135M.4 - PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM REQUIREMENTS.
135M.4 PRESCRIPTION DRUG DONATION REPOSITORY PROGRAM
REQUIREMENTS.
1. A prescription drug or supplies may be accepted and dispensed
under the prescription drug donation repository program if all of the
following conditions are met:
a. The prescription 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 remains intact.
b. The prescription drug bears an expiration date that is
more than six months after the date the prescription drug was
donated. However, a donated prescription drug bearing an expiration
date that is six months or less after the date the prescription drug
was donated may be accepted and distributed if the drug is in high
demand and can be dispensed for use prior to the drug's expiration
date.
c. The prescription drug or supplies are inspected before the
prescription drug or supplies are dispensed by a licensed pharmacist
employed by or under contract with the medical facility or pharmacy,
and the licensed pharmacist determines that the prescription drug or
supplies are not adulterated or misbranded.
d. The prescription drug or supplies are prescribed by a
health care practitioner for use by an eligible individual and are
dispensed by a pharmacist or are dispensed to an eligible individual
by the prescribing health care practitioner or the practitioner's
authorized agent.
2. A prescription drug or supplies donated under this chapter
shall not be resold.
3. a. If a person who donates prescription drugs under this
chapter to a medical facility or pharmacy receives a notice from a
pharmacy that a prescription drug has been recalled, the person shall
inform the medical facility or pharmacy of the recall.
b. If a medical facility or pharmacy receives a recall
notification from a person who donated prescription drugs under this
chapter, the medical facility or pharmacy shall perform a uniform
destruction of all of the recalled prescription drugs in the medical
facility or pharmacy.
4. A prescription drug dispensed through the prescription drug
donation repository program shall not be eligible for reimbursement
under the medical assistance program.
5. The department shall adopt rules establishing all of the
following:
a. Requirements for medical facilities and pharmacies to
accept and dispense donated prescription drugs and supplies,
including all of the following:
(1) Eligibility criteria for participation by medical facilities
and pharmacies.
(2) Standards and procedures for accepting, safely storing, and
dispensing donated prescription drugs and supplies.
(3) Standards and procedures for inspecting donated prescription
drugs to determine if the prescription drugs are in their original
sealed and tamper-evident packaging, or if the prescription drugs are
in single-unit doses or blister packs and the outside packaging is
opened, if the single-unit dose packaging remains intact.
(4) Standards and procedures for inspecting donated prescription
drugs and supplies to determine that the prescription drugs and
supplies are not adulterated or misbranded.
b. (1) Eligibility criteria for individuals to receive
donated prescription drugs and supplies dispensed by medical
facilities and pharmacies under the program. The standards shall
prioritize dispensing to individuals who are indigent or uninsured,
but may permit dispensing to other individuals if an uninsured or
indigent individual is unavailable.
(2) Eligibility criteria for individuals to receive donated
prescription drugs and supplies dispensed directly by the department
through persons licensed to dispense prescription drugs and supplies.
The department shall accept and dispense donated prescription drugs
and supplies received from the prescription drug donation repository
contractor during or in preparation for a state of disaster emergency
proclaimed by the governor pursuant to section 29C.6 or during or in
preparation for a public health disaster as defined in section
135.140, subsection 6.
c. Necessary forms for administration of the prescription
drug donation repository program, including forms for use by
individuals who donate, accept, distribute, or dispense the
prescription drugs or supplies under the program.
d. A means by which an individual who is eligible to receive
donated prescription drugs and supplies may indicate such
eligibility.
e. The maximum handling fee that a medical facility or
pharmacy may charge for accepting, distributing, or dispensing
donated prescription drugs and supplies under the program.
f. A list of prescription drugs that the prescription drug
donation repository program will accept. Section History: Recent Form
2005 Acts, ch 97, §4; 2007 Acts, ch 159, §24; 2008 Acts, ch 1058,
§6; 2009 Acts, ch 127, §3