§ 19-02.1-14.1 — Definitions - Label of prescription drugs - Selecting and dispensing generic name drugs - Identification of prescription drugs

North Dakota § 19-02.1-14.1

• Jurisdiction: North Dakota
• Title 19: Foods, Drugs, Oils, and Compounds
• Ch. 19-02.1: North Dakota Food, Drug, and Cosmetic Act

Text

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.