Citations Affected: IC 25-26-13.
Synopsis: Distribution of unused drugs. Allows a pharmacy or
pharmacist to donate medications to certain health clinics. Allows a
pharmacist to accept returned medications from a hospice program.
Effective: July 1, 2003.
January 23, 2003, read first time and referred to Committee on Health and Provider
A BILL FOR AN ACT to amend the Indiana Code concerning
professions and occupations.
SECTION 1. IC 25-26-13-25, AS AMENDED BY P.L.1-2002,
SECTION 98, IS AMENDED TO READ AS FOLLOWS [EFFECTIVE
JULY 1, 2003]: 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 its duly
authorized agent or representative.
(b) Except as provided in subsection (c) before the expiration of subsection (c) on June 30, 2003, 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 or oral authorization of a licensed practitioner.
(c) 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 one (1)
time without the written 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 (f).
(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 (d).
(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 minimum amount necessary to supply the
patient through the prescribing practitioner's next business day.
However, a pharmacist may dispense a drug in an amount greater
than the minimum amount necessary to supply the patient through
the prescribing practitioner's next business day if:
(A) the drug is packaged in a form that requires the pharmacist to dispense the drug in a quantity greater than the minimum amount necessary to supply the patient through the prescribing practitioner's next business day; or
(B) the pharmacist documents in the patient's record the amount of the drug dispensed and a compelling reason for dispensing the drug in a quantity greater than the minimum amount necessary to supply the patient through the prescribing practitioner's next business day.
(9) Not more than one (1) pharmacist initiated refill is dispensed under this subsection for a single prescription.
(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". This subsection expires June 30, 2003.
(d) 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.
(e) The original prescription form or the other board approved record described in subsection (d) 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.
(f) A prescription is valid for not more than one (1) year after the original date of issue.
(g) 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.
(h) A pharmacist may not knowingly dispense a prescription after the demise of the patient.
(i) 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 a patient:
(A) residing in an institutional facility (as defined in 856 IAC 1-28-1(a)); or
(B) in a hospice program under IC 16-25;
(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 Type II permit (as described in IC 25-26-13-17).
(j) A pharmacist may use the pharmacist's professional judgment as to whether to accept medication for return under subsection
(k) A pharmacist who violates subsection (c) commits a Class A infraction.
SECTION 2. IC 25-26-13-26.2 IS ADDED TO THE INDIANA CODE AS A NEW SECTION TO READ AS FOLLOWS [EFFECTIVE JULY 1, 2003]: Sec. 26.2. (a) A pharmacist or pharmacy may donate medications, including a medication that has been returned under section 25(i) of this chapter, to any of the following:
(1) A federally qualified health center (as defined in 42 U.S.C. 1396d(l)(2)(B)).
(2) A rural health clinic (as defined in 42 U.S.C. 1396d(l)(1)).
(3) A nonprofit health clinic that provides medical care to patients who are indigent, uninsured, or underinsured.
(b) A prescription or drug order is not required for a pharmacist or pharmacy to provide medications under subsection (a).
(c) A medication donated under this section may not be distributed to a patient until the medication has been inspected by
a licensed physician or pharmacist at the facility that receives the donation.