Public Act 102-0389
Section 1 Short title.
This Act may be cited as the Illinois Drug Reuse Opportunity Program Act (HB119 Senate Amendment 1)
Section 5 Definitions.
"Controlled substance" means a drug, substance, or immediate precursor in Schedules I through V of 21 CFR 1308.
"Dispense" has the same meaning as defined in Section 3 of the Pharmacy Practice Act.
"Donor" means any person, including an individual member of the public, or any entity legally authorized to possess medicine, including, but not limited to, a wholesaler or distributor, third party logistic provider, pharmacy, dispenser, clinic, surgical or health center, detention and rehabilitation center, jail, prison laboratory, medical or pharmacy school, prescriber or other health care professional, long-term care facility, or healthcare facility.
"Donor" includes government agencies and entities that are federally authorized to possess medicine, including, but not limited to, drug manufacturers, repackagers, relabelers, outsourcing facilities, health care facilities operated by the U.S. Department of Veterans Affairs, and prisons.
"Drug" means a prescription drug, over-the-counter drug, or supplies needed to administer a prescription or
"Eligible patient" means an individual: (1) with a prescription for the drug, if a prescription is required to dispense the drug, or who reports symptoms treated by the drug if the drug is over-the-counter; and (2) who is registered with the drug's manufacturer in accordance with federal Food and Drug Administration requirements, if the registration is required to dispense the drug.
"Manufacturer" has the same meaning as defined in Section 15 of the Wholesale Drug Distribution Licensing Act.
"Pharmacist" means an individual licensed to engage in the practice of pharmacy under the Pharmacy Practice Act or licensed to engage in the practice of pharmacy in another state.
"Practitioner" means a person licensed in this State to dispense or administer drugs or who is licensed in another state as a person authorized to dispense or administer drugs.
"Prescription drug" means any prescribed drug that may be legally dispensed by a pharmacy. "Prescription drug" does not include a drug for the treatment of cancer that can only be dispensed to a patient registered with the drug manufacturer in accordance with the federal Food and Drug Administration's
"Priority patient" means an eligible patient who is an Illinois resident and who is indigent, uninsured, underinsured, or enrolled in a public health benefits program.
"Recipient" means any person or entity legally authorized to possess medicine with a license or permit in the state which the person or entity is located, including, but not limited to, a wholesaler or distributor, reverse distributor, repackager, hospital, pharmacy, or clinic.
"Returns processor" has the same meaning as defined in paragraph (18) of 21 U.S.C. 360eee. "Returns processor" includes, but is not limited to, a reverse distributor.
"Unopened tamper-evident packaging" has the same meaning as defined in the United States Pharmacopeia (USP) General Chapter 659, Packaging and Storage Requirements, including,but not limited to, unopened unit-dose, multiple-dose, immediate, secondary, and tertiary packaging.
Section 10 Donating and receiving drugs.
Notwithstanding any other law or rule, donors may donate drugs to recipients and recipients may receive donated drugs from donors. Recipients shall only dispense or administer drugs to eligible patients as described in Section 20, further donate drugs to another recipient as described in Section 30, or dispose of drugs as described in Section 35.
Section 15 Cost-free provision of drugs.
Drugs donated for use under this Act are considered nonsaleable. When dispensing a drug to an eligible patient, the recipient must do so at no cost to the eligible patient, except that a uniform reasonable handling fee may be charged. The handling fee may not exceed the direct or indirect cost to the recipient of providing the drug. Charging the fee does not constitute Reselling.
Section 20 Requirements for dispensing drugs; priority.
(a) A recipient may only dispense or administer a prescription drug or provide an over-the-counter drug:
(1) if the recipient is otherwise permitted by law to dispense or administer the drug;
(2) that meets the requirements in Section 25;
(3) that is repackaged into a new container or is in its original container with all previous patient
information redacted or removed;
(4) that is properly labeled in accordance with the rules and regulations of the Board of Pharmacy;
(5) that has an expiration or beyond-use date brought forward from the donated prescription drug or over-the-counter drug that will not expire before the use by the eligible patient based on the prescribing practitioner's directions for use or, for over-the-counter medicine, on the package's label; and
(6) that is not adulterated or misbranded, as determined by a pharmacist or practitioner.
(b) Recipients shall, to the greatest extent practicable, dispense drugs received under this Act to priority patients.
Section 25 Requirements for accepting drugs.
A drug received but not yet accepted into inventory shall be kept in a separate designated area. A drug may be accepted under this Act only if all of the following requirements are met:
(1) The drug is in unopened tamper-evident packaging or has been repackaged according to Section 30.
(2) The drug is not expired.
(3) The drug is not a controlled substance.
(4) The recipient maintains a written or electronic record of a donation made under this Act consisting of the name, strength, and quantity of each accepted drug and the name, address, and telephone number of the donor, unless a recipient is further donating to a recipient under common ownership or common control. Notwithstanding any other law or rule, no other record of a donation is required.
(5) The donor has removed or redacted any patient name and prescription number and any other patient identifying information on the drug or otherwise maintains patient confidentiality by executing a confidentiality agreement with the recipient according to all State and federal medical patient privacy laws, rules, or regulations.
(6) The drug has a method recognized by the United States Pharmacopeia to detect improper temperature
variations if the drug requires temperature control other than room temperature storage.
Section 30 Donating and repackaging.
Notwithstanding any other law or rule, a recipient may:
(1) further donate drugs to another recipient;
(2) repackage donated drugs as necessary for storage, dispensing, administration, or transfers in accordance
with the following:
(A) repackaged medicine shall be labeled with the drug's name, strength, and expiration date, and shall
be kept in a separate designated area until inspected and initialed by a pharmacist, practitioner, or a
pharmacy technician; and
(B) if multiple packaged donated medicines with varied expiration dates are repackaged together, the
shortest expiration date shall be used; and
(3) replenish a drug of the same drug name and strength previously dispensed or administered to an eligible patient in accordance with Section 340B of the federal Public Health Service Act.
Section 35 Disposition of drugs.
A donated drug that does not meet the requirements of Section 25 must be disposed of by returning it to the donor, destroying it by an incinerator, medical waste hauler, or other lawful method, or transferring to a returns processor. A record of disposal shall consist of the disposal method, the date of disposal, and the name and quantity of the drug disposed of. Notwithstanding any other law or rule, no other record of disposal shall be required.
Section 40 Participation not required.
Nothing in this Act requires that a pharmacy or pharmacist be a recipient of drugs under this Act.
Section 45 Recordkeeping requirements.
When performing any action associated with a program under this Act or otherwise processing a donated drug for tax, manufacturer, or other credit, a recipient shall be considered to be acting as a returns processor and shall comply with all recordkeeping requirements for nonsaleable returns under federal law.
Section 50 Change of ownership.
A donation or other transfer of possession or control of a drug under this Act shall not be construed as a change of ownership unless it is specified as such by the recipient. If a record of the donation's transaction information or history is required, the history shall begin with the donor of the drug, include all prior donations, and, if the drug was previously dispensed, only include drug information required to be on the patient label in accordance with the Board of Pharmacy's rules and Regulations.
Section 55 Retention of records.
All records required under this Act shall be retained in physical or electronic format and on or off the recipient's premises for a period of 6 years. Donors or recipients may contract with one another or a third party to create or maintain records on each other's behalf. An identifier, such as a serial number or bar code, may be used in place of any or all information required by a record or label pursuant to this Act if it allows for such information to be readily retrievable. Upon request by a State or federal regulatory agency, the identifier used for requested records shall be replaced with the original information. An identifier shall not be used on patient labels when dispensing or administering a drug.
Section 60 Authority.
This Act supersedes any inconsistent law or rule for activities conducted under this Act.
Section 65 Immunity.
(a) Except as provided in subsection (b), no manufacturer, donor, or recipient shall be liable in any criminal or civil action, or be subject to professional discipline, for activities solely and directly attributable to donating, receiving, or dispensing drugs under this Act.
(b) The immunity provided in subsection (a) shall not apply:
(1) if it is shown that the act or omission was an unreasonable, willful, wanton, or reckless act;
(2) if it is shown that the person or entity knew or should have known that the donated drug was adulterated or misbranded; or
(3) to acts or omissions outside the scope of a program under this Act.
Section 90 The Pharmacy Practice Act is amended by changing Section 4 as follows:
(225 ILCS 85/4) (from Ch. 111, par. 4124)
Sec. 4. Exemptions. Nothing contained in any Section of this Act shall apply to, or in any manner interfere with: ......
(g-5) the donation or acceptance, or the packaging, repackaging, or labeling, of drugs to the extent permitted under the Illinois Drug Reuse Opportunity Program Act; and
Section 95 The Wholesale Drug Distribution Licensing Act is amended by changing Section 15 as follows:
(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
Sec. 15. Definitions. As used in this Act: .......
"Manufacturer" means a person licensed or approved by the FDA to engage in the manufacture of drugs or devices, consistent with the definition of "manufacturer" set forth in the FDA's regulations and guidances implementing the Prescription Drug Marketing Act. "Manufacturer" does not include anyone who is engaged in the packaging, repackaging, or labeling of drugs only to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
"Wholesale distribution" means the distribution of prescription drugs to persons other than a consumer or patient, but does not include any of the following:
(11) The donation of drugs to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
Section 100 The Senior Pharmaceutical Assistance Act is amended by changing Section 10 as follows:
(320 ILCS 50/10)
Sec. 10. Definitions. In this Act:
The term also does not include anyone who is engaged in the packaging, repackaging, or labeling of drugs only to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
Section 105 The Illinois Food, Drug and Cosmetic Act is amended by changing Section 16 as follows:
(410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
Sec. 16. (a) The Director is hereby authorized to promulgate regulations exempting from any labeling or packaging requirement of this Act drugs and devices which are… (ii) packaged, repackaged, or labeled to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
Section 110 The Illinois Controlled Substances Act is amended by changing Section 102 as follows:
(720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
Sec. 102. Definitions. As used in this Act, unless the context otherwise requires: ……….
(h) ….. "Deliver" or "delivery" does not include the donation of drugs to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
(z) "Manufacture" means…except that this term does not include: (3) the packaging, repackaging, or labeling of drugs only to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.
Section 115 The Cannabis and Controlled Substances Tort Claims Act is amended by changing Section 3 as follows:
(740 ILCS 20/3) (from Ch. 70, par. 903)
Sec. 3. Definitions. As used in this Act, unless the context otherwise requires: …..
"Deliver" or "delivery" does not include the donation of drugs to the extent permitted under the Illinois Drug Reuse Opportunity Program Act.