Second Regular Session
Seventy-third General Assembly
STATE OF COLORADO
INTRODUCED
LLS NO. 22-0640.01 Brita Darling x2241
SENATE BILL 22-098
Senate Committees House Committees
Health & Human Services
A BILL FOR AN ACT
C
ONCERNING THE CREATION OF A PR OGRAM ALLOWING FOR THE USE101
OF DONATED UNUSED DRUGS .102
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 creates the Colorado drug reuse opportunity program
(program). The program allows members of the public, health-care
providers, pharmacies, health-care facilities, drug manufacturers, and
other entities to donate prescription drugs, excluding controlled
substances, and "over-the-counter" medicine (drugs) to be distributed or
redispensed to Colorado residents with a prescription for such a drug or
SENATE SPONSORSHIP
Rodriguez,
HOUSE SPONSORSHIP
(None),
Shading denotes HOUSE amendment. Double underlining denotes SENATE amendment.
Capital letters or bold & italic numbers indicate new material to be added to existing statute.
Dashes through the words indicate deletions from existing statute. symptoms treatable with such a drug (eligible patients). Donated drugs
are free to eligible patients, although there may be a fee for processing
and redispensing the drugs.
The bill establishes requirements for:
! Donating unused drugs, receiving and accepting drug
donations, and redispensing and administering unused
drugs to eligible patients;
! Storing, repackaging, and labeling donated drugs;
! Disposing of donated drugs that cannot be redispensed; and
! Record keeping relating to the donation, receipt, and reuse
of the donated drugs.
In redispensing the donated drugs, to the extent possible, the
program gives priority to eligible patients who are not covered by health
insurance or who lack adequate health insurance coverage or whose
income falls below a certain income level.
The state board of pharmacy shall promulgate rules, including
rules for donating and receiving drugs, labeling and repackaging drugs,
and redispensing or administering drugs by persons authorized to
dispense or administer drugs.
With certain exceptions, the bill provides immunity from civil or
criminal liability or professional discipline for a manufacturer, donor, or
receiver of drugs for activities directly attributable to donating, receiving,
redispensing, or administering a drug under the program.
Be it enacted by the General Assembly of the State of Colorado:1
SECTION 1. In Colorado Revised Statutes, add part 7 to article2
280 of title 12 as follows:3
PART 74
COLORADO DRUG REUSE OPPORTUNITY PROGRAM5
12-280-701. Short title. T
HE SHORT TITLE OF THIS PART 7 IS THE6
"C
OLORADO DRUG REUSE OPPORTUNITY PROGRAM ACT".7
12-280-702. Definitions. A
S USED IN THIS PART 7, UNLESS THE8
CONTEXT OTHERWISE REQUIRES :9
(1) "C
ORRECTIONAL FACILITY" HAS THE MEANING SET FORTH IN10
SECTION 12-280-135 (1)(a).11
(2) (a) "D
ONOR" MEANS AN INDIVIDUAL MEMBER OF THE PUBLIC12
SB22-098-2- OR ANY ENTITY LEGALLY AUTHORIZED TO POSSESS DRUGS , INCLUDING A1
WHOLESALER, A THIRD-PARTY LOGISTICS PROVIDER, A PHARMACY, AN2
OTHER OUTLET, A PRACTITIONER, A HOSPITAL, A HOSPITAL SATELLITE3
PHARMACY, A LICENSED FACILITY, OR A CORRECTIONAL FACILITY.4
(b) "D
ONOR" INCLUDES A MANUFACTURER , A REPACKAGER, OR A5
HEALTH-CARE FACILITY OPERATED BY THE UNITED STATES DEPARTMENT6
OF VETERANS AFFAIRS.7
(3) "D
RUG" MEANS A PRESCRIPTION DRUG OR AN8
OVER-THE-COUNTER MEDICATION AND SUPPLIES NEEDED TO ADMINISTER9
A PRESCRIPTION DRUG OR OVER-THE-COUNTER MEDICATION; EXCEPT THAT10
"
DRUG" DOES NOT INCLUDE A CONTROLLED SUBSTANCE OR ANY11
METHAMPHETAMINE PRECURSOR .12
(4) "E
LIGIBLE PATIENT" MEANS A COLORADO RESIDENT WITH A13
PRESCRIPTION FOR A DRUG, IF A PRESCRIPTION IS REQUIRED TO DISPENSE14
THE DRUG, OR WHO REPORTS SYMPTOMS THAT MAY BE TREATED BY AN15
OVER-THE-COUNTER MEDICATION.16
(5) "L
ICENSED FACILITY" HAS THE MEANING SET FORTH IN SECTION17
12-280-135 (1)(b).18
(6) "P
RIORITY PATIENT" MEANS AN ELIGIBLE PATIENT WHO IS NOT19
COVERED BY HEALTH INSURANCE , LACKS ADEQUATE HEALTH INSURANCE20
COVERAGE, OR HAS AN INCOME THAT DOES NOT EXCEED TWO HUNDRED21
PERCENT OF THE FEDERAL POVERTY LINE .22
(7) "P
ROGRAM" MEANS THE COLORADO DRUG REUSE OPPORTUNITY23
PROGRAM CREATED IN SECTION 12-280-703.24
(8) "R
ECEIVER" MEANS ANY PERSON, INCLUDING A WHOLESALER25
OR DISTRIBUTOR, REVERSE DISTRIBUTOR , REPACKAGER, HOSPITAL,26
PHARMACY, OR CLINIC, THAT POSSESSES A LICENSE, REGISTRATION, OR27
SB22-098
-3- PERMIT IN THE STATE IN WHICH THE PERSON IS LOCATED, WHICH LICENSE,1
REGISTRATION, OR PERMIT AUTHORIZES THE PERSON TO LEGALLY POSSESS2
MEDICINE.3
(9) "U
NOPENED, TAMPER-EVIDENT PACKAGING" HAS THE MEANING4
SET FORTH IN THE OFFICIAL COMPENDIA, CHAPTER 659, PACKAGING AND5
STORAGE REQUIREMENTS , AND INCLUDES UNOPENED UNIT -DOSE,6
MULTIPLE-DOSE, IMMEDIATE, SECONDARY, AND TERTIARY PACKAGING.7
12-280-703. Colorado drug reuse opportunity program -8
creation - donated drugs - receiving, accepting, redispensing, and9
administering donated drugs - eligible patients - priority patients.10
(1) E
FFECTIVE JANUARY 1, 2023, THE COLORADO DRUG REUSE11
OPPORTUNITY PROGRAM IS HEREBY CREATED TO PROVIDE UNUSED12
DONATED DRUGS AT NO COST TO ELIGIBLE PATIENTS , WITH PRIORITY13
GIVEN, TO THE EXTENT POSSIBLE, TO PRIORITY PATIENTS.14
(2) N
OTWITHSTANDING ANY LAW TO THE CONTRARY , A DONOR15
MAY DONATE DRUGS TO A RECEIVER , AND A RECEIVER MAY RECEIVE THE16
DONATED DRUGS. A RECEIVER MAY TAKE ONE OF THE FOLLOWING17
ACTIONS:18
(a) R
EDISPENSE OR ADMINISTER DONATED DRUGS TO ELIGIBLE19
PATIENTS PURSUANT TO SUBSECTION (7) OF THIS SECTION;20
(b) R
EPACKAGE OR REPLENISH DONATED DRUGS PURSUANT TO21
SUBSECTION (6) OF THIS SECTION;22
(c) F
URTHER DONATE DRUGS TO ANOTHER RECEIVER PURSUANT TO23
SUBSECTION (6) OF THIS SECTION; OR24
(d) D
ISPOSE OF DONATED DRUGS PURSUANT TO SUBSECTION (5) OF25
THIS SECTION.26
(3) N
OTHING IN THIS PART 7 REQUIRES A PHARMACY OR27
SB22-098
-4- PHARMACIST TO BE A RECEIVER UNDER THE PROGRAM .1
(4) U
PON RECEIPT OF A DRUG FROM A DONOR , A RECEIVER SHALL2
KEEP THE DRUG IN A SEPARATE AREA DESIGNATED FOR RECEIVING3
DONATED DRUGS UNTIL THE DRUG IS ACCEPTED INTO THE RECEIVER 'S4
INVENTORY FOR THE PROGRAM . A DONATED DRUG MAY BE ACCEPTED FOR5
REUSE UNDER THE PROGRAM ONLY IF ALL OF THE FOLLOWING6
REQUIREMENTS ARE MET:7
(a) T
HE DRUG IS IN UNOPENED, TAMPER-EVIDENT PACKAGING OR8
HAS BEEN REPACKAGED AS DESCRIBED IN SUBSECTION (6) OF THIS9
SECTION;10
(b) T
HE DRUG IS NOT EXPIRED;11
(c) T
HE RECEIVER MAINTAINS A WRITTEN OR ELECTRONIC RECORD12
OF THE DONATION CONSISTING OF THE NAME , STRENGTH, AND QUANTITY13
OF EACH ACCEPTED DRUG AND THE NAME , ADDRESS, AND TELEPHONE14
NUMBER OF THE DONOR, UNLESS A RECEIVER IS FURTHER DONATING TO A15
RECEIVER UNDER COMMON OWNERSHIP OR COMMON CONTROL . NO OTHER16
RECORD OF A DONATION IS REQUIRED.17
(d) T
HE DONOR REMOVES OR REDACTS ANY PATIENT NAME AND18
PRESCRIPTION NUMBER OR ANY OTHER PATIENT -IDENTIFYING19
INFORMATION ON THE DRUG OR PACKAGING OR OTHERWISE MAINTAINS20
CONFIDENTIALITY BY EXECUTING A CONFIDENTIALITY AGREEMENT WITH21
THE RECEIVER ACCORDING TO APPLICABLE STATE AND FEDERAL HEALTH22
INFORMATION PRIVACY LAWS ; AND23
(e) T
HE DRUG OR PACKAGING HAS A METHOD RECOGNIZED BY THE24
OFFICIAL COMPENDIA TO DETECT IMPROPER TEMPERATURE VARIATIONS IF25
THE DRUG REQUIRES TEMPERATURE CONTROL OTHER THAN ROOM26
TEMPERATURE STORAGE .27
SB22-098
-5- (5) (a) IF A DONATED DRUG DOES NOT MEET THE ACCEPTANCE1
REQUIREMENTS SET FORTH IN SUBSECTION (4) OF THIS SECTION, THE2
RECEIVER SHALL DISPOSE OF THE DRUG BY :3
(I) R
ETURNING THE DRUG TO THE DONOR ; OR4
(II) D
ESTROYING THE DRUG BY A LAWFUL METHOD OR BY5
TRANSFERRING THE DRUG TO A RETURNS PROCESSOR .6
(b) A
RECEIVER SHALL MAKE A RECORD OF THE DISPOSAL OF A7
DONATED DRUG, WHICH RECORD MUST INCLUDE THE DISPOSAL METHOD ,8
THE DATE OF DISPOSAL, AND THE NAME AND QUANTITY OF THE DISPOSED9
DRUG. NO OTHER RECORD OF DISPOSAL IS REQUIRED .10
(6) N
OTWITHSTANDING ANY LAW TO THE CONTRARY , A RECEIVER11
OF A DONATED DRUG THAT MEETS THE ACCEPTANCE REQUIREMENTS SET12
FORTH IN SUBSECTION (4) OF THIS SECTION MAY:13
(a) D
ONATE THE DRUG TO ANOTHER RECEIVER ;14
(b) R
EPACKAGE THE DRUG AS NECESSARY FOR STORAGE ,15
REDISPENSING, ADMINISTRATION, OR TRANSFER IN ACCORDANCE WITH THE16
FOLLOWING REQUIREMENTS :17
(I) A
REPACKAGED DRUG MUST BE LABELED WITH THE DRUG 'S18
NAME, STRENGTH, AND EXPIRATION DATE AND AND KEPT IN A SEPARATE19
DESIGNATED AREA UNTIL INSPECTED AND INITIALED BY A PHARMACIST ,20
PRACTITIONER, OR PHARMACY TECHNICIAN; AND21
(II) I
F MULTIPLE PACKAGED DONATED DRUGS WITH VARIED22
EXPIRATION DATES ARE REPACKAGED TOGETHER , A RECEIVER SHALL ACT23
BASED ON THE SOONEST EXPIRATION DATE ON THE NEW PACKAGING ; AND24
(c) U
SE THE DRUG TO REPLENISH A DRUG OF THE SAME DRUG NAME25
AND STRENGTH PREVIOUSLY DISPENSED OR ADMINISTERED TO AN ELIGIBLE26
PATIENT IN ACCORDANCE WITH SECTION 340B OF THE FEDERAL "PUBLIC27
SB22-098
-6- HEALTH SERVICE ACT", 42 U.S.C. SEC. 201 ET SEQ., AS AMENDED.1
(7) (a) A
RECEIVER MAY REDISPENSE OR ADMINISTER A DRUG TO2
AN ELIGIBLE PATIENT ONLY IF:3
(I) T
HE RECEIVER IS OTHERWISE AUTHORIZED BY LAW TO4
REDISPENSE OR ADMINISTER THE DRUG ;5
(II) T
HE DRUG MEETS THE REQUIREMENTS OF SUBSECTION (4) OF6
THIS SECTION FOR ACCEPTING DONATED DRUGS FOR REUSE ;7
(III) T
HE DRUG IS REPACKAGED PURSUANT TO SUBSECTION (6)(b)8
OF THIS SECTION OR IS IN ITS UNOPENED, TAMPER-EVIDENT PACKAGING9
WITH ALL PREVIOUS PATIENT INFORMATION REDACTED OR REMOVED ;10
(IV) T
HE DRUG IS PROPERLY LABELED IN ACCORDANCE WITH11
SECTION 12-280-124, IF APPLICABLE, AND BOARD RULES;12
(V) T
HE DONATED DRUG IS NOT EXPIRED AND WILL NOT EXPIRE ,13
BASED ON THE EXPIRATION OR BEYOND -USE DATE FOR THE DRUG, BEFORE14
USE BY THE ELIGIBLE PATIENT , BASED ON THE PRESCRIBING15
PRACTITIONER'S DIRECTIONS FOR USE OR, FOR A NONPRESCRIPTION DRUG,16
BASED ON THE EXPIRATION DATE ON THE DRUG CONTAINER 'S LABEL; AND17
(VI) T
HE DRUG IS NOT ADULTERATED OR MISBRANDED , AS18
DEFINED IN SECTIONS 25-5-410 AND 25-5-411 FOR THE PURPOSES OF THE19
"C
OLORADO FOOD AND DRUG ACT", PART 4 OF ARTICLE 5 OF TITLE 25, AS20
DETERMINED BY A PHARMACIST OR PRACTITIONER .21
(b) A
RECEIVER SHALL, TO THE GREATEST EXTENT PRACTICABLE ,22
REDISPENSE DRUGS RECEIVED UNDER THIS PART 7 TO PRIORITY PATIENTS.23
(8) A
PERSON, INCLUDING A RECEIVER, WHO RECEIVES DRUGS24
DONATED FOR USE PURSUANT TO THIS PART 7 SHALL NOT SELL OR RESELL25
OR OFFER TO SELL OR RESELL THE DONATED DRUGS . WHEN REDISPENSING26
OR ADMINISTERING A DRUG TO AN ELIGIBLE PATIENT, A RECEIVER MUST DO27
SB22-098
-7- SO AT NO COST TO THE ELIGIBLE PATIENT; EXCEPT THAT THE RECEIVER1
MAY CHARGE A UNIFORM , REASONABLE, END-USER HANDLING FEE FOR2
PROCESSING AND DISPENSING THE DRUG , WHICH FEE MUST NOT EXCEED3
THE DIRECT OR INDIRECT COST TO THE RECEIVER OF PROVIDING THE DRUG .4
C
HARGING THE FEE DESCRIBED IN THIS SUBSECTION (8) DOES NOT5
CONSTITUTE SELLING OR RESELLING THE DRUG .6
12-280-704. Change of ownership - record-keeping7
requirements. (1) A
DONATION OR OTHER TRANSFER OF POSSESSION OR8
CONTROL OF A DRUG PURSUANT TO THIS PART 7 IS NOT A CHANGE OF9
OWNERSHIP UNLESS IT IS SPECIFIED AS SUCH BY THE RECEIVER .10
(2) W
HEN PERFORMING ACTIONS PURSUANT TO THIS PART 7 OR11
OTHERWISE PROCESSING A DONATED DRUG FOR TAX , MANUFACTURER, OR12
OTHER CREDIT, A RECEIVER IS CONSIDERED TO BE ACTING AS A RETURNS13
PROCESSOR AND SHALL COMPLY WITH ALL RECORD -KEEPING14
REQUIREMENTS FOR RETURNED DRUGS THAT CANNOT BE SOLD UNDER15
FEDERAL LAW.16
12-280-705. Board rules - program administration - program17
application. T
HE BOARD SHALL ADOPT RULES FOR THE IMPLEMENTATION18
OF THIS PART 7, INCLUDING RULES FOR DONATING AND RECEIVING DRUGS ,19
LABELING AND REPACKAGING DRUGS , REDISPENSING OR ADMINISTERING20
DRUGS BY PERSONS AUTHORIZED TO DISPENSE OR ADMINISTER DRUGS , AND21
RECORD-KEEPING REQUIRED UNDER THE PROGRAM .22
12-280-706. Immunity from criminal and civil liability -23
professional discipline - exceptions. (1) (a) E
XCEPT AS PROVIDED IN24
SUBSECTION (1)(b) OF THIS SECTION, A MANUFACTURER , DONOR, OR25
RECEIVER IS NOT LIABLE IN ANY CRIMINAL OR CIVIL ACTION, OR SUBJECT26
TO PROFESSIONAL DISCIPLINE, FOR ACTS OR OMISSIONS SOLELY AND27
SB22-098
-8- DIRECTLY ATTRIBUTABLE TO DONATING , RECEIVING, REDISPENSING, OR1
ADMINISTERING A DRUG PURSUANT TO THIS PART 7.2
(b) T
HE IMMUNITY PROVIDED IN SUBSECTION (1)(a) OF THIS3
SECTION DOES NOT APPLY:4
(I) I
F THE ACT OR OMISSION WAS GROSSLY NEGLIGENT , WILLFUL,5
WANTON, OR RECKLESS; OR6
(II) I
F THE PERSON OR ENTITY KNEW OR SHOULD HAVE KNOWN7
THAT THE DONATED DRUG WAS ADULTERATED OR MISBRANDED .8
(2) N
OTHING IN THIS SECTION:9
(a) C
REATES OR ABROGATES ANY LIABILITY OF A MANUFACTURER10
FOR THE STORAGE, DONATION, ACCEPTANCE, OR REDISPENSING OF AN11
UNUSED DONATED DRUG ; OR12
(b) C
REATES ANY CIVIL CAUSE OF ACTION AGAINST A13
MANUFACTURER IN ADDITION TO THAT WHICH IS AVAILABLE UNDER14
APPLICABLE LAW.15
SECTION 2. Act subject to petition - effective date. This act16
takes effect at 12:01 a.m. on the day following the expiration of the17
ninety-day period after final adjournment of the general assembly; except18
that, if a referendum petition is filed pursuant to section 1 (3) of article V19
of the state constitution against this act or an item, section, or part of this20
act within such period, then the act, item, section, or part will not take21
effect unless approved by the people at the general election to be held in22
November 2022 and, in such case, will take effect on the date of the23
official declaration of the vote thereon by the governor.24
SB22-098
-9-