Drug Manufacturers - Drug Take-Back Programs (Take It Back Maryland Act)

EXPLANATION: CAPITALS INDICATE MATTER ADDED TO EXISTING LAW. [Brackets] indicate matter deleted from existing law. *sb0575* SENATE BILL 575 J1 3lr2186 CF HB 517 By: Senator Lewis Young Introduced and read first time: February 6, 2023 Assigned to: Finance A BILL ENTITLED AN ACT concerning 1 Drug Manufacturers – Drug Take–Back Programs 2 (Take It Back Maryland Act) 3 FOR the purpose of requiring manufacturers of certain drugs to operate a certain drug 4 take–back program or enter into a certain agreement with a drug take –back 5 organization or the Maryland Department of Health, in conjunction with the 6 Department of the Environment; requiring the Maryland Department of Health, in 7 conjunction with the Department of the Environment, to determine whether a drug 8 take–back program complies with certain requirements and to provide notification 9 of its determination within a certain time period; requiring a manufacturer to update 10 its drug take –back program and submit a certain proposal to the Maryland 11 Department of Health on a certain basis; requiring a certain manufacturer to show 12 evidence of joining a certain program or to submit a certain proposal within a certain 13 time period; and generally relating to drug manufacturers and drug take –back 14 programs. 15 BY adding to 16 Article – Health – General 17 Section 21–228 18 Annotated Code of Maryland 19 (2019 Replacement Volume and 2022 Supplement) 20 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 21 That the Laws of Maryland read as follows: 22 Article – Health – General 23 21–228. 24 (A) (1) IN THIS SECTION THE FOLL OWING WORDS HAVE THE MEANINGS 25 2 SENATE BILL 575 INDICATED. 1 (2) “AUTHORIZED COLLECTOR” MEANS: 2 (I) A PERSON THAT IS REGIS TERED WITH THE U.S. DRUG 3 ENFORCEMENT ADMINISTRATION TO COLLECT CONTROLLED SUBSTANCES FOR THE 4 PURPOSES OF SAFE DISPOSAL AND DESTRUCTION; 5 (II) A STATE OR LOCAL LAW ENFORCEMENT AGENCY; OR 6 (III) A PERSON AUTHORIZED BY THE DEPARTMENT, IN 7 CONJUNCTION WITH THE DEPARTMENT OF THE ENVIRONMENT, TO PROVIDE 8 ALTERNATIVE COLLECTI ON METHODS FOR COVER ED DRUGS THAT ARE NO T 9 CONTROLLED SUBSTANCES. 10 (3) “COVERED DRUG ” MEANS ANY SUBSTANCE RECOGNIZED AS A 11 DRUG UNDER 21 U.S.C. § 321(G)(1) THAT IS SOLD , OFFERED FOR SALE , OR 12 DISPENSED IN THE STATE, WHETHER DIRECTLY OR THROUGH A WHOLESALER, IN 13 ANY FORM, INCLUDING PRESCRIPTION AND NONPRESCRIPTI ON DRUGS, DRUGS IN 14 MEDICAL DEVICES AND COMBINATION PRODUCTS, BRAND AND GENERIC DR UGS, 15 AND DRUGS FOR VETERINARY USE. 16 (4) “DRUG TAKE –BACK ORGANIZATION ” MEANS AN ORGANIZATIO N 17 DESIGNATED BY A MANUFACTURER OR A GROUP OF MANUFACTURERS TO ACT AS AN 18 AGENT ON BEH ALF OF THE MANUFACTU RER OR GROUP OF MANU FACTURERS TO 19 OPERATE AND IMPLEMENT A DRUG TAKE–BACK PROGRAM AS AUTHORIZED BY THIS 20 SECTION. 21 (5) “MANUFACTURER” MEANS A PERSON ENGAG ED IN THE 22 MANUFACTURE OF COVERED DRUGS SOLD IN THE STATE. 23 (B) (1) EACH MANUFACTURER OF A CO VERED DRUG THAT IS S OLD OR 24 DISTRIBUTED IN THE STATE SHALL: 25 (I) OPERATE A DRUG TAKE–BACK PROGRAM APPROVED BY THE 26 DEPARTMENT, IN CONJUNCTION WITH THE DEPARTMENT OF THE ENVIRONMENT; 27 (II) ENTER INTO AN AGREEME NT WITH A DRUG TAKE –BACK 28 ORGANIZATION TO OPER ATE A DRUG TAKE –BACK PROGRAM APPROVE D BY THE 29 DEPARTMENT, IN CONJUNCTION WITH THE DEPARTMENT OF THE ENVIRONMENT; 30 OR 31 (III) ENTER INTO AN AGREEME NT WITH THE DEPARTMENT, IN 32 SENATE BILL 575 3 CONJUNCTION WITH THE DEPARTMENT OF THE ENVIRONMENT, TO OPERAT E A 1 DRUG TAKE–BACK PROGRAM ON BEHALF OF THE MANUFACTURER. 2 (2) A MANUFACTURER MAY OPERATE A DRUG TAKE–BACK PROGRAM 3 UNDER PARAGRAPH (1) OF THIS SUBSECTION J OINTLY WITH OTHER 4 MANUFACTURERS. 5 (C) ON OR BEFORE JANUARY 1, 2024, EACH MANUFACTURER AN D EACH 6 DRUG TAKE–BACK ORGANIZATION THAT HAS A CONTRACT WITH A MANUFACTURER 7 SHALL SUBMIT TO THE DEPARTMENT, IN A MANNER AND FORM DETERMINED BY THE 8 DEPARTMENT, A PROPOSAL FOR A DRU G TAKE –BACK PROGRAM THAT , AT A 9 MINIMUM: 10 (1) CERTIFIES THAT THE DRUG TAKE–BACK PROGRAM WILL ACCEPT 11 ALL COVERED DRUGS REGARDLESS OF THE PRODUCER OF THE DRUG; 12 (2) PROVIDES CONTACT INFO RMATION FOR THE PERS ON 13 SUBMITTING THE PLANNED DRUG TAKE–BACK PROGRAM; 14 (3) DETAILS A COLLECTION SYSTEM THAT IS GEOGR APHICALLY 15 DISTRIBUTED IN A WAY TO ENSURE ACCESS IN RURAL AND UNDERSERVED AREAS TO 16 PROVIDE CONVENIENT, ONGOING COLLECTION SERVICES TO ALL PERSONS SEEKING 17 TO DISPOSE OF COVERED DRUGS UNDER THIS SECTION; 18 (4) DESCRIBES OTHER COLLE CTION METHODS THROUG H WHICH 19 COVERED DRUGS WILL BE COLLECTED BY AN AUTHORIZED COLLECTOR; 20 (5) EXPLAINS HOW COVERED DRUGS WILL BE SAFELY AND SECURELY 21 TRACKED AND HANDLED FROM COLLECTION THRO UGH FINAL DISPOSAL A ND 22 DESTRUCTION AND THE POLICIES THAT WILL B E IMPLEMENTED TO ENS URE 23 SECURITY AND COMPLIA NCE WITH ALL APPLICA BLE L AWS AND REGULATIONS , 24 INCLUDING DISPOSAL A ND DESTRUCTION AT AN AUTHORIZED WASTE DIS POSAL 25 FACILITY THAT MEETS FEDERAL REQUIREMENTS; 26 (6) DESCRIBES THE PUBLIC EDUCATION AND OUTREACH ACTIVITIES 27 THAT WILL BE PERFORM ED, INCLUDING THE ADVERT ISING OF COLLECTION 28 LOCATIONS ON A WEBSI TE AND THE USE OF SI GNAGE AND OTHER WRIT TEN 29 MATERIALS, AND HOW THE EFFECTIVENESS OF PUBLIC EDUCATION AND OUTREACH 30 ACTIVITIES WILL BE EVALUATED; 31 (7) (I) DETAILS HOW THE COSTS OF AN AUTHORIZED COLLECTOR 32 WILL BE REIMBURSED, INCLUDING COSTS RETROACTIVE TO OCTOBER 1, 2023; AND 33 4 SENATE BILL 575 (II) IF MORE THAN ONE MANUFACTURER WILL BE INVOLVED IN 1 THE PLANNED DRUG TAK E–BACK PROGRAM, DETAILS A PLAN FOR T HE FAIR AND 2 REASONABLE MANNER OF ALLOCA TING COSTS AMONG THE PARTICIPANTS IN THE 3 PROGRAM SO THAT THE COSTS PAID BY EACH M ANUFACTURER ARE REAS ONABLY 4 RELATED TO THE VOLUME OR VALUE OF COVERED DRUGS SOLD IN THE STATE; AND 5 (8) PROVIDES ANY FURTHER INFORMATION CONSIDER ED 6 APPROPRIATE BY THE DEPARTMENT, IN CONJUNCTION WITH THE DEPARTMENT OF 7 THE ENVIRONMENT. 8 (D) (1) EACH MANUFACTURER SHA LL PAY ALL ADMINISTR ATIVE AND 9 OPERATIONAL FEES ASS OCIATED WITH THE MAN UFACTURER’S DRUG TAKE –BACK 10 PROGRAM, INCLUDING THE COST OF COLLECTING, TRANSPORTING, AND DISPOSING 11 OF COVERED DRUGS FRO M AN AUTHORIZED COLL ECTOR AND THE RECYCL ING OR 12 DISPOSAL OF PACKAGING COLLECTED WITH THE COVERED DRUGS. 13 (2) EACH MANUFACTURER SHA LL PAY COSTS INCURRE D BY THE 14 STATE IN THE ADMINIST RATION AND ENFORCEME NT OF THE M ANUFACTURER’S 15 DRUG TAKE–BACK PROGRAM. 16 (3) THE STATE MAY RECOVER FROM THE MANUFACTURER ONLY THE 17 STATE’S ACTUAL COSTS RELATED TO ADMINISTRATION AND ENFORCEMENT OF THE 18 MANUFACTURER’S DRUG TAKE–BACK PROGRAM. 19 (4) IF MANUFACTURERS JOIN TLY CONDUCT A DRUG T AKE–BACK 20 PROGRAM, THE COSTS OF ADMINISTRATION AND ENFORCEMENT SHALL BE FAIRLY 21 AND REASONABLY ALLOCATED AMONG THE MANUFACTURERS IN A MANNER THAT IS 22 REASONABLY RELATED T O THE VOLUME OR VALU E OF COVERED DRUGS S OLD BY 23 THE MANUFACTURERS IN THE STATE. 24 (5) A MANUFACTURER MAY NOT CHARGE A POINT –OF–SALE OR 25 OTHER FEE TO A CONSUMER, OR A FEE THAT COULD BE PASSED ON TO A CONSUMER, 26 TO RECOUP THE COST OF THE MANUFACTURER’S DRUG TAKE–BACK PROGRAM. 27 (E) (1) WITHIN 60 DAYS AFTER RECEIPT O F A PROPOSAL FOR A D RUG 28 TAKE–BACK PROGRAM , THE DEPARTMENT, IN CONJUNCTION WITH THE 29 DEPARTMENT OF THE ENVIRONMENT, SHALL DETERMINE WHET HER THE 30 PROPOSED DRUG TAKE –BACK PROGRAM COMPLIE S WITH THE REQUIREME NTS OF 31 THIS SECTION AND SHA LL NOTIFY THE APPLIC ANT OF THE DEPARTMENT’S 32 DETERMINATION. 33 (2) THE DEPARTMENT, IN CONJUNCTION WITH THE DEPARTMENT OF 34 THE ENVIRONMENT, MAY CONDUCT A PUBLIC HEARING BEFORE APPRO VING A 35 SENATE BILL 575 5 PROPOSED DRUG TAKE–BACK PROGRAM. 1 (3) IF THE DRUG TAKE –BACK PROGRAM IS APPR OVED, THE 2 DEPARTMENT SHALL NOTIFY THE APPLICANT IN WRITING OF THE APPROVAL. 3 (4) IF THE DRUG TAKE –BACK PROGRAM IS NOT APPROVED, THE 4 DEPARTMENT SHALL NOTI FY THE APPLICANT IN WRITING AND THE APPL ICANT 5 SHALL SUBMIT A REVISED DRUG TAKE–BACK PROGRAM PROPOSAL WITHIN 30 DAYS 6 AFTER RECEIVING NOTIFICATION THAT THE PROGRAM WAS NOT APPROVED. 7 (5) IF THE DEPARTMENT REJECTS TH E REVISED PROPOSAL 8 SUBMITTED UNDER PARA GRAPH (4) OF THIS SUBSECTION , THE MANUFACTURER 9 SUBMITTING THE PROPO SAL SHALL BE CONSIDE RED OUT OF COMPLIANC E WITH 10 THIS SECTION AND SHA LL BE SUBJECT TO THE PENALTY ESTABLISHED U NDER 11 SUBSECTION (G) OF THIS SECTION. 12 (6) THE DEPARTMENT SHALL PROVIDE, AND UPDATE ANNUALLY ON 13 THE DEPARTMENT’S WEBSITE, A LIST OF ALL MANUFA CTURERS PARTICIPATING IN 14 A DRUG TAKE–BACK PROGRAM APPROVED BY THE DEPARTMENT. 15 (F) (1) AT LEAST EVERY 3 YEARS, EACH MANUFACTURER AN D DRUG 16 TAKE–BACK ORGANIZATION SH ALL UPDATE THE DRUG TAKE–BACK PROGRAM 17 OPERATED BY THE MANU FACTURER OR DRUG TAK E–BACK ORGANIZATION AN D 18 SUBMIT AN UPDATED PROPOSAL TO THE DEPARTMENT. 19 (2) A MANUFACTURER THAT BEGINS TO OFFER A COVERE D DRUG IN 20 THE STATE AFTER OCTOBER 1, 2023, SHALL PROVIDE EVIDEN CE OF JOINING AN 21 APPROVED DRUG TAKE –BACK PROGRAM OR SUBM IT A PROPOSAL FOR A DRUG 22 TAKE–BACK PROGRAM WITHIN 90 DAYS FOLLOWING THE I NITIAL OFFER FOR SALE 23 OF A COVERED DRUG IN THE STATE. 24 (3) ANY PROPOSED CHANGE TO A DRUG TAKE–BACK PROGRAM SHALL 25 BE SUBMITTED IN WRITING AND APPROVED BY THE DEPARTMENT, IN CONJUNCTION 26 WITH THE DEPARTMENT OF THE ENVIRONMENT. 27 (G) (1) A PERSON IN VIOLATION OF THIS SECTION IS SUBJECT TO A CIVIL 28 PENALTY NOT EXCEEDING $1,000. 29 (2) EACH DAY ON WHICH A VIOLATION OF THIS SECTION OCCURS IS A 30 SEPARATE VIOLATION. 31 (H) EACH APPROVED DRUG TA KE–BACK PROGRAM SHALL R EPORT TO THE 32 DEPARTMENT AT A DATE AND MANNER ESTABLISH ED BY THE DEPARTMENT, IN 33 6 SENATE BILL 575 CONJUNCTION WITH THE DEPARTMENT OF THE ENVIRONMENT. 1 (I) ON OR BEFORE OCTOBER 1 EACH YEAR , THE DEPARTMENT, IN 2 CONJUNCTION WITH THE DEPARTMENT OF THE ENVIRONMENT, SHALL SUBMIT TO 3 THE GOVERNOR, THE SECRETARY, AND, IN ACCORDANCE WITH § 2–1257 OF THE 4 STATE GOVERNMENT ARTICLE, THE GENERAL ASSEMBLY A REPORT ON: 5 (1) ALL DRUG TAKE–BACK PROGRAM ACTIVITIES; 6 (2) THE WEIGHT OF COVERED DRUGS COLLECTED BY E ACH 7 PROGRAM; 8 (3) A DESCRIPTION OF COLLECTION ACTIVITIES; 9 (4) THE NAME AND LOCATION OF ALL COLLECTION SITES; 10 (5) PUBLIC EDUCATION AND OUTREACH ACTIVITIES; 11 (6) AN EVALUATION OF THE EFFICACY OF THE PROG RAM AND OF 12 EACH COLLECTION METHOD; AND 13 (7) ANY MANUFACTURER OUT OF COMPLIANCE OR SUB JECT TO A 14 PENALTY UNDER SUBSECTION (G) OF THIS SECTION. 15 SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 16 October 1, 2023. 17