Amendments for SB24-061
Senate Journal, April 11
After consideration on the merits, the Committee recommends that SB24-061 be amended
as follows, and as so amended, be referred to the Committee on Appropriations with
favorable recommendation.
Amend printed bill, strike everything below the enacting clause and substitute:
"SECTION 1. In Colorado Revised Statutes, add 12-280-135.5 as
follows:
12-280-135.5. Colorado drug donation program - created - rules -
records - definitions. (1) AS USED IN THIS SECTION, UNLESS THE CONTEXT
OTHERWISE REQUIRES:
(a) "COLORADO 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 (5).
(c) (I) "DONATION RECIPIENT" MEANS ANY ENTITY THAT:
(A) IS LEGALLY AUTHORIZED TO POSSESS MEDICINE;
(B) HAS A LICENSE OR REGISTRATION IN GOOD STANDING IN THE STATE
IN WHICH THE ENTITY IS LOCATED; AND
(C) RECEIVES A DONATION OF MEDICINE.
(II) "DONATION RECIPIENT" INCLUDES THE DRUG REPOSITORY, A
DISTRIBUTOR, A THIRD-PARTY LOGISTICS PROVIDER, A REVERSE DISTRIBUTOR,
A REPACKAGER, A HOSPITAL, A PHARMACY, A CLINIC, A HEALTH-CARE
PROVIDER, OR A PRESCRIBER OFFICE.
(d) (I) "DONOR" MEANS ANY PERSON LEGALLY AUTHORIZED TO POSSESS
MEDICINE, INCLUDING AN INDIVIDUAL MEMBER OF THE PUBLIC, THE DRUG
REPOSITORY, A DISTRIBUTOR, A THIRD-PARTY LOGISTICS PROVIDER, A
PHARMACY, A DISPENSER, A CLINIC, A SURGICAL OR HEALTH CENTER, A
DETENTION AND REHABILITATION CENTER, A JAIL, A PRISON, A LABORATORY, A
PRESCRIBER OR OTHER HEALTH-CARE PROFESSIONAL, OR A LONG-TERM CARE
FACILITY OR HEALTH-CARE FACILITY, WHICH PERSON DONATES MEDICINE.
(II) "DONOR" INCLUDES GOVERNMENT AGENCIES AND ENTITIES THAT
ARE FEDERALLY AUTHORIZED TO POSSESS MEDICINE, INCLUDING
MANUFACTURERS, REPACKAGERS, RELABELERS, OUTSOURCING FACILITIES,
VETERANS AFFAIRS HOSPITALS, AND FDA-AUTHORIZED IMPORTERS SUCH AS
THOSE DESCRIBED UNDER THE "FEDERAL FOOD, DRUG, AND COSMETIC ACT",
21 U.S.C. SECS. 801 AND 804, AS AMENDED, OR SIMILAR PROVISIONS, AND
FEDERAL PRISONS.
(e) "DRUG REPOSITORY" MEANS THE ENTITY PROVIDING DRUG
REPOSITORY SERVICES FOR THE PROGRAM PURSUANT TO SECTION 25-1.5-121.
(f) "ELIGIBLE PATIENT" MEANS A COLORADO RESIDENT WITH A NEED
FOR DONATED MEDICINE WHO IS INDIGENT, UNINSURED, UNDERINSURED, OR
ENROLLED IN A PUBLIC HEALTH BENEFITS PROGRAM. OTHER PATIENTS ARE
CONSIDERED "ELIGIBLE PATIENTS" IF A NEED FOR A DONATED MEDICINE IS NOT
IDENTIFIED AMONG COLORADO RESIDENTS WHO ARE INDIGENT, UNINSURED,
UNDERINSURED, OR ENROLLED IN A PUBLIC HEALTH BENEFITS PROGRAM.
(g) "HEALTH-CARE PROFESSIONAL" MEANS A PERSON WHO IS LICENSED
TO PRACTICE AS A PHYSICIAN, 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.
(h) (I) "MEDICINE" MEANS BOTH PRESCRIPTION AND NONPRESCRIPTION
OR OVER-THE-COUNTER DRUGS, INCLUDING FDA-APPROVED DRUGS LABELED
FOR INVESTIGATIONAL USE.
(II) "MEDICINE" INCLUDES:
(A) MEDICINE THAT REQUIRES REFRIGERATION, FREEZING, OR SPECIAL
STORAGE IF THE MEDICINE IS DONATED DIRECTLY BY AN ENTITY REGULATED BY
THE BOARD AND THE MEDICINE HAS BEEN CONTINUALLY MAINTAINED
PURSUANT TO THE MANUFACTURER'S STORAGE REQUIREMENTS; AND
(B) PRESCRIPTION AND NONPRESCRIPTION SUPPLIES AND DEVICES.
(III) "MEDICINE" DOES NOT INCLUDE:
(A) COMPOUNDED MEDICINE; OR
(B) MEDICATIONS DISPENSED BY PHARMACIES OUTSIDE OF THE UNITED
STATES.
(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 (18) AND INCLUDES A REVERSE DISTRIBUTOR.
(k) "UNOPENED 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.
"UNOPENED TAMPER-EVIDENT PACKAGING" MAY INCLUDE UNOPENED
UNIT-DOSE, MULTIPLE-DOSE, IMMEDIATE, SECONDARY, AND TERTIARY
PACKAGING.
(2) (a) THERE IS CREATED THE COLORADO DRUG DONATION PROGRAM
TO FACILITATE THE SAFE DONATION AND REDISPENSING OF UNUSED MEDICINE
TO COLORADANS IN NEED OF THE MEDICINE.
(b) PURSUANT TO SECTION 25-1.5-121, THE DEPARTMENT OF PUBLIC
HEALTH AND ENVIRONMENT CREATED IN SECTION 25-1-102 SHALL CONTRACT
FOR DRUG REPOSITORY SERVICES, INCLUDING THE RECEIPT OF, SAFE STORAGE
OF, DISTRIBUTION OF, AND DISPENSING OF MEDICINE; AN ELECTRONIC
INVENTORY OF MEDICINE; A PUBLIC-FACING WEBSITE; AN OUTREACH AND
MARKETING CAMPAIGN TO INFORM POTENTIAL DONORS, DONATION RECIPIENTS,
HEALTH-CARE PROFESSIONALS, ELIGIBLE PATIENTS, AND THE GENERAL PUBLIC;
AND OTHER SERVICES NECESSARY TO IMPLEMENT THE PROGRAM, AS
DETERMINED BY THE DEPARTMENT OF PUBLIC HEALTH AND ENVIRONMENT, IN
CONJUNCTION WITH THE BOARD.
(3) (a) NOTWITHSTANDING ANY OTHER LAW OR RULE TO THE
CONTRARY, A DONOR MAY DONATE MEDICINE TO A DONATION RECIPIENT. A
DONATION RECIPIENT MAY RECEIVE DONATED MEDICINE FROM DONORS.
(b) PRIOR TO THE FIRST DONATION FROM A NEW DONOR, A DONATION
RECIPIENT SHALL RECORD THE DONOR'S NAME, ADDRESS, PHONE NUMBER, AND
LICENSE NUMBER, IF APPLICABLE, AND, WITH RESPECT TO THE FOLLOWING:
(I) VERIFY THAT THE DONOR MEETS THE DEFINITION PROVIDED IN
SUBSECTION (1)(d) OF THIS SECTION;
(II) CONFIRM THAT THE DONOR AGREES TO MAKE DONATIONS OF
MEDICINE ONLY IN ACCORDANCE WITH THIS SECTION AND RULES PROMULGATED
BY THE BOARD RELATING TO DONATED MEDICINE; AND
(III) IF APPLICABLE, CONFIRM THAT THE DONOR AGREES TO REMOVE OR
REDACT ANY PATIENT NAMES AND PRESCRIPTION NUMBERS ON DONATED
MEDICINE OR OTHERWISE MAINTAIN PATIENT CONFIDENTIALITY BY EXECUTING
A CONFIDENTIALITY AGREEMENT WITH THE AUTHORIZED DONATION RECIPIENT.
(c) NO OTHER INFORMATION OR RECORDS ARE REQUIRED PRIOR TO
RECEIVING THE FIRST DONATION FROM A NEW DONOR OTHER THAN AS
DESCRIBED IN SUBSECTION (3)(b) OF THIS SECTION.
(4) A DONATION RECIPIENT SHALL MAINTAIN A WRITTEN OR
ELECTRONIC RECORD OF DONATED MEDICINE CONSISTING OF THE NAME,
STRENGTH, QUANTITY, AND LOT NUMBER, IF KNOWN, OF EACH ACCEPTED OR
TRANSFERRED DRUG AND THE NAME, ADDRESS, AND PHONE NUMBER OF THE
DONOR OR TRANSFERRING ENTITY. NO OTHER RECORD OF DONATION IS
REQUIRED.
(5) A DONATION RECIPIENT SHALL ENSURE THAT DONATED MEDICINE
IS IDENTIFIED SEPARATELY FROM REGULAR STOCK.
(6) NOTWITHSTANDING 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) IF THE DONATION RECIPIENT IS A PRESCRIPTION DRUG OUTLET,
REPACKAGE DONATED MEDICINE IN ACCORDANCE WITH SUBSECTION (8) OF THIS
SECTION AS NECESSARY FOR STORAGE, DISPENSING, ADMINISTRATION, OR
TRANSFER; OR
(c) IF THE DONATION RECIPIENT IS A PRESCRIPTION DRUG OUTLET,
REPLENISH MEDICINE OF THE SAME DRUG NAME AND STRENGTH PREVIOUSLY
DISPENSED OR ADMINISTERED TO ELIGIBLE PATIENTS IN ACCORDANCE WITH THE
FEDERAL 340B DRUG PRICING PROGRAM CODIFIED AT 42 U.S.C. SEC. 256b, AS
AMENDED.
(7) (a) DONATED MEDICINE THAT DOES NOT MEET THE REQUIREMENTS
SPECIFIED IN THIS SECTION AND RULES PROMULGATED BY THE BOARD MUST BE
DISPOSED OF BY:
(I) RETURNING THE DONATED MEDICINE TO THE DONOR;
(II) DESTROYING THE DONATED MEDICINE THROUGH AN INCINERATOR,
A MEDICAL WASTE HAULER, A REVERSE DISTRIBUTOR, OR OTHER LAWFUL
METHOD; OR
(III) TRANSFERRING THE DONATED MEDICINE TO A RETURNS
PROCESSOR.
(b) A DONATION RECIPIENT SHALL MAINTAIN A WRITTEN OR
ELECTRONIC RECORD OF DISPOSED MEDICINE CONSISTING OF THE DISPOSAL
METHOD, AS DESCRIBED IN THIS SUBSECTION (7); THE DATE OF DISPOSAL; AND
THE NAME, STRENGTH, AND QUANTITY OF EACH DISPOSED DRUG. NO OTHER
RECORD OF DISPOSAL IS REQUIRED.
(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. IF MULTIPLE PACKAGED, DONATED
MEDICINES WITH VARIED EXPIRATION DATES ARE REPACKAGED TOGETHER, THE
EARLIEST EXPIRATION DATE MUST BE USED.
(9) A DONATION RECIPIENT SHALL ONLY ADMINISTER OR REDISPENSE
MEDICINE THAT:
(a) MEETS THE REQUIREMENTS SET FORTH IN THIS SECTION BASED ON
INSPECTION BY A LICENSED PHARMACIST;
(b) IF DISPENSED TO AN ELIGIBLE PATIENT, IS REPACKAGED BY A
LICENSED PHARMACIST INTO A NEW CONTAINER OR A CONTAINER THAT HAS ALL
PREVIOUS PATIENT INFORMATION ON THE DONATED CONTAINER REDACTED OR
REMOVED;
(c) IS PROPERLY LABELED IN ACCORDANCE WITH THE RULES OF THE
BOARD;
(d) HAS AN EXPIRATION OR BEYOND-USE DATE BROUGHT FORWARD
FROM THE DONATED MEDICINE THAT WILL NOT EXPIRE BEFORE THE MEDICINE
IS USED BY THE ELIGIBLE PATIENT BASED ON THE PRESCRIBER'S DIRECTIONS FOR
USE OR, FOR OVER-THE-COUNTER MEDICINE, ON THE PACKAGE'S LABEL; AND
(e) IF THE MEDICINE REQUIRES REFRIGERATION, FREEZING, OR SPECIAL
STORAGE, IS DONATED DIRECTLY BY AN ENTITY REGULATED BY THE BOARD AND
HAS BEEN CONTINUALLY MAINTAINED PURSUANT TO THE MANUFACTURER'S
STORAGE REQUIREMENTS.
(10) A DONATION RECIPIENT:
(a) MAY DISPENSE OR ADMINISTER PRESCRIPTION DRUGS TO AN
ELIGIBLE PATIENT PURSUANT TO THIS SECTION ONLY IF OTHERWISE PERMITTED
BY LAW PURSUANT TO A VALID PRESCRIPTION OR PRESCRIPTION DRUG ORDER;
AND
(b) SHALL MAINTAIN ELIGIBLE PATIENT-SPECIFIC WRITTEN OR
ELECTRONIC RECORDS IN ACCORDANCE WITH BOARD RULES.
(11) WHEN A PRESCRIBED MEDICINE DOES NOT USE A UNIQUE DELIVERY
SYSTEM TECHNOLOGY, A DONATION RECIPIENT MAY SUBSTITUTE AN ORAL
TABLET, CAPSULE, OR LIQUID FORM OF THE PRESCRIBED MEDICINE SO LONG AS
THE FORM DISPENSED HAS THE SAME DOSE SCHEDULE AND IS A GENERIC
EQUIVALENT TO THE PRESCRIBED MEDICINE.
(12) THE DONATION, TRANSFER, RECEIPT, OR FACILITATION OF
DONATIONS, TRANSFERS, AND RECEIPT OF MEDICINE PURSUANT TO THIS SECTION
IS NOT WHOLESALE DISTRIBUTION AND DOES NOT REQUIRE LICENSING AS A
WHOLESALE DISTRIBUTOR. THE PROGRAM EXISTS UNDER A PRESCRIPTION DRUG
OUTLET LICENSE AND IS SUBJECT TO THE REQUIREMENTS FOR THAT LICENSE
TYPE.
(13) MEDICINE DONATED TO THE PROGRAM MUST NOT BE RESOLD AND
IS CONSIDERED NONSALEABLE; EXCEPT THAT HANDLING, 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. IF
THE DONATION RECIPIENT IS A FOR-PROFIT ENTITY, THESE CHARGES MUST NOT
EXCEED THE DONATION RECIPIENT'S COST OF PROVIDING THE MEDICINE,
INCLUDING THE CURRENT AND ANTICIPATED COSTS OF EDUCATING ELIGIBLE
DONORS, PROVIDING TECHNICAL SUPPORT TO PARTICIPATING DONORS, SHIPPING
AND HANDLING, LABOR, STORAGE, LICENSING, UTILITIES, ADVERTISING,
TECHNOLOGY, SUPPLIES, AND EQUIPMENT. EXCEPT AS DESCRIBED IN THIS
SUBSECTION (13), THE AMOUNT OF THESE CHARGES IS NOT SUBJECT TO ANY
ADDITIONAL LIMITATIONS.
(14) WHEN PERFORMING ANY ACTION ASSOCIATED WITH THE PROGRAM
OR OTHERWISE PROCESSING DONATED MEDICINE FOR TAX, MANUFACTURER, OR
OTHER CREDIT, A DONATION RECIPIENT IS CONSIDERED TO BE ACTING AS A
RETURNS PROCESSOR AND SHALL COMPLY WITH ALL RECORD-KEEPING
REQUIREMENTS UNDER FEDERAL LAW FOR NONSALEABLE RETURNS.
(15) ALL REQUIRED RECORDS MUST BE RETAINED IN PHYSICAL OR
ELECTRONIC FORMAT, ON OR OFF THE DONATION RECIPIENT'S 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 IDENTIFIER, SUCH AS A SERIAL NUMBER OR BARCODE, MAY BE
USED IN PLACE OF INFORMATION IF IT ALLOWS FOR THE INFORMATION TO BE
READILY RETRIEVABLE. UPON REQUEST BY A STATE OR FEDERAL REGULATOR,
THE IDENTIFIER USED FOR A REQUESTED RECORD MUST BE REPLACED WITH THE
ORIGINAL INFORMATION. AN IDENTIFIER MUST NOT BE USED ON LABELS WHEN
DISPENSING OR ADMINISTERING A DRUG TO AN ELIGIBLE PATIENT.
(16) A DONATION OR OTHER TRANSFER OF POSSESSION OR CONTROL IS
NOT A CHANGE OF OWNERSHIP UNLESS IT IS SPECIFIED AS SUCH BY THE
DONATION RECIPIENT. IF A RECORD OF THE DONATION'S TRANSACTION
INFORMATION OR HISTORY IS REQUIRED, THE HISTORY MUST BEGIN WITH THE
DONOR, MUST INCLUDE ALL PRIOR DONATIONS, AND, IF THE MEDICINE WAS
PREVIOUSLY DISPENSED, MUST INCLUDE ONLY DRUG INFORMATION THAT IS
REQUIRED TO BE ON THE PATIENT LABEL IN ACCORDANCE WITH BOARD RULES.
(17) AN ENTITY PARTICIPATING IN A DRUG DONATION OR REPOSITORY
PROGRAM OPERATED BY ANOTHER STATE MAY PARTICIPATE IN THE PROGRAM
IF THE ENTITY IS REGISTERED WITH THIS STATE AND, IF THE REGISTERED ENTITY
IS A PRESCRIPTION DRUG OUTLET, MAY DISPENSE DONATED DRUGS TO
RESIDENTS 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 LOCATED.
(18) THE BOARD SHALL PROMULGATE ANY RULES NECESSARY TO
IMPLEMENT THIS SECTION. THE RULES MUST REQUIRE THE LEAST AMOUNT OF
RECORD KEEPING NECESSARY TO ENSURE PATIENT SAFETY AND MUST ALLOW
FLEXIBILITY IN THE FORMAT FOR RECORD KEEPING.
(19) THE PROVISIONS OF THIS SECTION CONTROL THE PROGRAM AND
SUPERSEDE ANY INCONSISTENT LAW.
(20) WHEN 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
ACTION:
(a) AN INDIVIDUAL OR ENTITY INVOLVED IN THE SUPPLY CHAIN OF
DONATED MEDICINE, INCLUDING THE DONOR, THE DRUG REPOSITORY, THE
DONATION RECIPIENT, THE MANUFACTURER, THE REPACKAGER, THE
PRESCRIPTION DRUG OUTLET OR OTHER ENTITY REGULATED BY THE BOARD, AND
THE ELIGIBLE PATIENT;
(b) AN INDIVIDUAL OR ENTITY, INCLUDING AN EMPLOYEE, AN OFFICER,
A VOLUNTEER, AN OWNER, A PARTNER, A MEMBER, A DIRECTOR, A CONTRACTOR,
OR OTHER INDIVIDUAL OR ENTITY ASSOCIATED WITH THE INDIVIDUAL OR ENTITY
THAT, IN COMPLIANCE WITH THIS SECTION, PRESCRIBES, DONATES, RECEIVES
DONATIONS OF, DISPENSES, ADMINISTERS, TRANSFERS, REPLENISHES, OR
REPACKAGES MEDICINE OR FACILITATES ANY OF THE ACTIONS DESCRIBED IN
THIS SECTION; AND
(c) THE BOARD.
SECTION 2. In Colorado Revised Statutes, 12-280-135, amend
(2)(a)(II)(C), (2)(b)(II), (2)(b)(III), (2)(c) introductory portion, (2)(c)(I), and
(2)(c)(III); repeal (2)(c)(IV) and (5); and add (2)(b)(IV), (2)(c)(VI), and
(2)(c)(VII) as follows:
12-280-135. Unused medication - licensed facilities - correctional
facilities - reuse - definitions - rules. (2) (a) (II) (C) A person or entity is not
subject to civil or criminal liability or professional disciplinary action for
donating, accepting, dispensing, or facilitating the donation of materials in good
faith, without negligence OR WILLFUL OR WANTON MISCONDUCT, and in
compliance with this section.
(b) Medications are only available to be dispensed to another person or
donated to a nonprofit entity under this section if the medications are:
(II) Individually packaged and the packaging has not been damaged; or
(III) In the original, unopened, sealed, and tamper-evident unit-dose
packaging; OR
(IV) FOR MEDICATIONS THAT REQUIRE REFRIGERATION, FREEZING, OR
SPECIAL STORAGE, DONATED DIRECTLY BY AN ENTITY REGULATED BY THE
BOARD AND CONTINUALLY MAINTAINED PURSUANT TO THE MANUFACTURER'S
STORAGE REQUIREMENTS.
(c) The following medications may not be donated ARE NOT
ACCEPTABLE FOR DONATION:
(I) Medications THAT ARE NOT packaged in A traditional brown or
amber pill bottles DISPENSING SYSTEM, AS DEFINED IN RULES PROMULGATED BY
THE BOARD;
(III) EXCEPT AS PROVIDED IN SUBSECTION (2)(b)(IV) OF THIS SECTION,
medications that require refrigeration, freezing, or special storage;
(IV) Medications that require special registration with the manufacturer;
or
(VI) COMPOUNDED MEDICATIONS; AND
(VII) MEDICATIONS DISPENSED BY PHARMACIES OUTSIDE OF THE
UNITED STATES.
(5) The board shall adopt rules that allow a pharmacist to redispense
medication pursuant to this section and section 25.5-5-502 and to donate
medication pursuant to this section.
SECTION 3. In Colorado Revised Statutes, add 25-1.5-121 as follows:
25-1.5-121. Colorado drug donation program - contract for drug
repository services - electronic inventory - website - outreach and
marketing campaign - definitions. (1) AS USED IN THIS SECTION, UNLESS THE
CONTEXT OTHERWISE REQUIRES:
(a) "BOARD OF PHARMACY" MEANS THE STATE BOARD OF PHARMACY
CREATED IN SECTION 12-280-104.
(b) "COLORADO DRUG DONATION PROGRAM" OR "CDDP" MEANS THE
COLORADO DRUG DONATION PROGRAM CREATED IN SECTION 12-280-135.5.
(c) "CONTRACTOR" MEANS THE ENTITY OR ENTITIES WITH WHICH THE
DEPARTMENT CONTRACTS PURSUANT TO SUBSECTION (2) OF THIS SECTION.
(d) "DONATION RECIPIENT" HAS THE MEANING SET FORTH IN SECTION
12-280-135.5.
(e) "DONOR" HAS THE MEANING SET FORTH IN SECTION 12-280-135.5.
(f) "DRUG REPOSITORY" MEANS THE ENTITY CONTRACTED BY THE
DEPARTMENT PURSUANT TO SUBSECTION (2) OF THIS SECTION TO PROVIDE
REPOSITORY SERVICES FOR THE CDDP.
(g) "ELIGIBLE PATIENT" HAS THE MEANING SET FORTH IN SECTION
12-280-135.5.
(h) "MEDICINE" HAS THE MEANING SET FORTH IN SECTION 12-280-135.5.
(2) SUBJECT TO AVAILABLE APPROPRIATIONS, THE DEPARTMENT, IN
CONSULTATION WITH THE BOARD OF PHARMACY, SHALL CONTRACT WITH AN
ENTITY OR ENTITIES TO IMPLEMENT THE COLORADO DRUG DONATION PROGRAM
CREATED IN SECTION 12-280-135.5. THE CDDP EXISTS UNDER A PRESCRIPTION
DRUG OUTLET LICENSE AND IS SUBJECT TO THE REQUIREMENTS FOR THAT
LICENSE TYPE AND ANY OTHER REQUIREMENTS SPECIFIED BY THE BOARD OF
PHARMACY OR THE DEPARTMENT. THE CDDP CONTRACT MUST INCLUDE THE
FOLLOWING:
(a) DRUG REPOSITORY SERVICES AT ONE LOCATION IN COLORADO,
INCLUDING THE RECEIPT OF, SAFE STORAGE OF, DISTRIBUTION OF, AND
DISPENSING OF MEDICINE TO FACILITATE THE SAFE DONATION AND
REDISPENSING OF UNUSED MEDICINE TO COLORADANS AND OTHERS IN NEED OF
THE MEDICINE;
(b) AN ELECTRONIC, SEARCHABLE INVENTORY OF CDDP MEDICINE;
(c) THE CREATION OF A PUBLIC-FACING WEBSITE WITH INFORMATION ON
THE CDDP, INCLUDING THE MISSION OF THE CDDP, THE REQUIREMENTS FOR
MEDICINE TO BE ELIGIBLE FOR DONATION, THE METHODS OF DONATING UNUSED
MEDICINE, AND HOW AN ELIGIBLE PATIENT MAY ACCESS UNUSED MEDICINE; AND
(d) THE CREATION AND IMPLEMENTATION OF AN OUTREACH AND
MARKETING CAMPAIGN TO INFORM POTENTIAL DONORS OF MEDICINE, DONATION
RECIPIENTS, HEALTH-CARE PROFESSIONALS, ELIGIBLE PATIENTS, AND THE
GENERAL PUBLIC ABOUT THE COLORADO DRUG DONATION PROGRAM AND TO
ENCOURAGE PARTICIPATION IN THE CDDP.
(3) (a) SUBJECT TO THE PROVISIONS SPECIFIED IN THE CONTRACT AND
THE AMOUNT OF THE CONTRACT, THE CDDP OUTREACH AND MARKETING
CAMPAIGN MUST INCLUDE OUTREACH AND MARKETING TO POTENTIAL DONORS
OF MEDICINE, DONATION RECIPIENTS, HEALTH-CARE PROFESSIONALS, ELIGIBLE
PATIENTS, AND THE GENERAL PUBLIC.
(b) (I) THE INITIAL PHASE OF THE CDDP OUTREACH AND MARKETING
CAMPAIGN MUST FOCUS ON BUILDING SUFFICIENT INVENTORY OF DONATED
MEDICINE, AS SPECIFIED IN THE CONTRACT.
(II) TO BUILD THE INVENTORY OF DONATED MEDICINE, THE
CONTRACTOR, IN CONSULTATION WITH THE DEPARTMENT AND THE BOARD OF
PHARMACY, MAY:
(A) BUILD RELATIONSHIPS WITH LARGE NURSING FACILITIES AND THE
PHARMACIES THAT SERVICE THOSE NURSING FACILITIES;
(B) BUILD RELATIONSHIPS WITH CORRECTIONAL FACILITIES;
(C) MEET WITH THE SCHOOLS OF PHARMACY IN COLORADO TO CREATE
AN AWARENESS PROGRAM FOR THE CDDP THAT PROVIDES OPPORTUNITIES FOR
PHARMACY STUDENTS TO ENGAGE IN CO-CURRICULAR ACTIVITIES AND TO
COMMUNICATE INFORMATION ABOUT CDDP WHEN INTERACTING WITH
PATIENTS, HEALTH-CARE PROFESSIONALS AND PRESCRIBERS, AND HEALTH
FACILITIES; AND
(D) ESTABLISH PARTNERSHIPS WITH PHARMACIES IN THE DENVER
METROPOLITAN AREA TO SERVE AS CONSUMER DONATION SITES AND ESTABLISH
PARTNERSHIPS FOR ADDITIONAL DONATION SITES IN OTHER AREAS OF THE
STATE.
(III) THE CONTRACTOR, IN CONSULTATION WITH THE DEPARTMENT AND
THE BOARD OF PHARMACY, MAY CREATE A SUPPLY OF SELF-ADDRESSED,
POSTAGE-PAID MAILING ENVELOPES FOR INDIVIDUAL CONSUMERS TO USE TO
MAIL UNUSED MEDICINE TO THE DRUG REPOSITORY. THE DEPARTMENT AND THE
BOARD OF PHARMACY SHALL ESTABLISH A PROCESS TO MAKE MAILERS CREATED
PURSUANT TO THIS SUBSECTION (3)(b)(III) AVAILABLE TO INTERESTED PERSONS
AND MAY DISTRIBUTE THE MAILERS AT PHARMACY AND PUBLIC HEALTH
CONFERENCES.
(c) THE SECOND PHASE OF THE CDDP OUTREACH AND MARKETING PLAN
MUST CREATE AWARENESS AMONG INDIVIDUALS WHO MAY BENEFIT FROM
RECEIVING DONATED MEDICINE. AS SPECIFIED IN THE CONTRACT, ACTIVITIES TO
INCREASE AWARENESS MAY INCLUDE:
(I) A GENERAL LISTING OF MEDICINE ON THE CDDP WEBSITE THAT IS
AVAILABLE FOR REUSE;
(II) OUTREACH TO SAFETY-NET AND PATIENT OUTREACH GROUPS IN
COLORADO, INCLUDING THE COLORADO COMMUNITY HEALTH NETWORK, THE
CHRONIC CARE COLLABORATIVE, LOCAL AREA AGENCIES ON AGING, AND OTHER
GROUPS;
(III) OUTREACH TO PHARMACY ORGANIZATIONS, SUCH AS RXPLUS
PHARMACIES, INC., THE COLORADO PHARMACISTS SOCIETY, AND OTHERS, TO
CREATE AWARENESS OF THE CDDP AND TO PROVIDE INFORMATION ON HOW TO
OBTAIN DONATED MEDICINE, AS WELL AS DISTRIBUTING ANY POSTERS OR OTHER
MARKETING MATERIAL CREATED FOR THE CDDP;
(IV) OUTREACH TO LEGISLATORS, IN CONSULTATION WITH THE
DEPARTMENT AND THE BOARD OF PHARMACY, TO INCREASE AWARENESS AMONG
CONSTITUENTS IN COLORADO'S LEGISLATIVE DISTRICTS;
(V) ONCE THE CDDP IS FULLY OPERATIONAL, OUTREACH TO
COLORADO MEDIA CONCERNING THE CDDP, AS WELL AS DISTRIBUTING ANY
RELEVANT MARKETING MATERIALS; AND
(VI) ANY OTHER OUTREACH AND MARKETING EFFORTS, AS SPECIFIED IN
THE CONTRACT.
(4) THE CONTRACTOR SHALL REPORT DATA AND INFORMATION
REGARDING THE DRUG REPOSITORY AND OTHER SERVICES PROVIDED BY THE
CONTRACTOR TO THE DEPARTMENT AND TO THE BOARD OF PHARMACY IN THE
MANNER AND FREQUENCY DETERMINED BY THE DEPARTMENT AND THE BOARD
OF PHARMACY.
SECTION 4. 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 pursuant to
section 12-280-135 12-280-135 OR 12-280-135.5; or
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-day period
after final adjournment of the general assembly; except that, if a referendum
petition 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 November 2024 and, in such case, will take
effect on the date of the official declaration of the vote thereon by the
governor.".
Judiciary