2006 Code of Virginia § 54.1-3462 - Misbranded drug or device

54.1-3462. Misbranded drug or device.

A drug or device shall be deemed to be misbranded:

1. If its labeling is false or misleading in any particular.

2. If its package does not bear a label containing the name and place ofbusiness of the manufacturer, packer, or distributor. However, allprescription drugs intended for human use and devices shall bear a labelcontaining the name and place of business of the manufacturer of the finaldosage form of the drug and, if different, the name and place of business ofthe packer or distributor and an accurate statement of the quantity of thecontents in terms of weight, measure, or numerical count. Reasonablevariations shall be permitted, and exemptions for small packages shall beallowed in accordance with regulations of the Board.

3. If any word, statement, or other information required by or underauthority of this chapter to appear on the label or labeling is notprominently placed with such conspicuousness, as compared with other words,statements, designs or devices, in the labeling, and in such terms as torender it likely to be read and understood by the ordinary individual undercustomary conditions of purchase and use.

4. If it is for use by man and contains any quantity of the narcotic orhypnotic substances alpha-eucaine, barbituric acid, beta-eucaine, bromal,carbromal, chloral, coca, cocaine, codeine, morphine, opium, paraldehyde, orsulfonmethane, or any chemical derivative of such substances, whichderivative, after investigation has been found to be and designated as, habitforming, by regulations issued by the Board under this chapter, unless itslabel bears the name and quantity or proportion of such substance orderivative and in juxtaposition therewith the statement "Warning - May BeHabit Forming."

5. If it is a drug, unless its label bears, to the exclusion of any othernonproprietary name, except the applicable systematic chemical name or thechemical formula, the established name of the drug, and in case it isfabricated from two or more ingredients, the established name and quantity ofeach active ingredient, including the kind and quantity or proportion of anyalcohol, and the established name and quantity or proportion of any bromides,ether, chloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine,atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides,mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative orpreparation of any such substances. However, the requirement for stating thequantity of the active ingredients, other than the quantity of thosespecifically named in this subdivision, shall apply only to prescriptiondrugs. Any prescription drug shall have the established name of the drug oringredient printed on its label prominently and in type at least half aslarge as that used for any proprietary name or designation for such drug oringredient. Exemptions may be allowed under regulations of the Board.

As used in this subdivision, the term "established name," with respect toa drug or ingredient, means the applicable official name designated pursuantto 508 of the federal act, or if there is no such name and such drug, orsuch ingredient, is an article recognized in an official compendium, then theofficial title in such compendium or if neither exists, then the common orusual name, if any, of such drug or of such ingredient. Whenever, an articleis recognized in the United States Pharmacopoeia National Formulary and inthe Homeopathic Pharmacopoeia under different official titles, the officialtitle used in the United States Pharmacopoeia National Formulary shall applyunless it is labeled and offered for sale as a homeopathic drug, in whichcase the official title used in the Homeopathic Pharmacopoeia shall apply.

6. Unless its labeling bears adequate directions for use and such adequatewarnings against use in those pathological conditions or by children whereits use may be dangerous to health, or against unsafe dosage or methods orduration of administration or application, in such manner and form, as arenecessary for the protection of users. The Board shall promulgate regulationsexempting such drug or device from such requirements when these requirementsare not necessary to protect the public health and the articles are alsoexempted under regulations issued under 502(f) of the federal act.

7. If it purports to be a drug the name of which is recognized in an officialcompendium, unless it is packaged and labeled as prescribed. The method ofpacking may be modified with the consent of the Board, or if consent isobtained under the federal act. Whenever a drug is recognized in both theUnited States Pharmacopoeia National Formulary and the HomeopathicPharmacopoeia of the United States, it shall be subject to the requirementsof the United States Pharmacopoeia National Formulary with respect topackaging and labeling unless it is labeled and offered for sale as ahomeopathic drug, in which case it shall be subject to the provisions of theHomeopathic Pharmacopoeia of the United States and not to those of the UnitedStates Pharmacopoeia National Formulary. However, in the event ofinconsistency between the requirements of this subdivision and those ofsubdivision 5 as to the name by which the drug or its ingredients shall bedesignated, the requirements of subdivision 5 shall prevail.

8. If it is dangerous to health when used in the dosage, or with thefrequency or duration prescribed, recommended, or suggested in the labelingor advertising.

9. If it is, or purports to be, or is represented as a drug composed whollyor partly of insulin, unless it is from a batch for which a certificate orrelease has been issued pursuant to 506 of the federal act, and suchcertificate or release is in effect with respect to such drug.

10. If it is, or purports to be, or is represented as a drug composed whollyor partly of any kind of penicillin, streptomycin, chlortetracycline,chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative,unless it is from a batch, for which a certificate or release has been issuedpursuant to 507 of the federal act, and such certificate or release is ineffect for such drug. This subdivision shall not apply to any drug or classof drugs exempted by regulations promulgated under 507(c) or (d) of thefederal law.

For the purpose of this subdivision the term "antibiotic drug" means anydrug intended for use by man containing any quantity of any chemicalsubstance which is produced by microorganisms and which has the capacity toinhibit or destroy microorganisms in dilute solution, including, thechemically synthesized equivalent of any such substance.

11. If it is a color additive, the intended use of which in or on drugs isfor coloring only, unless its packaging and labeling are in conformity withsuch packaging and labeling requirements applicable to such color additive,prescribed under the provisions of the federal act.

12. In the case of any prescription drug distributed or offered for sale inthis Commonwealth, unless the manufacturer, packer, or distributor includesin all advertisements and other descriptive printed matter a true statementof (i) the established name, as defined in this section, printed prominentlyand in type at least half as large as that used for any trade or brand name,(ii) the formula showing quantitatively each ingredient of such drug to theextent required for labels under this section, and (iii) such otherinformation in brief summary relating to side effects, contraindications, andeffectiveness as are required in regulations issued under the federal act.

13. If a trademark, trade name or other identifying mark, imprint or deviceof another or any likeness of the foregoing has been placed thereon or uponits container with intent to defraud.

Drugs and devices which are, in accordance with the practice of the trade, tobe processed, labeled or repacked in substantial quantities at establishmentsother than those where originally processed or packed shall be exempt fromany labeling or packaging requirements of this chapter if such drugs anddevices are being delivered, manufactured, processed, labeled, repacked orotherwise held in compliance with regulations issued by the Board.

(Code 1950, 54-463; 1958, c. 551; 1970, c. 650, 54-524.93; 1976, c. 644;1988, c. 765.)