SB 133 — AN ACT CONCERNING REGULATION OF PRESCRIPTION DRUGS AND RELATED PROFESSIONS.

89 [(16)] (22) "Institutional pharmacy" means that area within a care- giving institution or within a correctional or juvenile training institution, commonly known as the pharmacy, that is under the direct charge of a pharmacist and in which drugs are stored and dispensed;

(A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETICPublic ACT;Act No.

24-73 5 of 40 Substitute Senate Bill No.

133 COSMETIC ACT;

[(21)] (27) "Nonlegend device" means a device that is not a legend sSB133device; / File No.

89 5 sSB133 File No.

89 device;

(30) "Order entry" means the process by which pharmacyprescription personneldata enteris entered into an electronic data processing system used by a pharmacy softwareto systemrecord dispensed products, which prescription data,data including,shall include, but notneednot limitedbelimitedto:(A)Patient to:demographicdata;(B)drug nameand strength;

(A) Patient demographic data;

(B) drug name and strength;

and (E) the number of authorized refills, including, but not limited to, any use of "PRN" or "ad lib"inlieuofaspecificnumberofauthorizedrefills;and(F)anyrequiredlib" cautionaryin statement;lieu of a specific number of authorized refills;

(31) "Patient" means a human or other animal who receives any health care service fromprovided by a health care providerprovider, forincluding, treatmentbut ofnot alimited currentto, ora futurepharmacist, medicalfor: condition;

(A) The purpose of curing, diagnosing, Public Act No.

24-73 6 of 40 Substitute Senate Bill No.

133 mitigating, palliating, preventing, screening for or treating a past, current or futuremedicalcondition;or (B)anyresearch-relatedpurpose;

[(28)] (36) "Pharmacy softwaretechnician" system" means thean computerindividual softwarewho andis programmingregistered thatwith athe pharmacydepartment uses to log and verifyqualified prescriptionin information,accordance including,with butsection not20-598a, limitedas to,amended anyby datathis requiredact; to be sSB133 / File No.

89[(29)] 6(37) sSB133"Polypharmacy" Filemeans No.the use of multiple drugs by a patient, including any medication that is inappropriate or not medically necessary, such as those not indicated, not effective or constituting a therapeutic duplication;

89[(30)](38)"Practice collectedofpharmacy"or "to practice pharmacy"meansthe sum total of knowledge, understanding, judgments, procedures, securities, controls and maintainedethics underused anyby applicablea lawpharmacist orto regulation;assure optimal safety and accuracy in the distributing, dispensing and use of drugs and devices;

[(28)][(31)] (37)(39) "Pharmacy"Prescribing technician"practitioner" means an individual wholicensed is registered with the department and qualified in accordance with section 20-598a, as amended by thisPublic act;Act No.

[(29)]24-73 (38)7 "Polypharmacy" means the use of multiple40 drugsSubstitute bySenate aBill patient,No. including any medication that is inappropriate or not medically necessary, such as those not indicated, not effective or constituting a therapeutic duplication;

[(30)](39)"Practice133 ofpharmacy"orthe "tostate practiceof pharmacy"meanstheConnecticut, sumany totalother state of knowledge,the understanding,United judgments,States, procedures,the securities,District controlsof andColumbia, ethicsthe usedCommonwealth byof aPuerto pharmacistRico toor assureany optimalterritory safetyor andinsular accuracypossession insubject to the distributing,jurisdiction dispensingof andthe useUnited States who is authorized to issue a prescription within the scope of drugsthe andindividual's devices;practice;

[(31)][(32)] (40) "Prescribing"Prescription" practitioner" means ana individuallawful licensedorder by the state of Connecticut,a anyprescribing otherpractitioner statetransmitted ofeither theorally, Unitedin States,writing theor Districtby ofelectronic Columbia,means thefor Commonwealtha ofdrug Puerto Rico or anydevice territoryfor or insular possession subject to the jurisdiction of the United States who is authorized to issue a prescriptionspecific withinpatient; the scope of the individual's practice;

[(32)](41)"Redispense" (41)meansto "Prescription"reprocessany meansdrug: a lawful order of a prescribing practitioner transmitted either orally, in writing or by electronic means for a drug or device for a specific patient;

(A)That is prescribed to a patient, waspreviously dispensed in compliance packaging and has been returned to the dispensing pharmacy due to a change in the patient's prescription or prescriptions;

(B) by comparing the directions on the prescription label with the directions on the prescription to ensure accuracy;

(C) by selecting such drug from the returned compliance packaging or from stock to fill a current prescription for such drug;

(D) by counting such drug and placing such drug in the proper container or compliance packaging compartment for return to the patient;

and (E) by affixing to thecontainer or compliance packaging a label containing (i) the prescription information set forth in section 20- and required under section 4 of this act, and (ii) any additional notations required due to the prescribing practitioner's directions;

[(35)] (44) "Third-party logistics provider" means a person who distributes drugs, devices or cosmetics while taking possession of the sSB133Public /Act File No.

8924-73 78 sSB133of File40 Substitute Senate Bill No.

89133 drugs, devices or cosmetics but who does not take title of the drugs, devices or cosmetics;

(NEW) (Effective October 1, 2024) (a) (1) No individualpharmacy technician may perform the duties of an advanced pharmacy technician,technician in this state, including, but not limited to, dispensing or redispensing to patients compatible drugs in compliance packaging under section 4 of this act, unless such individual is a pharmacy technician whohas appliesapplied for and receivesreceived an advanced pharmacy technician endorsementdesignation in accordance with the provisions of this section.

(2) Each advanced pharmacy technician endorsementdesignation issued under thissectionshallbethis inasection formandmannershall prescribedbybe thedepartment,issued in a form and manner prescribed by the commissioner, shall be valid for one year and may be renewed for successive one-year periods upon submission of a complete application inand payment of the mannerrenewal setfee forthrequired in section 20-601 of the general statutes, as amended by this section.act.

(b) The department shall issue an advanced pharmacy technician endorsementdesignation to a pharmacy technician who:

(1)Public SubmitsAct toNo. the department, in a form and manner prescribed by the department, an application for an endorsement as an advanced pharmacy technician under this section;

(2)24-73 Is9 activelyof registered40 andSubstitute qualifiedSenate asBill a pharmacy technician in sSB133 / File No.

89133 8(1) sSB133Submits Fileto No.the department, in a form and manner prescribed by the commissioner, (A) a complete application for designation as an advanced pharmacy technician, and (B) the application fee required in section 20-601 of the general statutes, as amended by this act;

89(2) Is actively registered and qualified as a pharmacy technician in accordance with section 20-598a of the general statutes, as amended by this act;

(3) Was continuously registered as a pharmacy technician in accordance with section 20-598a of the general statutes, as amended by this act, for the three-year period immediately preceding the date on which such pharmacy technician applies for an advanced pharmacy technician endorsementdesignation under this section;

(4) Continuously held a certification from the Pharmacy Technician Certification Board, or any other equivalent pharmacy technician certification program approved by the department, for the three-year period immediately preceding the date on which such pharmacy technician applies for an advanced pharmacy technician endorsementdesignation under this section, and maintains such certification in good standing;

(5) Successfully completed (A) an educationalcourse, during the one- year period immediately preceding the date on which such pharmacy technician applies for an initial advanced pharmacy technician endorsementdesignation under this section, that (i) is accredited by the Accreditation Council for Pharmacy Education or another appropriate national accrediting body, andor (B)(ii) athe competencycommissioner, assessmentin performedthe bycommissioner's adiscretion, pharmacistdeems equivalent to an educational course accredited as set forth in accordancesubparagraph with(A)(i) requirementsof this subdivision, and (B) a competency assessmentperformedbyapharmacistinaccordancewithrequirements established by the commissioner in regulations adopted pursuant to subsection (e) of this section;

(6)Public WorksAct underNo. the direct supervision of a pharmacist who satisfies the requirements established in subsection (c) of this section;

and24-73 (7)10 Isof employed40 bySubstitute aSenate pharmacyBill orNo. institutional pharmacy that satisfies the requirements established in subsection (d) of this section.

(c)133 (1)(6) ExceptIs asemployed providedby ina subdivisionpharmacy (2)or ofinstitutional this subsection, the pharmacist who directly supervises an advanced pharmacy technicianthat assatisfies requiredthe underrequirements subdivisionestablished (6)in of subsection (b)(d) of this sectionsection; shall (A) perform all drug utilization reviews, and (B) verify that (i) all prescription data entered into the pharmacy software system are correct, and (ii) the original prescription and the contents of the sSB133 / File No.

89and 9(7) sSB133(A) FileWorks No.under the direct supervision of a pharmacist who satisfies the requirements established in subdivision (1) of subsection (c) of this section;

89or prescription(B) labelIs andsupervised prescription(i) containerin arethe correct.manner set forth in section 20-609a of the general statutes, or (ii) in any manner approved by the commissioner or commission.

(2)(c) (1) The pharmacist who directly supervises an advanced pharmacy technician may allowdelegate to the advanced pharmacy techniciantechnician: to verify that the original prescription and the contents of the prescription label and prescription container are correct.

(d)(A) (1) The pharmacist's authority to perform final verifications, provided the pharmacy or institutional pharmacy that employs ansuch advanced pharmacy technician shall:satisfies the requirements established in subsection (d) of this section;

(A)(B) UseThe barpharmacist's codeauthority technology,to oradminister anothervaccines technologyin approvedaccordance with the provisions of section 20-633 of the general statutes, as amended by this act, and the department,regulations adopted pursuant to assistsubsection in(d) dispensingof drugs;said section;

and (B)(C) NotThe permitpharmacist's theauthority ratioto ofadminister advancedCOVID-19-related pharmacytests, techniciansinfluenza-related totests pharmacistsand physicallyHIV-related presenttests in accordance with the pharmacyprovisions premisesof orsection institutional20-633f pharmacyof tothe exceedgeneral onestatutes, advancedas pharmacyamended technicianby this act, and the regulations adopted pursuant to onesubsection (g) of said section, except the pharmacist providingshall directnot supervision.delegate such pharmacist's responsibility to present the results of any such test to the patient.

A(2) pharmacyNo orpharmacist institutionalwho pharmacymakes mayany employdelegation a ratio of three pharmacy technicians to one supervising pharmacist, as provided in section 20- 576-33 of the regulations of Connecticut state agencies, and an advanced pharmacy technician shallunder notsubdivision be(1) countedof inthis determiningsubsection whethershall suchPublic pharmacyAct orNo. institutional pharmacy satisfies such three-to-one ratio if the advanced pharmacy technician exclusively engages in the duties of an advanced pharmacy technician.

(2)24-73 If11 an advanced pharmacy technician is employed by a pharmacy, the pharmacy shall, in addition to satisfying the requirements established in subdivision (1) of this40 subsection,Substitute useSenate aBill technologyNo. that includes images of the medication that is reviewed as part of a final verification.

(3)133 Ifdelegate anto the advanced pharmacy technician isany employeddiscretionary bydecision-making anauthority institutionalconcerning pharmacy, the institutionalpropriety pharmacyof shall,any drug in additionrelation to satisfyinga thepatient's requirementsmedical establishedcondition inor subdivisiontreatment (1)plan. of this subsection, use bar code scanning at the point of administration to confirm accuracy in dispensing.

(e)(d) (1) The commissionerpharmacy shallor adoptinstitutional regulations,pharmacy inthat accordanceemploys withan sSB133advanced /pharmacy Filetechnician: No.

89(A) 10Shall sSB133use Filebar No.code technology, or another technology approved by the department, to assist in dispensing drugs and confirm accuracy in dispensing;

89and chapter(B) 54Shall ofnot permit the generalratio statutes,of advanced pharmacy technicians to implementpharmacists physically present in the provisionspharmacy ofpremises thisor section.Suchregulationsshall,ataminimum,institutional establish(1)requirementspharmacy forto performanceexceed ofone competencyadvanced assessmentspharmacy requiredtechnician underto subparagraphone (B)pharmacist ofproviding subdivisiondirect (5)supervision, ofexcept subsectionsuch (b)pharmacy ofor thisinstitutional section,pharmacy andmay (2)deviate additionalfrom requirementssuch concerningratio if such deviation is authorized by the dutiescommissioner ofor advancedcommission, pharmacyincluding, technicians.but not limited to, in any regulation adopted by the commissioner pursuant to subsection (e) of this section.

The commissioner or commission shall not provide for a ratio of pharmacy technicians to supervising pharmacists that is lower than three-to-one, and no advanced pharmacy technician shall be counted toward such ratio.

(2) If a pharmacy employs an advanced pharmacy technician, the pharmacy shall, in addition to satisfying the requirements set forth in subdivision (1) of this subsection, not allow the advanced pharmacy technician to perform any final verification under subparagraph (A) of subdivision (1) of subsection (c) of this section unless such advanced pharmacy technician, in performing such final verification, uses a technology that includes images of each drug that such advanced pharmacy technician reviews in performing such final verification.

The provisions of this subdivision shall not apply to an institutional pharmacy.

Public Act No.

24-73 12 of 40 Substitute Senate Bill No.

133 (3) If an institutional pharmacy employs an advanced pharmacy technician, the institutional pharmacy shall, in addition to satisfying the requirementsset forthinsubdivision(1)of thissubsection,not allow the advanced pharmacy technician to perform any final verification under subparagraph (A) of subdivision (2) of subsection (c) of this section unless such institutional pharmacy uses bar code scanning, or another technology or process approved by the department, at the point of administration to confirm accuracy in dispensing.

(e) The commissioner shall adopt regulations, in accordance with the provisions of chapter 54 of the general statutes, to implement the provisions of this section.

Such regulations shall, at a minimum, establish:

(1) Requirements for performance of the competency assessment required under subparagraph (B) of subdivision (5) of subsection (b) of this section;

(2) ratios of pharmacists to advanced pharmacy technicians;

and (3) additional requirements concerning the duties of advanced pharmacy technicians.

(NEW) (Effective October 1, 2024) (a) NoExcept for an individual maywho performis otherwise registered with, or licensed by, the dutiesdepartment under chapter 400j of athe clerkgeneral unlessstatutes, sucheach individual iswho registeredwill physically work in an area of a pharmacy or institutional pharmacy where controlled substances or other legend drugs are dispensed by, or under the supervision of, a pharmacist shall register with the department as a clerk in accordance with the provisions of this section.

(b)For (1)the Thepurposes departmentof shallthis registersection, asan ainstitutional clerkpharmacy anyshall individualnot whobe (A)deemed submits to theinclude department,any inpatient acare formarea andor mannerautomated prescribedprescription bydispensing themachine department,that anis applicationlocated foroutside registrationof asthe aarea clerkcommonly underknown thisas section,the andpharmacy. (B) satisfies all requirements established in any regulations adopted pursuant to subsection (e) of this section.

(2)(b) Each(1) registrationThe issueddepartment undershall thisregister sectionas shalla beclerk validany forindividual onewho yearsubmits to the department, in a form and maymanner beprescribed renewedby the commissioner, (A) a complete application for successiveregistration one-yearas periodsa uponclerk, and (B) the application fee required in section 20-601 of the mannergeneral setstatutes, forthas inamended by this section.act.

(c)Public AAct clerkNo. may handle dispensed drugs and deliver such drugs to patients (1) under the direct supervision of a pharmacist, or (2) as otherwise authorized in regulations adopted by the commissioner pursuant to subsection (e) of this section.

(d)24-73 No13 clerk shall (1) perform any drug utilization review, (2) verify the accuracy of the40 prescriptionSubstitute dataSenate enteredBill intoNo. a pharmacy software system, an original prescription, the contents of a prescription label or the contents of a prescription container, (3) perform any task that requires any professional pharmaceutical judgment, or (4) participate in order entry.

(e)133 The(2) commissionerEach mayclerk adoptregistration regulations,issued inunder accordancethis withsection chaptershall 54be ofissued thein generala statutes,form toand implementmanner prescribed by the provisionscommissioner, ofshall thisbe section,including,valid butfor nottwo limitedto,regulationsestablishingyears additionaland requirementsmay (1)be renewed for registrationsuccessive astwo-year aperiods clerk,upon application and (2)payment concerningof (A)the renewal fee required in section 20-601 of the sSB133general /statutes, Fileas No.amended by this act.

89(3) 11The sSB133department Fileshall No.not refuse to issue any clerk registration under thissection,orrefuse to renewanyclerkregistrationissuedunder this section, because the applicant for such registration or renewal has been convicted of a felony, unless such refusal is rendered in accordance with the provisions of section 46a-80 of the general statutes.

89(c) scopeA clerk may, under the direct supervision of clerks'a authority,pharmacist, (1) handle dispensed drugs and (B)deliver such drugs to patients, (2) collect patient demographic information, (3) collect a prescription number for the purposes of a refill, (4) deliver a drug to an automated prescription dispensing machine or other care-giving area within a care-giving institution or within a correctional or juvenile training institution, (5) perform the duties of a cashier, including, but not limited to, receiving payment for dispensed drugs, (6) conduct inventory management, (7) return to stock any product used to fill a prescription but not sold to a patient, and performance(8) perform any other duties set forth in regulations adopted by the commissioner pursuant to subsection (e) of clerks.this section.

(d) No clerk shall (1) review any drug to determine whether such drug is an appropriate treatment, (2) verify the accuracy of the prescription data entered into an electronic data processing system used by a pharmacy, an original prescription, the contents of a prescription label or the contents of a prescription container, (3) perform any task that requires any professional pharmaceutical judgment, or (4) participate in order entry.

(e) The commissioner may adopt regulations, in accordance with the provisions of chapter 54 of the general statutes, to implement the Public Act No.

24-73 14 of 40 Substitute Senate Bill No.

133 provisions of this section, including, but not limited to, regulations establishing additional requirements for registration as a clerk.

(NEW) (Effective October 1, 2024) (a) (1) A pharmacist or advanced pharmacy technician may, at the request of a patientpatient, the patient's representative or the patient's prescribing practitioner, dispense to the patient compatible drugs in compliance packaging.

(2) (A) If a patient's prescribing practitioner modifies the patient's prescription or prescriptions by, among other things, issuing any new prescription or discontinuing or deprescribing any drug that was previously dispensed to the patient in compliance packaging, the pharmacy that first dispensed such previously dispensed drug in such compliance packaging may, at the request of such patient, representative or prescribing practitioner and if such pharmacy documents such modification in writing, (i) accept such compliance packaging from such patient or representative, (ii) receive and remove any drugs from such returned compliance packaging and redispense such drugs to such patient, and (iii) dispense any newly prescribed and compatible drugs in the redispensed compliance packaging.

(B) Any pharmacy that accepts any compliance packaging returned under this subdivision shall do so exclusively to (i) dispense to the patient any compatible drugs that are newly prescribed to such patient, and (ii) redispense to the patient any drugs contained in such returned compliance packaging in the same quantities that were contained in such returned compliance packaging when such pharmacy accepted such returned compliance packaging.

(C) Each pharmacy that redispenses any drug contained in any compliance packaging returned under this subdivision shall redispense such drug to the patient in (i) compliance packaging that exclusively contains drugs currently prescribed to such patient, or (ii) a separate container that is labeled in accordance with the provisions of section 20- Public Act No.

24-73 15 of 40 Substitute Senate Bill No.

133 of the general statutes and subparagraph (D) of this subdivision.

(D) If a pharmacy accepts any compliance packaging returned under this subdivision and such returned compliance packaging contains one or more drugs that have been deprescribed, discontinued or have otherwise been deemed to be inappropriate for inclusion in compliance packaging, as determined by the patient's prescribing practitioner or a pharmacist, the pharmacy shall redispense such drugs to the patient in oneor more separate containers,eachofwhichshall(i)includenot more than one drug type or dosage, and (ii) bear a label that includes the patient's name, the original prescription serial number or serial numbers, the drug name or names, the dosage form or forms, the quantity or quantities redispensed and instructions for use or disposal, as applicable, which instructions shall disclose, at a minimum, (I) the procedures for any lawfully available means of destroying such drug or drugs at home, and (II) the nearest location where such drug or drugs may be deposited for destruction, including, but not limited to, the nearest retail location allowed to accept such drug or drugs under the regulations adopted pursuant to section 20-576a of the general statutes.

(E) No pharmacy, pharmacist, pharmacy intern or advanced pharmacy technician shall return to a pharmacy's general inventory or regular stock any returned drug that was previously contained in any compliance packaging returned under this subdivision, unless accepting such drug for return to the pharmacy's general inventory or regular stock is otherwise permitted or required by law.

(1) Exclusively contain (A) individual compartments that are tamper- proofevident, andand(B) tamper-evident, and (B) drugs that are(i)are (i)currently prescribedprescribedto asinglepatient pursuant to aan singleorder patientor prescription by the patient's prescribing practitioner, and (ii) dispensed or redispensed to a single patient by a pharmacist or an advanced pharmacy technician;

(2)Public BeAct labeledNo. or relabeled by a pharmacist in accordance with the provisions of section 20-617 of the general statutes;

(3)Bechild-resistantunlessthepharmacyprovidestothepatient,and24-73 the16 patientof returns40 toSubstitute theSenate pharmacy,Bill aNo. waiver explaining that the drugs contained in the compliance packaging are not in a child-resistant container;

(4)133 Identify,(2) onBe eachlabeled individualor compartment,relabeled by a pharmacist in accordance with the nameprovisions andof strengthsection 20-617 of the druggeneral statutes, except if the compliance packaging contains an opioid drug, as defined in section 20- 14o of the general statutes, only one sticker or label shall be affixed to such compliance packaging pursuant to section 20-636 of the general statutes and not to each individual compartment contained in such compartment;compliance packaging;

(5)(3)Bechild-resistantunlessthepharmacyprovidestothepatient,and Notthe containpatient moreacknowledges thanand returns to the pharmacy, a sixty-five-daywaiver supplyexplaining ofthat anythedrugscontainedinthecompliance drug,packaging asare prescribed;not in a child-resistant container;

(4) Identify, on each individual compartment, the name and strength of the drug or drugs contained in such compartment;

(5) Not contain more than a ninety-day supply of any drug, as prescribed, except as otherwise provided in any applicable state or federal law;

(c) Compliance(1) packagingAn mayindividual containcompartment reusableof componentscompliance andpackaging multipledrugs,prescribedtothesamepatient,thatarecontainedwithinmay individualcontain compartmentsmultiple comprisingprescribed adrugs, singleprovided: package.

An(A) individualA compartmentofcompliancepackagingmaycontainmultipleprescribedpharmacist drugs,has provided:determined that all drugs contained in such compartment are compatible drugs;

(1)(B) AAll pharmacistdrugs hascontained determinedin thatsuch allcompartment drugsare containedsubject into suchthe sSB133same /instructions Fileconcerning No.time of administration;

89and 12(C) sSB133No Filedrug No.contained in such compartment has instructions for use that permit such drug to be used on an as needed basis.

89(2) compartmentNo arecontrolled compatiblesubstance drugs;shall be contained in any compliance Public Act No.

(2)24-73 All17 drugs contained in such compartment are subject to the same instructions concerning time of administration40 orSubstitute durationSenate betweenBill doses;No.

and133 (3)packaging Nothat drugcontains containedany inother suchdrug, compartmentunless (A) has instructions for use that permit such other drug tois bea usedcontrolled onsubstance anof asthe neededsame basis,drug ortype (B)prescribed isat a controlleddifferent substance.dose.

(d) (1)A If a patient's prescribing practitioner modifies the patient's prescription for any previously dispensed drug by deprescribing or issuing a new prescription for such drug by way of any oral, written or electronic means, the pharmacy that firstprovides dispensed such drug in compliance packaging may,services ifshall: such pharmacy documents such modification in writing, receive and remove any previously dispensed drugs from such compliance packaging and repackage such drugs, in themannersetforthinsubdivision(2)ofthissubsection,forthepurpose ofensuring thatthepatient'scompliance packaging exclusively contains drugs that are currently prescribed to the patient.

(2)(1) OnceMaintain aan pharmacyarea receivesdedicated anyto compliancethe packagingpreparation containingof previouslydrugs dispensedthat drugsare asto setbe forthdispensed inor subdivisionredispensed (1)in ofcompliance thispackaging, subsection,which aarea pharmacistshall atinclude suchall pharmacyequipment shall:necessary to:

(A) RemoveEnsure fromthat theall compliance packaging anyis drugaccurately (i)prepared; that the patient's prescribing practitioner has deprescribed, or (ii) for which the patient's prescribing practitioner has issued a new prescription;

and (B) DispensePrevent in compliance packaging (i) any compatiblecontamination drugof thatsuch wasnotdrugs; previously includedincompliance packaging,but for whichthe patient's prescribing practitioner has since issued a prescription, and (ii) any previously dispensed and compatible drug (I) that the patient's prescribing practitioner has not deprescribed, or (II) for which the patient's prescribing practitioner has not issued a new prescription;

(C)(2) LabelMaintain orstandard relabeloperating theprocedures: compliance packaging in accordance with the provisions of section 20-617 of the general statutes;

(A) For the use of compliance packaging and sSB133associated /equipment, Filewhich No.procedures shall include, at a minimum, provisions concerning (i) inspections of compliance packaging integrity, (ii) cleaning, (iii) labeling, (iv) dispensing and redispensing, (v) proper hand hygiene, (vi) quarantine, and (vii) handling of dispensed drugs that are removed from compliance packaging and redispensed to patients in the manner set forth in subdivision (2) of subsection (a) of this section;

89and 13(B) sSB133That Filespecify No.which drugs (i) are not compatible drugs, (ii) are suitable to be dispensed or redispensed in compliance packaging, or (iii) require special consideration to be dispensed or redispensed in compliance packaging;

89and (D)(3) NotMaintain return any drug described in subparagraph (A) of this subdivision to the pharmacy'sfollowing generalrecords: inventory or regular stock.

(3)If a pharmacist removesfromany compliance packaging any drug described in subparagraph (A) ofA subdivisionrecord (2) of thisall subsection,drugs that the pharmacistpharmacy shalldispenses return such drug to thea patient in acompliance separatepackaging, container with instructions for proper use or disposal, as applicable, which disposalrecord instructions shall discloseinclude (A) the procedures for any lawfully available means of destroying such drug at home,least and (B) the nearestfollowing location where such drug may be deposited for destruction,each including, but not limited to, thenearest retaillocationallowedto accept such drugdrug: under regulations adopted pursuant to section 20-576a of the general statutes.

(e)(i) AThe pharmacypatient's thatname providesand complianceaddress; packaging services shall:

(1)Public MaintainAct anNo. area dedicated to the preparation of drugs that are to be dispensed in compliance packaging, which area shall include all equipment necessary to (A) ensure that all compliance packaging is accurately prepared, and (B) prevent any contamination of such drugs;

(2)24-73 Maintain18 standard operating procedures (A) for the use of compliance40 packagingSubstitute andSenate associatedBill equipment,No. which procedures shall include, at a minimum, provisions concerning (i) inspections of compliance packaging integrity, (ii) cleaning, (iii) labeling, (iv) dispensing, (v) proper hand hygiene, (vi) quarantine, and (vii) handling of dispensed drugs that are removed from compliance packaging and returned to patients in the manner set forth in subsection (d) of this section, and (B) that specify which drugs (i) are not compatible drugs, (ii) are suitable to be dispensed in compliance packaging, or (iii) require special consideration to be dispensed in compliance packaging;

(3)133 Maintain(ii) aThe logidentification ofnumber, allif drugsany, thatfor the pharmacy dispenses in compliance packaging,packaging whichinwhichsuchpharmacy logdispensedsuchdrug, shallthedate include,suchcompliance atpackaging awas minimum,prepared, forthe eachinitials drugof that the pharmacyindividual dispenseswho inprepared anysuch compliance packaging,packaging (A) the patient's name and address, (B) the identificationinitials numberof for the complianceindividual packagingwho inperformed whicha suchfinal pharmacyverification dispensedfor such drug,compliance sSB133packaging; / File No.

89(iii) 14The sSB133name, Filestrength, No.lot number and national drug code number for such drug;

89(iv) theThe date such compliance packaging was prepared, the initials of the individual who prepared such compliance packaging and the initials of the individual who conducted a final performance check of such compliance packaging, (C) the name, strength, lot number and national drug code number for such drug, (D) the serial number of the prescription for such drug, and (E) a visual description of such drug;

(4) Maintain a log of all drugs, other than controlled substances, that are removed from compliance packaging and returned(v) toA patientsvisual indescription the manner set forth in subsection (d) of this section, which log shall include, at a minimum, for each removed and returned drug, (A) the patient's name, (B) the identification number for the compliance packaging that contained such drug,drug; (C) the serial number of the prescription, (D) the date such drug was dispensed, (E) the name and strength of such drug, and (F) the quantity of such drug that was removed and returned;

(5)(B) MaintainA arecord log of all controlleditems substancesof compliance packaging that arethe removedpharmacy accepts from compliancea packagingpatient for return and returnedredispensing to patientsthe patient in the manner set forth in subdivision (2) of subsection (d)(a) of this section, which logrecord shall include,include at aleast minimum, for each removed and returned controlled substance, the informationfollowing required under subdivision (4) of this subsection for drugseach thatsuch areitem removed and returned to patients in the manner set forth in subsection (d) of thiscompliance section;packaging:

and(i) (6)The Notpatient's latername thanand forty-eightaddress; hours after the department requests that the pharmacy disclose a copy of a log maintained pursuant to subdivision (4) or (5) of this subsection, disclose such copy to the department in electronic form or, if such pharmacy is unable to disclose such copy in electronic form, in paper form.

(f)(ii) The commissioneridentification maynumber, adoptif regulations,any, infor accordancesuch withitem chapter 54 of thecompliance generalpackaging; statutes, to implement the provisions of this section.

(iii) The date on which such pharmacy accepted such item of compliance packaging for return and redispensing in such manner;

(iv) The name of the pharmacist or pharmacy technician who documented the return of such item of compliance packaging;

and (v) The name, formulation and quantity of each drug contained in such item of compliance packaging when such pharmacy accepted such item of compliance packaging for return and redispensing in such manner, including a designation disclosing whether any such drug was deprescribed if the patient's prescribing practitioner has discontinued the prescription;

Public Act No.

24-73 19 of 40 Substitute Senate Bill No.

133 (C) A record of all items of compliance packaging in which the pharmacy redispenses any drug to a patient in the manner set forth in subdivision (2) of subsection (a) of this section, which record shall include at least the following for each such item of compliance packaging:

(i) The patient's name and address;

(ii) The identification number, if any, for such item of compliance packaging;

(iii) The date such item of compliance packaging was prepared for redispensing in such manner;

(iv) The serial number of the prescription for each drug redispensed in such item of compliance packaging in such manner;

(v) The name, formulation and quantity of each drug redispensed in such item of compliance packaging in such manner;

(vi) The name or initials of the redispensing pharmacist;

(vii) The initials of the individual who prepared such item of compliance packaging for redispensing in such manner;

and (viii) The initials of the individual who performed a final verification for such item of compliance packaging for redispensing in such manner;

and (D) A record of all drugs that the pharmacy redispenses to a patient in any container, other than compliance packaging, in the manner set forth in subdivision (2) of subsection (a) of this section, which record shall include at least the following for each such drug:

(i) The patient's name and address;

Public Act No.

24-73 20 of 40 Substitute Senate Bill No.

133 (ii) The date such drug was prepared for redispensing in such container in such manner;

(iii) The serial number of the prescription for such drug;

(iv) The name and formulation of such drug and the quantity of such drug that was redispensed in such container in such manner;

and (v) The name or initials of the redispensing pharmacist.

(e) Each pharmacy shall maintain all records that such pharmacy is requiredto maintainpursuant tothissectionfor aperiodofatleast three years.Notlaterthanforty-eighthoursafterthedepartmentrequeststhat a pharmacy disclose a copy of any record the pharmacy is required to maintain pursuant to this section, such pharmacy shall disclose such copy to the department in electronic form or, if such pharmacy is unable to disclose such copy in electronic form, in paper form.

(f) The commissioner may adopt regulations, in accordance with the provisions of chapter 54 of the general statutes, to implement the provisions of this section.

Subsection (a) of section 20-579 of the general statutes is repealed andthefollowing issubstituted inlieuthereof(EffectiveOctober sSB1331, /2024): File No.

89(a) 15The sSB133commission Filemay refuse to authorize the issuance of a temporary permit to practice pharmacy, may refuse to authorize the issuance or renewal of a license to practice pharmacy, a license to operate a pharmacy or a registration of a pharmacy intern or pharmacy technician, and may revoke, suspend or place conditions on a license or temporarypermittopracticepharmacy,alicensetooperateapharmacy, or a registration of a pharmacy intern or a pharmacy technician, and may assess a civil penalty of up to one thousand dollars per violation of any provision of this chapter or take other action permitted in Public Act No.

8924-73 1,21 2024):of 40 Substitute Senate Bill No.

(a)133 The commission may refuse to authorize the issuance of a temporary permit to practice pharmacy, may refuse to authorize the issuance or renewal of a license to practice pharmacy, a license to operate a pharmacy or a registration of a pharmacy intern or pharmacy technician, and may revoke, suspend or place conditions on a license or temporarypermittopracticepharmacy,alicensetooperateapharmacy, or a registration of a pharmacy intern or a pharmacy technician, and may assess a civil penalty of up to one thousand dollars per violation of any provision of this chapter or take other action permitted in subdivision (7) of section 21a-7 if the applicant or holder of the license, temporary permit or registration:(1)Hasviolatedastatute orregulation relating to drugs, devices or the practice of pharmacy of this state, any state oftheUnitedStates,theUnitedStates,theDistrictoftheUnitedStates, theUnitedStates,theDistrict ofColumbia, the Commonwealth of Puerto Rico, any territory or insular possession subject to the jurisdiction of the United States or a foreign jurisdiction;

(7) has made false, sSB133misleading /or Filedeceptive No.representations to the public or the commission;

89 16 sSB133 File No.

89 misleading or deceptive representations to the public or the commission;

(10) has accepted, for return to regular stock, any drug already dispensed in good faith or delivered from a pharmacy, and exposed to possible and uncontrolledcontaminationorsubstitution;(11)Public hasaccepted,forreturnAct toNo. general inventory or regular stock, any drug sold or delivered to a patient;

(12)24-73 has22 split fees for professional services, including a discount or rebate, with a prescribing practitioner or an administrator or owner of a40 nursingSubstitute home,Senate hospitalBill orNo. other health care facility;

133 uncontrolledcontaminationorsubstitution;(11) hasaccepted,forreturn to general inventory or regular stock, any drug sold or delivered to a patient, unless accepting such drug for return to general inventory or regular stock is otherwise permitted or required by law;

(12) has split fees for professional services, including a discount or rebate, with a prescribingpractitioneroranadministratororownerofanursinghome, hospital or other health care facility;

[(17)] (18) has permitted a person not licensed to practice pharmacy in this state to practice pharmacy in violation of section 20-20-605, 605, to use a pharmacist license or pharmacy display document in violation of section 20-608, or to use words, displays or symbols in violation of section 20-609;

[(18)] (19)(19)hasfailedtomaintaintheentirepharmacypremises,itscomponents has failed to maintain the entire pharmacy premises, its components and contents in a clean, orderly and sanitary condition;

or [(20)] (21) has failed to demonstrate adherence to applicable provisions of United States Pharmacopeia, Chapter 795, sSB133Pharmaceutical /Compounding File– No.Nonsterile Preparations, as amended from time to time.

89 17 sSB133 File No.

89 Pharmaceutical Compounding – Nonsterile Preparations, as amended from time to time.

Subsections (a) to (c), inclusive, of section 20-598a of the general statutes are repealed and the following is substituted in lieu thereofPublic (EffectiveAct OctoberNo. 1, 2024):

24-73 23 of 40 Substitute Senate Bill No.

133 thereof (Effective October 1, 2024):

(b) The department shall [, upon authorization of the commission,] register as a pharmacy technician any person who presents evidence satisfactory to the department that such person is qualified to perform, under the direct[direct] supervision of a pharmacist, routine functions in the dispensing of drugs that do not require the use of professional judgment.

The qualifications for registration as a pharmacy technician under this section shall be in accordance with (1) the standards of an institutional pharmacy, a care-giving institution or a correctional or juvenile training institution, in the case of employment in any such pharmacy or institution, or (2) the standards established by regulation adopted by the commissioner in accordance with the provisions of chapter 54, in the case of employment in a pharmacy.

[As used in this subsection, "direct supervision" means a supervising pharmacist (A) is physicallyphysicallypresentintheareaorlocationwherethepharmacytechnician presentis inperforming theroutine areadrug ordispensing locationfunctions, whereand the(B) pharmacyconducts technicianin-process isand performingfinal routinedrugdispensingfunctions,and(B)conductsin-processandfinal checks on the pharmacy technician's performance.] (c) The department shall [, upon authorization of the commission,] certify as a pharmacy technician any person who meets the requirements for registration as a pharmacy technician, pursuant to subsection (b) of this section, and who holds a certification from the Pharmacy Technician Certification Board or any other equivalent pharmacy technician certificationprogramcertification program approved by the sSB133department. / File No.

89Public 18Act sSB133 File No.

8924-73 department.24 of 40 Substitute Senate Bill No.

133 Sec.

Before the commission or commissioner grants a license to an applicant who has notheldalicenseauthorizedbythecommissionorcommissionernotheldalicenseauthorizedbythecommissionorcommissionerwithin within five years of the date of application, the applicant shall pay the fee required in subdivision (1) of this section.

(6) The fee for notice of a change in officers or directors of a corporation[corporation] business entity holding a pharmacy license is sixty dollars for each pharmacy license held.

(7) The fee for filing notice of a change in name, ownership or managementofapharmacyisninetydollars.Alatefeeforfailingtogive such notice within ten days of the change is fifty dollars in addition to thePublic feeAct forNo. notice.

(8)24-73 The25 feeof for40 applicationSubstitute forSenate registrationBill as a pharmacy intern is sSB133 / File No.

89133 19the sSB133fee Filefor No.notice.

89(8) The fee for application for registration as a pharmacy intern is sixty dollars.

(14) The fee for notice of a change in officers or directors of a corporation[corporation] business entity holding a nonresident pharmacy certificate of registration is sixty dollars for each pharmacy license held.

A late fee for failing to give suchnoticesuch notice within tendaysoftheten days of the change isfiftyis dollars,inadditionfifty dollars, in addition to the fee for notice.

(17) The fee for renewal of a registration as a pharmacy technician is fiftyPublic dollars.Act No.

(18)24-73 The26 fee for issuance of a40 temporarySubstitute permitSenate toBill practiceNo. pharmacy is two hundred dollars.

133 fifty dollars.

(18) The fee for application for designation as an advanced pharmacy technician is twenty-five dollars, which fee shall be in addition to the fee required in subdivision (16) of this section.

(19) The fee for renewal of a designation as an advanced pharmacy technician is twenty-five dollars, which fee shall be in addition to the fee required in subdivision (17) of this section.

[(18)] (20) The fee for issuance of a temporary permit to practice pharmacy is two hundred dollars.

(21) The fee for application for registration, and renewal of a registration, as a clerk is twenty-five dollars.

Section 20-601 of the 2024 supplement to the general statutes, sSB133as /amended Fileby No.section 7 of this act, is repealed and the following is substituted in lieu thereof (Effective July 1, 2025):

89 20 sSB133 File No.

89 as amended by section 259 of public act 23-204, is repealed and the following is substituted in lieu thereof (Effective July 1, 2025):

(2) The fee for renewal of a pharmacist license is [the professional services fee for class A, as defined in section 33-182l] one hundred five dollars.

(3)Public TheAct feeNo. for issuance of a pharmacy license is seven hundred fifty dollars.

24-73 27 of 40 Substitute Senate Bill No.

133 (3) The fee for issuance of a pharmacy license is seven hundred fifty dollars.

(6) The fee for notice of a change in officers or directors of a corporationbusiness entity holding a pharmacy license is sixty dollars for each pharmacy license held.

sSB133(8) /The Filefee No.for application for registration as a pharmacy intern is [sixty dollars] sixty-five dollars.

89On 21or sSB133before Filethe No.last day of January, April, July and October in each year, the commissioner shall transfer five dollars of each fee collected pursuant to this subdivision to the pharmacy professional assistance program account established in section 20-638c.

89 (8) The fee for application for registration as a pharmacy intern is sixty-five dollars.

On or before the last day of January, April, July and October ineachyear, thecommissioner shall transfer five dollarsofeach fee collected pursuant to this subdivision to the pharmacy professional assistance program account established in section 20-638c.

(11) The late fee for failing to notify the [commission] department of a change of ownership, name or location of the premises of a permit to sell nonlegendPublic drugsAct withinNo. five days of the change is twenty dollars.

24-73 28 of 40 Substitute Senate Bill No.

133 nonlegend drugs within five days of the change is twenty dollars.

(14) The fee for notice of a change in officers or directors of a corporationbusiness entity holding a nonresident pharmacy certificate of registration is sixty dollars for each pharmacy license held.

A late fee for failing to give suchnoticesuch notice within tendaysofthechangeten isfiftydays dollars,inadditionof the change is fifty dollars, in addition to the fee for notice.

sSB133(18) /The Filefee No.for application for designation as an advanced pharmacy technician is twenty-five dollars, which fee shall be in addition to the fee required in subdivision (16) of this section.

89(19) 22The sSB133fee Filefor No.renewal of a designation as an advanced pharmacy technician is twenty-five dollars, which fee shall be in addition to the fee required in subdivision (17) of this section.

89(20) (18) The fee for issuance of a temporary permit to practice pharmacy is two hundred dollars.

Public Act No.

24-73 29 of 40 Substitute Senate Bill No.

133 (21) The fee for application for registration, and renewal of a registration, as a clerk is twenty-five dollars.

SubsectionSection (a) of section 20-633 of the 2024 supplement to the general statutes is repealed and the following is substituted in lieu thereof (Effective fromOctober passage):1, 2024):

(a) (1) Any person licensed as a pharmacist under part II of this chapter may orderorder, prescribe and administer:

[.] (B) Any vaccine not included on the National Centers for Disease Control and Prevention's Adult Immunization Schedule,Schedule to any patient who is eighteen years of age or older, provided the vaccine administration instructions for such vaccine are available on the National Centers for Disease Control and Prevention's Internet web site;

(A) Vaccine manufacturer's packagePublic insertAct orNo. the orders of a prescribing practitioner;

24-73 30 of 40 Substitute Senate Bill No.

133 package insert or the orders of a prescribing practitioner;

(4) A pharmacist may delegate to an advanced pharmacy technician the pharmacist's authority to administer a vaccine described in subparagraph (A) of subdivision (1) of this subsection to a patient described in said subparagraph, provided the advanced pharmacy technician administers the vaccine:

(A) Under the direct supervision of such pharmacist;

and (B) in accordance with the provisions of this section and the regulations adopted pursuant to subsection (d) of this section.

(b) A pharmacist who has completed the training required in regulations adopted pursuant to subsection (d) of this section may administer an epinephrine cartridge injector, as defined in section 19a- 909, to a patient whom the pharmacist reasonably believes, based on such pharmacist's knowledge and training, is experiencing anaphylaxis, regardless of whether such patient has a prescription for an epinephrine cartridge injector.

Such pharmacist, or such pharmacist's designee, shall callthe9-1-1 emergency telephone number either before or immediately after such pharmacist administers the epinephrine cartridge injector to such patient.

Such pharmacist shall document the date, time and circumstancesinwhichsuchpharmacist administeredsuchepinephrine cartridge injector, and maintain such documentation for at least three years.

(c)(1)A certifiedandregisteredpharmacy technicianmay administer a vaccine to a patient at a pharmacy if:

(A) The managing pharmacist of such pharmacy is authorized to administer vaccines under this section;

and (B) such pharmacy technician (i) has successfully completed a course of hands-on training, certified by the American Council for Pharmacy Education, concerning the administration of vaccines, (ii) has been trained at such pharmacy regarding the process for administering vaccines to patients at such pharmacy, (iii) successfully completes at Public Act No.

24-73 31 of 40 Substitute Senate Bill No.

133 least one hour of annual continuing education concerning immunization, (iv) has been evaluated by the managing pharmacist of such pharmacy, and (v) administers such vaccine at the direction of the pharmacist on duty at such pharmacy.

(2) During the period beginning on September first and ending on March thirty-first of the succeeding calendar year, a certified and registered pharmacy technician shall not count toward the pharmacist- to-technician ratio set forth in section 20-576-33 of the regulations of Connecticut state agencies if such pharmacy technician:

(A) Is authorizedtoadministervaccinesunderthissection;and(B)exclusively performs duties related to the administration of vaccines during such period.

(d) (1) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health and the Commission of Pharmacy, shall adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of this section.

Such regulations shall:

[(1)] (A) Require any pharmacist who administers a vaccine pursuant to this section to successfully complete an immunization training programfor pharmacists;

[(2)] (B) define thebasicrequirements of such training program, which shall include training and instruction in pre-administration education and screening, vaccine storage and handling, subcutaneous and intramuscular injections, recordkeeping, vaccine safety, cardiopulmonary resuscitation,basic cardiaclife support and adverse event reporting;

[(3)] (C) identify qualifying training programs, which are accredited by the National Centers for Disease Control Prevention, the Accreditation Council for Pharmacy Education or another appropriate national accrediting body;

and [(4)] (D) establish a system of control and reporting.

(2) The Commissioner of Consumer Protection may amend the regulations adopted pursuant to subdivision (1) of this subsection, in accordancewiththeprovisionsofchapter54,to:(A)Establishadditional Public Act No.

24-73 32 of 40 Substitute Senate Bill No.

133 requirements concerning delegations by pharmacists to advanced pharmacy technicians under this section;

and (B) the administration of vaccines by advanced pharmacy technicians under this section.

(EffectiveSection from20-633f passage)of (a)the There2024 supplement to the general statutes is establishedrepealed aand taskthe forcefollowing tois sSB133substituted /in Filelieu No.thereof (Effective October 1, 2024):

89(a) 23For sSB133the Filepurposes No.of this section:

89(1) study"COVID-19" means the impactrespiratory ofdisease unannounceddesignated retailby pharmacythe closures.World Health Organization on February 11, 2020, as coronavirus 2019, and any related mutation thereof recognized by said organization;

(2) "COVID-19-related test" means any laboratory test, or series of laboratory tests, for any virus, antibody, antigen or etiologic agent thought to cause, or indicate the presence of, COVID-19;

(3) "HIV-related prophylaxis" means any drug approved by the federalFoodandDrugAdministrationor anysuccessor agency asapre- exposure or post-exposure prophylaxis for the human immunodeficiency virus;

(4) "HIV-related test" has the same meaning as provided in section 19a-7o;

and (5) "Influenza-related test" means any laboratory test, or series of laboratory tests, for any virus, antibody, antigen or etiologic agent thought to cause, or indicate the presence of, influenza disease.

(b) (1) Any pharmacist licensed under this chapter may order, and administer to a patient,a COVID-19-relatedtest or influenza-relatedtest if:

(A) Such pharmacist (i) is employed by a pharmacy that has submitted to the Department of Public Health a complete clinical laboratory improvement amendment applicationfor certificationforthe Public Act No.

24-73 33 of 40 Substitute Senate Bill No.

133 COVID-19-related test or influenza-related test and the Department of PublicHealthhasapprovedsuchapplication,and(ii)hascompletedany training required by the Department of Consumer Protection;

and (B) thepatientis(i)eighteenyearsofageorolder,or(ii)atleasttwelveyears of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(2) Any pharmacist licensed under this chapter may order, and administer to a patient,a COVID-19-relatedtest or influenza-relatedtest if:

(A) Such pharmacist is employed by a hospital;

and (B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(3) Any pharmacist licensed under this chapter may delegate to an advanced pharmacy technician the pharmacist's authority to administer to a patient a COVID-19-related test or influenza-related test under this subsectionif:

(A)The advancedpharmacy technicianhascompletedany training required by the Department of Consumer Protection concerning the proper administration of the COVID-19-related test or influenza-related test;

and (B) the advanced pharmacy technician administerstheCOVID-19-relatedtest or influenza-relatedtest (i)under the direct supervision of such pharmacist, and (ii) in accordance with the provisions of this section and the regulations adopted pursuant to subsection (g) of this section.

(c) (1) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under this chapter may order, and administer to a patient, an HIV-related test if:

(A) Such pharmacist (i) is employed by a pharmacy that has submitted to the Department of Public Health a complete clinical laboratory Public Act No.

24-73 34 of 40 Substitute Senate Bill No.

133 improvement amendment application for certification for the HIV- related test and the Department of Public Health has approved such application, and (ii) has completed the training required under regulations adopted pursuant to subsection (g) of this section;

and (B) thepatientis(i)eighteenyearsofageorolder,or(ii)atleasttwelveyears of age but younger than eighteen years of age with (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(2) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under this chapter may order, and administer to a patient, an HIV-related test if:

(A) Such pharmacist is employed by a hospital;

and (B) the patient is (i) eighteen years of age or older, or (ii) at least twelve years of age but younger than eighteen years of age and such pharmacist has obtained (I) the consent of such patient's parent, legal guardian or other person having legal custody of such patient, or (II) proof that such patient is an emancipated minor.

(3) Any pharmacist licensed under this chapter may delegate to an advanced pharmacy technician the pharmacist's authority to administer to a patient an HIV-related test under this subsection and the regulations adopted pursuant to subsection (g) of this section if:

(A) The advanced pharmacy technician has completed any training required by the Department of Consumer Protection concerning the proper administration of the HIV-related test;

and (B) the advanced pharmacy technician administers the HIV-related test (i) under the direct supervision of such pharmacist, and (ii) in accordance with the provisions of this section and the regulations adopted pursuant to subsection (g) of this section.

(d) (1) If a pharmacist orders and administers, or if a pharmacist orders and an advanced pharmacy technician working under the pharmacist's direct supervision administers, a COVID-19-related test or Public Act No.

24-73 35 of 40 Substitute Senate Bill No.

133 influenza-related test under subsection (b) of this section, or an HIV- relatedtestundersubsection(c)ofthissection,thepharmacistshall:[(1)] (A) Provide the results of such test to [(A)] (i) the patient, in writing, [(B)] (ii) the patient's primary care provider, if the patient identifies any such primary care provider, and [(C)] (iii) the Commissioner of Consumer Protection or said commissioner's designee, upon request by said commissioner or such designee;

[(2)] (B) report the results of such test to the director of health of the town, city or borough in which such case resides and to the Department of Public Health in the manner set forth in section 19a-215 and applicable regulations;

and [(3)] (C) maintain a record of the results of such test for three years.

(2)No pharmacist shall delegateto anadvancedpharmacy technician the pharmacist's duty to provide to the patient the results of:

(A) A COVID-19-related test or influenza-related test ordered and administered under subsection (b) of this section;

or (B) an HIV-related test ordered and administered under subsection (c) of this section.

(e) (1) If a pharmacist orders and administers, or if a pharmacist orders and an advanced pharmacy technician working under the pharmacist's direct supervision administers, an HIV-related test under subsection (c) of this section and the result of such test is negative, the pharmacist may prescribe and dispense to the patient any HIV-related prophylaxis according to the manufacturer's package insert, provided:

(A) Such pharmacist has completed the training required under the regulations adopted pursuant to subsection (g) of this section;

(B) such patient satisfies the criteria established in such package insert;

and (C) such HIV-related prophylaxis is prescribed and dispensed in accordance with all applicable requirements established in (i) this section, (ii) this chapter, or (iii) any regulations adopted pursuant to subsection (g) of this section or this chapter.

(2) If a pharmacist prescribes any HIV-related prophylaxis under subdivision (1) of this subsection, the pharmacist shall provide to the Public Act No.

24-73 36 of 40 Substitute Senate Bill No.

133 Commissioner of Consumer Protection or the commissioner's designee, upon request by said commissioner or such designee:

(A) A copy of the results of the HIV-related test described in subdivision (1) of this subsection;

(B) prescription information maintained pursuant to this chapter;

and (C) any other documentation the commissioner may require in regulations adopted pursuant to subsection (g) of this section.

(f) Notwithstanding the provisions of section 1-210, all information a pharmacist submits to the Department of Consumer Protection pursuant to this section, or any regulation adopted pursuant to subsection (g) of this section, shall be confidential.

The department shall use such information to perform the department's duties concerning pharmacy, to ensure compliance with and enforce provisions of the general statutes and regulations of Connecticut state agencies concerning pharmacy and for no other purpose.

If the department brings an enforcement action and uses any such information as part of suchaction,thedepartmentmaydisclosesuchinformationtotheparties to such action only if such disclosure is required by applicable law.

No such party shall further disclose such information except to a tribunal, the Commission of Pharmacy, an administrative agency or a court with jurisdiction over such action.

Such tribunal, commission, agency or court shall ensure that such information is subject to a qualified protective order, as defined in 45 CFR 164.512(e), as amended from time to time.

(g) (1) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, the Commission of Pharmacy, a state-wide professional society representingthe interestsof physicians practicing medicine in this state and a state-wide organization representing the interests of health care professionals and scientists specializing in the control and prevention of infectious diseases, shall adopt regulations, in accordance with the provisions of chapter 54, to implement the provisions of this section.

Such regulations shall, at a Public Act No.

24-73 37 of 40 Substitute Senate Bill No.

133 minimum:

[(1)] (A) Ensure compliance with all applicable guidance issued by the federal Centers for Disease Control and Prevention;

[(2)] (B) ensure that each HIV-related prophylaxis prescribed and dispensed under subsection (e) of this section is prescribed and dispensed in accordance with the approval the federal Food and Drug Administration has granted for such HIV-related prophylaxis;

[(3)] (C) establish permissible routes of administration;

[(4)] (D) establish prescriptiondurationlimitsnot to exceed [(A)] (i) sixty daysfor any pre- exposure HIV-related prophylaxis, or [(B)] (ii) thirty days for any post- exposure HIV-related prophylaxis;

[(5)] (E) specify [(A)] (i) how frequently a pharmacist shall provide treatment to a patient under this section, [(B)] (ii) when a pharmacist providing treatment to a patient under this section shall refer such patient to such patient's primary care provider or any other health care provider identified by such patient, and [(C)] (iii) the circumstances in which a pharmacist shall recommend that a patient undergo screenings for sexually transmitted infections other than the human immunodeficiency virus;

[(6)] (F) establish requirements concerning private areas for consultations between pharmacists and patients;

[(7)] (G) establish training requirements concerning [(A)] (i) methods to obtain a patient's complete sexual history, [(B)] (ii) delivering a positive HIV-related test result to apatient, [(C)] (iii) referring a patient who has tested positive for the human immunodeficiency virus to the services that are available to such patient, and [(D)] (iv) using HIV-related prophylaxes for patients who have tested negative for the human immunodeficiency virus;

[(8)] (H) identify qualifying training programs, which are accredited by the National Centers for Disease Control and Prevention, the Accreditation Council for Pharmacy Education or another appropriate national accrediting body;

and [(9)] (I) establish a system of control and reporting.

(2) The Commissioner of Consumer Protection may amend the regulations adopted pursuant to subdivision (1) of this subsection, in Public Act No.

24-73 38 of 40 Substitute Senate Bill No.

133 accordancewiththeprovisionsofchapter54,to:(A)Establishadditional requirements concerning delegations by pharmacists to advanced pharmacy technicians under this section;

and (B) the administration of COVID-19-related tests, influenza-related tests and HIV-related tests by advanced pharmacy technicians under this section.

Sec.

11.

(Effective from passage) (a) There is established a task force to study the impact of unannounced retail pharmacy closures.

(d)Public AllAct initialNo. appointments to the task force shall be made not later thanthirty daysafter theeffective date ofthis section.Any vacancy shall be filled by the appointing authority.

24-73 39 of 40 Substitute Senate Bill No.

133 (d) All initial appointments to the task force shall be made not later thanthirty daysafter theeffective date ofthis section.Any vacancy shall be filled by the appointing authority.

sSB133(f) /The Fileadministrative No.staff of the joint standing committee of the General Assembly having cognizance of matters relating to consumer protection shall serve as administrative staff of the task force.

89 24 sSB133 File No.

89 (f) The administrative staff of the joint standing committee of the General Assembly having cognizance of matters relating to consumer protection shall serve as administrative staff of the task force.

ThisSec. act shall take effect as follows and shall amend the following sections:

Section12. 1 October 1, 2024 20-571 Sec.

2Section October259 1,of 2024public Newact section23-204 Sec.is repealed.

3(Effective October 1, 2024) Approved May 28, 2024 NewPublic sectionAct Sec.No.

424-73 October40 1,of 202440 New section Sec.

5 October 1, 2024 20-579(a) Sec.

6 October 1, 2024 20-598a(a) to (c) Sec.

7 October 1, 2024 20-601 Sec.

8 July 1, 2025 20-601 Sec.

9 from passage 20-633(a) Sec.

10 from passage New section Statement of Legislative Commissioners:

In Section 2(d)(1)(B), "physically" was added before "present" for internal consistency;

in Section 4(d)(2), "containing previously dispensed drugs" was added after "compliance packaging" for clarity;

in Section 4(e)(3)(B), "performed a final check" was changed to "conducted a final performance check" for internal consistency;

and in Section 4(e)(5), "said subsection (d)" was changed to "subsection (d) of this section" for consistency with standard drafting conventions.

GL Joint Favorable Subst.

sSB133 / File No.

89 25 sSB133 File No.

89 The following Fiscal Impact Statement and Bill Analysis are prepared for the benefit of the members of the General Assembly, solely for purposes of information, summarization and explanation and do not represent the intent of the General Assembly or either chamber thereof for any purpose.

In general, fiscal impacts are based upon a variety of informational sources, including the analyst’s professional knowledge.

Whenever applicable, agency data is consulted as part of the analysis, however final products do not necessarily reflect an assessment from any specific department.

OFA Fiscal Note State Impact:

Agency Affected Fund-Effect FY 25 $ FY 26 $ Resources of the General Fund GF - Potential See Below See Below Revenue Gain Note:

GF=General Fund Municipal Impact:

None Explanation The bill adds to the reasons for which the state Pharmacy Commissionmay take disciplinary action (whichincludes issuing acivil penalty of up to $1,000) resulting in a potential revenue gain to the state to the extent violations occur and civil penalties are issued.

The bill also establishes a task force to study the impact of unannounced retail pharmacy closures resulting in no fiscal impact because the task force has the expertise to meet the requirements of the bill.

The Out Years The annualized ongoing fiscal impact identified above would continue into the future subject to the number of violations that result in civil penalties.

sSB133 / File No.

89 26 sSB133 File No.

89 OLR Bill Analysis sSB 133 AN ACT CONCERNING REGULATION OF PRESCRIPTION DRUGS AND RELATED PROFESSIONS.

SUMMARY This bill makes various changes to laws on pharmacies and pharmacists.

It establishes the advanced pharmacy technician and clerk occupational categories.

Among other related provisions, it sets certain parameters of their allowable duties.

The bill authorizes pharmacists and advanced pharmacy technicians to dispense to patientstheir prescriptiondrugsincompliance packaging (packaging that separates drugs into individual compartments by dose) if they follow certain criteria.

Pharmacies that provide compliance packaging are required to keep logs with specific details of the drugs they dispense and who they dispense them to.

The bill also allows for the repackaging of pharmaceutical drug compliance packaging, subject to certain requirements.

This includes the requirement to return any drugs removed from compliance packaging to the patient with directions on how to properly dispose of the drugs.

The bill makes it a punishable offense for pharmacists, pharmacy operators, pharmacy interns, and pharmacy technicians to return to the general inventory or regular drug stock of the pharmacy any drug that has been sold or delivered to a patient, in addition to existing law’s prohibition on such returns of drugs exposed to possible contamination or substitution.

sSB133 / File No.

89 27 sSB133 File No.

89 The bill allows individuals enrolled in pharmacy technician education programs toengage in dutiesof a pharmacy technician if they are under the direct supervision of a pharmacist who is an instructor in the program.

It allows pharmacists to order and administer, not just administer, vaccines for certain patients, and applies this authority to all federally approved vaccines on the Centers for Disease Control and Prevention’s (CDC) age-appropriate immunization schedule.

The bill establishes a task force to study the impact of unannounced retail pharmacy closures.

For purposes of the state’s pharmacy laws, the bill generally defines a “patient” as a human or other animal receiving health care services from a provider to treat a current or future medical condition (§ 1).

The bill also makes minor, technical, and conforming changes.

EFFECTIVE DATE:

October 1, 2024, except (1) upon passage for provisions on pharmacists ordering vaccinations and the task force and (2) July 1, 2025, for a technical change.

§§ 1 & 2 — ADVANCED PHARMACY TECHNICIANS The bill establishes the advanced pharmacy technician occupational category.

It prohibits anyone from performing the duties of this occupation without getting an advanced pharmacy technician endorsement from the Department of Consumer Protection (DCP).

To get the endorsement, a person must:

1.

be an actively registered and qualified pharmacy technician;

2.

have been registered as a pharmacy technician for the three-year period immediately before applying for an advanced pharmacy technician endorsement;

3.

have continuously held a certification from the Pharmacy Technician Certification Board, or equivalent certification sSB133 / File No.

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89 program approved by DCP, for the three-year period immediately before applying for an advanced pharmacy technician endorsement, and keep that certification in good standing;

4.

have successfully completed an educational course accredited by a nationally recognized accreditation body within one year of the date of applying to be an advanced pharmacy technician;

5.

have successfully completed a competency assessment proctored by a pharmacist in keeping with requirements to be set by the commissioner;

6.

work under the direct supervision of a licensed pharmacist;

and 7.

be employed by a pharmacy (including institutional pharmacies).

An advanced pharmacy technician endorsement is valid for one year and may be renewed for successive one-year periods.

An advanced pharmacy technician’s duties may include, among other things, dispensing to patients compatible drugs in compliance packaging (see § 4 below).

Supervisory and Staffing Requirements Under the bill, a pharmacist that directly supervises an advanced pharmacy technician generally must perform all drug utilization reviews (generally, reviewing a pharmacist’s prescribing, dispensing, and utilization activities to ensure appropriate decision-making), and verify that (1) prescription drug data entered in the pharmacy software systems is correct and (2) the original prescription and contents of the label and container are correct.

However, a pharmacist may allow the advanced pharmacy technician himself or herself to verify the accuracy of the original prescription and the contents of the label and container.

A pharmacy that employs an advanced pharmacy technician must:

sSB133 / File No.

89 29 sSB133 File No.

89 1.

use bar codes or a similar technology approved by DCP to assist in the dispensing of drugs and 2.

keep the on-site ratio of advanced pharmacy technicians to pharmacists providing direct supervision at no more than 1:1.

Advanced pharmacy technicians do not count towards the existing 3:1 ratio of pharmacy technicians to supervising pharmacists if the advanced pharmacy technician exclusively performs duties of an advanced technician.

Pharmacies that employ advanced pharmacy technicians are required to use technology that includes images of each type of medication as part of a final verification check of dispensed drugs.

Institutional pharmacies employing advanced pharmacy technicians must use bar code scanning at the point of administration to the patient to confirm the correct drugs have been dispensed.

Regulations The bill requires the DCP commissioner to adopt implementing regulations that, at minimum, set (1) performance requirements for the competency assessment required for endorsement as an advanced pharmacy technician, and (2) additional requirements for the duties of advanced pharmacy technicians.

§ 3 — PHARMACY CLERKS The bill establishes the clerk occupational category and prohibits anyone from performing a clerk’s duties unless registered as such with DCP.

To become registered, an applicant must satisfy the registration requirements set by any DCP regulations on the matter (see below).

A clerk’s registration is valid for one year and may be renewed for successive one-year periods.

Clerks are authorized to handle dispensed drugs and deliver those drugs to patients under the direct supervision of a pharmacist or sSB133 / File No.

89 30 sSB133 File No.

89 otherwise as authorized in regulations.

Clerks may not:

1.

perform drug utilization reviews;

2.

verify the accuracy of prescription data entered into the pharmacy’s software system, the prescription itself, and the contents of a prescription label or container;

3.

perform any task that requires professional pharmaceutical judgment;

or 4.

participate in order entry (generally, the process of entering prescription data into the pharmacy’s software system).

Clerks are also not involved in the dispensing process or preparing a prescription for final verification.

The commissioner is authorized to establish regulations that include, among other things, creating additional requirements for clerk registration, the scope of clerks’ professional authority, and the professional duties of clerks.

§ 4 — COMPLIANCE PACKAGING The bill authorizes pharmacists and advanced pharmacy technicians to dispense to patients compatible drugs in compliance packaging, at thepatient’sorprescribingpractitioner’srequest.Generally,compliance packaging is packaging prepared at a pharmacy that separates drugs into individual compartments by dose as prescribed to an individual patient.

Compliance packaging must:

1.

only contain individual compartments that are tamper-proof and tamper-evident, 2.

only contain drugs prescribed to a single patient by their prescribing practitioner and dispensed to that patient by a sSB133 / File No.

89 31 sSB133 File No.

89 pharmacist or an advanced pharmacy technician, 3.

be labeled or relabeled by a pharmacist under existing requirements, 4.

be child-resistant unless the patient signs a waiver, 5.

identify on each individual compartment the name and strength of the drug it contains, 6.

not contain more than a 65-day supply of any drug, and 7.

be compliant with the United States Pharmacopeia.

Reusable Components, Multiple Drugs, and Repackaging The bill allows compliance packaging to contain reusable components and multiple drugs (for one patient) within individual compartments in the same package.

It also allows an individual compartment to contain multiple drugs if (1) a pharmacist determines that the drugs are compatible (i.e., not contraindicated or adversely impacted by each other);

(2) the drugs have the same instructions for the time between doses and none are to be taken on an as-needed basis;

and (3) none of the drugs are controlled substances.

The bill allows a pharmacy that dispensed drugs in compliance packaging to remove dispensed drugs from the packaging and repack them in keeping with a modified prescription from the patient’s prescribing practitioner.

To repackage compliance packaging, a pharmacist must:

1.

remove any drugs that the patient’s prescribing practitioner has deprescribed or issued a new prescription for, 2.

dispense the new prescribed compatible drugs in compliance packaging, 3.

dispense the previously dispensed compatible drugs in compliance packaging, sSB133 / File No.

89 32 sSB133 File No.

89 4.

label the new compliance packaging, and 5.

never return any drug removed from compliance packaging into the pharmacy’s general inventory.

The bill requires a pharmacist to return any drugs removed from compliance packaging to the patient in a separate container with instructions for proper use or disposal, as applicable (e.g., the location of the nearest pharmacy that accepts drugs for disposal).

Standard Operating Procedures The bill requires pharmacies that provide compliance packaging services to maintain an area dedicated to that purpose and that contains the equipment necessary to ensure all compliance packaging is accurate and drug contaminant free.

The bill also requires these pharmacies to maintain a set of standard operating procedures for the use of compliance packaging and associated equipment that includes at least the following:

1.

inspections of the integrity of compliance packaging, 2.

cleaning, 3.

labeling, 4.

dispensing, 5.

proper hand hygiene, 6.

quarantine, and 7.

handling of dispensed drugs that are removed from compliance packaging and returned to patients.

The standardoperating proceduresalso must specify which drugs(1) are not compatible, (2) are suitable for compliance packaging, or (3) require special consideration to be dispensed in this way.

Requirement to Maintain Records sSB133 / File No.

89 33 sSB133 File No.

89 The bill requires pharmacies that provide compliance packaging services to maintain a log (record) of drugs that the pharmacy dispenses in this packaging.

That log must have:

1.

the patient’s name and address;

2.

the compliance package’s identification number;

3.

the date the package was prepared;

4.