Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-04 - Eligible drugs and storage requirements

Current through all regulations passed and filed through July 1, 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.