IC 16-42-22-1 "Brand name" defined
Sec. 1. As used in this chapter, "brand name" means the
proprietary or trade name selected by the drug manufacturer and
placed upon a drug or the drug's container, label, or wrappings at the
time 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Repealed
(Repealed by P.L.239-1999, SEC.9.)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 individual
for whom a prescription is written or electronically transmitted or the
individual'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 drug
product" means a multiple source drug product:
(1) that contains an identical quantity of identical active
ingredients in the identical dosage forms (but not necessarily
containing the same inactive ingredients) that meet the identical
physical and chemical standards in The United States
Pharmacopeia (USP) described in IC 16-42-19-2, or its
supplements, as the prescribed brand name drug; and
(2) if applicable, for which the manufacturer or distributor holds
either an approved new drug application or an approved
abbreviated new drug application unless other approval by law
or of the federal Food and Drug Administration is required.
(b) A drug does not constitute a generically equivalent drug
product if it is listed by the federal Food and Drug Administration on
or after July 1, 1987, as having actual or potential bioequivalence
problems. 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 the
following:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatric medicine in
Indiana.
(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 the
authority 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 a
generically equivalent drug product in place of the brand name drug
product 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 other
than 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 must
have two (2) signature lines printed at the bottom of the prescription
form, one (1) of which must be signed by the practitioner for the
prescription to be valid. Under the blank line on the left side of the
form must be printed the words "Dispense as written.". Under the
blank line on the right side of the form must be printed the words
"May substitute.".
(b) Each electronically transmitted prescription issued by a
practitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions "Dispense
as 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 than
a prescription filled under the Medicaid program (42 U.S.C. 1396 et
seq.), the children's health insurance program established under
IC 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 than
substitution 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 the
pharmacist orally or electronically, the pharmacist shall:
(1) indicate the instructions in the pharmacist's own handwriting
on the written copy of the prescription order; or
(2) record the electronically transmitted instructions in an
electronic 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 program
established under IC 12-17.6-2, or the Medicare program (42 U.S.C.
1395 et seq.), the pharmacist shall substitute a generically equivalent
drug product and inform the customer of the substitution if the
substitution 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 electronically
transmitted prescription; or
(2) the practitioner has indicated that the pharmacist may not
substitute a generically equivalent drug product by:
(A) orally stating that a substitution is not permitted; or
(B) for an electronically transmitted prescription, indicating
with the electronic prescription that a substitution is not
permitted.
(b) If a practitioner orally states that a generically equivalent drug
product may not be substituted, the practitioner must subsequently
forward to the pharmacist a written or electronically transmitted
prescription with the "Brand Medically Necessary" instruction
appropriately indicated in the physician's own handwriting.
(c) This section does not authorize any substitution other than
substitution 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 by
a practitioner, the prescription container label must identify the brand
name drug for which the substitution is made and the generic drug.
The identification required under this subsection must take the form
of the following statement on the drug container label, with the
generic 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 drug
product on prescription
Sec. 12. The pharmacist shall record on the prescription in writing
or in an electronic format for an electronically transmitted
prescription the name of the manufacturer or distributor, or both, of
the actual drug product dispensed under this chapter. As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005,
SEC.13.
IC 16-42-22-1 "Brand name" defined
Sec. 1. As used in this chapter, "brand name" means the
proprietary or trade name selected by the drug manufacturer and
placed upon a drug or the drug's container, label, or wrappings at the
time 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 individual
for whom a prescription is written or electronically transmitted or the
individual'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 drug
product" means a multiple source drug product:
(1) that contains an identical quantity of identical active
ingredients in the identical dosage forms (but not necessarily
containing the same inactive ingredients) that meet the identical
physical and chemical standards in The United States
Pharmacopeia (USP) described in IC 16-42-19-2, or its
supplements, as the prescribed brand name drug; and
(2) if applicable, for which the manufacturer or distributor holds
either an approved new drug application or an approved
abbreviated new drug application unless other approval by law
or of the federal Food and Drug Administration is required.
(b) A drug does not constitute a generically equivalent drug
product if it is listed by the federal Food and Drug Administration on
or after July 1, 1987, as having actual or potential bioequivalence
problems. 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 the
following:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatric medicine in
Indiana.
(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 the
authority 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 a
generically equivalent drug product in place of the brand name drug
product 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 other
than 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 must
have two (2) signature lines printed at the bottom of the prescription
form, one (1) of which must be signed by the practitioner for the
prescription to be valid. Under the blank line on the left side of the
form must be printed the words "Dispense as written.". Under the
blank line on the right side of the form must be printed the words
"May substitute.".
(b) Each electronically transmitted prescription issued by a
practitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions "Dispense
as 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 than
a prescription filled under the Medicaid program (42 U.S.C. 1396 et
seq.), the children's health insurance program established under
IC 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 than
substitution 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 the
pharmacist orally or electronically, the pharmacist shall:
(1) indicate the instructions in the pharmacist's own handwriting
on the written copy of the prescription order; or
(2) record the electronically transmitted instructions in an
electronic 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 program
established under IC 12-17.6-2, or the Medicare program (42 U.S.C.
1395 et seq.), the pharmacist shall substitute a generically equivalent
drug product and inform the customer of the substitution if the
substitution 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 electronically
transmitted prescription; or
(2) the practitioner has indicated that the pharmacist may not
substitute a generically equivalent drug product by:
(A) orally stating that a substitution is not permitted; or
(B) for an electronically transmitted prescription, indicating
with the electronic prescription that a substitution is not
permitted.
(b) If a practitioner orally states that a generically equivalent drug
product may not be substituted, the practitioner must subsequently
forward to the pharmacist a written or electronically transmitted
prescription with the "Brand Medically Necessary" instruction
appropriately indicated in the physician's own handwriting.
(c) This section does not authorize any substitution other than
substitution 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 by
a practitioner, the prescription container label must identify the brand
name drug for which the substitution is made and the generic drug.
The identification required under this subsection must take the form
of the following statement on the drug container label, with the
generic 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 drug
product on prescription
Sec. 12. The pharmacist shall record on the prescription in writing
or in an electronic format for an electronically transmitted
prescription the name of the manufacturer or distributor, or both, of
the actual drug product dispensed under this chapter. As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005,
SEC.13.
IC 16-42-22-1 "Brand name" defined
Sec. 1. As used in this chapter, "brand name" means the
proprietary or trade name selected by the drug manufacturer and
placed upon a drug or the drug's container, label, or wrappings at the
time 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 individual
for whom a prescription is written or electronically transmitted or the
individual'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 drug
product" means a multiple source drug product:
(1) that contains an identical quantity of identical active
ingredients in the identical dosage forms (but not necessarily
containing the same inactive ingredients) that meet the identical
physical and chemical standards in The United States
Pharmacopeia (USP) described in IC 16-42-19-2, or its
supplements, as the prescribed brand name drug; and
(2) if applicable, for which the manufacturer or distributor holds
either an approved new drug application or an approved
abbreviated new drug application unless other approval by law
or of the federal Food and Drug Administration is required.
(b) A drug does not constitute a generically equivalent drug
product if it is listed by the federal Food and Drug Administration on
or after July 1, 1987, as having actual or potential bioequivalence
problems. 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 the
following:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatric medicine in
Indiana.
(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 the
authority 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 a
generically equivalent drug product in place of the brand name drug
product 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 other
than 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 must
have two (2) signature lines printed at the bottom of the prescription
form, one (1) of which must be signed by the practitioner for the
prescription to be valid. Under the blank line on the left side of the
form must be printed the words "Dispense as written.". Under the
blank line on the right side of the form must be printed the words
"May substitute.".
(b) Each electronically transmitted prescription issued by a
practitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions "Dispense
as 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 than
a prescription filled under the Medicaid program (42 U.S.C. 1396 et
seq.), the children's health insurance program established under
IC 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 than
substitution 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 the
pharmacist orally or electronically, the pharmacist shall:
(1) indicate the instructions in the pharmacist's own handwriting
on the written copy of the prescription order; or
(2) record the electronically transmitted instructions in an
electronic 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 program
established under IC 12-17.6-2, or the Medicare program (42 U.S.C.
1395 et seq.), the pharmacist shall substitute a generically equivalent
drug product and inform the customer of the substitution if the
substitution 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 electronically
transmitted prescription; or
(2) the practitioner has indicated that the pharmacist may not
substitute a generically equivalent drug product by:
(A) orally stating that a substitution is not permitted; or
(B) for an electronically transmitted prescription, indicating
with the electronic prescription that a substitution is not
permitted.
(b) If a practitioner orally states that a generically equivalent drug
product may not be substituted, the practitioner must subsequently
forward to the pharmacist a written or electronically transmitted
prescription with the "Brand Medically Necessary" instruction
appropriately indicated in the physician's own handwriting.
(c) This section does not authorize any substitution other than
substitution 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 by
a practitioner, the prescription container label must identify the brand
name drug for which the substitution is made and the generic drug.
The identification required under this subsection must take the form
of the following statement on the drug container label, with the
generic 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 drug
product on prescription
Sec. 12. The pharmacist shall record on the prescription in writing
or in an electronic format for an electronically transmitted
prescription the name of the manufacturer or distributor, or both, of
the actual drug product dispensed under this chapter. As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005,
SEC.13.
