Pure Food, Drug and Cosmetic Device Act of 1998

ELEVENTH NORTHERN MARIANAS COMMONWEALTH LEGISLATURE H.B. NO. 11-101, HD1 FIRST REGULAR SESSION, 1998 AN ACT To ensure that foods are pure, wholesome, safe to eat and produced under sanitary conditions; drugs and devices are safe and effective for their intended uses; cosmetics are safe and made from approved ingredients; and that all labeling and packaging must be informative and truthful; and for other purposes. BE IT ENACTED BY THE ELEVENTH NORTHERN MARIANAS COMMONWEALTH LEGISLATURE: Section 1. Title. This act shall be cited as the “Pure Food, Drug and Cosmetic Device 1 Act of 1998”. 2 Section 2. Amendment. 3 CMC, Division 2, is hereby amended to add a new Chapter 7 3 entitled “Pure Food and Drug Control” to read as follows: 4 “CHAPTER 7 5 PURE FOOD AND DRUG CONTROL 6 Article 1. 7 General Provisions. 8 Section 101. Definitions. 9 (a) The term "adulterated" for the purposes of this act shall have the 10 following meanings: 11 (1) If a food bears or contains any poisonous or deleterious 12 substance which may render it injurious to health; unless the substance is 13 not an added substance, but rather a naturally occurring substance the 14 quantity of which does not ordinarily render it injurious to health; or 15 (2) If a food, drug, cosmetic, or device consists in whole or in 16 part of any filthy, putrid, or decomposed substance, or in the case of 17 food, if it is otherwise unfit for food; or 18 HOUSE BILL NO. 11-101, HD1 Page 2 (3) If a food, drug, cosmetic, or device has been prepared, 1 packed, or held under unsanitary conditions whereby it may have 2 become contaminated with filth, or whereby it may have been rendered 3 injurious to health; or 4 (4) If a food is in whole or in part, the product of a diseased 5 animal or of an animal which has died otherwise than by slaughter at a 6 facility licensed by the CNMI. 7 (b) The term "advertisement" includes any representation by any means 8 whatever for the purpose of promoting directly or indirectly the sale or disposal 9 of any foods, drugs, cosmetics, and devices. 10 (c) The term “Commonwealth” means the Commonwealth of the 11 Northern Mariana Islands (“CNMI”). 12 (d) The term “cosmetic" means articles intended to be rubbed, poured, 13 sprinkled, or sprayed on, introduced into, or otherwise applied to the human 14 body or any part thereof for cleansing, beautifying, promoting attractiveness, or 15 altering the appearance, and articles intended for use a component of any such 16 articles. 17 (e) The term "Department" means the Department of Public Health. 18 (f) The term "device" means an instrument, apparatus, implement, 19 machine, contrivance, implant, in vitro reagent, or other similar or related 20 article, including any component, part, or accessory which is; 21 (1) recognized in an official compendium as defined in this Act, 22 or any supplement to them; or 23 (2) intended for use in the diagnosis of disease or other 24 conditions, or in the cure, mitigation, treatment, or prevention of disease, 25 in man or other animals, or 26 (3) intended to affect the structure or any function of the body of 27 man or other animals. 28 (g) The term "drug" means an article recognized in an official 29 compendium as defined in this Act or any supplements to any of them; and 30 includes any substance or mixture of substances manufactured, sold or 31 represented for use in: 32 HOUSE BILL NO. 11-101, HD1 Page 3 (1) the diagnosis, cure treatment, mitigation or prevention of a 1 disease, disorder or abnormal physical or mental state, or its symptoms, 2 in human beings or animals, 3 (2) restoring, correcting or modifying organic functions in 4 human beings or animals, or 5 (3) articles intended for use as a component of any such articles 6 as mentioned above. 7 This definition does not include any natural substances used as a 8 traditional drug as defined in this Act. 9 (h) The term "food" includes any article manufactured, sold or 10 represented for use as food or drink for human beings, chewing gum, and any 11 ingredient that may be mixed with food for any purpose whatsoever. 12 (i) The term “foreign drug” shall mean a drug prescribed, purchased or 13 manufactured in a jurisdiction other than the Commonwealth, the United States 14 of America, its territories and possessions. 15 (j) The term "unsanitary conditions" means such conditions or 16 circumstances as might contaminate with dirt or filth, or render injurious to 17 health, a food, drug, cosmetic, or device. 18 (k) The term "inspector" means any person designated as an inspector 19 for the purpose of the enforcement of this Act. 20 (l) The term "label" includes any legend, word or mark attached to, 21 included in, belonging to, in close proximity to, or accompanying any food, 22 drug, cosmetic, device, or package. 23 (m) The term "official compendium" means the most recent editions, 24 including all errata, supplements, revisions and addenda of the following: 25 Commonwealth Health Center Formulary, official United States 26 Pharmacopoeia, official Homeopathic Pharmacopoeia of the United States, 27 official National Formulary, and Remington Pharmaceuticals. 28 (n) The term “package” includes anything in which any food, drug, 29 cosmetic or device is wholly or partially contained, placed or packed. 30 (o) The term "prescribed" means required by the regulations. 31 HOUSE BILL NO. 11-101, HD1 Page 4 (p) The term "Secretary" means the Secretary of the Department of 1 Public Health for the Commonwealth of the Northern Mariana Islands. 2 (q) The term "sell" includes offer for sale, expose for sale, have in 3 possession for sale and distribution, whether or not the distribution is made for 4 compensation of any kind. 5 (r) The term "traditional drug" means natural substances used by the 6 Chamorro and Carolinian people, or by any other people who reside in the 7 Commonwealth, in the diagnosis, cure, treatment, mitigation or prevention of a 8 disease, disorder or abnormal physical and mental state, or its symptoms, in 9 human beings or animals. 10 Section 102. General Provisions Governing Advertising. 11 (a) No person shall advertise any food, drug, cosmetic, or device to the 12 general public as a treatment, preventative or cure for any of the diseases, 13 disorders or abnormal physical states that are listed in Schedule A. 14 (b) Any food, drug, cosmetic, or device advertised to the general public 15 as a treatment, preventative or cure for any disease, disorder or abnormal 16 physical state shall be made in the English, or Carolinian or Chamorro 17 languages. An advertisement made in any other language shall be accompanied 18 by an accurate and full English translation. 19 Section 103. Prohibited label or advertisement where promotion for sale is 20 made. 21 (a) No person shall sell any food, drug, cosmetic or device 22 (1) that is not represented by label; or 23 (2) that the person advertises to the general public as a 24 treatment, preventative or cure for any of the diseases, disorders or 25 abnormal physical states listed in Schedule A. 26 (3) that the person advertises to the general public as a 27 treatment, preventative or cure for any of the diseases, disorders or 28 abnormal physical states in a language other than English, Chamorro or 29 Carolinian unless accompanied by an accurate and full English 30 translation. 31 HOUSE BILL NO. 11-101, HD1 Page 5 Section 104. Construction with respect to the traditional art of healing. Nothing 1 in this Act shall be construed to inhibit the traditional art of healing as it is practiced by 2 the Chamorro and Carolinian people. 3 Article 2. 4 Regulation of Food 5 Section 201. Prohibited sales of food. 6 (a) No person shall sell an article of food for human consumption that; 7 (1) has in or on it any poisonous or harmful substance; 8 (2) is unfit for human consumption; 9 (3) consists in whole or in part of any filthy, putrid, disgusting, 10 rotten, decomposed or diseased animal or vegetable substance; 11 (4) is adulterated; or 12 (5) was manufactured, prepared, preserved, packaged, 13 distributed, or stored under unsanitary conditions. 14 (6) contains wholly or in part the flesh of cats or dogs. 15 Section 202. Deception regarding food. 16 No person shall label, package, treat, process, distribute, sell or advertise any 17 food in a manner that is false, misleading or deceptive or is likely to create an erroneous 18 impression regarding its character, value, quantity, composition, merit or safety. 19 Section 203. Food labeled or packaged in contravention of regulations. 20 An article of food that is not labeled or packaged as required by, or is labeled or 21 packaged contrary to, the regulations shall be deemed to be labeled or packaged 22 contrary to subsection (1). 23 Section 204. Importation of food. 24 (a) Where a standard for a food has been prescribed, no person shall; 25 (1) import into the Commonwealth, or 26 (2) send, convey or receive for conveyance within the 27 Commonwealth, or 28 (3) have in possession for the purpose of sending or conveying 29 within the Commonwealth, 30 HOUSE BILL NO. 11-101, HD1 Page 6 any article that is intended for sale and that is likely to be 1 mistaken for the food for which the regulations prescribe a standard 2 unless that article complies with the prescribed standard. 3 (b) Not applicable to carriers. 4 Paragraphs (a)(2) and (3) do not apply to an operator of a conveyance 5 that is used to carry an article or to a carrier of an article whose sole concern, in 6 respect of the article, is the conveyance of the article unless the operator or 7 carrier could, with reasonable diligence, have ascertained that the conveying or 8 receiving for conveyance of the article or the possession of the article for the 9 purpose of conveyance would be in contravention of subsection (a). 10 Section 205. Labeling of food that is imported or moved within the 11 Commonwealth. 12 (a) Where a standard for a food has been prescribed, no person shall 13 label, package, sell or advertise any article that 14 (1) has been imported into Commonwealth 15 (2) has been sent or conveyed within the Commonwealth, or 16 (3) is intended to be sent or conveyed within the Commonwealth 17 that it is likely to be mistaken for that food unless the article complies in 18 such a manner with the prescribed standard. 19 Section 206. Authority of the Secretary to identify standard. 20 (a) The secretary may, by regulation, identify a standard prescribed for a 21 food as being necessary to prevent injury to the health of the consumer or 22 purchaser of the food. 23 (b) Where a standard prescribed for a food is identified by the secretary 24 pursuant to subsection (a), no person shall label, package, sell or advertise any 25 article in such a manner that it is likely to be mistaken for that food unless that 26 article complies with the standard so identified. 27 Section 207. Unsanitary manufacture of food. 28 No person shall manufacture, prepare, preserve, package or store for sale any 29 food under unsanitary conditions. 30 31 HOUSE BILL NO. 11-101, HD1 Page 7 Section 208. Prohibition regarding slaughter of dogs and cats. 1 It is the policy of the Commonwealth Department of Public Health that the sale 2 of dogs and cats for human consumption is prohibited and shall be deemed a violation 3 of this Act. 4 Article 3. 5 Regulation of Drugs 6 Section 301. Prohibited sales of drugs. 7 No person shall sell any drug that 8 (a) was manufactured, prepared, preserved, packaged, distributed or 9 stored under unsanitary conditions; or 10 (b) is adulterated. 11 Section 302. Deception regarding drugs. 12 No person shall label, package, treat, process, distribute, sell or advertise any 13 drug in a manner that is false, misleading or deceptive or is likely to create erroneous 14 impression regarding its character, value, quantity, composition, merit or safety. 15 Section 303. Drugs labeled or packaged in contravention of regulations. 16 A drug that is not labeled or packaged as required by, or is labeled or packaged 17 contrary to the regulations shall be deemed to be labeled or packaged contrary to 18 section 302. 19 Section 304. Where standard prescribed for drug. 20 Where a standard has been prescribed for a drug by the World Health 21 Organization (WHO) or in official compendium as defined in this act, no person shall 22 label, package, distribute, sell or advertise any substance in such a manner that it is 23 likely to be mistaken for that drug, unless the substance complies with the prescribed 24 standard. 25 Section 305. Unsanitary manufacture of drug. 26 No person shall manufacture, prepare, preserve, package, distribute, or store for 27 sale any drug under unsanitary conditions. 28 Section 306. Drugs not to be sold unless safe manufacture indicated. 29 No person shall sell any drug described in Schedule B or C unless the Secretary 30 has, in prescribed form and manner, indicated that the premises in which the drug was 31 HOUSE BILL NO. 11-101, HD1 Page 8 manufactured and the process and conditions of manufacture therein are suitable to 1 ensure that the drug will not be unsafe for use. 2 Section 307. Drugs not to be sold unless safe batch indicated. 3 No person shall sell any drug described in Schedule D unless the Secretary has, 4 in prescribed form and manner, indicated that the batch from which the drug was taken 5 is not unsafe for use. 6 Section 308. Samples. 7 (a) No person shall distribute or cause to be distributed any drug as a 8 sample. 9 (b) Subsection (a) does not apply to the distribution, under prescribed 10 conditions, of samples of drugs to physicians, dentists, veterinary surgeons or 11 pharmacists. 12 Section 308. Importation of Drugs. 13 No person shall import foreign drugs unless: 14 (a) the foreign drug was purchased or acquired for personal use; 15 (b) the intended use of the foreign drug is appropriately identified and 16 such prescription or product shall not extend in excess of three months; 17 (c) the patient seeking to import or who imports the product(s) shall 18 affirm in writing that it is for personal use and shall provide the name and 19 address of the licensed physician in the U.S. or foreign countries responsible for 20 such prescription and the name and telephone number of an authorized 21 pharmaceutical business establishment where the foreign drug was purchased. 22 Article 4. 23 Regulation of Cosmetics and Devices. 24 Section 401. Prohibited sales of cosmetics. 25 No person shall sell any cosmetic that 26 (a) has in or on it any substance that may cause injury to the health of 27 the user when the cosmetic is used, 28 (1) according to the directions on the label or accompanying the 29 cosmetic, or 30 (2) for such purposes and by such methods of use as are 31 customary or usual therefore; 32 HOUSE BILL NO. 11-101, HD1 Page 9 (b) consists in whole or in part of any filthy or decomposed substance or 1 of any foreign matter; or 2 (c) was manufactured prepared, preserved, packaged, distributed, or 3 stored under unsanitary conditions. 4 Section 402. Where standard prescribed for cosmetic. 5 Where a standard has been prescribed under Commonwealth regulation for a 6 cosmetic, no person shall label, package, sell or advertise any article in such a manner 7 that it is likely to be mistaken for that cosmetic, unless the article complies with the 8 prescribed standard. 9 Section 403. Unsanitary conditions. 10 No person shall manufacture, prepare, preserve, package or store for sale any 11 cosmetic under unsanitary conditions. 12 Section 404. Prohibited sales of devices. 13 No person shall sell any device that, when used according to directions or under 14 such conditions as are customary or usual, may cause injury to the health of the 15 purchaser or use thereof. 16 Section 405. Deception regarding devices. 17 No person shall label, package, treat, process, sell or advertise any device in a 18 manner that is false, misleading or deceptive or is likely to create an erroneous 19 impression regarding its design, construction, performance, intended use, quantity, 20 character, value, composition, merit or safety. 21 Section 406. Devices labeled or packaged in contravention of regulations. 22 A device that is not labeled or packaged as required by, or is labeled or 23 packaged contrary to, the regulations shall be deemed to be labeled or packaged 24 contrary to section 405. 25 Section 407. Where standard prescribed for device. 26 Where a standard has been prescribed by the World Health Organization 27 (WHO) or in an official compendium as defined in this act, for a device, no person shall 28 label, package, sell or advertise any article in such a manner that it is likely to be 29 mistaken for that device, unless that article complies with the prescribed standard. 30 31 HOUSE BILL NO. 11-101, HD1 Page 10 Article 5. 1 Administration and Enforcement. 2 Section 501. Inspection, Seizure and Forfeiture. 3 (a) The Secretary may designate any person employed by the 4 Department of Public Health as an inspector and, in coordination with the 5 Secretary of Finance, request employees in Customs Service, to act on his or her 6 behalf, as an inspector for the purpose of the enforcement of this Act. 7 (b) An inspector shall be furnished with a prescribed certificate or 8 credentials of his or her designation as an inspector and upon entering any place 9 pursuant to subsection (c) herein, an inspector shall, if so required, produce the 10 certificate or credentials to the person in charge of that place. 11 (c) Subject to the limitation of section 502, an inspector may enter any 12 place during any reasonable time of operations where the inspector believes on 13 reasonable grounds any article to which this Act the regulations apply is 14 manufactured, prepared, preserved, packaged, distributed, or stored, and may 15 (1) examine any such article and take samples thereof and 16 examine anything that the inspector believes on reasonable grounds is 17 used or capable of being used for the manufacture, preparation, 18 preservation, packaging or storing. 19 (2) enter any conveyance that the inspector believes on 20 reasonable grounds is used to carry any article to which section 204 21 applies and examine any such article found therein and take samples 22 thereof. 23 (3) open and examine any receptacle or package that the 24 inspector believes on reasonable grounds contains any article to which 25 this Act or the regulations apply. 26 (4) examine and make copies of, or extracts from, any books, 27 documents or other records found in any place referred to in this 28 subsection that the inspector believes on reasonable grounds contains 29 any information relevant to the enforcement of this Act with respect to 30 any article to which this Act or the regulations apply; and 31 HOUSE BILL NO. 11-101, HD1 Page 11 (5) seize and detain for such time as may be necessary any 1 article by means of or in relation to which the inspector believes on 2 reasonable grounds any provision of this Act or any regulations 3 promulgated thereunder has been contravened. 4 Section 502. Warrant required to enter into any dwelling-house. 5 Where any place mentioned in section 501 (c) is a dwelling-house, an inspector 6 may not enter that dwelling-house without the consent of the occupant except under the 7 authority of a warrant issued under section 503. 8 Section 503. Authority to issue warrant. 9 Where on ex parte application of the Department, a judge of the Commonwealth 10 is satisfied by information on oath 11 (a) that the conditions for entry described in section 501 (c) exist in 12 relation to a dwelling-house, 13 (b) that entry to the dwelling-house is necessary for any reasonable 14 purpose relating to the administration or enforcement of this Act, and 15 (c) that entry to the dwelling-house has been refused or that there are 16 reasonable grounds for believing that entry thereto will be refused; 17 The judge may issue a warrant under his or her hand authorizing the inspector named 18 therein to enter that dwelling-house subject to such conditions as may be specified in the 19 warrant. 20 Section 504. Use of force. In executing a warrant issued under section 503, the 21 inspector named therein shall not use force unless the inspector is accompanied by a 22 Department of Public Safety police officer, and the use of force has been specifically 23 authorized in the warrant. 24 Section 505. Definition of “article to which this Act or the regulations apply:” 25 (a) In section 501 (c), “article to which this Act or the regulations 26 apply” includes; 27 (1) any food, drug, cosmetic, or device; 28 (2) anything used for the manufacture, preparation, preservation, 29 packaging or storing thereof; and 30 (3) any labeling or advertising material. 31 HOUSE BILL NO. 11-101, HD1 Page 12 Section 506. Assistance and information to be given inspector. The owner or 1 person in charge of a place entered by an inspector pursuant to section 501 (c) and every 2 person found therein shall give the inspector all reasonable assistance and furnish the 3 inspector with any information he or she may reasonably require. 4 Section 507. Obstruction and false statement. No person shall obstruct or 5 hinder, or knowingly make any false or misleading statement either orally or in writing 6 to an inspector while the inspector is engaged in carrying out his or her duties or 7 functions under this Act or the regulations. 8 Section 508 Interference. Except with the authority of an inspector, no person 9 shall remove, alter or interfere in any way with anything seized under this Act or the 10 regulations. 11 Section 509. Storage and removal. Any article seized under this Article 5 may, 12 at the option of an inspector, be kept or stored in the building or place where it was 13 seized or, at the direction of an inspector, the article may be removed to any other 14 proper place. 15 Section 510. Release of seized articles. An inspector who has seized any 16 article under this Article 5 shall release it when he or she is satisfied that all the 17 provisions of this Act and the regulations with respect thereto have been complied with. 18 Section 511. Destruction with consent. Where an inspector has seized an 19 article under this Article 5 and its owner or the person in whose possession the article 20 was at the time of seizure consents to its destruction, the article is thereupon forfeited to 21 the Commonwealth and may be destroyed or otherwise disposed of as the Secretary 22 may direct. 23 Section 512. Forfeiture on conviction. 24 Where a person has been convicted of a contravention of this Act or the 25 regulations, the court or judge may order that any article by means of or in relation to 26 which the offense was committed, and anything of a similar nature belonging to or in 27 the possession of the accused or found with the article, be forfeited and, on the making 28 of the order, the article and thing are forfeited to the Commonwealth and may be 29 disposed of as the Secretary may direct. 30 Section 513. Order for forfeiture on application of inspector. Without prejudice 31 to section 512, a judge of a court of the Commonwealth under this Article 5 may, on the 32 HOUSE BILL NO. 11-101, HD1 Page 13 application of an inspector and on such notice to such persons as the judge directs, 1 order that the article and anything of a similar nature found therewith be forfeited to 2 Commonwealth, to be disposed of as the Secretary may direct, if the judge finds, after 3 making such inquiry as the judge considers necessary, that the article is one by means of 4 or in relation to which any of the provisions of this Act or the regulations have been 5 contravened. 6 Section 514. Designation of Analysts. The Secretary may designate any person 7 as an analyst for the purpose of the enforcement of this Act. 8 Section 515. Analysis and examination 9 (a) An inspector may submit to an analyst, for analysis or examination, 10 any article seized by the inspector, or any sample taken by the inspector. 11 (b) An analyst who has made an analysis or examination may issue a 12 certificate or report setting out the results of the analysis or examination. 13 Section 516. Authority to make regulations. The Secretary may make 14 regulations for carrying the purposes and provisions of this Act into effect, and, in 15 particular, but without restricting the generality of the foregoing, may make regulations: 16 (a) declaring that any food, drug, cosmetic, or device or class of foods, 17 drugs, cosmetics, or devices are adulterated if any prescribed substance or class 18 of substances is present therein or has been added thereto or extracted or 19 omitted there from; 20 (b) respecting: 21 (1) the labeling and packaging and the offering, exposing and 22 advertising for sale of a food, drug, cosmetic, or device 23 (2) the size, dimensions fill and other specifications of packages 24 of a food, drug, cosmetic, or device 25 (3) the sale or the conditions of sale of any food, drug, cosmetic, 26 or device and 27 (4) the use of any substance as an ingredient or component in 28 any food, drug, cosmetic, or device to prevent the purchaser or consumer 29 thereof from being deceived or misled in respect of the design, 30 construction, performance, intended use, quantity, character, value, 31 HOUSE BILL NO. 11-101, HD1 Page 14 composition, merit or safety thereof, or to prevent injury to the health of 1 the purchaser or consumer; 2 (c) prescribing standards of composition, strength, potency, purity, 3 quality or other property of any article of food, drug, cosmetic or device; 4 (d) respecting the importation of foods, drugs, cosmetics, devices in 5 order to ensure compliance with this Act and regulations; 6 (e) respecting the method of manufacture, preparation, preserving, 7 packing, storing and testing of any food, drug, cosmetic, device in the interest 8 of, or for the prevention of injury to, the health of the purchaser or consumer; 9 (f) requiring persons who sell drugs and devices to register their place of 10 business and list their products, and maintain such books and records as the 11 Secretary considers necessary for the proper enforcement and administration of 12 this Act and regulations; 13 (g) respecting the form and manner of the Secretary’s indication under 14 section 306, including the fees payable therefor, and prescribing what premises 15 or what processes or conditions of manufacture, including qualifications of 16 technical staff, shall or shall not be deemed to be suitable for the purposes of 17 that section; 18 (h) requiring manufacturers of any drugs described in Schedule D to 19 submit test portions of any batch of those drugs and respecting the form and 20 manner of the Secretary’s indication under section 307, including the fees 21 payable therefor; 22 (i) respecting the powers and duties of inspectors and analysts and the 23 taking of samples and the seizure, detention, forfeiture and disposition of 24 articles; 25 (j) exempting any food or drug from all or any of the provisions of this 26 Act and prescribing the conditions of the exemption; 27 (k) prescribing forms for the purposes of this Act and the regulations; 28 (l) providing for the analysis of a food, drug, cosmetic, or device other 29 than for the purposes of this Act and prescribing a tariff of fees to be paid for 30 that analysis. 31 HOUSE BILL NO. 11-101, HD1 Page 15 (m) adding anything to any of the schedules, in the interest of, or for the 1 prevention of injury to, the health of the purchaser or consumer, or deleting 2 anything therefrom; 3 (n) respecting the distribution or the conditions of distribution of 4 samples of any drug; 5 (o) respecting 6 (1) the method of manufacture, preparation, preserving, packing, 7 labeling, storing, holding, and testing of any new drug, and 8 (2) the sale or the conditions of sale of any new drug, and 9 defining for the purposes of this Act the expression “new drug”. 10 Section 517. Regulations respecting drugs manufactured outside the United 11 States. Without limiting or restricting the authority conferred by any other provisions 12 of this Act or any part thereof for carrying into effect the purposes and provisions of 13 this Act or any part thereof, the Secretary may make such regulations governing, 14 regulating or prohibiting: 15 (a) the importation into the Commonwealth of any drug or device or 16 class of drugs or devices manufactured outside the United States, or 17 (b) the distribution or sale in the Commonwealth, or the offering, 18 exposing or having in possession for sale in the Commonwealth, of any drug or 19 device or class of drugs or devices manufactured outside the United States, as 20 the Secretary deems necessary for the protection of the public in relation to the 21 safety and quality of any such drug or device or class of drugs devices. 22 Section 518. Offenses and Punishment: Contravention of Act or regulations. 23 Every person who contravenes any of the provisions of this Act, or of the regulations 24 made pursuant to sections 516 and 517, is guilty of an offense and liable: 25 (a) on conviction for a first offense to a fine not exceeding five hundred 26 dollars ($500) or to imprisonment for a term not exceeding three (3) months or 27 to both and for a subsequent offense, to a fine not exceeding one thousand 28 dollars ($1,000) or to imprisonment for a term not exceeding six months, or 29 both; and 30 HOUSE BILL NO. 11-101, HD1 Page 16 (b) on conviction for a subsequent offense to a fine not exceeding five 1 thousand dollars ($5,000) or to imprisonment for a term not exceeding three (3) 2 years, or both. 3 Section 519. Limitation period. A prosecution under paragraph section 518 4 may be instituted at any time within but not later than twelve months from the time the 5 subject-matter of the prosecution arose. 6 Section 520. Certificate of analyst. Subject to this section, in any prosecution 7 for an offense under section 518, a certificate purporting to be signed by an analyst and 8 stating that an article, sample or substance has been submitted to, and analyzed or 9 examined by, the analyst and stating the results of the analysis or examination is 10 admissible in evidence and, in the absence of evidence to the contrary, is proof of the 11 statements contained in the certificate without proof of the signature or official 12 character of the person appearing to have signed the certificate. 13 Section 521. Requiring attendance of analyst. The party against whom a 14 certificate of an analyst is produced pursuant to section 520 may, with leave of the 15 court, require the attendance of the analyst for the purposes of cross-examination. 16 Section 522. Notice of intention to produce certificate. No certificate shall be 17 admitted in evidence pursuant to section 520 unless, before the trial, the party intending 18 to produce the certificate has given reasonable notice of that intention, together with a 19 copy of the certificate, to the party against whom it is intended to be produced. 20 Section 523. Proof of service. For the purposes of this Act, service of any 21 certificate referred to in section 520 may be proved by oral evidence given under oath 22 by, or by the affidavit or solemn declaration of, the person claiming to have served it. 23 Section 524. Requirement to appear before court. Notwithstanding section 523, 24 the court may require the person who appears to have signed an affidavit or solemn 25 declaration referred to in that subsection to appear before it for examination or cross-26 examination in respect of the issue of proof of service. 27 Section 525. Proof as to manufacturer or packer. In a prosecution for a 28 contravention of this Act, or of the regulations made pursuant to it, proof that a package 29 containing any article to which this Act or the regulations apply bore a name or address 30 purporting to be the name or address of the person by who it was manufactured or 31 packaged is, in the absence of evidence to the contrary, proof that the article was 32 HOUSE BILL NO. 11-101, HD1 Page 17 manufactured or packaged, as the case may be, by the person whose name or address 1 appeared on the package. 2 Section 526. Offense by employee or agent. In a prosecution for a 3 contravention described in section 525, it is sufficient proof of the offense to establish 4 that it was committed by an employee or agent of the accused whether or not the 5 employee or agent is identified or has been prosecuted for the offense. 6 Section 527. Certified copies and extracts. In a prosecution for a contravention 7 described in section 525, a copy of a record or an extract therefrom certified to be a true 8 copy by the inspector who made it pursuant to section 501 (c) (4) is admissible in 9 evidence and is, in the absence of evidence to the contrary, proof of its contents. 10 Section 528. Where accused had adulterating substances. Where a person is 11 prosecuted under this Article for having manufactured an adulterated food or drug for 12 sale, and it is established that the person had in his or her possession or on his or her 13 premises any substance the addition of which to that food or drug has been declared by 14 regulation to cause the adulteration of the food or drug, the onus of proving that the 15 food or drug was not adulterated by the addition of that substance lies on the accused. 16 SCHEDULE A 17 Alcoholism 18 Alopecia 19 Anxiety state 20 Appendicitis 21 Arteriosclerosis 22 Arthritis 23 Asthma 24 Bladder Disease 25 Cancer 26 Convulsions 27 Depression 28 Diabetes 29 Disease of the prostate 30 Prostate (maladies) 31 Disorder of menstrual flow 32 HOUSE BILL NO. 11-101, HD1 Page 18 Dysentery 1 Edematous state 2 Epilepsy 3 Gall bladder disease 4 Gangrene 5 Glaucoma 6 Gout 7 Heart disease 8 Hernia 9 Hypertension 10 Hyportension 11 Impetigo 12 Kidney disease 13 Leukemia 14 Liver disease 15 Nausea and vomiting of pregnancy 16 Pleurisy 17 Rheumatic fever 18 Septicemia 19 Sexual Impotence 20 Thrombotic and Embolic disorders 21 Thyroid disease 22 Tumor 23 Ulcer of the gastro intestinal tract 24 Venereal disease 25 SCHEDULE B 26 Drugs, other than radionuclides, sold or represented for use in the preparation of 27 radiopharmaceuticals 28 Radiopharmaceuticals 29 SCHEDULE C 30 Allergenic substances used for the treatment or diagnoses of allergic or 31 immunological diseases 32 HOUSE BILL NO. 11-101, HD1 Page 19 Substances... 1 Anterior pituitary extracts 2 Aprotinin 3 Aprotinine 4 Blood and blood derivatives 5 Cholecystokinin 6 Cholecystokinine 7 Drugs obtained by recombinant DNA procedures 8 Drugs, other than antibiotics, prepared from micro-organisms 9 Glucagon 10 Gonadotrophins 11 Gonadotrophines 12 Human plasma collected by plasmapheresis 13 Plasma... 14 Immunizing agents 15 Insulin 16 Interferon 17 Monoclonal antibodies, their conjugates and derivatives 18 Secretin 19 Sensitivity Discs and Sensitivity Tablets 20 Snake Venom 21 Urokinase 22 SCHEDULE D 23 Any drugs intended for use in the treatment, prevention, or cure of any diseases, 24 disorders, or abnormal physical states listed in Schedule A, or any drugs listed in 25 Schedule B and C.” 26 Section 3. Severability. If any provision of this Act or the application of any such 27 provision to any person or circumstance should be held invalid by a court of competent 28 jurisdiction, the remainder of this Act or the application of its provisions to persons or 29 circumstances other than those to which it is held invalid shall not be affected thereby. 30 Section 4. Savings Clause. This Act and any repealer contained herein shall not be 31 construed as affecting any existing right acquired under contract or acquired under statutes 32 HOUSE BILL NO. 11-101, HD1 Page 20 repealed or under any rule, regulation or order adopted under the statutes. Repealers contained 1 in this Act shall not affect any proceeding instituted under or pursuant to prior law. The 2 enactment of this Act shall not have the effect of terminating, or in any way modifying, any 3 liability, civil or criminal, which shall already be in existence at the date this Act becomes 4 effective. 5 Section 5. Effective Date. This Act shall take effect upon its approval by the Governor 6 or upon its becoming law without such approval. 7 CERTIFIED BY: ATTESTED BY: DIEGO T. BENAVENTE EVELYN C. FLEMING Speaker House Clerk House of Representatives this day of , 1998 PEDRO P. TENORIO Governor Commonwealth of the Northern Mariana Islands