Substitute Senate Bill No. 1102 Public Act No. 23-19 AN ACT CONCERNING PHARMACIES AND PHARMACISTS. Be it enacted by the Senate and House of Representatives in General Assembly convened: Section 1. Section 20-571 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): As used in this chapter and sections 2 to 4, inclusive, of this act, unless the context otherwise requires: (1) "Administer" or ["Administration"] "administration" means the direct application of a drug or device to the body of a patient or research subject by injection, inhalation, ingestion or any other means; (2) "Automated prescription dispensing machine" means a device and associated software operated by a pharmacy or a pharmacy that is registered as a nonresident pharmacy pursuant to section 20-627, in a nursing home or skilled nursing facility licensed pursuant to sections 19a-490 and 19a-491, that packages and labels patient-specific medication or multiple medications for the purposes of administration by a registered nurse or a licensed practical nurse based on a prescription that has completed final verification by a licensed pharmacist; (3) "Care-giving institution" means an institution that provides Substitute Senate Bill No. 1102 Public Act No. 23-19 2 of 35 medical services and is licensed, operated, certified or approved by the Commissioner of Public Health, the Commissioner of Developmental Services or the Commissioner of Mental Health and Addiction Services; (4) "Commission" means the Commission of Pharmacy appointed under the provisions of section 20-572; (5) "Commissioner" means the Commissioner of Consumer Protection; (6) "Compound" means to combine, mix or put together two or more ingredients pursuant to a prescription and includes the preparation of drugs or devices in anticipation of prescriptions based on routine, regularly-observed prescribing patterns; (7) "Correctional or juvenile training institution" means a facility for the detention or incarceration of persons convicted or accused of crimes or offenses or for training of delinquent juveniles, including those state facilities under the jurisdiction of the Commissioner of Correction, training schools for delinquent juveniles and any other facilities operated by the state or municipalities for such detention, incarceration or training; (8) "Device" means instruments, apparatuses and contrivances, including their components, parts and accessories, intended: (A) [for] For use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; [,] or (B) to affect the structure or any function of the body of humans or other animals, but does not mean contact lenses; (9) "Department" means the Department of Consumer Protection; (10) "Deprescribing" means the systematic process of identifying and discontinuing drugs in instances in which existing or potential harms outweigh existing or potential benefits within the context of an Substitute Senate Bill No. 1102 Public Act No. 23-19 3 of 35 individual patient's care goals, current level of functioning, life expectancy, values and preferences; (11) "Dispense" means those acts of processing a drug or device for delivery or for administration for a patient pursuant to a prescription consisting of: (A) Comparing the directions on the label with the directions on the prescription to determine accuracy; (B) the selection of the drug or device from stock to fill the prescription; (C) the counting, measuring, compounding or preparation of the drug or device; (D) the placing of the drug or device in the proper container; (E) the affixing of the label to the container; and (F) the addition to a written prescription of any required notations. "Dispense" does not include the acts of delivering a drug or device to a patient or of administering the drug or device to the patient; (12) "Dispensing outpatient facility" means a facility operated by a corporation or municipality which provides medical services to patients on an outpatient basis and which maintains stocks of drugs for dispensing of drugs on a regular basis to patients for use off the premises; (13) "Drug" means: (A) [an] An article recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them; [,] (B) an article intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in humans or other animals; [,] (C) an article, other than food, intended to affect the structure or any function of the body of humans or any other animal; [,] and (D) an article intended for use as a component of any article specified in this subdivision, but does not include a device; (14) "Health care institution" means institution, as defined in section 19a-490; Substitute Senate Bill No. 1102 Public Act No. 23-19 4 of 35 (15) "Health care institutional pharmacy" means an institutional pharmacy located within a health care institution; [(14)] (16) "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; [(15)] (17) "Legend device" means a device that is required by applicable federal or state law to be dispensed pursuant only to a prescription or is restricted to use by prescribing practitioners only or that, under federal law, is required to bear either of the following legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN."; [(16)] (18) "Legend drug" means a drug that is required by any applicable federal or state law to be dispensed pursuant only to a prescription or is restricted to use by prescribing practitioners only, or means a drug that, under federal law, is required to bear either of the following legends: (A) "RX ONLY" IN ACCORDANCE WITH GUIDELINES ESTABLISHED IN THE FEDERAL FOOD, DRUG AND COSMETIC ACT; or (B) "CAUTION: FEDERAL LAW RESTRICTS THIS DRUG FOR USE BY OR ON THE ORDER OF A LICENSED VETERINARIAN."; [(17)] (19) "Medical device and oxygen provider" means a person who distributes devices or oxygen pursuant to a medical order or prescription, except if such person already maintains an active pharmacy license; [(18)] (20) "Medication reconciliation" means a process of comparing the medications a patient is taking and should be taking with newly Substitute Senate Bill No. 1102 Public Act No. 23-19 5 of 35 ordered medications: (A) [for] For the purpose of addressing duplications, omissions and interactions and the need to continue current medications; [,] and (B) by looking at information such as the medication name, dose, frequency, route of administration and purpose; [(19)] (21) "Nonlegend device" means a device that is not a legend device; [(20)] (22) "Nonlegend drug" means a drug that is not a legend drug; (23) "Nonresident pharmacy" has the same meaning as provided in section 20-627; [(21)] (24) "Person" means an individual, corporation, business trust, estate trust, partnership, association, joint venture or any other legal or commercial entity; [(22)] (25) "Pharmacist" means an individual who is licensed to practice pharmacy under the provisions of section 20-590, 20-591, 20-592 or 20-593, and who is thereby recognized as a health care provider by the state of Connecticut; [(23)] (26) "Pharmacy" means a place of business where drugs and devices may be sold at retail and for which a pharmacy license has been issued to an applicant under the provisions of section 20-594, as amended by this act; [(24)] (27) "Pharmacy intern" means an individual registered under the provisions of section 20-598; [(25)] (28) "Pharmacy technician" means an individual who is registered with the department and qualified in accordance with section 20-598a; [(26)] (29) "Polypharmacy" means the use of multiple drugs by a Substitute Senate Bill No. 1102 Public Act No. 23-19 6 of 35 patient, including any medication that is inappropriate or not medically necessary, such as those not indicated, not effective or constituting a therapeutic duplication; [(27)] (30) "Practice of pharmacy" or "to practice pharmacy" means the sum total of knowledge, understanding, judgments, procedures, securities, controls and ethics used by a pharmacist to assure optimal safety and accuracy in the distributing, dispensing and use of drugs and devices; [(28)] (31) "Prescribing practitioner" means an individual licensed by the state of Connecticut, any other state of the United States, the District of Columbia, the Commonwealth of Puerto Rico or any territory or insular possession subject to the jurisdiction of the United States who is authorized to issue a prescription within the scope of the individual's practice; [(29)] (32) "Prescription" means 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; [(30)] (33) "Sale" includes barter, exchange or gift or offer and each such transaction made by a person whether as principal proprietor, agent, servant or employee; [(31)] (34) "Substitute" means to dispense without the prescribing practitioner's express authorization a different drug product than the drug product prescribed; [(32)] (35) "Third-party logistics provider" means a person who distributes drugs, devices or cosmetics while taking possession of the drugs, devices or cosmetics but who does not take title of the drugs, devices or cosmetics; [(33)] (36) "Virtual manufacturer" means a person who engages in the Substitute Senate Bill No. 1102 Public Act No. 23-19 7 of 35 manufacture of drugs, devices or cosmetics for which such person: (A) Owns the new drug application or abbreviated new drug application number, if a prescription drug; (B) owns the unique device identification number, as available, for a prescription device; (C) contracts with a contract manufacturing organization for the physical manufacture of the drugs, devices or cosmetics; (D) is not involved in the physical manufacture of the drugs, devices or cosmetics; and (E) at no time takes physical possession of or stores the drugs, devices or cosmetics; and [(34)] (37) "Virtual wholesale distributor" means a person who facilitates or brokers the transfer of drugs, devices or cosmetics without taking physical possession of the drugs, devices or cosmetics. Sec. 2. (NEW) (Effective July 1, 2023) (a) For the purposes of this section: (1) "COVID-19" means the respiratory disease designated by the 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 federal Food and Drug Administration or any successor agency as a pre- exposure or post-exposure prophylaxis for the human immunodeficiency virus; (4) "HIV-related test" has the same meaning as provided in section 19a-7o of the general statutes; 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. Substitute Senate Bill No. 1102 Public Act No. 23-19 8 of 35 (b) (1) Any pharmacist licensed under chapter 400j of the general statutes may order, and administer to a patient, a COVID-19-related test or influenza-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 improvement amendment application for certification for the COVID-19-related test or influenza-related test and the Department of Public Health has approved such application, and (ii) has completed any training required by the Department of Consumer Protection; 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. (2) Any pharmacist licensed under chapter 400j of the general statutes may order, and administer to a patient, a COVID-19-related test or influenza-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 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. (c) (1) On or after the adoption of regulations pursuant to subsection (g) of this section, any pharmacist licensed under chapter 400j of the general statutes 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 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) the patient is (i) eighteen years of age or older, or (ii) at least twelve years Substitute Senate Bill No. 1102 Public Act No. 23-19 9 of 35 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 chapter 400j of the general statutes 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. (d) If a pharmacist orders and administers a COVID-19-related test or influenza-related test under subsection (b) of this section, or an HIV- related test under subsection (c) of this section, the pharmacist shall: (1) Provide the results 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; (2) 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 of the 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 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; Substitute Senate Bill No. 1102 Public Act No. 23-19 10 of 35 (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) prescription information maintained pursuant 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 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 11 of 35 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. Such regulations shall, at a minimum: (1) Ensure compliance with all applicable guidance issued by the federal Centers for Disease Control and Prevention; (2) 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) 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-related test 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 12 of 35 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. Sec. 3. (NEW) (Effective July 1, 2023) (a) (1) A pharmacy may apply to the department, in a form and manner prescribed by the commissioner, to operate a mobile pharmacy in a temporary location for the purpose of: (A) Conducting (i) a temporary pharmacy operation, (ii) a vaccination event, or (iii) an opioid antagonist training and prescribing event; or (B) serving a community that may not have adequate access to pharmacy services. (2) No pharmacy may operate a mobile pharmacy without prior written approval from the department. Each mobile pharmacy shall be supervised by a pharmacist. The department may inspect a mobile pharmacy before pharmacy services are provided in the mobile pharmacy, and at any time during usual business hours or while such mobile pharmacy is in operation. The department may issue an order closing a mobile pharmacy if the department determines that: (A) The mobile pharmacy has failed to comply with (i) any provision of this section or chapter 400j of the general statutes, (ii) any regulation adopted 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; (B) conditions are unsafe to store or dispense drugs; or (C) there is insufficient security at such mobile pharmacy. (b) A pharmacy that operates a mobile pharmacy under this section shall: (1) Maintain a record of all drugs that are removed from the pharmacy premises for the purpose of operating such mobile 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 13 of 35 than twenty-four hours after such drug is dispensed; (3) except as provided in subsection (c) of this section, inventory and return all unused drugs to the pharmacy premises by the close of business each day; (4) while operating such mobile pharmacy, store all drugs in such mobile pharmacy in a manner that (A) prevents any drug diversion, and (B) is consistent with the storage conditions specified by the manufacturers of such drugs; (5) establish and maintain a patient communication plan to ensure that patients can obtain prescription refills if such mobile pharmacy is unavailable; and (6) if permitted by the federal Drug Enforcement Administration or a successor agency, store controlled substances in the mobile pharmacy in accordance with regulations adopted by the commissioner pursuant to section 21a-262 of the general statutes. (c) No pharmacy shall, without prior approval from the department: (1) Operate a mobile pharmacy for more than (A) seven consecutive days in a single location, or (B) fourteen days within a five-mile radius of the prior mobile pharmacy location; or (2) store drugs overnight in a mobile pharmacy or outside of the pharmacy premises. (d) The commissioner may, with the advice and consent of the commission, adopt regulations in accordance with chapter 54 of the general statutes to implement the provisions of this section. Sec. 4. (NEW) (Effective July 1, 2023) (a) For the purposes of this section, "pharmacy district manager" means an individual who (1) supervises at least three pharmacies within this state, and (2) is responsible for the activities within such pharmacies, including, but not limited to, staffing, payroll and hiring. (b) Each pharmacy shall maintain a plan to manage unscheduled closings. Such plan shall be reviewed and updated, if necessary, on an annual basis, and be provided to, and reviewed with, all pharmacy personnel on an annual basis. Such plan shall include: Substitute Senate Bill No. 1102 Public Act No. 23-19 14 of 35 (1) The name of the individual who is responsible for notifying the Commission of Pharmacy of an unscheduled closing; (2) The name of the individual who is responsible for updating the hours of operation in the pharmacy's electronic record system to prevent acceptance of electronically transmitted prescriptions during an unscheduled closing; (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; (4) A list of all pharmacies that are located within a two-mile radius of the pharmacy that is experiencing an unscheduled closing, or the next closest pharmacy if there is no pharmacy within such two-mile radius; and (5) The name of the individual who is responsible for posting, at the entrance to such pharmacy and at each entrance of the structure if such pharmacy is located within another structure, signage stating the duration of an unscheduled closing. (c) If a pharmacy experiences an unscheduled closing, the pharmacist manager of the pharmacy or, if the pharmacy operates more than five pharmacy locations in this state, the pharmacy district manager shall: (1) Modify such pharmacy's hours of operation in such pharmacy's electronic record system to prevent the acceptance of electronically transmitted prescriptions during the unscheduled closing; (2) Adjust such pharmacy's telephone system to prevent the acceptance of orally transmitted prescriptions during the unscheduled Substitute Senate Bill No. 1102 Public Act No. 23-19 15 of 35 closing; (3) Provide a telephone system message alert to patients notifying patients that (A) such pharmacy is not open, and (B) patients may obtain medications from a nearby pharmacy; (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, or (ii) the next closest pharmacy if there is no pharmacy within such two-mile radius; and (5) Upon request by another pharmacy to transfer a prescription to such other pharmacy, transfer any prescription dispensed by the pharmacy experiencing the unscheduled closing and reverse any third- party payor claims associated with such prescription. (d) Any pharmacy that verifies that another phar macy is experiencing an unscheduled closing may, upon a patient's request, dispense a prescription that is dispensed and waiting at the pharmacy experiencing the unscheduled closing by using information obtained from the closed pharmacy, the electronic prescription drug monitoring program or another source that the pharmacist dispensing such prescription believes provides a reasonable assurance of accurate information necessary to dispense such prescription. In the event that a pharmacy dispenses a prescription during an unscheduled closing of another pharmacy: (1) The pharmacy dispensing such prescription shall contact the pharmacy experiencing the unscheduled closing not later than twenty- four hours after such closed pharmacy reopens to transfer such prescription, in accordance with section 20-616 of the general statutes; Substitute Senate Bill No. 1102 Public Act No. 23-19 16 of 35 (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; and (3) The pharmacy that experienced the unscheduled closing shall reverse any third-party payor claims associated with such transferred prescription not later than twenty-four hours after such pharmacy reopens. (e) The Department of Consumer Protection shall adopt regulations, in accordance with chapter 54 of the general statutes, to implement the provisions of this section. Such regulations shall include, but need not 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. Prior to the effective date of such regulations, the department may temporarily permit the use and placement of a secured container at a pharmacy, provided the pharmacy submits to the department, for the department's approval, written protocols prior to placing, providing access to or using the secured container and such pharmacy receives written approval from the department for such placement, access or use. To obtain temporary approval under this subsection, a secure container shall: (1) Weigh more than seven hundred fifty pounds or be affixed to the physical structure of the building where the pharmacy is located, and be located immediately adjacent to the portion of such building where such pharmacy is located; (2) Only permit access to authorized pharmacy personnel or individuals retrieving the prescriptions with a unique identification system; Substitute Senate Bill No. 1102 Public Act No. 23-19 17 of 35 (3) Be under video surveillance at all times; (4) Be capable of maintaining a record of all products that are placed inside of the secure container, and the date and time each individual prescription is accessed; and (5) Comply with any other protocol required by the department to ensure patient confidentiality, ensure public health and safety and prevent diversion. Sec. 5. Section 20-633 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (a) (1) Any person licensed as a pharmacist under part II of this chapter may [(1)] administer: [, to an adult, any] (A) Any vaccine, approved or authorized by the United States Food 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, the influenza vaccine approved by the United States Food and Drug Administration, provided the administration of any vaccine 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: (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. (B) Any vaccine not included on the National Centers for Disease Control and Prevention's Adult Immunization Schedule, provided the vaccine administration instructions for such vaccine are available on the National Centers for Disease Control and Prevention's Internet web site; Substitute Senate Bill No. 1102 Public Act No. 23-19 18 of 35 and (C) Any vaccine pursuant to a verbal or written prescription of a prescribing practitioner for a specific patient. (2) A pharmacist shall make a reasonable effort to review a patient's vaccination history to prevent any inappropriate use of a requested vaccine. (3) All vaccines administered pursuant to this section shall be administered in accordance with the: (A) Vaccine manufacturer's package insert or the orders of a prescribing practitioner; and (B) 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 call the 9-1-1 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 circumstances in which such pharmacist administered such epinephrine cartridge injector, and maintain such documentation for at least three years. (c) (1) A certified and registered pharmacy technician may 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 19 of 35 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 authorized to administer vaccines under this section; 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. Such regulations shall: (1) [require] Require any pharmacist who administers a vaccine pursuant to this section to successfully complete an immunization training program for pharmacists; (2) define the basic requirements 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 cardiac life support and adverse event reporting; (3) identify qualifying training programs, which are accredited by the National Centers for Disease Control Prevention, the Accreditation Council for Pharmacy Education or [other] another appropriate national accrediting body; and (4) establish a system of control and reporting. [(c) For purposes of this section, "adult" means a person who has Substitute Senate Bill No. 1102 Public Act No. 23-19 20 of 35 attained the age of eighteen years.] Sec. 6. Subsection (a) of section 20-576 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (a) The commissioner may, with the advice and assistance of the commission, adopt regulations, in accordance with chapter 54, to govern the performance of the commission's duties, the practice of pharmacy and the business of retailing drugs and devices. Such 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. Sec. 7. Section 20-594 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (a) Except as limited by section 20-596, a pharmacist, health care institution or any other person may apply to the commission for a pharmacy license or for renewal of a pharmacy license. (b) The applicant shall disclose on the application the name and address of the applicant and the owner of the pharmacy, the name and street and mailing address of the pharmacy and the name, address and license number of the pharmacist who manages the pharmacy. The Substitute Senate Bill No. 1102 Public Act No. 23-19 21 of 35 commissioner may, by 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) 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 regulations adopted by the commissioner in accordance with chapter 54, and (2) issue a renewal of a pharmacy license to an applicant on payment of the fee required in section 20-601. (d) Pharmacy licenses shall expire annually. Pharmacy licenses may be renewed on application and payment of the fee required in section 20-601 for a period not to exceed one year. (e) When a pharmacy is transferred to a new location the pharmacy license for such pharmacy shall terminate. A pharmacy license that has been terminated under this subsection may be renewed under the provisions of subsection (d) of this section 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 regulations adopted by the commissioner in accordance with chapter 54. (f) Each pharmacy licensed pursuant to this section shall report to the department any administrative or legal action commenced against [it] such pharmacy by any state or federal regulatory agency or accreditation entity not later than ten business days after receiving notice of the commencement of such action. Substitute Senate Bill No. 1102 Public Act No. 23-19 22 of 35 Sec. 8. Section 20-633b of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (a) As used in this section: (1) "Medical order" means a written, oral or electronic order by a prescribing practitioner [, as defined in section 20-14c,] for a drug to be dispensed by a pharmacy for administration to a patient; (2) "Prescribing practitioner" has the same meaning as provided in section 20-14c; [(2)] (3) "Sterile compounding pharmacy" means a pharmacy [, as defined in section 20-571, a] or nonresident pharmacy [registered pursuant to section 20-627,] that dispenses or compounds sterile pharmaceuticals; [(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; and [(4)] (5) "USP chapters" means chapters 797, 800 and 825 of the United States Pharmacopeia that pertain to compounding sterile pharmaceuticals and their referenced companion documents, as amended from time to time. (b) (1) (A) If an applicant for a new pharmacy license [pursuant to] under section 20-594, as amended by this act, intends to compound sterile pharmaceuticals, the applicant shall file an addendum to [its] the pharmacy license application such applicant files pursuant to section 20- 594, as amended by this act, to include sterile pharmaceutical compounding. 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 23 of 35 applicant's application has been approved by the department and the [Commission of Pharmacy] commission. Nothing in this section shall be construed to affect a licensed hospital's ability to compound sterile pharmaceuticals for such hospital's patients consistent with federal law. [(2)] (B) If an existing pharmacy licensed pursuant to section 20-594, as amended by this act, intends to compound sterile pharmaceuticals for the first time on or after July 1, 2014, such pharmacy shall [file an] apply for an addendum [application to its] to such pharmacy's application on file with the department to include sterile pharmaceutical compounding. The [Department of Consumer Protection] department shall inspect the pharmacy premises of such pharmacy and [the] such pharmacy shall not compound sterile pharmaceuticals until [it] such pharmacy receives written notice that such addendum application has been approved by the department and the [Commission of Pharmacy] commission. (C) If an existing health care institutional pharmacy licensed pursuant to section 20-594, as amended by this act, intends to compound 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. The department shall inspect the pharmacy premises of such health care institutional pharmacy, and such health care institutional pharmacy shall not compound sterile pharmaceuticals until such health care institutional pharmacy receives written notice that such health care institutional pharmacy's addendum application has been approved by the department and the commission. [(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 Substitute Senate Bill No. 1102 Public Act No. 23-19 24 of 35 to include sterile pharmaceutical compounding. [The] Such applicant shall provide to the department [with] written proof [it] that such applicant has passed inspection by the appropriate state agency in the state where such [nonresident pharmacy] applicant is located. Such [pharmacy] applicant shall not compound sterile pharmaceuticals for sale or delivery in this state until [it] such applicant receives written notice that [the] such addendum [application] has been approved by the department and the [Commission of Pharmacy] commission. [(4)] (B) If [a] an existing nonresident pharmacy [registered pursuant to section 20-627] intends to compound sterile pharmaceuticals for sale or delivery in this state for the first time on or after July 1, 2014, [the] such nonresident pharmacy shall [file] apply for an addendum to [its] such nonresident pharmacy's application on file with the department to include sterile pharmaceutical compounding. [The] Such nonresident pharmacy shall provide to the department [with] written proof [it] that such nonresident pharmacy has passed inspection by the appropriate state agency in the state where such nonresident pharmacy is located. 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 department and the [Commission of Pharmacy] commission. (c) A sterile compounding pharmacy shall comply with the USP chapters. A sterile compounding pharmacy shall also comply with all applicable federal and state statutes and regulations. [(d) An institutional pharmacy within a facility licensed pursuant to section 19a-490 that compounds sterile pharmaceuticals shall comply with the USP chapters, and shall also comply with all applicable federal and state statutes and regulations. 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 25 of 35 shown. The commissioner may grant an extension for a length of time not to exceed six months. Nothing in this section shall prevent such institutional pharmacy from requesting a subsequent extension of time or shall prevent the commissioner from granting such extension.] [(e)] (d) (1) A sterile compounding pharmacy may only provide patient-specific sterile pharmaceuticals to patients, to practitioners of medicine, osteopathy, podiatry, dentistry or veterinary medicine, or to an acute care or long-term care hospital or health care facility licensed by the Department of Public Health. (2) If a sterile compounding pharmacy provides sterile pharmaceuticals without a patient-specific prescription or medical order, the sterile compounding pharmacy shall also obtain a certificate of registration from the Department of Consumer Protection pursuant to section 21a-70, as amended by this act, and any required federal license or registration. A sterile compounding pharmacy may prepare and maintain on-site inventory of sterile pharmaceuticals no greater than a thirty-day supply, calculated from the completion of compounding, which thirty-day period shall include the period required for third-party analytical testing, to be performed in accordance with the USP chapters. [(f)] (e) (1) If a sterile compounding pharmacy plans to remodel any area utilized for 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. Such written notification shall include a plan for such remodel, relocation, upgrade or repair and such plan shall be subject to Substitute Senate Bill No. 1102 Public Act No. 23-19 26 of 35 department review and approval. If a sterile compounding pharmacy makes an emergency repair, the sterile compounding pharmacy shall notify the department of such emergency repair, in writing, not later than twenty-four hours after such repair is commenced. (2) If the USP chapters require sterile recertification after such remodel, relocation, upgrade or repair, the sterile compounding pharmacy shall provide a copy of [its] such sterile compounding pharmacy's sterile recertification to the Department of Consumer Protection not later than five days after the sterile recertification approval. The recertification shall only be performed by an independent licensed environmental monitoring entity. [(g)] (f) A sterile compounding pharmacy shall report, in writing, to the Department of Consumer Protection any known violation or noncompliance with viable and nonviable environmental sampling testing, as defined in the USP chapters, not later than the end of the next business day after discovering such violation or noncompliance. [(h)] (g) (1) If a sterile compounding pharmacy initiates a recall of sterile pharmaceuticals that were dispensed pursuant to a patient- specific prescription or medical order, the sterile compounding pharmacy shall notify each patient or patient care giver, the prescribing practitioner and the Department of Consumer Protection of such recall not later than twenty-four hours after such recall was initiated. (2) If a sterile compounding pharmacy initiates a recall of sterile pharmaceuticals that were not dispensed pursuant to a patient-specific prescription or a medical order, the sterile compounding pharmacy shall notify: (A) 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 27 of 35 was initiated. [(i)] (h) Each sterile compounding pharmacy [and each institutional pharmacy within a facility licensed pursuant to section 19a-490] shall prepare and maintain a policy and procedure manual. The policy and procedure manual shall comply with the USP chapters. [(j)] (i) Each sterile compounding pharmacy shall report to the Department of Consumer Protection any administrative or legal action commenced against [it] such sterile compounding pharmacy by any state or federal regulatory agency or accreditation entity not later than five business days after receiving notice of the commencement of such action. [(k)] (j) Notwithstanding the provisions of [subdivisions (3) and (4)] subdivision (2) of subsection (b) of this section, a sterile compounding pharmacy that is a nonresident pharmacy shall provide to the Department of Consumer Protection proof that [it] such nonresident pharmacy has passed an inspection in such nonresident pharmacy's home state, based on the USP chapters. Such nonresident pharmacy shall submit to the Department of Consumer Protection a copy of the most recent inspection report with [its] such nonresident pharmacy's initial nonresident pharmacy application and shall submit to the department a copy of [its] such nonresident pharmacy's most recent inspection report every two years thereafter. 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 required in the USP chapters. [(l)] (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 Substitute Senate Bill No. 1102 Public Act No. 23-19 28 of 35 dispensing or any suspected adulterated sterile pharmaceuticals to the Department of Consumer Protection. [(m)] (l) (1) For purposes of this subsection, a "designated pharmacist" means a pharmacist responsible for overseeing the compounding of sterile pharmaceuticals and the application of the USP chapters, as said chapters pertain to sterile compounding. (2) Any pharmacy licensed pursuant to section 20-594, as amended by this act, [or institutional pharmacy licensed pursuant to section 19a- 490] that provides sterile pharmaceuticals shall notify the department of [its] such pharmacy's designated pharmacist. (3) The designated pharmacist shall be responsible for providing proof [he or she] such designated pharmacist has completed a program approved by the commissioner that demonstrates the competence necessary for the compounding of sterile pharmaceuticals, in compliance with all applicable federal and state statutes and regulations. (4) The designated pharmacist shall immediately notify the department whenever [he or she] such designated pharmacist ceases such designation. (5) Nothing in this section shall prevent a designated pharmacist from being the pharmacy manager. [(n)] (m) The Commissioner of Consumer Protection may adopt regulations, in accordance with chapter 54, to implement the provisions of this section. Sec. 9. Subsections (a) and (b) of section 21a-65 of the general statutes are repealed and the following is substituted in lieu thereof (Effective July 1, 2023): Substitute Senate Bill No. 1102 Public Act No. 23-19 29 of 35 (a) A licensed manufacturer or licensed wholesaler may sell hypodermic needles and syringes only to the following: (1) To a licensed manufacturer, licensed wholesaler or licensed pharmacy; (2) to a physician, dentist, veterinarian, embalmer, podiatrist or scientific investigator licensed to practice in this state; (3) to a person in charge of a care-giving institution, as defined in [subdivision (3) of] section 20-571, as amended by this act, incorporated college or scientific institution, but only for use by or in such care-giving institution, college or institution for medical or scientific purposes; (4) to a person in charge of a licensed or registered laboratory, but only for use in that laboratory for scientific and medical purposes; (5) to a farmer but only for use on the farmer's own animals or poultry; (6) to a business authorized in accordance with the regulations adopted under section 21a-66 to purchase hypodermic needles and syringes but only for legitimate industrial or medical use within that business; and (7) to a syringe services program established pursuant to section 19a-124. (b) Except as provided in subsection (a) of this section, no licensed manufacturer, licensed wholesaler or licensed pharmacist shall sell and no person shall buy a hypodermic needle or syringe except upon a prescription of a prescribing practitioner, as defined in [subdivision (28) of] section 20-571, as amended by this act, in a quantity greater than ten. Any such prescription shall be retained on file by the seller for a period of not less than three years and shall be accessible to any public officer engaged in the enforcement of this section. Such a prescription shall be valid for one year from the date thereof and purchases and sales may be made thereunder during such period, provided the seller shall confirm the continued need for such sales with such practitioner at least every six months if sales continue to be made thereunder. Hypodermic needles and syringes in a quantity of ten or less without a prescription may be provided or sold at retail only by the following: (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 Substitute Senate Bill No. 1102 Public Act No. 23-19 30 of 35 the pharmacist's direct supervision; (2) by a syringe service program established pursuant to section 19a-124; and (3) by a health care facility or a licensed health care practitioner for use by their own patients. Sec. 10. Subsection (a) of section 21a-70 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (a) As used in this section: (1) "Drugs", "devices" and "cosmetics" have the same meanings as defined in section 21a-92, "wholesaler" or "distributor" means a person, including, but not limited to, a medical device and oxygen provider, a third-party logistics provider, a virtual manufacturer or a virtual wholesale distributor, as such terms are defined in section 20-571, as amended by this act, whether within or without the boundaries of the state of Connecticut, who supplies drugs, devices or cosmetics prepared, produced or packaged by manufacturers, to other wholesalers, manufacturers, distributors, hospitals, prescribing practitioners, as defined in [subdivision (28) of] section 20-571, as amended by this act, pharmacies, federal, state or municipal agencies, clinics or any other person as permitted under subsection (h) of this section, except that: (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 authorized practitioner for research purposes, (C) a retail pharmacy 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, Substitute Senate Bill No. 1102 Public Act No. 23-19 31 of 35 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 prescription or medication order of an authorized practitioner, 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; (2) "manufacturer" means (A) a person, whether within or without the boundaries of the state of Connecticut, who produces, prepares, cultivates, grows, propagates, compounds, converts or processes, directly or indirectly, by extraction from substances of natural origin or by means of chemical synthesis or by a combination of extraction and chemical synthesis, or who packages, repackages, labels or relabels a container under such manufacturer's own or any other trademark or label any drug, device or cosmetic for the purpose of selling such items, or (B) a sterile compounding pharmacy, as defined in section 20-633b, as amended by this act, that dispenses sterile pharmaceuticals without a prescription or a patient-specific medical order; (3) "drug", "device" and "cosmetic" have the same meanings as provided in section 21a-92; and (4) "commissioner" means the Commissioner of Consumer Protection or [his or her] the commissioner's designee. Sec. 11. Subsection (k) of section 21a-106 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (k) If it is a legend drug, as defined in [subdivision (16) of] section 20- 571, as amended by this act, that is not administered, dispensed, prescribed or otherwise possessed or distributed in accordance with federal and state laws and regulations; Substitute Senate Bill No. 1102 Public Act No. 23-19 32 of 35 Sec. 12. Subsection (e) of section 21a-115 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (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 [subdivision (7) of] section 20-571, as amended by this act, the Commissioner of Consumer Protection shall act in place of the director. Existing regulations shall continue in effect unless superseded by action of said commissioner pursuant to this subsection. Sec. 13. Subsection (j) of section 21a-249 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (j) A pharmacy may sell and dispense controlled substances upon the prescription of a prescribing practitioner, as defined in [subdivision (28) of] section 20-571, as amended by this act. Sec. 14. Section 38a-492a of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): Each individual health insurance policy providing coverage of the type specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 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. Such benefits shall be subject to any policy provisions that apply to other services covered by such policy. Sec. 15. Section 38a-518a of the general statutes is repealed and the Substitute Senate Bill No. 1102 Public Act No. 23-19 33 of 35 following is substituted in lieu thereof (Effective July 1, 2023): Each group health insurance policy providing coverage of the type specified in subdivisions (1), (2), (4), (6), (10), (11) and (12) of section 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. Such benefits shall be subject to any policy provisions that apply to other services covered by such policy. Sec. 16. Subdivision (1) of subsection (b) of section 53a-13 of the general statutes is repealed and the following is substituted in lieu thereof (Effective July 1, 2023): (b) (1) It shall not be a defense under this section if such mental disease or defect was proximately caused by the voluntary ingestion, inhalation or injection of intoxicating liquor or any drug or substance, or any combination thereof, unless such drug was prescribed for the defendant by a prescribing practitioner, as defined in [subdivision (28) of] section 20-571, as amended by this act, and was used in accordance with the directions of such prescription. Sec. 17. Section 19a-112h of the general statutes is repealed and the following is substituted in lieu thereof (Effective from passage): (a) The Commissioner of Public Health 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 Substitute Senate Bill No. 1102 Public Act No. 23-19 34 of 35 Prevention and the state of Connecticut Technical Guidelines for Health Care Response to Victims of Sexual Assault. The commissioner shall give priority for benefits under the program established pursuant to this section to sexual assault victims who are uninsured or underinsured and for whom the program is a payer of last resort. The commissioner shall issue a request for proposal 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. The program 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 prescribed by a licensed physician consistent with the recommendations of the National Centers for Disease Control and Prevention. For the purposes of this subsection, "financial assistance" includes, but need not be limited to, payments for out-of-pocket costs, copayments, coinsurance, and up to full cost payments toward a deductible for individuals who are underinsured and for whom the program is the payer of last resort. (b) The commissioner shall give 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. (c) The commissioner may adopt regulations in accordance with the provisions of chapter 54 to implement the provisions of this section. The commissioner may implement policies and procedures necessary to Substitute Senate Bill No. 1102 Public Act No. 23-19 35 of 35 administer the provisions of this section while in the process of adopting such policies and procedures as regulations, provided notice of intent to adopt regulations is published on the eRegulations System not later than twenty days after the date of implementation. Policies and procedures implemented pursuant to this section shall be valid until the time final regulations are adopted.