2014 -- S 2518

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LC004581

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2014

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A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS-PHARMACIES

     

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

     Date Introduced: February 27, 2014

     Referred To: Senate Health & Human Services

     It is enacted by the General Assembly as follows:

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     SECTION 1. Section 5-19.1-2 of the General Laws in Chapter 5-19.1 entitled

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"Pharmacies" is hereby amended to read as follows:

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

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      (b) "Change of ownership" means:

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

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change which results in a new partner acquiring a controlling interest in the partnership;

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      (2) In the case of a pharmacy, manufacturer or wholesaler which is a sole proprietorship,

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the transfer of the title and property to another person;

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

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

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and assets of the corporation; or

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

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

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corporation; or

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

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

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interest in the corporation; or

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

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corporation, any change in membership, which results in a new person acquiring a controlling

 

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vote in the corporation.

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

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

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

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

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

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only occur in the pharmacy where the drug or device is dispensed to the patient or caregiver and

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includes the preparation of drugs or devices in anticipation of prescription orders based upon

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routine, regularly observed prescribing patterns.

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

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

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

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

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

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components, parts, and accessories, intended:

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

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or other animals; or

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

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

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

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

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

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or administration.

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

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dispensing.

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      (j) "Drug" means:

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

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Homeopathic Pharmacopoeia of the U.S.;

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

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prevention of disease in man, woman or other animals;

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

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body of man, woman or other animals; or

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

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

 

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their component parts or accessories.

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

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

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

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

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department of health.

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      (l) "Intern" means:

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

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program of pharmacy;

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

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program of pharmacy; or

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

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

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Association of Boards of Pharmacy.

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      (m) "Legend drugs" means any drugs, which are required by any applicable federal or

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state law or regulation to be dispensed on prescription only or are restricted to use by practitioners

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only.

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

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

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      (o) "Non-legend" or "nonprescription drugs" means any drugs, which may be lawfully

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sold without a prescription.

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

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

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

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

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of a patient's symptoms, or arresting or slowing of a disease process. "Pharmaceutical care"

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includes the judgment of a pharmacist in dispensing an equivalent and interchangeable drug or

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device in response to a prescription, after appropriate communication with the prescriber and the

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patient.

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      (r) "Pharmacist-in-charge" means a pharmacist licensed in this state as designated by the

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owner as the person responsible for the operation of a pharmacy in conformance with all laws and

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regulations pertinent to the practice of pharmacy and who is personally in full and actual charge

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of such pharmacy and personnel.

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

 

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

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legend drugs.

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

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

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

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

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

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

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research; the administration of adult immunizations pursuant to a valid prescription or physician

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approved protocol and in accordance with regulations, to include training requirements as

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promulgated by the department of health; the administration of all forms of influenza

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immunizations to individuals between the ages of nine (9) years and eighteen (18) years,

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inclusive, pursuant to a valid prescription or prescriber approved protocol, in accordance with the

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provisions of section 5-19.1-31 and in accordance with regulations, to include necessary training

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requirements specific to the administration of influenza immunizations to individuals between the

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ages of nine (9) years and eighteen (18) years, inclusive, as promulgated by the department of

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health; provision of patient counseling and the provision of those acts or services necessary to

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provide pharmaceutical care; and/or the responsibility for the supervision for compounding and

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

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non-prescription drugs and commercially packaged legend drugs and devices), proper and safe

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storage of drugs and devices, and maintenance of proper records for them. Nothing in this

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

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profession.

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      (v) "Practitioner" means a physician, dentist, veterinarian, nurse, clinical pharmacist

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practitioner, or other person duly authorized by law in the state in which they practice to prescribe

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drugs.

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

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this state, who has the responsibility for training interns.

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

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

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

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

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corporations, individuals, or entities other than consumers.

 

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     SECTION 2. This act shall take effect upon passage.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO BUSINESSES AND PROFESSIONS-PHARMACIES

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     This act would include "clinical pharmacist practitioners" within the definition of

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"practitioner" for purposes of presenting drugs.

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     This act would take effect upon passage.

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