Authority to Make Regulations

3 CMC § 2786 — under Pure Food and Drug Control.

3 CMC § 2786

TITLE 3: HUMAN RESOURCES

DIVISION 2: HEALTH

§ 2786. Authority to Make Regulations. The secretary may make regulations for carrying the purposes and provisions of this chapter into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations: (a) Declaring that any food, drug, cosmetic, or device or class of foods, drugs, cosmetics, or devices are adulterated if any prescribed substance or class of substances is present therein or has been added thereto or extracted or omitted there from; (b) Respecting: (1) The labeling and packaging and the offering, exposing and advertising for sale of a food, drug, cosmetic, or device (2) The size, dimensions fill and other specifications of packages of a food, drug, cosmetic, or device (3) The sale or the conditions of sale of any food, drug, cosmetic, or device and (4) The use of any substance as an ingredient or component in any food, drug, cosmetic, or device to prevent the purchaser or consumer thereof from being deceived or misled in respect of the design, construction, performance, intended use, quantity, character, value, composition, merit or safety thereof, or to prevent injury to the health of the purchaser or consumer; (c) Prescribing standards of composition, strength, potency, purity, quality or other property of any article of food, drug, cosmetic or device; (d) Respecting the importation of foods, drugs, cosmetics, devices in order to ensure compliance with this chapter and regulations; (e) Respecting the method of manufacture, preparation, preserving, packing, storing and testing of any food, drug, cosmetic, device in the interest of, or for the prevention of injury to, the health of the purchaser or consumer; (f) Requiring persons who sell drugs and devices to register their place of business and list their products, and maintain such books and records as the secretary considers necessary for the proper enforcement and administration of this chapter and regulations; (g) Respecting the form and manner of the secretary's indication under 3 CMC § 2736, including the fees payable therefor, and prescribing what premises or what processes or conditions of manufacture, including qualifications of technical staff, shall or shall not be deemed to be suitable for the purposes of that section; (h) Requiring manufacturers of any drugs described in Schedule D to submit test portions of any batch of those drugs and respecting the form and manner of the secretary's indication under 3 CMC § 2737, including the fees payable therefor; (i) Respecting the powers and duties of inspectors and analysts and the taking of samples and the seizure, detention, forfeiture and disposition of articles;

TITLE 3: HUMAN RESOURCES

DIVISION 2: HEALTH

(j) Exempting any food or drug from all or any of the provisions of this chapter and prescribing the conditions of the exemption; (k) Prescribing forms for the purposes of this chapter and the regulations; (1) Providing for the analysis of a food, drug, cosmetic, or device other than for the purposes of this chapter and prescribing a tariff of fees to be paid for that analysis. (m) Adding anything to any of the schedules, in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, or deleting anything therefrom; (n) Respecting the distribution or the conditions of distribution of samples of any drug; (o) Respecting: (1) The method of manufacture, preparation, preserving, packing, labeling, storing, holding, and testing of any new drug, and (2) The sale or the conditions of sale of any new drug, and defining for the purposes of this chapter the expression “new drug”. Source: PL 11-40, § 2 (§ 516), modified. Commission Comment: Schedule D of PL 11-40 read as follows: SCHEDULE D Any drugs intended for use in the treatment, prevention, or cure of any diseases, disorders, or abnormal physical states listed in Schedule A, or any drugs listed in Schedule B and C.” See Commission Comments to 3 CMC §§ 2703 and 2736 for Schedules A, B, and C.