{"formats":[{"name":"JSON","format":"json","url":"\/downloads\/2025\/code-json\/54.1-3461.json"},{"name":"Plain Text","format":"text","url":"\/downloads\/2025\/code-text\/54.1-3461.txt"},{"name":"XML","format":"xml","url":"\/downloads\/2025\/code-xml\/54.1-3461.xml"},{"name":"HTML","format":"html","url":"\/downloads\/2025\/code-html\/54.1-3461.html"}],"law_id":68796,"edition_id":1,"section_id":68796,"structure_id":14492,"section_number":"54.1-3461","catch_line":"Adulterated drug or device","history":"Code 1950, \u00a7 54-461; 1970, c. 650, \u00a7 54-524.92; 1988, c. 765.","full_text":"A\n\nA drug or device shall be deemed to be adulterated:1\n\nIf it consists in whole or in part of any filth, putrid or decomposed substance;2\n\nIf it has been produced, prepared, packed, or held under insanitary conditions whereby it has been contaminated with filth, or whereby it has been rendered injurious to health;3\n\nIf it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter;4\n\nIf it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;5\n\nIf it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act or § 54.1-3460; or6\n\nIt is a color additive, the intended use of which in or on drugs is for purposes of coloring only, and is unsafe within the meaning of the federal act or § 54.1-3460.B\n\nA drug or device shall be deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination of strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in such compendium, if the difference in strength, quality, or purity from such standard is plainly stated on its label.\n\t\t\tWhenever 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 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.C\n\nA drug or device shall be deemed to be adulterated if it is not subject to the provisions of subsection B of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.D\n\nA drug or device shall be deemed to be adulterated if it is a drug and any substance has been (i) mixed or packed with it so as to reduce its quality or strength or (ii) substituted wholly or in part for it.","order_by":null,"text":{"0":{"id":249043,"text":"A drug or device shall be deemed to be adulterated:","type":"section","prefixes":["A"],"prefix":"A","entire_prefix":"A","prefix_anchor":"A","level":1,"next_prefix":"A1"},"1":{"id":249044,"text":"If it consists in whole or in part of any filth, putrid or decomposed substance;","type":"section","prefixes":["A","1"],"prefix":"1","entire_prefix":"A1","prefix_anchor":"A1","level":2,"prior_prefix":"A","next_prefix":"A2"},"2":{"id":249045,"text":"If it has been produced, prepared, packed, or held under insanitary conditions whereby it has been contaminated with filth, or whereby it has been rendered injurious to health;","type":"section","prefixes":["A","2"],"prefix":"2","entire_prefix":"A2","prefix_anchor":"A2","level":2,"prior_prefix":"A1","next_prefix":"A3"},"3":{"id":249046,"text":"If it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter;","type":"section","prefixes":["A","3"],"prefix":"3","entire_prefix":"A3","prefix_anchor":"A3","level":2,"prior_prefix":"A2","next_prefix":"A4"},"4":{"id":249047,"text":"If it is a drug and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health;","type":"section","prefixes":["A","4"],"prefix":"4","entire_prefix":"A4","prefix_anchor":"A4","level":2,"prior_prefix":"A3","next_prefix":"A5"},"5":{"id":249048,"text":"If it is a drug and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act or § 54.1-3460; or","type":"section","prefixes":["A","5"],"prefix":"5","entire_prefix":"A5","prefix_anchor":"A5","level":2,"prior_prefix":"A4","next_prefix":"A6"},"6":{"id":249049,"text":"It is a color additive, the intended use of which in or on drugs is for purposes of coloring only, and is unsafe within the meaning of the federal act or § 54.1-3460.","type":"section","prefixes":["A","6"],"prefix":"6","entire_prefix":"A6","prefix_anchor":"A6","level":2,"prior_prefix":"A5","next_prefix":"B"},"7":{"id":249050,"text":"A drug or device shall be deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination of strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug defined in an official compendium shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in such compendium, if the difference in strength, quality, or purity from such standard is plainly stated on its label.\n\t\t\tWhenever 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 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.","type":"section","prefixes":["B"],"prefix":"B","entire_prefix":"B","prefix_anchor":"B","level":1,"prior_prefix":"A6","next_prefix":"C"},"8":{"id":249051,"text":"A drug or device shall be deemed to be adulterated if it is not subject to the provisions of subsection B of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.","type":"section","prefixes":["C"],"prefix":"C","entire_prefix":"C","prefix_anchor":"C","level":1,"prior_prefix":"B","next_prefix":"D"},"9":{"id":249052,"text":"A drug or device shall be deemed to be adulterated if it is a drug and any substance has been (i) mixed or packed with it so as to reduce its quality or strength or (ii) substituted wholly or in part for it.","type":"section","prefixes":["D"],"prefix":"D","entire_prefix":"D","prefix_anchor":"D","level":1,"prior_prefix":"C"}},"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":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},"next_section":{"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},"metadata":false,"official_url":"https:\/\/law.lis.virginia.gov\/vacode\/54.1-3461\/","history_text":"

The record of this law\u2019s original creation isn\u2019t available online. It has been modified 2 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 1970, chapter 650; in 1988, chapter 765.<\/p>","references":false,"refers_to":[{"id":82971,"section_number":"54.1-3460","catch_line":"Poisonous or deleterious substance, or color additive","order_by":null,"url":"\/54.1-3460\/"}],"permalink":{"id":243703,"object_type":"law","relational_id":68796,"identifier":"54.1-3461","token":"54.1\/III\/34\/6\/54.1-3461","url":"\/54.1-3461\/","edition_id":1,"permalink":0,"preferred":1},"url":"\/54.1-3461\/","token":"54.1\/III\/34\/6\/54.1-3461","dublin_core":{"Title":"Adulterated drug or device","Type":"Text","Format":"text\/html","Identifier":"\u00a7 54.1-3461","Relation":"Code of Virginia"},"html":"\n\t\t\t\t\t\t

A.<\/span> A drug<\/span> or device<\/span> shall be deemed to be adulterated: <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

1.<\/span> If it consists in whole or in part of any filth, putrid or decomposed substance; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

2.<\/span> If it has been produced, prepared, packed, or held under insanitary conditions whereby it has been contaminated with filth, or whereby it has been rendered injurious to health; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

3.<\/span> If it is a drug<\/span> and the methods used in, or the facilities or controls used for, its manufacture<\/span>, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug<\/span> meets the requirements of this chapter; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

4.<\/span> If it is a drug<\/span> and its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

5.<\/span> If it is a drug<\/span> and it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of the federal act or § 54.1-3460<\/a>; or <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

6.<\/span> It is a color additive, the intended use of which in or on drugs<\/span> is for purposes of coloring only, and is unsafe within the meaning of the federal act or § 54.1-3460<\/a>. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

B.<\/span> A drug<\/span> or device<\/span> shall be deemed to be adulterated if it purports to be or is represented as a drug<\/span> the name of which is recognized in an official compendium<\/span>, and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Such determination of strength, quality, or purity shall be made in accordance with the tests or methods of assay set forth in such compendium, or in the absence of or inadequacy of such tests or methods of assay, those prescribed under authority of the federal act. No drug<\/span> defined in an official compendium<\/span> shall be deemed to be adulterated under this subsection because it differs from the standard of strength, quality, or purity set forth in such compendium, if the difference in strength, quality, or purity from such standard is plainly stated on its label<\/span>.\n\t\t\tWhenever a drug<\/span> 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 unless it is labeled and offered for sale<\/span> as a homeopathic drug<\/span>, 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. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

C.<\/span> A drug<\/span> or device<\/span> shall be deemed to be adulterated if it is not subject to the provisions of subsection B of this section and its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess. <\/i><\/a><\/p><\/section>\n\t\t\t\t\t\t

D.<\/span> A drug<\/span> or device<\/span> shall be deemed to be adulterated if it is a drug<\/span> and any substance has been (i) mixed or packed with it so as to reduce its quality or strength or (ii) substituted wholly or in part for it. <\/i><\/a><\/p><\/section>","plain_text":" CODE OF VIRGINIA\n\nADULTERATED DRUG OR DEVICE (\u00a7 54.1-3461)\n\nA. A drug or device shall be deemed to be adulterated:\n\n 1. If it consists in whole or in part of any filth, putrid or decomposed\n substance;\n\n 2. If it has been produced, prepared, packed, or held under insanitary\n conditions whereby it has been contaminated with filth, or whereby it has been\n rendered injurious to health;\n\n 3. If it is a drug and the methods used in, or the facilities or controls used\n for, its manufacture, processing, packing, or holding do not conform to or are\n not operated or administered in conformity with current good manufacturing\n practice to assure that such drug meets the requirements of this chapter;\n\n 4. If it is a drug and its container is composed, in whole or in part, of any\n poisonous or deleterious substance which may render the contents injurious to\n health;\n\n 5. If it is a drug and it bears or contains, for purposes of coloring only, a\n color additive which is unsafe within the meaning of the federal act or §\n 54.1-3460; or\n\n 6. It is a color additive, the intended use of which in or on drugs is for\n purposes of coloring only, and is unsafe within the meaning of the federal act\n or § 54.1-3460.\n\nB. A drug or device shall be deemed to be adulterated if it purports to be or is\nrepresented as a drug the name of which is recognized in an official compendium,\nand its strength differs from, or its quality or purity falls below, the\nstandard set forth in such compendium. Such determination of strength, quality,\nor purity shall be made in accordance with the tests or methods of assay set\nforth in such compendium, or in the absence of or inadequacy of such tests or\nmethods of assay, those prescribed under authority of the federal act. No drug\ndefined in an official compendium shall be deemed to be adulterated under this\nsubsection because it differs from the standard of strength, quality, or purity\nset forth in such compendium, if the difference in strength, quality, or purity\nfrom such standard is plainly stated on its label.\n\t\t\tWhenever a drug is recognized in both the United States Pharmacopoeia\nNational Formulary and the Homeopathic Pharmacopoeia of the United States it\nshall be subject to the requirements of the United States Pharmacopoeia National\nFormulary unless it is labeled and offered for sale as a homeopathic drug, in\nwhich case it shall be subject to the provisions of the Homeopathic\nPharmacopoeia of the United States and not to those of the United States\nPharmacopoeia National Formulary.\n\nC. A drug or device shall be deemed to be adulterated if it is not subject to\nthe provisions of subsection B of this section and its strength differs from, or\nits purity or quality falls below, that which it purports or is represented to\npossess.\n\nD. A drug or device shall be deemed to be adulterated if it is a drug and any\nsubstance has been (i) mixed or packed with it so as to reduce its quality or\nstrength or (ii) substituted wholly or in part for it.\n\nHISTORY: Code 1950, \u00a7 54-461; 1970, c. 650, \u00a7 54-524.92; 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}}