Chapter 157 |
2015 -- H 5497 SUBSTITUTE A Enacted 07/09/2015 |
A N A C T |
RELATING TO BUSINESSES AND PROFESSIONS - PHARMACIES |
Introduced By: Representatives Serpa, and Fellela |
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, 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. |
======== |
LC000979/SUB A/2 |
======== |