§ 25-26-26-14 — Restrictions; requirements; inventory; record retention; repackaging; disposal

Indiana § 25-26-26-14

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 26: PHARMACISTS, PHARMACIES, DRUG STORES
• Ch. 26: Prescription Drug Donation Repository Program

Text

(a) Except for prescription drugs donated
directly from a drug manufacturer, a prescription drug that requires
storage temperatures other than normal room temperature as specified
by the drug manufacturer or the United States Pharmacopoeia, or its
supplements, may not be donated or accepted as part of the program.
(b) The central repository or a local repository may accept or
dispense a prescription drug and supplies if the following requirements
are met:
(1) The drug is in its original sealed and tamper evident
packaging. However, a prescription drug in a single unit dose or
blister pack with the outside packaging opened may be accepted
if the single unit dose packaging is undisturbed.
(2) The drug has been stored according to manufacturer or United
States Pharmacopoeia, or its supplements, storage requirements,
unless a United States Pharmacopoeia recognized method to
detect improper temperature variations has been used.
(3) The packaging contains the expiration date of the drug and the
drug has not expired.
(4) The drug or its packaging does not have any physical signs of
tampering, misbranding, deterioration, compromised integrity, or
adulteration.
(5) If a prescription drug is subject to risk evaluation and
mitigation under 21 U.S.C. 355-1(f)(3), all of the required
guidelines for the prescription drug are followed.
(6) The supplies are in its original sealed packaging and are not
expired.
(c) The donated prescription drugs and supplies must be inventoried
at the central repository or a local repository. If the drug:
(1) has been continually under the control of a practitioner or drug
manufacturer, the inventory must include the name of the drug,
strength of the drug, quantity of the drug, and date of donation; or
(2) has not been continually under the control of a practitioner or
drug manufacturer, the repository shall collect a donation form
that is signed by the person making the donation or the person's
authorized representative.
(d) The central repository or a local repository shall maintain
records of the prescription drugs and supplies that are donated,
accepted, distributed, and dispensed under the program. The records
must be maintained for two (2) years from the date the prescription
drugs or supplies are donated, accepted, distributed, and dispensed
under the program.
(e) The central repository or a local repository may repackage
donated prescription drugs as necessary for storage, dispensing,
administration, or transfers if the repackaged prescription drug is:
(1) labeled with the drug name, strength, and expiration date; and
(2) kept in a separate designated area until inspected and initialed
by a practitioner with knowledge or experience with the
prescription drug.
If multiple packaged donated prescription drugs with varied expiration
dates are repackaged together, the shortest expiration date shall be
used. A drug manufacturer's original expiration date may be used in
place of a beyond use date.
(f) Donated prescription drugs that do not meet the requirements of
this section must be disposed of by:
(1) returning it to the drug donor;
(2) destroying it by an incinerator, medical waste hauler, or other
lawful method; or
(3) transferring it to a reverse distributor.
(g) A record of disposed prescription drugs under subsection (f)
must contain the following information:
(1) The disposal method that was used.
(2) The date of disposal.
(3) The name, strength, and quantity of each drug disposed.
Any other information concerning the disposal of the prescription drugs
is not required.

Legislative History

As added by P.L.208-2023, SEC.5.