Chapter 40

COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 1CHAPTER 40 GUAM FOOD ,DRUG AND COSMETI C ACT NOTE: P.L. 15 -96 amended and renumbered Subchapter W of Chapter VI of Title X, which appears here as Chapter 40 of this Title. § 40101. Title. § 40102. Definitions. § 40103. Prohibited Acts. § 40104. Jurisdicti on. § 40105. Penalty . § 40106. T ags for Adulterated Articles; V iolations. § 40107. Institution of Proceedings. § 40108. Regulations under Federal Act Apply . § 40109. Adulterated Food. § 40110. Misbranded Food. § 40111. Imports. § 40112. Exemptions from Lab eling Requirement. § 40113. Unsafe Substances. § 40114. Adulterated Drugs. § 40115. Misbranded Drugs. § 40116. Habit -Forming Drugs; Toxic Drugs. § 40117. Sale of New Drugs. § 40118. Adulterated Cosmetics. § 40119. Misbranded Cosmetics. § 40120. Labeling Re quirements. § 40121. Advertising. § 40122. Regulations. § 40123. Inspections. § 40124. Report of Minor V iolations. § 40125. Emergency Permit Control. § 40126. Reports of Judgment and Decrees. § 40127. Severability . § 40128. Effective Date. § 40129. Authori zation. § 40101. Title.

24. Report of Minor V iolations. § 40125. Emergency Permit Control. § 40126. Reports of Judgment and Decrees. § 40127. Severability . § 40128. Effective Date. § 40129. Authori zation. § 40101. Title. This Act may be cited as the 'Guam Food, Drug and Cosmetic Act.' SOURCE: GC§ 9720.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 2NOTE: The terms t his Act and Subchapter were used synonymously in the original version of P .L. 13 -143, with Subchapter being changed to Chapter here. § 40102. Definitions. For the purpose of this Act: (a) The effective date means the date this Act shall be implemented. (b) The Director means the Director of the Department of Public Health and Social Services. (c) The term person includes ind ividual, partnership, corporation and association. (d) The term foodmeans: (1) Articles used for food or drink for man or other animals; (2) Chewing gum; and (3) Articles used for components of any such article. (e) The term drug means: (1) Arti cles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official Nations Formulary , or any supplement to any of them; and (2) Articles

cles recognized in the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States or official Nations Formulary , or any supplement to any of them; and (2) Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (3) Articles (other than food) intended to affect the structure of any function of the body of man or other animals; and (4) Articles intended for use as a component of any article, specified i n clause (1), (2) or (3); but does not include devices or their components, parts or accessories. (f) The term counterfeit drug means a drug which, or the container or labeling of which, without authorization, bears the trademark, trade name or other iden tifying mark, imprint or device, or any likeness thereof, of a drug manufacturer, processor , packer or distributor other than the person or persons who in fact manufactured, pro cessed, packed or distributed such drug and which thereby falsely purports or is repre sented to be the product of, or to have been packed or distributed by , such other drug manufacturer, processor , packer or distributor .

uted such drug and which thereby falsely purports or is repre sented to be the product of, or to have been packed or distributed by , such other drug manufacturer, processor , packer or distributor . COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 3(g) The term device (except when used in Paragraph (o) of this Section and in §§ 40103(k), 40110(f), 40115(c) a nd (o) and 40119(c) means instruments, apparatus and contrivances, including their components, parts and accessories, intended: (1) For use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; or (2) T o affect t he structure or any function of the body of man or other animals. (h) The term cosmetic means: (1) Articles intended to be rubbed, poured, sprinkled or sprayed on, intro duced into or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attrac tiveness or altering the appearance; and (2) Articles intended for use as a component of any such articles, except that such term shall not include soap. (i) The term official compendium means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the

omponent of any such articles, except that such term shall not include soap. (i) The term official compendium means the official United States Pharmacopoeia, official Homeopathic Pharmacopoeia of the United State s, official National Formulary or any supplement to any of them. (j) The term consumer commodity ,except as otherwise specifically provided by this Subsection, means any food, drug, device or cosmetic as these terms are defined by this Act or by the Federal Act. Such term does not include: (1) Any tobacco or tobacco product; (2) Any commodity subject to packaging or labeling re quirements imposed under the Guam Purchasing and Labeling Law ( the Federal Insecticide, Fungicide and Rodenticide Act) or the provisions of the eighth paragraph under the heading 'Bu reau of Animal Industry' of the Act of March 4, 1913 (37 Stat. 832 -833; 21 U.S.C. 151 -157), commonly known as the V irus-Serum Toxin Act; (3) Any drug subject to the provisions of '40116(a) or (b), or '40115(k) of this Act, or '503(b) (1) or '506 of the Federal Act; (4) Any beverage subject to or comply ing with packaging or labeling require ments imposed under the Federal Alcohol Adminis tration Act (27 U.S.C., et

Act, or '503(b) (1) or '506 of the Federal Act; (4) Any beverage subject to or comply ing with packaging or labeling require ments imposed under the Federal Alcohol Adminis tration Act (27 U.S.C., et seq.); or COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 4(5) Any commodity subject to the provisions of the Federal Seed Act (7 U.S.C. 1551 -1610). (k) The term label means a display of English language written or printed or graph ic matter upon the immediate container of any article; and a requirement made by or under authority of this Act that any word, statement or other information appear on the label shall not be considered to be complied with unless such word, statement or other informa tion also appears on the outside container or wrapper, if any there be, of the retail pack age of such article, or is easily legible through the outside container or wrapper . (l) The term principal display panel means that part of a label that is most likely to be displayed, presented, s hown or examined under normal and customary conditions of display for retail sale. (m) The term container does not includes package liners.

f a label that is most likely to be displayed, presented, s hown or examined under normal and customary conditions of display for retail sale. (m) The term container does not includes package liners. (n) The term package means any container or wrapping in which any consumer commodity is enclosed for use in the de livery or display of that consumer commodity to retail purchas ers, but does not include: (1) Shipping containers or wrapping used solely for the transportation of any consumer commodity in bulk or in quantity to manufacturers, packers or processors or to wholesale or retail distributors thereof; (2) Shipping containers or outer wrap pings used by retailers to ship or deliver any commodity to retail customers if such containers and wrappings bear no printed matter pertaining to any particular commodity . (o) The term labeling means all labels and other English language written, printed or graphic matter: (1) Upon an article or any of its con tainers or wrappers; or (2) Accompanying such article. (p) The term advertisement means all representations dissem inated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to

ccompanying such article. (p) The term advertisement means all representations dissem inated in any manner or by any means, other than by labeling, for the purpose of inducing, or which are likely to induce, directly or indirectly , the pur chase of food, drugs, devices or cosmetics. (q) The representation of a drug, in its labeling or adve rtisement, as an antiseptic shall be considered to be a representation that it is a germicide, COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 5except in the case of a drug purporting to be, or represented as, an antiseptic for inhibitory use as a wet dress ing, ointment, dusting powder or such other useas involves prolonged contact with the body . (r) The term new drug means: (1) Any drug the composition of which is such that such drug is not generally recognized, among experts qualified by scientific training and experience to evalu ate the safety an d effectiveness of drugs, as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling thereof; or (2) Any drug the composition of which is such that such drug, as a result of investigations to determine its saf ety and effectiveness

prescribed, recommended or suggested in the labeling thereof; or (2) Any drug the composition of which is such that such drug, as a result of investigations to determine its saf ety and effectiveness for use under such condi tions, has become so recognized, but which has not, otherwise than in such investigations, been used to a material extent or for a material time under such conditions. (s) The term contaminated with filth applies to any food, drug, device or cosmetic not securely protected from dust, dirt or bacteria, and as far as may be necessary by all reasonable means, from all foreign or injurious contaminations. (t) The provisions of this Act regarding the selling of fo od, drugs, devices or cosmet ics shall be considered to include the manu facture, production, processing, packing, exposure, offer , possession and holding of any such article for sale; and the sale, dispensing and giving of any such article, and the supply ing or applying of any such articles in the conduct of any food, drug or cosmetic establishment. (u) The term pesticide chemical means any substance which, alone, in chemical combina tion, or in formulation with one or more other substances is an

duct of any food, drug or cosmetic establishment. (u) The term pesticide chemical means any substance which, alone, in chemical combina tion, or in formulation with one or more other substances is an 'economi c poison' within the meaning of (the Federal Insecticide, Fungicide and Rodenticide Act, 7 U.S.C. ''135-135K, as now enac ted or as hereafter amended) and which is used in the production, storage or transportation of raw agricultural commodities. (v) The t erm rawagricultural commodity means any food in its raw or natural state, including all fruits that are washed, colored or otherwise treated in their unpeeled natural form prior to marketing. (w) The term food additive means any substance, the intended u seof which results or may be reasonably expected to result, directly or indirectly , in its becoming a component or otherwise affecting the charac teristics of COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 6any food (including any substance intended for use in producing, manufactur ing, packing, proces sing, preparing, treat ing, packaging, transporting or holding food; and including any source of radiation intend ed for any such use) if such

ed for use in producing, manufactur ing, packing, proces sing, preparing, treat ing, packaging, transporting or holding food; and including any source of radiation intend ed for any such use) if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety , as having been adequately shown through scientific procedures (or, in the case of a substance used in a food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditio ns of its intended use; except that such term does not include: (1) A pesticide chemical in or on a raw agricultural commodity; or (2) A pesticide chemical to the extent that it is intended for use or is used in the production, storage or transportation of any raw agricultural commodity; or (3) A color additive; or (4) Any substance used in accordance with a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958, pursuant to the Fed eral Act; the Poultry Products Ins pection Ac t (21 U.S.C. 541 et. seq.) or the Meat Inspection Act of March 4, 1907 (34 Stat.

e enactment of the Food Additives Amendment of 1958, pursuant to the Fed eral Act; the Poultry Products Ins pection Ac t (21 U.S.C. 541 et. seq.) or the Meat Inspection Act of March 4, 1907 (34 Stat. 1260), as amended and extended (21 U.S.C. 71 et. seq.). (x) (1) The term color additive means a material which (a) is a dye, pigment or other substance made by a p rocess of synthesis or similar artificer, or extracted, isolated or otherwise derived, with or without intermediate or final change of identity , from a vegetable, animal, mineral or other source; or (b) when added or applied to a food, drug or cosmeti c, or to the human body or any part thereof, is capable (alone or through reaction with other substance) or imparting color there to; except that such term does not include any material which has been or hereafter is exempted under the Federal Act. (2) The term color includes black, white and intermediate grays. (3) Nothing in clause (1) of Section 2 (x) shall be construed to apply to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely be cause of its effect in aidin g, retarding or otherwise affecting, directly or indirectly , the growth or

ly to any pesticide chemical, soil or plant nutrient, or other agricultural chemical solely be cause of its effect in aidin g, retarding or otherwise affecting, directly or indirectly , the growth or other natural COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 7physiological process of produce of the soil and thereby affecting its color, whether before or after harvest. (y) The term Federal Act means the Drug and Cosmetic Act(Title 21 U.S.C. 301 et. seq.) and the Federal Fair Packaging and Labeling Act. (z) The term pull date means the calendar date printed by the manufacturer on the package or wrapping which represents the date after which the manufacturer recommends that t he product not be sold: (aa) The term pack date means the com plete date (month in letters, day and year in numbers) printed by the manufacturer on the package, which represents the date the product has been produced and packaged. SOURCE: GC§ 9720.1, as amended by P .L. 14 -17. § 40103. Prohibited Acts. The following acts and the causing thereof within the territory of Guam are hereby prohibited: (1) The manufacture, sale or delivery , holding or offering for sale of any food, drug,

Prohibited Acts. The following acts and the causing thereof within the territory of Guam are hereby prohibited: (1) The manufacture, sale or delivery , holding or offering for sale of any food, drug, device or cosmetic th at is adulterated or misbranded; (2) The adulteration or misbranding of any food, drug, device or cosmetic, except that, in the case of a food for which the pull date has expired, it may be sold, provided that a sign or notice clearly expressing the fact that the pull date has expired is placed in a conspicuous place next to the items in such a manner as to clearly inform the consumer as to the affected commodities; (3) The receipt in commerce of any food, drug, device or cosmetic that is adulterated or m isbranded, and the delivery or proffered delivery thereof for pay or otherwise; (4) The distribution in commerce of a consumer commodity if such commodity is contained in a package, or if there is affixed to that commodity a label, which does not conform to the provisions of this Chapter and of regulations promulgated under authority of this Chapter; provided, however, that this prohibition shall not apply to persons engaged in business as wholesale or retail

ovisions of this Chapter and of regulations promulgated under authority of this Chapter; provided, however, that this prohibition shall not apply to persons engaged in business as wholesale or retail distributors of consumer commodities except to the extent that such persons: (i) are engaged in the packaging or labeling of such commoditie s; or COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 8(ii) prescribe or specify by any means the manner in which such commodities are packaged or labeled; (5) The sale, delivery for sale, holding for sale, or o ffering for sale of any article in violation of ''40111 or 40117; (6) The dissemination of any false advertisement; (7) The refusal to permit entry or inspec tion, or to permit the taking of a sample, or to permit access to or copying of any record as au thorized by '40123; (8) The giving of a guaranty or undertak ing which is false; (9) The removal or disposal of a detained or embargoed article in violation of '40106; (10) The alteration, mutilation, destruction, obliteration or removal of the whole or part of the labeling of, or the doing of any other Act with respect to a food, drug, device or cosmetic, if such act

) The alteration, mutilation, destruction, obliteration or removal of the whole or part of the labeling of, or the doing of any other Act with respect to a food, drug, device or cosmetic, if such act is done while such article is held for sale and results in such article being adulterated or misbranded; (11) Repackaging of food, drugs or cosmet ics unless the repackaged product conforms to all labeling requirements set out in this Act; (12) Forging, counterfeiting, simulating or falsely representing, or without proper au thority using any mark, stamp, tag, label or other identification device, authorized or required by regulations promulgated under the provisions of this Chapter or of the Federal Act; (13) The using by any person to his own advantage, or revealing, other than to the Consumer Counsel or his authorized represen tative or to the Courts when relevant in any judicial proceeding of any information ac - quired under authority of this Chapter concerning any method or process which as a trade secret is entitled to protection; (14) The using, on the labeling of any drug or in any advertisement relating to such drug, or any representation or suggestion that an application

s which as a trade secret is entitled to protection; (14) The using, on the labeling of any drug or in any advertisement relating to such drug, or any representation or suggestion that an application with respect to such drug is effective under '40117, or that such drug complies with the provisions of such Section; (15) In the case of a prescription drug distr ibuted or offered for sale in this Territo ry, the failure of the manufacturer , packer or distributor thereof to maintain for trans mittal or to transmit, to any practitioner licensed by applicable law to administer such drug who makes written request for COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 9informa tion as to such drug, true and correct copies of all printed matter which is required to be included in any package in which that drug is distributed or sold, or such other printed matter as is approved under the Federal Act. Nothing in this Paragr aph shall be construed to exempt any person from labeling require ments imposed by or under other provisions of this Chapter; (16) (i) Placing or causing to be placed upon any drug or device or container thereof, with intent to defraud, the trade name

eling require ments imposed by or under other provisions of this Chapter; (16) (i) Placing or causing to be placed upon any drug or device or container thereof, with intent to defraud, the trade name or other identifying mark, or imprint of another or any likeness of any of the foregoing; or (ii) Selling, dispensing, disposing of or causing to be sold, dispensed of, or disposed of, or concealing or keeping in possession, control or custody , with inten t to sell, dispense or dispose of any drug, device or any container thereof, with knowledge that the trade name or other identifying mark or imprint of another or any likeness of any of the foregoing has been placed thereon in a manner prohibited by Paragr aph (i) hereof; or (iii) Making, selling or disposing of, causing to be made, sold or disposed of, keeping in possession, control or custody , or concealing any punch, die, plate, stone or other thing designed to print, imprint or reproduce the trademark, trade name or other identifying mark, imprint or device of another, or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug; (17) The doing of any act

ying mark, imprint or device of another, or any likeness of any of the foregoing upon any drug or container or labeling thereof so as to render such drug a counterfeit drug; (17) The doing of any act which causes a drug to be a c ounterfeit drug, or the sale or dispensing, or the holding for sale or dis pensing of counterfeit drug; (18) Dispensing or causing to be dispensed a different drug or brand of drug in place of the drug or brand of drug ordered or pre scribed without the express permission in each case of the person ordering or prescribing. SOURCE: GC§ 9720.2. § 40104. Jurisdiction. In addition to the remedies hereinafter provided, the Consumer Counsel or Director is hereby authorized to apply to the Superior Court for, and such Court shall have jurisdiction upon hearing and for cause shown, to grant a temporary or permanent injunction restraining any person from COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 10violating any provision of '40103; irrespective of whether or not there exists an adequate remedy at law . SOURCE: GC§ 9720.3, as amended by P .L. 15 -96. § 40105. Penalty.

OD,DRUG AND COSMETIC ACT 10violating any provision of '40103; irrespective of whether or not there exists an adequate remedy at law . SOURCE: GC§ 9720.3, as amended by P .L. 15 -96. § 40105. Penalty. (a) Any person who violates any of the provisions of '40103 shall be guilty of a misdemeanor. (b) No person shall be subject to the penal ties of Subsection (a) of this Section, for having violated Section 3(a) or (c) if he establishes a guaranty or undertaking signed by , and contain ing the name and address of, the person resid ing in the territory of Guam from whom he received in good faith the article, to the effect that such article is not adulterated or misbrand - ed within the meaning of this Act, designated this Act. (c) No publisher , radio -broadcast licensee or agency or medium for the dissemination of an advertisement, except the manufacturer , packer , distributor or seller of the art icle to which a false advertisement relates, shall be liable under this Section for the dissemination of such false advertisement. SOURCE: GC§ 9720.4, as amended by P .L. 13 -187. NOTE: Subsection (b) appears here as in the original P .L. 13 -143. See note to '40115. § 40106.

on for the dissemination of such false advertisement. SOURCE: GC§ 9720.4, as amended by P .L. 13 -187. NOTE: Subsection (b) appears here as in the original P .L. 13 -143. See note to '40115. § 40106. T ags for Adulterated Articles; Violations. (a) Whenever a duly authorized agent of the Director finds or has probable cause to believe that any food, drug, device, cosmetic or consumer commodity , as defined by this Act, is adulterat ed or so misbranded as to be dangerous or fraudulent, within the meaning of this Act or is in violation of ''40111 or 40117 of this Act, he shall affix to such articles a tag or other appropriate marking giving notice that such article is or is suspected o f being adulterated or misbranded and has been detained or embargoed, and warning all persons not to remove or dispose of such article by sale or otherwise until permission for removal or disposal is given by an authorized agent of the Director or the Cour t. It shall be unlawful for any person to remove or dispose of such detained or embargoed article by sale or otherwise without such permission. (b) When an article is adulterated or mis branded or is in violation of ''40111 or 40117 of this Act it

or dispose of such detained or embargoed article by sale or otherwise without such permission. (b) When an article is adulterated or mis branded or is in violation of ''40111 or 40117 of this Act it shall b e liable to be proceeded against by petition of the judge of the Court for libel for condemnation of such article. COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 11When an authorized agent has found that an article which is embargoed or detained is not adulterated or misbranded, he shall remove the tag o r other marking. (c) If the Court finds that a sampled, detained or embargoed article is adulterated or misbranded, such article shall, after entry of the decree, be destroyed at the expense of the owner thereof under the supervision of an authorized agen t, and all Court costs and fees, storage and other proper expenses shall be taxed against the owner of such article or his agent; provided, that when the adulteration or misbranding can be corrected by proper labeling or processing of the article, the Cour t, after entry of the decree and after such costs, fees and expenses have been paid and a good and sufficient bond, conditioned that such article

roper labeling or processing of the article, the Cour t, after entry of the decree and after such costs, fees and expenses have been paid and a good and sufficient bond, conditioned that such article shall be so labeled or processed has been exe cuted, may be order direct that such article be delivered to the owner thereof for such labeling or processing under the supervision of an agent of the Director . The expense of such supervi sion shall be paid by the owner. The article shall be returned to the owner and the bond shall be discharged on the representation to the Court by the Director that the article is no longer in violation of this Act and that the expenses for such supervision have been paid. (d) Whenever the Director or any of his authorized agents shall find in any room, build ing, vehicle of transpo rtation or other structure, any meat, seafood, poultry , vegetable, fruit or other perishable articles which are unsound or contain any filthy , decomposed or putrid sub stance or that may be poisonous or deleterious to health or otherwise unsafe, the same b eing hereby declared to be a nuisance, the Director of his authorized agent shall forthwith condemn or destroy the

ce or that may be poisonous or deleterious to health or otherwise unsafe, the same b eing hereby declared to be a nuisance, the Director of his authorized agent shall forthwith condemn or destroy the same or in any other manner render the same unsalable as human food. SOURCE: GC§ 9720.5, as amended by P .L. 15 -96. § 40107. Institution of Proceedings. It shall be the duty of the Director to cause appropriate proceedings to be instituted in the proper courts without delay and to be prosecuted in the manner required by law . Before the institution of a criminal proceeding, the person agains t whom such proceeding is contemplated shall be given appropriate notice and an opportunity to present his views before the Director or his designated agent, either orally or in writing, in person or by attorney , with regard to such contemplated proceeding . SOURCE: GC§ 9720.6.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 12§ 40108. Regulations under Federal Act Apply. (a) Definitions and standards of identity , quality and fill of container and their amendments, now or hereafter adopted under authority of the Federal Act are the definitions and stan dards of identity ,

efinitions and standards of identity , quality and fill of container and their amendments, now or hereafter adopted under authority of the Federal Act are the definitions and stan dards of identity , quality and fill of container in this T erritory . However, when in his judgment such action will promote honesty and fair dealing in the interest of consumers, the Director may promulgate regulations estab lishing definitions and standard s of identity , quality and fill of container for foods where no Federal regulations exist. In addition, the Director may promulgate amendments to any Federal or local regulations which set definitions and standards of identity , and may promulgate amendment s to any Federal or local regulations which set standards of quality and fill of con tainer for foods. (b) T emporary permits now or hereafter granted for import of experimental packs of food varying from the requirements of Fede ral defini - tions and standa rds of identity are automatically effective in this Territory under the conditions provided in such permits. In addition, the Director may issue additional permits where they are necessary to the completion of conclusiveness of an otherwise

ve in this Territory under the conditions provided in such permits. In addition, the Director may issue additional permits where they are necessary to the completion of conclusiveness of an otherwise adequate invest igation and where the interests of consumers are safeguarded. Such permits are subject to the terms and condi tions the Director may prescribe by regulation. SOURCE: GC§ 9720.7. § 40109. Adulterated Food. A food shall be deemed to be adulterated: (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; (2) (A) if it bears or contains any added poisonous or added deleterious substance, other than one which is (i) a pesticide chemical in or on a raw agricul tural commodity; (ii) a food addit ive; or (iii) a color additive, which is unsafe within the meaning of Section 14(a); or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemi cal which is unsafe within the meaning of the

or additive, which is unsafe within the meaning of Section 14(a); or (B) if it is a raw agricultural commodity and it bears or contains a pesticide chemi cal which is unsafe within the meaning of the Federal Act; or COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 13(C) if it is or it bears or contains any food additive which is unsafe within the meaning of the Federal Act provided, that where a pesticide chemical has been used in or on a raw agricultural commodity in conformity with an exemption granted or tolerance prescribed by th e Federal Act and such raw agricultural commodity has been subjected to processing such as canning, cooking, freezing, dehydrating or milling, the residue of such pesticide chemical remaining in or on such processed food shall, notwithstanding the provisio ns of '40113 and clause (C) of this Paragraph not be deemed unsafe if such residue in or on the raw agricultural commodity has been removed to the extent possible in good manufacturing practice, and the concen tration of such residue in the processed food when ready -to-eat is not greater than the tolerance prescribed for the raw agricultural commodity; (3) If it consists in

turing practice, and the concen tration of such residue in the processed food when ready -to-eat is not greater than the tolerance prescribed for the raw agricultural commodity; (3) If it consists in wholly or in part of a diseased, contaminated, filthy , putrid or decomposed substance, or if it is otherwise unfit for food; (4) If i t has been produced, prepared, packed or held under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been ren dered diseased, unwholesome or injurious to health; (5) If it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter , or of an animal that has been fed upon the uncooked offal from a slaughterhouse; (6) If its container is composed, in whole or in part, of any poisonous or deleterious subst ance which may render the contents injurious to health; (7) If it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemp tion in effect pursuant to '40113 of this Act or '409 of the Fede ral Act; (8) If any valuable constituent has been in whole or in part omitted or abstracted

in conformity with a regulation or exemp tion in effect pursuant to '40113 of this Act or '409 of the Fede ral Act; (8) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; (9) If any substance has been substituted wholly or in part therefor; (10) If damage or inferiority has been concealed in any manner; (11) If any sub stance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality of strength or make it appear better or of greater value than it is; COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 14(12) If it is confectionery , and (i) has partially or completely im bedded therein any non -nutritive object; provided, that this clause shall not apply in the case of any non -nutritive objective if in the judgment of the Director as provided by regulations, such object is of practical functional value to the confectionery product and would not render the product injurious or hazardous to health; (ii) bears or contains any alcohol other than alcohol not in excess of one -half of the one percent (1/2 of 1%) by volume derived solely from the use of flavoring extracts; or

or hazardous to health; (ii) bears or contains any alcohol other than alcohol not in excess of one -half of the one percent (1/2 of 1%) by volume derived solely from the use of flavoring extracts; or (iii) bears or contains any non - nutritive sub stance; provided, that this clause shall apply to a safe non - nutritive substance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture, packaging or storing of such confectionery if the use of the substance does not promote deception of the consumer or otherwise result in adulteration or misbrand ing in violation of any provision of this Act; and provided further , that the Director may, for the purpose of avoidin g or resolving uncertainty as to the application of this clause, issue regulations allowing or prohibit ing the use of particular non -nutritive substances. (13) If it is or bears or contains any color additive which is unsafe within the meaning of the Fed eral Act; or (14) If the product has a pull date on the packaging which has expired. SOURCE: GC§ 9720.8. NOTE: Subsection (2)(A)(iii) appears here as in the original P .L. 13 -143. See Note to '40115. § 40110.

or (14) If the product has a pull date on the packaging which has expired. SOURCE: GC§ 9720.8. NOTE: Subsection (2)(A)(iii) appears here as in the original P .L. 13 -143. See Note to '40115. § 40110. Misbranded Food. A food shall be deemed to b e misbranded: (1) If its labeling is false or misleading in any particular; (2) If its labeling or packaging fails to conform with the requirements of '40120 of this Act; (3) If it is offered for sale under the name of another food; (4) If it is an imi tation of another food unless its label bears in type of uniform size and prominence the word, imitation , and, immediately thereafter , the name of the food imitated; (5) If its container is so made, formed or filled as to be misleading; (6) If in package form, unless it bears a label containing (i) the name and place of business of the manufacturer, packer or distributor; (ii) an COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 15accurate statement of the net quantity of the contents in terms of weight, measure or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label; provided, that

contents in terms of weight, measure or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label; provided, that under clause (ii) of this Paragraph reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the Director; (7) If any word, statement or other infor mation required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspic uousness (as compared with other wor ds, statements, designs or devices in the label ing) 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; (8) If it purports to be or is represented as food for which a definition and standard of identity has been prescribed by regulations as provided by '40118, unless (i) it conforms to such definition and standard, and (ii) its label bears the name of the food specified in the definition and standards, and, insofar a s may berequired by such regulations, the common names of optional ingredients (other than

ard, and (ii) its label bears the name of the food specified in the definition and standards, and, insofar a s may berequired by such regulations, the common names of optional ingredients (other than spices, flavoring and coloring) present in such food; (9) If it purports to be or is represented as: (i) a food for which a standard of quality has been prescribed by regulations as provided by '40108, and its quality falls below such standard, unless its label bears, in such manner and form as regulations specify , a statement that it falls below such standard; or (ii) a food for which a standard or standards of fil l of container have been prescribed by regulation as provided by '40108, and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify , a statement that it falls below s uch standard; (10) If it is not subject to the provisions of Paragraph (8) of this Section unless it bears labeling clearly giving (i) the common or usual name of the food, if any there be and (ii) in case it is fabricated from two or more ingredients, th e common or usual name of each such ingredient; except that

clearly giving (i) the common or usual name of the food, if any there be and (ii) in case it is fabricated from two or more ingredients, th e common or usual name of each such ingredient; except that spices, flavorings and colorings, other than those sold as such may be designated as spices, flavorings and colorings, without naming each; provided, that to the extent that compliance with the re quirements of clause (ii) of this Paragraph is impractical or results in deception or unfair competition, exemptions shall be established by regulations promul gated by the Director; COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 16(11) If it purports to be or is represented for special dietary uses, un less its labels bears such information concerning its vitamin, mineral and other dietary properties as the Director determines to be, and by regulations prescribes as, necessary in order to fully inform purchasers as to its value for such uses; (12) If it bears or contains any artificial flavoring, coloring or c hemical preservative, unless it bears labeling stating that fact; provided, that to the extent that compliance with the requirements of this Paragraph is

tains any artificial flavoring, coloring or c hemical preservative, unless it bears labeling stating that fact; provided, that to the extent that compliance with the requirements of this Paragraph is impracticable, exemptions shall be establish ed by regulations promulgated bythe Director . The provisions of this Paragraph and Para graphs (8) and (10) with respect to artificial coloring do not apply to butter, cheese or ice cream. The provisions of the paragraph with respect to chemical preservat ives do not apply to a pesticide chemical when used in or on a raw agricultural commodity which is the produce of the soil; (13) If it is a raw agricultural commodity bearing or containing a pesticide chemical applied after harvest, unless the shipping co ntainer of such commodity bears labeling which declares the presence of such chemical in or on such commodity and the common or usual name and the function of such chemical; provided, however, that no such declaration shall be required while such commodity , having been removed from the shipping container , is being held or displayed for sale at retail out of such container in accordance with the custom of the trade; (14) If it is a

hile such commodity , having been removed from the shipping container , is being held or displayed for sale at retail out of such container in accordance with the custom of the trade; (14) If it is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded; or (15) If it is a color additive unless its packaging and labeling requirements applica ble to such color additive prescribed under the provisions of t he Federal Act. (16) If any locally packaged and/or pro cessed food bears no calendar date indicating the pack date' written in English and which is easily legible and visible to the consumer. SOURCE: GC§ 9720.9, as amended by P .L. 14 -17. § 40111. Impor ts. (a) The owner or con signee of each import shipment of any article subject to the provisions of this Chapter, shall furnish to the Director , at least seven (7) working days prior to importation, accurate information with COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 17respect to the identity , quan tity and value, source and origin, ownership, location of the import shipment and

nformation with COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 17respect to the identity , quan tity and value, source and origin, ownership, location of the import shipment and any other perti nent information needed or required by regulation to be promulgated by the Director . (b) The Director , Customs & Quarantine Agency , shall deliver to the Director , upon his request, samples of food, drugs, devices and cosmetics which are being imported or offered for import into Guam, giving notice thereof to the owner or consignee, who may appear before the Director and have the right to introduce testimony .The Director shall furnish to the Customs & Quarantine Agency a list of estab lishments registered in accordance with Subsec tion (i) of '510 of the Federal Act, and shall re quest that if any drugs manufactured, pre pared, propagated, compounded or proce ssed in an establishment not so registered are imported or offered for import into Guam, samples of such drugs be delivered to the Director with notice of such delivery to the owner of consignee, who may appear before the Director and have the right to int roduce testimony .

t into Guam, samples of such drugs be delivered to the Director with notice of such delivery to the owner of consignee, who may appear before the Director and have the right to int roduce testimony . If it appears from the examination of such samples of food, drugs, devices and cosmetics, or otherwise that (1) such article has been manufactured, processed or packed under insanitary conditions, or (2) such article is forbidden or restr icted in sale in the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded or is in violation of '40117 of this Chapter , then such article shall be refused admission, except as provided in Subsection (c) of this Section. The Customs & Quarantine Agency shall cause the destruction of any such article refused admission unless such article is exported under regulations prescribed by the Customs & Quarantine Agency within ninety (90) days of the date of t he notice such refusal or within such additional time as may be permitted pursuant to such regulations. This Paragraph shall not be construed to prohib it the admission of narcotic drugs, the importa tion of which is permitted under the Guam

tional time as may be permitted pursuant to such regulations. This Paragraph shall not be construed to prohib it the admission of narcotic drugs, the importa tion of which is permitted under the Guam Uniform Contro lled Substances Act. (c) Pending decision as to the admission of an article being imported or offered for import, the Custopms & Quarantine Agency may authorize delivery of such article to the owner or consignee upon the execution by him of a good and suf ficient bond providing for the payment of such liquidated damages in the event of default as may be required pursuant to the regulations of the Customs & Quarantine Agency . If it appears to the Director that an article included within the provisions of cla use (3) of Subsection (a) of this Section can, by relabeling or other action, be brought into compliance with this Chapter or rendered other than a food, drug, device or cosmetic, final determination as to admission of such article may COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 18be deferred and, upo n filling of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions

H.40GUAM FOOD,DRUG AND COSMETIC ACT 18be deferred and, upo n filling of timely written application by the owner or consignee and the execution by him of a bond as provided in the preceding provisions of this Subsection, the Director may in accordance with regulations, authorize the applicant to perform such relabe ling or other action specified in such authorization (including destruction or export of rejected articles or portions thereof, as may be specified in the Director's authorization). All such relabeling or other action pursuant to such authorization shall i n accordance with regulations be under the supervision of an officer or em ployee of the Department of Public Health and Social Services designated by the Director or an officer or employee of the Department of Com merce, Customs and Quarantine designated by the Director of that Department. (d) All expenses (including travel, per diem or subsistence, and salaries of officers or employees of the government of Guam) in con nection with the destruction provided for in Subsection (b) of this Section and the su pervi - sion of the relabeling or other action authorized under the provisions of Subsection (c) of this Section,

ection with the destruction provided for in Subsection (b) of this Section and the su pervi - sion of the relabeling or other action authorized under the provisions of Subsection (c) of this Section, the amount of such expenses to be determined in accordance with regulations, and all expenses in connection with the storage, cartage or labor w ith respect to any article refused admission under Subsection (b) of this Section, shall be paid by the owner or consignee and in default of such payment shall constitute a lien against any future importations made by such owner or consignees. SOURCE: GC § 9720.10. NOTE: The Legislature has separated Customs & Quarantine from the Department of Commerce. See 5 GCA Chapter 73. § 40112. Exemptions from Labeling Require ment. The Director shall promulgate regula tions e xempting from any labeling requirement of this Act food which is, in accordance with the practice of the trade, to be processed, labeled or repacked in substantial quantities at e stab- lishments other than those where originally processed or packed, on condition that such food is not adulterate d or misbranded under the provisions of this Act upon removal from such processing,

tab- lishments other than those where originally processed or packed, on condition that such food is not adulterate d or misbranded under the provisions of this Act upon removal from such processing, labeling or repacking establishment. Regulations now or hereafter adopted under authority of the Federal Act relating to such exemptions are automatically effective in this Territory . However, the Director may promul gate additional regulations or amendments to existing regulations concerning exemptions. SOURCE: GC§ 9720.11.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 19§ 40113. Unsafe Substances. (a) Any added poisonous or deleterious substance, any food additive, any pesticide chemical in or on a raw agricultural commodity or any color additive, shall with respect to any particular use or intended use be deemed unsafe for the purpose of application of clause (2) of '40109 with re spect to any food, '40114 with respec t to any drug or device or '40118 with respect to any cosmetic, unless there is in effect a regulation pursuant to '40122 of this Act or Subsection (b) of this Section limiting the quantity of such substance, and the use or intended use of such

t to any cosmetic, unless there is in effect a regulation pursuant to '40122 of this Act or Subsection (b) of this Section limiting the quantity of such substance, and the use or intended use of such substance c onforms to the terms prescribed by such regulation. While such regulations relating to such substance are in effect, a food, drug or cosmetic shall not, by reason of bearing or containing such substance in accordance with the regulations, be considered adu lterated within the meaning of clause (1), ''40109, 401 14 or 40118. (b) The Director, whenever public health or other considerations in this Territory so require, is authorized to adopt, amend or repeal regula tions whether or not in accordance with regul ations promulgated under the Federal Act, prescribing therein tolerances for any added, poisonous or deleterious substances, for food additives, for pesticide chemicals in or on raw agricultural commodities, or for color additives, including, but not limited to, zero tolerances and exemptions from tolerances in the case of pesti cide chemicals in or on raw agricultural commodi ties, and prescribing the conditions under which a food additive or a color additive may be

rances and exemptions from tolerances in the case of pesti cide chemicals in or on raw agricultural commodi ties, and prescribing the conditions under which a food additive or a color additive may be safely used and exemptions where such f ood additive or color additive is to be used solely for inves tigational or experimental purposes, upon his own motion or upon the petition of any interest ed party requesting that such a regulation be established. It shall be incumbent upon such petitione r to establish by data submitted to the Director that a necessity exists for such regula tions, and that its effect will not be detrimental to the public health. If the data furnished by the petitioner is not sufficient to allow the Director to determine w hether such regulation should be promulgated, the Director may require additional data to be submitted and failure to comply with the request shall be sufficient grounds to deny the request. In adopting, amending or repealing regulations relating to such s ubstances the Director shall consider among other relevant factors the following which the petitioner , if any , shall furnish: (1) The name and all pertinent information concerning such

ng to such s ubstances the Director shall consider among other relevant factors the following which the petitioner , if any , shall furnish: (1) The name and all pertinent information concerning such substance including where available, its chemical identity and COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 20composi tion, a statement of the conditions of the proposed use, including directions, recommen dations and suggestions and including speci mens of proposed labeling, all relevant data bearing on the physical or other technical effect and the quantity required to produce such effect; (2) The probable composition of any sub stance formed in or on a food, drug or cosmetic resulting from the use of such substance; (3) The probable consumption of such substance in the diet of man and animals taking into account any chemically or pharma - cologically related substance in such diet; (4) Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such substances for the use or uses for which they are proposed to be used, are generally recog nized as appropriate for the use of animal experimentation

ing and experience to evaluate the safety of such substances for the use or uses for which they are proposed to be used, are generally recog nized as appropriate for the use of animal experimentation data; (5) The availability of any needed practi cable methods of analysis for determining the identity and quantity of (i) such substance in or on an article; (ii) anysubstance formed in or on such article because of the use of such substance; and (iii) the pure substance and all intermediates and impurities; and (6) Facts supporting a contention that the proposed use of such substance will serve a useful purpose. SOURCE: GC§ 9720.12. § 40114. Adulterated Drugs. A drug or device shall be deemed to be adulterated: (1) If it consists in whole or in part of any filthy , putrid or decomposed substance; (2) If it has been produced, prepared, packed or held under uns anitary conditions where by it may have been rendered injurious to health; (3) 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 administ ered in conformity with current good manufacturing practice to assure

facilities or controls used for its manufacture, processing, packing or holding do not conform to or are not operated or administ ered in conformity with current good manufacturing practice to assure that such drug meets the require ments of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented t o possess; COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 21(4) If it is a drug and its container is composed, in whole or in part, or any poison ous or deleterious substance which may render the contents injurious to health; (5) If it is a drug and it bears or contains for purposes of coloring only , acolor additive which is unsafe within the meaning of the Federal Act; (6) If 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; (7) 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 com pendium.

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 com pendium. Such determination as to strength, quality or purity sha ll 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 s hall be deemed to be adulterated under this Paragraph because it differs from the standard of strength, quality or purity therefor set forth in such compendium, if its difference in strength, quality or purity from such standard is plainly stated on its la bel. Whenever a drug is recognized in both the United States Pharmacopoeia and the Homeopathic Pharmaco poeia of the United States it shall be subject to the requirements of the United States Pharmacopoeia unless it is labeled and offered for sale as a ho meopathic 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

is labeled and offered for sale as a ho meopathic 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; (8) If it is not subject to the provisions of Paragraph (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; or (9) If it is a drug and any substance has been (i) mixed or packed therewith so as to reduce its quality or strength; or (ii) substi tuted wholly or in part therefor . SOURCE: GC§ 9705.13. § 40115. Misbranded Drugs. A drug or device shall be deemed to be misbranded: COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 22(1) If its labeling is false or misleading in any particular, or if its labeling or packaging fails to conform with the requirements of '40120 of this Act; (2) If in package form unless it bears a label containing (i) the name and place of business of the manufacturer , packer or distributor; and (ii) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, which statement shall be separately and

ess of the manufacturer , packer or distributor; and (ii) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label, except as exempted with respect to this clause by '40102(i)(3) of this Act; provided, that under cla use (ii) of this Paragraph reasonable variations shall be permitted, and exemptions as to small packag esshall be allowed in accordance with regula tions prescribed by the Consumer Counsel or issued under the Federal Act; (3) If any word, statement or ot her infor mation required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspic uousness (as compared with other words, statements, designs or devices in the label ing) 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) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha -eucaine, barbituric acid, beta -eucaine, bramble, cannabis, carbromal, chloral,

of purchase and use; (4) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha -eucaine, barbituric acid, beta -eucaine, bramble, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marihuana, morphine, opium, paraldehyde, peyote or sulfonmethane, or any chemical derivative of such substance, which deriva tive after investigation has been found to be and desig nated as habit forming, by regula tions issued by the Director under this Act, or by regulations issued pursuant to '502(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; (5) If it is a drug, unless: (A) its label bears, to the exclusion of any other non -proprietary name (except the applicable systematic chemical name or the chemical formula), (i) the established nam e as defined in Paragraph (6) of the drug, if such there be; and (ii) in case it is fabricated from two or more ingredi ents, the established name and quantity of each active ingredient, including the kind and quantity or proportion of any alcohol and also including, whether

e it is fabricated from two or more ingredi ents, 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 COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 23and quantity or proportion of any bromides, ether , chloro form, acetanilid, acetphenetidin, aminopyrine, antipyrine , atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucoside, mercury , ouabain, strophanthin, strychnine, thyroid or any derivative or preparation of any such substances, contained therein; provided, that the requirement for stating the quan tity of the active ingredients, other than the quantity of those specifically named i n this Paragraph, shall apply only to pre scription drugs; and (B) for any prescription drug the established name of such drug or ingredi ent as the case may be, on such label (and on any labeling on which a name for such drug or ingredient is used) is pr inted prominently and in type at least half as large as that used thereon for any propri etary name or designation for such drug or ingredient; and provided that to the extent

gredient is used) is pr inted prominently and in type at least half as large as that used thereon for any propri etary name or designation for such drug or ingredient; and provided that to the extent that compliance with the require ments of clause (A)(ii) or clause (B) of this Subparagraph is impracticable, exemptions shall be allowed under regulations promulgated by the Director , or under the Federal Act; (6) As used in this Paragraph and Para graph (5), the term 'established name,' with respect to a drug or ingredient thereo f, means: (A) the applicable official name desig nated pursuant to '508 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 official title thereof in such compend ium, or (C) if neither clause (A) nor Clause (B) of this Subparagraph applies, then the common or usual name, if any , of such drug or of such ingredient; provided further, that where clause (B) of this Subparagraph applies to an article recog nized in th e United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharma

ragraph applies to an article recog nized in th e United States Pharmacopoeia and in the Homeopathic Pharmacopoeia under different official titles, the official title used in the United States Pharma copoeia shall apply unless it is labeled and offered for sale as a homeopathic drug, in which case the o fficial title used in the Homeopathic Pharmacopoeia shall apply; (7) Unless its labeling bears (i) adequate directions for use, and (ii) such adequate warnings against use in those pathological conditions or by children where its use may be dangerous to h ealth, or against unsafe dosage or methods or duration of administra tion or application, in such manner and COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 24form, as are necessary for the protection of users; provided, that where any requirement of clause (i) of this Paragraph, as applied to any drug or device, is not necessary for the protection of the public health, the Director shall promulgate regulations exempting such drug or device from such requirements; provided further, that articles exempted under regulations issued under '502(f) of the Federa l Act may also be exempt; (8) If it purports to be a

xempting such drug or device from such requirements; provided further, that articles exempted under regulations issued under '502(f) of the Federa l Act may also be exempt; (8) If it purports to be a drug the name of which is recognized in an official compendi um, unless it is packaged and labeled as prescribed therein; provided, that the method of packing may be modified with the consent of the Dir ector or if consent is obtained under the Federal Act. 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 packag ing and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provi sions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharma copoeia; provided further , that in the event of inconsistency between the requirements of this Paragraph and those of Paragraph (5) as to the name by which the drug or its ingredients shall be designated, the requirements of Paragraph (e) shall prevail; (9) If it has been found by

ents of this Paragraph and those of Paragraph (5) as to the name by which the drug or its ingredients shall be designated, the requirements of Paragraph (e) shall prevail; (9) If it has been found by the Director or under the Federal Act to be a drug liable to deterioration, unless it is packaged in such form and manner, and its label bears a state ment of such precautions, as the regulations issued bythe Director or under t he Federal Act require as necessary for the protection of public health; (10) If it is a drug and its container is so made, formed or filled as to be misleading (i) if it is an imitation of another drug; (ii) if it is offered for sale under the name of an other drug; (11) If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended or sugge sted in the labeling thereof; (12) If it is, or purports to be, or is represented as a drug composed wholly or partl y of insulin, unless (i) it is from a batch with respect to which a certificate or release has been issued pursuant to '506 of the Federal Act, and (ii) such certificate or release is in effect with respect to such drug; (13) If it is, or purports to be, or

o which a certificate or release has been issued pursuant to '506 of the Federal Act, and (ii) such certificate or release is in effect with respect to such drug; (13) If it is, or purports to be, or is represented as a drug composed wholly or partly of any kind of penicillin, streptomycin, chlortetracycline, COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 25chloramphenicol, bacitracin or any other antibiotic drug, or any deriva tive thereof, unless (i) it is from a batch with respect to which a ce rtificate or release has been issued pursuant to '507 of the Federal Act, and (ii) such certificate or release is in effect with respect to such drug; provided, that this Paragraph shall not apply to any drug or class of drugs exempted by regulations promu lgated under '507(c) or (d) of the Federal Act. For the purpose of this Paragraph the term 'antibiotic drug' means any drug intended for use by man containing any quantity of any chemical substance which is produced by microorgan isms and which has the cap acity to inhibit or destroy microorganisms in dilute solution (including, the chemically synthesized equiva lent of any such substance); (14) If it is a color

by microorgan isms and which has the cap acity to inhibit or destroy microorganisms in dilute solution (including, the chemically synthesized equiva lent of any such substance); (14) If it is a color additive, the intended use of which in or on drugs is for the pur pose of coloring only , unless its packaging and labeling are in conformity with such packaging and labeling requirements applica ble to such color additive, prescribed under the provisions of '40113 or of the Federal Act; (15) In the case of any prescription drug distributed or offere d for sale in this Territo ry unless the manufacturer , packer or dis tributor 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 t rue statement of (i) the established name, as defined in Section 16(c)(2) of this Act, printed prominently and in type at least half as large as that used for any trade or brand name thereof, (ii) the formula showing quantitatively each ingredient of such drug to the extent required for labels under '502(c) of the Federal Act, and (iii) such other information in brief summary relating

of, (ii) the formula showing quantitatively each ingredient of such drug to the extent required for labels under '502(c) of the Federal Act, and (iii) such other information in brief summary relating to side effects, contraindications and ef fectiveness as shall be required in regulations issued under the Federal Act; (16)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; or (17) Drugs and devices which are in accor dance 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 re quirements of this Act; provided, that such drugs and de vices are being delivered, manufactured, processed, labeled, repacked or otherwise held in compliance with regula - tions issued by the Director or under the Federal Act. SOURCE: GC§ 9720.14.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 26NOTE: The reference in Subsection (15)(i) of this Section to 'Se ction 16(c)(2) of this Act' indicates

Act. SOURCE: GC§ 9720.14.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 26NOTE: The reference in Subsection (15)(i) of this Section to 'Se ction 16(c)(2) of this Act' indicates that an earlier draft of the bill which became P .L. 13 -143 was numbered differently , and that the numbering was not changed when Government Code section numbers were added. This may also explain the provisions of ''40105(b), 40116(a) and (c), and 40109(2)(A)(iii). Assuming that '40101 of this Chapter was Section 1 of the original bill, then the numbers referred to in the sections cited above would appear to correspond to numbers of sections in the Government Code as ren umbered and included in this compilation, as follows: Section 3(a) or (c)' as referred to in '40105(b) would be '40103(1) or (3), (note the subsection num bers have apparently been changed from alphabetical in the original bill to numerical in P .L. 13 -143); 'Section 14(a)' as referred to in '40109(2)(A)(iii) would be '40114(1); 'Section 16(c)(2)' as referred to in this Section would be '40117(a)(B), (note that P .L. 13 -143, and consequently this Chapter, is not consistent in numbering subsections either alp

d be '40114(1); 'Section 16(c)(2)' as referred to in this Section would be '40117(a)(B), (note that P .L. 13 -143, and consequently this Chapter, is not consistent in numbering subsections either alp habetically or numerically , with the result that renumbering or relettering one section would require renumbering and relettering of all cross -references in each Section. § 40116. Habit -Forming Drugs; T oxic Drugs. (a) A drug intended for use by man whic h: (A) is a habit -forming drug to which '40115(d) applies; or (B) because of its toxicity or other poten tiality for harmful effect, or the method of its use, or the collateral measures necessary to its use is not safe for use except under the supervisio n of a practitioner licensed by law to administer such drug; or (C) is limited by an approved application under '505 of the Federal Act or Section 18 of this Act to use under the professional supervision of a practitioner licensed by law to administer suc h drug, shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced prompt ly to writing and filed by

ly (i) upon a written prescription of a practitioner licensed by law to administer such drug, or (ii) upon an oral prescription of such practitioner which is reduced prompt ly to writing and filed by the pharmacist, or (iii) by refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescrip tion or by oral order which is reduced promptly to writing and filed by the pharma cist. If any prescription for such drug does not indicate the times it may be refilled, if any , such prescription may not be refilled unless, the pharmacist is subsequently au thorized to do so by the practitioner. The act of dispensing a drug contrary to the provisions of this Paragraph shall be deemed to be an act which results in a drug being misbranded while held for sale. COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 27(b) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of '40115, except Subsections (a)(i)(2) and (3), (k) and (1) and the packaging requirements of Subsections (g) and (h), if the drug

y law to administer such drug shall be exempt from the requirements of '40115, except Subsections (a)(i)(2) and (3), (k) and (1) and the packaging requirements of Subsections (g) and (h), if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its fi lling, the name of the prescriber and, if stated in the prescription the name of the patient, and the directions for use and cautionary statements, if any , contained in such prescription. This exemption shall not apply to any drugs dispensed in the course of the conduct of a busi ness of dispensing drugs pursuant to diagnosis by mail, or to a drug dispensed in violation of Paragraph (a) of this Section. (c) The Director may , byregulation, remove drugs subject to '40115(d) and Section 18 from the requirem ents of Paragraph (a) of this Section when such requirements are not necessary for the protection of the public health. Drugs removed from the prescription requirements of the Federal Act by regulations issued thereunder may also, by regulations issued by the Director , be removed from the requirement of Paragraph (a).

rugs removed from the prescription requirements of the Federal Act by regulations issued thereunder may also, by regulations issued by the Director , be removed from the requirement of Paragraph (a). (d) A drug which is subject to Paragraph (a) of this Section shall be deemed to be misbranded if at any time prior to dispensing its label fails to bear the statement Caution: Federal Law Pr ohibits Dispensing W ithout Prescription or Caution: State Law Prohibits Dispensing W ithout Prescription. A drug to which Paragraph (a) of this Section does not apply shall be deemed to be misbranded if at any time prior to dispensing its label bears the c aution statement quoted in the preceding sentence. (e) Nothing in this Section shall be construed to relieve any person from any requirement prescribed by or under authority of law with respect to drugs now included or which may hereafter be included with in the classifications of narcotic drugs or marihuana as defined in the applicable Federal and local laws relating to narcotic drugs and marihuana. SOURCE: GC§ 9720.15. NOTE: Reference to 'Section 18' appear here as in P .L. 13 -143. See NOTE to '744. § 40117. Sale of New Drugs.

le Federal and local laws relating to narcotic drugs and marihuana. SOURCE: GC§ 9720.15. NOTE: Reference to 'Section 18' appear here as in P .L. 13 -143. See NOTE to '744. § 40117. Sale of New Drugs. (a) No person shall sell, deliver, offer for sale, hold for sale or give away any new drug unless (1) an appli cation with respect thereto has been approved and said approval has not been withdrawn under '505 of the Federal Act, or (2) when not subject to the Federal Act, unless such drug has COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 28been tested and has been found to be safe for use and effective in use under the conditions pre scribed, recommended or suggested in the label ing thereof, and prior to selling or offering f or sale such drug, there has been filed with the Director an application setting forth (i) full reports of investigations which have been made to show whether or not such drug is safe for use and whether such drug is effective in use; (ii) a full list of t he articles used as components of such drug; (iii) a full statement of the com - position of such drug; (iv) a full description of the methods used in, and the facilities and controls

full list of t he articles used as components of such drug; (iii) a full statement of the com - position of such drug; (iv) a full description of the methods used in, and the facilities and controls used for the manufacturer , processing and packing of such drug; (v) such s amples of such drug and of the articles used as compo - nents thereof as the Director may require; and (vi) specimens of the labeling proposed to be used for such drug. (b) An application provided for in Subsection (a)(2) shall become effective on the one h undred eightieth day after the filing thereof, except that if the Director finds, after due notice to the applicant and giving him an opportunity for a hearing (1) that the drug is not safe or not effective for use under the conditions pre scribed, recomme nded or suggested in the pro posed labeling thereof; or (2) the methods used in and the facilities and controls used for the manufacturer, processing and packing of such drugs are inadequate to preserve its identity , strength, quality and purity; or (3) ba sed on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall, prior to the effective date of the

identity , strength, quality and purity; or (3) ba sed on a fair evaluation of all material facts, such labeling is false or misleading in any particular; he shall, prior to the effective date of the application issue an order refusing to permit the application to become effective. (c) V acant. (d) The Dir ector shall promulgate regulations for exempting from the operation of the forego ing Subsections of this Section drugs intended solely for investigational use by experts qualified by scientific training and experience to investi gate the safety and effect iveness of drugs. Such regulations may , within the discretion of the Director among other conditions relating to the protection of the public health, provide for conditioning such exemption upon: (1) the submission to the Director, before any clinical tes ting of a new drug is under taken, of reports by the manufacturer or the sponsor of the investigation of such drug, of pre -clinical tests (including tests on animals) of such drug adequate to justify the proposed clinical testing; COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 29(2) the manufacturer or the sponsor of the investigation of a new drug

h drug adequate to justify the proposed clinical testing; COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 29(2) the manufacturer or the sponsor of the investigation of a new drug proposed to be distributed to investigators for clinical testing obtaining a signed agreement from each of such investigators that patients to whom the drug is administered will be under his per sonal supervis ion, or under the supervision of investigators responsible to him and that he will not supply such drug to any other investigator or to clinics for administration to human beings; and (3) the establishment and maintenances of such records and the making o f such reports to the Director by the manufacturer or the sponsor of the investigation of such drug of data (including but not limited to analytical reports by investigators) obtained as the result of such investigational use of such drug, as the Director finds will enable him to evaluate the safety and effectiveness of such drug in the event of the filing of an applica tion pursuant to Subsection (b). Such regulations shall provide that such exemption shall be conditioned upon the manufac turer, or the sp onsor of the

h drug in the event of the filing of an applica tion pursuant to Subsection (b). Such regulations shall provide that such exemption shall be conditioned upon the manufac turer, or the sp onsor of the investigation, requiring that experts using such drugs for investigational purposes certify to such manufac turer or sponsor that they will inform any human beings to whom such drugs, or any controls used in connection therewith, are being administered, or their representatives, that such drugs are being used for investigational purposes and will obtain the consent of such human beings or their representatives, except where they deem it not feasible or, in their professional judgment, contrary to the best interests of such human beings. Nothing in this Subsection shall be construed to require any clinical investigator to submit directly to the Director reports on the investigational use of drugs; provided, that the regulations adopted under Sec tion 505(i) of the Federal Act shall be the regulations in this Territory; provided further, that the Director may in his discretion promulgate regulations whether or not in accordance with regulations promulgated under the Federal Act.

be the regulations in this Territory; provided further, that the Director may in his discretion promulgate regulations whether or not in accordance with regulations promulgated under the Federal Act. (e)(1) In the case of any drug for which an approval of an application filed pursuant to this Section is in effect, the applic ant shall establish and maintain such records and make such reports to the director of data relating to clinical experience and other data or inform ation received or otherwise obtained by such applicant with respect to such drug, as the Director may by general regulation or by order with respect to such application pre scribe; provided, however, that regulations and orders issued under this Subsectio n and under Subsection (d) shall have due regard for the professional ethics of the COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 30medical profession and the interests of patients and shall provide, where the Director deems it to be appropriate, for the examination, upon request by the persons to whom such regula tions or orders are applicable, of similar information received or otherwise obtained by the director .

eems it to be appropriate, for the examination, upon request by the persons to whom such regula tions or orders are applicable, of similar information received or otherwise obtained by the director . (2) Every person required under this Section to maintain records, and veryperson in charge or custody thereof, shall, upon reque st of a n officer or employee designated by the Director , permit such officer or employee at all reasonable times to have access to and copy and ce rtify such records. (f) The Director may , after affording an opportunity for public hearing and judicial appeal, revoke an application approved pursuant to this Sec tion if he finds that the drug, based on evidence acquired after such approval, may not be safe or effective for its intended use or that the facilities or controls used in the manu facture, processing or labeling of such drug may present a hazard to the public health. (g) This Section shall not apply: (1) to a drug sold in this Territory or introduced into interstate commerce at any time prior to the enactment of the Federal Act, if its labeling containe d the same repre sentations concerning the conditions of its use; or (2) to any drug which is

into interstate commerce at any time prior to the enactment of the Federal Act, if its labeling containe d the same repre sentations concerning the conditions of its use; or (2) to any drug which is licensed under the Public Health Service Act of July 1, 1944 (42 U.S.C. 201 et. seq.), or under the Animal Virus-Serum -Toxin Act of March 4, 1913 (13 Stat. 832; 21 U.S.C. 151 et. seq.); or (3) to any drug which is subject to Sec tion 16(1) of this Act. SOURCE: GC§ 9720.16. NOTE: For explanation of Subsection (g)(3) see NOTE to '40115. § 40118. Adulterated Cosmetics. A cosmetic shall be deemed to be adulterat ed: (1) If it bears or contains any poisonous or deleterious substance which mayrender it injurious to users under the conditions of use prescribed in the labeling or advertisement thereof, or under such conditions of use as are customary or usual; provi ded, that this provision shall not apply to coal -tar hair dye, the label of which bears the following legend conspicuously COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 31displayed thereon: 'Caution -This product contains ingredients which may cause skin irritation on certain individuals and a prelimin ary

610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 31displayed thereon: 'Caution -This product contains ingredients which may cause skin irritation on certain individuals and a prelimin ary test according to accompa nying directions should first be made. This product must not be used for dyeing the eyelashes or eyebrows; to do so may cause blindness,' and the labeling of which bears adequate directions for such preliminary testing. For th e purpose of the paragraph and Paragraph (c) the term 'hair dye' shall not include eyelash dyes or eyebrow dyes; (2) If it consists in whole or in part of any filthy , putrid or decomposed substance; (3) If it has been produced, prepared, packed or held u nder insanitary conditions whereby it may have been rendered injurious to health; (4) If its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (5) If it is not a ha ir dye and it is, or it bears or contains a color additive which is unsafe within the meaning of '40113(a). SOURCE: GC§ 9720.17. § 40119. Misbranded Cosmetics.

ous to health; or (5) If it is not a ha ir dye and it is, or it bears or contains a color additive which is unsafe within the meaning of '40113(a). SOURCE: GC§ 9720.17. § 40119. Misbranded Cosmetics. A cosmetic shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular; (2) If its labeling or packaging fails to conform with the requirements of '40120 of this Act; (3) If in package form unless it bears a label containing (i) the name and place of business of the manufacturer , packer or distributor; and (i i) an accurate statement of the quantity of the contents in terms of weight, measure or numerical count, which statement shall be separately and accurately stated in a uniform location upon the principal display panel of the label; provided, that under cla use (ii) of this Paragraph reasonable variations shall be permitted, and exemption as to small packages shall be established by regulations prescribed by the Director; (4) If any word, statement or other infor mation required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspic uousness (as compared with other words,

atement or other infor mation required by or under authority of this Act to appear on the label or labeling is not prominently placed thereon with such conspic uousness (as compared with other words, statements, designs or devices in the label ing) and in such terms as to render COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 32it likely to be read and understood by the o rdinary individual under customary conditions of purchase and use; (5) If its container is so made, formed or filled as to be misleading; (6) If it is a color additive, 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. This Paragraph shall not apply to packages of color additives which, with re spect to their use for cosmetics, are marketed and intended for use only in or on hair dyes (as defined in the last sentence of '40118(a)(1); or (7) A cosmetic which is, in accordance with the practice of the trade , to be pro cessed, labeled or repacked in substantial quantities at an establishment other than the establishment where i t was originally pro - cessed or

n accordance with the practice of the trade , to be pro cessed, labeled or repacked in substantial quantities at an establishment other than the establishment where i t was originally pro - cessed or packed, is exempted from the affirmative labeling re quirements of this Act while it is in transit in commerce from the one establishment to the other, if such transit is made in good faith for such completion pur poses only; but is otherwise subject to all applicable provisions of this Act. SOURCE: GC§ 9720.18. § 40120. Labeling Requirements. (a) All labels of consumer commodities, as defined by this Act, shall conform with the requirements for the declaration of net quanti ty of contents of Section 4 of the Fair Packaging and Labeling Act (15 U.S.C. 1451, et. seq.) and the regulations promulgated pursuant thereto; provided, that consumer commodities exempted from such re quirements of Section 4 of the Fair Packaging and Labe ling Act shall also be exempt from this Subsection. (b) The label of any package of a consumer commodity which bears a representation as to the number of servings of such commodity contained in such package shall bear a statement of the net quantity (in t erms

abel of any package of a consumer commodity which bears a representation as to the number of servings of such commodity contained in such package shall bear a statement of the net quantity (in t erms of weight, measure or numerical count) of each such serving. (c) If an article is alleged to be misbranded because the labeling is misleading, or if an advertisement is alleged to be false because it is misleading, then in determining whether the lab eling or advertisement is misleading, there shall be taken into account (among other things) not only representations made or suggested by statement, word, design, device, sound or in any combination thereof, but also the extent to which the labeling or ad vertisement fails to reveal facts material in the light of such COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 33repre sentations or material with respect to conse quences which may result from the use of the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual.

f the article to which the labeling or advertisement relates under the conditions of use prescribed in the labeling or advertisement thereof or under such conditions of use as are customary or usual. (d) No person shall distribute or cause to be distributed in commerce any packaged consumer commodity if any qualifying words or phrases appear in conjunctio n with the separate statement of the net quantity of contents required by Subsection (a), but nothing in this Section shall prohibit supplemental statements, at other places on the package, de scribing in nondeceptive terms the net quantity of contents; pro vided, that such supplemental statements of net quanti ty of contents shall not include any term quali fying a unit of weight, measure or count that tends to exaggerate the amount of the commodity contained in the package. (e) Whenever the Director determ ines that regulations containing prohibitions or require ments other than those prescribed by Section 21(a) are necessary to prevent the deception of consumers or to facilitate value comparisons as to any consumer commodity , the Director shall promulgate with respect to that commodity regu lations effective to: (1) establish

vent the deception of consumers or to facilitate value comparisons as to any consumer commodity , the Director shall promulgate with respect to that commodity regu lations effective to: (1) establish and define standards for the characterization of the size of a package enclosing any consumer commodity , which may be used to supplement the label statement of net quantity of contents of packages contain ing such commodity , but this Paragraph shall not be construed as authorizing any limitation on the size, shape, weight, dimensions or number of packages which may be used to enclose any commodity; (2) regulate the placement upon any pac kage containing any commodity or upon any label affixed to such commodity , of any printed matter stating or representing by implication that such commodity is offered for retail sale at a price lower than the ordinary retail sale price or that a retail sal e price advantage is accorded to purchasers thereof by reason of the size of that package or the quantity of its contents; (3) require that the label on each package of a consumer commodity bear (A) the common or usual name of such consumer commodity , if any, and (B) in case such consumer

r the quantity of its contents; (3) require that the label on each package of a consumer commodity bear (A) the common or usual name of such consumer commodity , if any, and (B) in case such consumer commodi ty consists of two or more ingredients, the common or usual name of each such ingredient listed in order of decreasing predominance, but nothing in COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 34this Paragraph shall be deemed to require that any trade secret be divulged; or (4) prevent the nonfunctional slack -fill of packages containing consumer commodities. For the purpose of Paragraph (4) of Subsec tion (e), a package shall be deemed to be non functional slack -filled if it is filled of substantially less thanits capacity for reasons other than (A) protection of the contents of such package or (B) the requirements of ma chines used for enclosing the contents in such package; provided, that the Director may adopt any regulations promulgated pursuant to the Fair Packaging and Labeling Act which shall have the force and effect of law in this Territory . (f) Any food, drug or consumer commodity for which the manufacturer or distributor has established or

Fair Packaging and Labeling Act which shall have the force and effect of law in this Territory . (f) Any food, drug or consumer commodity for which the manufacturer or distributor has established or recommended a pull date or other date by which the food, drug or consumer commodity should be used shall: (1) Have the pull date , 'best if used by date, expiration date or other date bywhich the food, drug or consumer commodity should be used, clearly marked on the packaging or labeling. Color coding may be used if the meanings of the color codes are clearly and plainly displayed in close proximity to the consumer commodities. Any product with a date on it shall be clearly marked as to whether the date is the date of packaging, the pull date, the expiration date, or some other date. (2) Any outdated food, drug or consumer commodity which is still fit for human con sumption and which is more than two days outdated, maybesold, displayed in a retail store or offered for sale only if the item is still fit for human cons umption and each package is clearly marked with the word ' Outdated or 'Expired Merchandise or such other words of similar meaning as may be approved by regulations

e item is still fit for human cons umption and each package is clearly marked with the word ' Outdated or 'Expired Merchandise or such other words of similar meaning as may be approved by regulations promulgated by the Director of the Department of Public Health. (3)Notwithstanding any prov ision of law, all fresh or frozen packaged meat, fresh eggs, bread, fresh milk and fresh daily products and ice cream, and such other food, drug and consumer commodity designated by the Director of the Department of Public Health and Social Services shall have a clearly designated expiration date on each package offered for retail sale. Notwithstanding any other provision of law, in lieu of stamping any required labels whatsoever on individual eggs, such information may instead be stamped on each egg carto n if COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 35the eggs are packed in individual cartons of twelve (12) eggs or less as required by 5 GCA Chapter 66, the Chicken Egg Regulation .(g) Any dented or damaged package or can of consumer products shall clearly be marked ' Damaged.

idual cartons of twelve (12) eggs or less as required by 5 GCA Chapter 66, the Chicken Egg Regulation .(g) Any dented or damaged package or can of consumer products shall clearly be marked ' Damaged. (h) Any fresh or frozen meat or poultry products which have had water added shall be clearly labeled ' Water added . Any meat products which have been previously given a United States Department of Agriculture grade or category shall have the grade or category clearly marked on ea ch package of meat offered for sale, whether or not later repackaged. (i) It shall be unlawful to sell any rusty canned goods or goods with rusty metal lids, unless the rust can be removed by rubbing with a cotton cloth. (j) It shall be a misdemeanor for a ny person to sell or offer for sale any food, drug or consumer commodity which is not clearly labeled and marked in English or Chamorro as herein provided for in this Chapter . (k) In addition to criminal penalties for the violation of this Sec tion, the Director of Public Health and Social Services shall, by rules and regulations to be established seize and destroy all food, drug, or consumer products which are displayed or offered for sale which are not

tor of Public Health and Social Services shall, by rules and regulations to be established seize and destroy all food, drug, or consumer products which are displayed or offered for sale which are not properly marked or labeled in the English or Chamorro languages, and shall pursuant to regulations, impose civil penalties and fines not exceed Five Hundred Dollars ($500) for each failure to properly label or mark products in English or Chamorro languages as provided by this Chapter , and may , pursuant to regulation, and close repeated offenders; shall (l) In addition to any other penalties provid ed for by law , each violation of this Section shall be counted as at least one or more demerits as the conditions dictate, in determining demerit points in the issua nce of sanitary permits or renewals thereof as provided for in 10 GCA Chapter 21. For purposes of this subsection, a minimum of one (1) demerit point must be given for each different inventory item found in viola tion of this Section, but exactly identical items found in violation may be counted as one violation. (m) Any seller of food, drugs and consumer commodities found to have more than twenty (20) different products

Section, but exactly identical items found in violation may be counted as one violation. (m) Any seller of food, drugs and consumer commodities found to have more than twenty (20) different products displayed or offered for sale which do not comply with the provisions of this Section s hall be immediately closed in the same manner as an unsanitary establishment pursuant to the provisions of 10 GCA Chapter 21.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 36(n) The Director of the Department of Public Health and Social Services shall promulgate rules and regulations to implement this S ection pursu ant to the Administrative Adjudication Act. SOURCE: GC§ 9720.19. Subsection (f) -(n) were added to '40120 by P .L. 19 -41:1. Subsection (f)(3) amended by P .L. 28 -33:4. NOTE: The reference in Subsection (e) to 'Section 21(a)' appears to be a r eference to the Subsection (a) of this Section, which tends to confirm the explanation of these anomalous references presented in the note to '40115. § 40121. Advertising. (a) An advertisement of a food, drug, device or cosmetic shall be deemed to be false if it is false or misleading in any particular .

references presented in the note to '40115. § 40121. Advertising. (a) An advertisement of a food, drug, device or cosmetic shall be deemed to be false if it is false or misleading in any particular . (b) For the purpose of this Act the adver tisement of a drug or device representing it to have any effect in albuminuria, appendicitis, arteriosclerosis, blood poison, bone diseases, Bright's disease, c ancer , carbuncles, cholecystitis, diabetes, diphtheria, dropsy , erysipelas, gallstones, heart and vascular dis eases, high blood pressure, mastoiditis, measles, meningitis, mumps, nephritis, otitis, media, paralysis, pneumonia, poliomyelitis (infantile par alysis), prostate gland disorders, pyelitis, scarlet fever, sexual impotence, sinus infection, smallpox, tuberculosis, tumors, typhoid, uremia or venereal disease shall also be deemed to be false, except that no advertisement not in viola tion of Subsectio n if it is disseminated only to members of the medical, dental or veterinary professions, or appe ars only in the scientific periodicals of these professions or is disseminat ed only for the purpose of public health educa tion by persons not commercially interested, directly or

ofessions, or appe ars only in the scientific periodicals of these professions or is disseminat ed only for the purpose of public health educa tion by persons not commercially interested, directly or indirectly in the sale of such drugs or devices; provided, that whenever the Director determines that an advance in medical science has made any type of self -medication safe as to any of the diseases named above, the Director shall by regulation authorize the advertisement of drugs having curative or therapeutic effect for such disease, subject to such conditions and restrictions as the Director may deem necessary in the interests of public health; provided, that this Subsection shall not be construed as indi cating that self -medication for diseases other than those named herein is safe or efficacious. SOURCE: GC§ 9720.20. § 40122. Regulations. (a) The authority to promulgate regulations for the efficient enforce - ment of this Act is hereby vested in the Direc tor. The Director is hereby COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 37authorized to make the regulations promulgated under this Act conform, insofar as practicable, with those promulgated under

reby COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 37authorized to make the regulations promulgated under this Act conform, insofar as practicable, with those promulgated under the Federal Act. (b) Hearings authorized or required by this Act shall be con ducted by the Director or such officer , agent or employee as the Director may designate for the purpose. (c) All pesticide chemical regulations and their amendments now or hereafter adopted under authority of the Federal Food, Drug and Cosmetic Act are the pesticide chemical regulations in this Territory . (d) All food additive regulations and their amendments now or hereafter adopted under authority of the Federal Food, Drug and Cosmet ic Act are the food additive regulations in this Territory . (e) All co lor additive regulations and their amendments now or hereafter adopted under authority of the Federal Food, Drug and Cosmet ic Act are the color additive regulations in this Territory . (f) All special dietary use regulations and their amendments now or hereafter adopted under authority of the Federal Food, Drug and Cosmetic Act are the special dietary use regula tions in this Territory .

l special dietary use regulations and their amendments now or hereafter adopted under authority of the Federal Food, Drug and Cosmetic Act are the special dietary use regula tions in this Territory . (g) All regulations and their amendments now or hereafter adopted under the Fair Packaging and Labeling Act shall be th e regulations in this Territory . However, the Director may , if he finds it necessary in the interest of consumers, prescribe packaging and labeling regulations for consumer commodities, whether or not in accor dance with regulations promulgated under the F ederal Act; provided, that no such regulations shall be promulgated which are contrary to the labeling requirements for the quantity of con tents required pursuant to Section 4 of the Fair Packaging and Labeling Act and the regulations promul gated thereu nder. (h) A Federal regulation automatically adopted pursuant to this Act takes effect in this Territo ryon the date it becomes effective as a Federal regulation. The Director shall publish all other proposed regulations in a newspaper of general daily c irculation.

is Act takes effect in this Territo ryon the date it becomes effective as a Federal regulation. The Director shall publish all other proposed regulations in a newspaper of general daily c irculation. A person who may be ad versely affected by a regulation may , within thirty (30) days after publication of any other regulation, file with the Director in writing objections and a request for a hearing. The timely filing of substantial objection s to a Federal regulation automatically adopted stays the effect of the regulation. If no substantial objections are received and no hearings are requested within 30 COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 38(thirty) days after publication of a proposed regulation, it shall take effect on a date s et by the Director. The effective date shall be at least sixty (60) days after the time for filing objections has expired. If timely substantial objections are made to a Federal regulation within thirty (30) days after it is automatically adopted or to a p roposed regulation within thirty (30) days after it is published, the Director after notice, shall conduct a public hearing to receive evidence on the issues raised by

automatically adopted or to a p roposed regulation within thirty (30) days after it is published, the Director after notice, shall conduct a public hearing to receive evidence on the issues raised by the objections. Any interested person or his representative may be heard. The Director shall act upon objections by order and shall mail the order to objectors by certified mail as soon after the hearing as practicable. The order shall be based on substantial evidence in the record of the hearing. If the order concerns a Federal regulation, it may reinstate, rescind or modify it. If the order concerns a proposed regulation, it may withdraw it or set an effective date for the regulation as published or as modified by the order. The effective date shall be at least sixty (60) days after publica tion of the order . SOURCE: GC§ 9720.21 . § 40123. Inspections. (a) For purposes of enforcement of this Act, the Director or any of his authorized agents, are authorized upon presenting appropriate credentials to the owner, operator or agent in charge: (1) to enter at reasonable times any facto ry, warehouse or establishment in which food, drugs, devices or cosmetics are manufac - tured,

priate credentials to the owner, operator or agent in charge: (1) to enter at reasonable times any facto ry, warehouse or establishment in which food, drugs, devices or cosmetics are manufac - tured, processed or packed or held for introduction into commerce or after such introduction or to enter any vehicle being use d to transport or hold such food, drugs, devices or cosmetics in commerce; and (2) to inspect at reasonable times and within reasonable limits and in a reasonable manner such factory , warehouse, establish ment or vehicle and all pertinent equipment, finis hed and unfinished mate rials, containers and labeling therein, and to obtain samples necessary to the enforcement of this Act. In the case of any factory , warehouse, estab - lishment or consulting laboratory in which prescription drugs are manufactured, pro cessed, packed or held, the inspection shall e xtent to all things therein (including records, files, papers, processes, controls and facilities) bearing on whether prescription drugs which are adulterated or misbranded within the meaning of this Act or whi ch maynot be manufactured, introduced into com merce or sold or offered for sale by reason of any

whether prescription drugs which are adulterated or misbranded within the meaning of this Act or whi ch maynot be manufactured, introduced into com merce or sold or offered for sale by reason of any provision of this Act, have been or are being COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 39manufactured, processed, packed, transported or held in any such place or otherwise bearing on violation of thi s Act. No inspection authorized for prescription drugs by the preceding sentence shall extend to (A) financial data, (B) sales data other than shipment data, (C) pricing data, (D) personnel data (other than data as to the qualifications of technical and pr ofessional personnel performing functions subject to this Act), and (E) research data (other than data relating to new drugs and antibiotic drugs, subject to reporting and inspection under regulations lawfully issued pursuant to Sec tion 505(i) or (j) or S ection 507(d) and (g) of the Federal Act, and data, relating to other drugs, which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to Section 505(j) of the Federal Act).

ral Act, and data, relating to other drugs, which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to Section 505(j) of the Federal Act). Such inspection shall b e commenced and completed with reasonable promptness. The provisions of the second sentence of this Subsection shall not apply to: (i) pharmacies which maintain estab lishments in conformance with local laws regulating the practice of pharmacy and medicin e and which are regularly engaged in dispensing prescription drugs, upon prescriptions of practitioners licensed to administer such drugs to patients under the care of such practitioners in the course of their professional prac tice and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound or process drugs for sale other than in the regular course of their business of dispensing or selling drugs at retail; (ii) practitioners licensed by law to prescribe or adminis ter drugs and who manufacture, prepare, propagate, com pound or process drugs solely for use in the course of their professional practice; (iii) persons who manufacture, prepare, propagate, compound or

r drugs and who manufacture, prepare, propagate, com pound or process drugs solely for use in the course of their professional practice; (iii) persons who manufacture, prepare, propagate, compound or process drugs solely for use in research, teaching or chemical analysis and not for sale; (iv) such other classes of persons as the Director may by regulation exempt from the application of this Section upon a finding that inspection as applied to such classes of persons in accordance with this Section is n ot necessary for the protection of the public health; andCOL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 40(3) to have access to and to copy all records of carriers in commerce showing the movement in commerce of any food, drug, device or cosmetics, or the holding thereof during or after such movement, a nd the quantity , shipper and consignee thereof; provided, that evidence obtained under this Subsection shall not be used in a criminal prosecution of the person from whom ob tained; and provided further , that carriers shall not be subject to the other prov isions of this Act by reason of their receipt, carriage, holding or delivery of food, drugs, devices or

rom whom ob tained; and provided further , that carriers shall not be subject to the other prov isions of this Act by reason of their receipt, carriage, holding or delivery of food, drugs, devices or cosmetics in the usual course of business as carriers. (b) Upon completion of any such inspection of a factory , warehouse, consulting laboratory or oth er establishment and prior to leaving the premises, the authorized agent making the inspection shall give to the owner, operator or agent in charge a report in writing setting forth any conditions or practices observed by him which in his judgment indicate that any food, drug, device or cosmetic in such establishment (1) consists in whole or in part of any filthy , putrid or decomposed substance or (2) has been prepared, packed or held under insanitary conditions whereby it may have become contami nated with filth or whereby it may have been rendered injurious to health. A copy of such report shall be sent promptly to the Director. (c) If the authorized agent making any such inspection of a factory , warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to

the authorized agent making any such inspection of a factory , warehouse or other establishment has obtained any sample in the course of the inspection, upon completion of the inspection and prior to leaving the premises, he shall give to the owner, operator or agent in charge a receipt describing the samples obtained. (d) When in the course of any such inspec tion of a fact ory or other establishment where food is manufactured, processed or packed, the of ficer or employee making the inspection obtains a sample of any such food and an analysis is made of such sample for the purpose of ascer taining whether such food consists i n whole or in part of any filthy , putrid or decomposed substance or is otherwise unfit for food, a copy of the results of such analysis shall be furnished promptly to the owner, operator or agent in charge. SOURCE: GC§ 9720.22. § 40124. Report of Minor Violations. Nothing in this Subchapter shall be construed as requir ing the Director to report for the institution of proceedings under this Chapter, minor COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 41violations of this Chapter , whenever the Director believes that the public

institution of proceedings under this Chapter, minor COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 41violations of this Chapter , whenever the Director believes that the public interest will be adequa telyserved in the circumstances by a suitable written notice or warning. SOURCE: GC§ 9720.23. § 40125. Emergency Permit Control. (a) When ever the Director finds after investigation that the distribution in the territory of Guam of any class of food m ay, by reason of contamination with microorganism during manu facture, processing or packing thereof in any locality , be injurious to health and that such injurious nature cannot be adequately determined after such articles have entered commerce, he then, and in such case only , shall promulgate regula tions providing for the issuance to manu facturers, processors or packers of such class of food in such locality of permits to which shall be attached such conditions governing the manufac ture, processing or packing, or packing of such class of food, for such temporary period of time as may be necessary to protect the public health; and after the effective date of such regulations and during such temporary period,

r packing of such class of food, for such temporary period of time as may be necessary to protect the public health; and after the effective date of such regulations and during such temporary period, no person shall introduce or deliver for introduction into commerce any such food manufac tured, processed or packed by any such manufacturer , processor or packer unless such manufacturer, processor or packer holds a permit issued by the Director as provided by such regulations. (b) The Director is authorized to suspend immediately upon notice any permit issued under authority of this Section if it is found that any of the conditions of the permit have been violat ed. The holder of a permit so suspended shall be privileged at any time to apply for r einstatement of such permit and the Director shall immediately after prompt hearing and inspection of the establishment, reinstate such permit if it is found that adequate measures have been taken to comply with and maintain the conditions of the permit, as originally issued or as amended. (c) Any officer or employee duly designated by the Director shall have access to any factory or establishment, the operator of which holds a permit

of the permit, as originally issued or as amended. (c) Any officer or employee duly designated by the Director shall have access to any factory or establishment, the operator of which holds a permit from the Director for the purpose of ascertaining whether or not the conditions of the permit are being complied with and denial of access for such inspection shall be grounds for suspension of the permit until access is freely given by the operator . SOURCE: GC§ 9720.24. § 40126. Reports of Judgment and Decrees.COL12010610GCA HEALTH ANDSAFETY CH.40GUAM FOOD,DRUG AND COSMETIC ACT 42(a) The Di rector shall cause to be published from time to time reports summarizing all judg ments, decrees and court orders which have been rendered under this Act, including the nature of the charge and the disposition thereof. (b) The Director shall also cause to be dis seminated such information regarding food, drugs, devices and cosmetics as the Director deems necessary in the interest of public health and the protection of the consumer against fraud. Nothing in this Section shall be construed to prohibit the Director from collect ing, reporting and illustrating the results of the investigations of the

the protection of the consumer against fraud. Nothing in this Section shall be construed to prohibit the Director from collect ing, reporting and illustrating the results of the investigations of the Director . SOURCE: GC§ 9720.25. § 40127. Severability. If any provision of this Act is declared unconstitutional or the applicability thereof to any person or circum stances is held invalid, the constitutionality of the remainder of the Act and applicability there of to other persons and circumstances shall not be affected thereby . SOURCE: GC§ 9720.26. § 40128. Effective Date. The effective date of this legi slation shall be one hundred eighty (180) days from the passage of this Act. Monthly reports of inspection, investigation and enforcement of this Act shall be made in a public newspaper of wide general circulation thereafter. SOURCE: GC§ 9720.27. § 40129 . Authorization. There is hereby authorized to be appropriated the sum of One Hundred One Thousand Two Hundred and Forty Dollars ($101,240) to the Department of Public Health and Social Services, Bureau of Environ mental Health and Consumer Protection fo r the implementation and administration of this Act. SOURCE: GC§ 9720.28.

($101,240) to the Department of Public Health and Social Services, Bureau of Environ mental Health and Consumer Protection fo r the implementation and administration of this Act. SOURCE: GC§ 9720.28. ----------COL120106