Arkansas Administrative Code
Agency 070 - Board of Pharmacy
Rule 070.00.01-008 - 07-00-0006 - Generic Substitution
Current through Register Vol. 49, No. 2, February 2024
07-00-0006 -GENERIC SUBSTITUTION
The Arkansas State Board of Pharmacy recognizes the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (The Orange Book) as the basis for the determination of generic equivalency within the limitations stipulated in that publication. If the FDA 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), an Arkansas pharmacist, or any pharmacist dispensing drugs to patients in Arkansas, may substitute that product consistent with law. 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. When a pharmacist substitutes a bioequivalent drug product for the drug prescribed, the patient shall be notified of the I substitution by a pharmacist involved in the dispensing process.
