(II) Individually packaged and the packaging has not been damaged;

or (III) In the original,pened, sealed, and tamper-evident unit dose packaging;OR (IV) FORMEDICINETHATREQUIRESREFRIGERATION ,FREEZING OR SPECIALSTORAGE ,CONTINUALLYMAINTAINEDBYTHEDONORPURSUANT -4- 289 TOTHEMANUFACTURER 'SSTORAGEREQUIREMENTS ,SOLONGASTHECOLD CHAIN CAN BE VERIFIE.

(c) The following medications may not be donatedICINE IS NOT ACCEPTABLE FOR DONATION :

(I) Medications EDICINE THAT IS NOpackaged inA traditional brown or amber pill bottlesSPENSING SYSTEM ,AS DEFINED BY THE BOARD BY RULE ;

(III) MedicationEXCEPTASPROVIDEDINSUBSECTION (2)(b)(IV) OFTHISSECTION ,MEDICINE thatrequirREQUIRESrefrigeration,freezing, or special storage;

(IV) Medications that require special registration with the manufacturer;

or (V) MedicationsM EDICINEthat arISadulterated or misbranded, as determined bya person legallyauthorizedto dispense the medications MEDICINE on behalf of the nonprofit entiOR A PERSON LEGALLY AUTHORIZED TO DISPENSE THE MEDICINE;

(VI) COMPOUNDED MEDICINE ;

(VII) M EDICINE DISPENSED BY PHARMACIES OUTSIDE OF THE U NITEDS TATES;OR (VIII) M EDICINE THAT IS SUBJECT TO RISK EVALUATION AND MITIGATION STRATEGIES (REMS) UNDER 21 U.S.C.

SEC.

355-1 (f)(3) UNLESS ALL OF THE REQUIRED GUIDELINES FOR THE MEDICINE ARE FOLLOWED OR REMS DRUGS THAT WERE INITIALLY DISPENSED BY A PHARMACYPURSUANT TO A RESTRICTED REMS DISTRIBUTIONCHANNEL .

(3) MedicationM EDICINE dispensed or donated pursuant to this section must not be expired.

A medication shall not be dispensed PRESCRIBING PRACTITIONER SHALL NOT DISPENSE MEDICINE that will -5- 289 expirebeforetheusebythepatientbasedontheprescribingpractitioner's directions for use.

(4) MedicationM EDICINE,medicalsupplies,andmedicaldevices donated pursuant to this section mayL not be resold for profit.

The entity that receives the donated materials may charge the end user a handling fee, which fee shall not exceed the amount specified by rule of theboard ANDARECONSIDEREDNONSALEABLE ;EXCEPTTHATHANDLING , DISPENSING, OR USUAL AND CUSTOMARY CHARGES TO AN ELIGIBLE PATIENT ,HEALTH PLAN ,PHARMACY BENEFIT MANAGER ,PHARMACY SERVICE ,ADMINISTRATIVE ORGANIZATION , GOVERNMENT AGENCY ,OR OTHER ENTITY IS NOT CONSIDERED RESELLING .

F THE DONATION RECIPIENT IS A FO-PROFIT ENTIT,THESE CHARGES MUST NOT EXCEED THEDONATIONRECIPIENT SCOSTOFPROVIDINGTHEMEDICINE ,INCLUDING THE CURRENT AND ANTICIPATED COSTS OF EDUCATING ELIGIBLE DONORS AND INDIVIDUAL DONORS , PROVIDING TECHNICAL SUPPORT TO PARTICIPATING DONORS AND INDIVIDUAL DONORS , SHIPPING AND HANDLING , LABOR , STORAGE , LICENSING, UTILITIE, ADVERTISING , TECHNOLOGY ,SUPPLIES,AND EQUIPMENT .EXCEPT AS DESCRIBED IN THIS SUBSECTION (4)THE AMOUNT OF THESE CHARGES IS NOT SUBJECT TO ADDITIONAL LIMITATIONS.

(5) The board shall adopt rules that allow a pharmacist to redispensemedicationpursuanttothissectionandsection25.5-5-502and to donate medication pursuant to this section.

(6) Nothing in this section or section 25.5-5-502 creates or abrogates any liability on behalf of a prescription drug manufacturer for the storage, donation, acceptance, or dispensing of and donated medication MEDICINE or creates any civil cause of action against a -6- 289 prescription drug manufacturer in addition to that which is available under applicable law.

SECTION2.

InColoradoRevisedStatutes,add12-280-135.5as follows:

12-280-135.5.

Colorado drug donation program - created - rules - records - definitions.

(1) AED IN THIS SECTI,UNLESS THE CONTEXT OTHERWISE REQUIRES :

(a) "C OLORADO DRUG DONATION PROGRAM " OR "PROGRAM " MEANS THE COLORADO DRUG DONATION PROGRAM CREATED IN THIS SECTION .

(b) "CONTROLLED SUBSTANCE " HAS THE MEANING SET FORTH IN SECTION 18-18-102.

(c) (I) "DNATION RECIPIENT" MEANS AN ENTITY THAT :

(A) IS LEGALLY AUTHORIZED TO POSSESS MEDICINE ;

(B) H AS A LICENSE OR REGISTRATION IN GOOD STANDING IN THE STATE IN WHICH THE ENTITY IS LOCATE;

AND (C) R ECEIVES A DONATION OF MEDICINE.

(II) "DONATION RECIPIENT " INCLUDES A HOSPITAL , A PHARMACY , A CLINIC,A HEALTH -CARE PROVIDER , OR A PRESCRIBER OFFICE.

(III) "DONATION RECIPIENT" ALSO INCLUDES A WHOLESALER , A DISTRIBUTOR , A THIRD -PARTY LOGISTICS PROVIDER , A REVERSE DISTRIBUTOR ,ORAREPACKAGERIFTHEENTITYISANONPROFITENTITYOR IS DIRECTLY OR INDIRECTLY OWNED ,CONTROLLED , OR COULD BE CONTROLLED BY A NONPROFIT ENTITY .

(d) (I) "DONOR "MEANS ANY ENTITY LEGALLY AUTHORIZED TO POSSESS MEDICINE ,INCLUDING A WHOLESALER ,A DISTRIBUTOR, A -7- 289 THIRD PARTYLOGISTICSPROVIDER ,APHARMACY ,ADISPENSER ACLINIC , ASURGICALORHEALTHCENTER ,AREHABILITATIONCENTER ,ADETENTION CENTER ,A JAIL,A PRISON ,A LABORATORY ,A PRESCRIBER OR OTHER HEALTH -CARE PROFESSIONAL , A LONG-TERM CARE FACILITY OR HEALTH -CARE FACILITY,AND ANY OTHER ENTITY REGULATED BY THE BOARD THAT DONATES MEDICINE .

(II) "DONOR "INCLUDES GOVERNMENT AGENCIES AND ENTITIES THAT ARE FEDERALLY AUTHORIZED TO POSSESS MEDICINE , INCLUDING MANUFACTURERS ,REPACKAGERS ,RELABELERS OUTSOURCINGFACILITIES , VETERANS AFFAIRS HOSPITALS , FDA-AUTHORIZED IMPORTERS SUCH AS THOSE DESCRIBED UNDER THE FEDERAL "FOOD, DRUG ,AND C OSMETIC A CT", 21 U.S.C.

SECS.

801 AND 804, AS AMENDED ,OR SIMILAR PROVISIONS,AND FEDERAL PRISONS .

(e) (I) "EIGIBLE PATIEN" MEANS AN INDIVIDUAL WITH A NEED FOR DONATED MEDICINE WHO IS INDIGENT, UNINSURED , OR UNDERINSURED .

(II) "EIGIBLE PATIEN" INCLUDES OTHER INDIVIDUALS IFA NEED FORDONATEDMEDICINEISNOTIDENTIFIEDAMONGINDIVIDUALSWHOARE INDIGENT ,UNINSURED,OR UNDERINSURED .

(f) "HEALTH-CAREPROFESSIONAL "MEANSANINDIVIDUALWHOIS LICENSED TO PRACTICE AS A PHYSICIA,REGISTERED NURSE ,ADVANCED PRACTICE REGISTERED NURSE , PRACTICAL NURSE ,OPTOMETRIST , OR PHARMACIST ;

A CERTIFIED MIDWIFE WITH PRESCRIPTIVE AUTHORITY PURSUANT TO SECTION 12-255-112;OR ANY OTHER PRACTITIONER AUTHORIZED TO DISPENSE OR ADMINISTER MEDICINE.

(g) "INDIVIDUAL DONOR "MEANS A NONLICENSED INDIVIDUAL MEMBER OF THE PUBLIC .

-8- 289 (h) (I) "EDICINE"MEANS PRESCRIPTION DRUGS.

(II) "MEDICIN" INCLUDES:

(A) A PRESCRIPTION DRUG THAT REQUIRES REFRIGERATION , FREEZING,ORSPECIALSTORAGEIFTHEMEDICINEHASBEENCONTINUALLY MAINTAINED BY THE DONOR PURSUANT TO THE MANUFACTURER S STORAGEREQUIREMENTS ,SOLONGASTHECOLDCHAINCANBEVERIFIED ;

AND (B) PRESCRIPTION SUPPLIES AND DEVICE.

(III) "MDICINE"DOES NOT INCLUDE :

(A) C OMPOUNDED DRUGS ;

(B) PRESCRIPTIONDRUGSDISPENSEDBYPHARMACIESOUTSIDEOF THE UNITED STATES;

(C) PRESCRIPTIONDRUGSTHATARESUBJECTTORISKEVALUATION ANDMITIGATIONSTRATEGIES (REMS) UNDER 21U.S.C.SEC.355-1(f)(3) UNLESS ALL OF THE REQUIRED GUIDELINES FOR THE MEDICINE ARE FOLLOWED OR REMS DRUGS THAT WERE INITIALLY DISPENSED BY A PHARMACYPURSUANT TOARESTRICTED REMS DISTRIBUTIONCHANNEL ;

OR (D) C ONTROLLED SUBSTANCES .

(i) "PRESCRIBER" HAS THE MEANING SET FORTH IN SECTION 12-280-125.7 (1)(f).

(j) "RETURNS PROCESSOR "HAS THE MEANING SET FORTH IN 21 U.S.C.SEC.

360eee (18AND INCLUDES A REVERSE DISTRIBUTOR.

(k)(I) "U NOPENED ,TAMPER EVIDENT PACKAGING " MEANS AN INTACT PACKAGING SYSTEM THAT RENDERS MEDICINE INACCESSIBLE WITHOUT OBVIOUS DESTRUCTION OF THE SEAL OR SOME PORTION OF THE PACKAGING SYSTEM .

-9- 289 (II) "UNOPENED, TAMPER-EVIDENT PACKAGING "MAY INCLUDE UNOPENED UNIT -DOSE, MULTIPLEDOSE ,IMMEDIATE ,SECONDARY , OR TERTIARY PACKAGING .

(2) TEREISCREATEDTHE C OLORADODRUGDONATIONPROGRAM TO FACILITATE THE SAFE DONATION AND REDISPENSING OF UNUSED MEDICINE TOC OLORADANS IN NEED OFTHE MEDICIN.PARTICIPATION IN THE PROGRAM IS VOLUNTARY .

(3) (a) NOTWITHSTANDING ANY OTHER LAW OR RULE TO THE CONTRARY ,A DONOR OR AN INDIVIDUAL DONOR MAY DONATE MEDICINE TO A DONATION RECIPIENT .

A DONATION RECIPIENT MAY RECEIVE DONATED MEDICINE FROM A DONOR OR AN INDIVIDUAL DONOR.

(b) PRIOR TO THE FIRST DONATION FROM A PERS,A DONATION RECIPIENTSHALLRECORDTHEPERSON 'SNAME ADDRESS ,PHONENUMBER , AND LICENSE NUMBER ,IF APPLICAB,AND SHALL :

(I) VRIFYTHATTHEPERSONMEETSTHEDEFINITIONPROVIDEDIN SUBSECTION (1)(dOF THIS SECTIO;

(II) CNFIRM THAT THE PERSON AGREES TO MAKE DONATIONS OF MEDICINEONLYINACCORDANCEWITHTHISSECTIONANDRULESADOPTED BY THE BOARD RELATING TO DONATED MEDICINE;AND (III) I APPLICABLE,CONFIRM THAT THE PERSON AGREES TO REMOVEORREDACTANYPATIENTNAMESANDPRESCRIPTIONNUMBERSON DONATED MEDICINE OR TO OTHERWISE MAINTAIN PATIENT CONFIDENTIALITY BY EXECUTING A CONFIDENTIALITY AGREEMENT WITH THE AUTHORIZED DONATION RECIPIENT.

(c) NOOTHERINFORMATIONORRECORDSAREREQUIREDPRIORTO THE FIRST DONATION FROM A NEW DONOR OR A NEW INDIVIDUAL DONOR OTHER THAN AS DESCRIBED IN SUBSECTIO(3)(b)OF THIS SECTIO.

-10- 289 (4) A DONATION RECIPIENT SHALL MAINTAIN A WRITTEN OR AN ELECTRONIC RECORD OF DONATED MEDICINE CONSISTING OF THE NAME, STRENGTH ,QUANTITY ,AND LOT NUMBER,IF KNOWN ,OF EACH ACCEPTED ORTRANSFERREDDRUGANDTHENAME ,ADDRESS ,ANDPHONENUMBEROF THE DONOR ,INDIVIDUAL DONOR ,OR TRANSFERRING ENTITY.

O OTHER RECORD OF DONATION IS REQUIRED.

(5) A DONATION RECIPIENT SHALL ENSURE THAT DONATED MEDICINE IS IDENTIFIED PHYSICALLY OR ELECTRONICALLY AS SEPARATE FROM REGULAR STOCK .

(6) N OTWITHSTANDING ANY OTHER LAW TO THE CONTRARY , A DONATION RECIPIENT MAY :

(a) TRANSFER DONATED MEDICINE TO ANOTHER DONATION RECIPIENT OR TO AN ENTITY PARTICIPATING IN A DRUG DONATION PROGRAM OPERATED BY ANOTHER STATE ;

(b) REPACKAGE DONATED MEDICINE IN ACCORDANCE WITH SUBSECTION (8) OF THIS SECTION AS NECESSARY FOR STORAGE , DISPENSING,ADMINISTRATION ,OR TRANSFER;OR (c) I THE DONATION RECIPIENT IS A PRESCRIPTION DRUG OUTLET OR OTHER OUTLET ,REPLACE MEDICINE OF THE SAME DRUG NAME AND STRENGTH PREVIOUSLY DISPENSED OR ADMINISTERED TO ELIGIBLE PATIENTS IN ACCORDANCE WITH 42 U.S.CSEC.

256b,AS AMENDED .

(7) (a) D ONATED MEDICINE THAT DOES NOT MEET THE REQUIREMENTS SPECIFIED IN THIS SECTION AND THE RULES ADOPTED BY THE BOARD MUST BE DISPOSED OF B:

(I) RETURNING THE DONATED MEDICINE TO THE DONOR;

(II) D ESTROYING THE DONATED MEDICINE THROUGH AN INCINERATOR ,A MEDICAL WASTE HAULER ,A REVERSE DISTRIBUTO,OR -11- 289 OTHER LAWFUL METHOD ;OR (III) TRANSFERRING THE DONATED MEDICINE TO A RETURNS PROCESSOR .

(b) A DONATION RECIPIENT SHALL MAINTAIN A WRITTEN OR AN ELECTRONICRECORDOFDISPOSEDMEDICINECONSISTINGOFTHEDISPOSAL METHOD ,ASDESCRIBEDINSUBSECTION (7)(aOFTHISSECTION;THEDATE OF DISPOSAL;

AND THE NAME ,STRENGTH ,AND QUANTITY OF EACH DISPOSED DRUG.

NO OTHER RECORD OF DISPOSAL IS REQUIR.D (8) REPACKAGED MEDICINE MUST BE LABELED WITH THE DRUG NAME ,STRENGTH ,AND EXPIRATION DATE ,IF THE EXPIRATION DATE IS KNOWN ,AND IDENTIFIED SEPARATELY FROM REGULAR STOCK UNTIL INSPECTED AND INITIALED BY A LICENSED PHARMACIST.

F MULTIPLE PACKAGED ,DONATED MEDICINES WITH VARIED EXPIRATION DATES ARE REPACKAGEDTOGETHER ,THEEARLIESTEXPIRATIONDATEMUSTBEUSED .

PRESCRIPTION DRUGS SPECIFIED BNDC NUMBER IN A RECALL NOTICE MUSTBECONSIDEREDRECALLEDUNLESSTHEPRESCRIPTIONDRUGHASAN AFFIXED LOT NUMBER THAT EXCLUDES IT FROM THE RECAL.

(9) A DONATION RECIPIENT SHALL ONLY ADMINISTER OR REDISPENSE MEDICINE THAT:

(a) I IN UNOPENED,TAMPER EVIDENT PACKAGING OR HAS BEEN REPACKAGED UNDER THIS PROGRAM ;

(b) MEETSTHEREQUIREMENTSSETFORTHINTHISSECTIONBASED ON AN INSPECTION BY A LICENSED PHARMACIS;

(c) I DISPENSED TO AN ELIGIBLE PATIE,IS REPACKAGED BY A LICENSED PHARMACIST INTO A NEW CONTAINER OR , IF KEPT IN THE DONATED CONTAINER ,IS IN A CONTAINER THAT HAS ALL PREVIOUS PATIENT INFORMATION REDACTED OR REMOVED ;

-12- 289 (d) I S PROPERLY LABELED IN ACCORDANCE WITH THE RULES ADOPTED BY THE BOARD ;

(e) H AS AN EXPIRATION OR BEYOND USE DATE THAT WILL NOT EXPIREBEFORETHEMEDICINEISUSEDBYTHEELIGIBLEPATIENTBASEDON THE PRESCRIBER'S DIRECTIONS FOR US;AND (f) IF THE MEDICINE REQUIRES REFRIGERATION ,FREEZING, OR SPECIAL STORAGE ,HAS BEEN CONTINUALLY MAINTAINED PURSUANT TO THE MANUFACTURER 'S STORAGE REQUIREMENTS ,SO LONG AS THE COLD CHAIN CAN BE VERIFIED.

(10) A DONATION RECIPIENT:

(a) M AY DISPENSE OR ADMINISTER PRESCRIPTION DRUGS TO AN ELIGIBLE PATIENT PURSUANT TO THIS SECTION ONLY IF OTHERWISE PERMITTEDBYLAWPURSUANTTOAVALIDPRESCRIPTIONORPRESCRIPTION DRUG ORDER ;

AND (b) S HALL MAINTAIN ELIGIBLE PATIENT-SPECIFIC WRITTEN OR ELECTRONIC RECORDS IN ACCORDANCE WITH RULES ADOPTED BY THE BOARD .

(11) A MANUFACTURER , PRESCRIPTION DRUG OUTLET , REPACKAGER ,DISPENSER, OR WHOLESALER ,OTHER THAN A RETURNS PROCESSOR ,PARTICIPATING IN THE PROGRAM SHALL COMPLY WITH THE REQUIREMENTS OF 21 U.S.C.SECS.

360eee-1TO360eee-4 RELATING TO DRUG SUPPLY CHAIN SECURITY .

(12) THE DONATION ,TRANSFER ,OR RECEIPT OF MEDICINE OR THE FACILITATION OF A DONATION ,TRANSFER ,OR RECEIPT OF MEDICINE PURSUANT TO THIS SECTION IS NOT WHOLESALE DISTRIBUTION AND DOES NOT REQUIRE LICENSING AS A WHOLESALE DISTRIBUTOR.

(13) M EDICINE DONATED TO THE PROGRAM MUST NOT BE RESOLD -13- 289 ANDISCONSIDEREDNONSALEABLE ;EXCEPTTHATHANDLING ,DISPENSING, OR USUAL AND CUSTOMARY CHARGES TO AN ELIGIBLE PATIENT ,HEALTH PLAN , PHARMACY BENEFIT MANAGER , PHARMACY SERVICES ADMINISTRATIVE ORGANIZATION , GOVERNMENT AGENCY , OR OTHER ENTITY IS NOT CONSIDERED RESELLING.F THE DONATION RECIPIENT IS A FOR PROFIT ENTITY,THESE CHARGES MUST NOT EXCEED THE DONATION RECIPIENT'SCOSTOFPROVIDINGTHEMEDICINE ,INCLUDINGTHECURRENT AND ANTICIPATED COSTS OF EDUCATING ELIGIBLE DONORS AND INDIVIDUALDONORS ,PROVIDINGTECHNICALSUPPORT TO PARTICIPATING DONORS AND INDIVIDUAL DONORS ,SHIPPING AND HANDLING , LABOR , STORAGE ,LICENSING,UTILITIES,ADVERTISING,TECHNOLOGY ,SUPPLIES, AND EQUIPMENT .

XCEPT AS DESCRIBED IN THIS SUBSECTION(13),THE AMOUNT OF THESE CHARGES IS NOT SUBJECT TO ANY ADDITIONAL LIMITATIONS.

(14) W HEN PERFORMING ANY ACTION ASSOCIATED WITH THE PROGRAM OR OTHERWISE PROCESSING DONATED MEDICINE FOR TAX ,A MANUFACTURER CREDIT , OR OTHER CREDIT,A DONATION RECIPIENT IS CONSIDEREDTOBEACTINGASARETURNSPROCESSORANDSHALLCOMPLY WITH ALL RECORD -KEEPING REQUIREMENTS UNDER FEDERAL LAW FOR NONSALEABLE RETURNS .

(15) ALL REQUIRED RECORDS MUST BE RETAINED IN PHYSICALOR ELECTRONIC FORMAT ,ON OR OFF THE DONATION RECIPIENTS PREMISES, FOR A PERIOD OF TWO YEARS .

DONORS OR DONATION RECIPIENTS MAY CONTRACT WITH ONE ANOTHER OR WITH A THIRD PARTY TO CREATE OR MAINTAIN RECORDS .

AN IDENTIFIE,SUCH AS A SERIAL NUMBER OR BAR CODE ,MAY BE USED IN PLACE OF INFORMATION IF IT ALLOWS FOR THE INFORMATION TO BE READILY RETRIEVABLE .UPON REQUEST BY A STATE -14- 289 ORFEDERALREGULATOR ,THEIDENTIFIERUSEDFORAREQUESTEDRECORD MUST BE REPLACED WITH THE ORIGINAL INFORMATION .

N IDENTIFIER MUST NOT BE USED ON LABELS WHEN DISPENSING OR ADMINISTERING A DRUG TO AN ELIGIBLE PATIEN.

(16) A DONATION OR OTHER TRANSFER OF POSSESSION OR CONTROLISNOTACHANGEOFOWNERSHIPUNLESSITISSPECIFIEDASSUCH BY THE DONATION RECIPIENT .

F A RECORD OF THE DONATION S TRANSACTIONINFORMATIONORHISTORYISREQUIRED ,THEHISTORYMUST BEGINWITHTHEDONORORINDIVIDUALDONOR MUSTINCLUDEALLPRIOR DONATIONS ,AND ,IF THE MEDICINE WAS PREVIOUSLY DISPENS,DMUST INCLUDE ONLY DRUG INFORMATION THAT IS REQUIRED TO BE ON THE PATIENT LABEL IN ACCORDANCE WITH RULES ADOPTED BY THE BOAR.

(17) AN ENTITY PARTICIPATING IN A DRUG DONATION OR REPOSITORY PROGRAM OPERATED BY ANOTHER STATE MAY PARTICIPATE INTHEPROGRAMAND ,IFTHEREGISTEREDENTITYISAPRESCRIPTIONDRUG OUTLET ,MAY DISPENSE DONATED DRUGS TO ELIGIBLE PATIENTS OF THIS STATE.

THE REGISTERED ENTITY IS REQUIRED TO COMPLY WITH ALL STATUTES AND RULES IN THIS STATE UNLESS THE STATUTES OR RULES DIFFER FROM OR CONFLICT WITH THE STATUTES OR RULES OF THE STATE IN WHICH THE ENTITY IS LOCAT.D (18) THE BOARD SHALL ADOPT ANY RULES NECESSARY TO IMPLEMENTTHISSECTION .THERULESMUSTREQUIRETHELEASTAMOUNT OF RECORD KEEPING NECESSARY TO ENSURE PATIENT SAFETY AND MUST ALLOW FLEXIBILITY IN THE FORMAT FOR RECORD KEEPI.G (19) NOTWITHSTANDING ANY LAW TO THE CONTRARY ,THIS SECTION CONTROLS ALL ACTIVITIES UNDER THE PROGRAM AND SUPERSEDES ANY INCONSISTENT LAW OR RULE.

-15- 289 (20) W HEN ACTING IN GOOD FAITH,WITHOUT NEGLIGENCE OR WILLFUL OR WANTON MISCONDUCT , THE FOLLOWING INDIVIDUALS OR ENTITIES ARE NOT SUBJECT TO CIVIL OR CRIMINAL LIABILITY OR PROFESSIONAL DISCIPLINARY ACTIO:

(a) ANINDIVIDUALORENTITYINVOLVEDINTHESUPPLYCHAINOF DONATEDMEDICINE INCLUDINGTHEDONOR ,THEINDIVIDUALDONOR ,THE DONATION RECIPIENT ,THE MANUFACTURER , THE REPACKAGER , THE PRESCRIPTION DRUG OUTLET OR OTHER ENTITY REGULATED BY THE BOARD ,AND THE ELIGIBLE PATIEN;

(b) A N INDIVIDUAL OR ENTIT, INCLUDING AN EMPLOYEE, AN OFFICER,A VOLUNTEER,AN OWNER ,A PARTNER,A MEMBER ,A DIRECTOR, ACONTRACTOR ,OROTHERINDIVIDUALORENTITYASSOCIATEDWITHTHE INDIVIDUAL OR ENTITY THAT , IN COMPLIANCE WITH THIS SECTION , PRESCRIBES , DONATES , RECEIVES DONATIONS OF, DISPENSES , ADMINISTERS, TRANSFERS, REPLACES, OR REPACKAGES MEDICINE OR FACILITATES ANY OF THE ACTIONS DESCRIBED IN THIS SEC;AND (c) THE BOARD.

(21) A DONATION RECIPIENT OPERATING PRIMARILY FOR THE PURPOSEOFPARTICIPATINGINTHISPROGRAMSHALLNOTBEREQUIREDTO POSSESS A COMPREHENSIVE OR MINIMUM SUPPLY OF MEDICIN.

SECTION 3.

In Colorado Revised Statutes, 25-15-328, amend (6)(a) as follows:

25-15-328.

Household medication take-back program - creation - collection and disposal of medication injection devices - liability - definitions - cash fund - rules.

(6) Nothing in this section:

(a) Affects the authority to collect and reuse medications MEDICINE pursuant to section 12-280-OR12-280-135.5;

or -16- 289 SECTION 4.

In Colorado Revised Statutes, add 12-315-127 as follows:

12-315-127.

Veterinarydrugdonationprogram-rules.(1) A N OWNER OF AN ANIMAL MAY DONATE A DRUG THAT IS DISPENSED FOR BUT NOT USED BY THE ANIMAL TO A LICENSED VETERINARIAN OR ANIMAL SHELTERINWHICHVETERINARYMEDICINE IS PRACTICED IFTHE LICENSED VETERINARIAN OR ANIMAL SHELTER ACCEPTS THE DRUG .

(2) EXCEPT AS PROVIDED IN SUBSECTION(4)(b)OF THIS SECTIO, A LICENSED VETERINARIAN MAY REISSUE A DONATED DRUG ACCEPTED PURSUANT TOTHISSECTION TO FILLOTHERPRESCRIPTIONSDISPENSEDBY THE LICENSED VETERINARIAN FREE OF CHARGE FOR AN ANIMAL IF:

(a) THE LICENSED VETERINARIAN DETERMINES THAT THE OWNER OFTHE ANIMAL IS ELIGIBLE FOR THE REISSUANCE OF THE DRUG BASED ON ECONOMIC NEED ;

(b) THE LICENSED VETERINARIAN DETERMINES THAT THE DRUGIS SUITABLE FOR REISSUANCE ;

(c) THE DRUG WAS ORIGINALLY DISPENSED BY A LICENSED VETERINARIAN ;

(d) THE DRUG IS NOT A CONTROLLED SUBSTANCE ;

(e) THE DRUG IS NOT A COMPOUNDED DRUG ;

(f) THEDRUGDOESNOTREQUIREREFRIGERATIONBEFOREOPENING AND THE DRUG WAS UNOPENED WHEN DONATED ;

(g) THE DRUGISNOTINALIQUIDFORMOR IFINLIQUIDFORM THE DRUG IS PACKAGED IN A SINGLE DOSE IN AN AMPULE OR VIA;

(h) THE DRUG HAS NOT EXPIRED ;

(i) THE PACKAGING OR BOTTLE CONTAINS THE EXPIRATION DATE OF THE DRUG ;AND -17- 289 (j) THE NAME OF THE ANIMAL AND THE NAME OF THE OWNER OF THE ANIMAL FOR WHICH THE DRUG WAS ORIGINALLY DISPENSED ,THE PRESCRIPTION NUMBER , AND ANY OTHER IDENTIFYING MARKS ARE OBLITERATED FROM THE PACKAGING OR BOTTLE BEFORE THE DRUG IS REISSUED .

(3) A LICENSED VETERINARIAN SHALL:

(a) IDENTIFY AND MAINTAIN SEPARATELY FROM OTHER STOCK A DONATED DRUG ACCEPTED PURSUANT TO THIS SECTION ;AND (b) M AKE A RECORD OF EACH DONATED DRUG ACCEPTED PURSUANT TO THIS SECTION THAT INCLUDES,AT A MINIMUM :

(A) T HE DATE ON WHICH THE DRUG WAS DONATED ;

(B) T HE NAME OF THE PERSON WHO DONATED THE DRUG ;AND (C) T HE EXPIRATION DATE OF THE DRU.

(4) A LICENSED VETERINARIAN SHALL NOT:

(a) SELL OR RESELL A DONATED DRUG ACCEPTED PURSUANT TO THIS SECTION;OR (b) D ISPENSE A DONATED DRUG ACCEPTED PURSUANT TO THIS SECTION TO FILL OTHER PRESCRIPTIONS DISPENSED BY THE LICENSED VETERINARIAN FOR AN ANIMAL IF THE ANIMAL IS RAISED TO PRODUCE FOOD FOR HUMAN CONSUMPTION OR THE ANIMAL IS ORDINARILY CONSUMEDBYANIMALSTHATARERAISEDTOPRODUCEFOODFORHUMAN CONSUMPTION .

(5) (a) A LICENSED VETERINARIAN,ANIMAL SHELTER IN WHICH VETERINARY MEDICINE IS PRACTICED,OR OTHERPERSON WHO EXERCISES REASONABLE CARE IN THE DONATION ,ACCEPTANCE , DISTRIBUTION,OR DISPENSATION OF A DRUG IN ACCORDANCE WITH THIS SECTION AND ANY RULES ADOPTED PURSUANT TO THIS SECTION IS NOT SUBJECT TO CIVIL OR -18- 289 CRIMINAL LIABILITY OR DISCIPLINARY ACTION BY A PROFESSIONAL LICENSINGBOARDFORANYLOSS ,INJURY,ORDEATHTHATRESULTSFROM THE DONATION ,ACCEPTANCE ,DISTRIBUTION,OR DISPENSATION OF THE DRUG .

(b) A MANUFACTURER OF A DRUG IS NOT SUBJECT TO CIVIL OR CRIMINAL LIABILITY FOR ANY CLAIM OR INJURY ARISING FROM THE DONATION ,ACCEPTANCE ,DISTRIBUTIO,OR DISPENSATION OF THE DRUG PURSUANTTOTHISSECTIONANDANYRULESADOPTEDPURSUANTTOTHIS SECTION.

(6) THE BOARD MAY ADOPT RULES AS NECESSARY TO IMPLEMENT THIS SECTIO,INCLUDING :

(a) EQUIREMENTSFORREISSUINGDONATEDDRUGSPURSUANTTO THIS SECTION,INCLUDING REQUIREMENTS THAT PROVIDE APPROPRIATE SAFEGUARDSFORENSURINGTHATTHEDRUGSARENOTCOMPROMISEDOR ILLEGALLY DIVERTED BEFORE BEING REISSUE;

(b) REQUIREMENTS FOR ACCEPTING DRUGS DONATED BY A LICENSED VETERINARIAN OR ANIMAL SHELTER;AND (c) REQUIREMENTSFORMAINTAININGRECORDSRELATINGTOTHE ACCEPTANCEANDUSEOFDONATEDDRUGSTOFILLOTHERPRESCRIPTIONS PURSUANT TO THIS SECTIO.

SECTION 5.

Act subject to petition - effective date.

This act takes effect at 12:01 a.m.

on the day following the expiration of the ninety-dayperiodafterfinaladjournmentofthegeneralassembly;except that, if a referendumpetition is filed pursuant to section 1 (3)of article V of the state constitution against this act or an item, section, or part of this act within such period, then the act, item, section, or part will not take effect unless approved by the people at the general election to be held in -19- 289 November 2026 and, in such case, will take effect on the date of the official declaration of the vote thereon by the governor.

-20- 289