First Regular Session
Seventy-fifth General Assembly
STATE OF COLORADO
INTRODUCED
LLS NO. 25-1042.01 Brita Darling x2241
SENATE BILL 25-289
Senate Committees House Committees
Health & Human Services
A BILL FOR AN ACT
C
ONCERNING THE CREATION OF A DRUG DONATION PROGRAM .101
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
SENATE SPONSORSHIP
Cutter,
HOUSE SPONSORSHIP
Brown,
Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
Capital letters or bold & italic numbers indicate new material to be added to existing law.
Dashes through the words or numbers indicate deletions from existing law. 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.
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. In Colorado Revised Statutes, 12-280-135, amend2
(1)(e), (2)(a), (2)(b) introductory portion, (2)(b)(II), (2)(b)(III), (2)(c)3
introductory portion, (2)(c)(I), (2)(c)(III), (2)(c)(V), (3), (4), and (6);4
repeal (2)(c)(IV) and (5); and add (2)(b)(IV), (2)(c)(VI), (2)(c)(VII), and5
(2)(c)(VIII) as follows:6
12-280-135. Unused medicine - licensed facilities - correctional7
facilities - reuse - definitions - rules. (1) As used in this section, unless8
the context otherwise requires:9
(e) (I) "Medication" means a prescription that is not a controlled
10
substance "MEDICINE" MEANS PRESCRIPTION DRUGS , INCLUDING11
SB25-289-2- FDA-APPROVED DRUGS LABELED FOR INVESTIGATIONAL USE .1
(II) "M
EDICINE" INCLUDES:2
(A) A
PRESCRIPTION DRUG THAT REQUIRES REFRIGERATION ,3
FREEZING, OR SPECIAL STORAGE IF THE PRESCRIPTION DRUG HAS BEEN4
CONTINUALLY MAINTAINED PURSUANT TO THE MANUFACTURER 'S STORAGE5
REQUIREMENTS; AND6
(B) P
RESCRIPTION SUPPLIES AND DEVICES.7
(III) "M
EDICINE" DOES NOT INCLUDE:8
(A) C
OMPOUNDED DRUGS ;9
(B) P
RESCRIPTION DRUGS DISPENSED BY PHARMACIES OUTSIDE OF10
THE UNITED STATES;11
(C) P
RESCRIPTION DRUGS THAT ARE SUBJECT TO RISK EVALUATION12
AND MITIGATION UNDER 21 U.S.C. SEC. 355-1 (f)(3) UNLESS ALL OF THE13
REQUIRED GUIDELINES FOR THE MEDICINE ARE FOLLOWED ; OR14
(D) C
ONTROLLED SUBSTANCES .15
(2) (a) (I) If donated by the patient, the resident, or the patient's or16
resident's next of kin, a licensed facility may return unused medications
17
MEDICINE or medical supplies and used or unused medical devices to a18
pharmacist within the licensed facility or a prescription drug outlet in19
order for the materials to be redispensed to another patient or donated to20
a nonprofit entity that has the legal authority to possess the materials or21
to a practitioner authorized by law to dispense the materials.22
(II) (A) A licensed facility or a prescription drug outlet may23
donate materials to a nonprofit entity that has legal authority to possess24
the materials or to a person legally authorized to dispense the materials.25
A licensed pharmacist shall review the process of donating the unused26
medications MEDICINE to the nonprofit entity.27
SB25-289
-3- (B) Nothing in this subsection (2)(a)(II) creates or abrogates any1
liability on behalf of a prescription drug manufacturer for the storage,2
donation, acceptance, or dispensing of a medication MEDICINE or A3
product or creates any civil cause of action against a prescription drug4
manufacturer in addition to that which is available under applicable law.5
(C) A person or entity is not subject to civil or criminal liability6
or professional disciplinary action for donating, accepting, dispensing, or7
facilitating the donation of materials in good faith, without negligence
OR8
WILLFUL OR WANTON MISCONDUCT , and in compliance with this section.9
(III) A correctional facility may return unused medications
10
MEDICINE or medical supplies and used or unused medical devices to the11
pharmacist within the correctional facility or a prescription drug outlet in12
order for the medication MEDICINE to be redispensed to another patient or13
donated to a nonprofit entity that has the legal authority to possess the14
materials or to a practitioner authorized by law to prescribe the materials.15
(b) Medications are MEDICINE IS only available to be dispensed to16
another person or donated to a nonprofit entity under this section if the17
medications are MEDICINE IS:18
(II) Individually packaged and the packaging has not been19
damaged; or20
(III) In the original, unopened, sealed, and tamper-evident unit21
dose packaging; OR22
(IV) F
OR MEDICINE THAT REQUIRES REFRIGERATION , FREEZING, OR23
SPECIAL STORAGE, CONTINUALLY MAINTAINED PURSUANT TO THE24
MANUFACTURER'S STORAGE REQUIREMENTS.25
(c) The following medications may not be donated
MEDICINE IS26
NOT ACCEPTABLE FOR DONATION :27
SB25-289
-4- (I) Medications MEDICINE THAT IS NOT packaged in A traditional1
brown or amber pill bottles DISPENSING SYSTEM, AS DEFINED BY THE2
BOARD BY RULE;3
(III) Medications EXCEPT AS PROVIDED IN SUBSECTION (2)(b)(IV)4
OF THIS SECTION, MEDICINE that require REQUIRES refrigeration, freezing,5
or special storage;6
(IV) Medications that require special registration with the7
manufacturer; or8
(V) Medications MEDICINE that are IS adulterated or misbranded,9
as determined by a person legally authorized to dispense the medications10
MEDICINE on behalf of the nonprofit entity OR A PERSON LEGALLY11
AUTHORIZED TO DISPENSE THE MEDICINE ;12
(VI) C
OMPOUNDED MEDICINE;13
(VII) M
EDICINE DISPENSED BY PHARMACIES OUTSIDE OF THE14
U
NITED STATES; OR15
(VIII) M
EDICINE THAT IS SUBJECT TO RISK EVALUATION AND16
MITIGATION UNDER 21 U.S.C. SEC. 355-1 (f)(3) UNLESS ALL OF THE17
REQUIRED GUIDELINES FOR THE MEDICINE ARE FOLLOWED .18
(3) Medication
MEDICINE dispensed or donated pursuant to this19
section must not be expired. A medication shall not be dispensed20
PRESCRIBING PRACTITIONER SHALL NOT DISPENSE MEDICINE that will21
expire before the use by the patient based on the prescribing practitioner's22
directions for use.23
(4) Medication MEDICINE, medical supplies, and medical devices24
donated pursuant to this section may not be resold for profit. The entity25
that receives the donated materials may charge the end user a handling26
fee, which fee shall MUST not exceed the amount specified by rule of the27
SB25-289
-5- board.1
(5) The board shall adopt rules that allow a pharmacist to2
redispense medication pursuant to this section and section 25.5-5-502 and3
to donate medication pursuant to this section.4
(6) Nothing in this section or section 25.5-5-502 creates or5
abrogates any liability on behalf of a prescription drug manufacturer for6
the storage, donation, acceptance, or dispensing of an unused donated7
medication MEDICINE or creates any civil cause of action against a8
prescription drug manufacturer in addition to that which is available9
under applicable law.10
SECTION 2. In Colorado Revised Statutes, add 12-280-135.5 as11
follows:12
12-280-135.5. Colorado drug donation program - created -13
rules - records - definitions. (1) A
S USED IN THIS SECTION, UNLESS THE14
CONTEXT OTHERWISE REQUIRES :15
(a) "C
OLORADO DRUG DONATION PROGRAM " OR "PROGRAM"16
MEANS THE COLORADO DRUG DONATION PROGRAM CREATED IN THIS17
SECTION.18
(b) "C
ONTROLLED SUBSTANCE " HAS THE MEANING SET FORTH IN19
SECTION 18-18-102.20
(c) (I) "D
ONATION RECIPIENT" MEANS AN ENTITY THAT:21
(A) I
S LEGALLY AUTHORIZED TO POSSESS MEDICINE ;22
(B) H
AS A LICENSE OR REGISTRATION IN GOOD STANDING IN THE23
STATE IN WHICH THE ENTITY IS LOCATED; AND24
(C) R
ECEIVES A DONATION OF MEDICINE.25
(II) "D
ONATION RECIPIENT" INCLUDES A WHOLESALER , A26
DISTRIBUTOR, A THIRD-PARTY LOGISTICS PROVIDER , A REVERSE27
SB25-289
-6- DISTRIBUTOR, A REPACKAGER, A HOSPITAL, A PHARMACY, A CLINIC, A1
HEALTH-CARE PROVIDER, OR A PRESCRIBER OFFICE.2
(d) (I) "D
ONOR" MEANS ANY PERSON LEGALLY AUTHORIZED TO3
POSSESS MEDICINE, INCLUDING AN INDIVIDUAL MEMBER OF THE PUBLIC , A4
WHOLESALER, A DISTRIBUTOR, A THIRD-PARTY LOGISTICS PROVIDER, A5
PHARMACY, A DISPENSER, A CLINIC, A SURGICAL OR HEALTH CENTER , A6
REHABILITATION CENTER, A DETENTION CENTER, A JAIL, A PRISON, A7
LABORATORY, A PRESCRIBER OR OTHER HEALTH-CARE PROFESSIONAL, OR8
A LONG-TERM CARE FACILITY OR HEALTH-CARE FACILITY, WHICH PERSON9
DONATES MEDICINE.10
(II) "D
ONOR" INCLUDES GOVERNMENT AGENCIES AND ENTITIES11
THAT ARE FEDERALLY AUTHORIZED TO POSSESS MEDICINE , INCLUDING12
MANUFACTURERS, REPACKAGERS, RELABELERS, OUTSOURCING FACILITIES,13
VETERANS AFFAIRS HOSPITALS, FDA-AUTHORIZED IMPORTERS SUCH AS14
THOSE DESCRIBED UNDER THE FEDERAL "FOOD, DRUG, AND COSMETIC15
A
CT", 21 U.S.C. SECS. 801 AND 804, AS AMENDED, OR SIMILAR16
PROVISIONS, AND FEDERAL PRISONS.17
(e) (I) "E
LIGIBLE PATIENT" MEANS AN INDIVIDUAL WITH A NEED18
FOR DONATED MEDICINE WHO IS INDIGENT , UNINSURED, UNDERINSURED,19
OR ENROLLED IN A PUBLIC HEALTH BENEFITS PROGRAM .20
(II) "E
LIGIBLE PATIENT" INCLUDES OTHER INDIVIDUALS IF A NEED21
FOR DONATED MEDICINE IS NOT IDENTIFIED AM ONG INDIVIDUALS WHO ARE22
INDIGENT, UNINSURED, UNDERINSURED, OR ENROLLED IN A PUBLIC HEALTH23
BENEFITS PROGRAM.24
(f) "H
EALTH-CARE PROFESSIONAL" MEANS AN INDIVIDUAL WHO IS25
LICENSED TO PRACTICE AS A PHYSICIAN, REGISTERED NURSE, ADVANCED26
PRACTICE REGISTERED NURSE , PRACTICAL NURSE, OPTOMETRIST, OR27
SB25-289
-7- PHARMACIST; A CERTIFIED MIDWIFE WITH PRESCRIPTIVE AUTHORITY1
PURSUANT TO SECTION 12-255-112; OR ANY OTHER PRACTITIONER2
AUTHORIZED TO DISPENSE OR ADMINISTER MEDICINE .3
(g) (I) "M
EDICINE" MEANS PRESCRIPTION DRUGS , INCLUDING4
FDA-
APPROVED DRUGS LABELED FOR INVESTIGATIONAL USE .5
(II) "M
EDICINE" INCLUDES:6
(A) A
PRESCRIPTION DRUG THAT REQUIRES REFRIGERATION ,7
FREEZING, OR SPECIAL STORAGE IF THE MEDICINE HAS BEEN CONTINUALLY8
MAINTAINED PURSUANT TO THE MANUFACTURER 'S STORAGE9
REQUIREMENTS; AND10
(B) P
RESCRIPTION SUPPLIES AND DEVICES.11
(III) "M
EDICINE" DOES NOT INCLUDE:12
(A) C
OMPOUNDED DRUGS ;13
(B) P
RESCRIPTION DRUGS DISPENSED BY PHARMACIES OUTSIDE OF14
THE UNITED STATES;15
(C) P
RESCRIPTION DRUGS THAT ARE SUBJECT TO RISK EVALUATION16
AND MITIGATION UNDER 21 U.S.C. SEC. 355-1 (f)(3) UNLESS ALL OF THE17
REQUIRED GUIDELINES FOR THE MEDICINE ARE FOLLOWED ; OR18
(D) C
ONTROLLED SUBSTANCES .19
(h) "P
RESCRIBER" HAS THE MEANING SET FORTH IN SECTION20
12-280-125.7 (1)(f).21
(i) "R
ETURNS PROCESSOR" HAS THE MEANING SET FORTH IN 2122
U.S.C.
SEC. 360eee (18) AND INCLUDES A REVERSE DISTRIBUTOR .23
(j) (I) "U
NOPENED, TAMPER-EVIDENT PACKAGING" MEANS AN24
INTACT PACKAGING SYSTEM THAT RENDERS MEDICINE INACCESSIBLE25
WITHOUT OBVIOUS DESTRUCTION OF THE SEAL OR SOME PORTION OF THE26
PACKAGING SYSTEM.27
SB25-289
-8- (II) "UNOPENED, TAMPER-EVIDENT PACKAGING" MAY INCLUDE1
UNOPENED UNIT-DOSE, MULTIPLE-DOSE, IMMEDIATE, SECONDARY, OR2
TERTIARY PACKAGING.3
(2) T
HERE IS CREATED THE COLORADO DRUG DONATION PROGRAM4
TO FACILITATE THE SAFE DONATION AND REDISPENSING OF UNUSED5
MEDICINE TO COLORADANS IN NEED OF THE MEDICINE . PARTICIPATION IN6
THE PROGRAM IS VOLUNTARY .7
(3) (a) N
OTWITHSTANDING ANY OTHER LAW OR RULE TO THE8
CONTRARY, A DONOR MAY DONATE MEDICINE TO A DONATION RECIPIENT .9
A
DONATION RECIPIENT MAY RECEIVE DONATED MEDICINE FROM DONORS .10
(b) P
RIOR TO THE FIRST DONATION FROM A PERSON , A DONATION11
RECIPIENT SHALL RECORD THE PERSON'S NAME, ADDRESS, PHONE NUMBER,12
AND LICENSE NUMBER, IF APPLICABLE, AND SHALL:13
(I) V
ERIFY THAT THE PERSON MEETS THE DEFINITION PROVIDED IN14
SUBSECTION (1)(d) OF THIS SECTION;15
(II) C
ONFIRM THAT THE PERSON AGREES TO MAKE DONATIONS OF16
MEDICINE ONLY IN ACCORDANCE WITH THIS SECTION AND RULES ADOPTED17
BY THE BOARD RELATING TO DONATED MEDICINE ; AND18
(III) I
F APPLICABLE, CONFIRM THAT THE PERSON AGREES TO19
REMOVE OR REDACT ANY PATIENT NAMES AND PRESCRIPTION NUMBERS ON20
DONATED MEDICINE OR TO OTHERWISE MAINTAIN PATIENT21
CONFIDENTIALITY BY EXECUTING A CONFIDENTIALITY AGREEMENT WITH22
THE AUTHORIZED DONATION RECIPIENT .23
(c) N
O OTHER INFORMATION OR RECORDS ARE REQUIRED PRIOR TO24
THE FIRST DONATION FROM A NEW DONOR OTHER THAN AS DESCRIBED IN25
SUBSECTION (3)(b) OF THIS SECTION.26
(4) A
DONATION RECIPIENT SHALL MAINTAIN A WRITTEN OR AN27
SB25-289
-9- ELECTRONIC RECORD OF DONATED MEDICINE CONSISTING OF THE NAME ,1
STRENGTH, QUANTITY, AND LOT NUMBER, IF KNOWN, OF EACH ACCEPTED2
OR TRANSFERRED DRUG AND THE NAME , ADDRESS, AND PHONE NUMBER OF3
THE DONOR OR TRANSFERRING ENTITY . NO OTHER RECORD OF DONATION4
IS REQUIRED.5
(5) A
DONATION RECIPIENT SHALL ENSURE THAT DONATED6
MEDICINE IS IDENTIFIED PHYSICALLY OR ELECTRONICALLY AS SEPARATE7
FROM REGULAR STOCK.8
(6) N
OTWITHSTANDING ANY OTHER LAW TO THE CONTRARY , A9
DONATION RECIPIENT MAY:10
(a) T
RANSFER DONATED MEDICINE TO ANOTHER DONATION11
RECIPIENT OR TO AN ENTITY PARTICIPATING IN A DRUG DONATION12
PROGRAM OPERATED BY ANOTHER STATE ;13
(b) R
EPACKAGE DONATED MEDICINE IN ACCORDANCE WITH14
SUBSECTION (8) OF THIS SECTION AS NECESSARY FOR STORAGE ,15
DISPENSING, ADMINISTRATION, OR TRANSFER; OR16
(c) I
F THE DONATION RECIPIENT IS A PRESCRIPTION DRUG OUTLET17
OR OTHER OUTLET, REPLENISH MEDICINE OF THE SAME DRUG NAME AND18
STRENGTH PREVIOUSLY DISPENSED OR ADMINISTERED TO ELIGIBLE19
PATIENTS IN ACCORDANCE WITH THE FEDERAL 340B DRUG PRICING20
PROGRAM CODIFIED AT 42 U.S.C. SEC. 256b, AS AMENDED.21
(7) (a) D
ONATED MEDICINE THAT DOES NOT MEET THE22
REQUIREMENTS SPECIFIED IN THIS SECTION AND THE RULES ADOPTED BY23
THE BOARD MUST BE DISPOSED OF BY:24
(I) R
ETURNING THE DONATED MEDICINE TO THE DONOR ;25
(II) D
ESTROYING THE DONATED MEDICINE THROUGH AN26
INCINERATOR, A MEDICAL WASTE HAULER, A REVERSE DISTRIBUTOR, OR27
SB25-289
-10- OTHER LAWFUL METHOD ; OR1
(III) T
RANSFERRING THE DONATED MEDICINE TO A RETURNS2
PROCESSOR.3
(b) A
DONATION RECIPIENT SHALL MAINTAIN A WRITTEN OR AN4
ELECTRONIC RECORD OF DISPOSED MEDICINE CONSISTING OF THE DISPOSAL5
METHOD, AS DESCRIBED IN SUBSECTION (7)(a) OF THIS SECTION; THE DATE6
OF DISPOSAL; AND THE NAME, STRENGTH, AND QUANTITY OF EACH7
DISPOSED DRUG. NO OTHER RECORD OF DISPOSAL IS REQUIRED .8
(8) R
EPACKAGED MEDICINE MUST BE LABELED WITH THE DRUG9
NAME, STRENGTH, AND EXPIRATION DATE, IF THE EXPIRATION DATE IS10
KNOWN, AND IDENTIFIED SEPARATELY FROM REGULAR STOCK UNTIL11
INSPECTED AND INITIALED BY A LICENSED PHARMACIST . IF MULTIPLE12
PACKAGED, DONATED MEDICINES WITH VARIED EXPIRATION DATES ARE13
REPACKAGED TOGETHER , THE EARLIEST EXPIRATION DATE MUST BE USED.14
(9) A
DONATION RECIPIENT SHALL ONLY ADMINISTER OR15
REDISPENSE MEDICINE THAT:16
(a) I
S IN UNOPENED, TAMPER-EVIDENT PACKAGING OR HAS BEEN17
REPACKAGED UNDER THIS PROGRAM ;18
(b) M
EETS THE REQUIREMENTS SET FORTH IN THIS SECTION BASED19
ON AN INSPECTION BY A LICENSED PHARMACIST ;20
(c) I
F DISPENSED TO AN ELIGIBLE PATIENT, IS REPACKAGED BY A21
LICENSED PHARMACIST INTO A NEW CONTAINER OR , IF KEPT IN THE22
DONATED CONTAINER , IS IN A CONTAINER THAT HAS ALL PREVIOUS23
PATIENT INFORMATION REDACTED OR REMOVED ;24
(d) I
S PROPERLY LABELED IN ACCORDANCE WITH THE RULES25
ADOPTED BY THE BOARD;26
(e) H
AS AN EXPIRATION OR BEYOND -USE DATE THAT WILL NOT27
SB25-289
-11- EXPIRE BEFORE THE MEDICINE IS USED BY THE ELIGIBLE PATIENT BASED ON1
THE PRESCRIBER'S DIRECTIONS FOR USE; AND2
(f) I
F THE MEDICINE REQUIRES REFRIGERATION , FREEZING, OR3
SPECIAL STORAGE, HAS BEEN CONTINUALLY MAINTAINED PURSUANT TO4
THE MANUFACTURER'S STORAGE REQUIREMENTS.5
(10) A
DONATION RECIPIENT:6
(a) M
AY DISPENSE OR ADMINISTER PRESCRIPTION DRUGS TO AN7
ELIGIBLE PATIENT PURSUANT TO THIS SECTION ONLY IF OTHERWISE8
PERMITTED BY LAW PURSUANT TO A VALID PRESCRIPTION OR PRESCRIPTION9
DRUG ORDER; AND10
(b) S
HALL MAINTAIN ELIGIBLE PATIENT -SPECIFIC WRITTEN OR11
ELECTRONIC RECORDS IN ACCORDANCE WITH RULES ADOPTED BY THE12
BOARD.13
(11) A
MANUFACTURER , REPACKAGER, DISPENSER, OR14
WHOLESALER, OTHER THAN A RETURNS PROCESSOR, PARTICIPATING IN THE15
PROGRAM SHALL COMPLY WITH THE REQUIREMENTS OF 21 U.S.C. SECS.16
360eee-1
TO 360eee-4 RELATING TO DRUG SUPPLY CHAIN SECURITY .17
(12) T
HE DONATION, TRANSFER, OR RECEIPT OF MEDICINE OR THE18
FACILITATION OF A DONATION , TRANSFER, OR RECEIPT OF MEDICINE19
PURSUANT TO THIS SECTION IS NOT WHOLESALE DISTRIBUTION AND DOES20
NOT REQUIRE LICENSING AS A WHOLESALE DISTRIBUTOR .21
(13) M
EDICINE DONATED TO THE PROGRAM MUST NOT BE RESOLD22
AND IS CONSIDERED NONSALEABLE ; EXCEPT THAT HANDLING, DISPENSING,23
OR USUAL AND CUSTOMARY CHARGES TO AN ELIGIBLE PATIENT , HEALTH24
PLAN, PHARMACY BENEFIT MANAGER , PHARMACY SERVICES25
ADMINISTRATIVE ORGANIZATION , GOVERNMENT AGENCY , OR OTHER26
ENTITY IS NOT CONSIDERED RESELLING. IF THE DONATION RECIPIENT IS A27
SB25-289
-12- FOR-PROFIT ENTITY, THESE CHARGES MUST NOT EXCEED THE DONATION1
RECIPIENT'S COST OF PROVIDING THE MEDICINE, INCLUDING THE CURRENT2
AND ANTICIPATED COSTS OF EDUCATING ELIGIBLE DONORS , PROVIDING3
TECHNICAL SUPPORT TO PARTICIPATING DONORS , SHIPPING AND HANDLING,4
LABOR, STORAGE, LICENSING, UTILITIES, ADVERTISING, TECHNOLOGY,5
SUPPLIES, AND EQUIPMENT. EXCEPT AS DESCRIBED IN THIS SUBSECTION6
(13),
THE AMOUNT OF THESE CHARGES IS NOT SUBJECT TO ANY7
ADDITIONAL LIMITATIONS.8
(14) W
HEN PERFORMING ANY ACTION ASSOCIATED WITH THE9
PROGRAM OR OTHERWISE PROCESSING DONATED MEDICINE FOR TAX , A10
MANUFACTURER CREDIT , OR OTHER CREDIT, A DONATION RECIPIENT IS11
CONSIDERED TO BE ACTING AS A RETURNS PROCESSOR AND SHALL COMPLY12
WITH ALL RECORD-KEEPING REQUIREMENTS UNDER FEDERAL LAW FOR13
NONSALEABLE RETURNS .14
(15) A
LL REQUIRED RECORDS MUST BE RETAINED IN PHYSICAL OR15
ELECTRONIC FORMAT, ON OR OFF THE DONATION RECIPIENT'S PREMISES,16
FOR A PERIOD OF TWO YEARS. DONORS OR DONATION RECIPIENTS MAY17
CONTRACT WITH ONE ANOTHER OR WITH A THIRD PARTY TO CREATE OR18
MAINTAIN RECORDS. AN IDENTIFIER, SUCH AS A SERIAL NUMBER OR BAR19
CODE, MAY BE USED IN PLACE OF INFORMATION IF IT ALLOWS FOR THE20
INFORMATION TO BE READILY RETRIEVABLE . UPON REQUEST BY A STATE21
OR FEDERAL REGULATOR, THE IDENTIFIER USED FOR A REQUESTED RECORD22
MUST BE REPLACED WITH THE ORIGINAL INFORMATION . AN IDENTIFIER23
MUST NOT BE USED ON LABELS WHEN DISPENSING OR ADMINISTERING A24
DRUG TO AN ELIGIBLE PATIENT.25
(16) A
DONATION OR OTHER TRANSFER OF POSSESSION OR26
CONTROL IS NOT A CHANGE OF OWNERSHIP UNLESS IT IS SPECIFIED AS SUCH27
SB25-289
-13- BY THE DONATION RECIPIENT . IF A RECORD OF THE DONATION 'S1
TRANSACTION INFORMATION OR HISTORY IS REQUIRED , THE HISTORY MUST2
BEGIN WITH THE DONOR, MUST INCLUDE ALL PRIOR DONATIONS , AND, IF3
THE MEDICINE WAS PREVIOUSLY DISPENSED , MUST INCLUDE ONLY DRUG4
INFORMATION THAT IS REQUIRED TO BE ON THE PATIENT LABEL IN5
ACCORDANCE WITH RULES ADOPTED BY THE BOARD .6
(17) A
N ENTITY PARTICIPATING IN A DRUG DONATION OR7
REPOSITORY PROGRAM OPERATED BY ANOTHER STATE MAY PARTICIPATE8
IN THE PROGRAM AND, IF THE REGISTERED ENTITY IS A PRESCRIPTION DRUG9
OUTLET, MAY DISPENSE DONATED DRUGS TO ELIGIBLE PATIENTS OF THIS10
STATE. THE REGISTERED ENTITY IS REQUIRED TO COMPLY WITH ALL11
STATUTES AND RULES IN THIS STATE UNLESS THE STATUTES OR RULES12
DIFFER FROM OR CONFLICT WITH THE STATUTES OR RULES OF THE STATE13
IN WHICH THE ENTITY IS LOCATED.14
(18) T
HE BOARD SHALL ADOPT ANY RULES NECESSARY TO15
IMPLEMENT THIS SECTION. THE RULES MUST REQUIRE THE LEAST AMOUNT16
OF RECORD KEEPING NECESSARY TO ENSURE PATIENT SAFETY AND MUST17
ALLOW FLEXIBILITY IN THE FORMAT FOR RECORD KEEPING .18
(19) T
HIS SECTION CONTROLS THE REQUIREMENTS FOR THE19
DONATION AND DISTRIBUTION OF MEDICINE UNDER THE PROGRAM AND20
SUPERSEDES ANY INCONSISTENT LAW .21
(20) W
HEN ACTING IN GOOD FAITH, WITHOUT NEGLIGENCE OR22
WILLFUL OR WANTON MISCONDUCT , THE FOLLOWING INDIVIDUALS OR23
ENTITIES ARE NOT SUBJECT TO CIVIL OR CRIMINAL LIABILITY OR24
PROFESSIONAL DISCIPLINARY ACTION:25
(a) A
N INDIVIDUAL OR ENTITY INVOLVED IN THE SUPPLY CHAIN OF26
DONATED MEDICINE, INCLUDING THE DONOR, THE DONATION RECIPIENT,27
SB25-289
-14- THE MANUFACTURER, THE REPACKAGER, THE PRESCRIPTION DRUG OUTLET1
OR OTHER ENTITY REGULATED BY THE BOARD , AND THE ELIGIBLE PATIENT;2
(b) A
N INDIVIDUAL OR ENTITY, INCLUDING AN EMPLOYEE , AN3
OFFICER, A VOLUNTEER, AN OWNER, A PARTNER, A MEMBER, A DIRECTOR,4
A CONTRACTOR, OR OTHER INDIVIDUAL OR ENTITY ASSOCIATED WITH THE5
INDIVIDUAL OR ENTITY THAT , IN COMPLIANCE WITH THIS SECTION ,6
PRESCRIBES, DONATES, RECEIVES DONATIONS OF , DISPENSES,7
ADMINISTERS, TRANSFERS, REPLENISHES, OR REPACKAGES MEDICINE OR8
FACILITATES ANY OF THE ACTIONS DESCRIBED IN THIS SECTION ; AND9
(c) T
HE BOARD.10
(21) A
DONATION RECIPIENT OPERATING PRIMARILY FOR THE11
PURPOSE OF PARTICIPATING IN THIS PROGRAM SHALL NOT BE REQUIRED TO12
POSSESS A COMPREHENSIVE OR MINIMUM SUPPLY OF MEDICINE .13
SECTION 3. In Colorado Revised Statutes, 25-15-328, amend14
(6)(a) as follows:15
25-15-328. Household medication take-back program -16
creation - collection and disposal of medication injection devices -17
liability - definitions - cash fund - rules. (6) Nothing in this section:18
(a) Affects the authority to collect and reuse medications
19
MEDICINE pursuant to section 12-280-135 OR 12-280-135.5; or20
SECTION 4. Act subject to petition - effective date. This act21
takes effect at 12:01 a.m. on the day following the expiration of the22
ninety-day period after final adjournment of the general assembly; except23
that, if a referendum petition is filed pursuant to section 1 (3) of article V24
of the state constitution against this act or an item, section, or part of this25
act within such period, then the act, item, section, or part will not take26
effect unless approved by the people at the general election to be held in27
SB25-289
-15- November 2026 and, in such case, will take effect on the date of the1
official declaration of the vote thereon by the governor.2
SB25-289
-16-