2023 -- S 0585
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LC002269
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S TATE OF RHODE IS LAND
IN GENERAL ASSEMBLY
JANUARY SESSION, A.D. 2023
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A N A C T
RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES
Introduced By: Senators Miller, DiPalma, Euer, DiMario, Lawson, Valverde, Murray,
and Kallman
Date Introduced: March 07, 2023
Referred To: Senate Health & Human Services
It is enacted by the General Assembly as follows:
SECTION 1. Section 5-19.1-2 of the General Laws in Chapter 5-19.1 entitled "Pharmacies" 1
is hereby amended to read as follows: 2
5-19.1-2. Definitions. 3
(a) “Biological product” means a “biological product” as defined in the “Public Health 4
Service Act,” 42 U.S.C. § 262. 5
(b) “Board” means the Rhode Island board of pharmacy. 6
(c) “Change of ownership” means: 7
(1) In the case of a pharmacy, manufacturer, or wholesaler that is a partnership, any change 8
that results in a new partner acquiring a controlling interest in the partnership; 9
(2) In the case of a pharmacy, manufacturer, or wholesaler that is a sole proprietorship, the 10
transfer of the title and property to another person; 11
(3) In the case of a pharmacy, manufacturer, or wholesaler that is a corporation: 12
(i) A sale, lease exchange, or other disposition of all, or substantially all, of the property 13
and assets of the corporation; or 14
(ii) A merger of the corporation into another corporation; or 15
(iii) The consolidation of two (2) or more corporations resulting in the creation of a new 16
corporation; or 17
(iv) In the case of a pharmacy, manufacturer, or wholesaler that is a business corporation, 18
any transfer of corporate stock that results in a new person acquiring a controlling interest in the 19
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corporation; or 1
(v) In the case of a pharmacy, manufacturer, or wholesaler that is a non-business 2
corporation, any change in membership that results in a new person acquiring a controlling vote in 3
the corporation. 4
(d) “Compounding” means the act of combining two (2) or more ingredients as a result of 5
a practitioner’s prescription or medication order occurring in the course of professional practice 6
based upon the individual needs of a patient and a relationship between the practitioner, patient, 7
and pharmacist. Compounding does not mean the routine preparation, mixing, or assembling of 8
drug products that are essentially copies of a commercially available product. Compounding shall 9
only occur in the pharmacy where the drug or device is dispensed to the patient or caregiver and 10
includes the preparation of drugs or devices in anticipation of prescription orders based upon 11
routine, regularly observed prescribing patterns. 12
(e) “Controlled substance” means a drug or substance, or an immediate precursor of such 13
drug or substance, so designated under, or pursuant to, the provisions of chapter 28 of title 21. 14
(f) “Deliver” or “delivery” means the actual, constructive, or attempted transfer from one 15
person to another of a drug or device, whether or not there is an agency relationship. 16
(g) “Device” means instruments, apparatus, and contrivances, including their components, 17
parts, and accessories, intended: 18
(1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans 19
or other animals; or 20
(2) To affect the structure or any function of the body of humans or other animals. 21
(h) “Director” means the director of the Rhode Island state department of health. 22
(i) “Dispense” means the interpretation of a prescription or order for a drug, biological 23
product, or device and, pursuant to that prescription or order, the proper selection, measuring, 24
compounding, labeling, or packaging necessary to prepare that prescription or order for delivery or 25
administration. 26
(j) “Distribute” means the delivery of a drug or device other than by administering or 27
dispensing. 28
(k) “Drug” means: 29
(1) Articles recognized in the official United States Pharmacopoeia or the Official 30
Homeopathic Pharmacopoeia of the U.S.; 31
(2) Substances intended for use in the diagnosis, cure, mitigation, treatment, or prevention 32
of disease in humans or other animals; 33
(3) Substances (other than food) intended to affect the structure, or any function, of the 34
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body of humans or other animals; or 1
(4) Substances intended for use as a component of any substances specified in subsection 2
(k)(1), (k)(2), or (k)(3), but not including devices or their component parts or accessories. 3
(l) “HIV” means human immunodeficiency virus. 4
(m) “HIV prevention drug” means a drug approved by the United States Food and Drug 5
Administration for the prevention of HIV, including, but not limited to, pre-exposure prophylaxis. 6
(l)(n) “Equivalent and interchangeable” means a drug, excluding a biological product, 7
having the same generic name, dosage form, and labeled potency, meeting standards of the United 8
States Pharmacopoeia or National Formulary, or their successors, if applicable, and not found in 9
violation of the requirements of the United States Food and Drug Administration, or its successor 10
agency, or the Rhode Island department of health. 11
(m)(o) “Interchangeable biological product” means a biological product that the United 12
States Food and Drug Administration has: 13
(1) Licensed and determined meets the standards for interchangeability pursuant to 42 14
U.S.C. § 262(k)(4) or lists of licensed, biological products with reference product exclusivity and 15
biosimilarity or interchangeability evaluations; or 16
(2) Determined is therapeutically equivalent as set forth in the latest edition of, or 17
supplement to, the United States Food and Drug Administration’s Approved Drug Products with 18
Therapeutic Equivalence Evaluations. 19
(n)(p) “Intern” means: 20
(1) A graduate of an American Council on Pharmaceutical Education (ACPE)-accredited 21
program of pharmacy; 22
(2) A student who is enrolled in at least the first year of a professional ACPE-accredited 23
program of pharmacy; or 24
(3) A graduate of a foreign college of pharmacy who has obtained full certification from 25
the FPGEC (Foreign Pharmacy Graduate Equivalency Commission) administered by the National 26
Association of Boards of Pharmacy. 27
(o)(q) “Legend drugs” means any drugs that are required by any applicable federal or state 28
law or regulation to be dispensed on prescription only or are restricted to use by practitioners only. 29
(p)(r) “Limited-function test” means those tests listed in the federal register under the 30
Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests. For the purposes 31
of this chapter, limited-function test shall include only the following: blood glucose, hemoglobin 32
A1c, cholesterol tests, and/or other tests that are classified as waived under CLIA and are approved 33
by the United States Food and Drug Administration for sale to the public without a prescription in 34
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the form of an over-the-counter test kit. 1
(q)(s) “Manufacture” means the production, preparation, propagation, compounding, or 2
processing of a drug or other substance or device or the packaging or repackaging. 3
(r)(t) “Non-legend” or “nonprescription drugs” means any drugs that may be lawfully sold 4
without a prescription. 5
(s)(u) “Person” means an individual, corporation, government, subdivision, or agency, 6
business trust, estate, trust, partnership, or association, or any other legal entity. 7
(t)(v) “Pharmaceutical care” is the provision of drugs and other pharmaceutical services 8
intended to achieve outcomes related to cure or prevention of a disease, elimination or reduction of 9
a patient’s symptoms, or arresting or slowing of a disease process. “Pharmaceutical care” includes 10
the judgment of a pharmacist in dispensing an equivalent and interchangeable drug or device in 11
response to a prescription after appropriate communication with the prescriber and the patient. 12
(u)(w) “Pharmacist in charge” means a pharmacist licensed in this state as designated by 13
the owner as the person responsible for the operation of a pharmacy in conformance with all laws 14
and regulations pertinent to the practice of pharmacy and who is personally in full and actual charge 15
of such pharmacy and personnel. 16
(v)(x) “Pharmacy” means that portion or part of a premise where prescriptions are 17
compounded and dispensed, including that portion utilized for the storage of prescription or legend 18
drugs. 19
(w)(y) “Pharmacy technician” means an individual who meets minimum qualifications 20
established by the board, that are less than those established by this chapter as necessary for 21
licensing as a pharmacist, and who works under the direction and supervision of a licensed 22
pharmacist. 23
(x)(z) “Practice of pharmacy” means the interpretation, evaluation, and implementation of 24
medical orders; the dispensing of prescription drug orders; participation in drug and device 25
selection; the compounding of prescription drugs; drug regimen reviews and drug or drug-related 26
research; the administration of adult immunizations and, medications approved by the department 27
of health in consultation with the board of pharmacy for administration by a pharmacist except as 28
provided by § 5-25-7, pursuant to a valid prescription or physician-approved protocol and in 29
accordance with regulations, to include training requirements as promulgated by the department of 30
health; the administration of all forms of influenza immunizations to individuals between the ages 31
of nine (9) years and eighteen (18) years, inclusive, pursuant to a valid prescription or prescriber-32
approved protocol, in accordance with the provisions of § 5-19.1-31 and in accordance with 33
regulations, to include necessary training requirements specific to the administration of influenza 34
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immunizations to individuals between the ages of nine (9) years and eighteen (18) years, inclusive, 1
as promulgated by the department of health; provision of patient counseling and the provision of 2
those acts or services necessary to provide pharmaceutical care; the responsibility for the 3
supervision for compounding and labeling of drugs and devices (except labeling by a manufacturer, 4
repackager, or distributor of nonprescription drugs and commercially packaged legend drugs and 5
devices), proper and safe storage of drugs and devices, and maintenance of proper records for them; 6
and the performance of clinical laboratory tests, provided such testing is limited to limited-function 7
tests as defined herein. Nothing in this definition shall be construed to limit or otherwise affect the 8
scope of practice of any other profession. 9
(y)(aa) “Practitioner” means a physician, dentist, veterinarian, nurse, or other person duly 10
authorized by law in the state in which they practice to prescribe drugs. 11
(z)(bb) “Preceptor” means a pharmacist registered to engage in the practice of pharmacy 12
in this state who has the responsibility for training interns. 13
(cc) “Pre-exposure prophylaxis” means a drug or drug combination that is taken or 14
administered to reduce the risk of HIV acquisition and meets the same clinical eligibility 15
recommendations provided in current guidelines of the federal Centers for Disease Control and 16
Prevention. 17
(aa)(dd) “Prescription” means an order for drugs or devices issued by the practitioner duly 18
authorized by law in the state in which he or she practices to prescribe drugs or devices in the course 19
of his or her professional practice for a legitimate medical purpose. 20
(bb)(ee) “Wholesaler” means a person who buys drugs or devices for resale and distribution 21
to corporations, individuals, or entities other than consumers. 22
SECTION 2. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby amended 23
by adding thereto the following section: 24
5-19.1-19.2. Pharmacists -- Prescribing, dispensing and administering PrEP. 25
(a) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs in 26
accordance with regulations promulgated by the department of health as set forth in this section. 27
(b) A licensed pharmacist may prescribe, dispense or administer HIV prevention drugs 28
according to United States Food and Drug Administration guidance and product labeling if the 29
patient: 30
(1) Is HIV negative, as documented by a negative HIV test result obtained within the 31
previous seven (7) days from an HIV antigen and antibody test or antibody-only test or from a 32
rapid, point-of-care fingerstick blood test approved by the United States Food and Drug 33
Administration; provided, however, that if the patient does not provide evidence of a negative HIV 34
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test in accordance with this clause, the pharmacist may order an HIV test prior to prescribing, 1
dispensing or administering the drugs; provided further, that if the test results are not transmitted 2
directly to the pharmacist, the pharmacist shall verify the test results to the pharmacist’s satisfaction 3
prior to prescribing, dispensing or administering the drugs; and provided further, that if the patient 4
tests positive for HIV infection, the pharmacist or person administering the test shall direct the 5
patient to a primary care provider and provide the patient with a list of providers and clinics in the 6
region; 7
(2) Does not report any signs or symptoms of acute HIV infection on a self-reported 8
checklist of acute HIV infection signs and symptoms; and 9
(3) Does not report taking any contraindicated medication. 10
(c) A licensed pharmacist that prescribes, dispenses or administers HIV prevention drugs 11
shall: 12
(1) Provide counseling to the patient on the ongoing use of pre-exposure prophylaxis, 13
which may include education about side effects, safety during pregnancy and breastfeeding, 14
adherence to recommended dosing and the importance of timely testing and treatment, as 15
applicable, for HIV, renal function, hepatitis B, hepatitis C, sexually transmitted infections and 16
pregnancy for individuals of child-bearing capacity; 17
(2) Notify the patient that the patient is required to be seen by a primary care provider to 18
receive subsequent prescriptions for pre-exposure prophylaxis and that a pharmacist shall not 19
furnish a sixty (60) day supply of pre-exposure prophylaxis to a single patient more than once every 20
two (2) years: 21
(3) Document, to the extent possible, the services provided to the patient by the pharmacist 22
in the patient’s record in the record system maintained by the pharmacy and maintain records of 23
pre-exposure prophylaxis furnished to each patient; and 24
(4) Notify the patient’s primary care provider that the pharmacist completed the 25
requirements specified in this subsection; provided, however that, if the patient does not have a 26
primary care provider or refuses consent to notify the patient’s primary care provider, the 27
pharmacist shall provide the patient a list of physicians and surgeons, clinics or other health care 28
service providers to contact regarding ongoing care for pre-exposure prophylaxis. 29
(d) The department of health shall promulgate regulations to establish statewide drug 30
therapy protocols for prescribing, dispensing and administering pre-exposure prophylaxis and other 31
HIV prevention drugs approved by the United States Food and Drug Administration that are 32
consistent with federal Centers for Disease Control and Prevention guidelines not later than six (6) 33
months after the effective date of this act. The regulations shall include, but not be limited to, rules 34
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stating that a pharmacist shall not furnish a sixty (60) day supply of pre-exposure prophylaxis to a 1
single patient more than once every two (2) years. 2
SECTION 3. This act shall take effect upon passage. 3
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EXPLANATION
BY THE LEGISLATIVE COUNCIL
OF
A N A C T
RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES
***
This act would provide for the prescribing, dispensing and the administering human 1
immunodeficiency virus (HIV) prevention drugs. 2
This act would take effect upon passage. 3
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LC002269
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