Ohio Administrative Code
Title 4729:5 - Dangerous Drugs
Chapter 4729:5-10 - Outpatient Pharmacies
Section 4729:5-10-04 - Eligible drugs and storage requirements
Universal Citation: OH Admin Code 4729:5-10-04
Current through all regulations passed and filed through September 16, 2024
(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 nonprofit 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.
Replaces: 4729:5-10-04
Disclaimer: These regulations may not be the most recent version. Ohio may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
