1. No person may sell, deliver, offer for sale, hold for sale, or give away any new drug unless: a. An application with respect thereto has been approved and said approval has not been withdrawn under section 505 of the federal act; or b. When not subject to the federal act, unless such drug has been tested and has been found to be safe for use and effective in use under the conditions prescribed, recommended, or suggested in the labeling thereof, and prior to selling or offering for sale such drug, there has been filed with the department an application setting forth: (1) 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. (2) A full list of the articles used as components of such drug. (3) A full statement of the composition of such drug. (4) A full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and packing of such drugs. (5) Such samples of such drug and of the articles used as components thereof as the department may require. (6) Specimens of the labeling proposed to be used for such drug. 2. An application provided for in subdivision b of subsection 1 becomes effective on the one hundred eightieth day after the filing thereof, except that if the department finds, after due notice to the applicant and giving the applicant an opportunity for a hearing, that the drug is not safe or not effective for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, the department shall, prior to the effective date of the application, issue an order refusing to permit the application to become effective. 3. An order refusing to permit an application under this section to become effective may be revoked by the department. 4. This section does not apply: a. To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs,
provided the drug is plainly labeled in compliance with regulations issued by the department or pursuant to section 505(i) or 507(d) of the federal act; b. To a drug sold in this state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act; c. To any drug which is licensed under the Virus, Serum, and Toxin Act of July 1, 1902, U.S.C. 1958 ed. Title 42 Chapter 6A Sec. 262; or d. To any drug which is subject to subsection 5 of section 19-02.1-14. 5. The provisions of subsection 16 of section 19-02.1-01 do not apply to any drug which, on October 9, 1962, or on the date immediately preceding the enactment of this subsection: a. Was commercially sold or used in this state or in the United States; b. Was not a new drug as defined by subsection 16 of section 19-02.1-01 as then in force; and c. Was not covered by an effective application under section 19-02.1-16 or under section 505 of the federal act, when such drug is intended solely for use under conditions prescribed, recommended, or suggested in labeling with respect to such drug.
19-02.1-16.1. Pharmacy claim fees and pharmacy rights - Pharmacy benefits managers - Penalty. 1. As used in this section: a. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. b. "Plan sponsor" has the same meaning as in section 19-03.6-01. c. "Third-party payer" has the same meaning as in section 19-03.6-01. 2. A pharmacy benefits manager or third-party payer may not directly or indirectly charge or hold a pharmacy responsible for a fee related to a claim: a. That is not apparent at the time of claim processing; b. That is not reported on the remittance advice of an adjudicated claim; or c. After the initial claim is adjudicated at the point of sale. 3. Pharmacy performance measures or pay for performance pharmacy networks shall utilize the electronic quality improvement platform for plans and pharmacies or other unbiased nationally recognized entity aiding in improving pharmacy performance measures. a. A pharmacy benefits manager or third-party payer may not collect a fee from a pharmacy if the pharmacy's performance scores or metrics fall within the criteria identified by the electronic quality improvement platform for plans and pharmacies or other unbiased nationally recognized entity aiding in improving pharmacy performance measures. b. If a pharmacy benefits manager or third-party payer imposes a fee upon a pharmacy for scores or metrics or both scores and metrics that do not meet those established by the electronic quality improvement platform for plans and pharmacies or other nationally recognized entity aiding in improving pharmacy performance measures, a pharmacy benefits manager or third-party payer is limited to applying the fee to the professional dispensing fee outlined in the pharmacy contract. c. A pharmacy benefits manager or third-party payer may not impose a fee relating to performance metrics on the cost of goods sold by a pharmacy. 4. A pharmacy benefits manager or third-party payer may not charge a patient a copayment that exceeds the cost of the medication. If a patient pays a copayment, the dispensing provider or pharmacy shall retain the adjudicated cost and the pharmacy benefits manager or third-party payer may not redact the adjudicated cost. 5. A pharmacy benefits manager or third-party payer may not prohibit a pharmacist or pharmacy from participating in a class action lawsuit. A pharmacy or pharmacist may disclose to the plan sponsor or to the patient information regarding the adjudicated reimbursement paid to the pharmacy which is compliant under the federal Health
Insurance Portability and Accountability Act of 1996 [Pub. L. 104-191; 110 Stat. 1936; 29 U.S.C. 1181 et seq.]. 6. A pharmacist or pharmacy that belongs to a pharmacy service administration organization may receive a copy of a contract the pharmacy service administration organization entered with a pharmacy benefits manager or third-party payer on the pharmacy's or pharmacist's behalf. 7. A pharmacy or pharmacist may provide relevant information to a patient if the patient is acquiring prescription drugs. This information may include the cost and clinical efficacy of a more affordable alternative drug if one is available. Gag orders of such a nature placed on a pharmacy or pharmacist are prohibited. 8. A pharmacy or pharmacist may mail or deliver drugs to a patient as an ancillary service of a pharmacy. 9. A pharmacy benefits manager or third-party payer may not prohibit a pharmacist or pharmacy from charging a shipping and handling fee to a patient requesting a prescription be mailed or delivered. 10. Upon request, a pharmacy benefits manager or third-party payer shall provide a pharmacy or pharmacist with the processor control number, bank identification number, and group number for each pharmacy network established or administered by a pharmacy benefits manager to enable the pharmacy to make an informed contracting decision. 11. A pharmacy benefits manager or third-party payer may not require pharmacy accreditation standards or recertification requirements inconsistent with, more stringent than, or in addition to federal and state requirements for licensure as a pharmacy in this state. 12. A pharmacy benefits manager or other third-party payer that violates this section is guilty of a class B misdemeanor per violation occurrence.
19-02.1-16.2. Specialty pharmacy services and patient access to pharmaceuticals - Pharmacy benefits managers - Penalty. 1. As used in this section: a. "Pharmacy benefits manager" has the same meaning as in section 19-03.6-01. b. "Plan sponsor" has the same meaning as in section 19-03.6-01. c. "Specialty drug" means a prescription drug that: (1) Is not available for order or purchase by a retail community pharmacy and long-term care pharmacy, regardless of whether the drug is meant to be self-administered; and (2) Requires special storage and has distribution or inventory limitations not available at a retail community pharmacy or long-term care pharmacy. d. "Third-party payer" has the same meaning as in section 19-03.6-01. 2. If requested by a plan sponsor contracted payer, a pharmacy benefits manager or third-party payer that has an ownership interest, either directly or through an affiliate or subsidiary, in a pharmacy shall disclose to the plan sponsor contracted payer any difference between the amount paid to a pharmacy and the amount charged to the plan sponsor contracted payer. 3. A pharmacy benefits manager or a pharmacy benefits manager's affiliates or subsidiaries may not own or have an ownership interest in a patient assistance program and a mail order specialty pharmacy, unless the pharmacy benefits manager, affiliate, or subsidiary agrees to not participate in a transaction that benefits the pharmacy benefits manager, affiliate, or subsidiary instead of another person owed a fiduciary duty. 4. A pharmacy benefits manager or third-party payer may not require pharmacy accreditation standards or recertification requirements to participate in a network which are inconsistent with, more stringent than, or in addition to the federal and state requirements for licensure as a pharmacy in this state. 5. A licensed pharmacy or pharmacist may dispense any and all drugs allowed under that license.
6. A pharmacy benefits manager or other third-party payer that violates this section is guilty of a class B misdemeanor for each violation occurrence.