2003 -- S 0568
A N A C T
RELATING TO FOOD AND DRUGS
Introduced By: Senators Celona, Polisena, F Caprio, Tassoni, and Cote
Date Introduced: February 13, 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,
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
(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
(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
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
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,
(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.