§328-15  Drugs or devices deemed misbrandedwhen; prescriptions excepted, when.  A drug or device shall be deemed to bemisbranded:

(1)  If its labeling is false or misleading in anyparticular, or if its labeling or packaging fails to conform with the requirementsof section 328-19.1.

(2)  If in package form, unless it bears a labelcontaining:

(A)  The name and place of business of themanufacturer, packer, or distributor; and

(B)  An accurate statement of the quantity ofthe contents in terms of weight, measure, or numerical count, which statementshall be separately and accurately stated in a uniform location upon theprincipal display panel of the label, provided that under this subparagraphreasonable variations shall be permitted, and exemptions as to small packagesshall be allowed, in accordance with rules adopted by the director.  Anaccurate statement of the quantity of the contents in terms of weight, measure,or numerical count shall not be required for any commodity subject to packagingand labeling requirements imposed by the Secretary of Agriculture pursuant tothe Federal Insecticide, Fungicide, and Rodenticide Act or the provisions ofthe eighth paragraph under the heading "Bureau of Animal Industry" ofthe Act of March 4, 1913 (37 Stat. 832-833; 21 U.S.C. §§151-158), commonlyknown as the Virus-Serum-Toxin Act.

(3)  If any word, statement, or other informationrequired by or under authority of this part to appear on the label or labelingis not prominently placed thereon with such conspicuousness (as compared withother words, statements, designs, or devices, in the labeling) and in suchterms as to render it likely to be read and understood by the ordinaryindividual under customary conditions of purchase and use.

(4)  If it is for use by a person and contains anyquantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid,beta-eucaine, bromal, cannabis, cabromal, chloral, coca, cocaine, codeine,heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulphomethane, orany chemical derivative of such substance, which derivative, afterinvestigation, has been found to be and designated as habit forming, by rulesadopted by the director under this part, or by regulations issued pursuant tosection 502(d) of the Federal Act, unless its label bears the name and quantityor proportion of the substance or derivative and in juxtaposition therewith thestatement "Warning--May be habit forming."

(5)  (A)  If it is a drug unless:

(i)  Its label bears, to the exclusion of anyother nonproprietary name (except the applicable systematic chemical name orthe chemical formula), the established name, as defined in subparagraph (B), ofthe drug, if such there be; and in case it is fabricated from two or moreingredients, the established name and quantity of each active ingredient,including the kind and quantity or proportion of any alcohol, and alsoincluding, whether active or not, the established name and quantity orproportion of any bromides, ether, chloroform, acetanilid, acetophenetidin,amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis,glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or anyderivative or preparation of any such substances, contained therein; providedthat the requirement for stating the quantity of the active ingredients, otherthan the quantity of these specifically named in this paragraph, shall applyonly to prescription drugs; and

(ii)  For any prescription drug the establishedname of such drug or ingredient, as the case may be, on such label (and on anylabeling on which a name for such drug or ingredient is used) is printedprominently and in type at least half as large as that used thereon for anyproprietary name or designation for such drug or ingredient; provided furtherthat to the extent that compliance with the requirements of this subparagraphis impracticable, exemptions shall be allowed under rules adopted by thedirector.

(B)  As used in this paragraph, the term"established name", with respect to a drug or ingredient thereof,means:

(i)  The applicable official name designatedpursuant to section 508 of the Federal Act;

(ii)  If there is no such name and the drug, orthe ingredient, is an article recognized in an official compendium, then theofficial title thereof in the compendium; or

(iii)  If neither clause (i) nor clause (ii) ofthis subparagraph applies, then the common or usual name, if any, of such drugor of the ingredient;

provided further that where clause (ii) of thissubparagraph applies to an article recognized in the United StatesPharmacopoeia, in the United States Pharmacopoeia Dispensing Information, andin the Homeopathic Pharmacopoeia under different official titles, the officialtitle used in the United States Pharmacopoeia shall apply unless it is labeledand offered for sale as a homeopathic drug, in which case the official titleused in the Homeopathic Pharmacopoeia shall apply.

(6)  Unless its labeling bears:

(A)  Adequate directions for use; and

(B)  Such adequate warnings against use inthose pathological conditions or by children where its use may be dangerous tohealth, or against unsafe dosage or methods or duration of administration orapplication, in such manner and form, as are necessary for the protection ofusers; provided that where any requirement of subparagraph (A), as applied toany drug or device, is not necessary for the protection of the public health,the director shall adopt rules exempting the drug or device from suchrequirements; provided further that articles exempted under regulations issuedunder section 502(f) of the Federal Act may also be exempt.

(7)  If it purports to be a drug the name of which isrecognized in an official compendium, unless it is packaged and labeled asprescribed therein; provided that the method of packaging may be modified withthe consent of the director, or if consent is obtained under the Federal Act. Whenever a drug is recognized in both the United States Pharmacopoeia and theHomeopathic Pharmacopoeia of the United States, it shall be subject to therequirements of the United States Pharmacopoeia with respect to the packagingand labeling unless it is labeled and offered for sale as a homeopathic drug,in which case it shall be subject to the Homeopathic Pharmacopoeia of theUnited States and not to the United States Pharmacopoeia; provided that in theevent of inconsistency between the requirements of this paragraph and those ofparagraph (5) as to the name by which the drug or its ingredients shall bedesignated, the requirements of paragraph (5) shall prevail.

(8)  If it has been found by the director to be a drugliable to deterioration, unless it is packaged in such form and manner, and itslabel bears a statement of such precautions, as the rules adopted by the directoror regulations issued under the Federal Act require as necessary for theprotection of public health.  No such rule shall be established for any drugrecognized in an official compendium until the director shall have informed theappropriate body charged with the revision of the compendium of the need forsuch packaging or labeling requirements and such body shall have failed withina reasonable time to prescribe such requirements.

(9)  (A)  If it is a drug and its container is somade, formed, or filled as to be misleading;

(B)  If it is an imitation of another drug; or

(C)  If it is offered for sale under the nameof another drug.

(10)  If it is dangerous to health when used in thedosage, or with the frequency or duration prescribed, recommended, or suggestedin the labeling thereof.

(11)  If it is, purports to be, or is represented as adrug composed wholly or partly of insulin, unless:

(A)  It is from a batch with respect to which acertificate or release has been issued pursuant to section 506 of the FederalAct; and

(B)  The certificate or release is in effectwith respect to the drug.

(12)  If it is, purports to be, or is represented as adrug composed wholly or partly of any kind of penicillin, streptomycin,chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug,or any derivative thereof, unless:

(A)  It is from a batch with respect to which acertificate or release has been issued pursuant to section 507 of the FederalAct; and

(B)  The certificate or release is in effectwith respect to the drug; provided that this paragraph shall not apply to anydrug or class of drugs exempted by regulations promulgated under section 507(c)or (d) of the Federal Act.

For the purpose of this paragraph, the term"antibiotic drug" means any drug intended for use by a personcontaining any quantity of any chemical substance which is produced by amicroorganism and which has the capacity to inhibit or destroy microorganismsin dilute solution (including the chemically synthesized equivalent of any suchsubstance).

(13)  If it is a color additive, the intended use ofwhich in or on drugs is for the purpose of coloring only, unless its packagingand labeling are in conformity with the packaging and labeling requirementsapplicable to such color additive prescribed under section 328-13(b).

(14)  In the case of any prescription drug distributedor offered for sale in this State, unless the manufacturer, packer, ordistributor thereof includes in all advertisements and other descriptiveprinted matter issued or caused to be issued by the manufacturer, packer, ordistributor with respect to that drug a true statement of:

(A)  The established name, as defined inparagraph (5)(B), printed prominently and in type at least half as large asthat used for any trade or brand name thereof;

(B)  The formula showing quantitatively eachingredient of the drug to the extent required for labels under section 502(e)of the Federal Act; and

(C)  Such other information in brief summaryrelating to side effects, contra-indications, and effectiveness as shall berequired in rules adopted by the director.

(15)  If a trademark, trade name, or other identifyingmark, imprint, or device of another or any likeness of the foregoing has beenplaced thereon or upon its container with intent to defraud.

(16)  Drugs and devices which are, in accordance withthe practice of the trade, to be processed, labeled, or repacked in substantialquantities at establishments other than those where originally processed orpacked shall be exempt from any labeling or packaging requirements of thispart; provided that such drugs and devices are being delivered, manufactured,processed, labeled, repacked, or otherwise held in compliance with rulesadopted by the director.

(17)  If it has met or exceeded the expiration date established by the manufacturer or principal labeler. [L 1941, c 318, §11; RL1945, §2215; RL 1955, §51-15; am L Sp 1959 2d, c 1, §19; am L 1963, c 36, §1;am L 1964, c 15, §§2, 3; am L 1967, c 152, §9; HRS §328-15; am L 1972, c 151,§8; gen ch 1993; am L 1997, c 214, §3]