(A) An oral or written drug prescription must provide an authorization from the practitioner as to whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted.

(B) A written prescription must have two signature lines at opposite ends on the bottom of the form. Under the line at the left side must be clearly printed the words "DISPENSE AS WRITTEN". Under the line at the right side shall be clearly printed the words "SUBSTITUTION PERMITTED", unless the prescription is to be paid for with Medicaid funds. The practitioner shall communicate the instructions to the pharmacist by signing on the appropriate line. A written prescription is not valid without the signature of the practitioner on one of these lines.

(C) An oral prescription from the practitioner must instruct the pharmacist as to whether or not a therapeutically equivalent generic drug or interchangeable biological product may be substituted, unless the prescription is to be paid for with Medicaid funds. The pharmacist shall note the instructions on the file copy of the prescription and retain the prescription form for the period as prescribed by law.

(D) The pharmacist shall note the brand name or the manufacturer of the substituted drug or biological product dispensed on the file copy of a written or oral prescription or record this information electronically, or both.

(E) Substitution may not occur unless the pharmacist advises the patient that the practitioner has authorized substitution and the patient consents.

(F) If a pharmacist substitutes a generic drug for a name brand prescribed drug when dispensing a prescribed medication, the brand name and the name of the generic drug and its manufacturer, with an explanation of "generic for" or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label.

(G) If a pharmacist substitutes an interchangeable biological product for a specific biological product prescribed when dispensing a prescribed medication, the brand name and the name of the interchangeable biological product and its manufacturer, with an explanation of "interchangeable with" or similar language, to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label unless the prescribing practitioner indicated that the name of the biological product may not appear on the prescription label.

HISTORY: 1978 Act No. 595 Section 4; 1994 Act No. 416, Section 1, eff May 24, 1994; 2002 Act No. 314, Section 1, eff July 1, 2002; 2017 Act No. 11 (H.3438), Section 3, eff April 24, 2017.

Effect of Amendment

The 1994 amendment added the sixth paragraph, providing that if a pharmacist substitutes a generic drug for a name brand prescribed drug the generic drug must be listed first followed by the words "substituted for" and the name brand or this information must be affixed to the container.

The 2002 amendment designated the subsections; in subsection (A), substituted "An" for "Every", and "must" for "shall"; in subsection (B), substituted "must" for "shall", "the words 'SUBSTITUTION PERMITTED', unless the prescription is to be paid for with medicaid funds" for "the words 'SUBSTITUTION PERMITTED'", "A written prescription" for "No written prescription", and "is not" for "shall be"; in subsection (C), substituted "must" for "shall", and inserted "unless the prescription is to be paid for with medicaid funds"; rewrote subsections (D) and (F); and in subsection (E), substituted "may" for "shall".

2017 Act No. 11, Section 3, in (A) and (C), inserted "or interchangeable biological product"; in (D), inserted "or biological product"; and added (G), relating to prescription requirements to substitute interchangeable biological products.