(A) Except as provided in paragraphs (B)
and (C) of this rule, drugs donated to a repository program shall be in the
original sealed and tamper-evident unit dose packaging and shall meet all of
the following requirements:
(1) The packaging shall 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.
(2) If the drugs were packaged by a pharmacy, the name of
the pharmacy and any other pharmacy identifiers shall be removed from the
packaging prior to dispensing or personally furnishing to a recipient patient.
This may be accomplished by removing the drug from the pharmacy packaging or by
removing the name from the outside packaging of a multiple dose, unit dose
packaging system.
(3) The drugs have not been in the possession of the
patient and are under the control of the pharmacy, drug manufacturer,
government entity, or health care facility.
(4) The drugs have been stored according to federal and
state requirements.
(5) The drugs shall include an expiration date on the label
or packaging. If the prescription container is the manufacturer's original
sealed packaging, the expiration date is the expiration date listed on the
packaging. A repository program shall not dispense or personally furnish a
donated drug that is beyond the expiration date.
(6) The repository program shall develop and implement
standards and procedures to determine, based on a basic visual inspection by a
licensed pharmacist or prescriber, that the drugs appear to be unadulterated,
safe, and suitable for dispensing or personally furnishing.
(7) The drugs shall not have any physical signs of
tampering, misbranding, or adulteration.
(8) The drug packaging shall not have any physical signs of
tampering.
(9) Pursuant to division (J) of section 3715.873 of the
Revised Code the following drugs and drug types are prohibited from being
donated to a repository program in accordance with this paragraph, as they are
prohibited from donation by federal or state law or may pose a significant
health risk to employees or patients of a repository program:
(a) Controlled
substances, except for controlled substances in a long-acting or
extended-release form used for the treatment of opioid dependence or
addiction.
(b) Drug samples, unless
the repository is operated by a charitable pharmacy.
(c) Radiopharmaceuticals
as defined in rule 4729:5-8-01 of the Administrative Code.
(d) A drug for which the
United States food and drug administration requires, as a risk evaluation and
mitigation strategy, that the patient be registered with the drug's
manufacturer.
(e) Compounded
drugs.
(B) A
drug repository program operated by a pharmacy, hospital, or non-profit clinic
may accept donations of orally administered cancer drugs, as defined in rule
4729:5-10-01 of the Administrative Code, that are not in the original sealed
and tamper-evident unit dose packaging if all of the following requirements are
met:
(1) The repository program shall develop and implement
standards and procedures to determine, based on a basic visual inspection by a
licensed pharmacist or prescriber, that the drugs appear to be unadulterated,
safe, and suitable for dispensing or personally furnishing.
(2) The drugs have been stored according to federal and
state requirements.
(3) The drugs shall include an expiration date on the label
or packaging. If the prescription container is the manufacturer's original
sealed packaging, the expiration date is the expiration date listed on the
packaging. A repository program shall not dispense or personally furnish a
donated drug that is beyond the expiration date.
(4) The drugs shall not have any physical signs of
tampering, misbranding, or adulteration.
(5) The drugs do not require refrigeration, freezing, or
storage at a special temperature.
(6) Pursuant to division (J) of section 3715.873 of the
Revised Code the following drugs and drug types are prohibited from being
donated to a repository program in accordance with this paragraph, as they are
prohibited from donation by federal or state law or may pose a significant
health risk to employees or patients of a repository program:
(a) Controlled
substances.
(b) Drug samples, unless
the repository is operated by a charitable pharmacy.
(c) Radiopharmaceuticals
as defined in rule 4729:5-8-01 of the Administrative Code.
(d) A drug for which the
United States food and drug administration requires, as a risk evaluation and
mitigation strategy, that the patient be registered with the drug's
manufacturer.
(e) Compounded
drugs.
(7) Nothing in this paragraph prohibits a drug repository
program operated by a pharmacy, hospital, or non-profit clinic from accepting
donations of orally administered cancer drugs that are in the original sealed
and tamper-evident unit dose packaging if the program complies with the
requirements of this paragraph.
(C) A
drug repository program operated by a charitable pharmacy, hospital, or
non-profit clinic may accept donations of drugs, including any such drugs that
are orally administered cancer drugs or that may require storage at a special
temperature, that are not in the original sealed and tamper-evident unit dose
packaging if all of the following requirements are met:
(1) The repository program shall develop and implement
standards and procedures to determine, based on a basic visual inspection by a
licensed pharmacist or prescriber, that the drugs appear to be unadulterated,
safe, and suitable for dispensing or personally furnishing.
(2) The drugs have been stored according to federal and
state requirements.
(3) The drugs shall include an expiration date on the label
or packaging. If the prescription container is the manufacturer's original
sealed packaging, the expiration date is the expiration date listed on the
packaging. A repository program shall not dispense or personally furnish a
donated drug that is beyond the expiration date.
(4) The drugs shall not have any physical signs of
tampering, misbranding, or adulteration.
(5) Pursuant to division (J) of section 3715.873 of the
Revised Code the following drugs and drug types are prohibited from being
donated to a repository program in accordance with this paragraph, as they are
prohibited from donation by federal or state law or may pose a significant
health risk to employees or patients of a repository program:
(a) Controlled
substances.
(b) Drug samples, unless
the repository is operated by a charitable pharmacy.
(c) Radiopharmaceuticals
as defined in rule 4729:5-8-01 of the Administrative Code.
(d) A drug for which the
United States food and drug administration requires, as a risk evaluation and
mitigation strategy, that the patient be registered with the drug's
manufacturer.
(e) Compounded
drugs.
(6) Nothing in this paragraph prohibits a drug repository
program operated by a pharmacy, hospital, or non-profit clinic from accepting
donations of drugs that are in the original sealed and tamper-evident unit dose
packaging if the program complies with the requirements of this
paragraph.
(D) In the case of recalls, any donated drugs affected by
the recall shall not be dispensed or personally furnished unless the lot number
can be determined.
(E) A
repository shall quarantine the donated drugs separately from all dispensing
stock until the donated drugs have been inspected and approved in accordance
with this rule.
(F) No drugs may be dispensed or personally furnished by a
drug repository that contain any confidential patient information from the
original donor.
