Chapter 109

2011 -- H 5211 SUBSTITUTE A AS AMENDED

Enacted 06/22/11

 

A N A C T

RELATING TO BUSINESSES AND PROFESSIONS -- PHARMACIES

          

     Introduced By: Representative Patricia A. Serpa

     Date Introduced: February 03, 2011

 

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, which is a partnership, any

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

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

      (i) A sale, lease exchange, or other disposition of all or substantially 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, resulting in the creation of a new

corporation; or

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

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

interest in the corporation; or

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

corporation, any change in membership, which 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 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 or other animals;

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

body of man, 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 section 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) accredited

program of pharmacy;

      (2) A student who is enrolled in at least the first year of a professional 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) "Legend drugs" means any drugs, which 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) "Manufacture" means the production, preparation, propagation, compounding, or

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

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

sold without a prescription.

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

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

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

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

of a patient's 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, after appropriate communication with the prescriber and the

patient.

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

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

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

      (u) "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

research; the administration of adult immunizations pursuant to a valid prescription or 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 protocol, in accordance with the

provisions of section 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. Nothing in this

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

profession.

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

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

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

this state, who has the responsibility for training interns.

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

corporations, individuals, or entities other than consumers.

 

     SECTION 2. Chapter 5-19.1 of the General Laws entitled "Pharmacies" is hereby

amended by adding thereto the following section:

 

     5-19.1-31. Administration of influenza immunizations to individuals between the

ages of nine (9) years and eighteen (18) years, inclusive. (a) Parental consent shall be

required for all pharmacist-administered immunizations for individuals under the age of eighteen

(18) years.

     (b) The department of health shall require a pharmacist who is authorized to administer

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

years, inclusive, pursuant to section 5-19.1-2, to electronically report to the department all

immunizations administered within seven (7) days of administration in the format and for the

populations required by the department.

     (c)(1) The department of health shall require a pharmacist who is authorized to

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

eighteen (18) years, inclusive, pursuant to section 5-19.1-2 to provide notification of a patient's

immunization to the patient's primary care provider, if known, within fourteen (14) days of

administration.

     (2) The department of health's rules and regulations shall include provisions to ensure

that the administering pharmacist make a good faith effort to obtain information relating to the

identity of a patient's primary care provider or primary care practice, for the purposes of fulfilling

the reporting requirements of subdivision (c)(1) herein. If a patient does not have an existing

relationship with a primary care provider or primary care practice, the administering pharmacist

shall proceed with the reporting requirements contained in subsection (b) herein.

 

     SECTION 3. This act shall take effect upon passage.

     

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LC00794/SUB A

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