2017 -- H 5905

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LC002108

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     STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2017

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A N   A C T

RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND

COSMETICS ACT

     Introduced By: Representatives Tobon, Cunha, Shanley, Barros, and Maldonado

     Date Introduced: March 10, 2017

     Referred To: House Health, Education & Welfare

     It is enacted by the General Assembly as follows:

     SECTION 1. Section 21-31-2 of the General Laws in Chapter 21-31 entitled "Rhode

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

     21-31-2. Definitions.

     For the purpose of this chapter:

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

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

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

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

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

foreign or injurious contaminations.

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

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

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

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

this term shall not include soap.

     (4) "Device" (except when used in subdivision (23) of this section and in §§ 21-31-3(10),

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

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

mitigation, treatment, or prevention of disease in humans or other animals; or (ii) to affect the

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

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

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

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

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

consumption or use.

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

or suppository).

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

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

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

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

intended to affect the structure or any function of the body of humans or other animals; and (iv)

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

this subdivision; but does not include devices or their components, parts, or accessories.

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

ingredients along with other substances included during the manufacturing process.

     (10) (i) "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 department of health.

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

     (11) "Federal Act" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et

seq.

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

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

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

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

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

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

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

outside container or wrapper.

     (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 an

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

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

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

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

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

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

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

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

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

are customary or usual.

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

     (i) "Bay scallop" means Argopecten irradians.

     (ii) "Bay quahog" means Mercenaria mercenaria.

     (iii) "Steamer clams" means Mya arenaria.

     (iv) "Mussels" means Mytilus edulis.

     (v) "Oysters" means Crassostrea virginica.

     (15) "New drug" means: (i) any drug the composition of which is such that the drug is not

generally recognized among experts qualified by scientific training and experience to evaluate the

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

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

investigations to determine its safety for use under those conditions has become so recognized,

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

material time under those conditions.

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

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

supplement to any of them.

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

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

requiring a drug, for which a drug is prescribed.

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

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

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

pharmacists as defined by law.

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

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

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

sold.

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

osteopathy, chiropody, or veterinary medicine in this state.

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

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

the date of its issue, the name and address of the practitioner, the name and address of the patient

(and, if the drug is prescribed for an animal, the species of the animal), the name and quantity of

the drug prescribed, directions for the use of the drug, and the signature of the practitioner;

provided, that a prescription received by word of mouth, telephone, or other means of

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

this subdivision, and the record so made shall constitute the original prescription to be filed and

preserved by the pharmacist; and, provided, further, that any refill authorization received by word

of mouth, telephone, or other means of communication shall be reduced promptly to writing by

the pharmacist, with the date of it on the face or on the reverse side of the original prescription.

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

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

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

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

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

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

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

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

drug, or cosmetic establishment.

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

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

     21-31-18.1. Cosmetic ingredient disclosure.

     (a) The manufacturer of any cosmetic product manufactured, distributed, or offered for

retail or sale in this state shall disclose to the department of health a list of the fragrance

ingredients in the product. The manufacturer shall include the chemical abstract service (CAS)

number of each ingredient on the list provided to the department.

     (b) The department of health shall disclose on a searchable website information received

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pursuant to this act.

     (c) The ingredients shall be listed in descending order of predominance, except that an

ingredient present in a product at a concentration of one percent (1%) or less may be listed

without respect to the order of predominance after the list of ingredients present at concentrations

of more than one percent (1%).

     (d) If any person violates any provision of this section, or any regulation adopted

pursuant to this section, the director shall assess a fine of not less than ten thousand dollars

($10,000) per violation. If such violation is not corrected within six (6) months of the initial

violation, the manufacturer shall be fined not less than twenty-five thousand dollars ($25,000).

     SECTION 3. This act shall take effect on January 1, 2018.

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EXPLANATION

BY THE LEGISLATIVE COUNCIL

OF

A N   A C T

RELATING TO FOOD AND DRUGS -- RHODE ISLAND FOOD, DRUGS, AND

COSMETICS ACT

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     This act would require manufacturers to fully disclose to the department of health all

ingredients contained in their cosmetic products manufactured, distributed or sold in the state, and

would further subject a manufacturer to financial penalties for a violation of this requirement.

     This act would take effect on January 1, 2018.

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