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
substancePage 3, Line 1(II) "Medicine" includes:
Page 3, Line 2(A) A prescription drug that requires refrigeration,
Page 3, Line 3freezing, or special storage if the prescription drug has been
Page 3, Line 4continually maintained pursuant to the manufacturer's storage requirements; 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 under 21 U.S.C. sec. 355-1 (f)(3) unless all of the required guidelines for the medicine are followed; or
Page 3, Line 10(D) Controlled substances.
Page 3, Line 11(2) (a) (I) If donated by the patient, the resident, or the patient's or
Page 3, Line 12resident's next of kin, a licensed facility may return unused
medicationsPage 3, Line 13medicine or medical supplies and used or unused medical devices to a
Page 3, Line 14pharmacist within the licensed facility or a prescription drug outlet in
Page 3, Line 15order for the materials to be redispensed to another patient or donated to
Page 3, Line 16a 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 17(II) (A) A licensed facility or a prescription drug outlet may
Page 3, Line 18donate materials to a nonprofit entity that has legal authority to possess
Page 3, Line 19the materials or to a person legally authorized to dispense the materials.
Page 3, Line 20A licensed pharmacist shall review the process of donating the unused
Page 3, Line 21
medicationsPage 4, Line 1(B) Nothing in this subsection (2)(a)(II) creates or abrogates any
Page 4, Line 2liability on behalf of a prescription drug manufacturer for the storage,
Page 4, Line 3donation, acceptance, or dispensing of
a medicationPage 4, Line 4product 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 5(C) A person
or entityPage 4, Line 6or professional disciplinary action for donating, accepting, dispensing, or
Page 4, Line 7facilitating the donation of materials in good faith, without negligence or willful or wanton misconduct, and in compliance with this section.
Page 4, Line 8(III) A correctional facility may return unused
medicationsPage 4, Line 9medicine or medical supplies and used or unused medical devices to the
Page 4, Line 10pharmacist within the correctional facility or a prescription drug outlet in
Page 4, Line 11order for the
medicationPage 4, Line 12donated to a nonprofit entity that has the legal authority to possess the materials or to a practitioner authorized by law to prescribe the materials.
Page 4, Line 13(b)
Medications arePage 4, Line 14another person or donated to a nonprofit entity under this section if the
medications arePage 4, Line 15(II) Individually packaged and the packaging has not been damaged;
orPage 4, Line 16(III) In
the original,sealed, andunit dosePage 4, Line 17(IV) For medicine that requires refrigeration, freezing, or
Page 4, Line 18special storage, continually maintained pursuant to the manufacturer's storage requirements.
Page 4, Line 19(c) The following
medications may not be donatedPage 4, Line 20not acceptable for donation:
Page 5, Line 1(I)
MedicationsPage 5, Line 2
brown or amber pill bottlesPage 5, Line 3(III)
MedicationsPage 5, Line 4of this section, medicine that
requirePage 5, Line 5(IV)
Medications that require special registration with the manufacturer; orPage 5, Line 6(V)
MedicationsarePage 5, Line 7as determined by a person legally authorized to dispense the
medicationsPage 5, Line 8medicine on behalf of the nonprofit entity or a person legally authorized to dispense the medicine;
Page 5, Line 9(VI) Compounded medicine;
Page 5, Line 10(VII) Medicine dispensed by pharmacies outside of the United States; or
Page 5, Line 11(VIII) Medicine that is subject to risk evaluation and
Page 5, Line 12mitigation under 21 U.S.C. sec. 355-1 (f)(3) unless all of the required guidelines for the medicine are followed.
Page 5, Line 13(3)
MedicationPage 5, Line 14section must not be expired. A
medication shall not be dispensedPage 5, Line 15prescribing practitioner shall not dispense medicine that will
Page 5, Line 16expire before the use by the patient based on the prescribing practitioner's directions for use.
Page 5, Line 17(4)
MedicationPage 5, Line 18donated pursuant to this section may not be resold for profit. The entity
Page 5, Line 19that receives the donated materials may charge the end user a handling
Page 5, Line 20fee, which fee
shallPage 6, Line 1(5)
The board shall adopt rules that allow a pharmacist toPage 6, Line 2
redispense medication pursuant to this section and section 25.5-5-502 and to donate medication pursuant to this section.Page 6, Line 3(6) Nothing in this section or section 25.5-5-502 creates or
Page 6, Line 4abrogates any liability on behalf of a prescription drug manufacturer for
Page 6, Line 5the storage, donation, acceptance, or dispensing of
anPage 6, Line 6
medicationPage 6, Line 7prescription drug manufacturer in addition to that which is available under applicable law.
Page 6, Line 8SECTION 2. In Colorado Revised Statutes, add 12-280-135.5 as follows:
Page 6, Line 912-280-135.5. Colorado drug donation program - created -
Page 6, Line 10rules - records - definitions. (1) As used in this section, unless the context otherwise requires:
Page 6, Line 11(a) "Colorado drug donation program" or "program"
Page 6, Line 12means the Colorado drug donation program created in this section.
Page 6, Line 13(b) "Controlled substance" has the meaning set forth in section 18-18-102.
Page 6, Line 14(c) (I) "Donation recipient" means an entity that:
(A) Is legally authorized to possess medicine;
Page 6, Line 15(B) Has a license or registration in good standing in the state in which the entity is located; and
Page 6, Line 16(C) Receives a donation of medicine.
Page 6, Line 17(II) "Donation recipient" includes a wholesaler, a
Page 6, Line 18distributor, a third-party logistics provider, a reverse
Page 7, Line 1distributor, a repackager, a hospital, a pharmacy, a clinic, a health-care provider, or a prescriber office.
Page 7, Line 2(d) (I) "Donor" means any person legally authorized to
Page 7, Line 3possess medicine, including an individual member of the public, a
Page 7, Line 4wholesaler, a distributor, a third-party logistics provider, a
Page 7, Line 5pharmacy, a dispenser, a clinic, a surgical or health center, a
Page 7, Line 6rehabilitation center, a detention center, a jail, a prison, a
Page 7, Line 7laboratory, a prescriber or other health-care professional, or
Page 7, Line 8a long-term care facility or health-care facility, which person donates medicine.
Page 7, Line 9(II) "Donor" includes government agencies and entities
Page 7, Line 10that are federally authorized to possess medicine, including
Page 7, Line 11manufacturers, repackagers, relabelers, outsourcing facilities,
Page 7, Line 12veterans affairs hospitals, FDA-authorized importers such as
Page 7, Line 13those described under the federal "Food, Drug, and Cosmetic
Page 7, Line 14Act", 21 U.S.C. secs. 801 and 804, as amended, or similar provisions, and federal prisons.
Page 7, Line 15(e) (I) "Eligible patient" means an individual with a need
Page 7, Line 16for donated medicine who is indigent, uninsured, underinsured, or enrolled in a public health benefits program.
Page 7, Line 17(II) "Eligible patient" includes other individuals if a need
Page 7, Line 18for donated medicine is not identified among individuals who are
Page 7, Line 19indigent, uninsured, underinsured, or enrolled in a public health benefits program.
Page 7, Line 20(f) "Health-care professional" means an individual who is
Page 7, Line 21licensed to practice as a physician, registered nurse, advanced
Page 7, Line 22practice registered nurse, practical nurse, optometrist, or
Page 8, Line 1pharmacist; a certified midwife with prescriptive authority
Page 8, Line 2pursuant to section 12-255-112; or any other practitioner authorized to dispense or administer medicine.
Page 8, Line 3(g) (I) "Medicine" means prescription drugs, including FDA-approved drugs labeled for investigational use.
Page 8, Line 4(II) "Medicine" includes:
Page 8, Line 5(A) A prescription drug that requires refrigeration,
Page 8, Line 6freezing, or special storage if the medicine has been continually
Page 8, Line 7maintained pursuant to the manufacturer's storage requirements; and
Page 8, Line 8(B) Prescription supplies and devices.
(III) "Medicine" does not include:
Page 8, Line 9(A) Compounded drugs;
Page 8, Line 10(B) Prescription drugs dispensed by pharmacies outside of the United States;
Page 8, Line 11(C) Prescription drugs that are subject to risk evaluation
Page 8, Line 12and mitigation under 21 U.S.C. sec. 355-1 (f)(3) unless all of the required guidelines for the medicine are followed; or
Page 8, Line 13(D) Controlled substances.
Page 8, Line 14(h) "Prescriber" has the meaning set forth in section 12-280-125.7 (1)(f).
Page 8, Line 15(i) "Returns processor" has the meaning set forth in 21 U.S.C. sec. 360eee (18) and includes a reverse distributor.
Page 8, Line 16(j) (I) "Unopened, tamper-evident packaging" means an
Page 8, Line 17intact packaging system that renders medicine inaccessible
Page 8, Line 18without obvious destruction of the seal or some portion of the
Page 8, Line 19packaging system.
Page 9, Line 1(II) "Unopened, tamper-evident packaging" may include
Page 9, Line 2unopened unit-dose, multiple-dose, immediate, secondary, or tertiary packaging.
Page 9, Line 3(2) There is created the Colorado drug donation program
Page 9, Line 4to facilitate the safe donation and redispensing of unused
Page 9, Line 5medicine to Coloradans in need of the medicine. Participation in the program is voluntary.
Page 9, Line 6(3) (a) Notwithstanding any other law or rule to the
Page 9, Line 7contrary, a donor may donate medicine to a donation recipient. A donation recipient may receive donated medicine from donors.
Page 9, Line 8(b) Prior to the first donation from a person, a donation
Page 9, Line 9recipient shall record the person's name, address, phone number, and license number, if applicable, and shall:
Page 9, Line 10(I) Verify that the person meets the definition provided in subsection (1)(d) of this section;
Page 9, Line 11(II) Confirm that the person agrees to make donations of
Page 9, Line 12medicine only in accordance with this section and rules adopted by the board relating to donated medicine; and
Page 9, Line 13(III) If applicable, confirm that the person agrees to
Page 9, Line 14remove or redact any patient names and prescription numbers on
Page 9, Line 15donated medicine or to otherwise maintain patient
Page 9, Line 16confidentiality by executing a confidentiality agreement with the authorized donation recipient.
Page 9, Line 17(c) No other information or records are required prior to
Page 9, Line 18the first donation from a new donor other than as described in subsection (3)(b) of this section.
Page 9, Line 19(4) A donation recipient shall maintain a written or an
Page 10, Line 1electronic record of donated medicine consisting of the name,
Page 10, Line 2strength, quantity, and lot number, if known, of each accepted
Page 10, Line 3or transferred drug and the name, address, and phone number of
Page 10, Line 4the donor or transferring entity. No other record of donation is required.
Page 10, Line 5(5) A donation recipient shall ensure that donated
Page 10, Line 6medicine is identified physically or electronically as separate from regular stock.
Page 10, Line 7(6) Notwithstanding any other law to the contrary, a donation recipient may:
Page 10, Line 8(a) Transfer donated medicine to another donation
Page 10, Line 9recipient or to an entity participating in a drug donation program operated by another state;
Page 10, Line 10(b) Repackage donated medicine in accordance with
Page 10, Line 11subsection (8) of this section as necessary for storage, dispensing, administration, or transfer; or
Page 10, Line 12(c) If the donation recipient is a prescription drug outlet
Page 10, Line 13or other outlet, replenish medicine of the same drug name and
Page 10, Line 14strength previously dispensed or administered to eligible
Page 10, Line 15patients in accordance with the federal 340B drug pricing program codified at 42 U.S.C. sec. 256b, as amended.
Page 10, Line 16(7) (a) Donated medicine that does not meet the
Page 10, Line 17requirements specified in this section and the rules adopted by the board must be disposed of by:
Page 10, Line 18(I) Returning the donated medicine to the donor;
Page 10, Line 19(II) Destroying the donated medicine through an
Page 10, Line 20incinerator, a medical waste hauler, a reverse distributor, or other lawful method; or
Page 11, Line 1(III) Transferring the donated medicine to a returns processor.
Page 11, Line 2(b) A donation recipient shall maintain a written or an
Page 11, Line 3electronic record of disposed medicine consisting of the disposal
Page 11, Line 4method, as described in subsection (7)(a) of this section; the date
Page 11, Line 5of disposal; and the name, strength, and quantity of each disposed drug. No other record of disposal is required.
Page 11, Line 6(8) Repackaged medicine must be labeled with the drug
Page 11, Line 7name, strength, and expiration date, if the expiration date is
Page 11, Line 8known, and identified separately from regular stock until
Page 11, Line 9inspected and initialed by a licensed pharmacist. If multiple
Page 11, Line 10packaged, donated medicines with varied expiration dates are repackaged together, the earliest expiration date must be used.
Page 11, Line 11(9) A donation recipient shall only administer or redispense medicine that:
Page 11, Line 12(a) Is in unopened, tamper-evident packaging or has been repackaged under this program;
Page 11, Line 13(b) Meets the requirements set forth in this section based on an inspection by a licensed pharmacist;
Page 11, Line 14(c) If dispensed to an eligible patient, is repackaged by a
Page 11, Line 15licensed pharmacist into a new container or, if kept in the
Page 11, Line 16donated container, is in a container that has all previous patient information redacted or removed;
Page 11, Line 17(d) Is properly labeled in accordance with the rules adopted by the board;
Page 11, Line 18(e) Has an expiration or beyond-use date that will not
Page 12, Line 1expire before the medicine is used by the eligible patient based on the prescriber's directions for use; and
Page 12, Line 2(f) If the medicine requires refrigeration, freezing, or
Page 12, Line 3special storage, has been continually maintained pursuant to the manufacturer's storage requirements.
Page 12, Line 4(10) A donation recipient:
Page 12, Line 5(a) May dispense or administer prescription drugs to an
Page 12, Line 6eligible patient pursuant to this section only if otherwise
Page 12, Line 7permitted by law pursuant to a valid prescription or prescription drug order; and
Page 12, Line 8(b) Shall maintain eligible patient-specific written or
Page 12, Line 9electronic records in accordance with rules adopted by the board.
Page 12, Line 10(11) A manufacturer, repackager, dispenser, or
Page 12, Line 11wholesaler, other than a returns processor, participating in the
Page 12, Line 12program shall comply with the requirements of 21 U.S.C. secs.360eee-1 to 360eee-4 relating to drug supply chain security.
Page 12, Line 13(12) The donation, transfer, or receipt of medicine or the
Page 12, Line 14facilitation of a donation, transfer, or receipt of medicine
Page 12, Line 15pursuant to this section is not wholesale distribution and does not require licensing as a wholesale distributor.
Page 12, Line 16(13) Medicine donated to the program must not be resold
Page 12, Line 17and is considered nonsaleable; except that handling, dispensing,
Page 12, Line 18or usual and customary charges to an eligible patient, health
Page 12, Line 19plan, pharmacy benefit manager, pharmacy services
Page 12, Line 20administrative organization, government agency, or other
Page 12, Line 21entity is not considered reselling. If the donation recipient is a
Page 13, Line 1for-profit entity, these charges must not exceed the donation
Page 13, Line 2recipient's cost of providing the medicine, including the current
Page 13, Line 3and anticipated costs of educating eligible donors, providing
Page 13, Line 4technical support to participating donors, shipping and handling,
Page 13, Line 5labor, storage, licensing, utilities, advertising, technology,
Page 13, Line 6supplies, and equipment. Except as described in this subsection
Page 13, Line 7(13), the amount of these charges is not subject to any additional limitations.
Page 13, Line 8(14) When performing any action associated with the
Page 13, Line 9program or otherwise processing donated medicine for tax, a
Page 13, Line 10manufacturer credit, or other credit, a donation recipient is
Page 13, Line 11considered to be acting as a returns processor and shall comply
Page 13, Line 12with all record-keeping requirements under federal law for nonsaleable returns.
Page 13, Line 13(15) All required records must be retained in physical or
Page 13, Line 14electronic format, on or off the donation recipient's premises,
Page 13, Line 15for a period of two years. Donors or donation recipients may
Page 13, Line 16contract with one another or with a third party to create or
Page 13, Line 17maintain records. An identifier, such as a serial number or bar
Page 13, Line 18code, may be used in place of information if it allows for the
Page 13, Line 19information to be readily retrievable. Upon request by a state
Page 13, Line 20or federal regulator, the identifier used for a requested record
Page 13, Line 21must be replaced with the original information. An identifier
Page 13, Line 22must not be used on labels when dispensing or administering a drug to an eligible patient.
Page 13, Line 23(16) A donation or other transfer of possession or
Page 13, Line 24control is not a change of ownership unless it is specified as such
Page 14, Line 1by the donation recipient. If a record of the donation's
Page 14, Line 2transaction information or history is required, the history must
Page 14, Line 3begin with the donor, must include all prior donations, and, if
Page 14, Line 4the medicine was previously dispensed, must include only drug
Page 14, Line 5information that is required to be on the patient label in accordance with rules adopted by the board.
Page 14, Line 6(17) An entity participating in a drug donation or
Page 14, Line 7repository program operated by another state may participate
Page 14, Line 8in the program and, if the registered entity is a prescription drug
Page 14, Line 9outlet, may dispense donated drugs to eligible patients of this
Page 14, Line 10state. The registered entity is required to comply with all
Page 14, Line 11statutes and rules in this state unless the statutes or rules
Page 14, Line 12differ from or conflict with the statutes or rules of the state in which the entity is located.
Page 14, Line 13(18) The board shall adopt any rules necessary to
Page 14, Line 14implement this section. The rules must require the least amount
Page 14, Line 15of record keeping necessary to ensure patient safety and must allow flexibility in the format for record keeping.
Page 14, Line 16(19) This section controls the requirements for the
Page 14, Line 17donation and distribution of medicine under the program and supersedes any inconsistent law.
Page 14, Line 18(20) When acting in good faith, without negligence or
Page 14, Line 19willful or wanton misconduct, the following individuals or
Page 14, Line 20entities are not subject to civil or criminal liability or professional disciplinary action:
Page 14, Line 21(a) An individual or entity involved in the supply chain of
Page 14, Line 22donated medicine, including the donor, the donation recipient,
Page 15, Line 1the manufacturer, the repackager, the prescription drug outlet or other entity regulated by the board, and the eligible patient;
Page 15, Line 2(b) An individual or entity, including an employee, an
Page 15, Line 3officer, a volunteer, an owner, a partner, a member, a director,
Page 15, Line 4a contractor, or other individual or entity associated with the
Page 15, Line 5individual or entity that, in compliance with this section,
Page 15, Line 6prescribes, donates, receives donations of, dispenses,
Page 15, Line 7administers, transfers, replenishes, or repackages medicine or facilitates any of the actions described in this section; and
Page 15, Line 8(c) The board.
Page 15, Line 9(21) A donation recipient operating primarily for the
Page 15, Line 10purpose of participating in this program shall not be required to possess a comprehensive or minimum supply of medicine.
Page 15, Line 11SECTION 3. In Colorado Revised Statutes, 25-15-328, amend (6)(a) as follows:
Page 15, Line 1225-15-328. Household medication take-back program -
Page 15, Line 13creation - collection and disposal of medication injection devices - liability - definitions - cash fund - rules. (6) Nothing in this section:
Page 15, Line 14(a) Affects the authority to collect and reuse
medicationsPage 15, Line 15SECTION 4. Act subject to petition - effective date. This act
Page 15, Line 16takes effect at 12:01 a.m. on the day following the expiration of the
Page 15, Line 17ninety-day period after final adjournment of the general assembly; except
Page 15, Line 18that, if a referendum petition is filed pursuant to section 1 (3) of article V
Page 15, Line 19of the state constitution against this act or an item, section, or part of this
Page 15, Line 20act within such period, then the act, item, section, or part will not take
Page 15, Line 21effect unless approved by the people at the general election to be held in
Page 16, Line 1November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.