A drug or device must be deemed to be misbranded: 1. If its labeling is false or misleading in any particular. 2. If in package form unless it bears a label containing: a. The name and place of business of the manufacturer, packer, or distributor; and b. An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count; provided, that under this subdivision reasonable variations must be permitted, and exemptions as to small packages must be allowed, in accordance with regulations prescribed by the department or issued under the federal act. 3. If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use. 4. If it is for use by man and contains any quantity of the narcotic or hypnotic substance alpha-eucaine, barbituric acid, beta-eucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, or sulfonmethane, or any chemical derivative of such substance, which derivative, after investigation, has been found to be and designated as, habit-forming, by regulations issued by the department under this chapter, or by regulations issued pursuant to section 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 its label bears, to the exclusion of any other nonproprietary name, except the applicable systematic chemical name or the chemical formula: a. The established name, as defined in subsection 6, of the drug, if such there be; and b. The established name and quantity of each active ingredient, in case it is fabricated from two or more ingredients, including the kind and quantity or proportion of any alcohol, and also including, whether active or not, the established name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, digitalis glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substances, contained therein. Provided, that the requirement for stating the quantity of the active ingredients, other than the quantity of those specifically named in this subsection applies only to prescription drugs; provided, further, that to the extent that compliance with the
requirements of subdivision b of subsection 6 is impracticable, exemptions must be allowed under regulations promulgated by the department, or under the federal act. 6. As used in subsections 5 and 6, the term "established name", with respect to a drug or ingredient thereof, means: a. The applicable official name designated pursuant to section 508 of the federal act; b. If there is no such name and such drug, or such ingredient, is an article recognized in an official compendium, then the official title thereof in such compendium; or c. If neither subdivision a nor b applies, then the common or usual name, if any, of such drug or of such ingredient. Provided, further, that when subdivision b applies to an article recognized in the United States pharmacopeia and in the homeopathic pharmacopeia under different official titles, the official title used in the United States pharmacopeia applies unless it is labeled and offered for sale as a homeopathic drug, in which case the official title used in the homeopathic pharmacopeia applies. 7. Unless its labeling bears: a. Adequate directions for use; and b. Such adequate warnings against use in those pathological conditions or by children when its use may be dangerous to health, or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users. Provided, that if any requirement of subdivision a, as applied to any drug or device, is not necessary for the protection of the public health, the department shall promulgate regulations exempting such drug or device from such requirements; provided, further, that articles exempted under regulations issued under section 502(f) of the federal act may also be exempt. 8. If it purports to be a drug the name of which is recognized in an official compendium, unless it is packaged and labeled as prescribed therein; provided, that the method of packing may be modified with the consent of the department, or if consent is obtained under the federal act. Whenever a drug is recognized in both the United States pharmacopeia and the homeopathic pharmacopeia of the United States, it is subject to the requirements of the United States pharmacopeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it is subject to the provisions of the homeopathic pharmacopeia of the United States and not to those of the United States pharmacopeia; provided, further, that in the event of inconsistency between the requirements of this subsection and those of subsections 5 and 6 as to the name by which the drug or its ingredients must be designated, the requirements of subsections 5 and 6 must prevail. 9. If it has been found by the department 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 statement of such precautions, as the regulations issued by the department or under the federal act require as necessary for the protection of public health. No such regulation may be established for any drug recognized in an official compendium until the department shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements. 10. If it is a drug and: a. Its container is so made, formed, or filled as to be misleading; b. If it is an imitation of another drug; or c. If it is offered for sale under the name of another drug. 11. If it is dangerous to health when used in the dosage, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof. 12. If it is, or purports to be, or is represented as a drug composed wholly or partly of insulin, unless it is from a batch with respect to which a certificate or release has been
issued pursuant to section 506 of the federal act, and 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, chloramphenicol, bacitracin, or any other antibiotic drug, or any derivative thereof, unless it is from a batch with respect to which a certificate or release has been issued pursuant to section 507 of the federal act, and such certificate or release is in effect with respect to such drug; provided, that this subsection does not apply to any drug or class of drugs exempted by regulations promulgated under section 507(c) or (d) of the federal act. For the purpose of this subsection, the term "antibiotic drug" means any drug intended for use by man containing any quantity of any chemical substance which is produced by a micro-organism and which has the capacity to inhibit or destroy micro-organisms in dilute solution, including the chemically synthesized equivalent of any such substance. 14. If it is a color additive, the intended use of which in or on drugs is for the purpose of coloring only, unless its packaging and labeling are in conformity with such packaging and labeling requirements applicable to such color additive, prescribed under the provisions of subsection 2 of section 19-02.1-12 or of the federal act. 15. In the case of any prescription drug distributed or offered for sale in this state, unless the manufacturer, packer, or distributor thereof includes in all advertisements and other descriptive printed matter issued or caused to be issued by the manufacturer, packer, or distributor with respect to that drug a true statement of the established name as defined in subsection 6, the formula showing quantitatively each ingredient of such drug to the extent required for labels under section 502(e) of the federal act, and such other information in brief summary relating to side effects, contraindications, and effectiveness as are 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. 17. Drugs and devices which are, in accordance 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 are exempt from any labeling or packaging requirements of this chapter; provided, that such drugs and devices are being delivered, manufactured, processed, labeled, repacked, or otherwise held in compliance with regulations issued by the department, or under the federal act. 18. If it is a device and it has an established name, unless its label bears, to the exclusion of any other nonproprietary name, its established name, as defined in subsection 6, prominently printed in type at least half as large as that used thereon for any proprietary name or designation for the device, except that to the extent compliance with the requirements of this subsection is impracticable, exemptions will be established by rules adopted by the department. As used in this subsection, the term "established name" with respect to a device means: a. The applicable official name of the device designated pursuant to federal law. b. If there is no official name of the device designated pursuant to federal law and the device is an article recognized in an official compendium, then the official title of the device in the compendium. c. If neither subdivision a nor subdivision b applies, then any common or usual name of the device. 19. If it is a device subject to a performance standard established under federal law, unless it bears labeling prescribed in the performance standard.
19-02.1-14.1. Definitions - Label of prescription drugs - Selecting and dispensing generic name drugs - Identification of prescription drugs. 1. As used in this section, unless the subject matter or context otherwise requires: a. "Brand name" means the registered trademark name given to a drug or medicine by its manufacturer, labeler, or distributor.
b. "Code imprint" means a series of letters or numbers assigned by the manufacturer or distributor to a specific drug, or marks or monograms unique to the manufacturer or distributor of the drug, or both. c. "Distributor" means a person who distributes for resale a drug in solid dosage form under that person's own label even though that person is not the actual manufacturer of the drug. d. "Generic name" means the established name or official chemical name of the drug, drug product, or medicine. e. "Prescription drug" means a drug defined by section 503(b) of the federal Act and under which definition its label is required to bear the statement "Caution: Federal law prohibits dispensing without prescription" or "Rx Only". f. "Solid dosage form" means capsules or tablets intended for oral use. g. "Therapeutically equivalent" means a generic name drug product that would elicit the same therapeutic response from the same person as a brand name drug product. 2. Drugs or medicines dispensed pursuant to a prescription must bear a label permanently affixed to the immediate container in which the drug or medicine is dispensed or delivered and which is received by the purchaser or patient. The label must bear the brand name or the generic name, strength, quantity, serial number, date of dispensing, patient name, and directions for use of the drug or medicine, except when the physician or other health care provider authorized by law to prescribe drugs or medicine has notified the pharmacist that the appearance of the name on the label would be alarming to or detrimental to the well-being of the purchaser of the prescription. 3. If a practitioner prescribes a drug by its brand name, the pharmacist may exercise professional judgment in the economic interest of the patient by selecting a drug product with the same generic name and demonstrated therapeutical equivalency as the one prescribed for dispensing and sale to the patient unless the practitioner specifically indicates in the practitioner's own handwriting "brand medically necessary" on a written prescription or expressly indicates that an oral prescription is to be dispensed as communicated. If the prescription is created electronically by the prescriber, the required legend must appear on the practitioner's screen. The practitioner must take a specific overt action to include the "brand medically necessary" language with the electronic transmission. The pharmacist shall note the instructions on the file copy of the prescription, or maintain the digital record as transmitted if it is an electronic prescription. A reminder legend must be placed on all prescription forms or appear on the computer screen of the electronic prescribing system. The legend must state "In order to require that a brand name product be dispensed, the practitioner must handwrite the words 'brand medically necessary'.". The legend printed on the prescription form or appearing on the prescriber's computer screen must be in at least six-point uppercase print or font. The pharmacist may not substitute a generic name drug product unless its price to the purchaser is less than the price of the prescribed drug product. In addition, a pharmacist may not substitute drug products in the following dosage forms: enteric coated tablets, controlled release products, injectable suspensions other than antibiotics, suppositories containing active ingredients for which systemic absorption is necessary for therapeutic activity, and different delivery systems for aerosol and nebulizer drugs. In the event that any drug listed above is, subsequent to January 1, 1982, determined to be therapeutically equivalent, then the previously mentioned substitution ban is automatically removed for that drug. The pharmacist shall inform the person receiving the drug when a prescription for a brand name drug product does not require that the prescribed drug be dispensed and of the person's right to refuse a generic name drug product selected by the pharmacist. The pharmacy file copy of every prescription must include the brand name, if any, or the name of the manufacturer, packer, or distributor of the generic name drug dispensed. A pharmacist who selects and dispenses a therapeutically equivalent generic name drug product shall assume no greater liability
for selecting the dispensed drug product than would be incurred in filling a prescription for a drug product prescribed by its generic name. The practitioner is not liable for the substitution made by a pharmacist. 4. In the case of a prescription for which a maximum allowable cost program for purposes of reimbursement has been established under title XIX of the federal Social Security Act, the following also apply: a. If the practitioner has instructed the pharmacist to dispense as written, the words "brand medically necessary" must also be written on the prescription in the practitioner's own handwriting, or appear as part of the electronic prescription as noted in subsection 3. The pharmacist may dispense a therapeutically equivalent generic name drug product if this handwritten or electronic instruction does not appear on the prescription. b. If the pharmacist is instructed orally to dispense a brand name drug as prescribed, the pharmacist shall reduce the prescription to writing and shall note the instructions on the file copy of the prescription. c. If the practitioner has not instructed the pharmacist to dispense a brand name drug or medicine and the patient specifically requests a brand name drug or medicine, the patient shall pay the difference between the price to the patient of the brand name drug or medicine and the therapeutically equivalent generic name drug or medicine if the price of the brand name drug or medicine is higher. 5. A pharmacist may not select and dispense a different drug product for a prescribed drug product unless it has been manufactured with the following minimum manufacturing standards and practices by a manufacturer who: a. Marks capsules and tablets with identification code or monogram. b. Labels products with their expiration date. c. Provides reasonable services to accept return goods that have reached their expiration date. d. Provides the pharmacist with information from which it can be determined whether a drug product is therapeutically equivalent. e. Maintains recall capabilities for unsafe or defective drugs. 6. No prescription drug in solid dosage form may be manufactured or distributed in this state unless it is clearly marked or imprinted with a code imprint identifying the drug and the manufacturer or distributor of the drug. 7. All manufacturers and distributors of prescription drugs in solid dosage form shall provide to the department or state board of pharmacy, upon request, a listing of all such prescription drugs identifying by code imprint the manufacturer and the specific type of drug. The listing must at all times be kept current by all manufacturers and distributors subject to the provisions of this section. 8. The state board of pharmacy may grant exemptions from the requirements of this section upon application by any drug manufacturer or distributor which shows size, physical characteristics, or other unique characteristics of a drug that render the use of a code imprint on the drug impracticable or impossible. Any exemption granted by the state board of pharmacy must be included by the manufacturer or distributor in the listing required by this section. The listing must describe the physical characteristics and type of drug to which the exemption relates. 9. All prescription drugs in solid dosage form that are possessed, distributed, sold, or offered for sale in violation of the provisions of this section must be deemed misbranded and must be seized by the department or state board of pharmacy.
19-02.1-14.2. Maximum allowable cost lists for pharmaceuticals - Pharmacy benefits managers - Penalty. 1. For the purposes of this section: a. "Determination" means a decision that settles and ends a controversy or the resolution of a question through appeal.
b. "Maximum allowable cost price" means a maximum reimbursement amount for a group of therapeutically equivalent and pharmaceutically equivalent multiple source drugs. c. "Multiple source drug" means a therapeutically equivalent drug that is available from at least two manufacturers. d. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. 2. With respect to each contract between a pharmacy benefits manager and a pharmacy, each pharmacy benefits manager shall: a. Provide to the pharmacy, at the beginning of each contract and contract renewal, the sources utilized to determine the maximum allowable cost pricing of the pharmacy benefits manager. b. Update any maximum allowable cost price list at least every seven business days, and provide prompt notification of the pricing changes to network pharmacies. c. Disclose the sources utilized for setting maximum allowable cost price rates on each maximum allowable cost price list included under the contract and identify each maximum allowable cost price list that applies to the contracted pharmacy. A pharmacy benefits manager shall make the list of the maximum allowable costs available to a contracted pharmacy in a format that is readily accessible and usable to the contracted pharmacy. d. Ensure maximum allowable cost prices are not set below sources utilized by the pharmacy benefits manager. e. Provide a reasonable administrative appeals procedure to allow a dispensing pharmacy provider to contest a listed maximum allowable price rate. The pharmacy benefits manager shall provide a determination to a provider that has contested a maximum allowable price rate within seven business days. If an update to the maximum allowable price rate for an appealed drug is warranted, the pharmacy benefits manager shall make the change based on the date of the determination and make the adjustment effective for all similarly situated pharmacy providers in this state within the network. f. Ensure dispensing fees are not included in the calculation of maximum allowable cost price reimbursement to pharmacy providers. 3. A pharmacy benefits manager may not place a prescription drug on a maximum allowable price list unless: a. The drug has at least two nationally available, therapeutically equivalent, multiple source drugs or a generic drug is available only from one manufacturer; b. The drug is listed as therapeutically equivalent and pharmaceutically equivalent or "A" or "B" rated in the United States food and drug administration’s most recent version of the "Orange Book" or the drug is "Z" rated; and c. The drug is generally available for purchase by pharmacies in the state from national or regional wholesalers and not obsolete. 4. This section does not apply to state Medicaid programs. 5. A pharmacy benefits manager that violates this section is guilty of a class B misdemeanor.