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ES133
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It is enacted by the General Assembly as follows

SECTION 1. Section 5-19-38 of the General Laws in Chapter 5-19 entitled "Pharmacy" is hereby amended to read as follows:

5-19-38. Pharmacists -- Substitution of drugs. -- Pharmacists when dispensing a prescription shall, unless requested otherwise by the purchaser in writing, substitute drugs containing the same active chemical ingredients of the same strength, quantity, and dosage form as that drug requested by the prescriber from approved prescription drug products in accordance with the provisions of section 21-31-16 {ADD and section 21-31-16.1, ADD} of the general laws of Rhode Island, 1956, as amended, unless ordered by the prescribing physician to dispense as written on the prescription form, or if the prescriber gives oral direction to that effect to the dispensing pharmacist. The requirements of this section shall not apply to an order to dispense a drug for immediate administration to a hospital in-patient. The pharmacist will make a product selection from approved prescription drug products and shall pass the savings on to the ultimate consumer, exclusive of the pharmacist's professional fee. The pharmacist may not charge a higher or different professional fee for the prescription drug product dispensed than that charged for the prescription drug product prescribed. When a drug product selection is made, the pharmacist shall indicate the product dispensed on the written prescription, or on the oral prescription, which has been reduced to writing.

SECTION 2. Sections 21-31-2 and 21-31-16.1 of the General Laws in Chapter 21-31 entitled "Rhode Island Food, Drugs, and Cosmetics Act" are hereby amended to read as follows:

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

(a) The term "director" means the director of health of the state of Rhode Island.

(b) The term "person" includes individual, partnership, corporation, and association.

(c) The term "food" means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article.

(d) The term "drug" means (1) 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; and (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of humans or other animals; and (4) articles intended for use as a component of any article specified in clause (1), (2), or (3); but does not include devices or their components, parts, or accessories.

(e) The term "device" (except when used in subdivision (k) of this section and in sections 21-31-3 (j), 21-31-11 (f), 21-31-15 (c), and 21-31-18 (c)) means instruments, apparatus, and contrivances, including their components, parts, and accessories, intended (1) for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or other animals; or (2) to affect the structure or any function of the body of humans or other animals.

(f) The term "cosmetics" means (1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles, except that this term shall not include soap.

(g) The term "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.

(h)(1) The term "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 appear 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 there be, of the retail package of the article, or is easily legible through the outside container or wrapper.

(2) The term "immediate container" does not include package liners.

(3) The term "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.

(i) 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 thereof, but also the extent to which the labeling or advertisement fails to reveal facts material in the light of such 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 thereof or under such conditions of use as are customary or usual.

(j) The term "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.

(k) 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 such other use as involves prolonged contact with the body.

(1) The term "new drug" means (1) 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 thereof; or (2) any drug the composition of which is such that the drug, as a result of investigations to determine its safety for use under such conditions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions.

(m) The term "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.

(n) 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 such article for sale, and the sale, dispensing, and giving of any such article, and the supplying or applying of any such articles in the conduct of any food, drug, or cosmetic establishment.

(o) The term "federal act" means the Federal Food, Drug and Cosmetic Act ›section 21 U.S.C.! 301 et seq.;›52 stat. 1040 et seq.!.

(p) The term "patient" means, as the case may be, (1) the individual medically requiring a drug, for whom a drug is prescribed; or (2) the owner or the agent of the owner of an animal medically requiring a drug, for which a drug is prescribed.

(q) The term "practitioner" means a person authorized by law to practice medicine, dentistry, osteopathy, chiropody, or veterinary medicine in this state.

(r) The term "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.

(s) The term "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, telegraph, or other means of communication shall be reduced promptly to writing by the pharmacist in the form prescribed in this subsection, 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, telegraph, or other means of communication shall be reduced promptly to writing by the pharmacist, with the date thereof, on the face or on the reverse side of the original prescription.

(t) A "pharmacy" shall be considered to mean 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.

(u) "Distressed merchandise" shall mean 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.

(v) The term "dosage form" means the form of the completed drug product (such as tablet, syrup, or suppository).

(w) The term "drug product" means a dosage form containing one or more active therapeutic ingredients along with other substances included during the manufacturing process.

(x)(1) The term "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, {ADD which are designated in the U.S. Department of Health and Human Services' publication entitled, "Approved Drug Products with Therapeutic Equivalence Evaluations", and that carry an "A" rating in that publication, or are otherwise listed in this subsection, ADD} and not found in violation of the requirements of the United States food and drug administration, or its successor agency, or the Rhode Island department of health.

{ADD The term "equivalent and interchangeable" shall also mean those drugs listed herein, but only in the drug dosage form and strengths set forth below, and which drugs are not found in violation of the requirements of the United States Food and Drug Administration, or its successor agency, or the Rhode Island department of health. ADD}

{ADD DRUG	DOSAGE FORM(S)	STRENGTH(S)
Multi-Vitamin with Fluoride	Tablet	.5mg, 1mg
Levothyroxine Sodium	Tablet	25mcg,50mcg,75mcg
		88mcg,100mcg,112mcg
		125mcg,137mcg,150mcg
		175mcg,200mcg,300mcg
Multi-Vitamin with Fluoride	Drop	.25mg, .5mg
Tri-Vitamin with Fluoride	Drop	.25mg, .5mg
Phenylephrine Tannate	Suspension	2mg,5mg,12.5mg/5ml
Chlorpheniramine Tannate
Pyrilamine Tannate
Dextromethorphan HBr	Syrup	10mg,12.5mg,2mg/5ml
Phenylpropanolamine HCI
Brompheniramine Maleate
Guaifenesin	Tablet	600mg, 60mg
Pseudoephedrine HCI
Guaifenesin	Tablet Sustained	600mg, 120mg
Pseudoephedrine HCI	Release
Guaifenesin	Tablet Sustained	600mg
	Release
Guaifenesin	Tablet	600mg, 30mg
Dextromethorphan HBr
Guaifenesin	Tablet Sustained	400mg, 75mg
Phenylpropanolamine	Release
Carbinoxamine Maleate	Drops	2mg,25mg,4mg/ml
Pseudoephedrine HCI
Dextromethorphan HBr
Carbinoxamine Maleate	Syrup	4mg,60mg,15mg/5ml
Pseudoephedrine HCI
Dextromethorphan HBr
Hyoscyamine	Tablet	.125mg
Yohimbine	Tablet	5.4mg
Sodium Fluoride	Tablet	0.55mg,1.1mg,2.2mg(NAF)
Sodium Fluoride	Drops	.125mg(f)/drop
Sodium Fluoride	Chewable Tablets	0.55mg,1.1mg,2.2mg(NAF) ADD}

(2) The term "generic" means the chemical or established name of such drug or drug product.

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

(1) "Bay scallop" means {ADD Argopecten Irradians. ADD}

(2) "Bay quahog" means {ADD Mercenaria mercenaria. ADD}

(3) "Steamer clams" means {ADD Mya arenaria. ADD}

(4) "Mussels" means {ADD Mytilus edulis. ADD}

(5) "Oysters" means {ADD Crassostrea virginica. ADD}

{ADD 21-31-16.1. Substitution of generic drugs. -- ADD} (a) {ADD Product selection. ADD} The director shall permit substitution of less expensive generic, chemical, or brand name drugs and pharmaceuticals considered by the director as therapeutically equivalent and interchangeable with specific brand name drugs and pharmaceuticals, {DEL if they are found to be in compliance with section 21-31-16 and standards set forth by the United States food and drug administration under sections 505 and 507 of the Federal Food, Drug, and Cosmetic Act ›21 U.S.C.section 355,357! . The director shall consider, but not be limited to, the determination of the United States Food and Drug Administration, or its successor agency, as published under sections 505 and 507 of the Federal Food, Drug, and Cosmetic Act. The director shall provide for the distribution of copies of lists of prescription drug products that the director deems after evaluation not to be therapeutically equivalent, and revisions to the among physicians and pharmacists licensed and actively engaged in practice within the state, and other appropriate individuals, and shall supply a copy to any person on request. The list shall be revised from time to time so as to include new pertinent information on approved prescription drug products, reflecting current information as to standards for quality, safety, effectiveness, and therapeutic equivalence. DEL} {ADD which are designated in the U.S. Department of Health and Human Services' publication entitled, "Approved Drug Products with Therapeutic Equivalence Evaluations", and that carry an "A" rating in that publication, as amended from time to time and/or as are otherwise listed in subsection 21-31-2(x)(1). The director shall permit no substitutions except as designated. ADD}

{DEL (b) Appropriations. The director shall provide necessary space, personnel, and material to carry out the provisions of this section.

(c) DEL} {ADD (b) ADD} Liability. There shall be no civil liability incurred and no cause of action of any nature shall arise against the director, designated agents, or employees, as a result of the listing or omission of drugs or pharmaceuticals for product selection.

{DEL (d) Annual reports. The director shall make annual reports to the general assembly by February 10 of each year showing a list of approved prescription drug products with therapeutic equivalence, and an estimate of the average savings to the general public.

(e) DEL} {ADD (c) ADD} Pharmacists. When a pharmacist dispenses a therapeutically equivalent drug product, there shall be no additional liability imposed on the prescriber who authorizes that product selection, or on the pharmacist dispensing the product selection from a physician's oral or written order.

{DEL (f) DEL} {ADD (d) ADD} Enforcement provisions. It is hereby made the duty of the department of health, its agents so designated by the director of health, and of all peace officers within the state to enforce all provisions of this section and of sections 5-19-38, 5-37-18--5-37-18.2, and 21-31-3.

SECTION 3. This act shall take effect upon passage.
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This act directs the director of the Health Department to refer pharmacists to consult the U.S. Department of Health publication regarding drug equivalencies when substituting generic drugs for brand name drugs. The act also lists certain other drugs for which generic substitutions may be made.

This act would take effect upon passage.

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