SB 66 — Regulation of Compounded Weight-Loss Medication

Second Regular Session Seventy-fifth General Assembly STATE OF COLORADO ENGROSSEDREENGROSSED This Version Includes All Amendments Adopted on Second Reading in the House of Introduction LLS NO.

This summary applies to this bill as introduced and does n d 6 notreflectanyamendmentsthatmaybesubsequentlyadopted.Ifthisbill E e 0 passes third reading in the house of introduction, a bill summary that T d , N 3 1 applies to the reengrossed version of this bill will be available at S e r http://leg.colorado.gov.) n A e A Thebillestablishesregulationsforthesale,transfer,ordistribution of compounded weight-loss medications, which are custom-made medications that, unlike mass-produced medications, are not subject to gi approval by the federal food and drug administration (FDA).

A person da e6 2 maynotsell,transfer,ordistributeacompoundedweight-lossmedication R 0 T Rd , AN n2 1 Shading denotes HOUSE amendment.

ES de hc Capital letters or bold & italic numbers indicate new material to be added to existing law.n a Dashes through the words or numbers indicate deletions from existing law.

Dashes through the words or numbers indicate deletions from existing law.

and (d) TheTherefore, safetythe andgeneral integrityassemblyshould oftake action to protect Coloradans by requiring that compounded weight-loss medications andare theirsourced ingredientsfrom areFDA-registered paramountand for-inspected thefacilities health and well-beingthat ofthose patientsmedications incontain Colorado;safe and pharmaceutical-grade ingredients.

(e) Patients in Colorado deserve to have clear information regarding the safety of compounded weight-loss medications and their ingredients;

(f) Preserving the physician-patient relationship is critical to health outcomes and protecting a prescriber's scope of care with individual patients helps to ensure the health of Coloradans;

and (g) Therefore, the general assemblyshould take action to protect Coloradans by requiring that compounded weight-loss medications are sourced from FDA-registered and -inspected facilities and that those medications contain safe and pharmaceutical-grade ingredients.

-3- 066 6-1-741.

Regulation of compounded weight-loss medication - prohibited conduct - labeling requirements - deceptive advertising - enforcement by attorney general - rules - definitions.

(a) (I) "BK DRUG SUBSTANCE "OR" "ACTIVEOR"ACTIVE PHARMACEUTICAL INGREDIENT " MEANS A SUBSTANCE THAT IS INTENDED FOR INCORPORATION INTO A FINISHED DRUG PRODUCT AND IS INTENDED TO PROMOTEPHARMACOLOGICALACTIVITYOROTHERDIRECTEFFECTSINTHE -3- 066 DIAGNOSIS,CURE,MITIGATION,TREATMENT ,OR PREVENTION OF DISEASE OR TO AFFECT THE STRUCTURE OR FUNCTION OF THE BOD.

(II) "ULKDRUGSUBSTANCE"BLKDRUGSUBSTANCE "DOESNOTINCLUDEINTERMEDIATES USED IN THE SYNTHESIS OF THE SUBSTAN.E (b) "COMPOUNDED WEIGHT -LOSS MEDICATION"MEANS A DRUG THAT :

-4- 066 (2) Prohibited conduct.

(a)APERSON AENGAGES PERSON SHALL NOT ENGAGE IN THE SALE,TRANSFER ,OR DISTRIBUTION OF A COMPOUNDEDDECEPTIVE WEIGHTTRADE -LOSSPRACTICE MEDICATIONWHEN COMPOUNDEDUNDERSECTION,IN 503ATHE OFTHE"FEDERALCOURSE FOODOF ,DRUGTHE ,ANDPERSON CS OSMETICACTBUSINESS, ",21U.S.CSEC.353a,UNLESSTHEPERSONCOMPOUNDINGVOCATION THE,OR WEIGHT-LOSSOCCUPATION,THE MEDICATION:PERSON:

(I)(a) USESMAKES BULKA DRUGFALSE SUBSTANCESOR THAT:MISLEADING CLAIM , INCLUDING AN UNSUBSTANTIATED CLAIM , ABOUT A COMPOUNDED WEIGHT -LOSS MEDICATION WHEN THE PERSON IS ADVERTISING OR OTHERWISE PROMOTING THE COMPOUNDED WEIGHT -LOSS MEDICATION;

(A)(b) CDISTRIBUTESACOMPOUNDEDWEIGHT OMPLYLOSSMEDICATIONTOA WITHPERSON WHEN THE STANDARDSDISTRIBUTOR OFIS ANNOT APPLICABLELEGALLY UNITEDAUTHORIZED STATESTO PHARMACOPEIA-4- OR066 NATIONALDISTRIBUTE FORMULARYOR MONOGRAPHTRANSFER ,THE IFBULK ADRUG MONOGRAPHSUBSTANCES EXISTSUSED ,ANDIN THEUTHE NITEDSTATESCOMPOUNDED PHARMACOPEIAWEIGHT CHAPTER-LOSS ONMEDICATION; PHARMACY COMPOUNDING ;

(B)(c) FANATIONALFORMULARYMONOGRAPHDOESNOTEXISTMAKESAMATERIALLYFALSEORMISLEADINGREPRESENTATION ,ARETHAT COMPONENTSTHE OFCOMPOUNDED DRUGSWEIGHT -LOSS MEDICATION ISAPPROVED BY THE FDA WHEN THE COMPOUNDED WEIGHT -LOSS MEDICATION IS NOT APPROVED BY THE FDA;

OR (C)(d) IANATIONALFORMULARYMONOGRAPHDOESNOTEXISTANDM THEBULKDRUGSUBSTANCESARENOTCOMPONENTSOFDRUGSAPPROVEDAKES BYTHEA FDA,MATERIALLY APPEARONTHELISTDEVELOPEDBYTHESECRETARYOFTHEFALSE,MISLEADING,OR FEDERALUNVERIFIED DEPARTMENTCLAIMREGARDINGTHEEFFICACY ,SAFETY,COMPARATIVEPERFORMANCE , CLINICAL OUTCOMES , OR OTHER THERAPEUTIC BENEFITS OF HEALTHTHE ANDCOMPOUNDED HUMANWEIGHT-LOSS SERVICESMEDICATION PURSUANTWHEN TOTHE 21PERSON U.S.C.SEC.IS ADVERTISINGOROTHERWISEPROMOTINGTHECOMPOUNDEDWEIGHT -LOSS MEDICATION .

353a(3) (b)(1)(A)(i)(III);Enforcement.

(II)(a) CONFIRMSPURSUANT THATTO ,IFSECTION A6-1-105 BULK(1)(qqqq)THE DRUGATTORNEY SUBSTANCEGENERAL ISMAY USEDENFORCE IN ACCORDANCE WITH SUBSECTION (2)(a)(I)(BOF THIS SECTI,THESECTION BULK DRUG SUBSTANCE WAS REVIEWED AS PART OF A NEWDECEPTIVE DRUGTRADE APPLICATIONPRACTI.E THAT(b) THENOTWITHSTANDINGSECTION FDA6-1-103THEATTORNEYGENERAL HASHASEXCLUSIVEAUTHORITYTOENFORCETHISSECTIONPURSUANTTOTHIS APPROVEDARTICLE PURSUANT1. TO SECTION 505 OF THE "FEDERAL FOOD , RUG ,AND COSMETIC A CT", 21 U.S.SEC.

355;(c) NOTWITHSTANDINGANYOTHERPROVISIONOFTHISARTICLE 1, NOTHINGINTHISSECTIONPROVIDESTHEBASISFOR ORISTHESUBJECTOF , A PRIVATE RIGHT OF ACTION FOR A VIOLATION OF THIS SEC.ION (4) Applicability.

(III)T VERIFIESSECTION THATDOES THENOT BULKAPPLY DRUGT: SUBSTANCES IN THE COMPOUNDED WEIGHT -LOSS MEDICATION ARE HUMAN PHARMACEUTICAL GRADE PRODUCTS ;

(IV)(a) V ERIFIES THAT THE BULKCOMPOUNDING DRUGOF SUBSTANCES IN THE -5- 066 COMPOUNDED WEIGHT -LOSS MEDICATION HAVE A VALID CERTIFICATE OF ANALYSIS,INCLUDING THE IDENTIFICATION AND PURITY OF THOSE BULK DRUG SUBSTANCESADMINISTERED AND THE IDENTIFICATION OF EACH IMPURITY BY CHEMICALA NAMEPRACTITIONERATANENTITYLICENSEDPURSUANTTOSECTION AND25-1.5-103 AMOUNT(1)(a)(I)(A); PRESENT ;

(V)(b) V ERIFIES THAT THE BULK DRUG SUBSTANCES IN THE COMPOUNDED WEIGHT -LOSS MEDICATION WERE MANUFACTURED BY A MANUFACTURERLONG THAT-TERM ISCARE REGISTEREDFACILITY, WITHAS THEDEFINED FDA IN ACCORDANCESECTION WITH-5- 21066 U.S.C.SEC.12-280-103 (25);

360AND(c) (VI)AN VASSISTED ERIFIESLIVING THATRESIDENCE THE,AS BULKDEFINED DRUG SUBSTANCES IN THESECTION COMPOUNDED25-27-102 WEIGHT(1.3); -LOSS MEDICATION WERE MANUFACTURED BY A MANUFACTURER THAT HAS BEEN INSPECTED BY THE FDA AS A HUMAN DRUG ESTABLISHMENT AND THE INSPECTION CONFIRMED THAT THE MANUFACTURER WAS :

(A)(d) INA COMPLIANCEHOME WITHCARE CURRENTAGENCY GOOD,AS MANUFACTURINGDEFINED PRACTICEIN REQUIREMENTSSECTION25-27.5-102 THAT(3); COVERED THE BULK DRUG SUBSTANCES ;

AND(e) (B)THE CPACE LASSIFIEDPROGRAM AS"VOLUNTARY,AS ACTIONDESCRIBED INDICATEDIN "SECTIO25.5-5-412; OR "NO ACTION INDICATED"BY THE FDA.

(b)(f) BEFOREAN AADULT COMPOUNDEDDAY WEIGHTCARE -LOSSFACILITY MEDICATION,AS CONTAININGABULKDRUGSUBSTANCEISOFFEREDFORSALEINTHESTATEDEFINED ,IN THEMANUFACTURERORWHOLESALEROFTHECOMPOUNDEDWEIGHTSECTION -LOSS25.5-6-303 MEDICATIONSHALLCONDUCTANDDOCUMENTQUALITYCONTROLTESTING(1)OR OF(g) THE BULKCOMPOUNDING DRUGOF SUBSTANCEA PRIOR TO USING THE BULK DRUG SUBSTANCEFOR INANIMAL THEUSE COMPOUNDED. WEIGHT -LOSS MEDICATION, WHICH TESTING MUST CONFIRM:

(I)SECTION TE3. IDENTITY AND CONTENT OF THE BULK DRUG SUBSTANCE;

ANDIn -6-Colorado 066Revised (II)Statutes, HATANYIMPURITIESPRESENTINTHEBULKDRUGSUBSTANCE6-1-105, AREIDENTIFIEDadd CHARACTERIZED(1)(qqqq) QUANTIFIEDas ,ANDJUSTIFIEDGIVENTHEfollows: PRODUCT AND ITS INTENDED USE.

(c)6-1-105. A PERSON THAT COMPOUNDS ,SELLS, DISTRIBUTES, OR TRANSFERS A COMPOUNDED WEIGHT LOSS MEDICATION SHALL NOT :

(I)Unfair DISTRIBUTEor Adeceptive COMPOUNDEDtrade WEIGHTpractices -LOSS- MEDICATIONdefinitions. TO A PERSON WHEN THE DISTRIBUTOR IS NOT LEGALLY AUTHORIZED TO DISTRIBUTE OR TRANSFER THE BULK DRUG SUBSTANCES USED IN THE COMPOUNDED WEIGHT LOSS MEDICATION ;

(II)(1) D ISTRIBUTE,DISPENSE, OR ADMINISTER A COMPOUNDEDperson WEIGHTengages -LOSSin MEDICATIONa THATdeceptive IStrade COUNTERFEITpractice ,when, ADULTERATEDin ,the MISBRANDEDcourse ,DIVERTED,of ORthe OTHERWISEperson's INbusiness, VIOLATIONvocation, OFor FEDERALoccupation, ORthe STATEperson: LAW ;

(III)(qqqq) FILV TOIOLATES MAINTAINSECTION6-1-741. REASONABLE SAFEGUARDS TO PREVENT CONTAMINATION ,DIVERSION, THEFT,OR MISUSE OF THE COMPOUNDED WEIGHT -LOSS MEDICATION IN VIOLATION OF APPLICABLE FEDERAL OR STATE LAW ;

(IV) S HIP OR DISTRIBUTE FINISHED COMPOUNDED WEIGHT-LOSS MEDICATIONORACTIVEPHARMACEUTICALINGREDIENTSTOAPERSONNOT LEGALLY AUTHORIZED UNDER FEDERAL OR STATE LAW TO RECEIVE , COMPOUND ,MANUFACTURE ,DISTRIBUTE,OR DISPENSE SUCH DRUGS;

(V) M AKEAMATERIALLYFALSEORMISLEADINGREPRESENTATION THAT THE COMPOUNDED WEIGHT -LOSS MEDICATION ISAPPROVED BY THE FDA WHEN THE COMPOUNDED WEIGHT -LOSS MEDICATION IS NOT APPROVED BY THE FDA;

(VI) M AKE A MATERIALLY FALSE ,MISLEADING ,OR UNVERIFIED CLAIMREGARDINGTHEEFFICACY ,SAFETY COMPARATIVEPERFORMANCE , -7- 066 CLINICAL OUTCOMES , OR OTHER THERAPEUTIC BENEFITS OF THE COMPOUNDED WEIGHT -LOSS MEDICATION;OR (VII) REPRESENT DIRECTLY OR BY IMPLICATION THAT THE COMPOUNDED WEIGHT -LOSS MEDICATION HAS SUPERIOR EFFICACY OR SAFETY COMPARED TO ANOTHER MEDICALLY APPROPRIATE PRODUCT , UNLESS THAT SUPERIORITY HAS BEEN DEMONSTRATED BY WELL CONTROLLEDCLINICALSTUDIESANDISSUPPORTEDBYCOMPETENT SCIENTIFIC EVIDENC.

(3) Labeling requirements.

(a) THE LABEL OF A COMPOUNDED WEIGHT -LOSS MEDICATION MUST :