reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-7 - Charitable Pharmacies › Section 4729:5-7-05 - Dispensing a sample drug by a charitable pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								A pharmacist in a
			 charitable pharmacy must have a valid prescription prior to dispensing a sample
			 drug to a patient.
(B)
								The pharmacy shall comply with all requirements for the
			 dispensing of drugs pursuant to Chapter 4729:5-5 of the Administrative
			 Code.
(C)
								The charitable pharmacy shall determine the eligibility
			 requirements for a patient to receive a sample drug.
(D)
								The sample drug
			 shall be dispensed to the patient free of charge.
(E)
								The sample drug
			 may be dispensed:
(1)
									In the manufacturer's original container where the
			 container is clearly marked as a sample; or
(2)
									By removing the
			 sample drug from the original container only if the prescription label on the
			 appropriate container, pursuant to all state and federal requirements, clearly
			 states that the drug dispensed is a sample drug.
Replaces: 4729-36-06
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-8 - Non-resident Pharmacies › Section 4729:5-8-01 - Definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-8 of the
				Administrative Code:
(A)
								"Nonresident terminal distributor of dangerous drugs"
			 or "nonresident terminal distributor" means any person located outside of Ohio
			 that ships, mails, or delivers in any manner, dangerous drugs at retail into
			 Ohio. A nonresident terminal distributor of dangerous drugs shall maintain a
			 license in accordance with sections
			 4729.54 and
			 4729.55 of the Revised Code and
			 shall comply with all requirements set forth in this chapter. A nonresident
			 terminal distributor does not include a person shipping drugs into this state
			 for destruction or disposal by an Ohio licensed reverse
			 distributor.
(B)
								"Dangerous drug" has the same meaning as defined in
			 section 4729.01 of the Revised
			 Code.
(C)
								"Licensed health professional authorized to prescribe
			 drugs" or "prescriber" means an individual who is authorized by law to
			 prescribe drugs or dangerous drugs in the state where the individual is
			 practicing.
(D)
								"Pharmacist," as used in division (B) of section
			 4729.55 of the Revised Code,
			 means an individual who holds a current license to practice pharmacy in the
			 state where the individual is practicing.
(E)
								"Pharmacy" has
			 the same meaning as defined in section
			 4729.01 of the Revised
			 Code.
(F)
								"Responsible person" has the same meaning as defined in
			 rule
			 4729:5-2-01
			 of the Administrative Code and is responsible for the supervision and control
			 of dangerous drugs as required in division (B) of section
			 4729.55 of the Revised Code,
			 adequate safeguards as required in division (C) of section
			 4729.55 of the Revised Code,
			 security and control of dangerous drugs and maintaining all drug records
			 otherwise required.
Replaces: 4729-10-01
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-8 - Non-resident Pharmacies › Section 4729:5-8-02 - Licensure

Current through all regulations passed and filed through July 1, 2024
(A) A person
			 seeking a license as a nonresident terminal distributor of dangerous drugs
			 shall submit an application to the state board of pharmacy that includes all of
			 the following:
(1) Information necessary to
			 demonstrate the qualifications for licensure set forth in section
			 4729.55 of the Revised
			 Code.
(2)
									If the applicant's facility maintains a current license in
			 the state where it is located, all the following:
(a) Certification from
			 the appropriate state licensing agency that the applicant maintains at all
			 times a valid, unexpired license, permit, or registration authorizing the
			 possession and sale of dangerous drugs in the state in which the facility is
			 located and from where dangerous drugs are being sold at retail to residents in
			 Ohio. The certification(s) shall include licenses, permits, or registrations
			 required to cover the categories of dangerous drugs which the nonresident
			 terminal distributor of dangerous drugs will be selling at retail to persons in
			 the state of Ohio.
(b) A copy of the most recent inspection report, any
			 warning notices, notice of deficiency reports, or any other related reports
			 issued by a state licensing agency and drug law enforcement agencies of the
			 state in which it is located or any federal agencies regulating and enforcing
			 laws governing the legal distribution of drugs.
(3)
			 Any other information as determined by the board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-8 - Non-resident Pharmacies › Section 4729:5-8-03 - Compliance

Current through all regulations passed and filed through July 1, 2024
A nonresident terminal distributor of
				dangerous drugs shall:
(A)
								Maintain the following records of all dangerous drugs
			 dispensed or personally furnished to persons in this state:
(1)
									Name, strength,
			 dosage form, the serial number of the prescription, and quantity of the
			 dangerous drug dispensed or personally furnished;
(2)
									Full name and
			 date of birth of the patient for whom the drug is intended; or, if the patient
			 is an animal, the last name of the owner, name of animal (if applicable), and
			 species of the animal or animals; and
(3)
									Residential
			 address, including the physical street address and, if provided, the telephone
			 number of the patient or owner.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-8 - Non-resident Pharmacies › Section 4729:5-8-05 - Preparation, compounding, dispensing, and repackaging of radiopharmaceuticals by a nonresident pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 otherwise provided in this rule, terms used in this rule have the same meaning
			 as in rule 4729:5-6-01 of the Administrative Code.
(B)
								Only a pharmacy
			 licensed as a nonresident terminal distributor of dangerous drugs may dispense
			 or sell patient-specific radiopharmaceuticals into this state and shall comply
			 with all the following:
(1)
									All radiopharmaceuticals shall be dispensed pursuant to
			 a patient-specific prescription or order issued by a licensed health
			 professional authorized to prescribe drugs.
(a)
										A limited
			 quantity may be prepared and distributed in anticipation of prescriptions based
			 on routine, regularly observed prescribing patterns.
(b)
										In the event a
			 patient's name is not available at the time of dispensing, a nonresident
			 nuclear pharmacy shall have up to seventy-two hours to obtain the name of the
			 patient. No later than seventy-two hours after dispensing the
			 radiopharmaceutical, the patient's name must be associated with the
			 prescription in the dispensing records maintained by the nonresident
			 pharmacy.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-01 - Definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-9 of the
				Administrative Code:
(A)
								"Institutional facility" means any of the
			 following:
(1)
									A
			 public hospital or hospital as defined in section
			 3701.01 or
			 5122.01 of the Revised
			 Code.
(2)
									A freestanding emergency department.
(3)
									A freestanding
			 inpatient rehabilitation facility or inpatient rehabilitation facility as
			 defined in rule
			 3701-83-25 of the Administrative
			 Code.
(4)
									An ambulatory surgical facility as defined in rule
			 3701-83-15 of the Administrative
			 Code.
(5)
									A nursing home licensed under Chapter 3721. of the
			 Revised Code;
(6)
									An inpatient psychiatric service provider as defined in
			 rule 5122-14-01 of the Administrative
			 Code;
(7)
									A facility that provides medically supervised
			 detoxification services that meets the following requirements:
(a)
										Patients are
			 administered dangerous drugs to alleviate adverse physiological or
			 psychological effects incident to withdrawal from the continuous or sustained
			 use of drugs or alcohol;
(b)
										Patients are under the care of a licensed prescriber
			 and are provided continuous onsite monitoring by nurses licensed in accordance
			 with Chapter 4723. of the Revised Code;
(c)
										If the period of
			 detoxification is less than twenty-four hours, patients shall be transitioned
			 to an inpatient, residential, or outpatient treatment program;
			 and
(d)
										The facility holds the appropriate license or
			 certification by the Ohio department of mental health and addiction
			 services.
(8)
									A residential care facility licensed under Chapter
			 3721. of the Revised Code that provides skilled nursing care to its residents,
			 including medication administration as authorized in Chapter 3701-16 of the
			 Administrative Code, provided the facility meets the following
			 requirements:
(a)
										The administration of medication shall be in compliance
			 with this chapter and Chapter 3701-16 of the Administrative Code, including the
			 requirement to maintain individual medication records and documentation of
			 medication orders; and
(b)
										The residential care facility maintains an executed
			 contract or agreement with an institutional pharmacy for the provision of
			 institutional pharmacy services. The executed contract or agreement shall be
			 maintained in a readily retrievable manner.
(9)
									A state or local
			 correctional facility, as defined in section
			 5163.45 of the Revised
			 Code;
(10)
									A juvenile correctional facility that is under the
			 management and control of the department of youth services or a private entity
			 with which the department of youth services has contracted for the
			 institutional care; and
(11)
									Any other facility as determined by the
			 board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02 - Institutional pharmacies

Current through all regulations passed and filed through July 1, 2024
An institutional pharmacy as defined in
				rule 4729:5-9-01 of the Administrative Code shall comply with all requirements
				of this rule, including all supplemental rules adopted thereunder.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.1 - Minimum standards for institutional pharmacies

Current through all regulations passed and filed through July 1, 2024
(A)
								Library
(1)
									All pharmacists
			 working in an institutional pharmacy must be able to access all current federal
			 and state laws, regulations, and rules governing the legal distribution of
			 drugs in Ohio, including internet access to the following:
(a)
										The board's
			 website;
(b)
										LAWriter® Ohio laws and rules (
http://codes.ohio.gov
);
(c)
										The code of laws of the United States of America
			 (variously abbreviated to Code of Laws of the United States, United States
			 Code, U.S. Code, U.S.C., or USC); and
(d)
										The code of
			 federal regulations.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.2 - Security, storage and control of dangerous drugs in an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								All areas of an
			 institutional pharmacy shall be capable of being secured by key, or other
			 effective mechanism, to prevent access by unauthorized personnel.
(1)
									Except as
			 provided in paragraph (C)(5) of this rule and rule 4729:5-9-03.1 of the
			 Administrative Code, only a licensed pharmacist may have access to keys, alarm
			 codes, or other methods of gaining access to the pharmacy when the pharmacy is
			 closed.
(2)
									Keys to the pharmacy maintained on-site that are not in
			 the possession of a licensed pharmacist shall be secured to prevent
			 unauthorized access.
(3)
									All combinations or access codes, including alarm
			 codes, shall be changed upon termination of employment of an employee having
			 knowledge of the combination or access code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.3 - Record keeping at an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								An institutional
			 pharmacy shall document, using positive identification, the licensed or
			 registered individuals responsible for performing the following activities
			 authorized under Chapter 4729. of the Revised Code and agency 4729 of the
			 Administrative Code:
(1)
									Medication order or prescription information entered
			 into the record keeping system. This provision shall take effect one-year from
			 the effective date of this rule.
(2)
									Verification by
			 the pharmacist of the prescription information entered into the record keeping
			 system.
(3)
									Drug utilization review in accordance with rule
			 4729:5-9-02.6 of the Administrative Code, which shall be captured as a
			 standalone action or as part of either:
(a)
										The pharmacist
			 verification of prescription information as required by paragraph (A)(2) of
			 this rule; or
(b)
										The dispensing process in paragraph (A)(4) of this
			 rule.
(4)
									Dispensing, except that a pharmacist shall not be
			 required to perform a check of dangerous drugs prior to distribution if the
			 drug is dispensed in accordance with either:
(a)
										Paragraph (F)(5)
			 of this rule; or
(b)
										In accordance with rule 4729:5-3-17 of the
			 Administrative Code.
(5)
									Compounding in
			 accordance with Chapter 4729:7-2 of the Administrative Code.
(6)
									Administering
			 immunizations pursuant to section
			 4729.41 of the Revised
			 Code.
(7)
									Administering other injectable drugs pursuant to
			 section 4729.44 of the Revised
			 Code.
(8)
									Prescription information transcribed from an order
			 received by telephone or recording device.
(9)
									Any changes or
			 annotations made to a prescription or medication order.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.4 - Dispensing of controlled substances by an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
All controlled substances dispensed in
				quantities exceeding a seventy-two-hour supply shall be packaged in
				tamper-evident, unit-of-use containers except when unit-of-use packaging is not
				available including, but not limited to, multi-dose liquids and
				injectables.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.5 - Patient profiles

Current through all regulations passed and filed through July 1, 2024
All institutional pharmacies shall
				maintain a patient profile system which shall provide for immediate retrieval
				of information regarding those patients who have received medications from that
				pharmacy.
(A)
								All patient profile systems shall maintain, at a
			 minimum, the following data:
(1)
									The patient's data record, which shall consist of, but
			 is not limited to, the following information:
(a)
										Full name of the
			 patient for whom the drug is intended.
(b)
										Patient's date of
			 birth.
(c)
										Patient's gender, if provided.
(d)
										A list of current
			 patient specific data consisting of at least the following, if made known to
			 the pharmacist or agent of the pharmacist:
(i)
											Drug related
			 allergies;
(ii)
											Previous drug reactions;
(iii)
											History of or
			 active chronic conditions or disease states; and
(iv)
											Other drugs,
			 including nonprescription drugs, devices and nutritional supplements used on a
			 routine basis.
(e)
										The pharmacist's comments relevant to the individual
			 patient's drug therapy, including any other necessary information unique to the
			 specific patient or drug.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.6 - Pharmacist drug utilization review

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 provided in paragraph (F) of this rule, prior to dispensing any initial
			 medication order or medication order change, a pharmacist shall conduct a
			 prospective drug utilization review of the patient profile for the purpose of
			 identifying the following:
(1)
									Over-utilization or under-utilization of medications
			 dispensed in the institutional facility;
(2)
									Therapeutic
			 duplication;
(3)
									Drug-disease state contraindications;
(4)
									Drug-drug
			 interactions;
(5)
									Incorrect drug dosage;
(6)
									Drug-allergy
			 interactions;
(7)
									Abuse/misuse;
(8)
									Inappropriate
			 duration of drug treatment; and
(9)
									Food-nutritional
			 supplements-drug interactions.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.8 - Labeling of prescriptions for patients

Current through all regulations passed and filed through July 1, 2024
(A)
								All dangerous
			 drugs dispensed for use by inpatients in an institutional facility, whereby the
			 drug is not in the possession of the ultimate user prior to administration,
			 shall meet the following requirements:
(1)
									The label of a
			 single unit package of an individual-dose or unit-dose system of packaging of
			 drugs shall include:
(a)
										The non-proprietary or proprietary name of the
			 drug;
(b)
										Dosage form and route of
			 administration;
(c)
										The strength and volume, where applicable, of the
			 drug;
(d)
										The control number and expiration date;
(e)
										National drug
			 code, universal product code, or formulary code, if applicable, which may be
			 embedded in a barcode or quick response (QR) code on the label;
(f)
										Identification of
			 the manufacturer, packer or distributor, or, if the repackager is the
			 dispensing pharmacy, identification of the repackager shall be by name or by
			 the final seven digits of their terminal distributor of dangerous drugs license
			 number, and such identification shall be clearly distinguishable from the rest
			 of the label; and
(g)
										Special storage conditions, if
			 required.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.9 - Licensure of outpatient institutional pharmacies

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule, "outpatient institutional pharmacy" means a pharmacy located within or on
			 the campus of an institutional facility that provides outpatient pharmacy
			 services which is physically separate from, and not contiguous to, the area in
			 which inpatient pharmacy services are provided.
(B)
								An outpatient
			 institutional pharmacy shall have a separate terminal distributor of dangerous
			 drugs license in addition to the license for the institutional facility or
			 pharmacy. An outpatient institutional pharmacy shall comply with the
			 requirements of Chapter 4729:5-5 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.10 - Temporary absence of a pharmacist in an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								A pharmacist practicing within an institutional
			 facility may temporarily leave the pharmacy to engage in the practice of
			 pharmacy within the institutional facility without closing the pharmacy and
			 removing staff from the pharmacy if the practicing pharmacist can ensure there
			 are adequate security measures and policies to maintain the security of the
			 drug stock in the pharmacist's absence.
(B)
								If in the
			 pharmacist's professional judgment they determine, for reasons of security or
			 otherwise, that the pharmacy should close during the pharmacist's absence, then
			 the pharmacist shall close the pharmacy and remove all staff from the pharmacy
			 during the pharmacist's absence.
(C)
								During the
			 pharmacist's absence, no dangerous drugs shall be dispensed unless the
			 pharmacist has conducted a final association of the drug with a patient and has
			 complied with all other applicable rules prior to dispensing a dangerous
			 drug.
(D)
								During such times that the pharmacist is temporarily
			 absent from the pharmacy, the pharmacy staff may continue to perform the
			 non-discretionary duties authorized in accordance with Chapter 4729. of the
			 Revised Code and agency 4729 of the Administrative Code. However, any duty
			 performed by any member of the staff shall be reviewed by the pharmacist upon
			 the pharmacist's return to the pharmacy.
(E)
								The institutional
			 facility shall have written policies and procedures regarding the operation of
			 the pharmacy during the temporary absence of the pharmacist. The policies and
			 procedures shall include the authorized duties of pharmacy staff, the
			 pharmacist's responsibilities for checking all work performed by staff, and the
			 pharmacist's responsibility for maintaining the security and control of the
			 drug stock.
(F)
								Unless otherwise authorized in agency 4729 of the
			 Administrative Code, this rule does not permit non-pharmacist personnel from
			 having unsupervised access to drug stock when an institutional pharmacy is
			 closed.
Replaces: 4729-17-07
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.11 - Dispensing customized patient medication packages by an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
In lieu of dispensing two or more
				dangerous drugs in separate containers, a pharmacist practicing at an
				institutional pharmacy may dispense a customized patient medication package. A
				customized patient medication package is a package for a specific patient
				comprising a series of containers and containing two or more prescribed solid
				oral dosage forms that complies with the following requirements:
(A)
								The package is
			 designed, or each container is labeled, to indicate the day and time or period
			 of time when the contents within each container are to be taken by the
			 patient.
(B)
								The number of drugs placed in each container cannot
			 exceed the capability of the container to prevent damage to the dosage
			 forms.
(C)
								The quantity of the package dispensed may not be more
			 than a thirty-one-day supply.
(D)
								The labels must
			 be of sufficient size to properly and clearly label a thirty-one-day or less
			 supply with all information required in accordance with this chapter of the
			 Administrative Code, including the use of accessory labels. When a customized
			 medication packaging is utilized, including dispensing of single unit packages,
			 the drugs shall be dispensed in a container or package with an affixed label
			 containing the following information:
(1)
									Identification of
			 the dispensing pharmacy;
(2)
									The patient's full name;
(3)
									The date of
			 dispensing;
(4)
									The non-proprietary and/or proprietary name of the
			 drug;
(5)
									National drug code, universal product code, or
			 formulary code, if applicable, which may be embedded in a barcode or quick
			 response (QR) code on the label;
(6)
									The strength of
			 the drug;
(7)
									The pharmacy's expiration date or beyond-use date,
			 which shall not exceed the expiration date on the manufacturer's container or
			 six months from the date the drug was originally packaged, whichever date is
			 earlier. If multiple manufacturer containers are used, the expiration date
			 shall not exceed the expiration date on the manufacturer's container that will
			 expire first or six months from the date the drug was originally repackaged,
			 whichever date is earlier.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.12 - Drugs repackaged or relabeled by an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this rule, "repackaging" means the act of
			 taking a finished drug product from the container in which it was distributed
			 by the original manufacturer and placing it into a different container without
			 further manipulation of the drug. Repackaging also includes the act of placing
			 the contents of multiple containers (e.g., vials) of the same finished drug
			 product into one container, as long as the container does not include other
			 ingredients. If a drug is manipulated in any other way, including if the drug
			 is reconstituted, diluted, mixed, or combined with another ingredient, that act
			 is not considered repackaging.
(B)
								The following
			 rule applies to dangerous drugs repackaged by an institutional pharmacy. The
			 rule does not apply to any of the following:
(1)
									Repackaging drug
			 products for use in animals;
(2)
									Repackaging
			 non-dangerous drug products;
(3)
									Radiopharmaceuticals as defined in Chapter 4729:5-6 of the
			 Administrative Code;
(4)
									Repackaging conducted by outsourcing facilities or
			 repackagers licensed in accordance with section
			 4729.52 of the Revised
			 Code;
(5)
									Removing a drug product from the original container at
			 the point of care (e.g., patient's bedside) for immediate administration to a
			 single patient after receipt of a valid patient-specific prescription or order
			 for that patient (e.g., drawing up a syringe to administer directly to the
			 patient);
(6)
									Upon receipt of, or in anticipation of, a valid
			 patient-specific prescription or medication order, a licensed pharmacy removing
			 from one container the quantity of non-sterile drug products (e.g., oral dosage
			 forms) necessary to fill the prescription and placing it in a different
			 container to dispense directly to the patient; and
(7)
									Investigational
			 new drugs being studied under an investigational new drug
			 application.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-02.13 - Institutional central fill pharmacies

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 chapter:
(1)
									"Central fill pharmacy" means a pharmacy licensed as a
			 terminal distributor of dangerous drugs acting as an agent of an originating
			 pharmacy to fill or refill a medication order. A central fill pharmacy may be
			 used to replenish automated drug storage systems and automated pharmacy
			 systems.
(2)
									"Originating pharmacy" means an institutional pharmacy
			 licensed as a terminal distributor of dangerous drugs that uses a central fill
			 pharmacy to fill or refill medication order. A central fill pharmacy may be
			 used to replenish automated drug storage systems and automated pharmacy
			 systems.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03 - Institutional facilities

Current through all regulations passed and filed through July 1, 2024
An institutional facility as defined in
				rule 4729:5-9-01 of the Administrative Code shall comply with all requirements
				of this rule, including all supplemental rules adopted thereunder.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03.1 - Contingency drugs in an institutional facility and emergency access to an institutional pharmacy

Current through all regulations passed and filed through July 1, 2024
In the absence of an available on-site
				pharmacy, drugs prescribed for patient treatment in an institutional facility
				may be obtained in the following manner:
(A)
								Contingency
			 drugs, as defined in rule 4729:5-9-01 of the Administrative Code, may be made
			 available to licensed health care professionals authorized pursuant to the
			 Revised Code to administer drugs during the professional's
			 practice.
(B)
								An institutional facility maintaining contingency drugs
			 shall hold a license, which may include a campus license, as a terminal
			 distributor of dangerous drugs.
(C)
								An institutional
			 pharmacy may serve as the license holder for an institutional facility, if all
			 the following apply:
(1)
									The institutional pharmacy maintains a terminal
			 distributor of dangerous drugs license on behalf of the institutional
			 facility.
(2)
									The institutional pharmacy and institutional facility
			 maintain an executed contract or agreement outlining the services to be
			 provided and the responsibilities of each party in fulfilling the terms of the
			 contract or agreement in compliance with federal and state law, rules, and
			 regulations. The executed contract or agreement shall be maintained in a
			 readily retrievable manner.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03.2 - Security, storage and control of dangerous drugs in an institutional facility

Current through all regulations passed and filed through July 1, 2024
(A) As used in this rule, "blind count" means
			 a physical inventory taken by a person authorized by the institutional
			 facility's responsible person who performs a physical inventory without
			 knowledge of or access to the quantities currently shown on electronic or other
			 inventory systems.
(B) Except as
			 provided in this rule, all non-controlled dangerous drugs, including those
			 dispensed by an institutional pharmacy to inpatients, shall be stored in a
			 secure area to deter and detect unauthorized access.
(C) Non-controlled dangerous drug emergency
			 or contingency kits may be secured using a tamper-evident method. Drugs stored
			 using a tamper-evident method shall be routinely inspected to detect
			 unauthorized access in accordance with a policy developed by the facility. The
			 policy shall be made readily retrievable.
(D) All controlled substance dangerous drugs,
			 including those dispensed by an institutional pharmacy to inpatients,
			 maintained in areas outside of the institutional pharmacy that are not stored
			 as part of an automated drug storage system, shall meet the following
			 requirements, unless stored as part of an automated drug storage system that
			 meets the requirements of paragraph (E) of this rule:
(1) The drugs shall be a securely locked in a
			 substantially constructed cabinet or safe to deter and detect unauthorized
			 access.
(2) At every change of
			 shift, a reconciliation shall be conducted by both the departing and incoming
			 licensed health care professional responsible for the security and control of
			 the drugs in the area in which they are stored and shall include the following:
(a) A physical count and reconciliation of
			 the controlled substances and proof-of-use sheets or electronic records to
			 ensure the accountability of all doses;
(b) An inspection of the packaging to ensure
			 its integrity;
(c) The positive
			 identification of the persons conducting the reconciliation; and
(d) The immediate reporting of any unresolved
			 discrepancy to the appropriate personnel within the institution, including the
			 responsible person or the responsible person's designee.
(e) Paragraph (D)(2)(a) of this
			 rule does not apply to emergency or contingency drug kits secured using a
			 tamper-evident method.
(3) All controlled substances shall be
			 packaged in tamper-evident containers, except multi-dose liquids and
			 injectables where unit-of-use packaging is not available.
(4) Maintain a record keeping system for each
			 drug in accordance with rule
			 4729:5-9-03.3 of the Administrative
			 Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03.3 - Record keeping in an institutional facility

Current through all regulations passed and filed through July 1, 2024
This rule applies to records for
				dangerous drugs, including those dispensed by an institutional pharmacy to
				inpatients, maintained in areas outside of the institutional pharmacy by an
				institutional facility.
(A)
								An institutional facility shall maintain a record of
			 all dangerous drugs administered to patients that includes all the following
			 information:
(1)
									Name of the patient;
(2)
									Name, strength,
			 dosage form, route of administration, and quantity of the dangerous drugs
			 administered;
(3)
									Date and time the dangerous drugs were
			 administered;
(4)
									The positive identification of the person removing the
			 dangerous drug for patient administration;
(5)
									Positive
			 identification of the personnel administering the drug; and
(6)
									For controlled
			 substance dangerous drugs:
(a)
										If removed from a secured location, the positive
			 identification of the person removing the controlled substance for patient
			 administration; and
(b)
										The disposal of an unused portion of a controlled
			 substance conducted in accordance with paragraph (J) of rule 4729:5-9-03.2 of
			 the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03.4 - Automated drug storage systems in an institutional facility

Current through all regulations passed and filed through July 1, 2024
All automated drug storage systems
				utilized by an institutional facility shall comply with the
				following:
(A)
								Except as provided in paragraph (B) of this rule, the
			 computer program used to access all drugs within the automated drug storage
			 system shall have an electronic timeout of sixty seconds of
			 inactivity.
(B)
								For an automated drug storage system used exclusively
			 for administering anesthesia drugs that is under the immediate supervision of a
			 licensed healthcare provider authorized to administer such drugs, the computer
			 program used to access all drugs within the automated drug storage system shall
			 have an electronic timeout of no more than sixty minutes of inactivity, unless
			 an alternative method to ensure the security of the drug stock is approved by
			 the board.
(C)
								The institutional facility shall develop and implement
			 policies and procedures for all automated drug storage systems that include the
			 following:
(1)
									Provide for a written or electronic record documenting
			 access to the automated drug storage system. Such record shall include the
			 names, titles, and positive identification of all personnel accessing
			 medications, date and time of access, the name and quantity of drugs obtained,
			 and the name of the patient. All records shall be maintained in accordance with
			 paragraphs (K) and (L) of rule 4729:5-9-03.3 of the Administrative
			 Code.
(2)
									Provide security controls to prevent diversion of the
			 drugs.
(3)
									Develop policies and procedures to track access to
			 emergency override access keys.
(4)
									Provide
			 procedures for the inspection of the systems to ensure proper utilization and
			 replacement of the drug supply.
(5)
									If override
			 medications are utilized, the institutional facility shall develop and
			 implement a policy that describes the types of medication overrides that will
			 be reviewed for appropriateness and the frequency of the
			 reviews.
(6)
									All policies and procedures required in accordance with
			 this paragraph shall be maintained in a readily retrievable
			 manner.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03.5 - Hospital self-service employee prescription kiosks

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this rule:
(1)
									"Hazardous drug"
			 means any drug listed in table one on the national institute for occupational
			 safety and health's list of antineoplastic and other hazardous drugs in
			 healthcare settings as referenced in rule 4729:7-1-01 of the Administrative
			 Code.
(2)
									"Hospital" means a public hospital or hospital as
			 defined in section
			 3701.01
			 or
			 5122.01
			 of the Revised Code.
(3)
									"Self-service employee prescription kiosk" or "kiosk"
			 means a self-service kiosk for the pickup of new or refill prescriptions only
			 for hospital employees and their family members.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-9 - Drug Repositories › Section 4729:5-9-03.6 - Point of care locations in an institutional facility

Current through all regulations passed and filed through July 1, 2024
(A) "Point of care
			 location" has the same meaning as in rule
			 4729:5-9-01 of the
			 Administrative Code.
(B) Dangerous
			 drugs maintained at a point of care location shall be in a securely locked,
			 substantially constructed cabinet, including an automated drug storage system,
			 or safe to deter and detect unauthorized access.
(C) The responsible person for the point of
			 care location shall be an employee of the institutional pharmacy that owns the
			 drug stock and shall be responsible for all the following:
(1) Designating those who may obtain access
			 to the drug stock;
(2) Determining,
			 in conjunction with the appropriate interdisciplinary committees, the drugs
			 that are to be included at the point of care location;
(3) Providing controls to prevent the
			 diversion of the drug stock;
(4)
			 Instituting record keeping procedures to account for drugs removed from the
			 point of care location and for capturing the positive identification of the
			 person who obtained the drugs from the point of care location; and
(5) Providing procedures for the inspection
			 of the point of care location to ensure proper utilization and replacement of
			 the drug stock.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-01 - Definitions - drug repository programs

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-10 of the Administrative Code:
(A)
								"Charitable
			 pharmacy" has the same meaning as in section
			 3719.811 of the Revised
			 Code.
(B) "Controlled
			 substance" has the same meaning as in section
			 3719.01 of the Revised
			 Code.
(C) "Distributor of
			 dangerous drugs" or "drug distributor" has the same meaning as in rule
			 4729:6-1-01 of the
			 Administrative Code.
(D) "Dangerous drug"
			 has the same meaning as in section
			 4729.01 of the Revised
			 Code.
(E) "Drug repository
			 program" means a program authorized to accept prescription drugs donated or
			 given for the purpose of being dispensed or personally furnished to individuals
			 who are residents of this state and meets eligibility standards established in
			 this chapter.
(F) "Hospital" has the
			 same meaning as in section
			 3727.01 of the Revised
			 Code.
(G) "Institutional
			 facility" has the same meaning as defined in agency 4729 of the Administrative
			 Code.
(H) "Licensed health
			 care professional" has the same meaning as in section
			 3715.872 of the Revised
			 Code.
(I) "Nonprofit clinic"
			 has the same meaning as in section
			 3715.87 of the Revised
			 Code.
(J) "Orally
			 administered cancer drug" means either of the following:
(1) An orally administered dangerous drug
			 that is used to treat cancer or its side effects; or
(2) An orally administered dangerous drug
			 that is used to treat the side effects of a dangerous drug used to treat
			 cancer.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-02 - Eligibility requirements for a pharmacy, hospital, or nonprofit

Current through all regulations passed and filed through July 1, 2024
A pharmacy, hospital, or nonprofit clinic may elect to
				participate in a 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
			 applicable federal and state laws, rules, and regulations.
(C)
								A pharmacy,
			 hospital, or nonprofit clinic that operates a drug repository program that
			 receives donations or dispenses medications to the general public shall notify
			 the board, in a manner determined by the board, within thirty days of
			 establishing a repository program.
(D)
								A pharmacy,
			 hospital, or nonprofit clinic that no longer operates a drug repository program
			 that receives donations or dispenses medications to the general public shall
			 notify the board, in a manner determined by the board, within thirty days of
			 discontinuation.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-03 - Donating drugs

Current through all regulations passed and filed through July 1, 2024
(A) The following may donate
			 or facilitate the donation of a
			  drug, pursuant to the eligibility
			 requirements of rule
			 4729:5-10-04 of the
			 Administrative Code, to a pharmacy, hospital, or nonprofit clinic that elects
			 to participate in a drug repository program:
(1)
									Any pharmacy,
			 drug manufacturer, or health care facility, or other person or government
			 entity may donate or give drugs to a drug repository program.
(2)
									Any person or
			 government entity may facilitate the donation or gift of drugs to the
			 program.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-05 - Eligibility requirements to receive drugs

Current through all regulations passed and filed through July 1, 2024
A pharmacy, hospital, or nonprofit clinic that elects to
				participate in a 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 a drug repository program:
(A) Is a resident of Ohio
			 or currently resides in this state; and
(B) Meets any of the following criteria:
(1)
									
									Is uninsured or underinsured as defined in rule
			 4729:5-10-01 of the
			 Administrative Code; or
(2)
									
									Meets any other eligibility requirements, as determined
			 by the repository program's eligibility policy.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-06 - Required forms and record keeping

Current through all regulations passed and filed through July 1, 2024
(A) Each donor must sign
			 
								an electronic or
			 physical 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 
									entity that owns the
			 drugs.
(2)
									The full name, contact phone, and signature of the donor,
			 which may include any of the following:
(a)
										The person
			 designated by durable power of attorney, a guardian, an individual responsible
			 for the care and well-being of a patient;
(b)
										The executor,
			 administrator, or trustee of the estate of a deceased patient;
(c)
										The responsible
			 person or the responsible person's designee of a terminal distributor of
			 dangerous drugs or a drug distributor;
(d)
										The licensed
			 prescriber or pharmacist responsible for the oversight of the entity donating
			 the drug.
(3)
									The address of the donor or the entity donating the
			 drug.
(4) The date the form
			 was signed.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-10 - Outpatient Pharmacies › Section 4729:5-10-07 - Occasional sales and handling fee

Current through all regulations passed and filed through July 1, 2024
(A)
								A pharmacy,
			 hospital, or nonprofit clinic may charge the recipient of a donated drug a
			 handling fee up to twenty dollars to cover restocking and dispensing costs. If
			 a drug repository program chooses to charge a handling fee, then the fees
			 collected in any given year shall not exceed the program's total restocking and
			 dispensing costs for that given year.
(B)
								A charitable
			 pharmacy, hospital, or nonprofit clinic that operates a drug repository program
			 may conduct occasional sales at wholesale of drugs that have been donated or
			 given to the program if all of the following apply:
(1)
									The receiving
			 location is a charitable pharmacy, hospital, or nonprofit clinic that operates
			 a drug repository program in this state or an entity participating in a drug
			 repository program operated by another state subject to the laws of that
			 state.
(2)
									The seller maintains a record of or sale that contains
			 the following information:
(a)
										The name, strength, dosage form, national drug code,
			 and quantity of the dangerous drug transferred or sold, the address of the
			 location where the drugs were transferred or sold, the date of transfer or
			 sale; or
(b)
										In lieu of the requirements listed in paragraph
			 (B)(2)(a) of this rule, a hospital may document the transfer of the drug within
			 the hospital system in accordance with paragraph (F) of rule
			 4729:5-9-02.3 of the Administrative
			 Code.
(3)
									The seller provides a copy of the record of sale as
			 outlined in this paragraph to the receiver.
(4)
									The seller and
			 receiver maintain a record of the sale for three years from the date of
			 creation in a readily retrievable manner.