Sec. 25. (a) All original prescriptions, whether in written or electronic format, shall be numbered and maintained in numerical and chronological order, or in a manner approved by the board and accessible for at least two (2) years in the pharmacy. A prescription transmitted from a practitioner by means of communication other than writing must immediately be reduced to writing or recorded in an electronic format by the pharmacist. The files shall be open for inspection to any member of the board or the board's duly authorized agent or representative.
(b) A prescription may be electronically transmitted from the practitioner by computer or another electronic device to a pharmacy that is licensed under this article or any other state or territory. An electronic data intermediary that is approved by the board:
(1) may transmit the prescription information between the prescribing practitioner and the pharmacy;
(2) may archive copies of the electronic information related to the transmissions as necessary for auditing and security purposes; and
(3) must maintain patient privacy and confidentiality of all archived information as required by applicable state and federal laws.
(c) Except as provided in subsection (d), a prescription for any drug, the label of which bears either the legend, "Caution: Federal law prohibits dispensing without prescription" or "Rx Only", may not be refilled without written, electronically transmitted, or oral authorization of a licensed practitioner.
(d) A prescription for any drug, the label of which bears either the legend, "Caution: Federal law prohibits dispensing without prescription" or "Rx Only", may be refilled by a pharmacist without the written, electronically transmitted, or oral authorization of a licensed practitioner if all of the following conditions are met:
(1) The pharmacist has made every reasonable effort to contact the original prescribing practitioner or the practitioner's designee for consultation and authorization of the prescription refill.
(2) The pharmacist believes that, under the circumstances, failure to provide a refill would be seriously detrimental to the patient's health.
(3) The original prescription authorized a refill but a refill would otherwise be invalid for either of the following reasons:
(A) All of the authorized refills have been dispensed.
(B) The prescription has expired under subsection (h).
(4) The prescription for which the patient requests the refill was:
(A) originally filled at the pharmacy where the request for a refill is received and the prescription has not been transferred for refills to another pharmacy at any time; or
(B) filled at or transferred to another location of the same pharmacy or its affiliate owned by the same parent corporation if the pharmacy filling the prescription has full access to prescription and patient profile information that is simultaneously and continuously updated on the parent corporation's information system.
(5) The drug is prescribed for continuous and uninterrupted use and the pharmacist determines that the drug is being taken properly in accordance with IC 25-26-16.
(6) The pharmacist shall document the following information regarding the refill:
(A) The information required for any refill dispensed under subsection (e).
(B) The dates and times that the pharmacist attempted to contact the prescribing practitioner or the practitioner's designee for consultation and authorization of the prescription refill.
(C) The fact that the pharmacist dispensed the refill without the authorization of a licensed practitioner.
(7) The pharmacist notifies the original prescribing practitioner of the refill and the reason for the refill by the practitioner's next business day after the refill has been made by the pharmacist.
(8) Any pharmacist initiated refill under this subsection may not be for more than the quantity on the most recent fill or a thirty (30) day supply, whichever is less.
(9) Not more than one (1) pharmacist initiated refill is dispensed under this subsection for a single prescription in a six (6) month period.
(10) The drug prescribed is not a controlled substance.
A pharmacist may not refill a prescription under this subsection if the practitioner has designated on the prescription form the words "No Emergency Refill".
(e) When refilling a prescription, the refill record shall include:
(1) the date of the refill;
(2) the quantity dispensed if other than the original quantity; and
(3) the dispenser's identity on:
(A) the original prescription form; or
(B) another board approved, uniformly maintained, readily retrievable record.
(f) The original prescription form or the other board approved record described in subsection (e) must indicate by the number of the original prescription the following information:
(1) The name and dosage form of the drug.
(2) The date of each refill.
(3) The quantity dispensed.
(4) The identity of the pharmacist who dispensed the refill.
(5) The total number of refills for that prescription.
(g) This subsection does not apply:
(1) unless a patient requests a prescription drug supply of more than thirty (30) days;
(2) to the dispensing of a controlled substance (as defined in IC 35-48-1-9); or
(3) if a prescriber indicates on the prescription that the quantity of the prescription may not be changed.
A pharmacist may dispense, upon request of the patient, personal or legal representative of the patient, or guardian of the patient, not more than a ninety (90) day supply of medication if the patient has completed an initial thirty (30) day supply of the drug therapy and the prescription, including any refills, allows a pharmacist to dispense at least a ninety (90) day supply of the medication. However, a pharmacist shall comply with state and federal laws and regulations concerning the dispensing limitations concerning a prescription drug. The pharmacist shall inform the customer concerning whether the additional supply of the prescription will be covered under the patient's insurance, if applicable.
(h) A prescription is valid for not more than one (1) year after the original date of issue.
(i) A pharmacist may not knowingly dispense a prescription after the demise of the practitioner, unless in the pharmacist's professional judgment it is in the best interest of the patient's health.
(j) A pharmacist may not knowingly dispense a prescription after the demise of the patient.
(k) A pharmacist or a pharmacy shall not resell, reuse, or redistribute a medication that is returned to the pharmacy after being dispensed unless the medication:
(1) was dispensed to an individual:
(A) residing in an institutional facility (as defined in 856 IAC 1-28.1-1(6));
(B) in a hospice program under IC 16-25; or
(C) in a county jail or department of correction facility;
(2) was properly stored and securely maintained according to sound pharmacy practices;
(3) is returned unopened and:
(A) was dispensed in the manufacturer's original:
(i) bulk, multiple dose container with an unbroken tamper resistant seal; or
(ii) unit dose package; or
(B) was packaged by the dispensing pharmacy in a:
(i) multiple dose blister container; or
(ii) unit dose package;
(4) was dispensed by the same pharmacy as the pharmacy accepting the return;
(5) is not expired; and
(6) is not a controlled substance (as defined in IC 35-48-1-9), unless the pharmacy holds a Category II permit (as described in section 17 of this chapter).
(l) A pharmacist or a pharmacy shall not resell, reuse, or redistribute medical devices or medical supplies used for prescription drug therapy that have been returned to the pharmacy after being dispensed unless the medical devices or medical supplies:
(1) were dispensed to an individual in a county jail or department of correction facility;
(2) are not expired; and
(3) are returned unopened and in the original sealed packaging.
(m) A pharmacist may use the pharmacist's professional judgment as to whether to accept medication for return under this section.
(n) This subsection does not apply to a controlled substance, compounded drug, or biological product, or if the prescriber has indicated adaptation of a prescription is not permitted. A pharmacist, acting in good faith, exercising reasonable care, and obtaining patient consent, may do the following:
(1) Change the quantity of a medication prescribed if:
(A) the prescribed quantity or package size is not commercially available;
(B) the change in quantity is related to a change in dosage form; or
(C) the change in quantity reflects the intended day supply.
(2) Change the dosage form of the prescription if it is in the best interest of patient care, if the prescriber's directions are also modified to equate to an equivalent amount of drug dispensed as prescribed.
(3) Complete missing information on a prescription if there is sufficient evidence to support the change.
(4) Extend a maintenance drug for the limited quantity necessary to coordinate a patient's refills in a medication synchronization program.
A pharmacist who adapts a prescription in accordance with this subsection must document the adaptation in the patient's record.
(o) A pharmacist who violates subsection (d) commits a Class A infraction.
As added by Acts 1977, P.L.276, SEC.1. Amended by P.L.239-1989, SEC.1; P.L.33-1993, SEC.46; P.L.188-1995, SEC.6; P.L.187-1999, SEC.5; P.L.270-2001, SEC.4; P.L.288-2001, SEC.4; P.L.1-2002, SEC.98; P.L.182-2003, SEC.4; P.L.97-2004, SEC.95; P.L.75-2004, SEC.2; P.L.204-2005, SEC.16; P.L.174-2011, SEC.4; P.L.152-2012, SEC.13; P.L.159-2012, SEC.6; P.L.13-2013, SEC.69; P.L.202-2017, SEC.10; P.L.247-2019, SEC.3.