DRUGS - GENERIC SUBSTITUTION

"Generically equivalent drug" means a drug that contains identical amounts of the identical active ingredients in the identical dosage forms, but not necessarily containing the same inactive ingredients, that meets the identical compendial or other applicable standard of identity, strength, quality, and purity, including potency, and where applicable, content uniformity, disintegration times or dissolution rates, as the prescribed brand name drug and the manufacturer or distributor holds, if applicable, [on] either an approved new drug application or an approved abbreviated new drug application unless other approval by law or from the federal Food and Drug Administration is required.

No drug shall be considered a generically equivalent drug if it has been listed by the federal Food and Drug Administration as having proven bio-equivalence problems. ORC § 3715.01 (A)

"Unless instructed otherwise by the person receiving the drug pursuant to the prescription, a pharmacist filling a prescription for a drug prescribed by its brand name may select a generically equivalent drug...subject to the following conditions:

1. The pharmacist shall not select a generically equivalent drug if the prescriber handwrites "dispense as written," or "D.A.W.," on the written prescription, or, when ordering a prescription orally, the prescriber specifies that the prescribed drug is medically necessary. These designations shall not be pre-printed or stamped on the prescription.
2. The pharmacist shall not select a generically equivalent drug unless its price to the purchaser is less than the price of the prescribed drug, and shall pass on as a savings to the purchaser, other than the State Medical Assistance program, the full amount of the retail price difference between the prescribed brand name drug and the generically equivalent drug. The amount paid for the generic drug under the State Medical Assistance program shall be as provided by federal regulation.
3. The pharmacist, or the pharmacist's agent, assistant, or employee shall inform the person receiving the drug pursuant to the prescription of the selection of a lower cost, generically equivalent drug, of the price difference between the brand name drug and the generically equivalent drug, and of the person's right to refuse the drug selected." ORC § 4729.38 (A)

"Unless the prescriber instructs otherwise, the label of every drug dispensed shall include the drug's brand name, if any, or its generic name and the name of the distributor, using abbreviations if necessary. A pharmacist shall indicate on the container or its label the notation "generic substitution made" when dispensing at retail a generically equivalent drug for the brand name drug prescribed, and shall verbally notify the recipient that a generic substitution has been made." ORC § 4729.38 (B)

"The failure of a prescriber to restrict a prescription by specifying dispense as written,' or D.A.W.,'...shall not constitute evidence of the prescriber's negligence unless the prescriber had reasonable cause to believe that the health condition of the patient for whom the drug was intended warranted the prescription of a specific brand name drug and no other. No licensed prescriber shall be liable for civil damages or in any criminal prosecution arising from the interchange of a generically equivalent drug for a prescribed brand name drug by a pharmacist, unless the prescribed brand name drug would have reasonably caused the same loss, damage, injury, or death." ORC § 4729.38 (D)

"A pharmacist who selects a generically equivalent drug assumes no greater liability for selecting the dispensed drug than would be incurred in filling a prescription for a drug prescribed by its brand name." ORC § 4729.38 (C)

(See also: AMPHETAMINES; DISPENSING OF DRUGS, PHYSICIAN; and under State Medical Board Policy Positions: PRESCRIBING OF CONTROLLED SUBSTANCES BY POST-DOCTORAL TRAINEES; RESIDENCY TRAINING PROGRAMS)

DRUGS - GENERIC SUBSTITUTION