A Bill for an Act
Page 1, Line 101Concerning the creation of a drug donation program.
Bill Summary
(Note: This summary applies to this bill as introduced and does not reflect any amendments that may be subsequently adopted. If this bill passes third reading in the house of introduction, a bill summary that applies to the reengrossed version of this bill will be available at http://leg.colorado.gov.)
The bill amends statutory provisions relating to unused medication in facilities, including correctional facilities, nursing care facilities, assisted living residences, hospice, and other facilities, to change the defined term "medication" to "medicine" and to expand the types of unused medicines that may be redispensed to patients or donated to a nonprofit entity.
The bill creates the Colorado drug donation program (donation program). The donation program allows a person legally authorized to possess medicine, including an individual member of the public, a pharmacy, a long-term care facility, a surgical center, a prescriber or other health-care professional or facility, or others (donor) to donate unused medicine (donated medicine).
A donor may donate unused medicine to a donation recipient (donation recipient) that is authorized to possess medicine and that has a credential in good standing in the state in which the donation recipient is located. A donation recipient may include a wholesaler, distributor, third-party logistics provider, repackager, hospital, pharmacy, clinic, health-care provider, or prescriber's office.
The bill requires the donation recipient to:
- Keep a record of the donated medicine;
- Keep donated medicine separate from regular stock; and
- Have donated medicine inspected by a licensed pharmacist.
The donation recipient may transfer the donated medicine to another donation recipient or entity, repackage the donated medicine, or, if the donation recipient is a prescription drug outlet, replenish medicine.
The bill requires donated medicine to first be dispensed to an eligible patient who is an individual who is indigent, uninsured, underinsured, or enrolled in a public health benefits program. Donated medicine must not be resold; except that a donation recipient may charge a handling or dispensing fee for the donated medicine.
When acting in good faith, the participants in the donation program are not subject to criminal liability or professional disciplinary action.
Page 2, Line 1Be it enacted by the General Assembly of the State of Colorado:
Page 2, Line 2SECTION 1. In Colorado Revised Statutes, 12-280-135, amend
Page 2, Line 3(1)(e), (2)(a), (2)(b) introductory portion, (2)(b)(II), (2)(b)(III), (2)(c)
Page 2, Line 4introductory portion, (2)(c)(I), (2)(c)(III), (2)(c)(V), (3), (4), and (6);
Page 2, Line 5repeal (2)(c)(IV) and (5); and add (2)(b)(IV), (2)(c)(VI), (2)(c)(VII), and (2)(c)(VIII) as follows:
Page 2, Line 612-280-135. Unused medicine - licensed facilities - correctional
Page 2, Line 7facilities - reuse - definitions - rules. (1) As used in this section, unless the context otherwise requires:
Page 2, Line 8(e) (I)
"Medication" means a prescription that is not a controlledPage 2, Line 9
substance(II) "Medicine" includes:
Page 3, Line 1(A) A prescription drug that requires refrigeration,
Page 3, Line 2freezing, or special storage if the prescription drug has been
Page 3, Line 3continually maintained by a donor pursuant to the
Page 3, Line 4manufacturer's storage requirements, so long as the cold chain can be verified; and
Page 3, Line 5(B) Prescription supplies and devices.
(III) "Medicine" does not include:
Page 3, Line 6(A) Compounded drugs;
Page 3, Line 7(B) Prescription drugs dispensed by pharmacies outside of the United States;
Page 3, Line 8(C) Prescription drugs that are subject to risk evaluation
Page 3, Line 9and mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3)
Page 3, Line 10unless all of the required guidelines for the medicine are
Page 3, Line 11followed or REMS drugs that were initially dispensed by a
Page 3, Line 12pharmacy pursuant to a restricted REMS distribution channel; or
Page 3, Line 13(D) Controlled substances.
Page 3, Line 14(2) (a) (I) If donated by the patient, the resident, or the patient's or
Page 3, Line 15resident's next of kin, a licensed facility may return unused
medicationsPage 3, Line 16medicine or medical supplies and used or unused medical devices to a
Page 3, Line 17pharmacist within the licensed facility or a prescription drug outlet in
Page 3, Line 18order for the materials to be redispensed to another patient or donated to
Page 3, Line 19a nonprofit entity that has the legal authority to possess the materials or to a practitioner authorized by law to dispense the materials.
Page 3, Line 20(II) (A) A licensed facility or a prescription drug outlet may
Page 3, Line 21donate materials to
a nonprofitPage 4, Line 1possess the materials or to a person legally authorized to dispense the
Page 4, Line 2materials. A licensed pharmacist shall review the process of donating the unused
medicationsnonprofitPage 4, Line 3(B) Nothing in this subsection (2)(a)(II) creates or abrogates any
Page 4, Line 4liability on behalf of a prescription drug manufacturer for the storage,
Page 4, Line 5donation, acceptance, or dispensing of
a medicationPage 4, Line 6product or creates any civil cause of action against a prescription drug manufacturer in addition to that which is available under applicable law.
Page 4, Line 7(C) A person or entity is not subject to civil or criminal liability
Page 4, Line 8or professional disciplinary action for donating, accepting, dispensing, or
Page 4, Line 9facilitating the donation of materials in good faith, without negligence or willful or wanton misconduct, and in compliance with this section.
Page 4, Line 10(III) A correctional facility may return unused
medicationsPage 4, Line 11medicine or medical supplies and used or unused medical devices to the
Page 4, Line 12pharmacist within the correctional facility or a prescription drug outlet in
Page 4, Line 13order for the
medicationPage 4, Line 14donated to
a nonprofitPage 4, Line 15(b)
Medications arePage 4, Line 16another person or donated to
a nonprofitmedications arePage 4, Line 17(II) Individually packaged and the packaging has not been damaged;
orPage 4, Line 18(III) In
the original,sealed, andunit dosePage 4, Line 19(IV) For medicine that requires refrigeration, freezing, or
Page 4, Line 20special storage, continually maintained by the donor pursuant
Page 5, Line 1to the manufacturer's storage requirements, so long as the cold chain can be verified.
Page 5, Line 2(c) The following
medications may not be donatedPage 5, Line 3(I)
MedicationsPage 5, Line 4
brown or amber pill bottlesPage 5, Line 5(III)
MedicationsPage 5, Line 6of this section, medicine that
requirePage 5, Line 7(IV)
Medications that require special registration with the manufacturer; orPage 5, Line 8(V)
MedicationsarePage 5, Line 9as determined by a person legally authorized to dispense the
medicationsPage 5, Line 10medicine on behalf of the nonprofit entity or a person legally authorized to dispense the medicine;
Page 5, Line 11(VI) Compounded medicine;
Page 5, Line 12(VII) Medicine dispensed by pharmacies outside of the United States; or
Page 5, Line 13(VIII) Medicine that is subject to risk evaluation and
Page 5, Line 14mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3)
Page 5, Line 15unless all of the required guidelines for the medicine are
Page 5, Line 16followed or REMS drugs that were initially dispensed by a pharmacy pursuant to a restricted REMS distribution channel.
Page 5, Line 17(3)
MedicationPage 5, Line 18section must not be expired. A
medication shall not be dispensedPage 5, Line 19prescribing practitioner shall not dispense medicine that will
Page 6, Line 1expire before the use by the patient based on the prescribing practitioner's directions for use.
Page 6, Line 2(4)
MedicationPage 6, Line 3donated pursuant to this section
mayfor profit. ThePage 6, Line 4
entity that receives the donated materials may charge the end user aPage 6, Line 5
handling fee, which fee shall not exceed the amount specified by rule ofPage 6, Line 6
the boardPage 6, Line 7dispensing, or usual and customary charges to an eligible
Page 6, Line 8patient, health plan, pharmacy benefit manager, pharmacy
Page 6, Line 9service, administrative organization, government agency, or
Page 6, Line 10other entity is not considered reselling. If the donation
Page 6, Line 11recipient is a for-profit entity, these charges must not exceed
Page 6, Line 12the donation recipient's cost of providing the medicine, including
Page 6, Line 13the current and anticipated costs of educating eligible donors
Page 6, Line 14and individual donors, providing technical support to
Page 6, Line 15participating donors and individual donors, shipping and
Page 6, Line 16handling, labor, storage, licensing, utilities, advertising,
Page 6, Line 17technology, supplies, and equipment. Except as described in this
Page 6, Line 18subsection (4), the amount of these charges is not subject to additional limitations.
Page 6, Line 19(5)
The board shall adopt rules that allow a pharmacist toPage 6, Line 20
redispense medication pursuant to this section and section 25.5-5-502 and to donate medication pursuant to this section.Page 6, Line 21(6) Nothing in this section or section 25.5-5-502 creates or
Page 6, Line 22abrogates any liability on behalf of a prescription drug manufacturer for
Page 6, Line 23the storage, donation, acceptance, or dispensing of
anPage 6, Line 24
medicationPage 7, Line 1prescription drug manufacturer in addition to that which is available under applicable law.
Page 7, Line 2SECTION 2. In Colorado Revised Statutes, add 12-280-135.5 as follows:
Page 7, Line 312-280-135.5. Colorado drug donation program - created -
Page 7, Line 4rules - records - definitions. (1) As used in this section, unless the context otherwise requires:
Page 7, Line 5(a) "Colorado drug donation program" or "program"
Page 7, Line 6means the Colorado drug donation program created in this section.
Page 7, Line 7(b) "Controlled substance" has the meaning set forth in section 18-18-102.
Page 7, Line 8(c) (I) "Donation recipient" means an entity that:
(A) Is legally authorized to possess medicine;
Page 7, Line 9(B) Has a license or registration in good standing in the state in which the entity is located; and
Page 7, Line 10(C) Receives a donation of medicine.
Page 7, Line 11(II) "Donation recipient" includes a hospital, a
Page 7, Line 12pharmacy, a clinic, a health-care provider, or a prescriber office.
Page 7, Line 13(III) "Donation recipient" also includes a wholesaler, a
Page 7, Line 14distributor, a third-party logistics provider, a reverse
Page 7, Line 15distributor, or a repackager if the entity is a nonprofit entity or
Page 7, Line 16is directly or indirectly owned, controlled, or could be controlled by a nonprofit entity.
Page 7, Line 17(d) (I) "Donor" means any entity legally authorized to
Page 7, Line 18possess medicine, including a wholesaler, a distributor, a
Page 8, Line 1third-party logistics provider, a pharmacy, a dispenser, a clinic,
Page 8, Line 2a surgical or health center, a rehabilitation center, a detention
Page 8, Line 3center, a jail, a prison, a laboratory, a prescriber or other
Page 8, Line 4health-care professional, a long-term care facility or
Page 8, Line 5health-care facility, and any other entity regulated by the board that donates medicine.
Page 8, Line 6(II) "Donor" includes government agencies and entities
Page 8, Line 7that are federally authorized to possess medicine, including
Page 8, Line 8manufacturers, repackagers, relabelers, outsourcing facilities,
Page 8, Line 9veterans affairs hospitals, FDA-authorized importers such as
Page 8, Line 10those described under the federal "Food, Drug, and Cosmetic
Page 8, Line 11Act", 21 U.S.C. secs. 801 and 804, as amended, or similar provisions, and federal prisons.
Page 8, Line 12(e) (I) "Eligible patient" means an individual with a need
Page 8, Line 13for donated medicine who is indigent, uninsured, or underinsured.
Page 8, Line 14(II) "Eligible patient" includes other individuals if a need
Page 8, Line 15for donated medicine is not identified among individuals who are indigent, uninsured, or underinsured.
Page 8, Line 16(f) "Health-care professional" means an individual who is
Page 8, Line 17licensed to practice as a physician, registered nurse, advanced
Page 8, Line 18practice registered nurse, practical nurse, optometrist, or
Page 8, Line 19pharmacist; a certified midwife with prescriptive authority
Page 8, Line 20pursuant to section 12-255-112; or any other practitioner authorized to dispense or administer medicine.
Page 8, Line 21(g) "Individual donor" means a nonlicensed individual
Page 8, Line 22member of the public.
(h) (I) "Medicine" means prescription drugs.
Page 9, Line 1(II) "Medicine" includes:
Page 9, Line 2(A) A prescription drug that requires refrigeration,
Page 9, Line 3freezing, or special storage if the medicine has been continually
Page 9, Line 4maintainedby the donor pursuant to the manufacturer's
Page 9, Line 5storage requirements, so long as the cold chain can be verified; and
Page 9, Line 6(B) Prescription supplies and devices.
(III) "Medicine" does not include:
Page 9, Line 7(A) Compounded drugs;
Page 9, Line 8(B) Prescription drugs dispensed by pharmacies outside of the United States;
Page 9, Line 9(C) Prescription drugs that are subject to risk evaluation
Page 9, Line 10and mitigation strategies (REMS) under 21 U.S.C. sec. 355-1 (f)(3)
Page 9, Line 11unless all of the required guidelines for the medicine are
Page 9, Line 12followed or REMS drugs that were initially dispensed by a
Page 9, Line 13pharmacy pursuant to a restricted REMS distribution channel; or
Page 9, Line 14(D) Controlled substances.
Page 9, Line 15(i) "Prescriber" has the meaning set forth in section 12-280-125.7 (1)(f).
Page 9, Line 16(j) "Returns processor" has the meaning set forth in 21 U.S.C. sec. 360eee (18) and includes a reverse distributor.
Page 9, Line 17(k) (I) "Unopened, tamper-evident packaging" means an
Page 9, Line 18intact packaging system that renders medicine inaccessible
Page 9, Line 19without obvious destruction of the seal or some portion of the
Page 9, Line 20packaging system.
Page 10, Line 1(II) "Unopened, tamper-evident packaging" may include
Page 10, Line 2unopened unit-dose, multiple-dose, immediate, secondary, or tertiary packaging.
Page 10, Line 3(2) There is created the Colorado drug donation program
Page 10, Line 4to facilitate the safe donation and redispensing of unused
Page 10, Line 5medicine to Coloradans in need of the medicine. Participation in the program is voluntary.
Page 10, Line 6(3) (a) Notwithstanding any other law or rule to the
Page 10, Line 7contrary, a donor or an individual donor may donate medicine
Page 10, Line 8to a donation recipient. A donation recipient may receive donated medicine from a donor or an individual donor.
Page 10, Line 9(b) Prior to the first donation from a person, a donation
Page 10, Line 10recipient shall record the person's name, address, phone number, and license number, if applicable, and shall:
Page 10, Line 11(I) Verify that the person meets the definition provided in subsection (1)(d) of this section;
Page 10, Line 12(II) Confirm that the person agrees to make donations of
Page 10, Line 13medicine only in accordance with this section and rules adopted by the board relating to donated medicine; and
Page 10, Line 14(III) If applicable, confirm that the person agrees to
Page 10, Line 15remove or redact any patient names and prescription numbers on
Page 10, Line 16donated medicine or to otherwise maintain patient
Page 10, Line 17confidentiality by executing a confidentiality agreement with the authorized donation recipient.
Page 10, Line 18(c) No other information or records are required prior to
Page 10, Line 19the first donation from a new donor or a new individual donor
Page 10, Line 20other than as described in subsection (3)(b) of this section.
Page 11, Line 1(4) A donation recipient shall maintain a written or an
Page 11, Line 2electronic record of donated medicine consisting of the name,
Page 11, Line 3strength, quantity, and lot number, if known, of each accepted
Page 11, Line 4or transferred drug and the name, address, and phone number of
Page 11, Line 5the donor, individual donor, or transferring entity. No other record of donation is required.
Page 11, Line 6(5) A donation recipient shall ensure that donated
Page 11, Line 7medicine is identified physically or electronically as separate from regular stock.
Page 11, Line 8(6) Notwithstanding any other law to the contrary, a donation recipient may:
Page 11, Line 9(a) Transfer donated medicine to another donation
Page 11, Line 10recipient or to an entity participating in a drug donation program operated by another state;
Page 11, Line 11(b) Repackage donated medicine in accordance with
Page 11, Line 12subsection (8) of this section as necessary for storage, dispensing, administration, or transfer; or
Page 11, Line 13(c) If the donation recipient is a prescription drug outlet
Page 11, Line 14or other outlet, replace medicine of the same drug name and
Page 11, Line 15strength previously dispensed or administered to eligible patients in accordance with 42 U.S.C. sec. 256b, as amended.
Page 11, Line 16(7) (a) Donated medicine that does not meet the
Page 11, Line 17requirements specified in this section and the rules adopted by the board must be disposed of by:
Page 11, Line 18(I) Returning the donated medicine to the donor;
Page 11, Line 19(II) Destroying the donated medicine through an
Page 11, Line 20incinerator, a medical waste hauler, a reverse distributor, or other lawful method; or
Page 12, Line 1(III) Transferring the donated medicine to a returns processor.
Page 12, Line 2(b) A donation recipient shall maintain a written or an
Page 12, Line 3electronic record of disposed medicine consisting of the disposal
Page 12, Line 4method, as described in subsection (7)(a) of this section; the date
Page 12, Line 5of disposal; and the name, strength, and quantity of each disposed drug. No other record of disposal is required.
Page 12, Line 6(8) Repackaged medicine must be labeled with the drug
Page 12, Line 7name, strength, and expiration date, if the expiration date is
Page 12, Line 8known, and identified separately from regular stock until
Page 12, Line 9inspected and initialed by a licensed pharmacist. If multiple
Page 12, Line 10packaged, donated medicines with varied expiration dates are
Page 12, Line 11repackaged together, the earliest expiration date must be used.
Page 12, Line 12Prescription drugs specified by NDC number in a recall notice
Page 12, Line 13must be considered recalled unless the prescription drug has an affixed lot number that excludes it from the recall.
Page 12, Line 14(9) A donation recipient shall only administer or redispense medicine that:
Page 12, Line 15(a) Is in unopened, tamper-evident packaging or has been repackaged under this program;
Page 12, Line 16(b) Meets the requirements set forth in this section based on an inspection by a licensed pharmacist;
Page 12, Line 17(c) If dispensed to an eligible patient, is repackaged by a
Page 12, Line 18licensed pharmacist into a new container or, if kept in the
Page 12, Line 19donated container, is in a container that has all previous
Page 12, Line 20patient information redacted or removed;
Page 13, Line 1(d) Is properly labeled in accordance with the rules adopted by the board;
Page 13, Line 2(e) Has an expiration or beyond-use date that will not
Page 13, Line 3expire before the medicine is used by the eligible patient based on the prescriber's directions for use; and
Page 13, Line 4(f) If the medicine requires refrigeration, freezing, or
Page 13, Line 5special storage, has been continually maintained pursuant to
Page 13, Line 6the manufacturer's storage requirements, so long as the cold chain can be verified.
Page 13, Line 7(10) A donation recipient:
Page 13, Line 8(a) May dispense or administer prescription drugs to an
Page 13, Line 9eligible patient pursuant to this section only if otherwise
Page 13, Line 10permitted by law pursuant to a valid prescription or prescription drug order; and
Page 13, Line 11(b) Shall maintain eligible patient-specific written or
Page 13, Line 12electronic records in accordance with rules adopted by the board.
Page 13, Line 13(11) A manufacturer, prescription drug outlet,
Page 13, Line 14repackager, dispenser, or wholesaler, other than a returns
Page 13, Line 15processor, participating in the program shall comply with the
Page 13, Line 16requirements of 21 U.S.C. secs. 360eee-1 to 360eee-4 relating to drug supply chain security.
Page 13, Line 17(12) The donation, transfer, or receipt of medicine or the
Page 13, Line 18facilitation of a donation, transfer, or receipt of medicine
Page 13, Line 19pursuant to this section is not wholesale distribution and does not require licensing as a wholesale distributor.
Page 13, Line 20(13) Medicine donated to the program must not be resold
Page 14, Line 1and is considered nonsaleable; except that handling, dispensing,
Page 14, Line 2or usual and customary charges to an eligible patient, health
Page 14, Line 3plan, pharmacy benefit manager, pharmacy services
Page 14, Line 4administrative organization, government agency, or other
Page 14, Line 5entity is not considered reselling. If the donation recipient is a
Page 14, Line 6for-profit entity, these charges must not exceed the donation
Page 14, Line 7recipient's cost of providing the medicine, including the current
Page 14, Line 8and anticipated costs of educating eligible donors and
Page 14, Line 9individual donors, providing technical support to participating
Page 14, Line 10donors and individual donors, shipping and handling, labor,
Page 14, Line 11storage, licensing, utilities, advertising, technology, supplies,
Page 14, Line 12and equipment. Except as described in this subsection (13), the
Page 14, Line 13amount of these charges is not subject to any additional limitations.
Page 14, Line 14(14) When performing any action associated with the
Page 14, Line 15program or otherwise processing donated medicine for tax, a
Page 14, Line 16manufacturer credit, or other credit, a donation recipient is
Page 14, Line 17considered to be acting as a returns processor and shall comply
Page 14, Line 18with all record-keeping requirements under federal law for nonsaleable returns.
Page 14, Line 19(15) All required records must be retained in physical or
Page 14, Line 20electronic format, on or off the donation recipient's premises,
Page 14, Line 21for a period of two years. Donors or donation recipients may
Page 14, Line 22contract with one another or with a third party to create or
Page 14, Line 23maintain records. An identifier, such as a serial number or bar
Page 14, Line 24code, may be used in place of information if it allows for the
Page 14, Line 25information to be readily retrievable. Upon request by a state
Page 15, Line 1or federal regulator, the identifier used for a requested record
Page 15, Line 2must be replaced with the original information. An identifier
Page 15, Line 3must not be used on labels when dispensing or administering a drug to an eligible patient.
Page 15, Line 4(16) A donation or other transfer of possession or
Page 15, Line 5control is not a change of ownership unless it is specified as such
Page 15, Line 6by the donation recipient. If a record of the donation's
Page 15, Line 7transaction information or history is required, the history must
Page 15, Line 8begin with the donor or individual donor, must include all prior
Page 15, Line 9donations, and, if the medicine was previously dispensed, must
Page 15, Line 10include only drug information that is required to be on the patient label in accordance with rules adopted by the board.
Page 15, Line 11(17) An entity participating in a drug donation or
Page 15, Line 12repository program operated by another state may participate
Page 15, Line 13in the program and, if the registered entity is a prescription drug
Page 15, Line 14outlet, may dispense donated drugs to eligible patients of this
Page 15, Line 15state. The registered entity is required to comply with all
Page 15, Line 16statutes and rules in this state unless the statutes or rules
Page 15, Line 17differ from or conflict with the statutes or rules of the state in which the entity is located.
Page 15, Line 18(18) The board shall adopt any rules necessary to
Page 15, Line 19implement this section. The rules must require the least amount
Page 15, Line 20of record keeping necessary to ensure patient safety and must allow flexibility in the format for record keeping.
Page 15, Line 21(19) Notwithstanding any law to the contrary, this
Page 15, Line 22section controls all activities under the program and
Page 15, Line 23supersedes any inconsistent law or rule.
Page 16, Line 1(20) When acting in good faith, without negligence or
Page 16, Line 2willful or wanton misconduct, the following individuals or
Page 16, Line 3entities are not subject to civil or criminal liability or professional disciplinary action:
Page 16, Line 4(a) An individual or entity involved in the supply chain of
Page 16, Line 5donated medicine, including the donor, the individual donor, the
Page 16, Line 6donation recipient, the manufacturer, the repackager, the
Page 16, Line 7prescription drug outlet or other entity regulated by the board, and the eligible patient;
Page 16, Line 8(b) An individual or entity, including an employee, an
Page 16, Line 9officer, a volunteer, an owner, a partner, a member, a director,
Page 16, Line 10a contractor, or other individual or entity associated with the
Page 16, Line 11individual or entity that, in compliance with this section,
Page 16, Line 12prescribes, donates, receives donations of, dispenses,
Page 16, Line 13administers, transfers, replaces, or repackages medicine or facilitates any of the actions described in this section; and
Page 16, Line 14(c) The board.
Page 16, Line 15(21) A donation recipient operating primarily for the
Page 16, Line 16purpose of participating in this program shall not be required to possess a comprehensive or minimum supply of medicine.
Page 16, Line 17SECTION 3. In Colorado Revised Statutes, 25-15-328, amend (6)(a) as follows:
Page 16, Line 1825-15-328. Household medication take-back program -
Page 16, Line 19creation - collection and disposal of medication injection devices - liability - definitions - cash fund - rules. (6) Nothing in this section:
Page 16, Line 20(a) Affects the authority to collect and reuse
medicationsPage 16, Line 21medicine pursuant to section 12-280-135 or 12-280-135.5; or
Page 17, Line 1SECTION 4. In Colorado Revised Statutes, add 12-315-127 as follows:
Page 17, Line 212-315-127. Veterinary drug donation program - rules. (1) An
Page 17, Line 3owner of an animal may donate a drug that is dispensed for but
Page 17, Line 4not used by the animal to a licensed veterinarian or animal
Page 17, Line 5shelter in which veterinary medicine is practiced if the licensed veterinarian or animal shelter accepts the drug.
Page 17, Line 6(2) Except as provided in subsection (4)(b) of this section,
Page 17, Line 7a licensed veterinarian may reissue a donated drug accepted
Page 17, Line 8pursuant to this section to fill other prescriptions dispensed by the licensed veterinarian free of charge for an animal if:
Page 17, Line 9(a) The licensed veterinarian determines that the owner
Page 17, Line 10of the animal is eligible for the reissuance of the drug based on economic need;
Page 17, Line 11(b) The licensed veterinarian determines that the drug is suitable for reissuance;
Page 17, Line 12(c) The drug was originally dispensed by a licensed veterinarian;
Page 17, Line 13(d) The drug is not a controlled substance;
(e) The drug is not a compounded drug;
Page 17, Line 14(f) The drug does not require refrigeration before opening and the drug was unopened when donated;
Page 17, Line 15(g) The drug is not in a liquid form or, if in liquid form, the drug is packaged in a single dose in an ampule or vial;
Page 17, Line 16(h) The drug has not expired;
Page 17, Line 17(i) The packaging or bottle contains the expiration date
Page 17, Line 18of the drug; and
Page 18, Line 1(j) The name of the animal and the name of the owner of
Page 18, Line 2the animal for which the drug was originally dispensed, the
Page 18, Line 3prescription number, and any other identifying marks are
Page 18, Line 4obliterated from the packaging or bottle before the drug is reissued.
Page 18, Line 5(3) A licensed veterinarian shall:
Page 18, Line 6(a) Identify and maintain separately from other stock a donated drug accepted pursuant to this section; and
Page 18, Line 7(b) Make a record of each donated drug accepted pursuant to this section that includes, at a minimum:
Page 18, Line 8(A) The date on which the drug was donated;
(B) The name of the person who donated the drug; and
Page 18, Line 9(C) The expiration date of the drug.
(4) A licensed veterinarian shall not:
Page 18, Line 10(a) Sell or resell a donated drug accepted pursuant to this section; or
Page 18, Line 11(b) Dispense a donated drug accepted pursuant to this
Page 18, Line 12section to fill other prescriptions dispensed by the licensed
Page 18, Line 13veterinarian for an animal if the animal is raised to produce
Page 18, Line 14food for human consumption or the animal is ordinarily
Page 18, Line 15consumed by animals that are raised to produce food for human consumption.
Page 18, Line 16(5) (a) A licensed veterinarian, animal shelter in which
Page 18, Line 17veterinary medicine is practiced, or other person who exercises
Page 18, Line 18reasonable care in the donation, acceptance, distribution, or
Page 18, Line 19dispensation of a drug in accordance with this section and any
Page 18, Line 20rules adopted pursuant to this section is not subject to civil or
Page 19, Line 1criminal liability or disciplinary action by a professional
Page 19, Line 2licensing board for any loss, injury, or death that results from
Page 19, Line 3the donation, acceptance, distribution, or dispensation of the drug.
Page 19, Line 4(b) A manufacturer of a drug is not subject to civil or
Page 19, Line 5criminal liability for any claim or injury arising from the
Page 19, Line 6donation, acceptance, distribution, or dispensation of the drug
Page 19, Line 7pursuant to this section and any rules adopted pursuant to this section.
Page 19, Line 8(6) The board may adopt rules as necessary to implement this section, including:
Page 19, Line 9(a) Requirements for reissuing donated drugs pursuant to
Page 19, Line 10this section, including requirements that provide appropriate
Page 19, Line 11safeguards for ensuring that the drugs are not compromised or illegally diverted before being reissued;
Page 19, Line 12(b) Requirements for accepting drugs donated by a licensed veterinarian or animal shelter; and
Page 19, Line 13(c) Requirements for maintaining records relating to the
Page 19, Line 14acceptance and use of donated drugs to fill other prescriptions pursuant to this section.
Page 19, Line 15SECTION 5. Act subject to petition - effective date. This act
Page 19, Line 16takes effect at 12:01 a.m. on the day following the expiration of the
Page 19, Line 17ninety-day period after final adjournment of the general assembly; except
Page 19, Line 18that, if a referendum petition is filed pursuant to section 1 (3) of article V
Page 19, Line 19of the state constitution against this act or an item, section, or part of this
Page 19, Line 20act within such period, then the act, item, section, or part will not take
Page 19, Line 21effect unless approved by the people at the general election to be held in
Page 20, Line 1November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.