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.
This Unofficial Version Includes Committee
Amendments Not Yet Adopted on Second Reading
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 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 nonprofitPage 3, Line 19possess the materials or to a person legally authorized to dispense the
Page 3, Line 20materials. A licensed pharmacist shall review the process of donating the
Page 3, Line 21unused
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 entity is not subject to civil or criminal liability
Page 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
Page 4, Line 19manufacturer's storage requirements, so long as the cold chain can be verified.
Page 4, Line 20(c) The following
medications may not be donatedPage 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
mayfor profit. ThePage 5, Line 19
entity that receives the donated materials may charge the end user aPage 6, Line 1
handling fee, which fee shall not exceed the amount specified by rule ofPage 6, Line 2
the boardPage 6, Line 3dispensing, or usual and customary charges to an eligible
Page 6, Line 4patient, health plan, pharmacy benefit manager, pharmacy
Page 6, Line 5service, administrative organization, government agency, or
Page 6, Line 6other entity is not considered reselling. If the donation
Page 6, Line 7recipient is a for-profit entity, these charges must not exceed
Page 6, Line 8the donation recipient's cost of providing the medicine, including
Page 6, Line 9the current and anticipated costs of educating eligible donors
Page 6, Line 10and individual donors, providing technical support to
Page 6, Line 11participating donors and individual donors, shipping and
Page 6, Line 12handling, labor, storage, licensing, utilities, advertising,
Page 6, Line 13technology, supplies, and equipment. Except as described in this
Page 6, Line 14subsection (4), the amount of these charges is not subject to additional limitations.
Page 6, Line 15(5)
The board shall adopt rules that allow a pharmacist toPage 6, Line 16
redispense medication pursuant to this section and section 25.5-5-502 and to donate medication pursuant to this section.Page 6, Line 17(6) Nothing in this section or section 25.5-5-502 creates or
Page 6, Line 18abrogates any liability on behalf of a prescription drug manufacturer for
Page 6, Line 19the storage, donation, acceptance, or dispensing of
anPage 6, Line 20
medicationPage 6, Line 21prescription drug manufacturer in addition to that which is available under applicable law.
Page 6, Line 22SECTION 2. In Colorado Revised Statutes, add 12-280-135.5 as follows:
Page 6, Line 2312-280-135.5. Colorado drug donation program - created -
Page 7, Line 1rules - records - definitions. (1) As used in this section, unless the context otherwise requires:
Page 7, Line 2(a) "Colorado drug donation program" or "program"
Page 7, Line 3means the Colorado drug donation program created in this section.
Page 7, Line 4(b) "Controlled substance" has the meaning set forth in section 18-18-102.
Page 7, Line 5(c) (I) "Donation recipient" means an entity that:
(A) Is legally authorized to possess medicine;
Page 7, Line 6(B) Has a license or registration in good standing in the state in which the entity is located; and
Page 7, Line 7(C) Receives a donation of medicine.
Page 7, Line 8(II) "Donation recipient" includes a wholesaler, a
Page 7, Line 9distributor, a third-party logistics provider, a reverse
Page 7, Line 10distributor, a repackager, a hospital, a pharmacy, a clinic, a health-care provider, or a prescriber office.
Page 7, Line 11(d) (I) "Donor" means any entity legally authorized to
Page 7, Line 12possess medicine, including a wholesaler, a distributor, a
Page 7, Line 13third-party logistics provider, a pharmacy, a dispenser, a clinic,
Page 7, Line 14a surgical or health center, a rehabilitation center, a detention
Page 7, Line 15center, a jail, a prison, a laboratory, a prescriber or other
Page 7, Line 16health-care professional, a long-term care facility or
Page 7, Line 17health-care facility, and any other entity regulated by the board which donates medicine.
Page 7, Line 18(II) "Donor" includes government agencies and entities
Page 7, Line 19that are federally authorized to possess medicine, including
Page 7, Line 20manufacturers, repackagers, relabelers, outsourcing facilities,
Page 8, Line 1veterans affairs hospitals, FDA-authorized importers such as
Page 8, Line 2those described under the federal "Food, Drug, and Cosmetic
Page 8, Line 3Act", 21 U.S.C. secs. 801 and 804, as amended, or similar provisions, and federal prisons.
Page 8, Line 4(e) (I) "Eligible patient" means an individual with a need
Page 8, Line 5for donated medicine who is indigent, uninsured, or underinsured.
Page 8, Line 6(II) "Eligible patient" includes other individuals if a need
Page 8, Line 7for donated medicine is not identified among individuals who are indigent, uninsured, or underinsured.
Page 8, Line 8(f) "Health-care professional" means an individual who is
Page 8, Line 9licensed to practice as a physician, registered nurse, advanced
Page 8, Line 10practice registered nurse, practical nurse, optometrist, or
Page 8, Line 11pharmacist; a certified midwife with prescriptive authority
Page 8, Line 12pursuant to section 12-255-112; or any other practitioner authorized to dispense or administer medicine.
Page 8, Line 13(g) "Individual donor" means a nonlicensed individual member of the public.
Page 8, Line 14(h) (I) "Medicine" means prescription drugs.
(II) "Medicine" includes:
Page 8, Line 15(A) A prescription drug that requires refrigeration,
Page 8, Line 16freezing, or special storage if the medicine has been continually
Page 8, Line 17maintained pursuant to the manufacturer's storage so long as the cold chain can be verified; and
Page 8, Line 18(B) Prescription supplies and devices.
(III) "Medicine" does not include:
Page 8, Line 19(A) Compounded drugs;
Page 9, Line 1(B) Prescription drugs dispensed by pharmacies outside of the United States;
Page 9, Line 2(C) Prescription drugs that are subject to risk evaluation
Page 9, Line 3and mitigation under 21 U.S.C. sec. 355-1 (f)(3) unless all of the required guidelines for the medicine are followed; or
Page 9, Line 4(D) Controlled substances.
Page 9, Line 5(i) "Prescriber" has the meaning set forth in section 12-280-125.7 (1)(f).
Page 9, Line 6(j) "Returns processor" has the meaning set forth in 21 U.S.C. sec. 360eee (18) and includes a reverse distributor.
Page 9, Line 7(k) (I) "Unopened, tamper-evident packaging" means an
Page 9, Line 8intact packaging system that renders medicine inaccessible
Page 9, Line 9without obvious destruction of the seal or some portion of the packaging system.
Page 9, Line 10(II) "Unopened, tamper-evident packaging" may include
Page 9, Line 11unopened unit-dose, multiple-dose, immediate, secondary, or tertiary packaging.
Page 9, Line 12(2) There is created the Colorado drug donation program
Page 9, Line 13to facilitate the safe donation and redispensing of unused
Page 9, Line 14medicine to Coloradans in need of the medicine. Participation in the program is voluntary.
Page 9, Line 15(3) (a) Notwithstanding any other law or rule to the
Page 9, Line 16contrary, a donor or an individual donor may donate medicine
Page 9, Line 17to a donation recipient. A donation recipient may receive donated medicine from a donor or an individual donor.
Page 9, Line 18(b) Prior to the first donation from a person, a donation
Page 9, Line 19recipient shall record the person's name, address, phone number, and license number, if applicable, and shall:
Page 10, Line 1(I) Verify that the person meets the definition provided in subsection (1)(d) of this section;
Page 10, Line 2(II) Confirm that the person agrees to make donations of
Page 10, Line 3medicine only in accordance with this section and rules adopted by the board relating to donated medicine; and
Page 10, Line 4(III) If applicable, confirm that the person agrees to
Page 10, Line 5remove or redact any patient names and prescription numbers on
Page 10, Line 6donated medicine or to otherwise maintain patient
Page 10, Line 7confidentiality by executing a confidentiality agreement with the authorized donation recipient.
Page 10, Line 8(c) No other information or records are required prior to
Page 10, Line 9the first donation from a new donor or an individual donor other than as described in subsection (3)(b) of this section.
Page 10, Line 10(4) A donation recipient shall maintain a written or an
Page 10, Line 11electronic record of donated medicine consisting of the name,
Page 10, Line 12strength, quantity, and lot number, if known, of each accepted
Page 10, Line 13or transferred drug and the name, address, and phone number of
Page 10, Line 14the donor or transferring entity. No other record of donation is required.
Page 10, Line 15(5) A donation recipient shall ensure that donated
Page 10, Line 16medicine is identified physically or electronically as separate from regular stock.
Page 10, Line 17(6) Notwithstanding any other law to the contrary, a donation recipient may:
Page 10, Line 18(a) Transfer donated medicine to another donation
Page 10, Line 19recipient or to an entity participating in a drug donation program operated by another state;
Page 11, Line 1(b) Repackage donated medicine in accordance with
Page 11, Line 2subsection (8) of this section as necessary for storage, dispensing, administration, or transfer; or
Page 11, Line 3(c) If the donation recipient is a prescription drug outlet
Page 11, Line 4or other outlet, replace medicine of the same drug name and
Page 11, Line 5strength previously dispensed or administered to eligible patients in accordance with 42 U.S.C. sec. 256b, as amended.
Page 11, Line 6(7) (a) Donated medicine that does not meet the
Page 11, Line 7requirements specified in this section and the rules adopted by the board must be disposed of by:
Page 11, Line 8(I) Returning the donated medicine to the donor;
Page 11, Line 9(II) Destroying the donated medicine through an
Page 11, Line 10incinerator, a medical waste hauler, a reverse distributor, or other lawful method; or
Page 11, Line 11(III) Transferring the donated medicine to a returns processor.
Page 11, Line 12(b) A donation recipient shall maintain a written or an
Page 11, Line 13electronic record of disposed medicine consisting of the disposal
Page 11, Line 14method, as described in subsection (7)(a) of this section; the date
Page 11, Line 15of disposal; and the name, strength, and quantity of each disposed drug. No other record of disposal is required.
Page 11, Line 16(8) Repackaged medicine must be labeled with the drug
Page 11, Line 17name, strength, and expiration date, if the expiration date is
Page 11, Line 18known, and identified separately from regular stock until
Page 11, Line 19inspected and initialed by a licensed pharmacist. If multiple
Page 11, Line 20packaged, donated medicines with varied expiration dates are
Page 12, Line 1repackaged together, the earliest expiration date must be used.
Page 12, Line 2Prescription drugs specified by NDC number in a recall notice
Page 12, Line 3must be considered recalled unless the prescription drug has an affixed lot number that excludes it from the recall.
Page 12, Line 4(9) A donation recipient shall only administer or redispense medicine that:
Page 12, Line 5(a) Is in unopened, tamper-evident packaging or has been repackaged under this program;
Page 12, Line 6(b) Meets the requirements set forth in this section based on an inspection by a licensed pharmacist;
Page 12, Line 7(c) If dispensed to an eligible patient, is repackaged by a
Page 12, Line 8licensed pharmacist into a new container or, if kept in the
Page 12, Line 9donated container, is in a container that has all previous patient information redacted or removed;
Page 12, Line 10(d) Is properly labeled in accordance with the rules adopted by the board;
Page 12, Line 11(e) Has an expiration or beyond-use date that will not
Page 12, Line 12expire before the medicine is used by the eligible patient based on the prescriber's directions for use; and
Page 12, Line 13(f) If the medicine requires refrigeration, freezing, or
Page 12, Line 14special storage, has been continually maintained pursuant to
Page 12, Line 15the manufacturer's storage requirements, so long as the cold chain can be verified.
Page 12, Line 16(10) A donation recipient:
Page 12, Line 17(a) May dispense or administer prescription drugs to an
Page 12, Line 18eligible patient pursuant to this section only if otherwise
Page 12, Line 19permitted by law pursuant to a valid prescription or prescription drug order; and
Page 13, Line 1(b) Shall maintain eligible patient-specific written or
Page 13, Line 2electronic records in accordance with rules adopted by the board.
Page 13, Line 3(11) A manufacturer, prescription drug outlet,
Page 13, Line 4repackager, dispenser, or wholesaler, other than a returns
Page 13, Line 5processor, participating in the program shall comply with the
Page 13, Line 6requirements of 21 U.S.C. secs. 360eee-1 to 360eee-4 relating to drug supply chain security.
Page 13, Line 7(12) The donation, transfer, or receipt of medicine or the
Page 13, Line 8facilitation of a donation, transfer, or receipt of medicine
Page 13, Line 9pursuant to this section is not wholesale distribution and does not require licensing as a wholesale distributor.
Page 13, Line 10(13) Medicine donated to the program must not be resold
Page 13, Line 11and is considered nonsaleable; except that handling, dispensing,
Page 13, Line 12or usual and customary charges to an eligible patient, health
Page 13, Line 13plan, pharmacy benefit manager, pharmacy services
Page 13, Line 14administrative organization, government agency, or other
Page 13, Line 15entity is not considered reselling. If the donation recipient is a
Page 13, Line 16for-profit entity, these charges must not exceed the donation
Page 13, Line 17recipient's cost of providing the medicine, including the current
Page 13, Line 18and anticipated costs of educating eligible donors and
Page 13, Line 19individual donors, providing technical support to participating
Page 13, Line 20donors and individual donors, shipping and handling, labor,
Page 13, Line 21storage, licensing, utilities, advertising, technology, supplies,
Page 13, Line 22and equipment. Except as described in this subsection (13), the
Page 13, Line 23amount of these charges is not subject to any additional limitations.
Page 14, Line 1(14) When performing any action associated with the
Page 14, Line 2program or otherwise processing donated medicine for tax, a
Page 14, Line 3manufacturer credit, or other credit, a donation recipient is
Page 14, Line 4considered to be acting as a returns processor and shall comply
Page 14, Line 5with all record-keeping requirements under federal law for nonsaleable returns.
Page 14, Line 6(15) All required records must be retained in physical or
Page 14, Line 7electronic format, on or off the donation recipient's premises,
Page 14, Line 8for a period of two years. Donors or donation recipients may
Page 14, Line 9contract with one another or with a third party to create or
Page 14, Line 10maintain records. An identifier, such as a serial number or bar
Page 14, Line 11code, may be used in place of information if it allows for the
Page 14, Line 12information to be readily retrievable. Upon request by a state
Page 14, Line 13or federal regulator, the identifier used for a requested record
Page 14, Line 14must be replaced with the original information. An identifier
Page 14, Line 15must not be used on labels when dispensing or administering a drug to an eligible patient.
Page 14, Line 16(16) A donation or other transfer of possession or
Page 14, Line 17control is not a change of ownership unless it is specified as such
Page 14, Line 18by the donation recipient. If a record of the donation's
Page 14, Line 19transaction information or history is required, the history must
Page 14, Line 20begin with the donor or individual donor, must include all prior
Page 14, Line 21donations, and, if the medicine was previously dispensed, must
Page 14, Line 22include only drug information that is required to be on the patient label in accordance with rules adopted by the board.
Page 14, Line 23(17) An entity participating in a drug donation or
Page 15, Line 1repository program operated by another state may participate
Page 15, Line 2in the program and, if the registered entity is a prescription drug
Page 15, Line 3outlet, may dispense donated drugs to eligible patients of this
Page 15, Line 4state. The registered entity is required to comply with all
Page 15, Line 5statutes and rules in this state unless the statutes or rules
Page 15, Line 6differ from or conflict with the statutes or rules of the state in which the entity is located.
Page 15, Line 7(18) The board shall adopt any rules necessary to
Page 15, Line 8implement this section. The rules must require the least amount
Page 15, Line 9of record keeping necessary to ensure patient safety and must allow flexibility in the format for record keeping.
Page 15, Line 10(19) Notwithstanding any law to the contrary, this
Page 15, Line 11section controls all activities under the program and supersedes any inconsistent law or rule.
Page 15, Line 12(20) When acting in good faith, without negligence or
Page 15, Line 13willful or wanton misconduct, the following individuals or
Page 15, Line 14entities are not subject to civil or criminal liability or professional disciplinary action:
Page 15, Line 15(a) An individual or entity involved in the supply chain of
Page 15, Line 16donated medicine, including the donor, the individual donor, the
Page 15, Line 17donation recipient, the manufacturer, the repackager, the
Page 15, Line 18prescription drug outlet or other entity regulated by the board, and the eligible patient;
Page 15, Line 19(b) An individual or entity, including an employee, an
Page 15, Line 20officer, a volunteer, an owner, a partner, a member, a director,
Page 15, Line 21a contractor, or other individual or entity associated with the
Page 15, Line 22individual or entity that, in compliance with this section,
Page 16, Line 1prescribes, donates, receives donations of, dispenses,
Page 16, Line 2administers, transfers, replaces, or repackages medicine or facilitates any of the actions described in this section; and
Page 16, Line 3(c) The board.
Page 16, Line 4(21) A donation recipient operating primarily for the
Page 16, Line 5purpose of participating in this program shall not be required to possess a comprehensive or minimum supply of medicine.
Page 16, Line 6SECTION 3. In Colorado Revised Statutes, 25-15-328, amend (6)(a) as follows:
Page 16, Line 725-15-328. Household medication take-back program -
Page 16, Line 8creation - collection and disposal of medication injection devices - liability - definitions - cash fund - rules. (6) Nothing in this section:
Page 16, Line 9(a) Affects the authority to collect and reuse
medicationsPage 16, Line 10SECTION 4. Act subject to petition - effective date. This act
Page 16, Line 11takes effect at 12:01 a.m. on the day following the expiration of the
Page 16, Line 12ninety-day period after final adjournment of the general assembly; except
Page 16, Line 13that, if a referendum petition is filed pursuant to section 1 (3) of article V
Page 16, Line 14of the state constitution against this act or an item, section, or part of this
Page 16, Line 15act within such period, then the act, item, section, or part will not take
Page 16, Line 16effect unless approved by the people at the general election to be held in
Page 16, Line 17November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.