{"data":{"id":"us-ok/okla.-stat.-tit.-63-63-1-1409","jurisdiction":"us-ok","citation":"Okla. Stat. tit. 63, § 63-1-1409","heading":"Misbranding of drugs and devices","body":"A drug or device shall be deemed to be misbranded:\n\n(a) if its labeling is false or misleading in any particular.\n\n(b) if in package form unless it bears a label containing:\n\n(1) the name and place of business of the\n\nmanufacturer of any prescription drug or device and the packer or\n\ndistributor; and the name and place of business of the manufacturer,\n\npacker or distributor of any nonprescription drug or device.\n\nManufacturer, as used herein, shall mean the person or firm which\n\nhas mixed, tableted, encapsulated or otherwise prepared the drug in\n\nthe form in which it is offered for sale to pharmacies.\n\n(2) an accurate statement of the quantity of the\n\ncontents in terms of weight, measure or numerical count; provided\n\nthat under this clause reasonable variations shall be permitted, and\n\nexemptions as to small packages shall be established, by regulations\n\nprescribed by the State Board of Health.\n\n(c) if any word, statement, or other information required by or\n\nunder authority of this article to appear on the label or labeling\n\nis not prominently placed thereon with such conspicuousness (as\n\ncompared with other words, statements, designs or devices, in the\n\nlabeling) and in such terms as to render it likely to be read and\n\nunderstood by the ordinary individual under customary conditions of\n\npurchase and use.\n\n(d) if it is for use by man and contains any quantity of the\n\nnarcotic or hypnotic substance alpha-eucaine, barbituric acid,\n\nbetaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine,\n\ncodeine, heroin, marihuana, morphine, opium, paraldehyde, peyote, or\n\nsulphonmethane; or any chemical derivative of such substance, which\n\nderivative has been by the State Commissioner of Health, after\n\ninvestigation, found to be, and by regulations under this article\n\ndesignated as, habit forming, unless its label bears the name and\n\nquantity or proportion of such substance or derivative and in\n\njuxtaposition therewith the statement \"Warning-May Be Habit\n\nForming.\"\n\n(e) if it is a drug and is not designated solely by a name\n\nrecognized in an official compendium unless its label bears:\n\n(1) the common or usual name of the drug, if such\n\nthere be; and\n\n(2) in case it is fabricated from two or more\n\ningredients, the common or usual name of each active ingredient,\n\nincluding the kind, quantity and proportion of any alcohol, and also\n\nincluding, whether active or not, the name and quantity or\n\nproportion of any bromides, ether, chloroform, acetanilid,\n\nacetphenetidin, antipyrine, atropine, hyoscine, hyoscyamine, arsenic\n\ndigitalis, digitalis glucosides, mercury, ouabain, strophanthin,\n\nstrychnine, thyroid, or any derivative or preparation of any such\n\nsubstances, contained therein; provided, that to the extent that\n\ncompliance with the requirements of this clause is impracticable,\n\nexemptions shall be established by regulations promulgated by the\n\nBoard.\n\n(f) unless its labeling bears:\n\n(1) adequate directions for use, and\n\n(2) such adequate warnings against use in those\n\npathological conditions or by children where its use may be\n\ndangerous to health, or against unsafe dosage or methods or duration\n\nof administration or application, in such manner and form, as are\n\nnecessary for the protection of users; provided, that where any\n\nrequirement of clause (1) of this paragraph, as applied to any drug\n\nor device, is not necessary for the protection of the public health,\n\nthe Board shall promulgate regulations exempting such drug or device\n\nfrom such requirements.\nsafe dosage or methods or duration\n\nof administration or application, in such manner and form, as are\n\nnecessary for the protection of users; provided, that where any\n\nrequirement of clause (1) of this paragraph, as applied to any drug\n\nor device, is not necessary for the protection of the public health,\n\nthe Board shall promulgate regulations exempting such drug or device\n\nfrom such requirements.\n\n(g) if it purports to be a drug the name of which is recognized\n\nin an official compendium, unless it is packaged and labeled as\n\nprescribed therein; provided, that the method of packing may be\n\nmodified with the consent of the Board. Whenever a drug is\n\nrecognized in both the United States Pharmacopoeia, and the\n\nHomeopathic Pharmacopoeia of the United States, it shall be subject\n\nto requirements of the United States Pharmacopoeia with respect to\n\npackaging and labeling unless it is labeled and offered for sale as\n\na homeopathic drug, in which case it shall be subject to the\n\nprovisions of the Homeopathic Pharmacopoeia of the United States,\n\nand not to those of the United States Pharmacopoeia.\n\n(h) if it has been found by the Commissioner to be a drug\n\nliable to deterioration, unless it is packaged in such form and\n\nmanner, and its label bears a statement of such precautions, as the\n\nBoard shall by regulations require as necessary for the protection\n\nof public health. No such regulation shall be established for any\n\ndrug recognized in an official compendium until the Commissioner\n\nshall have informed the appropriate body charged with the revision\n\nof such compendium of the need for such packaging or labeling\n\nrequirements and such body shall have failed within a reasonable\n\ntime to prescribe such requirement.\n\n(i) if it is a drug and its container is so made, formed, or\n\nfilled as to be misleading; if it is an imitation of another drug;\n\nor if it is offered for sale under the name of another drug.\n\n(j) if it is dangerous to health when used in the dosage or\n\nwith the frequency or duration prescribed, recommended, or suggested\n\nin the labeling thereof.\n\n(k) if it is a drug intended for use by man which:\n\n(1) is a habit-forming drug to which paragraph (d)\n\nof this section applies; or\n\n(2) because of its toxicity or other potentiality\n\nfor harmful effect, or the method of use, or the collateral measures\n\nnecessary to its use, is not safe for use except under the\n\nsupervision of a physician, dentist or veterinarian; or\n\n(3) is limited by an effective application under\n\nSection 505 of the Federal Act to use under professional supervision\n\nby a physician, dentist or veterinarian, unless it is dispensed\n\nonly:\n\n(i) upon a written prescription of a physician,\n\ndentist or veterinarian, or\n\n(ii) upon the oral prescription of a physician,\n\ndentist or veterinarian which is reduced promptly to writing and\n\nfiled by the pharmacist, or\n\n(iii) by refilling any such written or oral\n\nprescription if such refilling is authorized by the prescriber\n\neither in the original prescription or by oral order which is\n\npromptly reduced to writing and filed by the pharmacist; provided,\n\nthat any drug dispensed by filling or refilling a written or oral\n\nprescription of a physician, dentist, or veterinarian shall be\n\nexempt from the requirements of this section, except paragraphs (a)\n\nand (i), if the drug bears a label containing the name and address\n\nof the dispenser, the serial number and date of the prescription or\n\nits filling, the name of the prescriber, and, if stated in the\n\nprescription, the name of the patient, and the directions for use\n\nand cautionary statements, if any, contained in such prescription.\n\nThis exemption shall not apply to any drug dispensed in the course\n\nof the conduct of a business of dispensing drugs, pursuant to\n\ndiagnosis by mail.\nthe serial number and date of the prescription or\n\nits filling, the name of the prescriber, and, if stated in the\n\nprescription, the name of the patient, and the directions for use\n\nand cautionary statements, if any, contained in such prescription.\n\nThis exemption shall not apply to any drug dispensed in the course\n\nof the conduct of a business of dispensing drugs, pursuant to\n\ndiagnosis by mail.\n\n(1) if the packaging, name or appearance of a prescription\n\ndrug product is deceptively similar to or would cause unnecessary\n\nconfusion with competitive, chemically-similar drug products which\n\nhave a previously established or substantial position in the\n\nmarketplace.","path":["OK Code","Title 63"],"source_url":"https://www.oklegislature.gov/OK_Statutes/CompleteTitles/os63.pdf","current_through":"2026-08-14","vintage":"open-us-law v2026.08, retrieved 2026-09-14","retrieved_at":"2026-09-14T18:32:36Z","sha256":"16ff286a968fda5c9091467fbfa8aea0d6387f43725a14fa6c96a05362d6ac0c","source_id":"us-ok","stale":false,"prev":"us-ok/okla.-stat.-tit.-63-63-1-1408","next":"us-ok/okla.-stat.-tit.-63-63-1-1410"},"notice":"GroundRules: Original legal text. Not legal advice."}