{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3462.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3462.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3462.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3462.html"}],"law_id":75409,"edition_id":1,"section_id":75409,"structure_id":14492,"section_number":"54.1-3462","catch_line":"Misbranded drug or device","history":"Code 1950, \u00a7 54-463; 1958, c. 551; 1970, c. 650, \u00a7 54-524.93; 1976, c. 644; 1988, c. 765.","full_text":"A drug or device shall be deemed to be misbranded:\n\n1\n\nIf its labeling is false or misleading in any particular.2\n\nIf its package does not bear a label containing the name and place of business of the manufacturer, packer, or distributor. However, all prescription drugs intended for human use and devices shall bear a label containing the name and place of business of the manufacturer of the final dosage form of the drug and, if different, the name and place of business of the packer or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Reasonable variations shall be permitted, and exemptions for small packages shall be allowed in accordance with regulations of the Board.3\n\nIf any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed with such conspicuousness, as compared with other words, statements, designs or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.4\n\nIf it is for use by man and contains any quantity of the narcotic or hypnotic substances alpha-eucaine, barbituric acid, beta-eucaine, bromal, carbromal, chloral, coca, cocaine, codeine, morphine, opium, paraldehyde, or sulfonmethane, or any chemical derivative of such substances, which derivative, after investigation has been found to be and designated as, habit forming, by regulations issued by the Board under this chapter, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning — May Be Habit Forming.”5\n\nIf it is a drug, unless its label bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula, the established name of the drug, and in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, 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 or preparation of any such substances. However, the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subdivision, shall apply only to prescription drugs. Any prescription drug shall have the established name of the drug or ingredient printed on its label prominently and in type at least half as large as that used for any proprietary name or designation for such drug or ingredient. Exemptions may be allowed under regulations of the Board.\n\t\t\tAs used in this subdivision, the term “established name,” with respect to a drug or ingredient, means the applicable official name designated pursuant to § 508 of the federal act, or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title in such compendium or if neither exists, then the common or usual name, if any, of such drug or of such ingredient. Whenever, an article is recognized in the United States Pharmacopoeia National Formulary and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia National Formulary shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply.6\n\nUnless its labeling bears adequate directions for use and such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. The Board shall promulgate regulations exempting such drug or device from such requirements when these requirements are not necessary to protect the public health and the articles are also exempted under regulations issued under § 502(f) of the federal act.7\n\nIf it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed. The method of packing may be modified with the consent of the Board, or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia National Formulary with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia National Formulary. However, in the event of inconsistency between the requirements of this subdivision and those of subdivision 5 as to the name by which the drug or its ingredients shall be designated, the requirements of subdivision 5 shall prevail.8\n\nIf it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling or advertising.9\n\nIf it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is from a batch for which a certificate or release has been issued pursuant to § 506 of the federal act, and such certificate or release is in effect with respect to such drug.10\n\nIf it is, or purports to be, or is represented as a drug composed wholly or 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 issued pursuant to § 507 of the federal act, and such certificate or release is in effect for such drug. This subdivision shall not apply to any drug or class of drugs exempted by regulations promulgated under § 507(c) or (d) of the federal law.\n\t\t\tFor the purpose of this subdivision the term “antibiotic drug” means any drug intended for use by man containing any quantity of any chemical substance which is produced by microorganisms and which has the capacity to inhibit or destroy microorganisms in dilute solution, including, the chemically synthesized equivalent of any such substance.11\n\nIf it is a color additive, the intended use of which in or on drugs is for coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, prescribed under the provisions of the federal act.12\n\nIn the case of any prescription drug distributed or offered for sale in this Commonwealth, unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter a true statement of (i) the established name, as defined in this section, printed prominently and 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 the extent required for labels under this section, and (iii) such other information in brief summary relating to side effects, contraindications, and effectiveness as are required in regulations issued under the federal act.13\n\nIf a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud.\n\t\t\tDrugs and devices which are, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed shall be exempt from any labeling or packaging requirements of this chapter if such drugs and devices are being delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with regulations issued by the Board.","order_by":null,"text":{"0":{"id":270699,"text":"A drug or device shall be deemed to be misbranded:","type":"section","prefixes":[""],"prefix":"","entire_prefix":"","prefix_anchor":"","level":1,"next_prefix":"1"},"1":{"id":270700,"text":"If its labeling is false or misleading in any particular.","type":"section","prefixes":["1"],"prefix":"1","entire_prefix":"1","prefix_anchor":"1","level":1,"prior_prefix":"","next_prefix":"2"},"2":{"id":270701,"text":"If its package does not bear a label containing the name and place of business of the manufacturer, packer, or distributor. However, all prescription drugs intended for human use and devices shall bear a label containing the name and place of business of the manufacturer of the final dosage form of the drug and, if different, the name and place of business of the packer or distributor and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Reasonable variations shall be permitted, and exemptions for small packages shall be allowed in accordance with regulations of the Board.","type":"section","prefixes":["2"],"prefix":"2","entire_prefix":"2","prefix_anchor":"2","level":1,"prior_prefix":"1","next_prefix":"3"},"3":{"id":270702,"text":"If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed with such conspicuousness, as compared with other words, statements, designs or devices, in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.","type":"section","prefixes":["3"],"prefix":"3","entire_prefix":"3","prefix_anchor":"3","level":1,"prior_prefix":"2","next_prefix":"4"},"4":{"id":270703,"text":"If it is for use by man and contains any quantity of the narcotic or hypnotic substances alpha-eucaine, barbituric acid, beta-eucaine, bromal, carbromal, chloral, coca, cocaine, codeine, morphine, opium, paraldehyde, or sulfonmethane, or any chemical derivative of such substances, which derivative, after investigation has been found to be and designated as, habit forming, by regulations issued by the Board under this chapter, unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning — May Be Habit Forming.”","type":"section","prefixes":["4"],"prefix":"4","entire_prefix":"4","prefix_anchor":"4","level":1,"prior_prefix":"3","next_prefix":"5"},"5":{"id":270704,"text":"If it is a drug, unless its label bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula, the established name of the drug, and in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, 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 or preparation of any such substances. However, the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subdivision, shall apply only to prescription drugs. Any prescription drug shall have the established name of the drug or ingredient printed on its label prominently and in type at least half as large as that used for any proprietary name or designation for such drug or ingredient. Exemptions may be allowed under regulations of the Board.\n\t\t\tAs used in this subdivision, the term “established name,” with respect to a drug or ingredient, means the applicable official name designated pursuant to § 508 of the federal act, or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title in such compendium or if neither exists, then the common or usual name, if any, of such drug or of such ingredient. Whenever, an article is recognized in the United States Pharmacopoeia National Formulary and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia National Formulary shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply.","type":"section","prefixes":["5"],"prefix":"5","entire_prefix":"5","prefix_anchor":"5","level":1,"prior_prefix":"4","next_prefix":"6"},"6":{"id":270705,"text":"Unless its labeling bears adequate directions for use and such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. The Board shall promulgate regulations exempting such drug or device from such requirements when these requirements are not necessary to protect the public health and the articles are also exempted under regulations issued under § 502(f) of the federal act.","type":"section","prefixes":["6"],"prefix":"6","entire_prefix":"6","prefix_anchor":"6","level":1,"prior_prefix":"5","next_prefix":"7"},"7":{"id":270706,"text":"If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed. The method of packing may be modified with the consent of the Board, or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia National Formulary with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia National Formulary. However, in the event of inconsistency between the requirements of this subdivision and those of subdivision 5 as to the name by which the drug or its ingredients shall be designated, the requirements of subdivision 5 shall prevail.","type":"section","prefixes":["7"],"prefix":"7","entire_prefix":"7","prefix_anchor":"7","level":1,"prior_prefix":"6","next_prefix":"8"},"8":{"id":270707,"text":"If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling or advertising.","type":"section","prefixes":["8"],"prefix":"8","entire_prefix":"8","prefix_anchor":"8","level":1,"prior_prefix":"7","next_prefix":"9"},"9":{"id":270708,"text":"If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is from a batch for which a certificate or release has been issued pursuant to § 506 of the federal act, and such certificate or release is in effect with respect to such drug.","type":"section","prefixes":["9"],"prefix":"9","entire_prefix":"9","prefix_anchor":"9","level":1,"prior_prefix":"8","next_prefix":"10"},"10":{"id":270709,"text":"If it is, or purports to be, or is represented as a drug composed wholly or 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 issued pursuant to § 507 of the federal act, and such certificate or release is in effect for such drug. This subdivision shall not apply to any drug or class of drugs exempted by regulations promulgated under § 507(c) or (d) of the federal law.\n\t\t\tFor the purpose of this subdivision the term “antibiotic drug” means any drug intended for use by man containing any quantity of any chemical substance which is produced by microorganisms and which has the capacity to inhibit or destroy microorganisms in dilute solution, including, the chemically synthesized equivalent of any such substance.","type":"section","prefixes":["10"],"prefix":"10","entire_prefix":"10","prefix_anchor":"10","level":1,"prior_prefix":"9","next_prefix":"11"},"11":{"id":270710,"text":"If it is a color additive, the intended use of which in or on drugs is for coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, prescribed under the provisions of the federal act.","type":"section","prefixes":["11"],"prefix":"11","entire_prefix":"11","prefix_anchor":"11","level":1,"prior_prefix":"10","next_prefix":"12"},"12":{"id":270711,"text":"In the case of any prescription drug distributed or offered for sale in this Commonwealth, unless the manufacturer, packer, or distributor includes in all advertisements and other descriptive printed matter a true statement of (i) the established name, as defined in this section, printed prominently and 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 the extent required for labels under this section, and (iii) such other information in brief summary relating to side effects, contraindications, and effectiveness as are required in regulations issued under the federal act.","type":"section","prefixes":["12"],"prefix":"12","entire_prefix":"12","prefix_anchor":"12","level":1,"prior_prefix":"11","next_prefix":"13"},"13":{"id":270712,"text":"If a trademark, trade name or other identifying mark, imprint or device of another or any likeness of the foregoing has been placed thereon or upon its container with intent to defraud.\n\t\t\tDrugs and devices which are, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed shall be exempt from any labeling or packaging requirements of this chapter if such drugs and devices are being delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with regulations issued by the Board.","type":"section","prefixes":["13"],"prefix":"13","entire_prefix":"13","prefix_anchor":"13","level":1,"prior_prefix":"12"}},"ancestry":[{"id":14492,"edition_id":1,"name":"Misbranded and Adulterated Drugs and Cosmetics","identifier":"6","label":"article","depth":4,"order_by":1,"parent_id":13240,"metadata":{},"date_created":"2026-06-26 03:48:20","date_modified":"2026-06-26 03:48:20","permalink":{"id":243685,"object_type":"structure","relational_id":14492,"identifier":"6","token":"54.1\/III\/34\/6","url":"\/54.1\/III\/34\/6\/","edition_id":1,"permalink":0,"preferred":1}},{"id":13240,"edition_id":1,"name":"Drug Control Act","identifier":"34","label":"chapter","depth":3,"order_by":1,"parent_id":12758,"metadata":{},"date_created":"2026-06-26 03:44:30","date_modified":"2026-06-26 03:44:30","permalink":{"id":243223,"object_type":"structure","relational_id":13240,"identifier":"34","token":"54.1\/III\/34","url":"\/54.1\/III\/34\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12758,"edition_id":1,"name":"Professions and Occupations Regulated by Boards Within the Department of Health Professions","identifier":"III","label":"subtitle","depth":2,"order_by":1,"parent_id":12754,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":241105,"object_type":"structure","relational_id":12758,"identifier":"III","token":"54.1\/III","url":"\/54.1\/III\/","edition_id":1,"permalink":0,"preferred":1}},{"id":12754,"edition_id":1,"name":"Professions and Occupations","identifier":"54.1","label":"title","depth":1,"order_by":1,"parent_id":null,"metadata":{},"date_created":"2026-06-26 03:43:51","date_modified":"2026-06-26 03:43:51","permalink":{"id":239313,"object_type":"structure","relational_id":12754,"identifier":"54.1","token":"54.1","url":"\/54.1\/","edition_id":1,"permalink":0,"preferred":1}}],"structure_contents":[{"id":83286,"structure_id":14492,"section_number":"54.1-3457","catch_line":"Prohibited acts","url":"\/54.1-3457\/","token":"54.1\/III\/34\/6\/54.1-3457","metadata":false},{"id":78702,"structure_id":14492,"section_number":"54.1-3458","catch_line":"Violations","url":"\/54.1-3458\/","token":"54.1\/III\/34\/6\/54.1-3458","metadata":false},{"id":82436,"structure_id":14492,"section_number":"54.1-3459","catch_line":"Tagging of adulterated or misbranded drugs, devices, or cosmetics; condemnation; destruction; expenses","url":"\/54.1-3459\/","token":"54.1\/III\/34\/6\/54.1-3459","metadata":false},{"id":82971,"structure_id":14492,"section_number":"54.1-3460","catch_line":"Poisonous or deleterious substance, or color additive","url":"\/54.1-3460\/","token":"54.1\/III\/34\/6\/54.1-3460","metadata":false},{"id":68796,"structure_id":14492,"section_number":"54.1-3461","catch_line":"Adulterated drug or device","url":"\/54.1-3461\/","token":"54.1\/III\/34\/6\/54.1-3461","metadata":false},{"id":75409,"structure_id":14492,"section_number":"54.1-3462","catch_line":"Misbranded drug or device","url":"\/54.1-3462\/","token":"54.1\/III\/34\/6\/54.1-3462","metadata":false},{"id":55895,"structure_id":14492,"section_number":"54.1-3463","catch_line":"Exemption of drugs dispensed by filling or refilling prescription","url":"\/54.1-3463\/","token":"54.1\/III\/34\/6\/54.1-3463","metadata":false},{"id":68497,"structure_id":14492,"section_number":"54.1-3464","catch_line":"Adulterated cosmetics","url":"\/54.1-3464\/","token":"54.1\/III\/34\/6\/54.1-3464","metadata":false},{"id":59606,"structure_id":14492,"section_number":"54.1-3465","catch_line":"Misbranded cosmetics","url":"\/54.1-3465\/","token":"54.1\/III\/34\/6\/54.1-3465","metadata":false}],"previous_section":{"id":68796,"structure_id":14492,"section_number":"54.1-3461","catch_line":"Adulterated drug or device","url":"\/54.1-3461\/","token":"54.1\/III\/34\/6\/54.1-3461","metadata":false},"next_section":{"id":55895,"structure_id":14492,"section_number":"54.1-3463","catch_line":"Exemption of drugs dispensed by filling or refilling prescription","url":"\/54.1-3463\/","token":"54.1\/III\/34\/6\/54.1-3463","metadata":false},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3462\/","history_text":"

The record of this law\u2019s original creation isn\u2019t available online. It has been modified 4 times. Those modifications are cataloged by \u201cThe Acts of Assembly,\u201d a state publication, by year and chapter. Those modifications that can be read on the General Assembly\u2019s website will be linked accordingly. Those modifications are as follows: in 1958, chapter 551; in 1970, chapter 650; in 1976, chapter 644; in 1988, chapter 765.<\/p>","references":[{"id":55895,"section_number":"54.1-3463","catch_line":"Exemption of drugs dispensed by filling or refilling prescription","order_by":null,"url":"\/54.1-3463\/"}],"refers_to":false,"permalink":{"id":243707,"object_type":"law","relational_id":75409,"identifier":"54.1-3462","token":"54.1\/III\/34\/6\/54.1-3462","url":"\/54.1-3462\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3462\/","token":"54.1\/III\/34\/6\/54.1-3462","dublin_core":{"Title":"Misbranded drug or device","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3462","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A drug<\/span> or device<\/span> shall be deemed to be misbranded:<\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> If its labeling<\/span> is false or misleading in any particular. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> If its package does not bear a label<\/span> containing the name and place of business of the manufacturer<\/span>, packer, or distributor<\/span>. However, all prescription drugs<\/span> intended for human use and devices<\/span> shall bear a label<\/span> containing the name and place of business of the manufacturer<\/span> of the final dosage form of the drug<\/span> and, if different, the name and place of business of the packer or distributor<\/span> and an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. Reasonable variations shall be permitted, and exemptions for small packages shall be allowed in accordance with regulations of the Board<\/span>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> If any word, statement, or other information required by or under authority of this chapter to appear on the label<\/span> or labeling<\/span> is not prominently placed with such conspicuousness, as compared with other words, statements, designs or devices<\/span>, in the labeling<\/span>, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> If it is for use by man and contains any quantity of the narcotic or hypnotic substances alpha-eucaine, barbituric acid, beta-eucaine, bromal, carbromal, chloral, coca, cocaine, codeine, morphine, opium, paraldehyde, or sulfonmethane, or any chemical derivative of such substances, which derivative, after investigation has been found to be and designated as, habit forming, by regulations issued by the Board<\/span> under this chapter, unless its label<\/span> bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning — May Be Habit Forming.” <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

5.<\/span> If it is a drug, unless its label<\/span> bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula, the established name of the drug, and in case it is fabricated from two or more ingredients, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol, 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 or preparation of any such substances. However, the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subdivision, shall apply only to prescription drugs<\/span>. Any prescription drug<\/span> shall have the established name of the drug or ingredient printed on its label<\/span> prominently and in type at least half as large as that used for any proprietary name or designation for such drug or ingredient. Exemptions may be allowed under regulations of the Board<\/span>.\n\t\t\tAs used in this subdivision, the term “established name,” with respect to a drug or ingredient, means the applicable official name designated pursuant to § 508 of the federal act, or if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium<\/span>, then the official title in such compendium or if neither exists, then the common or usual name, if any, of such drug or of such ingredient. Whenever, an article is recognized in the United States Pharmacopoeia National Formulary and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia National Formulary shall apply unless it is labeled and offered for sale<\/span> as a homeopathic drug, in which case the official title used in the Homeopathic Pharmacopoeia shall apply. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

6.<\/span> Unless its labeling<\/span> bears adequate directions for use and such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. The Board<\/span> shall promulgate regulations exempting such drug or device<\/span> from such requirements when these requirements are not necessary to protect the public health and the articles are also exempted under regulations issued under § 502(f) of the federal act. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

7.<\/span> If it purports to be a drug the name of which is recognized in an official compendium<\/span>, unless it is packaged and labeled as prescribed. The method of packing may be modified with the consent of the Board<\/span>, or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States Pharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia National Formulary with respect to packaging and labeling<\/span> unless it is labeled and offered for sale<\/span> as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopoeia National Formulary. However, in the event of inconsistency between the requirements of this subdivision and those of subdivision 5 as to the name by which the drug or its ingredients shall be designated, the requirements of subdivision 5 shall prevail. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

8.<\/span> If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling<\/span> or advertising. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

9.<\/span> If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is from a batch for which a certificate or release has been issued pursuant to § 506 of the federal act, and such certificate or release is in effect with respect to such drug. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

10.<\/span> If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug<\/span>, or any derivative, unless it is from a batch, for which a certificate or release has been issued pursuant to § 507 of the federal act, and such certificate or release is in effect for such drug. This subdivision shall not apply to any drug or class of drugs exempted by regulations promulgated under § 507(c) or (d) of the federal law<\/span>.\n\t\t\tFor the purpose of this subdivision the term “antibiotic drug<\/span>” means any drug intended for use by man containing any quantity of any chemical substance which is produced by microorganisms and which has the capacity to inhibit or destroy microorganisms in dilute solution, including, the chemically synthesized equivalent of any such substance. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

11.<\/span> If it is a color additive, the intended use of which in or on drugs is for coloring only, unless its packaging and labeling<\/span> are in conformity with such packaging and labeling<\/span> requirements applicable to such color additive, prescribed under the provisions of the federal act. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

12.<\/span> In the case of any prescription drug<\/span> distributed or offered for sale<\/span> in this Commonwealth, unless the manufacturer<\/span>, packer, or distributor<\/span> includes in all advertisements<\/span> and other descriptive printed matter a true statement of (i) the established name, as defined in this section, printed prominently and 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 the extent required for labels<\/span> under this section, and (iii) such other information in brief<\/span> summary relating to side effects, contraindications, and effectiveness as are required in regulations issued under the federal act. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

13.<\/span> If a trademark, trade name or other identifying mark, imprint or device<\/span> of another or any likeness of the foregoing has been placed thereon or upon its container with intent<\/span> to defraud.\n\t\t\tDrugs and devices<\/span> which are, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at establishments other than those where originally processed or packed shall be exempt from any labeling<\/span> or packaging requirements of this chapter if such drugs and devices<\/span> are being delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with regulations issued by the Board<\/span>. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nMISBRANDED DRUG OR DEVICE (\u00a7 54.1-3462)\n\nA drug or device shall be deemed to be misbranded:\n\n1. If its labeling is false or misleading in any particular.\n\n2. If its package does not bear a label containing the name and place of\nbusiness of the manufacturer, packer, or distributor. However, all prescription\ndrugs intended for human use and devices shall bear a label containing the name\nand place of business of the manufacturer of the final dosage form of the drug\nand, if different, the name and place of business of the packer or distributor\nand an accurate statement of the quantity of the contents in terms of weight,\nmeasure, or numerical count. Reasonable variations shall be permitted, and\nexemptions for small packages shall be allowed in accordance with regulations of\nthe Board.\n\n3. If any word, statement, or other information required by or under authority\nof this chapter to appear on the label or labeling is not prominently placed\nwith such conspicuousness, as compared with other words, statements, designs or\ndevices, in the labeling, and in such terms as to render it likely to be read\nand understood by the ordinary individual under customary conditions of purchase\nand use.\n\n4. If it is for use by man and contains any quantity of the narcotic or hypnotic\nsubstances alpha-eucaine, barbituric acid, beta-eucaine, bromal, carbromal,\nchloral, coca, cocaine, codeine, morphine, opium, paraldehyde, or sulfonmethane,\nor any chemical derivative of such substances, which derivative, after\ninvestigation has been found to be and designated as, habit forming, by\nregulations issued by the Board under this chapter, unless its label bears the\nname and quantity or proportion of such substance or derivative and in\njuxtaposition therewith the statement “Warning — May Be Habit\nForming.”\n\n5. If it is a drug, unless its label bears, to the exclusion of any other\nnonproprietary name, except the applicable systematic chemical name or the\nchemical formula, the established name of the drug, and in case it is fabricated\nfrom two or more ingredients, the established name and quantity of each active\ningredient, including the kind and quantity or proportion of any alcohol, and\nthe established name and quantity or proportion of any bromides, ether,\nchloroform, acetanilid, acetphenetidin, amidopyrine, antipyrine, atropine,\nhyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury,\nouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of\nany such substances. However, the requirement for stating the quantity of the\nactive ingredients, other than the quantity of those specifically named in this\nsubdivision, shall apply only to prescription drugs. Any prescription drug shall\nhave the established name of the drug or ingredient printed on its label\nprominently and in type at least half as large as that used for any proprietary\nname or designation for such drug or ingredient. Exemptions may be allowed under\nregulations of the Board.\n\t\t\tAs used in this subdivision, the term “established name,” with\nrespect to a drug or ingredient, means the applicable official name designated\npursuant to § 508 of the federal act, or if there is no such name and such\ndrug, or such ingredient, is an article recognized in an official compendium,\nthen the official title in such compendium or if neither exists, then the common\nor usual name, if any, of such drug or of such ingredient. Whenever, an article\nis recognized in the United States Pharmacopoeia National Formulary and in the\nHomeopathic Pharmacopoeia under different official titles, the official title\nused in the United States Pharmacopoeia National Formulary shall apply unless it\nis labeled and offered for sale as a homeopathic drug, in which case the\nofficial title used in the Homeopathic Pharmacopoeia shall apply.\n\n6. Unless its labeling bears adequate directions for use and such adequate\nwarnings against use in those pathological conditions or by children where its\nuse may be dangerous to health, or against unsafe dosage or methods or duration\nof administration or application, in such manner and form, as are necessary for\nthe protection of users. The Board shall promulgate regulations exempting such\ndrug or device from such requirements when these requirements are not necessary\nto protect the public health and the articles are also exempted under\nregulations issued under § 502(f) of the federal act.\n\n7. If it purports to be a drug the name of which is recognized in an official\ncompendium, unless it is packaged and labeled as prescribed. The method of\npacking may be modified with the consent of the Board, or if consent is obtained\nunder the federal act. Whenever a drug is recognized in both the United States\nPharmacopoeia National Formulary and the Homeopathic Pharmacopoeia of the United\nStates, it shall be subject to the requirements of the United States\nPharmacopoeia National Formulary with respect to packaging and labeling unless\nit is labeled and offered for sale as a homeopathic drug, in which case it shall\nbe subject to the provisions of the Homeopathic Pharmacopoeia of the United\nStates and not to those of the United States Pharmacopoeia National Formulary.\nHowever, in the event of inconsistency between the requirements of this\nsubdivision and those of subdivision 5 as to the name by which the drug or its\ningredients shall be designated, the requirements of subdivision 5 shall\nprevail.\n\n8. If it is dangerous to health when used in the dosage, or with the frequency\nor duration prescribed, recommended, or suggested in the labeling or\nadvertising.\n\n9. If it is, or purports to be, or is represented as a drug composed wholly or\npartly of insulin, unless it is from a batch for which a certificate or release\nhas been issued pursuant to § 506 of the federal act, and such certificate\nor release is in effect with respect to such drug.\n\n10. If it is, or purports to be, or is represented as a drug composed wholly or\npartly of any kind of penicillin, streptomycin, chlortetracycline,\nchloramphenicol, bacitracin, or any other antibiotic drug, or any derivative,\nunless it is from a batch, for which a certificate or release has been issued\npursuant to § 507 of the federal act, and such certificate or release is in\neffect for such drug. This subdivision shall not apply to any drug or class of\ndrugs exempted by regulations promulgated under § 507(c) or (d) of the\nfederal law.\n\t\t\tFor the purpose of this subdivision the term “antibiotic drug”\nmeans any drug intended for use by man containing any quantity of any chemical\nsubstance which is produced by microorganisms and which has the capacity to\ninhibit or destroy microorganisms in dilute solution, including, the chemically\nsynthesized equivalent of any such substance.\n\n11. If it is a color additive, the intended use of which in or on drugs is for\ncoloring only, unless its packaging and labeling are in conformity with such\npackaging and labeling requirements applicable to such color additive,\nprescribed under the provisions of the federal act.\n\n12. In the case of any prescription drug distributed or offered for sale in this\nCommonwealth, unless the manufacturer, packer, or distributor includes in all\nadvertisements and other descriptive printed matter a true statement of (i) the\nestablished name, as defined in this section, printed prominently and in type at\nleast half as large as that used for any trade or brand name, (ii) the formula\nshowing quantitatively each ingredient of such drug to the extent required for\nlabels under this section, and (iii) such other information in brief summary\nrelating to side effects, contraindications, and effectiveness as are required\nin regulations issued under the federal act.\n\n13. If a trademark, trade name or other identifying mark, imprint or device of\nanother or any likeness of the foregoing has been placed thereon or upon its\ncontainer with intent to defraud.\n\t\t\tDrugs and devices which are, in accordance with the practice of the trade, to\nbe processed, labeled or repacked in substantial quantities at establishments\nother than those where originally processed or packed shall be exempt from any\nlabeling or packaging requirements of this chapter if such drugs and devices are\nbeing delivered, manufactured, processed, labeled, repacked or otherwise held in\ncompliance with regulations issued by the Board.\n\nHISTORY: Code 1950, \u00a7 54-463; 1958, c. 551; 1970, c. 650, \u00a7 54-524.93; 1976,\nc. 644; 1988, c. 765.","edition":{"id":1,"name":"2025","slug":"2025","date_created":"2026-06-21 22:39:22","date_modified":"2026-06-21 22:39:22","current":1,"order_by":1,"last_import":null}}