Browse Arkansas Code titles and sections
17-92-503. Generic drug product and biological product substitutions.
Arkansas Code — all titles (historical 2020) · legal_authorities
17-92-503. Generic drug product and biological product substitutions.
(a)(1)(A) Except as provided in subsection (b) of this section, when a pharmacist receives a prescription for a brand or trade name drug product or biological product, the pharmacist may dispense a generically equivalent drug product or interchangeable biological product only when there will be a cost savings for the patient.
(B) The pharmacist shall disclose the amount of the cost savings at the request of the patient.
(2) The total amount charged for the substituted generically equivalent drug product or interchangeable biological product or for dispensing the drug product or biological product shall not exceed the amount normally and regularly charged under comparable circumstances by the pharmacist for that drug product or biological product or for the dispensing of that drug product or biological product.
(3) A pharmacist may not dispense a drug product or interchangeable biological product with a total charge that exceeds the total charge of the drug product or biological product originally prescribed unless agreed to by the purchaser.
(b) The pharmacist shall not dispense a generically equivalent drug product or interchangeable biological product under subsection (a) of this section if:
(1) The prescriber, in the case of a prescription in writing signed by the prescriber, indicates in his or her own handwriting by name or initial that no substitution shall be made;
(2) The prescriber, in the case of a prescription other than one in writing signed by the prescriber, expressly indicates that the prescription is to be dispensed as communicated;
(3) The person for whom the drug product or biological product is prescribed indicates that the prescription is to be dispensed as written
Source: Arkansas Code — historical release 78 (November 6, 2020) · 17-92-503
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. A text match is a research starting point; applicability is not established.
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Stable record: arkansas_code:legal_authorities:17-92-503
Source file: gov.ar.code.title.17.odt
Pages: Not recorded – Not recorded
Passage SHA-256: ab9898e2214443f062a9a14a8a2bac6f457aa488480a81f2859e0e8ee73cd596
Source location: content.xml paragraph 26119
Stored source content
17-92-503. Generic drug product and biological product substitutions.
(a)(1)(A) Except as provided in subsection (b) of this section, when a pharmacist receives a prescription for a brand or trade name drug product or biological product, the pharmacist may dispense a generically equivalent drug product or interchangeable biological product only when there will be a cost savings for the patient.
(B) The pharmacist shall disclose the amount of the cost savings at the request of the patient.
(2) The total amount charged for the substituted generically equivalent drug product or interchangeable biological product or for dispensing the drug product or biological product shall not exceed the amount normally and regularly charged under comparable circumstances by the pharmacist for that drug product or biological product or for the dispensing of that drug product or biological product.
(3) A pharmacist may not dispense a drug product or interchangeable biological product with a total charge that exceeds the total charge of the drug product or biological product originally prescribed unless agreed to by the purchaser.
(b) The pharmacist shall not dispense a generically equivalent drug product or interchangeable biological product under subsection (a) of this section if:
(1) The prescriber, in the case of a prescription in writing signed by the prescriber, indicates in his or her own handwriting by name or initial that no substitution shall be made;
(2) The prescriber, in the case of a prescription other than one in writing signed by the prescriber, expressly indicates that the prescription is to be dispensed as communicated;
(3) The person for whom the drug product or biological product is prescribed indicates that the prescription is to be dispensed as written or communicated; or
(4) The Arkansas State Board of Pharmacy has determined that the drug product or biological product should not be substituted and has notified all pharmacists of that determination.
(c)(1) The Arkansas State Board of Pharmacy shall determine which drugs are generically equivalent and which biological products are interchangeable biological products as defined in § 17-92-101, relying on standards scientifically supported and generally accepted in the field of pharmacy, and shall notify each licensed pharmacist and the Arkansas State Medical Board of this determination.
(2) In making this determination, the Arkansas State Board of Pharmacy may use a nationally recognized reference source that meets the requirements of this act, notifying each licensed pharmacist and the Arkansas State Medical Board of the reference source to be used and any additions or deletions the Arkansas State Board of Pharmacy may make in its discretion.
(d)(1) Within five (5) business days after dispensing an interchangeable biological product that has been substituted for a biological product, the dispensing pharmacist or his or her designee shall record the specific interchangeable biological product provided to the patient, including without limitation the name of the interchangeable biological product and the manufacturer of the interchangeable biological product.
(2) The record shall be electronically accessible to the prescriber through:
(A) An interoperable electronic medical records system;
(B) An electronic prescribing technology;
(C) A pharmacy benefits management system; or
(D) A pharmacy record.
(3) If requested by a prescriber, a pharmacist shall communicate to the prescriber within five (5) business days using facsimile, telephone, electronic transmission, or other prevailing means that an interchangeable biological product has been dispensed.
(4) A communication is not required when:
(A) An interchangeable biological product does not exist for the prescribed biological product; or
(B) A refill prescription for a biological product is not substituted with an interchangeable biological product on a subsequent filling of the prescription.
(5) The pharmacist or pharmacy shall maintain a record of biological products dispensed for at least two (2) years.
(6) Under subdivision (d)(2) of this section, the dispensing pharmacist or prescriber is not:
(A) Required to show proof that a prescriber has access to the record in any type of payment audit conducted by a payor or pharmacy benefits manager; or
(B) Subject to disciplinary action or civil penalties for failure to ensure that the record is accessible or for failure to access the record.
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Arkansas Code — all titles (historical 2020) · legal_authorities
17-92-101. Definitions.
As used in this chapter:
(1) “Biological product” means a biological product as defined by 42 U.S.C. § 262(i)(1), as it existed on January 1, 2019;
(2) “Credentialing” means the issuance of or approval by the Arkansas State Board of Pharmacy of a credential issued to a pharmacist by an agency approved by the Arkansas State Board of Pharmacy certifying that the pharmacist has met the standards of competency established by the Arkansas State Board of Pharmacy for disease state management or other pharmacy services necessitating a credential;
(3) “Dentist” means a practitioner of dentistry duly licensed under the laws of this or some other state;
(4)(A) “Disease state management” means a strategy that utilizes a team-oriented, multidisciplinary approach to improve healthcare outcomes and quality of care, and when possible, to control healthcare cost through management of targeted chronic disease states.
(B) Disease state management focuses on improving health care from prevention to diagnosis and treatment to ongoing follow-up.
(C) Disease state management will involve, but not be limited to, patient education, self-care techniques, and outpatient drug therapy management pursuant to a patient care plan;
(5) “Drug” shall include all medicines and preparations recognized in the United States Pharmacopeia or the National Formulary as substances intended to be used for the care, mitigation, or prevention of disease of either man or other animals;
(6) “Generically equivalent” means a drug that is pharmaceutically and therapeutically equivalent to the drug prescribed;
(7) “Interchangeable biological product” means a biological product that is interchangeable as defined by 42 U.S.C. § 262(i)(3), as it existed on January 1, 2019;
(8)(A)
Source: Arkansas Code — historical release 78 (November 6, 2020) · 17-92-101
Stored review status: Historical 2020-11-06 source release; later amendments not reconciled; machine-extracted, not independently legally reviewed; source heading status: text_in_historical_source. The source passage cites 17-92-101. This identifies an authority to review, not proof of applicability.