2019 Arkansas Code
Title 17 - Professions, Occupations, and Businesses
Subtitle 3 - Medical Professions
Chapter 92 - Pharmacists and Pharmacies
Subchapter 5 - Generic Drugs and Price Lists
§ 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.