Section 1. Amend Title 16 of the Delaware Code by adding
a new Chapter 30D to read as follows:
“Chapter 30D: Prescription Drug Repository Program.
§3001D. Definitions.
As used in this chapter:
(a)
‘Health Care Facility’ means:
1.
A hospital,
2.
A hospice care program,
3.
A nursing home,
4.
A home health agency,
5.
An intermediate care facility for the mentally
retarded,
6.
A facility that provides treatment or other services
for individuals who have mental disorders, or
7.
An assisted living program.
(b)
‘Health Care Practitioner’ means an individual licensed
or certified under Title 24 to provide health care.
(c)
‘Nonprofit clinic’ means a public or private nonprofit
organization that provides primary or specialty outpatient health care services
to indigent and uninsured individuals for free or at reduced cost.
(d)
‘Prescription Drug’ has the meaning stated in §3003B of
this Title.
(e)
‘Program’ means the Prescription Drug Repository
Program.
(f)
‘Board’ means the State Board of Pharmacy.
§3002D. Prescription drug repository program.
The Board shall establish a
prescription drug repository program to accept and dispense prescription drugs
donated for the purpose of dispensing to individuals who are residents of the State
and meet eligibility requirements established by the Board.
§3003D. Packaging of drugs.
Except as provided in subsection
(b) of this section, the Program may only accept and dispense drugs in their
original unopened, sealed, and tamper-evident unit dose packaging.
(a)
The Program may accept and dispense drugs packaged in
single unit doses when the outside packaging is opened if the single unit dose
packaging is undisturbed.
(b)
The Program may not accept or dispense drugs:
1.
Bearing an expiration date that is less than 6 months
from the date the drug is donated; or
2.
That may be deemed adulterated according to the
standards of §3303 of this Title.
§3004D. Donation of drugs.
(a)
Any person, including an individual, a drug
manufacturer, or a health care facility, may donate prescription drugs to the
Program.
(b)
Drugs may only be donated at a pharmacy, hospital, or
nonprofit clinic that participates in the Program.
§3005D. Dispensing of drugs.
(a)
A pharmacy, hospital, or nonprofit clinic that
participates in the Program may only dispense drugs donated through the
Program:
(1)
To individuals
who are residents of the State and meet the eligibility standards established
by the Board; or
(2)
To government entities and nonprofit private entities
to be dispensed to individuals who are residents of the State and meet the
eligibility standards established by the Board.
(b)
A drug donated
through the Program may only be dispensed on a prescription issued by an
authorized prescriber.
(c)
A pharmacy, hospital, or nonprofit clinic that accepts
donated drugs shall:
(1)
Comply with all
applicable Federal laws and laws of this State pertaining to storage and
distribution of prescription drugs; and
(2)
Inspect all drugs before dispensing to determine that
the drugs are not adulterated.
(d)
The pharmacy,
hospital, or nonprofit clinic may charge individuals receiving donated drugs a
handling fee established in accordance with regulations adopted by the Board.
(e)
Drugs donated to the Program may not be resold.
§3006D. Liability.
(a)
This Section applies to:
(1)
The Board;
(2)
The Secretary of the Department of Health and Social
Services;
(3)
Any person that donates drugs to the Program;
(4)
Any pharmacy, hospital, nonprofit clinic, or health
care practitioner that accepts or dispenses drugs under the Program; and
(5)
Any pharmacy, hospital, or nonprofit clinic that
employs a health care practitioner who accepts or dispenses drugs under the
Program.
(b)
For matters
related to donating, accepting, or dispensing drugs under the Program, a person
described in subsection (a) of this Section who acts in good faith may not be
subject to:
(1)
Criminal prosecution;
(2)
Liability in tort or other civil action for injury,
death, or loss to person or property; or
(3)
Disciplinary action by a professional licensing board.
(c)
A drug manufacturer acting in good faith may not be
subject to criminal prosecution or liability in tort or other civil action for
injury, death, or loss to person or property for matters related to the
donation, acceptance, or dispensing of a drug manufactured by the drug
manufacturer that is donated by any person under the Program, including
liability for failure to transfer or communicate product or consumer
information or the expiration date of the donated drug.
§3007D. Promulgation of Rules and Regulations.
(a)
On or before October
1, 2005, and in consultation with the Secretary, the Board shall
adopt regulations governing the Program.
(b)
The regulations shall establish:
(1)
Participation requirements for pharmacies, hospitals,
and nonprofit clinics to accept and dispense donated drugs under the Program;
(2)
Standards and procedures for accepting, safely storing,
and dispensing donated drugs;
(3)
Standards and procedures for inspecting donated drugs
to determine that:
i.
The original
unit dose packaging is sealed and tamper-evident; and
ii.
The drugs are unadulterated, safe, and suitable for
dispensing;
(4)
Eligibility standards based on economic need for individuals
to receive drugs;
(5)
A means, such as an identification card, by which an
individual who is eligible to receive donated drugs may demonstrate eligibility
to the pharmacy, hospital, or nonprofit clinic dispensing the drugs;
(6)
A form that an individual receiving a drug from the
Program must sign before receiving the drug to confirm that the individual
understands the immunity provisions of the Program;
(7)
A formula to determine the amount of a handling fee
that pharmacies, hospitals, and nonprofit clinics may charge to drug recipients
to cover restocking and dispensing costs;
(8)
A list of drugs that the repository will accept;
(9)
A list of drugs that the repository will not accept,
including a statement as to why the drug is ineligible for donation;
(10) For
an individual donor, a form each donor must sign stating that the donor is the
owner of the drugs and intends to voluntarily donate them to the Program; and
(11) Any
other standards and procedures the Board considers appropriate.”
Section 2. This Act shall take effect October 1, 2005.
