Chapter 182

2015 -- S 0320 SUBSTITUTE A Enacted 07/09/2015

A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES

Introduced By: Senators Doyle, Nesselbush, P Fogarty, and Ottiano

Date Introduced: February 12, 2015

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" is hereby amended to read as follows:

5-19.1-2. Definitions. -- (a) "Board" means the Rhode Island board of pharmacy.

(b) "Change of ownership" means:

(1) In the case of a pharmacy, manufacturer, or wholesaler, wholesaler which that is a

partnership, any change which that results in a new partner acquiring a controlling interest in the

partnership;

(2) In the case of a pharmacy, manufacturer manufacturer, or wholesaler which that

is a sole proprietorship, the transfer of the title and property to another person;

(3) In the case of a pharmacy, manufacturer, or wholesaler which that is a corporation:

(i) A sale, lease exchange, or other disposition of all all, or substantially all all, of the

property and assets of the corporation; or

(ii) A merger of the corporation into another corporation; or

(iii) The consolidation of two (2) or more corporations, corporations resulting in the

creation of a new corporation; or

(iv) In the case of a pharmacy, manufacturer, or wholesaler which that is a business

corporation, any transfer of corporate stock which that results in a new person acquiring a

controlling interest in the corporation; or

(v) In the case of a pharmacy, manufacturer, or wholesaler which that is a non-business

corporation, any change in membership, membership which that results in a new person

acquiring a controlling vote in the corporation.

(c) "Compounding" means the act of combining two (2) or more ingredients as a result

of a practitioner's prescription or medication order occurring in the course of professional practice

based upon the individual needs of a patient and a relationship between the practitioner, patient,

and pharmacist. Compounding does not mean the routine preparation, mixing mixing, or

assembling of drug products that are essentially copies of a commercially available product.

Compounding shall only occur in the pharmacy where the drug or device is dispensed to the

patient or caregiver and includes the preparation of drugs or devices in anticipation of

prescription orders based upon routine, regularly observed prescribing patterns.

(d) "Controlled substance" means a drug or substance, or an immediate precursor of such

drug or substance, so designated under or pursuant to the provisions of chapter 28 of title 21.

(e) "Deliver" or "delivery" means the actual, constructive, or attempted transfer from one

person to another of a drug or device, whether or not there is an agency relationship.

(f) "Device" means instruments, apparatus, and contrivances, including their

components, parts, and accessories, intended:

(1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man

or other animals; or

(2) To affect the structure or any function of the body of man or other animals.

(g) "Director" means the director of the Rhode Island state department of health.

(h) "Dispense" means the interpretation of a prescription or order for a drug, biological,

or device and, pursuant to that prescription or order, the proper selection, measuring,

compounding, labeling, or packaging necessary to prepare that prescription or order for delivery

or administration.

(i) "Distribute" means the delivery of a drug or device other than by administering or

dispensing.

(j) "Drug" means:

(1) Articles recognized in the official United States Pharmacopoeia or the Official

Homeopathic Pharmacopoeia of the U.S.;

(2) Substances intended for use in the diagnosis, cure, mitigation, treatment, or

prevention of disease in man, woman woman, or other animals;

(3) Substances (other than food) intended to affect the structure or any function of the

body of man, woman woman, or other animals; or

(4) Substances intended for use as a component of any substances specified in

subdivision (1), (2), or (3) of this subsection and § 5-19-1(16), but not including devices or their

component parts or accessories.

(k) "Equivalent and interchangeable" means having the same generic name, dosage form,

and labeled potency, meeting standards of the United States Pharmacopoeia or National

Formulary, or their successors, if applicable, and not found in violation of the requirements of the

United States Food and Drug Administration, or its successor agency, or the Rhode Island

department of health.

(l) "Intern" means:

(1) A graduate of an American Council on Pharmaceutical Education (ACPE) (ACPE)-

accredited program of pharmacy;

(2) A student who is enrolled in at least the first year of a professional ACPE ACPE-

accredited program of pharmacy; or

(3) A graduate of a foreign college of pharmacy who has obtained full certification from

the FPGEC (Foreign Pharmacy Graduate Equivalency Commission) administered by the National

Association of Boards of Pharmacy.

(m) "Limited function test" means those tests listed in the federal register under the

Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests. For the purposes

of this chapter, limited function test shall include only the following: blood glucose, hemoglobin

Alc, cholesterol tests, and/or other tests that are classified as waived under CLIA and are

approved by the United States Food and Drug Administration for sale to the public without a

prescription in the form of an over-the-counter test kit.

(m)(n) "Legend drugs" means any drugs, drugs which that are required by any

applicable federal or state law or regulation to be dispensed on prescription only or are restricted

to use by practitioners only.

(n)(o) "Manufacture" means the production, preparation, propagation, compounding, or

processing of a drug or other substance or device or the packaging or repackaging.

(o)(p) "Non-legend" or "nonprescription drugs" means any drugs, drugs which that

may be lawfully sold without a prescription.

(p)(q) "Person" means an individual, corporation, government, subdivision or agency,

business trust, estate, trust, partnership or association, or any other legal entity.

(q)(r) "Pharmaceutical care" is the provision of drugs and other pharmaceutical services

intended to achieve outcomes related to cure or prevention of a disease, disease elimination or

reduction of a patient's symptoms, symptoms or arresting or slowing of a disease process.

"Pharmaceutical care" includes the judgment of a pharmacist in dispensing an equivalent and

interchangeable drug or device in response to a prescription, prescription after appropriate

communication with the prescriber and the patient.

(r)(s) "Pharmacist-in-charge Pharmacist in charge " means a pharmacist licensed in

this state as designated by the owner as the person responsible for the operation of a pharmacy in

conformance with all laws and regulations pertinent to the practice of pharmacy and who is

personally in full and actual charge of such pharmacy and personnel.

(s)(t) "Pharmacy" means that portion or part of a premise where prescriptions are

compounded and dispensed, including that portion utilized for the storage of prescription or

legend drugs.

(t)(u) "Pharmacy technician" means an individual who meets minimum qualifications

established by the board, which that are less than those established by this chapter as necessary

for licensing as a pharmacist, and who works under the direction and supervision of a licensed

pharmacist.

(u)(v) "Practice of pharmacy" means the interpretation, evaluation, and implementation

of medical orders; the dispensing of prescription drug orders; participation in drug and device

selection; the compounding of prescription drugs; drug regimen reviews and drug or drug

related drug-related research; the administration of adult immunizations pursuant to a valid

prescription or physician approved physician-approved protocol and in accordance with

regulations, to include training requirements as promulgated by the department of health; the

administration of all forms of influenza immunizations to individuals between the ages of nine (9)

years and eighteen (18) years, inclusive, pursuant to a valid prescription or prescriber approved

prescriber-approved protocol, in accordance with the provisions of § 5-19.1-31 and in

accordance with regulations, to include necessary training requirements specific to the

administration of influenza immunizations to individuals between the ages of nine (9) years and

eighteen (18) years, inclusive, as promulgated by the department of health; provision of patient

counseling and the provision of those acts or services necessary to provide pharmaceutical care;

and/or the responsibility for the supervision for compounding and labeling of drugs and devices

(except labeling by a manufacturer, repackager, or distributor of non-prescription drugs and

commercially packaged legend drugs and devices), proper and safe storage of drugs and devices,

and maintenance of proper records for them; and the performance of clinical laboratory tests,

provided such testing is limited to limited-function tests as defined herein. Nothing in this

definition shall be construed to limit or otherwise affect the scope of practice of any other

profession.

(v)(w) "Practitioner" means a physician, dentist, veterinarian, nurse nurse, or other

person duly authorized by law in the state in which they practice to prescribe drugs.

(w)(x) "Preceptor" means a pharmacist registered to engage in the practice of pharmacy

in this state, state who has the responsibility for training interns.

(x)(y) "Prescription" means an order for drugs or devices issued by the practitioner duly

authorized by law in the state in which he or she practices to prescribe drugs or devices in the

course of his or her professional practice for a legitimate medical purpose.

(y)(z) "Wholesaler" means a person who buys drugs or devices for resale and

distribution to corporations, individuals, or entities other than consumers.

SECTION 2. Section 5-19.2-2 of the General Laws in Chapter 5-19.2 entitled

"Collaborative Pharmacy Practice" is hereby amended to read as follows:

5-19.2-2. Definitions. -- (a) "Collaborative practice agreement" is a written and signed

agreement, entered into voluntarily, between a pharmacist pharmacist, with advanced training

and experience relevant to the scope of collaborative practice practice, and one or more

physicians that defines the collaborative pharmacy practice in which the pharmacist and

physician(s) propose to engage. Collaborative practice agreements shall be made in the best

interest of public health.

(b) "Collaborative practice committee" shall consist of six (6) individuals: three (3)

individuals to be appointed by the board of pharmacy from nominees provided by the Rhode

Island Pharmacists Association; Association and three (3) individuals to be appointed by the

board of medical licensure and discipline from nominees provided by the Rhode Island Medical

Society. The collaborative practice committee shall advise the director on all issues pertinent to

the regulation of collaborative practice agreements.

(c) "Collaborative pharmacy practice" is that practice of pharmacy whereby a

pharmacist pharmacist, with advanced training and experience relevant to the scope of

collaborative practice agrees to work in collaboration with one or more physicians for the purpose

of drug therapy management of patients, such management to be pursuant to a protocol or

protocols authorized by the physician(s) and subject to conditions and/or limitations as set forth

by the department. A health care professional who has prescribing privileges and is employed by

a collaborating physician may be in such an agreement.

(d) "Drug therapy management" means the review, in accordance with a collaborative

practice agreement, of drug therapy regimen or regimens of patients by a pharmacist for the

purpose of rendering advice to one or more physicians that who are party to the agreement, or

their physician designees, regarding adjustment of the regimen. Decisions involving drug therapy

management shall be made in the best interests of the patient. In accordance with a collaborative

practice agreement, drug therapy management may include:

(1) Modifying and managing drug therapy;

(2) Collecting and reviewing patient histories;

(3) Obtaining and checking vital signs, including pulse, temperature, blood pressure, and

respiration; and

(4) Under the supervision of, or in direct consultation with a physician, ordering and

evaluating the results of laboratory tests directly related to drug therapy when performed in

accordance with approved protocols applicable to the practice setting and providing such

evaluation does not include any diagnostic component.

(e) "Limited-function test" means those tests listed in the federal register under the

Clinical Laboratory Improvement Amendments of 1988 (CLIA) as waived tests. For the purposes

of this chapter, limited-function test shall include only the following: blood glucose, hemoglobin

Alc, cholesterol tests, and/or other tests that are classified as waived under CLIA and are

approved by the United States Food and Drug Administration for sale to the public without a

prescription in the form of an over-the-counter test kit.

(e)(f) "Pharmacist with advanced training and experience relevant to the scope of

collaborative practice" means a licensed pharmacist in this state with post-graduate educational

training. Such training shall include, but not be limited to, residency training, training; board

certification, certification; certification from an accredited professional organization educational

institution, institution; or any other continuing education provider approved by the director of

health, health relevant to the proposed scope of the collaborative practice agreement.

(f)(g) "Practice of pharmacy" means the interpretation, evaluation, and implementation of

medical orders; orders, including the performance of clinical laboratory tests tests, provided

such testing is conducted in conformity with the federal Clinical Laboratories Improvement Act,

as amended, 42 U.S.C. § 263a limited to limited function tests as defined herein; the dispensing

of prescription drug orders; participation in drug and device selection; drug regiment reviews and

drug or drug related drug-related research; provision of patient counseling and the provision of

those acts or services necessary to provide pharmaceutical care; drug therapy management

pursuant to a collaborative practice agreement; and the responsibility for the supervision for

compounding and labeling of drugs and devices (except labeling by a manufacturer, repackager,

or distributor of nonprescription drugs and commercially packaged legend drugs and devices),

devices); proper and safe storage of drugs and devices, devices; and maintenance of proper

records for them.

SECTION 3. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby

amended by adding thereto the following section:

5-19.1-32. Limited function tests. – (a) Upon receiving consent from the patient, a

pharmacist performing a limited-function test in accordance with this chapter shall report test

results to the patient's primary care practitioner, if known, within a reasonable period of time. In

the event that a patient with an abnormal test result does not have an existing relationship with a

primary care practitioner, the pharmacist shall make efforts to refer the patient to a primary care

practitioner, practice, health center, or clinic.

(b)(1) The pharmacy shall develop policies and procedures for emergency situations

related to the provision of limited-function health tests, to include the prompt reporting of test

results to a patient's primary care practitioner, if known.

(2) The department shall promulgate rules and regulations to carry out the provisions of

this section. The department's rules and regulations may include the following:

(i) Requirements for the pharmacist to inform the patient that the limited-function test

results are intended for informational and educational purposes, rather than diagnostic purposes;

and

(ii) Requirements ensuring appropriate temperature and environmental controls to

maintain the efficacy of the limited-function test kit.

SECTION 4. Section 23-16.2-3 of the General Laws in Chapter 23-16.2 entitled

"Laboratories" is hereby amended to read as follows:

23-16.2-3. Application of law -- Exceptions. -- The provisions of this chapter shall

apply to all laboratories and stations performing analytical or clinical laboratory services or

specimens in this state except:

(1) A laboratory maintained by a hospital licensed under chapter 17 of this title, title or

by a licensed physician or group of licensed physicians who make the tests referred to in § 23-

16.2-2 personally and solely in connection with the treatment of their own patients; however, an

independent laboratory which that makes the tests on its own responsibility for a single physician

or group of physicians is subject to this chapter.

(2) Any temporary or ad hoc health promotion or screening program conducted for the

general public which that offers generally accepted mass screening mass-screening procedures;

provided the health promotion or screening program is conducted pursuant to a permit issued by

the department of health.

(3) Any person performing only limited function limited-function tests as defined in

regulation by the director.

(4) Licensed pharmacists performing limited function tests as defined in § 5-19.1-2(m).

SECTION 5. Section 23-16.3-4 of the General Laws in Chapter 23-16.3 entitled "Clinical

Laboratory Science Practice" is hereby amended to read as follows:

23-16.3-4. Exceptions. -- This chapter shall not apply to:

(1) Any person performing clinical laboratory tests within the scope of his or her practice

and for which he or she is licensed pursuant to any other provisions of the general laws.

(2) Clinical laboratory science practitioners employed by the United States government

or any bureau, division, or agency of the United States government while in the discharge of the

employee's official duties.

(3) Clinical laboratory science practitioners engaged in teaching or research, provided

that the results of any examination performed are not used in health maintenance, diagnosis, or

treatment of disease.

(4) Students or trainees enrolled in a clinical laboratory science education program

program, provided that these activities constitute a part of a planned course in the program,

program; that the persons are designated by title such as intern, trainee, or student, student; and

the persons work directly under the supervision of an individual licensed by this state to practice

laboratory science.

(5) Individuals performing limited function limited-function tests.

(6) Licensed pharmacists performing limited-function tests as defined in § 5-19.1-2(m).

SECTION 6. This act shall take effect upon passage.

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LC001064/SUB A/2

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