2014 -- H 7042

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LC003103

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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 FOOD & DRUGS - RHODE ISLAND FOOD DRUGS & COSMETICS ACT

     

     Introduced By: Representatives Canario, Azzinaro, Guthrie, Johnston, and Edwards

     Date Introduced: January 09, 2014

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

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     SECTION 1. Sections 21-31-2 and 21-31-15 of the General Laws in Chapter 21-31

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entitled "Rhode Island Food, Drugs, and Cosmetics Act" are hereby amended to read as follows:

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     21-31-2. Definitions. -- For the purpose of this chapter:

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      (1) "Advertisement" means all representations disseminated in any manner or by any

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means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly

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or indirectly, the purchase of food, drugs, devices, or cosmetics.

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      (2) "Color additive" means a material which: (i) Is a dye, pigment or other substance

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made by a process of synthesis or similar artifice, or extracted, isolated or otherwise derived, with

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or without intermediate or final change of identity, from a vegetable, animal, mineral or other

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source; and (ii) When added or applied to a food, drug or cosmetic, or to the human body or any

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of its parts, is capable, alone or through reaction with other substance, of imparting color thereto,

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except that the term "color additive" does not include any material exempted by regulation under

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the federal act, or which the commissioner, by regulation, determines is used, or intended to be

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used, solely for a purpose or purposes other than coloring; (iii) The term "color" includes black,

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white and intermediate grays, as well as all other colors; (iv) Nothing in subdivision (2) of this

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section shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other

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agricultural chemical used, or intended to be used, solely because of its effect in aiding, retarding

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or otherwise affecting, directly or indirectly, the growth or other natural physiological processes

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of produce of the soil which thereby affects its color, whether before or after harvest.

 

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      (2)(3) "Contaminated with filth" applies to any food, drug, device, or cosmetic not

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securely protected from dust, dirt, and, as far as may be necessary by all reasonable means, from

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all foreign or injurious contaminations.

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      (3)(4) "Cosmetics" means: (i) articles intended to be rubbed, poured, sprinkled, or

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sprayed on, introduced into, or applied to the humanbody human body or any part of the body its

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parts for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (ii)

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articles intended for use as a component of any articles described in this subdivision, except that

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this term shall not include soap.

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      (5) "Cultivated commercially" means grown or raised by a person or entity in the course

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of business or trade and sold within the state.

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      (4)(6) "Device" (except when used in subdivision (23) (40) of this section and in sections

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21-31-3(10), 21-31-11(6), 21-31-15(a)(3), and 21-31-18(3)) means instruments, apparatus, and

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contrivances, including their components, parts, and accessories, intended: (i) for use in the

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diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or (ii)

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to affect the structure or any function of the body of humans or other animals.

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      (5)(7) "Director" means the director of health.

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      (6)(8) "Distressed merchandise" means any food which has had the label lost or which

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has been subjected to possible damage due to accident, fire, flood, adverse weather, or to any

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other similar cause, and which may have been rendered unsafe or unsuitable for human or animal

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consumption or use.

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      (9) "Distributor" means a person or entity that sells, supplies, furnishes or transports food

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in this state that such person or entity does not produce.

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      (7)(10) "Dosage form" means the form of the completed drug product (such as tablet,

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syrup, or suppository).

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      (8)(11) "Drug" means: (i) articles recognized in the official United States

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Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, or official National

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Formulary, or any supplement to any of them; (ii) articles intended for use in the diagnosis, cure,

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mitigation, treatment, or prevention of disease in humans or other animals; (iii) articles (other

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than food) intended to affect the structure or any function of the body of humans or other animals;

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and (iv) articles intended for use as a component of any article specified in paragraphs (i), (ii) or

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(iii) of this subdivision; but does not include devices or their components, parts, or accessories.

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      (9)(12) "Drug product" means a dosage form containing one or more active therapeutic

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ingredients along with other substances included during the manufacturing process.

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      (13) "Enzyme" means a protein that catalyzes chemical reactions of other substances

 

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without being destroyed or altered upon completion of such reactions.

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      (10) (i) (14)(i) "Equivalent and interchangeable" means having the same generic name,

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

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

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requirements of the United States Food and Drug Administration, or its successor agency, or the

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department of health.

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      (ii) "Generic" means the chemical or established name of a drug or drug product.

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      (11) (15) "Federal Act" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

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section 301 et seq.

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      (12) (16) "Food" means: (i) articles used for food or drink for humans or other animals,

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(ii) chewing gum, and (iii) articles used for components of any article described in this

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subdivision.

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      (17) "Food additive" means any substance the intended use of which results or

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reasonably may be expected to result, directly or indirectly, in its becoming a component or

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otherwise affecting the characteristics of any food, including any substance intended for use in

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producing, manufacturing, packing, processing, preparing, treating, packaging, transporting or

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holding food; and including any source of radiation intended for any such use, if such substance

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is not generally recognized, among experts qualified by scientific training and experience to

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evaluate its safety, as having been adequately shown through scientific procedures or, in the case

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of a substance used in food prior to January 1, 1958, through either scientific procedures or

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experience based on common use in food, to be safe under the conditions of its intended use;

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except that such term does not include: (i) A pesticide chemical in or on a raw agricultural

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commodity; or (ii) A pesticide chemical to the extent that it is intended for use or is used in the

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production, storage or transportation of any raw agricultural commodity; or (iii) A color additive;

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or (iv) any substance used in accordance with a sanction or approval granted prior to June 12,

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1963, or the federal food, drug, and cosmetic act, the poultry products inspection act (21 U.S.C. §

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451 et seq.) or the meat inspection act of March 4, 1907, as amended.

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     (18) "Genetically engineered" or "genetic engineering" means a process whereby any

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food intended for human consumption: (i) Is produced from an organism or organisms in which

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the genetics are materially altered through the application of: (A) In vitro nucleic acid techniques,

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including recombinant DNA (deoxyribonucleic acid) techniques, the direct injection of nucleic

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acid into cells or organelles, encapsulation, gene deletion and doubling; or (B) Methods of fusing

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cells that do not fall within the same taxonomic family, that overcome natural physiological

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reproductive or recombinant barriers and that are not techniques used in traditional breeding and

 

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selection such as conjugation, transduction and hybridization; (ii) Is treated with a material

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described in subparagraph (A) of this subdivision, except manure that is used as a fertilizer for a

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raw agricultural commodity; or (iii) Contains an ingredient, component or substance described in

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subparagraph (i) of this subdivision.

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      (13) (19) (i) "Label" means a display of written, printed, or graphic matter upon the

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immediate container of any article; and a requirement made by or under authority of this chapter

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that any word, statement, or other information appearing on the label shall not be considered to be

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complied with unless the word, statement, or other information also appears on the outside

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container or wrapper, if any, of the retail package of the article, or is easily legible through the

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outside container or wrapper.

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      (ii) "Immediate container" does not include package liners.

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      (iii) "Labeling" means all labels and other written, printed, or graphic matter: (A) upon

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an article or any of its containers or wrappers, or (B) accompanying the article.

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      (iv) If an article is alleged to be misbranded because the labeling is misleading, or if an

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advertisement is alleged to be false because it is misleading, then in determining whether the

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labeling or advertisement is misleading there shall be taken into account (among other things) not

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only representations made or suggested by statement, word, design, device, sound, or in any

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combination of them, but also the extent to which the labeling or advertisement fails to reveal

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facts material in the light of the representations or material with respect to consequences which

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may result from the use of the article to which the labeling or advertisement relates under the

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conditions of use prescribed in the labeling or advertisement or under the conditions of use that

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are customary or usual.

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      (20) "Manufacturer" means a person who produces seed, stock or food and sells such

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item to a retailer or distributor.

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      (14) (21) "Native" means a product harvested in Rhode Island and is limited to the

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following:

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      (i) "Bay scallop" means Argopecten irradians.

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      (ii) "Bay quahog" means Mercenaria mercenaria.

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      (iii) "Steamer clams" means Mya arenaria.

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      (iv) "Mussels" means Mytilus edulis.

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      (v) "Oysters" means Crassostrea virginica.

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      (22) "Natural food" means food: (i) Which has not been treated with preservatives,

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antibiotics, synthetic additives, artificial flavoring or artificial coloring; (ii) Which has not been

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processed in a manner that makes such food significantly less nutritive; and (iii) Which has not

 

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been genetically engineered, as defined in § 21-31-2(18). Processing of food by extracting,

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purifying, heating, fermenting, concentrating, dehydrating, cooling or freezing shall not, of itself,

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prevent the designation of such food as "natural food".

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      (15) (23) "New drug" means: (i) any drug the composition of which is such that the drug

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is not generally recognized among experts qualified by scientific training and experience to

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evaluate the safety of drugs as safe for use under conditions prescribed, recommended, or

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suggested in the labeling of it; or (ii) any drug the composition of which is such that the drug, as a

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result of investigations to determine its safety for use under those conditions has become so

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recognized, but which has not, otherwise than in the investigations, been used to a material extent

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or for a material time under those conditions.

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      (16) (24) "Official compendium" means the official United States Pharmacopoeia,

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official Homeopathic Pharmacopoeia of the United States, official National Formulary, or any

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supplement to any of them.

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      (25) "Organically grown" means produced through organic farming methods, which

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involve a system of ecological soil management and mechanical or biological methods to control

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insects, weeds, pathogens and other pests and which rely on crop rotation, crop residues,

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composted animal manures, legumes, green manures, composted organic waste or mineral-

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bearing rocks and not genetically engineered, as defined in § 21-31-2(18).

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     (26) "Organism" means any biological entity capable of replication, reproduction or

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transferring genetic material.

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      (17) (27) "Patient" means, as the case may be: (i) the individual medically requiring a

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drug, for whom a drug is prescribed; or (ii) the owner or the agent of the owner of an animal

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medically requiring a drug, for which a drug is prescribed.

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      (18) (28) "Person" includes individual, partnership, corporation, and association.

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      (29) "Pesticide chemical" means any substance which, alone, in chemical combination or

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in formulation with one or more other substances is an "economic poison" within the meaning of

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the federal insecticide, fungicide and rodenticide act, 7 U.S.C. §§ 135-135k, and which is used in

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the production, storage or transportation of raw agricultural commodities.

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      (19) (30) "Pharmacist" means a person duly registered with the board of pharmacy as a

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compounder, dispenser, or supplier of drugs upon prescription, including registered assistant

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pharmacists as defined by law.

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      (20) (31) "Pharmacy" means a place where drugs, medicines, or poisons are sold at retail

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or where prescriptions of physicians, dentists, veterinarians, and other practitioners authorized to

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issue prescriptions for drugs, medicines, and poisons are compounded, dispensed, supplied or

 

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sold.

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      (21) (32) "Practitioner" means a person authorized by law to practice medicine, dentistry,

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osteopathy, chiropody, or veterinary medicine in this state.

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      (22) (33) "Prescription" means an order, issued in good faith in the course of

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professional practice only, by a practitioner to a pharmacist for a drug for a particular patient,

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which specifies the date of its issue, the name and address of the practitioner, the name and

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address of the patient (and, if the drug is prescribed for an animal, the species of the animal), the

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name and quantity of the drug prescribed, directions for the use of the drug, and the signature of

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the practitioner; provided, that a prescription received by word of mouth, telephone, or other

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means of communication shall be reduced promptly to writing by the pharmacist in the form

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prescribed in this subdivision, and the record so made shall constitute the original prescription to

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be filed and preserved by the pharmacist; and, provided, further, that any refill authorization

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received by word of mouth, telephone, or other means of communication shall be reduced

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promptly to writing by the pharmacist, with the date of it on the face or on the reverse side of the

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original prescription.

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      (34) "Processed food" means any food other than a raw agricultural commodity and

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includes any food produced from a raw agricultural commodity that has been processed through

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canning, smoking, pressing, cooking, freezing, dehydration, fermentation or milling.

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     (35) "Processing aid" means: (i) Any substance that is added to a food during the

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processing of such food but that is removed in some manner from the food before the food is

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packaged in a finished form; (ii) Any substance that is added to a food during processing, that is

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converted into constituents normally present in the food, and that does not significantly increase

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the amount of the constituents naturally found in the food; or (iii) Any substance that is added to a

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food for its technical or functional effect in the processing but that is present in the finished food

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at insignificant levels and that does not have any technical or functional effect in the finished

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food.

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      (36) "Raw agricultural commodity" means any food in its raw or natural state, including

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all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to

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marketing.

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     (37) "Retailer" means a person or entity that engages in the sale of food to a consumer.

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     (38) "Sale" means any and every sale and includes: (i) Manufacture, processing, packing,

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canning, bottling or any other production, preparation or putting up; (ii) Exposure, offer or any

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other proffer; (iii) Holding, storing or any other possessing; (iv) Dispensing, giving, delivering,

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serving or any other supplying; and (v) Applying, administering or any other using.

 

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      (23) (39) The representation of a drug, in its labeling or advertisement, as an antiseptic

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shall be considered to be a representation that it is a germicide, except in the case of a drug

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purporting to be, or represented as, an antiseptic for inhibitory use as a wet dressing, ointment,

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dusting powder, or any other use that involves prolonged contact with the body.

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      (24) (40) The provisions of this chapter regarding the selling of food, drugs, devices, or

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cosmetics shall be considered to include the manufacture, production, processing, packing,

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exposure, offer, possession, and holding of any article for sale, and the sale, dispensing, and

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giving of any article, and the supplying or applying of the articles in the conduct of any food,

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drug, or cosmetic establishment.

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

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misbranded:

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

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

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

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

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

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

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

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

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

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

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customary conditions of purchase and use.

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

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

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

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

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

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

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

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

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

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

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

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

 

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

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

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

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

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

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

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

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

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

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

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

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exempting the drug or device from those requirements.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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within a reasonable time to prescribe those requirements.

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

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

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

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duration prescribed, recommended, or suggested in its labeling.

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

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

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

 

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

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

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

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

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

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

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

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

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

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sale.

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

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

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

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

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

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

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

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the caution statement quoted in the preceding sentence.

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

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

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

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

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      (13) If it is genetically engineered, as defined in § 21-31-2, and does not bear labeling as

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required in accordance with § 21-31-25 unless: (i) It is a food produced without the producer's

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knowledge that a seed or other component of the food was genetically engineered; or (ii) It is a

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processed food, as defined in § 21-31-2, that are genetically engineered, as defined in § 21-31-25,

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provided such genetically engineered materials do not, in the aggregate, account for more than

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nine-tenths of one per cent (.09%) of the total weight of the processed food.

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

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

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

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

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

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

 

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

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

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

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

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

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judgment of the prescribing practitioner the brand name is medically necessary, the practitioner

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shall indicate "Brand name necessary" on the prescription. This exemption shall not apply to any

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drug dispensed in violation of paragraph (a)(11)(i) of this section.

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

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

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of the chosen product.

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

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multiple-source drugs.

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

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

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on the label.

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

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

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

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

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

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

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practitioners or pharmacists.

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

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

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

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     SECTION 2. Chapter 21-31 of the General Laws entitled "Rhode Island Food, Drugs,

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and Cosmetics Act" is hereby amended by adding thereto the following section:

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     21-31-25. Labeling of genetically engineered products. – (a) Any food, seed or seed

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stock offered or intended for retail sale in this state that is, or may have been, entirely or partially

31

genetically engineered, except a processed food in which one or more processing aids or enzymes

32

were produced or derived from genetic engineering, shall be labeled as follows: (1) In the case of

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food for retail sale contained in a package, by the manufacturer, distributor or retailer of the food,

34

with the clear and conspicuous words: "Produced with Genetic Engineering"; (2) In the case of

 

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food that is a raw agricultural commodity, on the package offered for retail sale or, in the case of

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any such commodity that is not separately packaged or labeled, on the retail store shelf or bin that

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holds such commodity displayed for sale, by the retailer, with the clear and conspicuous words

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"Produced with Genetic Engineering"; and (3) In the case of any seed or seed stock, on the

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container holding the seed or seed stock displayed for sale, the sales receipt, or any label

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identifying ownership or possession of the commodity, by the manufacturer or distributor, with

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the clear and conspicuous words: "Produced with Genetic Engineering".

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     (b) Notwithstanding any provision of law to the contrary contained in any general or

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public law, rule or regulation, the director of health may adopt regulations, pursuant to chapter 31

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of the general statutes, to implement and enforce the provisions of this section.

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     SECTION 3. This act shall take effect upon passage except the amendments to § 21-31-

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15, and the new § 21-31-25, which shall take effect on January 1, 2015.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD & DRUGS - RHODE ISLAND FOOD DRUGS & COSMETICS ACT

***

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     This act would update and refine the definition section in the statutes on food, drugs, and

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cosmetics, most notable a new definition for genetically engineered products. It would also set

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forth rules for labeling such products.

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     This act would take effect upon passage except the amendments to § 21-31-15, and the

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new § 21-31-25, which would take effect on January 1, 2015.

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