SB 25-289 — Creation of a Drug Donation Program

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

-10- 289 (II) CNFIRMONFIRM 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.

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

ONO OTHER RECORD OF DONATION IS REQUIRED.REQUIRE.

(6) NNOTWITHSTANDING OTWITHSTANDING ANY OTHER LAW TO THE CONTRARY ,,A A DONATION RECIPIENT MAYMAY: :

(b) REPACKAGE DONATED MEDICINE IN ACCORDANCE WITH SUBSECTION (8) OF THIS SECTION AS NECESSARY FOR STORAGE , -11- 289 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.

(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(7)(aOFTHISSECTION ;THEDATE OF DISPOSAL;

AND THE NAME ,STRENGTH ,AND, 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.PHARMACIST .

PRESCRIPTION DRUGS SPECIFIED BNDCBYNDC NUMBER IN A RECALL NOTICE MUSTBECONSIDEREDRECALLEDUNLESSTHEPRESCRIPTIONDRUGHASAN -12- 289 AFFIXED LOT NUMBER THAT EXCLUDES IT FROM THE RECAL.RECALL .

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

(b) MEETSTHEREQUIREMENTSSETFORTHINTHISSECTIONBASEDM EETSTHEREQUIREMENTSSETFORTHINTHISSECTIONBASED ON AN INSPECTION BY A LICENSED PHARMACIS;PHARMACIST;

(c) IIF DISPENSED TO AN ELIGIBLE PATIE,IS REPACKAGED BY A LICENSED PHARMACIST INTO A NEW CONTAINER OR ,,IF 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 BY THE DONOR PURSUANT TO THE MANUFACTURER 'SS STORAGE REQUIREMENTS ,SO LONG AS THE COLD CHAIN CAN BE VERIFIED.VERIFIE.

AND (b) S HALL MAINTAIN ELIGIBLE PATIENT-SPECIFIC WRITTEN OR ELECTRONIC RECORDS IN ACCORDANCE WITH RULES ADOPTED BY THE -13- 289 BOARD .

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

360eee-1TO360eee-4360eee-1TO RELATING360eee-4RELATING TO DRUG SUPPLY CHAIN SECURITYSECURITY. .

(12) THE DONATION ,TRANSFER,TRANSFER,OR ,OR RECEIPT OF MEDICINE OR THE FACILITATION OF A DONATION ,TRANSFER, ,ORTRANSFER, 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 GOVERNMENT AGENCY ,,OR OR OTHER ENTITY IS NOT CONSIDERED RESELLING.FRESELLIN.IF THE DONATION RECIPIENT IS A FOR PROFIT ENTITY,THESE CHARGES MUST NOT EXCEED THE DONATION RECIPIENT'SCOSTOFPROVIDINGTHEMEDICINERECIPIENTSCOSTOFPROVIDINGTHEMEDICINE ,INCLUDINGTHECURRENT AND ANTICIPATED COSTS OF EDUCATING ELIGIBLE DONORS AND INDIVIDUALDONORS ,PROVIDINGTECHNICALSUPPORT,PROVIDING TOTECHNICALSUPPORT PARTICIPATINGTOPARTICIPATING DONORS AND INDIVIDUAL DONORS ,SHIPPING AND HANDLING ,,LABOR LABOR , STORAGE ,LICENSING,UTILITIES,ADVERTISING,TECHNOLOGY,LICENSING,UTILITIE,ADVERTISING ,TECHNOLOGY ,SUPPLIES, AND EQUIPMENT .

XCEPTEXCEPT AS DESCRIBED IN THIS SUBSECTION(13),THESUBSECTIO(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 -14- 289 MANUFACTURER CREDIT ,,OR OR OTHER CREDIT,A DONATION RECIPIENT IS CONSIDEREDTOBEACTINGASARETURNSPROCESSORANDSHALLCOMPLY WITH ALL RECORD -KEEPINGKEEPING REQUIREMENTS UNDER FEDERAL LAW FOR NONSALEABLE RETURNS .

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

ANN 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 RETRIEVABLERETRIEVABL.U .UPONPON REQUEST BY A STATE -14- 289 ORFEDERALREGULATOR ,THEIDENTIFIERUSEDFORAREQUESTEDRECORDTHEIDENTIFIERUSEDFORAREQUESTEDRECORD MUST BE REPLACED WITH THE ORIGINAL INFORMATION .

(17) ANA N 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 -15- 289 STATE.

-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,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 -16- 289 (c) THE BOARD.

(21) N OTWITHSTANDING SUBSECTION (20) OF THIS SECTIO,A MANUFACTURER OF A PRESCRIPTION DRUG THAT IS SUBJECT TO RISK EVALUATION AND MITIGATION STRATEGIES (REMS) IS NOT SUBJECT TO CRIMINALPROSECUTIONORLIABILITYINTORTOROTHERCIVILACTIONFOR INJURY,DEATH ORLOSSTOPERSONORPROPERTYFORMATTERSRELATED TO THE DONATION , ACCEPTANCE ,OR DISPENSING OF A REMS DRUG MANUFACTUREDBYTHEDRUGMANUFACTURERTHATISDONATEDBYANY PERSON PURSUANT TO THE PROGRAM INCLUDING LIABILITY FOR FAILURE TO TRANSFER OR COMMUNICATE PRODUCT OR CONSUMER INFORMATION OR THE EXPIRATION DATE OF THE DONATED PRESCRIPTION DR.G (22) A DONATION RECIPIENT OPERATING PRIMARILY FOR THE PURPOSEOFPARTICIPATINGINTHISPROGRAMSHALLNOTBEREQUIREDTO POSSESS A COMPREHENSIVE OR MINIMUM SUPPLY OF MEDICIN.

or -16- 289 SECTION 4.

Veterinarydrugdonationprogram-rules.(1) AAN 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 SHELTERINWHICHVETERINARYMEDICINESHELTERIN ISWHICH PRACTICEDVETERINARY IFTHEMEDICINE ISPRACTICEDIFTHE LICENSED -17- 289 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 FILLOTHERPRESCRIPTIONSDISPENSEDBYTHIS SECTIONTOFILLOTHERPRESCRIPTIONSDISPENSEDBY THE LICENSED VETERINARIAN FREE OF CHARGE FOR AN ANIMAL IF:

(b) THE LICENSED VETERINARIANVETERINARIANDETERMINES DETERMINES THAT THE DRUGISDRUG IS SUITABLE FOR REISSUANCE ;

(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:SHALL :

-18- 289 (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)(I) TTHE HE DATE ON WHICH THE DRUG WAS DONATED ;

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

(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, 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 -19- 289 DONATION ,ACCEPTANCE ,DISTRIBUTIO,OR DISPENSATION OF THE DRUG PURSUANTTOTHISSECTIONANDANYRULESADOPTEDPURSUANTTOTHIS SECTION.

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

on the day following the expiration of the ninety-dayperiodafterfinaladjournmentofthegeneralassembly;except that, if aareferendumpetition referendumpetition is filed pursuant to section 1 (3)of(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.