reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-2 › Section 4729:7-2-03 - Drugs compounded in a pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)  For all non-sterile compounded drug preparations, the
				pharmacy shall comply with United States pharmacopeia chapter <795>. This
				paragraph does not apply to non-sterile compounded preparations exempted from
				the requirements of this chapter in accordance with paragraph (C) of rule 4729:7-2-01 of  the Administrative Code.
(B)  For all sterile compounded drug preparations, the pharmacy
				shall comply with United States pharmacopeia chapter <797>. This
				paragraph does not apply to sterile compounded drugs exempted from the
				requirements of this chapter in accordance with rule 4729:7-2-02 of  the Administrative Code.
(C)  For all antineoplastic compounded hazardous drug
				preparations 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, the pharmacy shall comply with United States pharmacopeia chapter <800>.
(D)  For all non-antineoplastic compounded hazardous drug
				preparations 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 and for all compounded hazardous drug preparations listed in table two or three 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, the pharmacy shall comply with either:
(1)  United States pharmacopeia chapter <800>; or
(2)  All the following:
(a)  Conduct a risk assessment for any hazardous drug
				preparations listed in paragraph (D) of this rule to determine if any
				additional containment strategies, work practices, and/or training is required
				to minimize occupational exposure. Risk assessments shall be made readily
				retrievable for review by an agent, inspector or employee of the state board of
				pharmacy. The risk assessment must be reviewed at least every twelve months and
				the review documented. If a risk assessment is not performed, the compounded
				drug preparations shall be prepared in accordance with paragraph (D)(1) of this
				rule. The risk assessment must, at a minimum, consider the following:
(i)  Type of hazardous drug (e.g., non-antineoplastic or
				reproductive risk only);
(ii)  Dosage form;
(iii)  Risk of exposure;
(iv)  Packaging; and
(v)  Manipulation.
(b)  Ensure that any employees of reproductive capability
				confirm in writing that they understand the potential risks of handling drugs
				listed in paragraph (D) of this rule.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-2 › Section 4729:7-2-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								In addition to the pharmacy record keeping requirements
			 of agency 4729 of the Administrative Code, a pharmacy shall maintain records of
			 all drugs compounded that include, at a minimum, all the following:
(1)
									The name of the
			 patient;
(2)
									Name of drug, strength or activity, and dosage
			 form;
(3)
									Assigned internal identification number (e.g.,
			 prescription, order, lot number);
(4)
									Date and time of
			 preparation;
(5)
									Name of each ingredient;
(6)
									Vendor, lot
			 number, and expiration date for each ingredient for compounded drug
			 preparations prepared for more than one patient and for any sterile compounded
			 product prepared from nonsterile ingredient(s);
(7)
									Weight or volume
			 of each ingredient;
(8)
									Total quantity compounded;
(9)
									The disposition
			 of unused controlled substances drug(s) and amount;
(10)
									Assigned
			 beyond-use date;
(11)
									The positive identification of the following:
(a)
										The pharmacy
			 personnel responsible for preparing the compounded drug
			 preparation;
(b)
										The pharmacist conducting the final check of the
			 compounded drug preparation; and
(c)
										The pharmacist
			 who dispenses the compounded drug preparation.
(12)
									All other drug
			 compounding records as required by USP 795, USP 797, and USP
			 800.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-2 › Section 4729:7-2-05 - Drugs compounded for veterinarian office use

Current through all regulations passed and filed through July 1, 2024
(A)
								This rule only
			 applies to compounded drugs intended for animal use by licensed
			 veterinarians.
(B)
								Pharmacies located in Ohio shall comply with the
			 applicable compounding requirements of this chapter.
(C)
								Pharmacies
			 licensed as nonresident terminal distributors shall comply with the applicable
			 requirements of rule 4729:5-8-04 of the Administrative Code.
(D)
								In accordance
			 with applicable federal laws and regulations, a pharmacy licensed as a terminal
			 distributor of dangerous drugs may sell, without a prescription, a non-patient
			 specific compounded drug pursuant to a request made by a veterinarian, or by an
			 agent of the veterinarian, for a drug to be used by the veterinarian for the
			 purpose of the direct administration to patients in the course of the
			 veterinarian's practice pursuant to division (C)(5) of section
			 4729.01
			 of the Revised Code and all the following:
(1)
									The pharmacy
			 shall only provide compounded drug preparations that are not commercially
			 available, as defined in division (C)(5) of section
			 4729.01
			 of the Revised Code, to a veterinarian for any of the following reasons:
(a)
										To treat an
			 emergency situation;
(b)
										For an unanticipated procedure or treatment for which a
			 time delay would negatively affect a patient outcome; or
(c)
										For diagnostic
			 purposes.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-02 - Exemptions

Current through all regulations passed and filed through July 1, 2024
(A)
								Licensing exemptions.
Persons listed in divisions (A)(1) to
				(A)(3) of section
				4729.541
				of the Revised Code shall be exempted from licensure as a terminal distributor
				of dangerous drugs as required in division (D)(1) of section
				4729.541
				of the Revised Code for any of the following:
(1)
									The preparation
			 of a device, as defined in Title 21 U.S. Code section 321 (12/13/2016),
			 containing dangerous drugs strictly in accordance with the manufacturer's
			 labeling for administration and beyond-use dating.
(2)
									The preparation
			 or reconstitution of non-hazardous, conventionally manufactured sterile
			 dangerous drug products for direct administration with no intervening steps in
			 accordance with the manufacturer's labeling for preparation, administration and
			 beyond-use dating.
(3)
									The compounding, preparation, dilution or
			 reconstitution of non-hazardous, non-sterile dangerous drug
			 preparations.
(4)
									The possession of compounded dangerous drug
			 preparations provided by an outsourcing facility.
(5)
									The dilution of
			 non-hazardous, conventionally manufactured sterile dangerous drug products
			 (e.g., diluting or mixing into a syringe to administer directly to the
			 patient).
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-03 - Non-hazardous drugs compounded by a prescriber

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 provided in paragraph (L) of this rule, all non-hazardous, non-sterile
			 compounded drug preparations shall be prepared in accordance with United States
			 pharmacopeia chapter <795>.
(B)
								Except as
			 provided in paragraph (C) of this rule, all non-hazardous, sterile compounded
			 drug preparations, shall be prepared in accordance with United States
			 pharmacopeia chapter <797>.
(C)
								For all
			 immediate-use, non-hazardous sterile compounded drug preparations, a prescriber
			 shall comply with either:
(1)
									Rule 4729:7-3-04 of the Administrative Code;
			 or
(2)
									United States pharmacopeia chapter
			 <797>.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-04 - Immediate-use, sterile non-hazardous drugs compounded by a prescriber

Current through all regulations passed and filed through July 1, 2024
(A)
								The responsible person of a facility where a prescriber
			 is engaged in the compounding of immediate-use, sterile non-hazardous dangerous
			 drug preparations in accordance with paragraph (B) of this rule shall be
			 responsible for all the following:
(1)
									Developing and implementing appropriate compounding
			 procedures;
(2)
									Overseeing facility compliance with this
			 rule;
(3)
									Compliance with Title 21 U.S.C. section 353a
			 (11/27/2013) and all other applicable federal and state laws, regulations and
			 rules;
(4)
									Ensuring training and competency of compounding
			 personnel;
(5)
									Ensuring that compounded drug preparations maintain
			 quality and sterility until administered;
(6)
									Maintaining drug
			 compounding records pursuant to rule
			 4729:7-3-06 of the
			 Administrative Code;
(7)
									The proper maintenance, cleanliness, and use of all
			 equipment used in compounding; and
(8)
									Ensuring aseptic
			 technique for the preparation of all sterile compounded drugs.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-05 - Hazardous drugs compounded by a prescriber

Current through all regulations passed and filed through July 1, 2024
(A)
								The responsible
			 person of a facility where a prescriber is engaged in the compounding or
			 handling of hazardous dangerous drugs shall be responsible for all of the
			 following:
(1)
									Developing and implementing appropriate compounding policies
			 and procedures;
(2)
									Overseeing facility compliance with this
			 rule;
(3)
									Compliance with Title 21 U.S. Code section 353a
			 (November 27, 2013) and all other applicable federal and state laws,
			 regulations and rules;
(4)
									Ensuring training and competency of compounding
			 personnel;
(5)
									Ensuring environmental control of the compounding
			 areas;
(6)
									Ensuring that compounded drug preparations maintain
			 quality and sterility until administered or personally
			 furnished;
(7)
									Ensuring appropriate equipment cleaning and disposal of
			 all hazardous drug waste;
(8)
									All drug compounding records pursuant to rule
			 4729:7-3-06 of the Administrative Code;
(9)
									The proper
			 maintenance, cleanliness, and use of all equipment used in compounding;
			 and
(10)
									Ensuring aseptic technique for the preparation of all
			 sterile compounded drugs.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-06 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								The responsible
			 person shall maintain the following records relating to the compounding of
			 dangerous drugs:
(1)
									All drug orders and records, including logs, relating
			 to the compounding of drugs. Such drug orders and records may be retained by
			 any process providing an exact duplicate of the original order or
			 prescription.
(2)
									All records maintained pursuant to this rule may be
			 electronically created and maintained, provided that the system that creates
			 and maintains the electronic record does so in accordance with the
			 following:
(a)
										Complies with the requirements of this rule;
(b)
										All paper records
			 shall be scanned in full color via technology designed to capture information
			 and reproduce it in an electronic medium presentable and usable to an end
			 user;
(c)
										Contains security features, such as unique user names
			 and passwords, to prevent unauthorized access; and
(d)
										Contains daily
			 back-up functionality to protect against record loss.
(3)
									Records of each
			 drug compounded shall, at a minimum, include all the following:
(a)
										The full name of
			 the patient, unless compounded in accordance with paragraph (G)(2) of rule
			 4729:7-3-04 of the Administrative Code;
(b)
										Name, strength,
			 and dosage form of the compounded drug;
(c)
										Name and quantity
			 of each ingredient;
(d)
										If a controlled substance, the disposition of unused
			 drug(s) and amount;
(e)
										Date and time of preparation;
(f)
										Beyond-use date
			 of the compounded drug;
(g)
										The positive identification of the personnel
			 responsible for compounding the drug;
(h)
										The positive
			 identification of either of the following:
(i)
											Person or persons
			 performing medication validation prior to the compounded drug being
			 administered; or
(ii)
											The prescriber personally furnishing the compounded
			 drug.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-07 - Pharmacists conducting medication validation

Current through all regulations passed and filed through July 1, 2024
(A)
								Notwithstanding
			 any provision of this chapter of the Administrative Code, a prescriber may
			 delegate a pharmacist to perform medication validation ("final check") of a
			 finished compounded drug preparation prior to it being administered to a
			 patient.
(B)
								A pharmacist performing medication validation in
			 accordance with paragraph (A) of this rule shall comply with the record keeping
			 provisions of rule
			 4729:7-3-06 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-1 - Definitions › Section 4729:8-1-01 - Ohio automated Rx reporting system - definitions

Current through all regulations passed and filed through July 1, 2024
As used in division 4729:8 of the
				Administrative Code:
(A)
								"Controlled substance" has the same meaning as in
			 section 3719.01 of the Revised
			 Code.
(B)
								"Distributor of dangerous drugs" or "drug distributor"
			 means the following persons licensed in accordance with section
			 4729.52 of the Revised Code and
			 division 4729:6 of the Administrative Code:
(1)
									Wholesale
			 distributors of dangerous drugs, including virtual wholesalers.
(2)
									Manufacturers of
			 dangerous drugs.
(3)
									Outsourcing facilities.
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-2 - Drugs Required to be Reported to Ohio Automated Rx Reporting System (OARRS) › Section 4729:8-2-01 - List of drugs to be reported

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				4729.75 of the Revised Code, the
				required information for the following drugs pursuant to an outpatient
				prescription, personally furnished by a prescriber, or sold at wholesale to a
				terminal distributor of dangerous drugs shall be submitted to the state board
				of pharmacy pursuant to sections
				4729.77,
				4729.78 and
				4729.79 of the Revised Code and
				this division of the Administrative Code:
(A)
								All schedule II
			 controlled substances;
(B)
								All schedule III controlled substances;
(C)
								All schedule IV
			 controlled substances;
(D)
								All schedule V controlled substances.
Replaces: 4729-37-02
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-2 - Drugs Required to be Reported to Ohio Automated Rx Reporting System (OARRS) › Section 4729:8-2-02 - Additional drugs to be reported

Current through all regulations passed and filed through July 1, 2024
(A)
								Pursuant to
			 section 4729.75 of the Revised Code, the
			 required information for the following drugs pursuant to an outpatient
			 prescription, personally furnished by a prescriber, or sold at wholesale to a
			 prescriber or terminal distributor of dangerous drugs shall be submitted to the
			 state board of pharmacy in accordance with sections
			 4729.77,
			 4729.78 and
			 4729.79 of the Revised Code and
			 this division of the Administrative Code:
All dangerous drug products containing
				gabapentin.
(B)
								Pursuant to section
			 4729.75 of the Revised Code, the
			 required information for the following drugs pursuant to an outpatient
			 prescription shall be submitted to the state board of pharmacy in accordance
			 with section 4729.77 of the Revised Code and
			 this division of the Administrative Code:
All dangerous drug products containing
				naltrexone that are indicated for the treatment of alcohol dependence or the
				prevention of relapse to opioid dependence.
Replaces: 4729-37-12
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-3 - Requirements for Drug Databases › Section 4729:8-3-01 - Entities required to submit information

Current through all regulations passed and filed through July 1, 2024
The following entities are required to
				submit the specified dispensing, personal furnishing, or wholesale sale
				information in accordance with this chapter of the Administrative Code to the
				state board of pharmacy for the operation of the drug database:
(A)
								All pharmacies
			 located within this state and licensed as a terminal distributor of dangerous
			 drugs shall report all drugs listed in Chapter 4729:8-2 of the Administrative
			 Code that are dispensed to outpatients.
(B)
								All pharmacies
			 located outside this state and licensed as a terminal distributor of dangerous
			 drugs shall report all drugs listed in Chapter 4729:8-2 of the Administrative
			 Code that are dispensed to outpatients residing in this state.
(C)
								Except as
			 provided in rule
			 4729:8-2-02
			 of the Administrative Code, all licensed drug distributors and terminal
			 distributors of dangerous drugs located within this state that sell at
			 wholesale drugs listed in Chapter 4729:8-2 of the Administrative Code to
			 prescribers or terminal distributors of dangerous drugs shall report those drug
			 transactions in accordance with the wholesale reporting requirements of this
			 chapter.
(D)
								Except as provided in rule
			 4729:8-2-02
			 of the Administrative Code, all licensed drug distributors and terminal
			 distributors of dangerous drugs located outside this state that sell at
			 wholesale drugs listed in Chapter 4729:8-2 of the Administrative Code to
			 prescribers or terminal distributors of dangerous drugs located within this
			 state shall report those drug transactions in accordance with the wholesale
			 reporting requirements of this chapter.
(E)
								Except as
			 provided in rule
			 4729:8-2-02
			 of the Administrative Code, all prescribers, except veterinarians, located
			 within this state shall report all drugs listed in Chapter 4729:8-2 of the
			 Administrative Code that are personally furnished to patients.
Replaces: 4729-37-03
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-3 - Requirements for Drug Databases › Section 4729:8-3-03 - Electronic format required for the transmission of drug sales

Current through all regulations passed and filed through July 1, 2024
(A)
								All prescription dispensing information or prescriber
			 personally furnishing information required to be submitted to the board of
			 pharmacy pursuant to rule 4729-8-3-02 of the Administrative Code must be
			 transmitted in the following format specified by the "American Society for
			 Automation in Pharmacy" (ASAP) for prescription monitoring programs:
ASAP Version 4.2 A Standard for
				Prescription Drug Monitoring Programs (3/15/2017).
(B)
								In the event that
			 a pharmacy or a prescriber cannot electronically transmit the required
			 information pursuant to paragraph (A) of this rule, the pharmacy or prescriber
			 may request a variance from the board's executive director or the director's
			 designee to submit drug sales information in a mutually acceptable
			 format.
(C)
								All wholesale data required to be submitted to the
			 board of pharmacy pursuant to rule 4729-8-3-02 of the Administrative Code shall
			 be transmitted in the report format used when transmitting controlled substance
			 data to the federal drug enforcement administration via the "Automation of
			 Reports and Consolidated Orders System (ARCOS)" or other mutually acceptable
			 format.
(D)
								In the event that a drug distributor or terminal
			 distributor cannot electronically transmit the required information pursuant to
			 paragraph (C) of this rule, the drug distributor or terminal distributor may
			 request a variance from the board's executive director or the director's
			 designee to submit drug sales information in a mutually acceptable
			 format.
Replaces: 4729-37-05, 4729-37-06
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-3 - Requirements for Drug Databases › Section 4729:8-3-04 - Frequency requirements for submitting drug database

Current through all regulations passed and filed through July 1, 2024
(A)
								A terminal distributor or prescriber that has been in
			 possession of a drug listed in Chapter 4729:8-2 of the Administrative Code for
			 dispensing or personally furnishing within the previous three years shall
			 submit to the board of pharmacy, at least daily, either of the following:
(1)
									All information
			 required to be submitted to the board of pharmacy pursuant to this division of
			 the Administrative Code.
(2)
									A zero report, if a terminal distributor has no drug
			 dispensing information or a prescriber has no personally furnishing information
			 required to be submitted to the board of pharmacy pursuant to this division of
			 the Administrative Code.
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-3 - Requirements for Drug Databases › Section 4729:8-3-05 - Corrections to the drug database

Current through all regulations passed and filed through July 1, 2024
(A)
								All information
			 required to be submitted in accordance with this division shall be submitted to
			 the drug database in an accurate and timely manner.
(B)
								If the omission
			 of drug sale information is discovered, the omitted information shall be
			 submitted to the board of pharmacy by the terminal distributor, prescriber, or
			 drug distributor during the next reporting time period after the
			 discovery.
(C)
								If erroneous drug sale information is discovered, the
			 terminal distributor, drug distributor or prescriber shall notify the board of
			 pharmacy within twenty-four hours of the discovery. The corrected information
			 must be submitted to the board of pharmacy by the terminal distributor,
			 prescriber or drug distributor within seven days of the
			 discovery.
(D)
								If the omission of data or erroneous data is the result
			 of a computer programming error, the terminal distributor, prescriber, or drug
			 distributor must notify the board of pharmacy immediately by telephone and
			 submit written or electronic documentation. The documentation shall fully
			 describe the error and propose a mutually agreed upon date for submitting the
			 corrected information.
(E)
								Except as noted in paragraph (D) of this rule, all data
			 must be submitted or corrected electronically unless prior permission for an
			 alternate method is granted by the board's executive director or the director's
			 designee.
Replaces: 4729-37-11
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-4 - Access and Statistics of Drug Database Information › Section 4729:8-4-01 - Procedures for obtaining drug database information and access by peer review committees

Current through all regulations passed and filed through July 1, 2024
(A)
								Persons that are
			 permitted pursuant to section
			 4729.80 of the Revised Code to
			 obtain information from the drug database shall comply with all application
			 procedures, requirements and acceptable use policies adopted by the
			 board.
(B)
								An individual seeking the individual's own database
			 information shall comply with the following:
(1)
									Complete a
			 notarized request form giving such information as required by the board of
			 pharmacy;
(2)
									Submit the completed form in person or by
			 mail;
(3)
									Receive the information in person at the board of
			 pharmacy office during normal business hours and show proof of identity with a
			 current government issued form of identification that contains a picture such
			 as a current state issued identification card, a current state issued driver's
			 license, or a valid passport; and
(4)
									The person may be
			 required to pay the cost of printing the document as determined by the board of
			 pharmacy's current per page rate.
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-4 - Access and Statistics of Drug Database Information › Section 4729:8-4-02 - Extension to the information storage requirements and the provision of database statistics

Current through all regulations passed and filed through July 1, 2024
(A)
								A government
			 entity or a law enforcement agency pursuant to section
			 4729.82 of the Revised Code may
			 request that specific information in the database related to an open
			 investigation be retained beyond the five-year information retention
			 requirement. The government entity or law enforcement agency must submit a
			 written request on a form giving such information as required by the board of
			 pharmacy.
(B)
								The board of pharmacy may provide or present database
			 statistics and law enforcement outcomes based on request information pursuant
			 to section 4729.80 of the Revised Code. The
			 information shall not identify a person and will be provided as determined by
			 the board of pharmacy in summary, statistical, or aggregate form.
Replaces: 4729-37-09, 4729-37-10
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-4 - Access and Statistics of Drug Database Information › Section 4729:8-4-03 - Access to opioid treatment program data provided by the Ohio department of mental health and addiction services

Current through all regulations passed and filed through July 1, 2024
(A)
								Pursuant to
			 division (A)(23) of section
			 4729.80
			 of the Revised Code, the following persons shall be permitted to access opioid
			 treatment program data provided by the Ohio Department of Mental Health and
			 Addiction Services in accordance with section
			 4729.772
			 of the Revised Code:
(1)
									Prescriber and prescriber delegates as authorized in
			 division (A)(5) of section
			 4729.80
			 of the Revised Code;
(2)
									Pharmacist and pharmacist delegates as authorized in
			 division (A)(6) of section
			 4729.80
			 of the Revised Code;
(3)
									The director of health as authorized in division
			 (A)(13) of section
			 4729.80
			 of the Revised Code;
(4)
									An individual listed in division (A)(5) or (A)(6) of
			 section
			 4729.80
			 who is from or participating with another state's prescription monitoring
			 program; and
(5)
									A coroner, deputy coroner, or coroner's delegate as
			 authorized in division (A)(17) of section
			 4729.80
			 of the Revised Code.
Ohio Administrative Code › Title 4729:8 - Drug Distributors › Chapter 4729:8-5 - Dispensary Reporting into the Prescription Monitoring Program › Section 4729:8-5-01 - Dispensary reporting into the prescription monitoring program

Current through all regulations passed and filed through July 1, 2024
(A)
								Pursuant to section
			 4729.771 of the Revised Code, a
			 dispensary licensed in accordance with Chapter 3796. of the Revised Code shall
			 transmit electronically to the state board of pharmacy, in a format suitable to
			 the board, the information set forth in this rule within five minutes of the
			 dispensing of any and all medical marijuana:
(1)
									State license
			 number, which shall be populated by a number provided by the department of
			 commerce;
(2)
									Dispensary name;
(3)
									Dispensary
			 address;
(4)
									Dispensary telephone number;
(5)
									Patient full
			 name;
(6)
									Patient registry identification number;
(7)
									Patient
			 residential address;
(8)
									Patient telephone number;
(9)
									Patient date of
			 birth;
(10)
									Patient gender;
(11)
									Recommending
			 physician's full name (first name and last name);
(12)
									Drug enforcement
			 administration physician identification number;
(13)
									Date
			 recommendation was issued by the recommending physician;
(14)
									Indication
			 whether the recommendation is new or a refill;
(15)
									Number of the
			 refill being dispensed;
(16)
									Date order filled, which shall be the date medical
			 marijuana is dispensed;
(17)
									Order number, which shall be the serial number assigned
			 to each medical marijuana product dispensed to a patient;
(18)
									Quantity;
(19)
									Days
			 supply;
(20)
									Product identifier, which shall be assigned by the
			 department of commerce;
(21)
									Date order written, which shall be the date the written
			 recommendation was issued;
(22)
									Payment code for
			 either cash or third-party provider; and
(23)
									Drug name, which
			 shall be the brand name of the medical marijuana.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-1 - Controlled Substance Schedules › Section 4729:9-1-01 - Schedule I controlled substances

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				3719.41 of the Revised Code,
				controlled substance schedule I is hereby established, which schedules include
				the following, subject to amendment pursuant to section
				3719.43 or
				3719.44 of the Revised
				Code.
(A) As used in this rule:
(1) "Synthetic" unless specifically excepted
			 or unless listed in another schedule, means any substance, material, compound,
			 mixture, or preparation that contains any quantity of a substance made
			 artificially by chemical reaction.
(2) "Pharmacophore" means the portion of a
			 chemical structure that confers the activity of the substance.
(3) "A report from an established forensic
			 laboratory" means a laboratory report from the bureau of criminal
			 identification and investigation, or a laboratory operated by another law
			 enforcement agency, or a laboratory established by or under the authority of an
			 institution of higher education that has its main campus in this state and that
			 is accredited by the association of American universities or the north central
			 association of colleges and secondary schools, primarily for the purpose of
			 providing scientific services to law enforcement agencies and signed by the
			 person performing the analysis as defined in division (A) of section
			 2925.51 of the Revised
			 Code.
(4) "Synthetic cannabinoids"
			 are drugs commonly found in herbal incense products (common names include but
			 are not limited to: spice, blaze, devil's advocate, genie, smoke, sense, zohai,
			 spike 99, and K2) that may mimic the effects of delta-9-tetrahydrocannabinol
			 (THC), an active central nervous system constituent compound of
			 marijuana.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-1 - Controlled Substance Schedules › Section 4729:9-1-02 - Schedule II controlled substances

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				3719.41 of the Revised Code,
				controlled substance schedule II is hereby established, which schedules include
				the following, subject to amendment pursuant to section
				3719.43 or
				3719.44 of the Revised
				Code.
(A)
								Narcotics-opium and opium derivatives
Unless specifically excepted under
				federal drug abuse control laws or unless listed in another schedule, any of
				the following substances whether produced directly or indirectly by extraction
				from substances of vegetable origin, independently by means of chemical
				synthesis, or by a combination of extraction and chemical
				synthesis:
(1)
									Opium and opiate, and any salt, compound, derivative,
			 or preparation of opium or opiate excluding apomorphine, thebaine-derived
			 butorphanol, dextrorphan, nalbuphine, naldemedine, nalmefene, naloxegol,
			 naloxone, and naltrexone, and their respective salts, but including the
			 following:
(a)
										Raw opium;
(b)
										Opium
			 extracts;
(c)
										Opium fluid extracts;
(d)
										Powdered
			 opium;
(e)
										Granulated opium;
(f)
										Tincture of
			 opium;
(g)
										Codeine;
(h)
										Dihydroetorphine;
(i)
										Ethylmorphine;
(j)
										Etorphine
			 hydrochloride;
(k)
										Hydrocodone;
(l)
										Hydromorphone;
(m)
										Metopon;
(n)
										Morphine;
(o)
										Noroxymorphone;
(p)
										Oripavine;
(q)
										Oxycodone;
(r)
										Oxymorphone;
(s)
										Thebaine.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-1 - Controlled Substance Schedules › Section 4729:9-1-03 - Schedule III controlled substances

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				3719.41 of the Revised Code,
				controlled substance schedule III is hereby established, which schedules
				include the following, subject to amendment pursuant to section
				3719.43 or
				3719.44 of the Revised
				Code.
(A) Stimulants
Unless specifically excepted under federal drug abuse control
				laws or unless listed in another schedule, any material, compound, mixture, or
				preparation that contains any quantity of the following substances having a
				stimulant effect on the central nervous system, including their salts, their
				optical isomers, position isomers, or geometric isomers, and salts of these
				isomers, whenever the existence of these salts, isomers, and salts of isomers
				is possible within the specific chemical designation:
(1) All stimulant compounds, mixtures, and
			 preparations included in schedule III pursuant to the federal drug abuse
			 control laws and regulations adopted under those laws;
(2) Benzphetamine;
(3) Chlorphentermine;
(4) Clortermine
(5) Phendimetrazine.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-1 - Controlled Substance Schedules › Section 4729:9-1-04 - Schedule IV controlled substances

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				3719.41 of the Revised Code,
				controlled substance schedule IV is hereby established, which schedules include
				the following, subject to amendment pursuant to section
				3719.43 or
				3719.44 of the Revised
				Code.
(A)
								Narcotic drugs
Unless specifically excepted by federal
				drug abuse control laws or unless listed in another schedule, any material,
				compound, mixture, or preparation that contains any of the following narcotic
				drugs, or their salts calculated as the free anhydrous base or alkaloid, in
				limited quantities set forth as follows:
(1)
									Not more than one
			 milligram of difenoxin and not less than twenty-five micrograms of atropine
			 sulfate per dosage unit;
(2)
									Dextropropoxyphene
			 (alpha-(+)-4-dimethylamino-1,2-diphenyl-3-methyl-2-propionoxybutane)[final
			 dosage forms];
(3)
									2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)cyclohexanol,
			 its salts, optical and geometric isomers and salts of these isomers (including
			 tramadol).
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-1 - Controlled Substance Schedules › Section 4729:9-1-05 - Schedule V controlled substances

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				3719.41 of the Revised Code,
				controlled substance schedule V is hereby established, which schedules include
				the following, subject to amendment pursuant to section
				3719.43 or
				3719.44 of the Revised
				Code.
(A)
								Narcotics-narcotic preparations
Narcotic drugs containing non-narcotic
				active medicinal ingredients. Any compound, mixture, or preparation that
				contains any of the following narcotic drugs, or their salts calculated as the
				free anhydrous base or alkaloid, in limited quantities as set forth below, and
				that includes one or more nonnarcotic active medicinal ingredients in
				sufficient proportion to confer upon the compound, mixture, or preparation
				valuable medicinal qualities other than those possessed by narcotic drugs
				alone:
(1)
									Not more than two hundred milligrams of codeine per one
			 hundred milliliters or per one hundred grams;
(2)
									Not more than one
			 hundred milligrams of dihydrocodeine per one hundred milliliters or per one
			 hundred grams;
(3)
									Not more than one hundred milligrams of ethylmorphine
			 per one hundred milliliters or per one hundred grams;
(4)
									Not more than 2.5
			 milligrams of diphenoxylate and not less than twenty-five micrograms of
			 atropine sulfate per dosage unit;
(5)
									Not more than one
			 hundred milligrams of opium per one hundred milliliters or per one hundred
			 grams;
(6)
									Not more than 0.5 milligram of difenoxin and not less
			 than twenty-five micrograms of atropine sulfate per dosage
			 unit.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-2 - Pharmaceutical Reference Manual › Section 4729:9-2-01 - Standard pharmaceutical reference manual

Current through all regulations passed and filed through July 1, 2024
All editions, with cumulative changes,
				if any, of the following reference works are recognized and approved by the
				state board of pharmacy pursuant to section
				2925.01 of the Revised
				Code:
(A)
								 "Drug Facts and Comparisons";
(B)
								 "Martindale: The
			 Extra Pharmacopoeia";
(C)
								 "Remington's Pharmaceutical Sciences";
(D)
								 "United States
			 Dispensatory";
(E)
								 "United States Pharmacopeia/National Formulary
			 (USP/NF)";
(F)
								 "American Hospital Formulary Service Drug Information
			 (AHFS Drug Information)";
(G)
								 A controlled substance reference table compiled by the
			 state board of pharmacy using any of the reference works listed in this rule.
			 This table shall be made available on the board's web site (
www.pharmacy.ohio.gov
).
Replaces: 4729-11-07
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-01 - Definition of ephedrine

Current through all regulations passed and filed through July 1, 2024
Ephedrine is a -[-(Methylamino)ethyl]benzene-methanol;
				a-[1-(methylamino) ethyl]benzyl alcohol; 2-methylamino-1-phenyl-1-propanol;
				1-phenyl-1-hydroxy-2-methylaminopropane; 1-phenyl-2- methylaminopropanol; a -
				hydroxy-B-methylaminopropylbenzene; a product which occurs in the Chinese herb
				Ma Huang (Ephedra vulgaris, Ephedra sinica Stapf., Ephedra equisetina Bunge,
				Gnetaceae) and in several other Ephedra spp. Isomeric forms include d- and
				l-ephedrine as well as dand l-pseudoephedrine with l-ephedrine and
				d-pseudoephedrine as the naturally occurring isomers.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-02 - Licensure

Current through all regulations passed and filed through July 1, 2024
(A)
								Any person who manufactures, sells at wholesale or
			 retail, dispenses, imports or exports products containing ephedrine, its salts
			 or isomers, or who proposes to engage in such activities, shall submit an
			 application for the appropriate category III license in accordance with section
			 4729.52 of the Revised Code or
			 section 4729.54 of the Revised Code to
			 conduct such activities in accordance with Chapters 3719. and 4729. of the
			 Revised Code.
(B)
								This rule does not apply if the ephedrine product is a
			 food product or a dietary supplement that is specifically excepted in division
			 (K)(2) of section 3719.44 of the Revised Code or
			 agency 4729 of the Administrative Code.
Replaces: 4729-12-02
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-03 - Security, storage, and sale

Current through all regulations passed and filed through July 1, 2024
(A) Schedule V products containing ephedrine
			 may be sold at wholesale or retail, and must be maintained in accordance with
			 Chapters 3719. and 4729. of the Revised Code and agency 4729 of the
			 Administrative Code.
(B) This rule
			 does not apply if the ephedrine product is a food product or a dietary
			 supplement that is specifically excepted in division (K)(2) of section
			 3719.44 of the Revised Code or
			 agency 4729 of the Administrative Code.
Replaces: 4729-12-03
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-04 - Inventory

Current through all regulations passed and filed through July 1, 2024
(A)
								 A licensee who possesses any quantity of ephedrine or
			 schedule V dangerous drug products containing ephedrine shall take an inventory
			 pursuant to rule
			 4729:5-3-07
			 or
			 4729:6-3-06
			 of the Administrative Code.
(B)
								 This rule does
			 not apply if the ephedrine product is a food product or a dietary supplement
			 that is specifically excepted in division (K)(2) of section
			 3719.44 of the Revised Code or
			 agency 4729 of the Administrative Code.
Replaces: 4729-12-04
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-05 - Records

Current through all regulations passed and filed through July 1, 2024
(A) All licensees
			 required to keep records pursuant to Chapter 3719. of the Revised Code and
			 agency 4729 of the Administrative Code shall maintain such records for
			 ephedrine and schedule V drug products containing ephedrine.
(B) This rule does not apply if the ephedrine
			 product is a food product or a dietary supplement that is specifically excepted
			 in division (K)(2) of section
			 3719.44 of the Revised Code or
			 agency 4729 of the Administrative Code.
Replaces: 4729-12-05
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-06 - Petitions for exception of ephedrine-containing products

Current through all regulations passed and filed through July 1, 2024
(A)
								 A petition requesting that a drug product containing
			 ephedrine be excepted by the board of pharmacy from being legally classified as
			 a schedule V controlled substance stimulant may be submitted by any person
			 engaged in the legitimate manufacture or wholesale sale of such products in the
			 United States. The petition shall include the following information:
(1)
									 Full name,
			 address, and telephone number of the manufacturer.
(a)
										 If incorporated,
			 the petition must include copies of the incorporation papers and the names,
			 dates of birth, addresses, and social security numbers of the officers of the
			 corporation and all stockholders holding more than ten percent of the
			 corporation's stock.
(b)
										 If a proprietorship, the petition must include the
			 name, address, date of birth, and social security number of the
			 owner(s).
(c)
										 If a partnership, the petition must include the names,
			 addresses, dates of birth, and social security numbers of the
			 partners.
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-07 - Exceptions

Current through all regulations passed and filed through July 1, 2024
Each of the following products
				containing ephedrine, its salts, its isomers, or the salts of its isomers is
				excepted from classification as a schedule V controlled substance:
(A)
								 All products
			 that contain the isomer known as pseudoephedrine or its salts, but do not also
			 contain any of the isomer known as ephedrine or its salts.
(B)
								 "Breathe
			 Easy®;" herb tea.
(C)
								 "Bronkaid® Dual Action" caplets.
(D)
								 "Hydrosal®"
			 hemorrhoidal ointment.
(E)
								 "Primatene® Dual Action Formula"
			 tablets.
(F)
								 "Primatene®" tablets.
(G)
								 "SnoreStopT"
			 tablets.
Replaces: 4729-12-09
Ohio Administrative Code › Title 4729:9 - Controlled Substances › Chapter 4729:9-3 - Ephedrine › Section 4729:9-3-08 - Criteria to be considered in denying a petition for exception or removing a drug product exception

Current through all regulations passed and filed through July 1, 2024
(A)
								 The board shall
			 consider the following factors in determining whether a particular
			 over-the-counter (OTC) drug product containing the schedule V controlled
			 substance ephedrine is manufactured and distributed for legitimate use in a
			 manner consistent with the pertinent OTC tentative or final monograph issued by
			 the United States food and drug administration and in a manner that reduces the
			 likelihood of inappropriate use and/or abuse:
(1)
									 The package size
			 and the manner of packaging;
(2)
									 Distribution,
			 advertising, and promotion of the product;
(3)
									 Labeling and the
			 name of the product;
(4)
									 The potential, duration, scope, and significance of
			 inappropriate use and/or abuse;
(5)
									 Other facts as
			 may be relevant to and consistent with public health and
			 safety.
Ohio Administrative Code › Title 4729:10 - Prescription Drugs › Chapter 4729:10-1 - Drug Collection Receptacle › Section 4729:10-1-02 - Authorized collectors

Current through all regulations passed and filed through July 1, 2024
(A) An
			 authorized collector may operate a drug collection receptacle if they meet the
			 requirements specified in 21
			 CFR Part 1300, 21 CFR Part
			 1301,
			 21
			 CFR Part
			 1304,
			 21
			 CFR Part
			 1305,
			 21
			 CFR Part
			 1307 and
			 21
			 CFR Part
			 1317 (4/1/2018).
(B) If an authorized collector operates a
			 drug collection receptacle for the collection of non-controlled substances
			 only, the collector shall meet all of the requirements specified in paragraph
			 (A) of this rule.
(C) A long-term
			 care facility may dispose of prescription medications, including controlled
			 substances, dangerous drugs, and over-the-counter medications on behalf of an
			 ultimate user who resides, or has resided, at that long-term care facility
			 pursuant to 21 CFR
			 1317.80 (4/1/2018).
(D) An authorized collector may operate a
			 mail-back program if they meet the requirements specified in
			 21 CFR Part 1300,
			 21 CFR Part
			 1301,
			 21
			 CFR Part
			 1304,
			 21
			 CFR Part
			 1305,
			 21
			 CFR Part
			 1307 and
			 21
			 CFR Part
			 1317 (4/1/2018).
(E) If an authorized collector operates a
			 mail-back program for the collection of non-controlled substances only, the
			 collector shall meet all of the requirements specified in paragraph (D) of this
			 rule.
(F) An authorized collector
			 shall indicate on a 
			 drug collection receptacle or with written materials
			 accompanying a mail-back package that the collection of any of the
			 following is prohibited:
(1) Medical sharps
			 and needles (e.g., insulin syringes), iodine-containing medications,
			 mercury-containing thermometers, radiopharmaceuticals, antineoplastic agents
			 (cancer chemotherapy drugs, cytotoxic drugs), and compressed cylinders or
			 aerosols (e.g., asthma inhalers); and
(2) Schedule I controlled
			 substances.