§ 21-218. Additional drug misbranding grounds
West's Annotated Code of MarylandHealth--GeneralEffective: June 1, 2022
Effective: June 1, 2022
MD Code, Health - General, § 21-218
§ 21-218. Additional drug misbranding grounds
(a) In this section, “antibiotic drug” means any drug that:
(b) In addition to any other ground that may apply under § 21-217 or § 21-220 of this subtitle, a drug is misbranded if:
(1) It is for use by a human being and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca leaves, cocaine, codeine, heroin, morphine, opium, paraldehyde, peyote, sulphonmethane, or any chemical derivative of any of these substances, which derivative, after investigation, has been designated as habit forming under a rule or regulation adopted under the federal act or by the Secretary under this subtitle, unless its label states the name and quantity or proportion of the substance or derivative and, immediately beside that information, a warning that states: “Warning--May be habit forming.”;
(3) Except as otherwise permitted by a rule or regulation adopted under the federal act or by the Secretary under subsection (d)(2) of this section, it is made from 2 or more ingredients and its label does not bear the established name, if any, of and the quantity of each active ingredient, including the kind and quantity or proportion of any alcohol and, 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 of these substances, but a nonprescription drug is not misbranded under this item on the ground that its label does not show the quantity or proportion of an active ingredient unless the ingredient is specifically named in this item;
1. The applicable official compendium; or
2. A consent order granted under the federal act or by the Secretary to modify the packaging requirements of the official compendium;
(12) It is or it is purported to be a drug composed in whole or in part of any kind of penicillin, streptomycin, chlortetracycline, chloramphenicol, bacitracin, or any other antibiotic drug, or of any derivative of these drugs and, unless the drug has been exempted by rules and regulations adopted under the federal act, it is not from a batch for which a currently unexpired certificate or release has been issued under the federal act;
(14) It is a prescription drug that is distributed or offered for sale in this State, and the manufacturer, packer, or distributor of the drug does not include in any advertisement, or in any other descriptive printed matter that it issues or causes to be issued regarding the drug, a true statement of:
(c)(1) For purposes of subsection (b)(5) of this section, which imposes packaging and labeling requirements on any drug that is purported to be recognized in an official compendium, the provisions of this subsection shall apply.
(2)(i) Except as otherwise provided in this subsection, if the drug is recognized in both the United States Pharmacopoeia and National Formulary and in the Homeopathic Pharmacopoeia of the United States, it is subject to the packaging and labeling requirements of the United States Pharmacopoeia and National Formulary.
(3) If there is an inconsistency between the provisions of paragraph (2) of this subsection and the requirements of subsection (b)(2), (3), or (4) of this section as to the name by which a drug or its ingredients shall be designated, the requirements of subsection (b)(2), (3), or (4) of this section control.
(d)(1) For purposes of subsection (b)(1) of this section, after investigation, the Secretary may adopt a rule or regulation that designates any chemical derivative of any substance named in that subsection as habit forming.
(ii) The Secretary may not adopt a rule or regulation under subparagraph (i) of this paragraph before the Secretary has informed the appropriate body that is charged with the revision of the official compendium of the need for the packaging or labeling requirements and that body has failed to adopt the requirements within a reasonable time.
Credits
Added as Health-Environmental § 4-218 by Acts 1982, c. 240, § 2, eff. July 1, 1982. Transferred to Health-General § 21-218 by Acts 1987, c. 306, § 2, eff. July 1, 1987. Amended by Acts 1987, c. 306, § 15, eff. July 1, 1987; Acts 1988, c. 6, §§ 1, 11, eff. July 1, 1988; Acts 2022, c. 135, § 5.
Formerly Art. 43, § 189B.
MD Code, Health - General, § 21-218, MD HEALTH GEN § 21-218
Current through legislation effective through May 9, 2024, from the 2024 Regular Session of the General Assembly. Some statute sections may be more current, see credits for details.
End of Document |