical drug take-back
25    reimbursement program or programs in which the

 

 

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1    manufacturer program operator has an agreement to
2    participate.
3    (c) The Agency shall either approve or reject the proposal
4in writing to the manufacturer program operator. If the Agency
5rejects the proposal, it shall provide the reason for
6rejection.
7    (d) No later than 30 days after receipt of a notice of
8rejection under subsection (c) of this Section, the
9manufacturer program operator shall submit a revised proposal
10to the Agency. Within 30 days of receipt of a revised proposal
11the Agency shall either approve or reject the revised proposal
12in writing to the manufacturer program operator.
13    (e) A manufacturer program operator must initiate
14operation of an approved drug take-back program no later than
15December 1, 2021.
 
16    Section 40. Proposed changes or modifications to the
17approved manufacturer drug take-back program. A manufacturer
18program operator shall submit a notice of any proposed changes
19to an approved drug take-back program to the Agency in writing
20at least 15 days before the change is scheduled to occur. These
21include, but are not limited to, changes in:
22        (1) participating covered manufacturers;
23        (2) collection methods;
24        (3) collection site locations;
25        (4) contact information for the program operator or

 

 

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1    collection sites; or
2        (5) agreements with pharmaceutical reimbursement
3    take-back programs.
 
4    Section 45. Drug take-back program promotion.Each drug
5take-back program must include a system of promotion,
6education, and public outreach about the proper collection and
7management of covered drugs. This may include, but is not
8limited to, signage, written materials to be provided at the
9time of purchase or delivery of covered drugs, and advertising
10or other promotional materials. At a minimum, each program must
11do the following:
12        (1) Promote the proper collection and management of
13    covered drugs by residents before disposal through a drug
14    take-back program.
15        (2) Discourage residents from disposing of covered
16    drugs in household waste, sewers, or septic systems.
17        (3) Promote the use of the drug take-back program so
18    that where and how to return covered drugs is reasonably
19    understood by residents.
20        (4) Maintain a toll-free telephone number and web site
21    publicizing collection options and collection sites, and
22    discouraging improper disposal practices for covered
23    drugs, such as disposal in household waste, sewers, or
24    septic systems.
25        (5) Prepare and distribute the educational and

 

 

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1    outreach materials to program collection sites for
2    dissemination to ultimate users. The materials must use
3    plain language and explanatory images to make collection
4    services and discouraged disposal practices readily
5    understandable to all residents, including residents with
6    limited English proficiency.
7        (6) Promotional materials prepared and distributed in
8    conjunction with an approved drug take-back program under
9    this Section may not be used to promote in-home disposal
10    products of any kind, including, but not limited to,
11    authorized collectors participating directly in a drug
12    take-back program or a pharmaceutical drug take-back
13    reimbursement program.
 
14    Section 50. Annual program report.
15    (a) By July 1st 2022, and each July 1st thereafter, a
16manufacturer program operator must submit to the Agency a
17report describing implementation of the drug take-back program
18during the previous calendar year. The report must include:
19        (1) a list of the covered manufacturers participating
20    in the drug take-back program;
21        (2) the total amount, by weight, of covered drugs
22    collected and the amount, by weight, from each collection
23    method used;
24        (3) the total amount, by weight, of covered drugs
25    collected from each collection site during the prior year;

 

 

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1        (4) the following details regarding the program's
2    collection system:
3            (A) a list of collection sites with addresses;
4            (B) collection sites where mailers were made
5        available to the public;
6            (C) dates and locations of collection events held;
7        and
8            (D) the transporters and disposal facility or
9        facilities used to dispose of the covered drugs
10        collected; and
11        (5) a description of the public education, outreach,
12    and evaluation activities implemented;
13        (6) a description of how collected packaging was
14    recycled to the extent feasible; and
15        (7) an evaluation of the program based on the
16    short-term and long-term goals established by the
17    manufacturer program operator in accordance with paragraph
18    (5) of Section 30.
 
19    Section 55. Manufacturer drug-take back program funding.
20    (a) A covered manufacturer or group of covered
21manufacturers must pay all administrative and operational
22costs associated with establishing and implementing the drug
23take-back program in which it participates. Such
24administrative and operational costs include, but are not
25limited to:

 

 

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1        (1) collection and transportation supplies for each
2    collection site;
3        (2) purchase of collection receptacles for each
4    collection site;
5        (3) ongoing maintenance or replacement of collection
6    receptacles when requested by authorized collectors;
7        (4) compensation of authorized collectors, if
8    applicable;
9        (5) operation of periodic collection events,
10    including, but not limited to, the cost of law enforcement
11    staff time;
12        (6) transportation of all collected covered drugs to
13    final disposal;
14        (7) environmentally sound disposal of all collected
15    covered drugs in compliance with subsection (g) of Section
16    25; and
17        (8) program promotion and outreach.
18    (b) A manufacturer program operator, covered manufacturer,
19authorized collector, or other person may not charge:
20        (1) a specific point-of-sale fee to consumers to recoup
21    the costs of a drug take-back program; or
22        (2) a specific point-of-collection fee at the time
23    covered drugs are collected from a person.
 
24    Section 60. Pharmaceutical take-back reimbursement
25program.

 

 

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1    (a) A pharmaceutical reimbursement program operator may
2establish and implement a pharmaceutical drug take-back
3reimbursement program. Any establishment of a pharmaceutical
4take-back reimbursement program must be approved by the Agency.
5    (b) Any authorized collector may participate in a
6pharmaceutical drug take-back reimbursement program. An
7authorized collector that elects to participate in a
8pharmaceutical drug take-back reimbursement program shall
9register its authorized collection locations with the
10pharmaceutical reimbursement program operator.
11    (c) A drug take-back program shall include and reimburse
12any authorized collection site registered with a
13pharmaceutical drug take-back reimbursement program.
14    (d) A pharmaceutical reimbursement program operator's
15proposal for the establishment and implementation of a
16pharmaceutical drug take-back reimbursement program shall be
17approved by the Agency if the pharmaceutical reimbursement
18program operator submits the following information on forms
19prescribed by the Agency:
20        (1) The identity and contact information of the
21    reimbursement program operator.
22        (2) The identity and contact information of each
23    participating covered manufacturer.
24        (3) The identity and contact information of each
25    participating pharmacy;
26        (4) The identity and contact information of each

 

 

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1    participating authorized collector that is not a pharmacy.
2        (5) A system of promotion, education, and public
3    outreach about the proper collection and management of
4    covered drugs. This may include, but is not limited to,
5    signage, written materials to be provided at the time of
6    purchase or delivery of covered drugs, and advertising or
7    other promotion materials.
8    (e) A pharmaceutical reimbursement program operator must
9notify the Agency in writing of any changes to the above
10information at least 15 days before such a change.
11    (f) By July 1st 2022, and by each July 1st thereafter, each
12pharmaceutical reimbursement program operator must submit to
13the Agency a report describing implementation of its
14pharmaceutical reimbursement take-back program during the
15previous calendar year. The report must include:
16        (1) a list of the covered manufacturers participating
17    in the program;
18        (2) a list of the pharmacies participating in the
19    program;
20        (3) a list of authorized collectors that are not
21    pharmacies participating in the program;
22        (4) a list of the transporters and disposal facilities
23    used to transport and dispose of the covered drugs
24    collected by the program; and
25        (5) the amount, by weight, of the covered drugs
26    collected from each collection site.

 

 

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1    (g) Nothing in this Act shall require a pharmaceutical drug
2take-back reimbursement program to have a minimum number of
3collection sites in the State, in a county, or in a
4municipality. Nothing in this Act shall limit the number of
5authorized collection sites participating in a pharmaceutical
6drug take-back reimbursement program or a drug take-back
7program.
8    (h) A pharmaceutical reimbursement program operator shall
9keep financial records of the pharmaceutical take-back
10reimbursement program and the collection, transportation, and
11disposal of covered drugs collected under the program. These
12records shall include, but not be limited to, costs related to:
13        (1) administration of the program, fees, and
14    collection and transportation of supplies for each
15    collection site;
16        (2) the purchase of collection receptacles for each
17    collection site;
18        (3) maintenance or replacement of collection
19    receptacles when requested by authorized collectors;
20        (4) prepaid, preaddressed mailers;
21        (5) compensation for authorized collectors;
22        (6) operation of periodic collection events,
23    including, but not limited to, the cost of staff time;
24        (7) transportation of all collected covered drugs to
25    final disposal;
26        (8) environmentally sound disposal of all collected

 

 

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1    covered drugs; and
2        (9) program promotion and outreach.
3    (i) Each authorized collection site that registers with a
4pharmaceutical reimbursement program operator shall provide
5collection, transportation, and disposal costs to the
6pharmaceutical reimbursement program operator. The
7pharmaceutical reimbursement program operator shall aggregate
8the total costs. The total costs shall be divided between all
9Illinois covered manufacturers. The covered manufacturers
10shall submit the required funding to the Agency. The Agency
11shall place the moneys in the Pharmaceutical Take-Back
12Reimbursement Program Fund. The pharmaceutical reimbursement
13program operator shall distribute the appropriate
14reimbursement moneys to the authorized collection sites.
15    (j) An annual independent financial audit of a
16pharmaceutical take-back reimbursement program's records may
17be requested by any participating covered manufacturer. The
18covered manufacturer requesting the audit shall fund the audit.
19The audit shall be conducted in accordance with auditing
20standards generally accepted in the United States of America,
21and standards set forth in Government Auditing Standards issued
22by the Comptroller General of the United States. The financial
23audit shall be prepared by an independent certified public
24accountant. The independent certified public accountant shall
25not perform nonaudit services for the covered manufacturers
26that would impair independence as defined in the Government

 

 

HB4888- 23 -LRB101 18479 CPF 67929 b

1Auditing Standards issued by the Comptroller General of the
2United States, including, but not limited to, accounting
3services, development of internal controls, and management
4decisions. The final report shall not include any proprietary
5information.
 
6    Section 65. Registration fee.
7    (a) By April 1, 2021, and by April 1 of each year
8thereafter, each covered manufacturer and manufacturer program
9operator shall submit to the Agency a $5,000 registration fee.
10    (b) All fees collected under this Section must be deposited
11in the Solid Waste Management Fund to be used in accordance
12with this Act.
 
13    Section 70. Rules; enforcement; penalties.
14    (a) The Agency may adopt any rules it deems necessary to
15implement and administer this Act.
16    (b) Except as otherwise provided in this Act, any person
17who violates any provision of this Act is liable for a civil
18penalty of $7,000 per violation, provided that the penalty for
19failure to register or pay a fee under this Act shall be double
20the applicable registration fee.
21    (c) The penalties provided for in this Section may be
22recovered in a civil action brought in the name of the People
23of the State of Illinois by the State's Attorney of the county
24in which the violation occurred or by the Attorney General. Any

 

 

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1penalties collected under this Section in an action in which
2the Attorney General has prevailed shall be deposited in the
3Solid Waste Management Fund, to be used in accordance with the
4provisions of this Act.
5    (d) The Attorney General or the State's Attorney of a
6county in which a violation occurs may institute a civil action
7for an injunction, prohibitory or mandatory, to restrain
8violations of this Act or to require such actions as may be
9necessary to address violations of this Act.
10    (e) The Agency may impose a civil penalty for a violation
11of this Act of $7,000 per violation, plus any hearing costs
12incurred by the Agency. Such penalties shall be made payable to
13the Solid Waste Management Fund to be used in accordance with
14this Act.
15    (f) The penalties and injunctions provided in this Act are
16in addition to any penalties, injunctions, or other relief
17provided under any other law. Nothing in this Act bars a cause
18of action by the State for any other penalty, injunction, or
19other relief provided by any other law.
20    (g) Any person who knowingly makes a false, fictitious, or
21fraudulent material statement, orally or in writing, to the
22Agency, related to or required by this Act or any rule adopted
23under this Act commits a Class 4 felony, and each such
24statement or writing shall be considered a separate Class 4
25felony. A person who, after being convicted under this
26subsection (g), violates this subsection (g) a second or

 

 

HB4888- 25 -LRB101 18479 CPF 67929 b

1subsequent time, commits a Class 3 felony
 
2    Section 75. Pharmaceutical Take-Back Reimbursement Program
3Fund.
4    (a) The Pharmaceutical Take-Back Reimbursement Program
5Fund is created as a special fund in the State treasury. Moneys
6in the Fund shall be used only for reimbursement of the
7pharmaceutical take-back reimbursement program, pharmaceutical
8reimbursement program operator, and participating authorized
9collectors. All moneys received by the Agency under this Act,
10except moneys received under Section 60 or 65, must be
11deposited in the Fund.
12    (b) The Fund shall not be subject to sweeps, administrative
13charges or chargebacks, or any other fiscal or budgetary
14maneuver that would in any way transfer any funds from the Fund
15into any other fund of the State.
 
16    Section 80. Antitrust immunity. The activities authorized
17by this Act require collaboration among covered manufacturers
18and among authorized collectors. These activities will enable
19safe and secure collection and disposal of covered drugs in
20Illinois and are therefore in the best interest of the public.
21The benefits of collaboration, together with active State
22supervision, outweigh potential adverse impacts. Therefore,
23the General Assembly intends to exempt from State antitrust
24laws, and provide immunity through the state action doctrine

 

 

HB4888- 26 -LRB101 18479 CPF 67929 b

1from federal antitrust laws, activities that are undertaken
2pursuant to this Act that might otherwise be constrained by
3such laws. The General Assembly does not intend and does not
4authorize any person or entity to engage in activities not
5provided for by this Act, and the General Assembly neither
6exempts nor provides immunity for such activities.
 
7    Section 85. Public disclosure. The Agency shall only use
8and disclose proprietary information submitted to the Agency
9under this Act in summary or aggregated form that does not
10directly or indirectly identify financial, production, or
11sales data of an individual covered manufacturer, authorized
12collector, or pharmacy.
 
13    Section 95. The Freedom of Information Act is amended by
14changing Section 7 as follows:
 
15    (5 ILCS 140/7)  (from Ch. 116, par. 207)
16    Sec. 7. Exemptions.
17    (1) When a request is made to inspect or copy a public
18record that contains information that is exempt from disclosure
19under this Section, but also contains information that is not
20exempt from disclosure, the public body may elect to redact the
21information that is exempt. The public body shall make the
22remaining information available for inspection and copying.
23Subject to this requirement, the following shall be exempt from

 

 

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1inspection and copying:
2        (a) Information specifically prohibited from
3    disclosure by federal or State law or rules and regulations
4    implementing federal or State law.
5        (b) Private information, unless disclosure is required
6    by another provision of this Act, a State or federal law or
7    a court order.
8        (b-5) Files, documents, and other data or databases
9    maintained by one or more law enforcement agencies and
10    specifically designed to provide information to one or more
11    law enforcement agencies regarding the physical or mental
12    status of one or more individual subjects.
13        (c) Personal information contained within public
14    records, the disclosure of which would constitute a clearly
15    unwarranted invasion of personal privacy, unless the
16    disclosure is consented to in writing by the individual
17    subjects of the information. "Unwarranted invasion of
18    personal privacy" means the disclosure of information that
19    is highly personal or objectionable to a reasonable person
20    and in which the subject's right to privacy outweighs any
21    legitimate public interest in obtaining the information.
22    The disclosure of information that bears on the public
23    duties of public employees and officials shall not be
24    considered an invasion of personal privacy.
25        (d) Records in the possession of any public body
26    created in the course of administrative enforcement

 

 

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1    proceedings, and any law enforcement or correctional
2    agency for law enforcement purposes, but only to the extent
3    that disclosure would:
4            (i) interfere with pending or actually and
5        reasonably contemplated law enforcement proceedings
6        conducted by any law enforcement or correctional
7        agency that is the recipient of the request;
8            (ii) interfere with active administrative
9        enforcement proceedings conducted by the public body
10        that is the recipient of the request;
11            (iii) create a substantial likelihood that a
12        person will be deprived of a fair trial or an impartial
13        hearing;
14            (iv) unavoidably disclose the identity of a
15        confidential source, confidential information
16        furnished only by the confidential source, or persons
17        who file complaints with or provide information to
18        administrative, investigative, law enforcement, or
19        penal agencies; except that the identities of
20        witnesses to traffic accidents, traffic accident
21        reports, and rescue reports shall be provided by
22        agencies of local government, except when disclosure
23        would interfere with an active criminal investigation
24        conducted by the agency that is the recipient of the
25        request;
26            (v) disclose unique or specialized investigative

 

 

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1        techniques other than those generally used and known or
2        disclose internal documents of correctional agencies
3        related to detection, observation or investigation of
4        incidents of crime or misconduct, and disclosure would
5        result in demonstrable harm to the agency or public
6        body that is the recipient of the request;
7            (vi) endanger the life or physical safety of law
8        enforcement personnel or any other person; or
9            (vii) obstruct an ongoing criminal investigation
10        by the agency that is the recipient of the request.
11        (d-5) A law enforcement record created for law
12    enforcement purposes and contained in a shared electronic
13    record management system if the law enforcement agency that
14    is the recipient of the request did not create the record,
15    did not participate in or have a role in any of the events
16    which are the subject of the record, and only has access to
17    the record through the shared electronic record management
18    system.
19        (e) Records that relate to or affect the security of
20    correctional institutions and detention facilities.
21        (e-5) Records requested by persons committed to the
22    Department of Corrections, Department of Human Services
23    Division of Mental Health, or a county jail if those
24    materials are available in the library of the correctional
25    institution or facility or jail where the inmate is
26    confined.

 

 

HB4888- 30 -LRB101 18479 CPF 67929 b

1        (e-6) Records requested by persons committed to the
2    Department of Corrections, Department of Human Services
3    Division of Mental Health, or a county jail if those
4    materials include records from staff members' personnel
5    files, staff rosters, or other staffing assignment
6    information.
7        (e-7) Records requested by persons committed to the
8    Department of Corrections or Department of Human Services
9    Division of Mental Health if those materials are available
10    through an administrative request to the Department of
11    Corrections or Department of Human Services Division of
12    Mental Health.
13        (e-8) Records requested by a person committed to the
14    Department of Corrections, Department of Human Services
15    Division of Mental Health, or a county jail, the disclosure
16    of which would result in the risk of harm to any person or
17    the risk of an escape from a jail or correctional
18    institution or facility.
19        (e-9) Records requested by a person in a county jail or
20    committed to the Department of Corrections or Department of
21    Human Services Division of Mental Health, containing
22    personal information pertaining to the person's victim or
23    the victim's family, including, but not limited to, a
24    victim's home address, home telephone number, work or
25    school address, work telephone number, social security
26    number, or any other identifying information, except as may

 

 

HB4888- 31 -LRB101 18479 CPF 67929 b

1    be relevant to a requester's current or potential case or
2    claim.
3        (e-10) Law enforcement records of other persons
4    requested by a person committed to the Department of
5    Corrections, Department of Human Services Division of
6    Mental Health, or a county jail, including, but not limited
7    to, arrest and booking records, mug shots, and crime scene
8    photographs, except as these records may be relevant to the
9    requester's current or potential case or claim.
10        (f) Preliminary drafts, notes, recommendations,
11    memoranda and other records in which opinions are
12    expressed, or policies or actions are formulated, except
13    that a specific record or relevant portion of a record
14    shall not be exempt when the record is publicly cited and
15    identified by the head of the public body. The exemption
16    provided in this paragraph (f) extends to all those records
17    of officers and agencies of the General Assembly that
18    pertain to the preparation of legislative documents.
19        (g) Trade secrets and commercial or financial
20    information obtained from a person or business where the
21    trade secrets or commercial or financial information are
22    furnished under a claim that they are proprietary,
23    privileged, or confidential, and that disclosure of the
24    trade secrets or commercial or financial information would
25    cause competitive harm to the person or business, and only
26    insofar as the claim directly applies to the records

 

 

HB4888- 32 -LRB101 18479 CPF 67929 b

1    requested.
2        The information included under this exemption includes
3    all trade secrets and commercial or financial information
4    obtained by a public body, including a public pension fund,
5    from a private equity fund or a privately held company
6    within the investment portfolio of a private equity fund as
7    a result of either investing or evaluating a potential
8    investment of public funds in a private equity fund. The
9    exemption contained in this item does not apply to the
10    aggregate financial performance information of a private
11    equity fund, nor to the identity of the fund's managers or
12    general partners. The exemption contained in this item does
13    not apply to the identity of a privately held company
14    within the investment portfolio of a private equity fund,
15    unless the disclosure of the identity of a privately held
16    company may cause competitive harm.
17        Nothing contained in this paragraph (g) shall be
18    construed to prevent a person or business from consenting
19    to disclosure.
20        (h) Proposals and bids for any contract, grant, or
21    agreement, including information which if it were
22    disclosed would frustrate procurement or give an advantage
23    to any person proposing to enter into a contractor
24    agreement with the body, until an award or final selection
25    is made. Information prepared by or for the body in
26    preparation of a bid solicitation shall be exempt until an

 

 

HB4888- 33 -LRB101 18479 CPF 67929 b

1    award or final selection is made.
2        (i) Valuable formulae, computer geographic systems,
3    designs, drawings and research data obtained or produced by
4    any public body when disclosure could reasonably be
5    expected to produce private gain or public loss. The
6    exemption for "computer geographic systems" provided in
7    this paragraph (i) does not extend to requests made by news
8    media as defined in Section 2 of this Act when the
9    requested information is not otherwise exempt and the only
10    purpose of the request is to access and disseminate
11    information regarding the health, safety, welfare, or
12    legal rights of the general public.
13        (j) The following information pertaining to
14    educational matters:
15            (i) test questions, scoring keys and other
16        examination data used to administer an academic
17        examination;
18            (ii) information received by a primary or
19        secondary school, college, or university under its
20        procedures for the evaluation of faculty members by
21        their academic peers;
22            (iii) information concerning a school or
23        university's adjudication of student disciplinary
24        cases, but only to the extent that disclosure would
25        unavoidably reveal the identity of the student; and
26            (iv) course materials or research materials used

 

 

HB4888- 34 -LRB101 18479 CPF 67929 b

1        by faculty members.
2        (k) Architects' plans, engineers' technical
3    submissions, and other construction related technical
4    documents for projects not constructed or developed in
5    whole or in part with public funds and the same for
6    projects constructed or developed with public funds,
7    including, but not limited to, power generating and
8    distribution stations and other transmission and
9    distribution facilities, water treatment facilities,
10    airport facilities, sport stadiums, convention centers,
11    and all government owned, operated, or occupied buildings,
12    but only to the extent that disclosure would compromise
13    security.
14        (l) Minutes of meetings of public bodies closed to the
15    public as provided in the Open Meetings Act until the
16    public body makes the minutes available to the public under
17    Section 2.06 of the Open Meetings Act.
18        (m) Communications between a public body and an
19    attorney or auditor representing the public body that would
20    not be subject to discovery in litigation, and materials
21    prepared or compiled by or for a public body in
22    anticipation of a criminal, civil, or administrative
23    proceeding upon the request of an attorney advising the
24    public body, and materials prepared or compiled with
25    respect to internal audits of public bodies.
26        (n) Records relating to a public body's adjudication of

 

 

HB4888- 35 -LRB101 18479 CPF 67929 b

1    employee grievances or disciplinary cases; however, this
2    exemption shall not extend to the final outcome of cases in
3    which discipline is imposed.
4        (o) Administrative or technical information associated
5    with automated data processing operations, including, but
6    not limited to, software, operating protocols, computer
7    program abstracts, file layouts, source listings, object
8    modules, load modules, user guides, documentation
9    pertaining to all logical and physical design of
10    computerized systems, employee manuals, and any other
11    information that, if disclosed, would jeopardize the
12    security of the system or its data or the security of
13    materials exempt under this Section.
14        (p) Records relating to collective negotiating matters
15    between public bodies and their employees or
16    representatives, except that any final contract or
17    agreement shall be subject to inspection and copying.
18        (q) Test questions, scoring keys, and other
19    examination data used to determine the qualifications of an
20    applicant for a license or employment.
21        (r) The records, documents, and information relating
22    to real estate purchase negotiations until those
23    negotiations have been completed or otherwise terminated.
24    With regard to a parcel involved in a pending or actually
25    and reasonably contemplated eminent domain proceeding
26    under the Eminent Domain Act, records, documents, and

 

 

HB4888- 36 -LRB101 18479 CPF 67929 b

1    information relating to that parcel shall be exempt except
2    as may be allowed under discovery rules adopted by the
3    Illinois Supreme Court. The records, documents, and
4    information relating to a real estate sale shall be exempt
5    until a sale is consummated.
6        (s) Any and all proprietary information and records
7    related to the operation of an intergovernmental risk
8    management association or self-insurance pool or jointly
9    self-administered health and accident cooperative or pool.
10    Insurance or self insurance (including any
11    intergovernmental risk management association or self
12    insurance pool) claims, loss or risk management
13    information, records, data, advice or communications.
14        (t) Information contained in or related to
15    examination, operating, or condition reports prepared by,
16    on behalf of, or for the use of a public body responsible
17    for the regulation or supervision of financial
18    institutions, insurance companies, or pharmacy benefit
19    managers, unless disclosure is otherwise required by State
20    law.
21        (u) Information that would disclose or might lead to
22    the disclosure of secret or confidential information,
23    codes, algorithms, programs, or private keys intended to be
24    used to create electronic or digital signatures under the
25    Electronic Commerce Security Act.
26        (v) Vulnerability assessments, security measures, and

 

 

HB4888- 37 -LRB101 18479 CPF 67929 b

1    response policies or plans that are designed to identify,
2    prevent, or respond to potential attacks upon a community's
3    population or systems, facilities, or installations, the
4    destruction or contamination of which would constitute a
5    clear and present danger to the health or safety of the
6    community, but only to the extent that disclosure could
7    reasonably be expected to jeopardize the effectiveness of
8    the measures or the safety of the personnel who implement
9    them or the public. Information exempt under this item may
10    include such things as details pertaining to the
11    mobilization or deployment of personnel or equipment, to
12    the operation of communication systems or protocols, or to
13    tactical operations.
14        (w) (Blank).
15        (x) Maps and other records regarding the location or
16    security of generation, transmission, distribution,
17    storage, gathering, treatment, or switching facilities
18    owned by a utility, by a power generator, or by the
19    Illinois Power Agency.
20        (y) Information contained in or related to proposals,
21    bids, or negotiations related to electric power
22    procurement under Section 1-75 of the Illinois Power Agency
23    Act and Section 16-111.5 of the Public Utilities Act that
24    is determined to be confidential and proprietary by the
25    Illinois Power Agency or by the Illinois Commerce
26    Commission.

 

 

HB4888- 38 -LRB101 18479 CPF 67929 b

1        (z) Information about students exempted from
2    disclosure under Sections 10-20.38 or 34-18.29 of the
3    School Code, and information about undergraduate students
4    enrolled at an institution of higher education exempted
5    from disclosure under Section 25 of the Illinois Credit
6    Card Marketing Act of 2009.
7        (aa) Information the disclosure of which is exempted
8    under the Viatical Settlements Act of 2009.
9        (bb) Records and information provided to a mortality
10    review team and records maintained by a mortality review
11    team appointed under the Department of Juvenile Justice
12    Mortality Review Team Act.
13        (cc) Information regarding interments, entombments, or
14    inurnments of human remains that are submitted to the
15    Cemetery Oversight Database under the Cemetery Care Act or
16    the Cemetery Oversight Act, whichever is applicable.
17        (dd) Correspondence and records (i) that may not be
18    disclosed under Section 11-9 of the Illinois Public Aid
19    Code or (ii) that pertain to appeals under Section 11-8 of
20    the Illinois Public Aid Code.
21        (ee) The names, addresses, or other personal
22    information of persons who are minors and are also
23    participants and registrants in programs of park
24    districts, forest preserve districts, conservation
25    districts, recreation agencies, and special recreation
26    associations.

 

 

HB4888- 39 -LRB101 18479 CPF 67929 b

1        (ff) The names, addresses, or other personal
2    information of participants and registrants in programs of
3    park districts, forest preserve districts, conservation
4    districts, recreation agencies, and special recreation
5    associations where such programs are targeted primarily to
6    minors.
7        (gg) Confidential information described in Section
8    1-100 of the Illinois Independent Tax Tribunal Act of 2012.
9        (hh) The report submitted to the State Board of
10    Education by the School Security and Standards Task Force
11    under item (8) of subsection (d) of Section 2-3.160 of the
12    School Code and any information contained in that report.
13        (ii) Records requested by persons committed to or
14    detained by the Department of Human Services under the
15    Sexually Violent Persons Commitment Act or committed to the
16    Department of Corrections under the Sexually Dangerous
17    Persons Act if those materials: (i) are available in the
18    library of the facility where the individual is confined;
19    (ii) include records from staff members' personnel files,
20    staff rosters, or other staffing assignment information;
21    or (iii) are available through an administrative request to
22    the Department of Human Services or the Department of
23    Corrections.
24        (jj) Confidential information described in Section
25    5-535 of the Civil Administrative Code of Illinois.
26        (kk) The public body's credit card numbers, debit card

 

 

HB4888- 40 -LRB101 18479 CPF 67929 b

1    numbers, bank account numbers, Federal Employer
2    Identification Number, security code numbers, passwords,
3    and similar account information, the disclosure of which
4    could result in identity theft or impression or defrauding
5    of a governmental entity or a person.
6        (ll) (kk) Records concerning the work of the threat
7    assessment team of a school district.
8        (mm) Proprietary information submitted to the
9    Environmental Protection Agency under the Pharmaceutical
10    Recovery Act.
11    (1.5) Any information exempt from disclosure under the
12Judicial Privacy Act shall be redacted from public records
13prior to disclosure under this Act.
14    (2) A public record that is not in the possession of a
15public body but is in the possession of a party with whom the
16agency has contracted to perform a governmental function on
17behalf of the public body, and that directly relates to the
18governmental function and is not otherwise exempt under this
19Act, shall be considered a public record of the public body,
20for purposes of this Act.
21    (3) This Section does not authorize withholding of
22information or limit the availability of records to the public,
23except as stated in this Section or otherwise provided in this
24Act.
25(Source: P.A. 100-26, eff. 8-4-17; 100-201, eff. 8-18-17;
26100-732, eff. 8-3-18; 101-434, eff. 1-1-20; 101-452, eff.

 

 

HB4888- 41 -LRB101 18479 CPF 67929 b

11-1-20; 101-455, eff. 8-23-19; revised 9-27-19.)
 
2    Section 100. The State Finance Act is amended by adding
3Section 5.930 as follows:
 
4    (30 ILCS 105/5.930 new)
5    Sec. 5.930. The Pharmaceutical Take-Back Reimbursement
6Program Fund.
 
7    Section 999. Effective date. This Act takes effect upon
8becoming law.