Chapter 047

2003 -- H 5949 SUBSTITUTE A

Enacted 06/25/03

A N A C T

RELATING TO FOOD AND DRUGS

Introduced By: Representative Steven M. Costantino

Date Introduced: February 12, 2003

It is enacted by the General Assembly as follows:

     SECTION 1. Section 5-37-18.1 of the General Laws in Chapter 5-37 entitled "Board of

Medical Licensure and Discipline" is hereby amended to read as follows:

5-37-18.1. Physicians required to authorize product selection. -- Every licensed

Rhode Island physician, when prescribing any drug by brand name, shall in each prescription,

oral, or written or electronic, authorize a less expensive generic equivalent drug product by

signing the prescription. However, if, in the professional judgment of the prescribing physician,

the brand name is medically necessary, the physician shall indicate write in his or her own

handwriting in a designated box "brand name necessary" on the prescription form. Pursuant to

section 42-127.1-7 and chapter 5-19.1, an electronic signature shall satisfy this requirement.

     SECTION 2. Section 21-31-15 of the General Laws in Chapter 21-31 entitled "Rhode

Island Food, Drugs, and Cosmetics Act" is hereby amended to read as follows:

21-31-15. Misbranded drug or device. -- (a) A drug or device shall be deemed to be

misbranded:

      (1) If its labeling is false or misleading in any way.

      (2) If in package form unless it bears a label containing: (i) the name and place of

business of the manufacturer, packer, or distributor; and (ii) an accurate statement of the quantity

of the contents in terms of weight, measure, or numerical count; provided, that under paragraph

(ii) of this subdivision reasonable variations shall be permitted, and exemptions as to small

packages shall be established, by regulations prescribed by the director of health.

      (3) If any word, statement, or other information required by or under authority of this

chapter to appear on the label or labeling is not prominently placed on it with such

conspicuousness (as compared with other words, statements, designs, or devices in the labeling)

and in such terms as to render it likely to be read and understood by the ordinary individual under

customary conditions of purchase and use.

      (4) If it is for use by humans and contains any quantity of the narcotic or hypnotic

substance alpha-eucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca,

cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or sulphonmethane,

or any chemical derivative of any of those substances, which derivative has been by the director

of health after investigation found to be, and by regulations under this chapter designated as, habit

forming, unless its label bears the name and quantity of the proportion of the substance or

derivative and in juxtaposition with it the statement "Warning -- May be habit forming."

      (5) If it is a drug and is not designated solely by a name recognized in an official

compendium unless its label bears: (i) the common or usual name of the drug, if there is one; and

(ii) in case it is fabricated from two (2) or more ingredients, the common or usual name of each

active ingredient, including the kind and quantity or proportion of any alcohol, and also

including, whether active or not, the name and quantity or proportion of any bromides, ether,

chloroform, acetanilid, acetphenetidin, amidopyrine, anti-pyrine, atropine, hysoeine,

hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid,

or any derivative or preparation of those substances contained in it; provided, that to the extent

that compliance with the requirements of paragraph (ii) of this subdivision is impracticable,

exemptions shall be established by regulations promulgated by the director of health.

      (6) Unless its labeling bears: (i) adequate directions for use; and (ii) adequate warnings

against use in those pathological conditions or by children where its use may be dangerous to

health, or against unsafe dosage or methods or duration of administration or application, in the

manner and form that are necessary for the protection of users; provided, that where any

requirement of paragraph (i) of this subdivision, as applied to any drug or device, is not necessary

for the protection of the public health, the director of health shall promulgate regulations

exempting the drug or device from those requirements.

      (7) If it purports to be a drug the name of which is recognized in an official

compendium, unless it is packaged and labeled as prescribed in the compendium; provided, that

the method of packing may be modified with the consent of the director of health. Whenever a

drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia

of the United States, it shall be subject to the requirements of the United States Pharmacopoeia

with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic

drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the

United States, and not to those of the United States Pharmacopoeia.

      (8) If it has been found by the director of health to be a drug liable to deterioration,

unless it is packaged in the form and manner, and its label bears a statement of the precautions,

that the director of health shall by regulations require as necessary for the protection of public

health. No regulation shall be established for any drug recognized in an official compendium until

the director of health shall have informed the appropriate body charged with the revision of the

compendium of the need for packaging or labeling requirements and that body shall have failed

within a reasonable time to prescribe those requirements.

      (9) If: (i) it is a drug and its container is made, formed, or filled as to be misleading; (ii)

it is an imitation of another drug; or (iii) it is offered for sale under the name of another drug.

      (10) If it is dangerous to health when used in the dosage, or with the frequency or

duration prescribed, recommended, or suggested in its labeling.

      (11) (i) A drug intended for use by humans which: (A) is a habit forming drug to which

subdivision (a)(4) of this section applies; (B) because of its toxicity or the potential for harmful

effect, or the method of its use, or the collateral measures necessary to its use, is not safe for use

except under the supervision of a practitioner licensed by law to administer that drug; or (C) is

limited by an effective application under section 21-31-16 to use under the professional

supervision of a practitioner licensed by law to administer that drug shall be dispensed only: (I)

upon a written prescription of a practitioner licensed by law to administer the drug, (II) upon an

oral prescription of the practitioner which is reduced promptly to writing and filed by the

pharmacist, or (III) by refilling any written or oral prescription if the refilling is authorized by the

prescriber either in the original prescription or by oral order which is reduced promptly to writing

and filed by the pharmacist. The act of dispensing a drug contrary to the provisions of this

subdivision shall be deemed to be an act that results in the drug being misbranded while held for

sale.

      (ii) The director of health may by regulation remove drugs subject to subdivision (a)(4)

of this section and section 21-31-16 from the requirements of paragraph (i) of this subdivision

when those requirements are not necessary for the protection of the public health.

      (iii) A drug which is subject to paragraph (i) of this subdivision shall be deemed to be

misbranded if at any time prior to dispensing its label fails to bear the statement "Caution: Federal

law prohibits dispensing without prescription." A drug to which paragraph (i) of this subdivision

does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears

the caution statement quoted in the preceding sentence.

      (iv) No prescription for any of the drugs described in this subdivision shall be refilled if

marked "non-repeat" or "N.R."

      (12) If it is a drug and its packaging or labeling is in violation of an applicable regulation

issued pursuant to section 23-24.1-3 or 23-24.1-4 of the Poison Prevention Packaging Act.

      (b) (1) Any drug dispensed by filling or refilling a written or oral prescription of a

practitioner licensed by law to prescribe the drug, and any drug dispensed to an ultimate user by a

practitioner, shall be exempt from the requirements of this section except subdivisions (a)(1), (9),

and (11) of this section, and the packaging requirements of subdivisions (a)(7), (8), and (12) of

this section, if the drug bears a label containing the name and address of the dispenser, the serial

number and date of the prescription or of its filling, the name of the prescriber, and, if stated in

the prescription, the name of the patient, and the directions for use and cautionary statements, if

any, contained in the prescription. When a practitioner prescribes a drug by brand name, oral or ,

written or electronic, he or she shall, in each prescription, authorize a less expensive generic

equivalent drug product by signing the prescription. Pursuant to section 42-127.1-7 and chapter

(5-19.1) an electronic signature shall satisfy this requirement. If in the professional judgment of

the prescribing practitioner the brand name is medically necessary, the practitioner shall indicate

write in his or her own handwriting in a designated box, "Brand name necessary" on the

prescription form. This exemption shall not apply to any drug dispensed in violation of paragraph

(a)(11)(i) of this section.

      (2) When dispensing a generic drug product, the word "INTERCHANGE" or the letters

"IC" must appear on the label followed by the generic name and manufacturer, and/or distributor,

of the chosen product.

      (3) The requirements of subdivision (2) of this subsection only apply to single entity,

multiple-source drugs.

      (4) When dispensing a single entity, single source drug, the trade name of the prescribed

drug will also appear on the label, and the generic name of the prescribed drug may also appear

on the label.

      (5) When dispensing a fixed combination product, the United States Pharmacopoeia's

publication of Pharmacy Equivalent Names (PEN Names) for fixed combination products is the

official list of abbreviations for that labeling, and will be the approved abbreviation for

identifying the combination product dispensed. If no PEN name has been officially issued by the

USP, the practitioner or pharmacist will label the medication secundum artem.

      (6) Subdivisions (2) -- (5) of this subsection apply in all cases of dispensing by

practitioners or pharmacists.

      (7) Nothing in this section shall be construed to relieve any person from any requirement

prescribed by or under authority of law with respect to drugs now included or which may

subsequently be included within the classifications stated in chapters 28 and 30 of this title.

     SECTION 3. This act shall take effect upon passage.

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LC02355/SUB A

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