CHAPTER 22. DRUGS: GENERIC DRUGS
IC 16-42-22
Chapter 22. Drugs: Generic Drugs
IC 16-42-22-1
"Brand name" defined
Sec. 1. As used in this chapter, "brand name" means theproprietary or trade name selected by the drug manufacturer andplaced upon a drug or the drug's container, label, or wrappings at thetime of packaging.
As added by P.L.2-1993, SEC.25.
IC 16-42-22-2
Repealed
(Repealed by P.L.239-1999, SEC.9.)
IC 16-42-22-3
"Customer" defined
Sec. 3. As used in this chapter, "customer" means the individualfor whom a prescription is written or electronically transmitted or theindividual's representative.
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.8.
IC 16-42-22-4
"Generically equivalent drug product" defined
Sec. 4. (a) As used in this chapter, "generically equivalent drugproduct" means a multiple source drug product:
(1) that contains an identical quantity of identical activeingredients in the identical dosage forms (but not necessarilycontaining the same inactive ingredients) that meet the identicalphysical and chemical standards in The United StatesPharmacopeia (USP) described in IC 16-42-19-2, or itssupplements, as the prescribed brand name drug; and
(2) if applicable, for which the manufacturer or distributor holdseither an approved new drug application or an approvedabbreviated new drug application unless other approval by lawor of the federal Food and Drug Administration is required.
(b) A drug does not constitute a generically equivalent drugproduct if it is listed by the federal Food and Drug Administration onor after July 1, 1987, as having actual or potential bioequivalenceproblems.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.4.
IC 16-42-22-4.5
"Practitioner" defined
Sec. 4.5. As used in this chapter, "practitioner" means any of thefollowing:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatric medicine inIndiana. (4) An optometrist who is:
(A) licensed to practice optometry in Indiana; and
(B) certified under IC 25-24-3.
(5) An advanced practice nurse licensed and granted theauthority to prescribe legend drugs under IC 25-23.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.5;P.L.157-2006, SEC.8.
IC 16-42-22-5
"Substitute" defined
Sec. 5. As used in this chapter, "substitute" means to dispense agenerically equivalent drug product in place of the brand name drugproduct prescribed by the practitioner.
As added by P.L.2-1993, SEC.25.
IC 16-42-22-5.5
Limitation of effect of chapter
Sec. 5.5. Nothing in this chapter authorizes any substitution otherthan substitution of a generically equivalent drug product.
As added by P.L.239-1999, SEC.6.
IC 16-42-22-6
Prescription forms
Sec. 6. (a) Each written prescription issued by a practitioner musthave two (2) signature lines printed at the bottom of the prescriptionform, one (1) of which must be signed by the practitioner for theprescription to be valid. Under the blank line on the left side of theform must be printed the words "Dispense as written.". Under theblank line on the right side of the form must be printed the words"May substitute.".
(b) Each electronically transmitted prescription issued by apractitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions "Dispenseas written." or "May substitute.".
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.9.
IC 16-42-22-7
Repealed
(Repealed by P.L.239-1999, SEC.9.)
IC 16-42-22-8
Requirements for substitution
Sec. 8. (a) For substitution to occur for a prescription other thana prescription filled under the Medicaid program (42 U.S.C. 1396 etseq.), the children's health insurance program established underIC 12-17.6-2, or the Medicare program (42 U.S.C. 1395 et seq.):
(1) the practitioner must:
(A) sign on the line under which the words "May substitute"appear; or (B) for an electronically transmitted prescription,electronically transmit the instruction "May substitute."; and
(2) the pharmacist must inform the customer of the substitution.
(b) This section does not authorize any substitution other thansubstitution of a generically equivalent drug product.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.7;P.L.291-2001, SEC.233; P.L.204-2005, SEC.10.
IC 16-42-22-9
Transmission of practitioner's instructions to pharmacist
Sec. 9. If the practitioner communicates instructions to thepharmacist orally or electronically, the pharmacist shall:
(1) indicate the instructions in the pharmacist's own handwritingon the written copy of the prescription order; or
(2) record the electronically transmitted instructions in anelectronic format.
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005,SEC.11.
IC 16-42-22-10
Substitution prohibited
Sec. 10. (a) If a prescription is filled under the Medicaid program(42 U.S.C. 1396 et seq.), the children's health insurance programestablished under IC 12-17.6-2, or the Medicare program (42 U.S.C.1395 et seq.), the pharmacist shall substitute a generically equivalentdrug product and inform the customer of the substitution if thesubstitution would result in a lower price unless:
(1) the words "Brand Medically Necessary" are:
(A) written in the practitioner's own writing on the form; or
(B) electronically transmitted with an electronicallytransmitted prescription; or
(2) the practitioner has indicated that the pharmacist may notsubstitute a generically equivalent drug product by:
(A) orally stating that a substitution is not permitted; or
(B) for an electronically transmitted prescription, indicatingwith the electronic prescription that a substitution is notpermitted.
(b) If a practitioner orally states that a generically equivalent drugproduct may not be substituted, the practitioner must subsequentlyforward to the pharmacist a written or electronically transmittedprescription with the "Brand Medically Necessary" instructionappropriately indicated in the physician's own handwriting.
(c) This section does not authorize any substitution other thansubstitution of a generically equivalent drug product.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.8;P.L.291-2001, SEC.234; P.L.204-2005, SEC.12.
IC 16-42-22-11
Substitution of generic drugs; identification of brand name drug
Sec. 11. If under this section a pharmacist substitutes a generically
equivalent drug product for a brand name drug product prescribed bya practitioner, the prescription container label must identify the brandname drug for which the substitution is made and the generic drug.The identification required under this subsection must take the formof the following statement on the drug container label, with thegeneric name and the brand name inserted on the blank lines:
"_____________ Generic for _____________".
As added by P.L.2-1993, SEC.25. Amended by P.L.186-1993, SEC.1.
IC 16-42-22-12
Identification of manufacturer or distributor of dispensed drugproduct on prescription
Sec. 12. The pharmacist shall record on the prescription in writingor in an electronic format for an electronically transmittedprescription the name of the manufacturer or distributor, or both, ofthe actual drug product dispensed under this chapter.
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005,SEC.13.