Sec. 21a-106. (Formerly Sec. 19-226). Misbranded drugs and devices. - Connecticut Statutes

      Sec. 21a-106. (Formerly Sec. 19-226). Misbranded drugs and devices. A drug or device shall be deemed to be misbranded:

      (a) If its labeling is false or misleading in any particular. Any statement on the label or labeling either directly or indirectly implying that the product is recommended or endorsed by any agency of the federal or state government shall be considered misleading, unless the agency concerned has approved the statement prior to its use, or unless such statement is authorized by Section 357(c) of the federal act;

      (b) If in package form, unless it bears a label containing (1) the name and place of business of the manufacturer, packer or distributor, except that the label of a prescription drug packaged after October 1, 1976, shall contain 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 (2) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, provided reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations promulgated by the commissioner and director, acting jointly, or by regulations issued under the federal act;

      (c) If any information or other word or statement, required by or under authority of this chapter to appear on the label or labeling, is not prominently placed thereon 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;

      (d) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote or sulphonmethane, or any chemical derivative of any such substance, which derivative has been designated as habit-forming by regulations promulgated under Section 352(d) of the federal act; 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";

      (e) (1) If it is a drug, unless (A) its label bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula, (i) the established name, as defined in subdivision (2) of this subsection, of the drug, if such there be, and (ii), 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 also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein: Provided the requirement for stating the quantity of the active ingredients, other than those specifically named in this paragraph, shall apply only to prescription drugs packaged prior to July 1, 1980, and provided further, the requirement for stating the quantity or proportion of the active ingredients, other than those specifically named in this paragraph, shall apply to all drugs packaged on or after July 1, 1980, except nonprescription drugs which are also cosmetics; and (B) if it is a prescription drug, unless the established name of such drug or ingredient, as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is printed prominently and in type at least half as large as that used thereon for any proprietary name or designation for such drug or ingredient. To the extent that compliance with the requirements of clause (A) (ii) or clause (B) is impracticable, exemptions shall be established by regulations promulgated by the commissioner and director, acting jointly, or by regulations issued under the federal act. (2) As used in this subsection (e), the term, "established name", with respect to a drug or ingredient thereof, means (A) the applicable official name designated pursuant to Section 358 of the federal act, or (B), if there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium, or (C) if neither clause (A) nor clause (B) applies, then the common or usual name, if any, of such ingredient. Where clause (B) applies to an article recognized in the United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharmacopoeia 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;

      (f) Unless its labeling bears (1) adequate directions for use and (2) 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; provided, when any requirement of subdivision (1) of this subsection, as applied to any drug or device, is not necessary for the protection of the public health, the commissioner and director, acting jointly, shall promulgate regulations exempting such drug or device from such requirement; provided further, articles exempted under regulations issued under Section 352(f) of the federal act shall also be exempt from the requirements of this subsection;

      (g) 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 therein; provided the method of packing may be modified with the consent of the commissioner and director, acting jointly, and provided whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopoeia 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; provided further, in the event of inconsistency between the requirements of this subsection and those of subsection (e) as to the name by which the drug or its ingredients shall be designated, the requirements of subsection (e) shall prevail;

      (h) If it has been found by the commissioner to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a statement of such precautions, as the commissioner and director, acting jointly, by regulations, require as necessary for the protection of public health; provided no such regulations shall be established for any drug recognized in an official compendium until the commissioner has informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body has failed within a reasonable time to prescribe such requirements;

      (i) (1) If it is a drug and its container is so made, formed or filled as to be misleading or (2) if it is an imitation of another drug or (3) if it is offered for sale under the name of another drug;

      (j) If it is dangerous to health when used in the dosage, or with the frequency or duration, prescribed, recommended or suggested in the labeling thereof;

      (k) If it is a legend drug, as defined in subdivision (14) of section 20-571, that is not administered, dispensed, prescribed or otherwise possessed or distributed in accordance with federal and state laws and regulations;

      (l) If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements contained in regulations issued under the federal act;

      (m) In the case of any prescription drug distributed or offered for sale in any state, unless the manufacturer, packer or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer or distributor with respect to that drug a true statement of (1) the established name, as defined in subsection (e) (2) of this section, printed prominently and in type at least half as large as that used for any trade or brand name thereof, (2) the formula showing quantitatively each ingredient of such drug to the extent required for labels under subsection (e) of this section, and (3) such other information in brief summary relating to side effects, contraindications and effectiveness as required in regulations issued under the federal act unless it is a drug which has been exempted from the labeling provisions of the federal act, as effective on April 26, 1974, or is permitted to be sold without a prescription under the federal act, as effective on said date;

      (n) If it is a drug and was manufactured, prepared, propagated, compounded or processed in an establishment in this state not duly registered under section 21a-70;

      (o) 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 thereof, unless (1) it is from a batch with respect to which a certificate or release has been issued pursuant to Section 357 of the federal act, and (2) such certificate or release is in effect with respect to such drug; provided that this subsection shall not apply to any drug or class of drugs exempted by regulations promulgated under Section 357 (c) or (d) of the federal act. For the purpose of this subsection, "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a microorganism and which has the capacity to inhibit or destroy microorganisms in dilute solution, and the chemically synthesized equivalent of any such substance.

      (1949 Rev., S. 3944; 1951, S. 2095d; 1953, S. 2096d; 1957, P.A. 104; 1963, P.A. 359, S. 6; P.A. 74-72, S. 2, 3; P.A. 76-129; P.A. 79-116, S. 1; P.A. 91-164, S. 2; P.A. 95-264, S. 55; P.A. 00-182, S. 2.)

      History: 1963 act, in Subsecs. (a) and (b), added references to statement authorized by section 357(c) of federal act; in Subsec. (e), changed technical language, added references to antipyrine and thyroid and proviso in Subdiv. (1)(A)(ii), deleted provision for exemptions to be established by regulations promulgated by commissioner and director and added Subdivs. (1)(B) and (2); in Subsec. (f), added proviso re articles exempt under federal regulations; in Subsec. (g) added that Subsec. (e) shall prevail in case of inconsistency and added Subsecs. (l) through (o); P.A. 74-72 exempted from consideration as misbranded, drugs "exempted from the labeling provisions of the federal act ... or permitted to be sold without a prescription under the federal act, as effective on April 26, 1974" in Subsec. (m); P.A. 76-129 added exception re prescription drugs and deleted reference to Subdiv. (2) in Subsec. (b); P.A. 79-116 amended proviso in Subsec. (e)(1) to require statement of active ingredients only for prescription drugs "packaged before July 1, 1980" and to require statement of quantity or proportion of active ingredients for all drugs packaged after that date except for nonprescription drugs which are also cosmetics; Sec. 19-226 transferred to Sec. 21a-106 in 1983; P.A. 91-164 amended Subsec. (k) to include reference to Sec. 20-184d; P.A. 95-264 amended Subsec. (k) to include electronic transmission as a possible means of prescription and deleted provisions re refills of prescriptions for substances covered by the subsection; P.A. 00-182 replaced language in Subsec. (k) re a drug sold at retail containing certain substances with language re a legend drug.

      Annotation to former section 19-226:

      Cited. 29 CS 333.