2006 -- S 2601

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LC01273

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STATE OF RHODE ISLAND

IN GENERAL ASSEMBLY

JANUARY SESSION, A.D. 2006

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A N A C T

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

ACT

     Introduced By: Senators Polisena, and Damiani

     Date Introduced: February 09, 2006

     Referred To: Senate Health & Human Services

It is enacted by the General Assembly as follows:

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

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Island Food, Drugs, and Cosmetics Act" is 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) "Contaminated with filth" applies to any food, drug, device, or cosmetic not securely

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

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foreign or injurious contaminations.

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

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

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beautifying, promoting attractiveness, or altering the appearance, and (ii) articles intended for use

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as a component of any articles described in this subdivision, except that this term shall not

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include soap.

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      (4) "Device" (except when used in subdivision (23) of this section and in sections 21-31-

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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) "Director" means the director of health.

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

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

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

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or suppository).

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

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

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

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

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

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

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

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

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

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

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United States Food and Drug Administration, or its successor agency, or the 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) "Federal Act" means the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. section

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301 et seq.

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

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

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      (13) (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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      (14) "Native" means a product harvested in Rhode Island and is limited to the 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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      (15) "New drug" means: (i) any drug the composition of which is such that the drug is

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

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

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

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

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

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material time under those conditions.

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

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

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supplement to any of them.

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

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

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requiring a drug, for which a drug is prescribed.

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

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

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

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

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

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

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

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

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

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

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

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

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

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Only a registered pharmacist may receive a prescription by word of mouth, telephone or other

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means of communication from a practitioner or prescriber and shall identify themselves to the

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practitioner or prescriber upon receipt of that prescription authorization.

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

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

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

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

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      (24) 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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     SECTION 2. Section 21-28-3.18 of the General Laws in Chapter 21-28 entitled "Uniform

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Controlled Substances Act" is hereby amended to read as follows:

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     21-28-3.18. Prescriptions. -- (a) An apothecary in good faith may sell and dispense

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controlled substances in schedule II to any person upon a written prescription by a practitioner

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licensed by law to prescribe or administer those substances, dated and signed by the person

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prescribing on the day when issued and bearing the full name and address of the patient to whom,

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or of the owner of the animal for which the substance is dispensed and the full name, address and

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registration number under the federal law of the person prescribing, if he or she is required by that

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law to be registered. If the prescription is for an animal, it shall state the species of the animal for

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which the substance is prescribed.

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      (b) The apothecary filling the prescription shall sign his or her full name and shall write

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the date of filling on the face of the prescription.

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      (c) The prescription shall be retained on file by the proprietor of the pharmacy in which

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it was filled for a period of two (2) years so as to be readily accessible for inspection by any

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public officer or employee engaged in the enforcement of this chapter.

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      (d) (1) Prescriptions for controlled substances in schedule II shall be filed separately and

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shall not be refilled. The form of record for prescription slips for controlled substances in

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schedule II shall consist of two (2) parts, an original and a duplicate which are required to be

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presented to the pharmacy by the ultimate user or his or her representative. Pharmacies

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dispensing controlled substances in schedule II are required to deliver to the director of health all

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duplicate copies of the prescriptions on or before the fifth day of the month following the date of

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dispensing. The prescription slip shall be a form provided by the director of health.

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      (2) The director of health may, after appropriate notice and hearing pursuant to section

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42-35-3, promulgate rules and regulations for the purpose of adopting a system for electronic data

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transmission of prescriptions for controlled substances in schedule II and III, and needles and

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syringes. This system, when operational, shall negate the necessity to utilize the two-part

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prescription described in subdivision (1) of this subsection.

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      (e) A prescription for a schedule II narcotic substance to be compounded for the direct

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administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal

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infusion may be transmitted by the practitioner or practitioner's agent to the pharmacy by

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facsimile. The facsimile will serve as the original prescription.

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      (f) A prescription written for a schedule II substance for a resident of a long term care

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facility may be transmitted by the practitioner or the practitioner's agent to the dispensing

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pharmacy by facsimile. The facsimile serves as the original prescription.

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      (g) A prescription for a schedule II narcotic substance for a patient residing in a hospice

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certified by Medicare under title XVIII of the Social Security Act, 42 U.S.C. section 1395 et seq.,

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or licensed by the state, may be transmitted by the practitioner or practitioner's agent to the

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dispensing pharmacy by facsimile. The practitioner or the practitioner's agent will note on the

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prescription that the patient is a hospice patient. The facsimile serves as the original written

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prescription.

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      (h)(1) An apothecary, in lieu of a written prescription, may sell and dispense controlled

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substances in schedules III, IV, and V to any person upon an oral prescription of a practitioner. In

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issuing an oral prescription the prescriber shall furnish the apothecary with the same information

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as is required by subsection (a) of this section in the case of a written prescription for controlled

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substances in schedule II, except for the written signature of the person prescribing, and the

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apothecary who fills the prescription, shall immediately reduce the oral prescription to writing

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and shall inscribe the information on the written record of the prescription made. This record shall

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be filed and preserved by the proprietor of the pharmacy in which it is filled in accordance with

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the provisions of subsection (c) of this section. In no case may a prescription for a controlled

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substance listed in schedules III, IV, or V be filled or refilled more than six (6) months after the

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date on which the prescription was issued and no prescription shall be authorized to be refilled

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more than five (5) times. Each refilling shall be entered on the face or back of the prescription

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and note the date and amount of controlled substance dispensed, and the initials or identity of the

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dispensing apothecary.

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     (2) Only a registered pharmacist may receive an oral prescription from a practitioner or

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prescriber and shall identify themselves to the practitioner or prescriber upon receipt of the oral

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authorization.

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      (i) In the case of an emergency situation as defined in federal law, an apothecary may

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dispense a controlled substance listed in schedule II upon receiving an oral authorization of a

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prescribing practitioner provided that:

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      (1) The quantity prescribed and dispensed is limited to the amount adequate to treat the

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patient during the emergency period and dispensing beyond the emergency period must be

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pursuant to a written prescription signed by the prescribing practitioner.

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      (2) The prescription shall be immediately reduced to writing and shall contain all the

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information required in subsection (a) of this section.

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      (3) The prescription must be dispensed in good faith in the normal course of professional

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practice.

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      (4) Within seven (7) days after authorizing an emergency oral prescription, the

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prescribing practitioner shall cause a written prescription for the emergency quantity prescribed to

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be delivered to the dispensing apothecary. The prescription shall have written on its face

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"Authorization for emergency dispensing" and the date of the oral order. The written prescription

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upon receipt by the apothecary shall be attached to the oral emergency prescription which had

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earlier been reduced to writing.

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     (5) Only a registered pharmacist may receive an emergency oral prescription of a

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controlled substance listed in Schedule II and pursuant to this subsection, and shall identify

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themselves to the practitioner or prescriber upon receipt of the oral authorization.

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      (j) (1) The partial filling of a prescription for a controlled substance listed in schedule II

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is permissible, if the apothecary is unable to supply the full quantity called for in a written

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prescription or emergency oral prescription and he or she makes a notation of the quantity

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supplied on the face of the written prescription or oral emergency prescription which has been

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reduced to writing. The remaining portion of the prescription may be filled within seventy-two

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(72) hours of the first partial filling, however, if the remaining portion is not, or cannot be filled

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within seventy-two (72) hours, the apothecary shall notify the prescribing practitioner. No further

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quantity may be supplied beyond seventy-two (72) hours without a new prescription.

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      (2) (i) A prescription for a schedule II controlled substance written for a patient in a long

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term care facility (LTCF), or for a patient with a medical diagnosis documenting a terminal

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illness, may be filled in partial quantities to include individual dosage units. If there is a question

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whether a patient may be classified as having a terminal illness, the pharmacist must contact the

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practitioner prior to partially filling the prescription. Both the pharmacist and the prescribing

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practitioner have a corresponding responsibility to assure that the controlled substance is for a

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terminally ill patient.

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      (ii) The pharmacist must record on the prescription whether the patient is "terminally ill"

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or an "LTCF patient." A prescription that is partially filled, and does not contain the notation

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"terminally ill" or "LTCF patient", shall be deemed to have been filled in violation of this chapter.

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      (iii) For each partial filling, the dispensing pharmacist shall record on the back of the

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prescription (or on another appropriate record, uniformly maintained, and readily retrievable),

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the:

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      (A) Date of the partial filling;

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      (B) Quantity dispensed;

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      (C) Remaining quantity authorized to be dispensed; and

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      (D) Identification of the dispensing pharmacist.

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      (iv) The total quantity of schedule II controlled substances dispensed in all partial fillings

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must not exceed the total quantity prescribed.

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      (v) Schedule II prescriptions for patients in a LTCF, or patients with a medical diagnosis

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documenting a terminal illness, are valid for a period not to exceed sixty (60) days from the issue

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date, unless sooner terminated by the discontinuance of medication.

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      (k) Automated data processing systems. - As an alternative to the prescription record

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keeping provision of subsection (h) of this section, an automated data processing system may be

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employed for the record keeping system, if the following conditions have been met:

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      (1) The system shall have the capability of producing sight-readable documents of all

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original and refilled prescription information. The term "sight-readable" means that an authorized

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agent shall be able to examine the record and read the information. During the course of an on-

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site inspection, the record may be read from the CRT, microfiche, microfilm, printout, or other

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method acceptable to the director. In the case of administrative proceedings, records must be

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provided in a paper printout form.

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      (2) The information shall include, but not be limited to, the prescription requirements

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and records of dispensing as indicated in subsection (h) of this section.

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      (3) The individual pharmacist responsible for completeness and accuracy of the entries

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to the system must provide documentation of the fact that prescription information entered into

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the computer is correct. In documenting this information, the pharmacy shall have the option to

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either:

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      (i) Maintain a bound log book, or separate file, in which each individual pharmacist

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involved in the dispensing shall sign a statement each day, attesting to the fact that the

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prescription information entered into the computer that day has been reviewed and is correct as

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shown. The book or file must be maintained at the pharmacy employing that system for a period

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of at least two (2) years after the date of last dispensing; or

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      (ii) Provide a printout of each day's prescription information. That printout shall be

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verified, dated, and signed by the individual pharmacist verifying that the information indicated is

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correct. The printout must be maintained at least two (2) years from the date of last dispensing.

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      (4) An auxiliary record keeping system shall be established for the documentation of

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refills, if the automated data processing system is inoperative for any reason. The auxiliary

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system shall ensure that all refills are authorized by the original prescription, and that the

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maximum number of refills is not exceeded. When this automated data processing system is

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restored to operation, the information regarding prescriptions filled and refilled during the

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inoperative period, shall be entered into the automated data processing system within ninety-six

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(96) hours.

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      (5) Any pharmacy using an automated data processing system must comply with all

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applicable state and federal laws and regulations.

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      (6) A pharmacy shall make arrangements with the supplier of data processing services or

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materials to ensure that the pharmacy continues to have adequate and complete prescription and

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dispensing records if the relationship with the supplier terminates for any reason. A pharmacy

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shall ensure continuity in the maintenance of records.

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      (7) The automated data processing system shall contain adequate safeguards for security

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of the records, to maintain the confidentiality and accuracy of the prescription information.

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Safeguards against unauthorized changes in data after the information has been entered and

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verified by the registered pharmacist shall be provided by the system.

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      (l) Prescriptions for controlled substances as found in schedules II, except those listed in

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subsection (n) of this section, III and IV of section 21-28-2.08 will become void unless dispensed

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within thirty (30) days of the original date of the prescription. The prescriptions in schedules III,

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IV, and V cannot be written for more than one hundred (100) dosage units and not more than one

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hundred (100) dosage units may be dispensed at one time. For purposes of this section, a "dosage

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unit" shall be defined as a single capsule, tablet or suppository, or not more than one teaspoon of

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an oral liquid.

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      (m) Prescriptions for controlled substances as found in schedule II, except those listed in

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subsection (n) below, may be written for up to a thirty (30) day supply, with a maximum of two

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hundred and fifty (250) dosage units, as determined by the prescriber's directions for use of the

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medication. In no event shall more than a thirty (30) days' supply, up to a maximum of two

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hundred and fifty (250) dosage units, be dispensed at one time.

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      (n) Prescriptions written for amphetamine sulfate, dextro amphetamine sulfate,

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methamphetamine hydrochloride, methylphenidate and amphetamine mixtures, may be written

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for up to a sixty (60) day supply with a maximum of two hundred fifty (250) dosage units, as

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determined by the prescriber's directions for use of the medication. In no event shall more than a

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sixty (60) day supply, up to a maximum of two hundred fifty (250) dosage units, be dispensed at

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one time.

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     SECTION 3. This act shall take effect upon passage.

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LC01273

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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 that the receipt of an oral prescription by a pharmacy be taken

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only by a registered pharmacist.

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     This act would take effect upon passage.

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LC01273

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