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Delaware News: Substitution
Published in the September 2008 Delaware State Board of Pharmacy Newsletter
Food and Drug Administration (FDA) approval for any drug product addresses quality concerns for the manufacturing process of that particular medication. Whether a product can be used as a generic equivalent of a brand-name product is dependent on the rating of the branded product. FDA rates medication via the “Orange Book,” which is acceptable under Delaware law. When FDA has rated a branded drug with an AB rating, then generic substitution may be utilized for the branded drug. If the branded product is not AB-rated then no generic products can be interchanged.
Delaware law 24 Del. C. §2549 currently allows for a pharmacist to receive a prescription drug order from a practitioner for a brand or trade name drug, the pharmacist may dispense a therapeutically equivalent drug if the following conditions are met:
(1) the practitioner, in the case of a written prescription, places his or her signature on the signature line along side or above the words ‘substitution permitted’ pursuant to subsection (c) of this section; or, in the case of a verbal prescription or a verbal prescription reduced to writing, the practitioner states that the substitution may be made; or, in the case of an order written in an institution licensed by the Division of Professional Regulations, Department of State pursuant to the Delaware Code, the practitioner has given written authorization to fill all prescription drug orders with therapeutically equivalent drugs unless otherwise indicated;
(2) the pharmacist informs the patient or the patient’s adult representative that a therapeutically equivalent drug has been dispensed;
(3) the pharmacist indicates on the prescription and on the prescription label the name of the manufacturer or distributor of the therapeutically equivalent drug substituted unless the practitioner indicates otherwise.
In addition, pharmacists must also follow all other state and federal laws required. This would include, but not be limited to, 24 Del. C. §2522, “Labeling” and 24 Del. C. §2549 (c), the prescription form requirements.
