SB 1102 — AN ACT CONCERNING PHARMACIES AND PHARMACISTS.

and(c) (C)(1) provideOn toor after the Commissioneradoption of Consumerregulations Protectionpursuant orto thesubsection commissioner's(g) designee,of uponthis asection, requestany madepharmacist bylicensed theunder commissionerchapter or400j of the commissioner'sgeneral designee,statutes amay copyorder, ofand theadminister resultsto ofa suchpatient, test.an HIV-related test if:

(c)(A) (1)Such Ifpharmacist a(i) pharmacistis ordersemployed andby administersa anypharmacy HIV-relatedthat testhas undersubmitted subdivisionto (1)the Department of subsectionPublic (b)Health ofa thiscomplete sectionclinical andlaboratory theimprovement resultamendment ofapplicationfor suchcertificationforthe HIV-related test isand negative, the pharmacistDepartment mayof prescribePublic Health has approved such application, and dispense(ii) tohas completed the patienttraining anyrequired HIV-relatedunder prophylaxisregulations accordingadopted pursuant to thesubsection manufacturer's(g) packageof insert,this provided:section;

(A)and Such(B) patientthepatientis(i)eighteenyearsofageorolder,or(ii)atleasttwelveyears satisfiesPublic theAct criteriaNo. established in such package insert;

and23-19 (B)8 suchof HIV-related35 prophylaxisSubstitute isSenate prescribedBill andNo. dispensed in accordance with all applicable requirements established in chapter 400j of the general statutes.

(2)1102 Ifof aage pharmacistbut prescribesyounger anythan HIV-relatedeighteen prophylaxisyears underof subdivisionage (1)with of(I) thisthe subsection,consent theof pharmacistsuch shallpatient's provideparent, tolegal theguardian Commissioneror ofother Consumerperson Protectionhaving orlegal thecustody commissioner'sof designee,such uponpatient, aor request(II) madeproof bythat thesuch commissionerpatient oris thean commissioner'semancipated designee:minor.

(A)(2) AOn copyor ofafter the resultsadoption of theregulations pursuant to subsection (g) ofthissection,any pharmacist licensed under chapter 400jof thegeneral statutes may order, and administer to a patient, an HIV-related test;test if:

(B)(A) prescriptionSuch informationpharmacist maintainedis pursuantemployed toby chaptera 400jhospital; of the general statutes;

and (C)(B) anythe otherpatient documentationis (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 commissionerconsent requiresof insuch regulationspatient's adoptedparent, pursuantlegal toguardian subsectionor (d)other person having legal custody of thissuch section.patient, or (II) proof that such patient is an emancipated minor.

(d) TheIf Commissionera ofpharmacist Consumerorders Protection,and inadministers consultationa withCOVID-19-related thetest Commissioneror influenza-related test under subsection (b) of Publicthis Healthsection, andor thean CommissionHIV- related test under subsection (c) of Pharmacy,this sSB1102section, /the Filepharmacist No.shall:

221(1) 8Provide sSB1102the Fileresults No.of such test to (A) the patient, in writing, (B) the patient's primary care provider, if the patient identifies any such primary care provider, and (C) the Commissioner of Consumer Protection or said commissioner's designee, upon request by said commissioner or such designee;

221(2) shallreport adoptthe regulations,results inof accordancesuch withtest chapterto 54the ofdirectorofhealth theofthetown,city generalor statutes,boroughinwhichsuch tocase implementresides theandtotheDepartmentofPublicHealthinthemannersetforthinsection provisions19a-215 of thisthe section.general statutes and applicable regulations;

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

(e) (1) If a pharmacist orders and administers an HIV-related test under subsection(c)of thissectionandtheresult ofsuchtest isnegative, 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;

Public Act No.

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1102 (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) chapter 400j of the general statutes, or (iii) any regulations adopted pursuant to subsection (g) of this section or chapter 400j of the general statutes.

(2) If a pharmacist prescribes any HIV-related prophylaxis under subdivision (1) of this subsection, the pharmacist shall provide to the 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)prescriptioninformationmaintainedpursuant to chapter 400j of the general statutes;

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 of the general statutes, 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 such action, the department may disclose such information to the parties 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 agencyor acourtwithjurisdictionover suchaction.Such tribunal, commission, agency or court shall ensure that such information is subject to a qualified protective order, as defined in 45 Public Act No.

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1102 CFR 164.512(e), as amended from time to time.

(g) The Commissioner of Consumer Protection, in consultation with the Commissioner of Public Health, the Commission of Pharmacy, a state-wide professional society representing the interests of 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 chapter 54 of the general statutes, to implement the provisions of this section.

(1)(1)Ensure Identifycompliance qualifyingwithall trainingapplicableguidance programs,issued which are accredited by the Nationalfederal Centers for Disease Control and Prevention,Prevention; the Accreditation Council for Pharmacy Education or another appropriate national accrediting body;

(2) ensure that each HIV-related prophylaxis prescribed and (2)dispensed establishunder asubsection system(e) of controlthis section is prescribed and reporting.dispensed in accordance with the approval the federal Food and Drug Administration has granted for such HIV-related prophylaxis;

(3) establish permissible routes of administration;

(4) establish prescription duration limits not to exceed (A) sixty days for any pre-exposure HIV-related prophylaxis, or (B) thirty days for any post-exposure HIV-related prophylaxis;

(5) specify (A) how frequently a pharmacist shall provide treatment to a patient under this section, (B) 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) the circumstances in which a pharmacist shall recommend that a patient undergo screenings for sexually transmitted infections other than the human immunodeficiency virus;

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

(7) establish training requirements concerning (A) methods to obtain a patient's complete sexual history, (B) delivering a positive HIV-relatedtest result to a patient, (C) referring a patient who has tested positive for the human immunodeficiency virus to the services that are available to such patient, and (D) using HIV-related prophylaxes for patients who have tested negative for the Public Act No.

23-19 11 of 35 Substitute Senate Bill No.

1102 human immunodeficiency virus;

(8) 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) establish a system of control and reporting.

(A) Conducting (i) a temporary clinic,pharmacy operation, (ii) a vaccination event, or (iii) an opioid antagonist training and prescribing event;

(A) The mobile pharmacy has failed to comply with the(i) provisionsany provision of this section;sectionorchapter400jofthegeneralstatutes,(ii)anyregulationadopted pursuant to subsection (d) of this section or chapter 400j of the general statutes, or (iii) any applicable law or regulation of any jurisdiction concerning drugs, devices or the practice of pharmacy;

(2) maintain a record of each drug that is dispensed at such mobile pharmacy and include such record in such pharmacy's records not later thanPublic twenty-fourAct hoursNo. after such drug is dispensed;

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1102 than twenty-four hours after such drug is dispensed;

(4) while operating such mobile pharmacy, store all drugs in such mobile pharmacy ina manner that (A)preventsany drug diversion,and sSB1102(B) /is Fileconsistent No.with the storage conditions specified by the manufacturers of such drugs;

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221 (B) is consistent with the storage conditions specified by the manufacturers of such drugs;

(1)Public TheAct nameNo. of the individual who is responsible for notifying the Commission of Pharmacy of an unscheduled closing;

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1102 (1) The name of the individual who is responsible for notifying the Commission of Pharmacy of an unscheduled closing;

sSB1102(3) /The Filename No.of the individual who is responsible for updating the pharmacy's telephone system during an unscheduled closing to (A) prevent the acceptance of orally transmitted prescriptions during the unscheduled closing, and (B) provide a message that alerts patients that such pharmacy will be closed and their prescriptions may be obtained from a nearby pharmacy;

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221 (3) The name of the individual who is responsible for updating the pharmacy's telephone system during an unscheduled closing to (A) prevent the acceptance of orally transmitted prescriptions during the unscheduled closing, and (B) provide a message that alerts patients that such pharmacy will be closed and their prescriptions may be obtained from a nearby pharmacy;

(2) Adjust such pharmacy's telephone system to prevent the acceptance of orally transmitted prescriptions during the unscheduled closing;Public Act No.

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1102 closing;

(4) Post signage at the entrance to such pharmacy, and at each entrance of the structure if such pharmacy is located within another structure, (A) stating that such pharmacy is closed, (B) disclosing the duration of the unscheduled closing, and (C) providing (i) a list of all pharmacies that are located within a two-mile radius of such pharmacy, sSB1102or /(ii) Filethe No.next closest pharmacy if there is no pharmacy within such two-mile radius;

221 11 sSB1102 File No.

221 or (ii) the next closest pharmacy if there is no pharmacy within such two-mile radius;

(2)Public TheAct pharmacyNo. that experienced the unscheduled closing shall provide to the pharmacy that dispensed such prescription during such unscheduled closing all information necessary for the transfer of such prescription;

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1102 (2) The pharmacy that experienced the unscheduled closing shall provide to the pharmacy that dispensed such prescription during such unscheduled closing all information necessary for the transfer of such prescription;

Such regulations shall include, but need not sSB1102be /limited Fileto, No.provisions for the placement of a secured container at a pharmacy that allows patients to, during the hours in which the pharmacy may be open or closed, obtain prescriptions that were dispensed by such pharmacy.

221 12 sSB1102 File No.

221 be limited to, provisions for the placement of a secured container at a pharmacy that allows patients to, during the hours in which the pharmacy may be open or closed, obtain prescriptions that were dispensed by such pharmacy.

(3)Public BeAct underNo. video surveillance at all times;

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1102 (3) Be under video surveillance at all times;

[, to an adult, any] (A) Any vaccine, approved or authorized by the United States Food sSB1102and /Drug FileAdministration No.that is listed on the National Centers for Disease Control and Prevention's Adult Immunization Schedule, [and (2) on and after July 1, 2022, administer to any person between the ages of twelve and seventeen, with the consent of such person's parent or guardian,theinfluenza vaccine approvedby the UnitedStatesFoodand Drug Administration,providedtheadministrationofanyvaccine under this subsection is conducted pursuant to the order of a licensed health care provider and in accordance with the regulations established pursuant to subsection (b) of this section.] to any patient who is:

221 13 sSB1102 File No.

221 and Drug Administration that is listed on the National Centers for Disease Control and Prevention's Adult Immunization Schedule, [and (2) on and after July 1, 2022, administer to any person between the ages of twelve and seventeen, with the consent of such person's parent or guardian,theinfluenza vaccine approvedby theUnitedStates Foodand Drug Administration,providedtheadministrationofanyvaccine under this subsection is conducted pursuant to the order of a licensed health care provider and in accordance with the regulations established pursuant to subsection (b) of this section.] to any patient who is:

andPublic (C)Act AnyNo. vaccine pursuant to a verbal or written prescription of a prescribing practitioner for a specific patient.

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1102 and (C) Any vaccine pursuant to a verbal or written prescription of a prescribing practitioner for a specific patient.

and (B) regulations adopted pursuant to subsection (c)(d) of this section.

(b) A pharmacist who has completed the training required in regulations adopted pursuant to subsection (c)(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, sSB1102regardless /of Filewhether No.such patient has a prescription for an epinephrine cartridge injector.

221 14 sSB1102 File No.

221 regardless of whether such patient has a prescription for an epinephrine cartridge injector.

[(b)](c)(1)A (c)certifiedandregisteredpharmacy Thetechnicianmay Commissioneradminister ofa Consumervaccine 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 implementa thepatient provisionsat ofa thispharmacy section.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 Public Act No.

23-19 18 of 35 Substitute Senate Bill No.

1102 been trained at such pharmacy regarding the process for administering vaccines to patients at such pharmacy, (iii) successfully completes at 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.

[(b)] (d) 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.

[(c) For purposes of this section, "adult" means a person who has attainedPublic theAct ageNo. of eighteen years.] Sec.

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1102 attained the age of eighteen years.] Sec.

Such sSB1102regulations /may Fileinclude, No.but are not limited to, provisions (1) concerning the licensing of any pharmacist or pharmacy, disciplinary action that may be taken against a licensee, the conduct of a pharmacist and the operation of a pharmacy, (2) specifying various classes of pharmacy licenses issued under section 20-594, as amended by this act, including, but not limited to, licenses for infusion therapy pharmacies, [and] nuclear pharmacies and health care institutional pharmacies, and specifying requirements for operation of pharmacies under the classes of pharmacy licenses permitted under the regulations, (3) concerning creation and maintenance of prescription records, and (4) concerning registration and activities of pharmacy interns, registered pharmacy technicians and certified pharmacy technicians.

221 15 sSB1102 File No.

221 regulations may include, but are not limited to, provisions (1) concerning the licensing of any pharmacist or pharmacy, disciplinary action that may be taken against a licensee, the conduct of a pharmacist and the operation of a pharmacy, (2) specifying various classes of pharmacy licenses issued under section 20-594, as amended by this act, including, but not limited to, licenses for infusion therapy pharmacies, [and] nuclear pharmacies and health care institutional pharmacies, and specifying requirements for operation of pharmacies under the classes of pharmacy licenses permitted under the regulations, (3) concerning creation and maintenance of prescription records, and (4) concerning registration and activities of pharmacy interns, registered pharmacy technicians and certified pharmacy technicians.

The commissionerPublic may,Act byNo. regulation adopted with the advice and assistance of the commission, in accordance with chapter 54, require such other information on the application as is necessary for the department to carry out [its] the department's duties under sections 20- 570 to 20-630, inclusive.

(c)23-19 The20 department shall, after receipt of an35 applicationSubstitute underSenate thisBill section, (1) issue, on authorization of the commission, a pharmacy license to an applicant for a new pharmacy on payment of the fee required in section 20-601 and on satisfactory evidence to the commission that the pharmacy will be managed by a pharmacist and will be operated in accordance with the general statutes and the regulationsadoptedbythecommissionerinaccordancewithchapter 54, sSB1102 / File No.

2211102 16commissioner sSB1102may, Fileby No.regulation adopted with the advice and assistance of the commission, in accordance with chapter 54, require such other information on the application as is necessary for the department to carry out [its] the department's duties under sections 20- to 20-630, inclusive.

221(c) The department shall, after receipt of an application under this section, (1) issue, on authorization of the commission, a pharmacy license to an applicant for a new pharmacy on payment of the fee required in section 20-601 and on satisfactory evidence to the commission that the pharmacy will be managed by a pharmacist and will be operated in accordance with the general statutes and the regulationsadoptedbythecommissionerinaccordancewithchapter 54, and (2) issue a renewal of a pharmacy license to an applicant on payment of the fee required in section 20-601.

Sec.Public Act No.

23-19 21 of 35 Substitute Senate Bill No.

1102 Sec.

sSB1102[(3)] /(4) File"Sterile No.pharmaceutical" means any dosage form of a drug, including, but not limited to, parenterals, injectables, surgical irrigants and ophthalmics devoid of viable microorganisms;

221 17 sSB1102 File No.

221 [(3)] (4) "Sterile pharmaceutical" means any dosage form of a drug, including, but not limited to, parenterals, injectables, surgical irrigants and ophthalmics devoid of viable microorganisms;

The [Department of Consumer Protection] department shall inspect the proposed pharmacy premises of [the] such applicant and [the] such applicant shall not compound sterile pharmaceuticals until [it] such applicant receives notice that the addendum to such applicant'sPublic applicationAct hasNo. been approved by the department and the [Commission of Pharmacy] commission.

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1102 applicant's application has been approved by the department and the [Commission of Pharmacy] commission.

(C) If an existing health care institutional pharmacy licensed pursuanttosection20-594,asamendedbythisact,intendstocompound sSB1102sterile /pharmaceuticals Filefor No.the first time on or after July 1, 2023, such health care institutional pharmacy shall apply for an addendum to such health care institutional pharmacy's application on file with the department to include sterile pharmaceutical compounding.

221 18 sSB1102 File No.

221 sterile pharmaceuticals for the first time on or after July 1, 2023, such health care institutional pharmacy shall apply for an addendum to such health care institutional pharmacy's application on file with the department to include sterile pharmaceutical compounding.

[(3)] (2) (A) If an applicant for a new nonresident pharmacy registration intends to compound sterile pharmaceuticals for sale or delivery in this state, the applicant shall file an addendum to [its] the registration application such applicant files pursuant to section 20-627 toPublic includeAct sterileNo. pharmaceutical compounding.

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1102 to include sterile pharmaceutical compounding.

Such nonresident pharmacy shall not compound sterile pharmaceuticals until [it] such nonresident pharmacy receives written notice that [the] such addendum application has been approved by the sSB1102department /and Filethe No.[Commission of Pharmacy] commission.

221 19 sSB1102 File No.

221 department and the [Commission of Pharmacy] commission.

Such institutional pharmacy may request from the Commissioner of Consumer Protection an extension of time, not to exceed six months, to comply, for state enforcement purposes, with any amendments to USP chapters, for good cause shown.Public Act No.

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1102 shown.

[(f)] (e) (1) If a sterile compounding pharmacy plans to remodel any sSB1102area /utilized Filefor No.the compounding of sterile pharmaceuticals or adjacent space, relocate any space utilized for the compounding of sterile pharmaceuticals or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary or secondary engineering controls for any space utilized for the compounding of sterile pharmaceuticals, the sterile compounding pharmacy shall notify the Department of Consumer Protection, in writing, not later than forty- five days prior to commencing such remodel, relocation, upgrade or repair.

221Such 20written sSB1102notification Fileshall include a plan for such remodel, relocation, upgrade or repair and such plan shall be subject to Public Act No.

22123-19 area25 utilized for the compounding of sterile35 pharmaceuticalsSubstitute orSenate adjacentBill space,No. relocate any space utilized for the compounding of sterile pharmaceuticals or upgrade or conduct a nonemergency repair to the heating, ventilation, air conditioning or primary or secondary engineering controls for any space utilized for the compounding of sterile pharmaceuticals, the sterile compounding pharmacy shall notify the Department of Consumer Protection, in writing, not later than forty- five days prior to commencing such remodel, relocation, upgrade or repair.

Such1102 written notification shall include a plan for such remodel, relocation, upgrade or repair and such plan shall be subject to department review and approval.

(2) If a sterile compounding pharmacy initiates a recall of sterile sSB1102pharmaceuticals /that Filewere No.not dispensed pursuant to a patient-specific prescription or a medical order, the sterile compounding pharmacy shall notify:

221(A) 21Each sSB1102purchaser Fileof such sterile pharmaceuticals, to the extent such sterile compounding pharmacy possesses contact information for each such purchaser, (B) the Department of Consumer Protection, and (C) the federal Food and Drug Administration of such recall not later than the end of the next business day after such recall Public Act No.

22123-19 pharmaceuticals26 thatof were35 notSubstitute dispensedSenate pursuantBill toNo. a patient-specific prescription or a medical order, the sterile compounding pharmacy shall notify:

(A)1102 Each purchaser of such sterile pharmaceuticals, to the extent such sterile compounding pharmacy possesses contact information for each such purchaser, (B) the Department of Consumer Protection, and (C) the federal Food and Drug Administration of such recall not later than the end of the next business day after such recall was initiated.

If the state in which [the] such nonresident pharmacy is located does not conduct inspections based on standards required in the USP chapters, such nonresident pharmacy shall provide satisfactory proof to the department that [it] such nonresident pharmacy is in compliance with the standards sSB1102required /in Filethe No.USP chapters.

221[(l)] 22(k) sSB1102A Filepractitioner, as specified in subdivision (1) of subsection [(e)] (d) of this section, a hospital or a health care facility that receives sterile pharmaceuticals shall report any errors related to such Public Act No.

22123-19 required27 inof the35 USPSubstitute chapters.Senate Bill No.

[(l)]1102 (k) A practitioner, as specified in subdivision (1) of subsection [(e)] (d) of this section, a hospital or a health care facility that receives sterile pharmaceuticals shall report any errors related to such dispensing or any suspected adulterated sterile pharmaceuticals to the Department of Consumer Protection.

Subsections (a) and (b) of section 21a-65 of the general statutes arerepealedandthefollowingissubstitutedinlieuthereof(EffectiveJuly sSB11021, /2023): File No.

221Public 23Act sSB1102 File No.

22123-19 1,28 2023):of 35 Substitute Senate Bill No.

1102 (a) A licensed manufacturer or licensed wholesaler may sell hypodermicneedlesandsyringesonly to thefollowing:

(1) By a pharmacy licensed in accordance with section 20-594, as amended by this act, and in such pharmacy only by a licensed pharmacist or under thePublic pharmacist'sAct directNo. supervision;

(2)23-19 by29 aof syringe35 serviceSubstitute programSenate sSB1102Bill / File No.

2211102 24the sSB1102pharmacist's Filedirect No.supervision;

221(2) by a syringe service program established pursuant to section 19a-124;

(A) A retail pharmacy or a pharmacy within a licensed hospital that supplies to another such pharmacy a quantity of a noncontrolled drug or a schedule II, III, IV or V controlled substance normally stocked by such pharmacies to provide for the immediate needs of a patient pursuant to a prescription or medication order of an authorized practitioner, (B) a pharmacy within a licensed hospital that supplies drugs to another hospital or an authorizedpractitionerfor researchpurposes, (C)aretailpharmacy that supplies a limited quantity of a noncontrolled drug or of a schedule II, III, IV or V controlled substance for emergency stock to a practitioner who is a medical director of a chronic and convalescent nursing home, of a rest home with nursing supervision, of a hospice inpatient facility licensed pursuant to section 19a-491 or of a state correctional institution, andPublic (D)Act a pharmacy within a licensed hospital that contains another hospital wholly within [its] such licensed hospital's physical structure that supplies to such contained hospital a quantity of a noncontrolled drug or a schedule II, III, IV, or V controlled substance normally stocked sSB1102 / File No.

22123-19 2530 sSB1102of File35 Substitute Senate Bill No.

2211102 and (D) a pharmacy within a licensed hospital that contains another hospital wholly within [its] such licensed hospital's physical structure that supplies to such contained hospital a quantity of a noncontrolled drug or a schedule II, III, IV, or V controlled substance normally stocked by such hospitals to provide for the needs of a patient, pursuant to a prescriptionormedicationorderofanauthorizedpractitioner,receiving inpatient care on a unit that is operated by the contained hospital, or receiving outpatient care in a setting operated by the contained hospital and such drug or substance is administered on-site by the contained hospital, shall not be deemed a wholesaler under this section;

Sec.Public Act No.

23-19 31 of 35 Substitute Senate Bill No.

1102 Sec.

(e) In the promulgation of regulations under the provisions of this section applicable to prescribing practitioners, care-giving institutions, and correctional and juvenile training institutions, as defined in sSB1102[subdivision /(7) Fileof] No.section 20-571, as amended by this act, the Commissioner of Consumer Protection shall act in place of the director.

221 26 sSB1102 File No.

221 [subdivision (7) of] section 20-571, as amended by this act, the Commissioner of Consumer Protection shall act in place of the director.

Each individual health insurance policy providing coverage of the typespecifiedinsubdivisions(1),(2),(4),(6),(10),(11)and(12)ofsectiontypespecifiedinsubdivisions(1),(2),(4),(6),(10),(11)and(12) ofsection 38a-469, delivered, issued for delivery, renewed, amended or continued in this state shall provide coverage for hypodermic needles or syringes prescribed by a prescribing practitioner, as defined in [subdivision (28) of] section 20-571, as amended by this act, for the purpose of administering medications for medical conditions, provided such medications are covered under the policy.

Section 38a-518a of the general statutes is repealed and the followingPublic isAct substitutedNo. in lieu thereof (Effective July 1, 2023):

Each23-19 group32 health insurance policy providing coverage of the35 typeSubstitute specifiedSenate inBill subdivisions(1),(2), (4), (6), (10), (11)and (12) ofsection38a- 469, delivered, issued for delivery, renewed, amended or continued in this state shall provide coverage for hypodermic needles or syringes prescribed by a prescribing practitioner, as defined in [subdivision (28) of] section 20-571, as amended by this act, for the purpose of administering medications for medical conditions, provided such sSB1102 / File No.

2211102 27following sSB1102is Filesubstituted No.in lieu thereof (Effective July 1, 2023):

221Each group health insurance policy providing coverage of the type specified in subdivisions(1),(2), (4), (6), (10), (11)and (12) ofsection38a- 469, delivered, issued for delivery, renewed, amended or continued in this state shall provide coverage for hypodermic needles or syringes prescribed by a prescribing practitioner, as defined in [subdivision (28) of] section 20-571, as amended by this act, for the purpose of administering medications for medical conditions, provided such medications are covered under the policy.

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

July17. 1, 2023 Section 1 20-571 Sec.

2Section July19a-112h 1,of 2023the Newgeneral sectionstatutes Sec.is repealed and the following is substituted in lieu thereof (Effective from passage):

3(a) JulyThe 1,Commissioner 2023of NewPublic sectionHealth Sec.shall establish and contract for the administration of a [program using AIDS Services funding to provide financial assistance to victims of sexual assault for drugs prescribed by a physician for nonoccupational post-exposure prophylaxis for human immunodeficiency virus consistent with recommendations of the National Centers for Disease Control and Public Act No.

423-19 July33 1,of 202335 NewSubstitute sectionSenate Sec.Bill No.

51102 JulyPrevention 1,and 2023the 20-633state Sec.of Connecticut Technical Guidelines for Health Care Response to Victims of Sexual Assault.

6The Julycommissioner 1,shall 2023give 20-576(a)priority Sec.for benefitsunder the programestablishedpursuant to this section to sexual assault victims who are uninsured or underinsured and for whom the program is a payer of last resort.

7The Julycommissioner 1,shall 2023issue 20-594a Julyrequest 1,for 2023proposal Sec.totaling twenty-five thousand dollars annually to which a qualified organization may apply to administer the program.] state-wide human immunodeficiency virus pre-exposure prophylaxis and post-exposure prophylaxis drug assistance program using appropriated AIDS Services funding, provided such funding is equal to or greater than twenty-five thousand dollars annually.

8The 20-633bprogram Sec.shall provide financial assistance to individuals at risk of acquiring human immunodeficiency for the purchase of pre-exposure and post-exposure prophylaxis for human immunodeficiency virus prescribedbyalicensedphysicianconsistentwiththerecommendations of the National Centers for Disease Control and Prevention.

9For Julythe 1,purposes 2023of 21a-65(a)this subsection, "financial assistance" includes, but need not be limited to, payments for out-of-pocket costs, copayments, coinsurance, and (b)up Sec.to full cost payments toward a deductible for individuals who are underinsured and for whom the program is the payer of last resort.

10(b) JulyThe 1,commissioner 2023shall 21a-70(a)give Sec.priority for benefits under the program established pursuant to this section to individuals who have an increased risk of acquiring human immunodeficiency virus or who have had a recent exposure to such virus, but are unable to purchase pre-exposure and post-exposure prophylaxis for human immunodeficiency virus and for whom the program is a payer of last resort.

11(c) JulyThe 1,commissioner 2023may 21a-106(k)adopt Sec.regulations in accordance with the provisions of chapter 54 to implement the provisions of this section.

12The Julycommissioner 1,may 2023implement 21a-115(e)policies Sec.and procedures necessary to Public Act No.

1323-19 July34 1,of 202335 21a-249(j)Substitute Sec.Senate Bill No.

141102 Julyadministertheprovisionsofthissectionwhile 1,intheprocessofadopting 2023such 38a-492apolicies Julyand 1,procedures 2023as Sec.regulations, provided notice of intent to adoptregulationsispublishedontheeRegulationsSystemnotlaterthan twenty days after the date of implementation.

15Policies 38a-518aand Sec.procedures implemented pursuant to this section shall be valid until the time final regulations are adopted.

16Approved JulyJune 1,7, 2023 53a-13(b)(1)Public StatementAct ofNo. Legislative Commissioners:

In23-19 Section35 2(b)(1),of Subparas.35

(A) and (B) were rewritten for clarity;

in Section 2(b)(2) and (c)(1), "to a patient" was deleted for conciseness;

in Section4(e), "provisions"wassubstituted for"regulationsproviding"for sSB1102 / File No.

221 28 sSB1102 File No.

221 consistency with standard drafting conventions;

in Section 4(e)(5), "ensure" was added before "public" for clarity;

in Section 5(a)(3), "upon" was deleted for clarity;

in Section 8(b)(1)(C), "addendum" was added before "application" for consistency;

in Section 8(d)(1), "to" was added before "practitioners" for consistency;

and in Section 8(j), "to" was added after "provide" for consistency.

GL Joint Favorable Subst.

sSB1102 / File No.

221 29 sSB1102 File No.

221 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:

None Municipal Impact:

None Explanation The bill makes various changes to statutes concerning pharmacists and consumer access to medications resulting in no fiscal impact to the state or municipalities.

The Out Years State Impact:

None Municipal Impact:

None sSB1102 / File No.

221 30 sSB1102 File No.

221 OLR Bill Analysis sSB 1102 AN ACT CONCERNING PHARMACIES AND PHARMACISTS.

SUMMARY This bill makes changes in the laws concerning pharmacists and consumer access to medications.

Specifically, it:

1.

establishes a licensing process for institutional pharmacies located in health care facilities (e.g., hospitals) to compound sterile pharmaceuticals and sell them at retail;

2.

allows pharmacists to order and administer tests for COVID-19, HIV, and influenza;

3.

allows pharmacists to prescribe and dispense HIV-related prophylaxis if a patient tests negative after a pharmacist- administered HIV test;

4.

expands the vaccine types that pharmacists can administer;

5.

allows pharmacists to administer an epinephrine cartridge injector to someone experiencing anaphylaxis;

6.

allows pharmacies to operate mobile pharmacies in temporary locations with the Department of Consumer Protection’s (DCP) approval;

7.

requires pharmacies to maintain a plan to manage unscheduled closings and specifies actions that can and must be taken during these closures;

and 8.

requiresDCPto adoptregulations onprescriptionpickuplockers at pharmacies, but allows for their use before the regulations are sSB1102 / File No.

221 31 sSB1102 File No.

221 adopted under specified circumstances.

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

EFFECTIVE DATE:

July 1, 2023 §§ 1 & 6-16 — HEALTH CARE INSTITUTIONAL PHARMACIES’ STERILE COMPOUNDING The bill establishes a process to allow institutional pharmacies located in licensed healthcare facilities (“health care institutional pharmacies”) to compound sterile pharmaceuticals for retail sale and subjects them to the same requirements that apply to other retail pharmacies compounding sterile pharmaceuticals.

Under current law, health care institutional pharmacies (1) are generally not licensed as pharmacies and (2) do not compound sterile pharmaceuticals for retail sale.

The bill authorizes DCP to adopt regulations creating a class or classes of pharmacy licenses specifically for health care institutional pharmacies.

It also explicitly authorizes health care institutions to apply for a pharmacy license, subject to the same existing licensure requirements as pharmacists and others applying for a license.

Sterile Compounding for Retail Sales Under existing law, if a pharmacy licensee intends to compound sterile pharmaceuticals, it must seek DCP’s approval by applying for an addendum to its pharmacy license application and submitting to a DCP inspection.

The bill requires a health care institutional pharmacy that wants to sell compounded sterile pharmaceuticals at retail to obtain a pharmacy license and similarly apply for an addendum and undergo an inspection.

By deeming health care institutional pharmacies that compound sterile pharmaceuticals for retail sale “sterile compounding pharmacies,” the bill also subjects them to the same requirements that apply to other retail pharmacies (e.g., required notices to DCP), including requirements adopted by regulation.

Compounding for Non-Retail Uses sSB1102 / File No.

221 32 sSB1102 File No.

221 Under current law, if an institutional pharmacy within a licensed health care facility compounds sterile pharmaceuticals, it does not need to apply for DCP approval, but like other sterile compounding pharmacies, it must comply with applicable state, federal, and U.S.

Pharmacopeia standards, unless it receives a temporary extension to do so.

The bill generally eliminates provisions in law regulating these institutional pharmacies’ compounding of sterile pharmaceuticals and specifiesthat thelaw onretailsterilecompounding pharmacies does not prohibit a licensed hospital from compounding sterile pharmaceuticals for its patients consistent with federal law.

In doing so, it also eliminates provisions specifically requiring institutional pharmacies to (1) prepare and maintain a policy and procedure manual and (2) inform DCP which pharmacist is responsible for overseeing the compounding of sterile pharmaceuticals.

§§ 2 & 5 — EXPANDING PHARMACISTS’ SCOPE OF PRACTICE The bill expands pharmacists’ scope of practice by authorizing them to (1) administer additional vaccinations and epinephrine cartridge injectors (§ 5);

(2) order and administer COVID-19, HIV, and influenza related tests (§ 2);

and (3) prescribe HIV-related prophylaxis if an HIV test they ordered and administered comes back negative (§ 2).

Vaccinations By law, pharmacists who comply with DCP regulations on vaccine administration training may administer to adults any approved vaccine on the Centers for Disease Control and Prevention’s (CDC) adult immunization schedule.

Currently, for children ages 12-17, they may administer an influenza vaccine ordered by a health care provider if they have the parent or guardian’s consent.

(Additionally, under temporary federal rules (see BACKGROUND), pharmacists can currently administer various vaccines to children ages 3 and older.) The bill permanently expands the types of vaccines pharmacists can administer to people ages 12 or older.

Under the bill, they must be administered in compliance with DCP regulations and according to the manufacturer’s package insert or a prescribing practitioner’s (e.g., sSB1102 / File No.

221 33 sSB1102 File No.

221 doctor or APRN) orders.

Specifically, the bill allows pharmacists to additionally administer any vaccine:

1.

on the adult immunization schedule and authorized by the FDA, 2.

not on the adult immunization schedule but for which the vaccine administration instructions are available on the CDC’s website, or 3.

prescribed by a prescribing practitioner for a specific patient.

Under the bill, pharmacists can administer vaccines to any patient ages 18 or older.

For patients who are ages 12-17, they may only do so with (1) the consent of the patient’s parent, legal guardian, or other person having legal custody or (2) proof that the patient is an emancipated minor.

For current law’s limits on influenza vaccines for minors, the bill correspondingly (1) eliminates the requirement that an influenza vaccine only be administered if ordered by a health care provider and (2) aligns the parameters on consent with those described above for other vaccines under the bill.

Before administering a vaccine, the pharmacist must make a reasonable effort to review the patient’s vaccination history to prevent a requested vaccine’s inappropriate use.

Under existing law, DCP must adopt regulations requiring that pharmacists administering vaccines complete an immunization training course.

The bill correspondingly extends this training requirement to pharmacists administering the additional vaccines the bill allows pharmacists to administer.

Administering Epinephrine If a pharmacist has taken the training required to administer a vaccine (see above), the bill allows him or her to administer an epinephrine cartridge injector to apatient reasonably believed, basedon the pharmacist’s knowledge and training, to be experiencing anaphylaxis.

This authorization applies regardless of whether the sSB1102 / File No.

221 34 sSB1102 File No.

221 patient has a prescription for an epinephrine cartridge injector.

The pharmacist or his or her designee must call 9-1-1 either before or immediately after administering the epinephrine cartridge injector.

The pharmacist must also document the date, time, and circumstances in which he or she administered it, and maintain the documentation for at least three years.

COVID-19, HIV, and Influenza Testing Under temporary federal rules, pharmacists can currently order and administer COVID-related tests.

The bill permanently allows pharmacists to order and administer COVID-19, HIV, and influenza related tests if they are employed by a:

1.

hospital or 2.

pharmacy that has given the Department of Public Health (DPH) a complete clinical laboratory improvement amendment application for certification for a COVID-19, HIV, or influenza related test.

They may do so for any patient ages18 or older.

For patients who are at least age 12, but younger than 18, they may only do so with (1) the consent of the patient’s parent, legal guardian, or other person having legal custody or (2) proof that the patient is an emancipated minor.

When pharmacists order and administer a test, they must give the patient the test results in writing and maintain a record of them for at least three years.

Prescribing HIV Prophylaxis If a pharmacist orders and administers an HIV-related test and the result is negative, the pharmacist may prescribe and dispense to the patient pre-exposure or post-exposure HIV-related prophylaxis.

The pharmacist may do so only if the (1) patient meets the criteria on the package insert and (2) prophylaxis is prescribed and dispensed in conformity with the state’s pharmacy laws.

sSB1102 / File No.

221 35 sSB1102 File No.

221 Sharing Test Results and HIV Prophylaxis Information With DCP Upon the DCP commissioner or his or her designee’s request, a pharmacist must share the results of a COVID-19, HIV, or influenza related test with DCP.

Similarly, if a pharmacist prescribes HIV-related prophylaxis, DCP may request a copy of the test results, prescription records, and any other documents the commissioner requires by regulations.

(Presumably,theregulations DCP must adopt,asdescribed below, will address applicable privacy laws.) Regulations Related to Testing and HIV Prophylaxis Prescribing The bill requires the DCP commissioner, in consultation with the DPH commissioner and Commission of Pharmacy, to adopt regulations to implement the bill’s testing and prescribing authorizations.

The regulationsmust (1)identify qualifying training programsaccreditedby the CDC, the Accreditation Council for Pharmacy Education, or another appropriate national accrediting body and (2) establish a control and reporting system.

§ 3 — OPERATING MOBILE PHARMACIES The bill allows retail pharmacies to apply to DCP for permission to operate a mobile pharmacy that offers (1) temporary clinics, vaccination events, or opioid antagonist training and prescribing events or (2) pharmacy services to an underserved community.

DCP sets the application form and must approve it, in writing, before a mobile pharmacycanoperate.DCPmayinspectthemobilepharmacyasitfinds necessary, including before it begins operations.

With the advice and consent of the Commission of Pharmacy, the DCP commissioner may adopt regulations to implement the bill’s mobile pharmacy provisions.

Operational Requirements Unless DCP approves an exception, mobile pharmacies cannot (1) operate in one place for more than seven consecutive days, (2) operate for more than 14 days within a five-mile radius of the prior mobile pharmacy location, or (3) serve as an overnight storage space for drugs.

sSB1102 / File No.

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221 Mobile pharmacies must be supervised by a pharmacist.

The pharmacy that operates them must:

1.

keep records indicating which drugs it removes from the pharmacy premises for use in the mobile pharmacy and which ones it dispenses;

2.

update the pharmacy’s records within 24 hours after dispensing a drug through a mobile pharmacy;

3.

inventory and return unused drugs to the pharmacy premises by the close of business each day unless DCP waives the bill’s prohibition on storing drugs in the mobile pharmacy overnight;

4.

store drugs in a way that prevents diversion, and meets the storage conditions specified by drugs’ manufacturers;

5.

establish and maintain a patient communication plan to ensure patient access to prescription refills if the mobile pharmacy is unavailable;

and 6.

store and handle controlled substances in conformity with DCP regulations, if the FDA allows mobile pharmacies to store controlled substances.

DCP may order a mobile pharmacy to close if it determines that (1) it failed to comply with the bill’s requirements, (2) it is unsafe to store drugs in it or dispense them from it, or (3) there is insufficient security.

§ 4 — UNSCHEDULED PHARMACY CLOSURES AND PRESCRIPTION PICKUP LOCKERS The bill creates rules for pharmacies when they face an unscheduled closure (which the bill does not define), including customer and prescriber notification and planning requirements.

It requires DCP to adopt regulations to (1) implement the bill’s provisions on unscheduled pharmacy closures and (2) allow and regulate prescription pickup lockers (see below).

sSB1102 / File No.

221 37 sSB1102 File No.

221 Plan’s Contents The bill requires retail pharmacies to have a plan to manage unscheduled closingsandannually reviewand update it.

The planmust also be given to and reviewed with all pharmacy personnel annually.

The plan must include the name of:

1.

the person responsible for notifying the Commission of Pharmacy about an unscheduled closing;

2.

the person responsible for updating the operation hours in the pharmacy’s electronic record system so that it will not accept electronically transmitted prescriptions during the unscheduled closing;

3.

the person responsible for updating the pharmacy’s telephone system during an unscheduled closing to (a) ensure orally transmitted prescriptions are not accepted during the unscheduled closing and (b) provide a message that alerts patients to the closure and their ability to obtain their prescriptions from a nearby pharmacy;

4.

all pharmacies located within a two-mile radius, or the next closest pharmacy if there is no pharmacy within that radius;

and 5.

the person responsible for posting a sign stating the closure’s duration at the pharmacy’s entrance and at each entrance of the structure containing it, if any.

Requirements During Unscheduled Closing When a pharmacy experiences an unscheduled closing, the pharmacist manager of the pharmacy or, if the pharmacy operates more than five pharmacy locations in Connecticut, the pharmacy district manager must:

1.

modify the pharmacy’s operating hours in its pharmacy’s electronic record system to prevent accepting electronically transmitted prescriptions during the unscheduled closing;

sSB1102 / File No.

221 38 sSB1102 File No.

221 2.

adjust the pharmacy’s telephone system to prevent accepting orally transmitted prescriptions during the unscheduled closing;

3.

provide a telephone system message alert to patients notifying them that the pharmacy is closed and they may obtain medications from a nearby pharmacy;

4.

post signs at the pharmacy’s entrance, and at each entrance of the structure if the pharmacy is located within another structure, stating that the pharmacy is closed, the duration of the unscheduled closing, and providing (a) a list of all pharmacies within a two-mile radius or (b) the next closest pharmacy if there is no pharmacy within a two-mile radius;

and 5.

on the request of another pharmacy, transfer a prescription and reverse any third-party payor claims associated with the already dispensed prescription.

Under the bill, the “pharmacy district manager” is the person who supervises at least three Connecticut pharmacies and is responsible for their activities, including staffing, payroll, and hiring.

Dispensing Prescriptions That Are Awaiting Pickup at a Closed Pharmacy If a pharmacy verifies that another pharmacy is experiencing an unscheduled closing, on a patient’s request, it may dispense a prescription that is dispensed and waiting for pickup at the closed pharmacy.

It may do so using information from the closed pharmacy, the electronic prescription drug monitoring program, or another source that the pharmacist believes is reasonably accurate.

If a prescription is dispensed under these circumstances, the dispensing pharmacy must contact the closed pharmacy within 24 hours after it reopens to transfer the prescription.

Under the bill, these transfers are subject to existing requirements for prescription transfers, which generally require the:

1.

transferring pharmacist to cancel the original prescription in his sSB1102 / File No.

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221 or her records and indicate in the records the pharmacy to which the prescription is transferred and transfer date and 2.

receiving pharmacist to indicate in his or her records the (a) transfer and the transferring pharmacy and pharmacist’s names, (b) original prescription’s issue date and number, (c) date the original prescription was first dispensed, (d) number of refills authorized by the original prescription and complete refill record as of the transfer date, and (e) number of valid refills remaining as of the transfer date.

The bill requires the pharmacy that experienced the unscheduled closure to give the dispensing pharmacy all information necessary for thetransfer.

It must also reverse any third-party payor claimsassociated with the transferred prescription within 24 hours after it reopens.

Secure Prescription Pickup Lockers ThebillrequiresDCPtoadoptregulationsonunscheduledpharmacy closures and include provisions on placing a “secured container” at a pharmacy that allows patients to collect dispensed prescriptions (prescription pickup lockers).

Before adopting the regulations, DCP may temporarily allow the use of prescription pickup lockers.

Pharmacies must first submit protocols on using these lockers to DCP for its written approval.

They may only be approved if the lockers:

1.

(a) weigh more than 750 pounds or are affixed to the pharmacy building’s structure and (b) are located immediately adjacent to the pharmacy’s location;

2.

limit access to authorized pharmacy personnel and individuals retrieving prescriptions with a unique identification system;

3.

are under constant video surveillance;

4.

are able to maintain a record of all products placed inside and the date and time each individual prescription is accessed;

and sSB1102 / File No.

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221 5.

comply with any other DCP protocols ensuring patient confidentiality, protecting public health and safety, and preventing prescription diversion.

BACKGROUND Federal PREP Act and Pharmacists’ Administration of Vaccines The federal Public Readiness and Emergency Preparedness Act authorizes the federal Health and Human Services (HHS) secretary to issue declarations protecting certain covered persons from liability related to the administration or use of medical countermeasures (42 U.S.C.

§ 247d–6d).

Under this authority, the HHS secretary issued a declaration authorizing state-licensed pharmacists, under certain criteria, to (1) order and administer vaccinations to minors ages 3 and older and (2) order and administer COVID-19 tests.

Related Bill sHB 6788, favorably reported by the General Law Committee, (1) establishes a new DCP registration for dispensing group practices and dispensing assistants that dispense prescriptions directly to patients, (2) authorizes pharmacists to refill prescriptions for certain legend devices;

(3) authorizes pharmacists to prescribe emergency or hormonal contraception, (4) expands reasons for enforcement action against a pharmacy to include delaying patients’ access to prescribed drugs or other pharmacy services, and (5) makes minor changes to laws related to compounding pharmaceuticals.

COMMITTEE ACTION General Law Committee Joint Favorable Substitute Yea 16 Nay 7 (03/09/2023) sSB1102 / File No.

221 41