- (a) The Arkansas State Board of Pharmacy recognizes the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book or The Green Book) as the basis for the determination of generic equivalency within the limitations stipulated in that publication.
- (b) If the Food and Drug Administration approves a drug product as bioequivalent and publishes that product with an “A” (AA, AB, AN, AO, AP, and AT) rating in the Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book or The Green Book), an Arkansas pharmacist or any pharmacist dispensing drugs to patients in Arkansas may substitute that product consistent with law.
- (c) Conversely, if the drug product is “B” rated, is changed from an “A” rating to a “B” rating, or is not rated, the pharmacist may not substitute without the consent of the prescribing practitioner.
- (d) When a pharmacist substitutes a bioequivalent drug product for the drug prescribed, the patient shall be notified of the substitution by a pharmacist involved in the dispensing process.
Codification Notes: This section as promulgated prior to codification into the Code of Arkansas Rules provided as follows: “(6/21/2001, Amended 5/31/2014)"