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S U M M A R Y O F L A W |
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DRUG REPOSITORY PROGRAM
(01/26/2006)
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ORC
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Section
3715.87 Definitions;
Drug Repository Program established.
[ORC: 04/07/04]
(A) As used in this section and in sections
3715.871, 3715.872, and 3715.873 of the Revised Code:
(1)
"Hospital" has the same meaning as in section 3727.01 of the
Revised Code.
(2)
"Nonprofit clinic" means a charitable nonprofit corporation
organized and operated pursuant to Chapter 1702. of the Revised Code, or any
charitable organization not organized and not operated for profit, that
provides health care services to indigent and uninsured persons as defined in
section 2305.234 of the Revised Code.
"Nonprofit clinic" does not include a hospital as defined in
section 3727.01 of the Revised Code, a facility licensed under Chapter 3721. of
the Revised Code, or a facility that is operated for profit.
(3)
"Prescription drug" means any drug to which the following
applies:
(a) Under
the "Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938), 21 U.S.C.A.
301, as amended, the drug is required to bear a label containing the legend,
"Caution: Federal law prohibits dispensing without prescription" or
"Caution: Federal law restricts this drug to use by or on the order of a
licensed veterinarian" or any similar restrictive statement, or the
drug may be dispensed only upon a prescription.
(b) Under
Chapter 3715. or 3719. of the Revised Code, the drug may be dispensed only upon
a prescription.
(B) The state board of pharmacy shall establish
a drug repository program to accept and dispense prescription drugs donated for
the purpose of being dispensed to individuals who are residents of this state
and meet eligibility standards established in rules adopted by the board
under section 3715.873 of the Revised Code.
Only drugs in their original sealed and tamper-evident unit dose
packaging may be accepted and dispensed.
The packaging must be unopened, except that drugs packaged in single
unit doses may be accepted and dispensed when the outside packaging is opened
if the single unit dose packaging is undisturbed. Drugs donated by individuals bearing an
expiration date that is less than six months from the date the drug is donated
shall not be accepted or dispensed. A
drug shall not be accepted or dispensed if there is reason to believe that it
is adulterated as described in section 3715.63 of the Revised Code. Subject to the limitation specified in this
division, unused drugs dispensed for purposes of the medicaid program may be
accepted and dispensed under the drug repository program.
Section 3715.871 Donating
drugs; dispensing drugs; handling fee.
[ORC: 04/07/04]
(A) Any person, including a drug manufacturer or
any health care facility as defined in section 1337.11 of the Revised Code, may
donate prescription drugs to the drug repository program. The drugs must be donated at a pharmacy,
hospital, or nonprofit clinic that elects to participate in the drug repository
program and meets criteria for participation in the program established in
rules adopted by the state board of pharmacy under section 3715.873 of the
Revised Code. Participation in the
program by pharmacies, hospitals, and nonprofit clinics is voluntary. Nothing in this or any other section of the
Revised Code requires a pharmacy, hospital, or nonprofit clinic to participate
in the program.
(B) A pharmacy, hospital, or nonprofit clinic
eligible to participate in the program shall dispense drugs donated under this
section to individuals who are residents of this state and meet the eligibility
standards established in rules adopted by the board under section 3715.873 of
the Revised Code or to other government entities and nonprofit private entities
to be dispensed to individuals who meet the eligibility standards. A drug may be dispensed only pursuant to a
prescription issued by a licensed health professional authorized to prescribe
drugs, as defined in section 4729.01 of the Revised Code. A pharmacy, hospital, or nonprofit clinic
that accepts donated drugs shall comply with all applicable federal laws and
laws of this state dealing with storage and distribution of dangerous drugs
and shall inspect all drugs prior to dispensing them to determine that they are
not adulterated. The pharmacy, hospital,
or nonprofit clinic may charge individuals receiving donated drugs a handling
fee established in accordance with rules adopted by the board under section
3715.873 of the Revised Code. Drugs
donated to the repository may not be resold.
Section
3715.872 Criminal
prosecution; liability; disciplinary action. [ORC: 04/07/04]
(A) As used in this section, "health care
professional" means any of the following who provide medical, dental, or
other health-related diagnosis, care, or treatment:
(1)
Individuals authorized under Chapter 4731. of the Revised Code to
practice medicine and surgery, osteopathic medicine and surgery, or podiatric
medicine and surgery;
(2)
Registered nurses and licensed practical nurses licensed under Chapter
4723. of the Revised Code;
(3)
Physician assistants authorized to practice under Chapter 4730. of the
Revised Code;
(4) Dentists
and dental hygienists licensed under Chapter 4715. of the Revised Code;
(5)
Optometrists licensed under Chapter 4725. of the Revised Code;
(6)
Pharmacists licensed under Chapter 4729. of the Revised Code.
(B) The
state board of pharmacy; the director of health; any person, including a drug
manufacturer, or government entity that donates drugs to the repository
program; any pharmacy, hospital, nonprofit clinic, or health care professional
that accepts or dispenses drugs under the program; and any pharmacy, hospital,
or nonprofit clinic that employs a health care professional who accepts or
dispenses drugs under the program shall not, in the absence of bad faith, be
subject to any of the following for matters related to donating, accepting, or
dispensing drugs under the program: criminal prosecution; liability in tort or
other civil action for injury, death, or loss to person or property; or
professional disciplinary action.
A
drug manufacturer shall not, in the absence of bad faith, 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 but not limited to
liability for failure to transfer or communicate product or consumer information
or the expiration date of the donated drug.
Section 3715.873 State
board of pharmacy shall adopt rules.
[ORC: 04/07/03]
In
consultation with the director of health, the state board of pharmacy shall
adopt rules governing the drug repository program that establish all of the
following:
(A)
Eligibility criteria for pharmacies, hospitals, and nonprofit clinics to
receive and dispense donated drugs under the program;
(B)
Standards and procedures for accepting, safely storing, and dispensing
donated drugs;
(C)
Standards and procedures for inspecting donated drugs to determine that
the original unit dose packaging is sealed and tamper-evident and that the
drugs are unadulterated, safe, and suitable for dispensing;
(D)
Eligibility standards based on economic need for individuals to receive
drugs;
(E) 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;
(F) A form
that an individual receiving a drug from the repository must sign before
receiving the drug to confirm that the individual understands the immunity
provisions of the program;
(G) 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;
(H) In
addition, for drugs donated to the repository by individuals:
(1) A list
of drugs, arranged either by category or by individual drug, that the
repository will accept from individuals;
(2) A list
of drugs, arranged either by category or by individual drug, that the
repository will not accept from individuals.
The list must include a statement as to why the drug is ineligible for
donation.
(3) A form
each donor must sign stating that the donor is the owner of the drugs and
intends to voluntarily donate them to the repository.
(I) In
addition, for drugs donated to the repository by health care facilities:
(1) A list
of drugs, arranged either by category or by individual drug, that the
repository will accept from health care facilities;
(2) A list
of drugs, arranged either by category or by individual drug, that the
repository will not accept from health care facilities. The list must include a statement as to why
the drug is ineligible for donation.
(J) Any
other standards and procedures the board considers appropriate.
The
rules shall be adopted in accordance with Chapter 119. of the Revised Code.
Rule 4729-35-01 Definitions. [OAC: 01/01/04]
As
used in Chapter 4729-35 of the Administrative Code:
(A)
“Dangerous drug” has the same meaning as in section 4729.01 of the
Revised Code and in rule 4729-9-01 of the Administrative Code.
(B) “Drug
repository program” has the same meaning as in sections 3715.87 to 3715.873 of
the Revised Code.
(C)
“Hospital” has the same meaning as in section 3715.87 of the Revised
Code.
(D)
“Institutional facility” has the same meaning as in rule 4729-17-01 of
the Administrative Code.
(E)
“Licensed health care professional” has the same meaning as in section
3715.872 of the Revised Code.
(F)
“Nonprofit clinic” has the same meaning as in section 3715.87 of the
Revised Code.
(G)
“Original sealed and tamper-evident unit dose packaging” includes single
unit dose packaging of oral medications from a manufacturer or a repackager
licensed with the federal food and drug administration, or from a pharmacy
licensed as a terminal distributor of dangerous drugs, and includes
injectables, topicals, and aerosols in the manufacturer’s or repackager’s
unopened original tamper-evident packaging.
Rule 4729-35-02 Eligibility
requirements for a pharmacy, hospital, or nonprofit clinic. [OAC: 01/01/04]
A
pharmacy, hospital, or nonprofit clinic may elect to participate in the drug
repository program, pursuant to sections 3715.87 to 3715.873 of the Revised
Code, if all of the following requirements are met:
(A) Must be
licensed as a terminal distributor of dangerous drugs pursuant to section
4729.54 of the Revised Code.
(B) Must comply
with all federal and state laws, rules, and regulations.
Rule
4729-35-03 Donating
drugs. [OAC: 01/01/04]
(A) The following may donate a dangerous drug,
pursuant to the eligibility requirements of rule 4729-35-04 of the
Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects
to participate in the drug repository program:
(1) A
licensed terminal distributor of dangerous drugs.
(2) A
licensed wholesale distributor of dangerous drugs.
(3) A person
who was legally dispensed a dangerous drug pursuant to a patient-specific drug
order.
(B) A person electing to donate an eligible
dangerous drug shall not have taken custody of the drug prior to the
donation. The person may direct the
donation through a terminal distributor of dangerous drugs.
(C) A
person who resides in an institutional facility and was legally dispensed a
dangerous drug pursuant to a patient-specific order may elect to sign and date
a donor form prior to donating a drug, which shall state “from this day
forward I wish to donate all my remaining unused drugs that are eligible,
pursuant to rule 4729-35-04 of the Administrative Code, to the drug repository
program”.
(D) A person designated by durable power of
attorney, a guardian, or other individual responsible for the care and
well-being of a patient may make the decision to donate an eligible dangerous
drug.
Rule
4729-35-04 Eligible
drugs. [OAC: 01/01/04]
All dangerous drugs, except controlled substances
and drug samples, may be donated to a pharmacy, hospital, or nonprofit clinic
that elects to participate in the drug repository program if the drugs meet all
of the following requirements:
(A) The
drugs are in their original sealed and tamper-evident unit dose packaging. The packaging must be unopened except that
the drugs packaged in single unit doses may be accepted and dispensed when the
outside packaging is opened if the single unit dose packaging is
undisturbed. If the drugs were packaged
by a pharmacy the name of the pharmacy and any other pharmacy identifiers must
be removed from the packaging prior to dispensing to a recipient patient. This may be accomplished by removing the name
from the outside packaging of a multiple dose unit dose packaging system.
(B) The
drugs have been in the possession of a licensed healthcare professional and not
in the possession of the ultimate user.
(C) The
drugs have been stored according to federal food and drug administration
storage requirements.
(D) The
drugs must have an expiration date of six months or greater.
(E) The
packaging must list the lot number and expiration date of the drug.
(F) The
drugs must not have any physical signs of tampering or adulteration.
(G) The drug
packaging must not have any physical signs of tampering.
(H) All
confidential patient information must have been removed from the drug
packaging.
Rule
4729-35-05 Eligibility
requirements to receive drugs. [OAC:
01/01/04]
A
pharmacy, hospital, or nonprofit clinic that elects to participate in the drug
repository program must determine if a person is eligible to receive
drugs. A person must meet the following
requirements to become an eligible recipient of drugs from the drug repository
program:
(A) Is a
resident of
(B) (1)
Has no active third party prescription drug reimbursement coverage for
the drug prescribed; or,
(2) Is a
patient of a nonprofit clinic.
Rule 4729-35-06 Donor
form. [OAC: 01/01/04]
(A) Each donor must sign a form stating that the
donor is the owner of the drug and intends to voluntarily donate the drug to
the drug repository program. The donor
form must be completed prior to any donation and include at least the
following:
(1) The name
of the person that was originally dispensed the drugs, or the name of the terminal
distributor of dangerous drugs or wholesale distributor of dangerous drugs
that owns the drugs.
(2) The
signature of the donor, which may include the person designated by durable
power of attorney, a guardian, an individual responsible for the care and
well-being of a patient, or the signature of the responsible person or
his/her designee from a terminal distributor of dangerous drugs or a
wholesale distributor of dangerous drugs.
(3) The date
the form was signed.
(B) The following donor information must also be
documented. This information may be
documented on the original signed donor form or on an alternate record. If an alternate record is used, the record
must include the name of the donor in addition to the required information in
this paragraph.
(1) The
brand name of the drug donated, or the generic name and list either the name of
the manufacturer or the national drug code number (NDC#).
(2) The
strength of the drug donated.
(3) The
quantity of the drug donated.
(4) The date
the drug was donated.
Rule
4729-35-07 Recipient
form. [OAC: 01/01/04]
Each
recipient of a donated drug from the drug repository program must sign a form
stating they understand the immunity provisions of the program pursuant to
division (B) of section 3715.872 of the Revised Code. The recipient form must also include at
least the following:
(A) The
signature of the recipient of the donated drug.
(B) The date
the form was signed by the recipient.
(C) The
brand name of the drug received, or the generic name and list either the name
of the manufacturer or the national drug code number (NDC#).
(D) The
strength of the drug received by the recipient.
(E) The
quantity of the drug received by the recipient.
Rule 4729-35-08 Record
keeping. [OAC: 01/01/04]
(A) Donor
forms must be maintained for a minimum of three years by a terminal distributor
of dangerous drugs, a wholesale distributor of dangerous drugs, or an
institutional facility.
(B) Recipient forms must be maintained for a
minimum of three years by a pharmacy, hospital, or nonprofit clinic.
(C) An invoice must be created by the donor
location, which includes a terminal distributor of dangerous drugs, a
wholesale distributor of dangerous drugs, or an institutional facility where
the donor resides. The invoice must
include at least the following information:
(1) The name
and address of the donor location.
(2) The
brand name of the drug donated, or the generic name and list either the name of
the manufacturer or the national drug code number (NDC#).
(3) The
strength of the drug.
(4) The
quantity of the drug.
(5) The date
the drug was sent to a pharmacy, hospital, or nonprofit clinic.
(6) The name
and address of the recipient pharmacy, hospital, or nonprofit clinic.
(D) A copy of the invoice must be maintained for
a minimum of three years by both the donor location, which includes a terminal
distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or
an institutional facility, and the recipient location, which includes a
pharmacy, hospital, or nonprofit clinic.
Rule
4729-35-09 Handling
fee. [OAC: 01/01/04]
A
pharmacy, a hospital, or a nonprofit clinic may charge the recipient of a
donated drug a maximum of two hundred per cent of the medicaid professional
dispensing fee to cover restocking and dispensing costs.
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