reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-21 - Point of dispensing locations during a public health emergency

Current through all regulations passed and filed through July 1, 2024
(A)
								A board of health, as defined in section
			 3701.048 of the Revised Code,
			 that is licensed as a terminal distributor of dangerous drugs may temporarily
			 remove dangerous drugs upon the governor's declaration of an emergency that
			 affects the public health.
(B)
								The dangerous
			 drugs removed from a location licensed as a terminal distributor shall be used
			 to establish a point of dispensing location or locations in the event of a
			 declared public health emergency to administer, deliver, dispense, or
			 distribute drugs in accordance with protocols developed pursuant to section
			 3701.048 of the Revised
			 Code.
(C)
								The dangerous drugs shall be returned to the board of
			 health within seventy-two hours of the cessation of the public health
			 emergency. An individual listed in divisions (B) and (C) of section
			 3701.048 of the Revised Code
			 shall maintain personal supervision and control over the dangerous drugs
			 removed from the terminal distributor.
(D)
								If personal
			 supervision is not provided, the dangerous drugs shall be physically secured in
			 a manner to prevent unauthorized access and diversion. The drugs shall be
			 stored at temperatures which will ensure the integrity of the drugs prior to
			 their use as stipulated by the USP/NF and/or the manufacturer's or
			 distributor's labeling.
(E)
								All point of dispensing sites established in accordance
			 with this rule shall cease to operate upon the cessation of the public health
			 emergency but may be extended at the request of the director of
			 health.
(F)
								The board's executive director, upon consultation with
			 the board president, may grant variances or extensions to the requirements set
			 forth in this rule if it is determined that such a variance is in the public
			 interest.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-4 - Disciplinary Actions by State Board of Pharmacy › Section 4729:5-4-01 - Disciplinary actions

Current through all regulations passed and filed through July 1, 2024
(A) The state board of pharmacy, in
			 accordance with Chapter 119. of the Revised Code, may impose any one or more of
			 the following sanctions on a person licensed as a terminal distributor of
			 dangerous drugs for any of the causes set forth in paragraph (B) of this rule:
(1) Suspend, revoke, restrict, limit, or
			 refuse to grant or renew a license;
(2) Reprimand or place the license holder on
			 probation;
(3) Impose a monetary
			 penalty or forfeiture as set forth in section
			 4729.57
			 of the Revised Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-01 - Definitions - outpatient pharmacies

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-5 of the
				Administrative Code:
(A)
								"Audit trail" means all materials and documents
			 required for the entire processing of a prescription, which shall be sufficient
			 to document or reconstruct the origin of the prescription and authorization of
			 subsequent modifications of that prescription.
(B)
								"Dispense" means
			 the final association of a drug with a particular patient pursuant to a
			 prescription, drug order, or other lawful order of a prescriber and the
			 professional judgment of and the responsibility for interpreting, preparing,
			 compounding, labeling, and packaging a specific drug.
(C)
								"OARRS report"
			 means a report of information related to a specific person generated by the
			 drug database established and maintained pursuant to section
			 4729.75 of the Revised
			 Code.
(D)
								"Original prescription" means any of the following
			 issued in accordance with division 4729:5 of the Administrative Code:
(1)
									A prescription
			 issued by a prescriber in writing;
(2)
									An oral
			 prescription transcribed by a pharmacist, pharmacy intern, or certified
			 pharmacy technician;
(3)
									An electronically transmitted prescription;
			 or
(4)
									A prescription transmitted by use of a facsimile
			 machine.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-02 - Minimum standards for the operation of an outpatient pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this rule, "pharmacy personnel" means any of
			 the following licensed or registered in accordance with Chapter 4729. of the
			 Revised Code:
(1)
									Pharmacist;
(2)
									Pharmacy
			 intern;
(3)
									Certified pharmacy technician;
(4)
									Registered
			 pharmacy technician;
(5)
									Pharmacy technician trainee.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-02.1 - Provision of ancillary services in an outpatient pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this rule, "ancillary services" are services
			 performed by pharmacy personnel that are performed in addition to, or outside
			 of, the dispensation of dangerous drugs.
(1)
									Ancillary
			 services include, but are not limited to, immunizations, drug administration,
			 medication therapy management, disease state management, and refill
			 reminders.
(2)
									Ancillary services do not include services provided by
			 an outpatient pharmacy to patients upon discharge from an institutional
			 facility as defined in Chapter 4729:5-9 of the Administrative
			 Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-02.2 - Mandatory rest breaks for pharmacy personnel

Current through all regulations passed and filed through July 1, 2024
(A)
								An outpatient
			 pharmacy licensed as a terminal distributor of dangerous drugs shall not
			 require pharmacy personnel to work longer than thirteen hours in any workday
			 and shall allow at least eight hours of off time between consecutive
			 shifts.
(1)
									A
			 pharmacist may volunteer to work longer than thirteen continuous
			 hours.
(2)
									The pharmacy must document and date the amount of time
			 worked beyond the thirteen hour limit along with the reason and make it
			 available in the pharmacy for immediate inspection for at least three years
			 from the date it was created.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-02.3 - Requests for additional staff and reports of staffing concerns in an outpatient pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								An outpatient
			 pharmacy shall develop a process for pharmacy staff to communicate requests for
			 additional staff or reports of staffing concerns. Requests for additional staff
			 or reports of staffing concerns shall be communicated and documented by the
			 responsible person or pharmacist on duty to the terminal
			 distributor.
(B)
								Executed requests for additional staffing or reports of
			 staffing concerns shall be provided to the immediate supervisor of the
			 responsible person or pharmacist on duty, with one copy maintained in the
			 pharmacy for three years for immediate inspection by an agent, inspector, or
			 employee of the board.
(C)
								Outpatient pharmacies licensed as terminal distributors
			 of dangerous drugs shall review all requests and reports of concern submitted
			 in accordance with this rule and shall resolve any issues listed in a timely
			 manner to ensure a safe working environment for pharmacy staff as required by
			 section 4729.55 of the Revised Code. A
			 written response to the request or report of concern shall occur within
			 fourteen business days of submission and be communicated to the responsible
			 person or pharmacy staff who submitted the request for additional staffing or
			 report of concern. A copy of this response shall be maintained in the pharmacy
			 for three years for immediate inspection by an agent, inspector, or employee of
			 the board.
(D)
								An outpatient pharmacy shall not retaliate or
			 discipline a pharmacist who, in good faith, makes a request for additional
			 staff or reports staffing concerns in accordance with this rule. As used in
			 this rule, retaliation or discipline of an employee includes, but is not
			 limited to, the following:
(1)
									Removing or suspending the employee from
			 employment;
(2)
									Withholding from the employee salary increases or
			 employee benefits to which the employee is otherwise entitled;
(3)
									Transferring or
			 reassigning the employee;
(4)
									Denying the employee a promotion that otherwise would
			 have been received;
(5)
									Reducing the employee in pay or
			 position.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-02.4 - Significant delays in the provision of pharmacy services

Current through all regulations passed and filed through July 1, 2024
(A)
								An outpatient pharmacy has a duty to properly dispense
			 lawful prescriptions for dangerous drugs or devices without significant
			 delay.
(1)
									For
			 purposes of this rule, "significant delay" means a prescription that was
			 submitted to the pharmacy for processing by a prescriber, patient, or caregiver
			 and has yet to be dispensed (e.g., final verification) by a pharmacist as
			 follows:
(a)
										For new prescriptions: within three business days of
			 receiving the prescription.
(b)
										For refill
			 prescriptions not generated by a pharmacy auto-refill program: within three
			 business days of receiving the prescription.
(c)
										For refill
			 prescriptions generated by a pharmacy auto-refill program: within five business
			 days of receiving the prescription.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-02.5 - Outpatient pharmacy access points

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule, "ancillary services" are those services performed by pharmacy personnel
			 that are not directly involved in the dispensation of dangerous drugs. Examples
			 of such services include, but are not limited to, immunizations, drug
			 administration, medication therapy management, disease state management, and
			 refill reminders.
(B)
								Except as provided for in paragraph (C) of this rule, a
			 pharmacy shall develop and implement an effective organizational policy that
			 permits a pharmacist to do all the following:
(1)
									Limit the
			 provision of ancillary services if, in the pharmacist's professional judgment,
			 the provision of such services cannot be safely provided or may negatively
			 impact patient access to medications. The pharmacy's policy shall include an
			 offer by pharmacy staff to make an appointment for a patient or refer a patient
			 to another location offering immunizations and other ancillary
			 services.
(2)
									Limit pharmacy access points, if, in the pharmacist's
			 professional judgment, limiting such access points will minimize fatigue,
			 distraction, or other conditions which interfere with a pharmacist's ability to
			 practice with reasonable safety and competence.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-03 - Filing and storage of prescriptions

Current through all regulations passed and filed through July 1, 2024
All original outpatient prescriptions
				shall be filed in the following manner:
(A)
								Prescriptions for
			 schedule II controlled substances shall be maintained in a separate
			 prescription file for schedule II prescriptions.
(B)
								Prescriptions for
			 schedule III, IV, and V controlled substances shall be maintained in a separate
			 prescription file for schedule III, IV, and V prescriptions.
(C)
								Prescriptions for
			 non-controlled substances shall be maintained in a separate prescription file
			 for non-controlled prescriptions.
(D)
								Prescriptions
			 containing multiple drug orders shall be filed in the most restrictive
			 file.
(E)
								All non-controlled hard copy prescriptions, including
			 facsimiles, maintained pursuant to this rule may be electronically maintained,
			 provided that the system creates and maintains electronic records in accordance
			 with the following:
(1)
									 All hard copy prescriptions for non-controlled
			 dangerous drugs may be electronically filed and then destroyed after one
			 hundred and eighty days from the date of creation or receipt. Disposal of the
			 hard copy shall use a secure method of destruction to ensure privacy and
			 confidentiality of the contents.
(2)
									All hard copy
			 prescriptions electronically filed in accordance with this rule shall be
			 scanned front and back in full color (i.e. retains color information and/or
			 color graphics in the document) via technology designed to capture information
			 in one form and reproduce it in an electronic medium presentable and usable to
			 an end user. Prior to scanning, the written or faxed prescription shall be
			 clearly notated to indicate it has been received by the pharmacy in a manner
			 that does not destroy any of the original information contained on the
			 prescription but prevents the unauthorized duplication of the
			 prescription.
(3)
									A record or image once created shall be unalterable but
			 may be annotated as necessary so long as the original record or image is still
			 available for review and the individual that made the annotation is
			 noted.
(4)
									The electronic form shows the exact and legible image
			 of the original hard copy prescription.
(5)
									All hard copy
			 prescriptions filed electronically in accordance with this rule shall be deemed
			 the original prescription.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								There shall be
			 positive identification of 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)
									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)
									Prospective drug utilization review, which shall be
			 captured as a standalone action or as part of either:
(a)
										 The pharmacist
			 verification of prescription information in paragraph (A)(2) of this rule;
			 or
(b)
										The dispensing process in paragraph (A)(4) of this
			 rule.
(4)
									Dispensing.
(5)
									
			 Compounding.
(6)
									Administering immunizations pursuant to section
			 4729.41 of the Revised
			 Code.
(7)
									Administering injectable drugs pursuant to section
			 4729.45 of the Revised
			 Code.
(8)
									Prescription information transcribed from an order
			 received by telephone, facsimile, or recording device.
(9)
									Any changes or
			 annotations made to a prescription.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-05 - Prescription format requirements

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 provided in paragraph (E) of this rule, no pharmacist shall dispense dangerous
			 drugs pursuant to a written outpatient prescription unless the following
			 conditions are met:
(1)
									The prescription is issued in compliance with rule
			 4729:5-5-15 of the Administrative Code.
(2)
									If handwritten,
			 typewritten, or computer-generated hard copy, there are no more than three
			 non-controlled substance prescription orders per prescription
			 form.
(3)
									If preprinted with multiple drug names or strength
			 combinations:
(a)
										There are no controlled substances among the
			 choices;
(b)
										There is only one prescription order selected per
			 form.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-06 - Labeling of drugs dispensed on prescription

Current through all regulations passed and filed through July 1, 2024
(A) No drug may be dispensed by outpatient
			 prescription unless a label is affixed to the container in which such drug is
			 dispensed, and such label includes:
(1) The
			 name or "doing business as" (DBA) name and address of the pharmacy as it
			 appears on the terminal distributor of dangerous drugs license;
(2)
									The contact phone
			 number of the dispensing pharmacy or a location where a pharmacist is employed
			 or contracted by the dispensing pharmacy who has full access to the dispensing
			 pharmacy's patient records;
(3) The full name of
			 the patient for whom the drug is prescribed; 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;
(4) The full name of
			 the prescriber or the first initial of the prescriber's first name and the full
			 last name of the prescriber;
(5) Directions for use
			 of the drug;
(6) The date of
			 dispensing;
(7) Any cautions which
			 may be required by federal or state law;
(8)
			 The serial number of the prescription;
(9) The proprietary
			 name, if any, or the generic name and the name of the distributor or national
			 drug code of the drug dispensed, and the strength, if more than one strength of
			 the drug is marketed. The dispensing pharmacist may omit the name and strength
			 of the drug only if the prescriber specifically requests omission and such
			 request is documented; and
(10) The quantity of
			 drug dispensed.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-07 - Patient profiles

Current through all regulations passed and filed through July 1, 2024
All outpatient pharmacies shall
				maintain a patient profile system which shall provide for immediate retrieval
				of information regarding those patients who have received prescriptions from
				the pharmacy.
(A)
								All patient profile systems shall maintain, at a
			 minimum, the following data:
(1)
									The patient's data record, which shall contain all the
			 following information:
(a)
										Full name 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.
(b)
										Residential
			 address, including the physical street address and telephone number of the
			 patient or owner.
(c)
										Patient's date of birth.
(d)
										Patient's
			 gender.
(e)
										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.
(f)
										The pharmacist's comments relevant to the 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 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-08 - Prospective drug utilization review

Current through all regulations passed and filed through July 1, 2024
(A) Prior to dispensing any prescription, a
			 pharmacist shall review the patient profile for the purpose of identifying the
			 following:
(1) Over-utilization or
			 under-utilization;
(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 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-09 - Patient counseling

Current through all regulations passed and filed through July 1, 2024
(A)
								A pharmacist or
			 the pharmacist's designee shall verbally offer to provide the service of
			 counseling pursuant to paragraph (B) of this rule to a patient or caregiver
			 whenever any prescription, new or refill, is dispensed. A pharmacist or
			 pharmacy intern under the personal supervision of a pharmacist shall not be
			 required to counsel a patient or caregiver when the patient or caregiver
			 refuses the offer of counseling or does not respond to the written offer to
			 counsel. If the patient or caregiver is not physically present, the offer to
			 counsel shall be made by telephone or in writing on a separate document
			 accompanying the dispensed drug or incorporated as part of documentation, in a
			 conspicuous manner, that is included with the dispensed drug. A written offer
			 to counsel shall include the hours a pharmacist is available and a telephone
			 number where a pharmacist may be reached. The telephone service must be
			 available at no cost to the pharmacy's primary patient
			 population.
(B)
								In the event a patient or caregiver accepts an offer to
			 counsel or requests counseling, a pharmacist, or a pharmacy intern under the
			 personal supervision of a pharmacist, shall counsel the patient or caregiver.
			 Such counseling may include, but is not limited to, the following:
(1)
									The name and
			 description of the drug;
(2)
									The dosage form, dose, strength, frequency, route of
			 administration, and duration of drug therapy;
(3)
									The intended use
			 of the drug and the expected action;
(4)
									Special
			 directions and precautions for preparation, administration, handling, storage,
			 disposal, and use by the patient;
(5)
									Common adverse
			 effects or interactions and therapeutic contraindications that may occur,
			 including possible methods to avoid them, and the action required if they
			 occur;
(6)
									Techniques for self-monitoring drug
			 therapy;
(7)
									Proper storage and disposal;
(8)
									Prescription
			 refill information;
(9)
									Action to be taken in the event of a missed dose;
			 and
(10)
									The pharmacist's comments relevant to the patient's
			 drug therapy, including other necessary information unique to the patient or
			 drug.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-10 - Manner of processing a prescription

Current through all regulations passed and filed through July 1, 2024
(A)
								A prescription,
			 to be valid, must be issued for a legitimate medical purpose by an individual
			 prescriber acting in the usual course of the prescriber's professional
			 practice. The responsibility for the proper prescribing is upon the prescriber,
			 but a corresponding responsibility rests with the pharmacist who dispenses the
			 prescription. An order purporting to be a prescription issued not in the usual
			 course of bona fide treatment of a patient is not a prescription and the person
			 knowingly dispensing such a purported prescription, as well as the person
			 issuing it, shall be subject to the penalties of law.
(B)
								A pharmacist
			 dispensing an outpatient prescription shall comply with the requirements of
			 this chapter, including, but not limited to, the following:
(1)
									Ensure that
			 patient information is profiled pursuant to rule 4729:5-5-07 of the
			 Administrative Code;
(2)
									Perform prospective drug utilization review pursuant to
			 rule 4729:5-5-08 of the Administrative Code; and
(3)
									Ensure that the
			 drug is labeled pursuant to rule 4729:5-5-06 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-11 - Prescription copy

Current through all regulations passed and filed through July 1, 2024
(A)
								An outpatient
			 pharmacy may send or receive copies of prescriptions in accordance with the
			 following:
(1)
									Copies of prescriptions shall be transferred only between
			 pharmacists, except as follows:
(a)
										Pharmacy interns in accordance with paragraph (G) of
			 this rule; and
(b)
										Certified pharmacy technicians in accordance with rule
			 4729:3-3-04
			 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-12 - Partial dispensing of schedule II controlled substances

Current through all regulations passed and filed through July 1, 2024
(A)
								A valid prescription for a schedule II controlled
			 substance may be partially dispensed as follows:
(1)
									 For a terminally
			 ill patient or a patient residing in a long-term care facility, compliance with
			 21 C.F.R.
			 1306.13 (03/31/2010).
(2)
									For a patient who
			 is not terminally ill or residing in a long-term care facility, the following
			 must be observed:
(a)
										The partial dispensing shall be requested by the
			 patient or the prescriber that issued the prescription;
(b)
										The total
			 quantity dispensed in all partial dispensings shall not exceed the total
			 quantity prescribed; and
(c)
										The remaining portions of a partially dispensed
			 schedule II controlled substance prescription shall be filled not later than
			 thirty days after the date on which the prescription is
			 written.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-13 - Serial numbering of prescriptions

Current through all regulations passed and filed through July 1, 2024
All outpatient prescriptions must be
				serially numbered when entered into a computer system or when dispensed under a
				manual system.
(A)
								The serial number must appear on the original
			 prescription.
(B)
								There must be a complete accounting of all numbers used
			 in the serial numbering system.
(C)
								All prescriptions
			 that cannot be refilled, either because of the dispensing of all refills or the
			 length of time since issuance, shall be assigned a new serial number upon an
			 authorization for additional dispensing by a prescriber or prescriber's
			 agent.
Replaces: 4729-5-19
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-14 - Prescription pick-up station

Current through all regulations passed and filed through July 1, 2024
(A)
								No pharmacist
			 shall accept prescriptions obtained from a place which offers, in any manner,
			 its services as a "pick-up station" or intermediary for the purpose of having
			 prescriptions filled unless such place is a pharmacy as defined in section
			 4729.01 of the Revised Code and
			 all of the following apply:
(1)
									The site is licensed as a terminal distributor of
			 dangerous drugs pursuant to Chapter 4729. of the Revised Code;
(2)
									The receipt,
			 storage, control, and distribution of prescriptions are in the full and actual
			 charge of a pharmacist licensed pursuant to Chapter 4729. of the Revised
			 Code;
(3)
									A record keeping system is in place that will provide
			 accountability for proper receipt, delivery, disposal and return of all
			 prescriptions;
(4)
									There is a documented method in place to ensure
			 compliance with rule 4729:5-5-09 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-16 - Pharmacist modifications to a prescription

Current through all regulations passed and filed through July 1, 2024
(A)
								For a schedule II
			 controlled substance prescription:
(1)
									A pharmacist shall not make changes to the drug
			 prescribed, except for substitution permitted by law, the prescriber's
			 signature, or the patient's name.
(2)
									Any other
			 modification, except for substitution permitted by law, may only be made after
			 consultation with and agreement of the prescriber.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-17 - Drugs repackaged or relabeled by a 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 outpatient 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 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 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-18 - Dispensing customized patient medication packages by an outpatient 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
				outpatient 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.
(E)
								The package must
			 include an 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.
(F)
								Dangerous drugs which have been dispensed in a
			 customized patient medication package may only be returned to stock or
			 re-dispensed in accordance with all the following:
(1)
									The drugs have
			 not been in the possession of the ultimate user; and
(2)
									The drugs have
			 not been placed in the same container with another dangerous drug (i.e. did not
			 come into direct contact with a different drug within the same
			 container).
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-19 - 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 prescription. A central fill pharmacy may also be
			 the originating pharmacy pursuant to paragraph (D) of this
			 rule.
(2)
									"Originating pharmacy" means an outpatient pharmacy
			 licensed as a terminal distributor of dangerous drugs that uses a central fill
			 pharmacy to fill or refill a prescription.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-20 - Remote outpatient prescription processing

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule:
(1)
									"Remote prescription processing" means the processing of a
			 prescription for an outpatient pharmacy licensed as a terminal distributor of
			 dangerous drugs by a remote pharmacist. Remote prescription processing does not
			 include the dispensing of a drug, but may include receiving, interpreting,
			 evaluating, clarifying and approval of prescriptions. Additionally, remote
			 prescription order processing may include order entry, other data entry,
			 performing prospective drug utilization review, interpreting clinical data,
			 performing therapeutic interventions, and providing drug information services.
			 The requirements of this rule shall be limited to the processing of outpatient
			 prescriptions dispensed in or into this state.
(2)
									"Remote pharmacy"
			 means either:
(a)
										A pharmacy licensed as a terminal distributor of
			 dangerous drugs that dispenses dangerous drugs; or
(b)
										A pharmacy
			 licensed as a limited category II terminal distributor of dangerous drugs that
			 does not stock, own, or dispense any dangerous drugs and whose sole business
			 consists of entry, review, and/or verification of prescriber orders and
			 consulting services under contract for outpatient pharmacies in this
			 state.
(3)
									"Remote pharmacist" means any of the following:
(a)
										If performing
			 remote prescription processing in this state: an Ohio licensed pharmacist,
			 either employed or a contract employee of an outpatient pharmacy or remote
			 pharmacy, who either processes prescriptions from a remote site, which may
			 include the pharmacist's residence or other location where the pharmacist and
			 the outpatient or remote pharmacy can ensure the confidentiality and integrity
			 of patient information, or on the premises of a remote pharmacy or outpatient
			 pharmacy; or
(b)
										If performing remote prescription processing outside of
			 this state: a pharmacist licensed or registered in the state where the remote
			 prescription processing is occurring, either employed or a contract employee of
			 an outpatient pharmacy or remote pharmacy who holds a nonresident pharmacy
			 license in accordance with Chapter 4729:5-8 of the Administrative Code, who
			 either processes prescriptions from a remote site, which may include the
			 pharmacist's residence or other location where the pharmacist and the
			 outpatient or remote pharmacy can ensure the confidentiality and integrity of
			 patient information, or on the premises of a remote pharmacy or outpatient
			 pharmacy.
A pharmacist shall only be permitted to
				conduct remote prescription processing within the United States, to include the
				District of Columbia, the Commonwealth of Puerto Rico or a territory or insular
				possession subject to the jurisdiction of the United States.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-22 - Return to stock in an outpatient pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule:
(1)
									"Pharmacy delivery agent" means an employee of the pharmacy,
			 United States postal service, or common or contract carrier who delivers
			 dangerous drugs that have been dispensed.
(2)
									"Psychiatric
			 outpatient facility" means a facility where psychiatric evaluation and
			 treatment is provided on an outpatient basis.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-5 - Outpatient Pharmacies › Section 4729:5-5-24 - Drug inventory records and other record keeping provisions

Current through all regulations passed and filed through July 1, 2024
(A) Records of
			 receipt shall contain the name, strength, dosage form, and quantity of the
			 dangerous drugs received, the name and address of the seller, the name and
			 address of the recipient, and the date of receipt.
(B) Temperature logs maintained in accordance
			 with paragraph (B) of rule
			 4729:5-5-23
			 of the Administrative Code shall include either:
(1) The date and time of observation, the
			 full name or the initials of the individual performing the check, and the
			 temperature recorded; or
(2) For
			 automated systems that provide temperature monitoring, either of the following:
(a) A report that provides, at a minimum, the
			 date and time of observation and the temperature recorded; or
(b) A report that provides temperature
			 excursions, if any, and the date, time, temperature recorded, and length of the
			 noted excursion.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-6 - Nuclear Pharmacies › Section 4729:5-6-02 - Applicability

Current through all regulations passed and filed through July 1, 2024
(A)
								The provisions in this chapter apply to the
			 preparation, preparation with minor deviation, compounding, dispensing, or
			 repackaging of radiopharmaceuticals for humans and animals prepared by a
			 pharmacy, including an institutional facility, licensed as a terminal
			 distributor of dangerous drugs. These standards apply to all
			 radiopharmaceuticals, including those with radionuclides that emit a single
			 photon, a positron, or a therapeutic particle, and intravascular radioactive
			 devices (e.g. radioactive microspheres).
(B)
								This chapter does
			 not apply to the preparation, preparation with minor deviation, compounding,
			 dispensing, personally furnishing, and repackaging of non-radioactive drugs,
			 including those used as pharmacologic adjuncts for certain nuclear medicine
			 procedures. These drugs shall be prepared in accordance with the applicable
			 provisions of division 4729:7 of the Administrative Code.
(C)
								Except if
			 specifically stated in this chapter, an outpatient pharmacy shall also comply
			 with Chapter 4729:5-5 of the Administrative Code.
(D)
								Except if
			 specifically stated in this chapter, an institutional pharmacy shall also
			 comply with Chapter 4729:5-9 of the Administrative Code.
(E)
								Except if
			 specifically stated in this chapter, a nonresident nuclear pharmacy shall
			 comply with the requirements of rule 4729:5-8-05 of the Administrative
			 Code.
(F)
								All terminal distributors of dangerous drugs engaged in
			 the preparation, preparation with minor deviation, compounding, dispensing, or
			 repackaging of radiopharmaceuticals for humans and animals shall comply with
			 Chapter 3701:1-58 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-6 - Nuclear Pharmacies › Section 4729:5-6-03 - Preparation, compounding, labeling, dispensing, and repackaging of radiopharmaceuticals

Current through all regulations passed and filed through July 1, 2024
(A)
								A terminal
			 distributor of dangerous drugs engaged in the preparation, compounding,
			 dispensing, or repackaging of radiopharmaceuticals for humans and animals shall
			 comply with USP <825>.
(B)
								All
			 radiopharmaceuticals shall be dispensed pursuant to a patient-specific
			 prescription issued by a licensed health professional authorized to prescribe
			 drugs.
(1)
									A
			 limited quantity may be prepared and distributed in anticipation of
			 prescriptions based on routine, regularly observed prescribing
			 patterns.
(2)
									In the event a patient's name is not available at the
			 time of dispensing, a 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 in accordance with rule
			 4729:5-6-04 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-6 - Nuclear Pharmacies › Section 4729:5-6-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								In addition to
			 the applicable record keeping requirements of division 4729:5 of the
			 Administrative Code, a terminal distributor shall maintain records in
			 compliance with USP <825> for all activities involved in repackaging,
			 preparing, preparing with minor deviations, compounding, or dispensing
			 radiopharmaceuticals.
(B)
								In addition to the requirements set forth in paragraph
			 (A) of this rule, there shall be positive identification of the authorized
			 nuclear pharmacist conducting the final check of the
			 radiopharmaceutical.
(C)
								All records maintained in accordance with this rule
			 shall be readily retrievable and uniformly maintained for at least three
			 years.
(1)
									Except as provided in paragraph (C)(2) of this rule, all
			 records maintained in accordance with this chapter shall be kept
			 on-site.
(2)
									A pharmacy located in this state intending to maintain
			 records at a location other than the location licensed by the state board of
			 pharmacy shall send a request in a manner determined by the board. The board
			 will provide written or electronic notification to the outpatient pharmacy
			 documenting the approval or denial of the request. A copy of the board's
			 approval shall be maintained at the licensed location. Any such alternate
			 location used to store records shall be secured and accessible only to
			 authorized representatives or contractors of the terminal distributor of
			 dangerous drugs.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-7 - Charitable Pharmacies › Section 4729:5-7-01 - Definitions - charitable pharmacies

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-7 of the
				Administrative Code:
(A)
								"Charitable pharmacy" means a pharmacy that meets all
			 of the following requirements:
(1)
									Holds a terminal distributor of dangerous drug license
			 issued under section 4729.54 of the Revised
			 Code;
(2)
									Is exempt from federal taxation pursuant to
			 26 U.S.C.
			 501(a) and (c)(3)
			 (5/28/2015); and
(3)
									Is not a hospital as defined in section
			 3727.01 of the Revised
			 Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-7 - Charitable Pharmacies › Section 4729:5-7-02 - Licensure, compliance, and support personnel

Current through all regulations passed and filed through July 1, 2024
(A) A pharmacy seeking authorization to be a
			 charitable pharmacy shall maintain a terminal distributor of dangerous drug
			 license. An application for licensure shall include the following:
(1) A completed terminal distributor
			 application requesting licensure as a charitable pharmacy;
(2) Documentation to support the exemption
			 from federal taxation pursuant to
			 26 U.S.C.
			 501(a) and (c)(3)
			 (5/28/2015);
(3) The fee for the
			 appropriate category of licensure; and
(4) Any other requirements set forth in
			 division 4729:5 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-7 - Charitable Pharmacies › Section 4729:5-7-03 - Persons eligible to transfer sample drugs to a charitable pharmacy

Current through all regulations passed and filed through July 1, 2024
(A) An eligible
			 sample drug shall only be transferred directly to a charitable pharmacy by any
			 of the following:
(1) A manufacturer licensed
			 in accordance with section
			 4729.52 of the Revised Code,
			 including a representative of the manufacturer;
(2) A person licensed in accordance with
			 section 4729.52 of the Revised Code
			 acting on behalf of a manufacturer; or
(3) A prescriber practicing at a location
			 that is licensed as a terminal distributor of dangerous drugs, unless exempt
			 from licensure pursuant to section
			 4729.541 of the Revised
			 Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-7 - Charitable Pharmacies › Section 4729:5-7-04 - Eligibility requirements for sample drugs received by a charitable pharmacy

Current through all regulations passed and filed through July 1, 2024
An eligible sample drug received by a
				charitable pharmacy shall meet all the following requirements:
(A)
								The sample drug
			 is in the original manufacturer's container and the container is clearly marked
			 as a sample.
(B)
								Prior to being transferred, the sample drug has been
			 stored under the proper conditions to prevent deterioration or
			 adulteration.
(C)
								The sample drug is clearly marked with an expiration
			 date and lot number.
(D)
								The sample drug is not expired.
(E)
								The sample drug
			 is not a controlled substance.
Replaces: 4729-36-05
Effective: 7/1/2019
Five Year Review
				(FYR) Dates: 07/01/2024
Promulgated Under:
				119.03
Statutory
				Authority: 3719.28,
				4729.26,
				3719.811
Rule
				Amplifies: 3719.81,
				3719.811,
				3719.812,
				3719.813
Prior
				Effective Dates: 01/01/2006