reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-11 - Pain Management Clinics › Section 4729:5-11-01 - Pain management clinics - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-11 of the
				Administrative Code:
(A)
								"Pain management clinic" means a facility licensed as a
			 terminal distributor of dangerous drugs in accordance with section
			 4729.552 of the Revised Code.
			 The facility shall comply with all requirements set forth in this
			 chapter.
(B)
								"Controlled substance" has the same meaning as in
			 section 3719.01 of the Revised
			 Code.
(C)
								"Dangerous drug" has the same meaning as in section
			 4729.01 of the Revised
			 Code.
(D)
								"Licensed health professional authorized to prescribe
			 drugs" or "prescriber" has the same meaning as in rule
			 4729:5-1-02
			 of the Administrative Code but shall be limited to a prescriber practicing
			 within the prescriber's applicable scope of practice.
(E)
								"Personal
			 supervision" means the person specified in rule shall be physically present at
			 the licensed location to deter and detect the diversion of dangerous
			 drugs.
(F)
								"Personally furnish" or "personally furnishing" means
			 the final association of a drug with a patient by a prescriber prior to the
			 distribution to a patient for use outside the prescriber's practice setting. A
			 prescriber at a pain management clinic who personally furnishes a dangerous
			 drug shall comply with the requirements of rule
			 4729:5-19-02
			 of the Administrative Code.
(G)
(1)
									"Positive identification" means a method of identifying
			 a person that does not rely on the use of a private personal identifier such as
			 a password, but must use a secure means of identification that includes any of
			 the following:
(a)
										A manual signature on a hard copy
			 record;
(b)
										A magnetic card reader;
(c)
										A bar code
			 reader;
(d)
										A biometric method;
(e)
										A proximity badge
			 reader;
(f)
										A board approved system of randomly generated personal
			 questions;
(g)
										A printout of every transaction that is verified and
			 manually signed within a reasonable period of time by the individual who
			 performed the action requiring positive identification. The printout must be
			 maintained for three years and made readily retrievable; or
(h)
										Other effective
			 methods for identifying individuals that have been approved by the
			 board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-11 - Pain Management Clinics › Section 4729:5-11-03 - Security, control and storage of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A) The security and control of dangerous
			 drugs is the responsibility of the responsible person on the terminal
			 distributor of dangerous drugs license and the terminal distributor of
			 dangerous drugs.
(B) Except as
			 provided in paragraphs (F) and (G)
			 of this rule, controlled substance dangerous drugs shall be stored in a
			 securely locked, substantially constructed cabinet or safe to deter and detect
			 unauthorized access.
(1) The cabinet or safe
			 shall be placed in an area that is not readily accessible to the
			 public.
(2) The cabinet or safe
			 shall remain locked and secured when not in use.
(3) In the case of a combination lock or
			 access code, the combination or access code shall be changed upon termination
			 of employment of an employee having knowledge of the combination or access
			 code.
(4) In the case of a key
			 lock, all keys shall be maintained in a secure place that is inaccessible to
			 anyone other than a prescriber or pharmacist if not being used by a prescriber,
			 pharmacist or a licensed health care professional in accordance with paragraph
			 (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in
			 good working order with keys removed therefrom.
(5) During non-business hours, the cabinet or
			 safe shall be maintained in an area secured by a physical barrier with suitable
			 locks, which may include a locked room or secure facility.
(6) Except as provided in paragraph
			 (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only a prescriber or
			 pharmacist shall be able to access the cabinet or safe.
(a) A prescriber or pharmacist may provide a
			 licensed health care professional with a temporary key for the purposes of
			 accessing the cabinet or safe. A licensed health care professional shall return
			 the key provided in accordance with this paragraph to the prescriber or
			 pharmacist or to a secured location with restricted access (such as a lockbox)
			 no later than the end of the provider's shift or if there is no longer a
			 prescriber or pharmacist available to provide personal supervision.
(b) A prescriber or pharmacist may provide a
			 licensed health care professional with a key, combination or access code for
			 the purposes of accessing the cabinet or safe, if all the following conditions
			 apply:
(i) The cabinet or safe is maintained
			 in a room secured by a physical barrier with suitable locks that can only be
			 unlocked by a prescriber or pharmacist; and
(ii) The room is locked during non-business
			 hours or when there is no longer a prescriber or pharmacist available to
			 provide personal supervision.
(c) Any other method approved by the board's
			 executive director or the director's designee that provides effective controls
			 and procedures to guard against theft and diversion.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-11 - Pain Management Clinics › Section 4729:5-11-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A) A pain management clinic shall keep a
			 record of all dangerous drugs received, administered, personally furnished,
			 disposed, sold or transferred.
(B)
			 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. An invoice from a drug
			 distributor licensed in accordance with division 4729:6 of the Administrative
			 Code containing the required information may be used to meet this
			 requirement.
(C) Records of
			 temperature control monitoring described in paragraph (K)(1) of rule
			 4729:5-11-03 of the
			 Administrative Code shall include any of the following:
(1) For temperature logs, either:
(a) The date and time of observation, the
			 full name or the initials of the individual performing the check, and the
			 temperature recorded; or
(b) For
			 systems that provide automated temperature monitoring, maintain a report that
			 provides, at a minimum, the date and time of observation and the temperature
			 recorded.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-12 - Medication Therapy Management › Section 4729:5-12-01 - Medication therapy management - definitions

Current through all regulations passed and filed through July 1, 2024
As used in in Chapter 4729:5-12 of the Administrative
				Code:
(A) "Personal supervision" or
			 "direct supervision" means a pharmacist shall be physically present in the
			 pharmacy, or in the area where the practice of pharmacy is occurring, and
			 provide personal review and approval of all professional activities.
(B) "Medication therapy management" or "MTM"
			 means:
(1) A distinct service or group of
			 services that is intended to optimize the therapeutic outcomes of a patient.
			 Medication therapy management can be an independent service provided by a
			 pharmacist or pharmacy intern under the direct supervision of a pharmacist or
			 can be in conjunction with the dispensing of a dangerous drug with the
			 objectives of:
(a) Enhancing appropriate
			 medication use;
(b) Improving
			 medication adherence;
(c)
			 Increasing detection of adverse drug events;
(d) Improving collaboration between a
			 prescriber and pharmacist; and
(e)
			 Improving outcomes.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-12 - Medication Therapy Management › Section 4729:5-12-02 - Medication therapy management

Current through all regulations passed and filed through July 1, 2024
(A) A pharmacist or pharmacy intern under the
			 direct supervision of a pharmacist who provides medication therapy management services
			 shall practice at a location that complies with one of the following:
(1) If the person or entity solely performs
			 medication therapy management in this state or to residents of this state, the
			 location shall be licensed as a limited category II terminal distributor of
			 dangerous drugs license with a medication therapy management classification;
			 or
(2) If the person or entity
			 engages in the sale of dangerous drugs, the location is appropriately licensed
			 as a terminal distributor of dangerous drugs.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-13 - First Aid Departments › Section 4729:5-13-01 - First aid departments - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-13 of the
				Administrative Code:
(A)
								"First aid department" means a facility licensed as a
			 limited terminal distributor of dangerous drugs in accordance with section
			 4729.54 of the Revised Code that
			 stocks or administers dangerous drugs in conjunction with the treatment of
			 medical emergencies. The facility shall comply with all requirements set forth
			 in this chapter.
(B)
								"Controlled substance" has the same meaning as in
			 section 3719.01 of the Revised
			 Code.
(C)
								"Dangerous drug" has the same meaning as in section
			 4729.01 of the Revised
			 Code.
(D)
								"Licensed health professional authorized to prescribe
			 drugs" or "prescriber" has the same meaning as in rule
			 4729:5-1-02
			 of the Administrative Code but shall be limited to a prescriber practicing
			 within the prescriber's applicable scope of practice.
(E)
								"Personal
			 supervision" means the person specified in rule shall be physically present at
			 the licensed location to deter and detect the diversion of dangerous
			 drugs.
(F)
								"Personally furnish" or "personally furnishing" means
			 the final association of a drug with a patient by a prescriber prior to the
			 distribution to a patient for use outside the prescriber's practice setting. A
			 prescriber at a first aid department who personally furnishes a dangerous drug
			 shall comply with the requirements of rule
			 4729:5-19-02
			 of the Administrative Code.
(G)
(1)
									"Positive identification" means a method of identifying
			 a person that does not rely on the use of a private personal identifier such as
			 a password, but must use a secure means of identification that includes any of
			 the following:
(a)
										A manual signature on a hard copy
			 record;
(b)
										A magnetic card reader;
(c)
										A bar code
			 reader;
(d)
										A biometric method;
(e)
										A proximity badge
			 reader;
(f)
										A board approved system of randomly generated personal
			 questions;
(g)
										A printout of every transaction that is verified and
			 manually signed within a reasonable period of time by the individual who
			 performed the action requiring positive identification. The printout must be
			 maintained for three years and made readily retrievable; or
(h)
										Other effective
			 methods for identifying individuals that have been approved by the
			 board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-13 - First Aid Departments › Section 4729:5-13-02 - Licensure and drug list

Current through all regulations passed and filed through July 1, 2024
(A)
								An application
			 for licensure shall include all the following:
(1)
									 A completed
			 application;
(2)
									A list of the dangerous drugs, known as a drug list,
			 that may be possessed and administered or personally furnished by a first aid
			 department, expressed in standard dose units, signed by the responsible person;
			 and
(3)
									The fee for the appropriate category of
			 licensure.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-13 - First Aid Departments › Section 4729:5-13-03 - Security, control and storage of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A) The security and control of dangerous
			 drugs is the responsibility of the responsible person on the terminal
			 distributor of dangerous drugs license and the terminal distributor of
			 dangerous drugs.
(B) Except as
			 provided in paragraphs (F) and (G)
			 of this rule, controlled substance dangerous drugs shall be stored in a
			 securely locked, substantially constructed cabinet or safe to deter and detect
			 unauthorized access.
(1) The cabinet or safe
			 shall be placed in an area that is not readily accessible to the
			 public.
(2) The cabinet or safe
			 shall remain locked and secured when not in use.
(3) In the case of a combination lock or
			 access code, the combination or access code shall be changed upon termination
			 of employment of an employee having knowledge of the combination or access
			 code.
(4) In the case of a key
			 lock, all keys shall be maintained in a secure place that is inaccessible to
			 anyone other than a prescriber or pharmacist if not being used by a prescriber,
			 pharmacist or a licensed health care professional in accordance with paragraph
			 (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in
			 good working order with keys removed therefrom.
(5) During non-business hours, the cabinet or
			 safe shall be maintained in an area secured by a physical barrier with suitable
			 locks, which may include a locked room or secure facility.
(6) Except as provided in paragraph
			 (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only a prescriber or
			 pharmacist shall be able to access the cabinet or safe.
(a) A prescriber or pharmacist may provide a
			 licensed health care professional with a temporary key for the purposes of
			 accessing the cabinet or safe. A licensed health care professional shall return
			 the key provided in accordance with this paragraph to the prescriber or
			 pharmacist or to a secured location with restricted access (such as a lockbox)
			 no later than the end of the provider's shift or if there is no longer a
			 prescriber or pharmacist available to provide personal supervision.
(b) A prescriber or pharmacist may provide a
			 licensed health care professional with a key, combination or access code for
			 the purposes of accessing the cabinet or safe, if all the following conditions
			 apply:
(i) The cabinet or safe is maintained
			 in a room secured by a physical barrier with suitable locks that can only be
			 unlocked by a prescriber or pharmacist; and
(ii) The room is locked during non-business
			 hours or when there is no longer a prescriber or pharmacist available to
			 provide personal supervision.
(c) Any other method approved by the board's
			 executive director or the director's designee that provides effective controls
			 and procedures to guard against theft and diversion.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-13 - First Aid Departments › Section 4729:5-13-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A) A first aid department shall keep a
			 record of all dangerous drugs received, administered, personally furnished,
			 disposed, sold or transferred.
(B)
			 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. An invoice from a drug
			 distributor licensed in accordance with division 4729:6 of the Administrative
			 Code containing the required information may be used to meet this
			 requirement.
(C) Records of
			 temperature control monitoring described in paragraph (K)(1) of rule
			 4729:5-13-03 of the
			 Administrative Code shall include any of the following:
(1) For temperature logs, either:
(a) The date and time of observation, the
			 full name or the initials of the individual performing the check, and the
			 temperature recorded; or
(b) For
			 systems that provide automated temperature monitoring, maintain a report that
			 provides, at a minimum, the date and time of observation and the temperature
			 recorded.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-14 - Emergency Medical Services › Section 4729:5-14-01 - Emergency medical services - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-14 of the
				Administrative Code:
(A)
								"Business day" means any day other than Saturday,
			 Sunday or a holiday recognized by the state of Ohio on which the offices of the
			 board of pharmacy are not open for business.
(B)
								"Certificate to
			 practice" means the level to which an individual is trained and licensed as
			 defined in sections 4765.01,
			 4765.011 and
			 4765.30 of the Revised Code and
			 rule
			 4765-1-01 of the
			 Administrative Code.
(C)
								"Direct supervision" or "personal supervision" means
			 EMS organization personnel shall be physically present at the licensed location
			 or within the immediate proximity of an EMS unit to deter and detect the
			 diversion of dangerous drugs.
(D)
								"Electronic
			 signature" means any of the following attached to or associated with an
			 electronic drug administration record by EMS organization personnel to
			 authenticate the drug administration record:
(1)
									A private, unique
			 personal identifier and secure passcode consisting of a combination of letters,
			 numbers, and symbols that is adapted or executed by an individual as that
			 individual's electronic signature.
(2)
									An electronic
			 image of an individual's handwritten signature that is captured following drug
			 administration and is created by using a writing apparatus (i.e. stylus). The
			 signature shall be legible and include the person's first name, last name and
			 credentials.
(3)
									Any other method approved by the board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-14 - Emergency Medical Services › Section 4729:5-14-02 - Licensure

Current through all regulations passed and filed through July 1, 2024
(A)
								An EMS organization that possesses dangerous drugs
			 shall apply for and maintain a license as a terminal distributor of dangerous
			 drugs with an emergency medical services classification.
(1)
									The location that
			 serves as the main station of the EMS organization will be deemed the
			 headquarters.
(2)
									Any satellite location associated with the headquarters
			 of the EMS organization where dangerous drugs will be stored must be licensed
			 as a terminal distributor of dangerous drugs.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-14 - Emergency Medical Services › Section 4729:5-14-03 - Security and control of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								The security and
			 control of dangerous drugs is the responsibility of the responsible person on
			 the terminal distributor of dangerous drugs license. The responsible person may
			 delegate the day-to-day tasks to EMS organization personnel who hold
			 appropriate certification/licensure to access the dangerous drugs for which the
			 personnel are responsible. A responsible person shall comply with the
			 requirements set forth in agency 4729 of the Administrative
			 Code.
(B)
								A licensed EMS organization shall provide effective
			 controls and procedures to deter and detect the theft and diversion of
			 dangerous drugs.
(C)
								All dangerous drugs must be secured in a tamper-evident
			 manner with access limited to EMS personnel based on certification status,
			 except for the following if stored in a sealed, tamper-evident manner:
(1)
									Solutions labeled
			 for irrigation use;
(2)
									Dextrose solutions;
(3)
									Saline
			 solutions;
(4)
									Lactated ringers;
(5)
									Sterile water;
			 and
(6)
									Naloxone hydrochloride.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-14 - Emergency Medical Services › Section 4729:5-14-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A) All EMS organizations shall keep a record
			 of all dangerous drugs received, administered, sold, transferred, destroyed,
			 disposed or used.
(B) Records of
			 receipt shall contain a description of all dangerous drugs received, the kind
			 and quantity of dangerous drugs received, the name and address of the persons
			 from whom received, and the date of receipt.
(C)
								
								All records of receipt, distribution, administration,
			 selling, disposing, destroying or using dangerous drugs shall be maintained for
			 a period of three years at the place where the dangerous drugs are located.
Records from satellites may be stored at the EMS organization
				headquarters if prior approval, in a manner determined by the board, is
				obtained by the EMS organization.
(D) Records of administering dangerous drugs
			 shall be legible and shall contain the first and last name of the EMS personnel
			 who administered the drug, name of the EMS organization, name and strength of
			 the drug administered, date of administration, time of administration, amount
			 of the dose administered, the name or other means of identifying the patient,
			 such as medical record number or run number, and the identification of the
			 individual administering the drug using either of the following methods:
(1) An electronic signature in a computerized
			 recordkeeping system; or
(2) Any
			 form of positive identification.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-15 - Animal Shelters › Section 4729:5-15-01 - Animal shelters - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-15 of the Administrative Code:
(A) "Animal shelter" means a facility
			 licensed as terminal distributor of dangerous drugs in accordance with section
			 4729.531
			 of the Revised Code or section
			 4729.54
			 of the Revised Code. An animal shelter shall be operated by a humane society or
			 any society organized under Chapter 1717. of the Revised Code or a dog pound
			 operated pursuant to Chapter 955. of the Revised Code and shall comply with all
			 requirements set forth in this chapter.
(1) An
			 animal shelter that does not have a licensed veterinarian serving as the
			 responsible person shall obtain a limited license as terminal distributor of
			 dangerous drugs in accordance with section
			 4729.531
			 of the Revised Code.
(2) An animal
			 shelter shall ensure that all agents and employees who perform euthanasia,
			 other than registered veterinary technicians or licensed veterinarians, shall
			 successfully complete a euthanasia technician certification course described in
			 section
			 4729.532
			 of the Revised Code.
(3) An animal
			 shelter shall comply with the initial licensure and renewal requirements set
			 forth in rule
			 4729:5-2-02
			 of the Administrative Code.
(4) The
			 board may suspend, revoke, restrict, limit, or refuse to grant or renew any
			 license issued to an animal shelter
			  in accordance with rule
			 4729:5-4-01
			 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-15 - Animal Shelters › Section 4729:5-15-02 - Security and control of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A) The security and control of dangerous
			 drugs is the responsibility of the responsible person on the terminal
			 distributor of dangerous drugs license and the terminal distributor of
			 dangerous drugs.
(B) Controlled
			 substance dangerous drugs used to perform euthanasia or
			 chemical capture shall be stored in a securely locked, substantially
			 constructed cabinet or safe.
(1) The cabinet
			 or safe shall be placed in an area that is not readily accessible to the
			 public. The public does not include volunteers of the animal shelter.
(2) The cabinet or safe shall remain locked
			 and secured when not in use.
(3) In
			 the case of a combination lock or access code, the combination or access code
			 shall be changed upon termination of employment of an employee having knowledge
			 of the combination or access code.
(4) In the case of a key lock, all keys shall
			 be maintained in a secure place that is inaccessible to anyone other than a
			 veterinarian, registered veterinary technician, responsible person, euthanasia
			 technician, certified officer, dog warden, or
			 executive director of the shelter. All locks shall be kept in good working
			 order with keys removed therefrom.
(5) When not staffed by shelter personnel,
			 the cabinet or safe shall be maintained in an area secured by a physical
			 barrier with suitable locks, which may include a locked room or secure
			 facility.
(6) Only a veterinarian,
			 registered veterinary technician, euthanasia technician, executive director of
			 the shelter, certified officer, dog warden, or
			 the licensee's responsible person shall be able to access
			 the cabinet or safe.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-15 - Animal Shelters › Section 4729:5-15-03 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A) An animal shelter or county dog warden shall keep a record of all
			 dangerous drugs received, administered, personally furnished, disposed, sold or
			 transferred.
(B) 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. An invoice from a drug distributor licensed
			 in accordance with division 4729:6 of the Administrative Code containing the
			 required information may be used to meet this requirement.
(C) Records of temperature control monitoring
			 described in paragraph (N) of rule 4729:5-15-02 of the Administrative Code
			 shall include any of the following:
(1) For
			 temperature logs, either:
(a) The date and
			 time of observation, the full name or the initials of the individual performing
			 the check, and the temperature recorded; or
(b) For systems that provide automated
			 temperature monitoring, maintain a report that provides, at a minimum, the date
			 and time of observation and the temperature recorded.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-15 - Animal Shelters › Section 4729:5-15-04 - Drugs approved for euthanasia

Current through all regulations passed and filed through July 1, 2024
(A)
								Pursuant to
			 section
			 4729.532
			 of the Revised Code, except for a licensed veterinarian or registered
			 veterinary technician, no agent or employee of an animal shelter and no county
			 dog warden or agent or employee of a county dog warden shall perform euthanasia
			 by means of lethal injection on an animal by use of any substance other than a
			 substance in a manufactured dosage form that the state veterinary medical
			 licensing board has approved under Chapter 4741. of the Administrative
			 Code.
(B)
								Before euthanasia, a euthanasia technician may
			 administer a solution of one or more of the following drugs exclusively for the
			 purpose of inducing anesthesia, sedation, or unconsciousness prior to
			 euthanasia:
(1)
									Ketamine;
(2)
									Tiletamine and
			 zolazepam; and
(3)
									Xylazine.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-15 - Animal Shelters › Section 4729:5-15-05 - Chemical capture classification

Current through all regulations passed and filed through July 1, 2024
(A) Upon application of an animal shelter or
			 county dog warden that holds a limited license issued under section
			 4729.531 of the Revised Code,
			 the state board of pharmacy may grant a chemical capture classification to the
			 limited license. The classification permits the holder to purchase, possess,
			 and administer a combination of drugs for chemical capture. Unless otherwise
			 approved by the board, no such classification shall authorize or permit the
			 distribution of these drugs to any person other than the originating wholesale
			 distributor of the drugs.
(1) To qualify for a
			 chemical capture classification under this rule, an applicant shall appoint or
			 employ a certified officer.
(2) An
			 animal shelter or county dog warden shall comply with the initial licensure and
			 renewal requirements set forth in rule
			 4729:5-2-02 of the
			 Administrative Code. As part of this licensing process, the animal shelter or
			 county dog warden shall provide a list of drugs, signed by the responsible
			 person, that will be used for chemical capture.
(3) A certified officer may use any of the
			 following drugs for use as part of the chemical
			 capture process:
(a) Ketamine;
(b) Xylazine;
(c)
			 Tiletamine and zolazepam;
(d)
										Yohimbine;
(e)
										Tolazoline;
			 and
(f)
										Atipamezole.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-16 - Laboratories › Section 4729:5-16-01 - Laboratories - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-16 of the
				Administrative Code:
(A)
								"Laboratory" means any facility licensed as a terminal
			 distributor of dangerous drugs in accordance with section
			 4729.54 of the Revised Code
			 where dangerous drugs and controlled substances are possessed for scientific,
			 clinical or instructional purposes. The facility shall comply with all
			 requirements set forth in this chapter. A laboratory does not include any of
			 the following:
(1)
									A laboratory licensed under Chapter 3796. of the
			 Revised Code; or
(2)
									Any other person or facility licensed as a terminal
			 distributor of dangerous drugs that is specifically defined and required to
			 comply with another chapter of this division (EMS organization, veterinary
			 clinic, pain management clinic, animal shelter, etc.).
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-16 - Laboratories › Section 4729:5-16-03 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								A laboratory
			 shall keep a record of all dangerous drugs and controlled substances received,
			 administered, personally furnished, used (i.e. chemical analysis or research),
			 disposed, destroyed or transferred.
(B)
								The acts of
			 administering, using (i.e. chemical analysis or research), and destroying or
			 disposing controlled substances shall be documented with positive
			 identification.
(C)
								Records of receipt shall contain a description of the
			 drug or substance and all the following if obtained from a person licensed in
			 accordance with section
			 4729.52 or
			 4729.54 of the Revised
			 Code:
(1)
									The
			 name, strength, dosage form, quantity of the drug;
(2)
									The name and
			 address of the seller;
(3)
									The name and address of the recipient;
			 and
(4)
									The date of receipt.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-17 - Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions › Section 4729:5-17-01 - Medical oxygen, nitrous oxide, medical gases and dialysis solutions - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-17 of the Administrative Code:
(A) "Licensed health professional authorized
				to prescribe drugs" or "prescriber" has the same meaning as in rule
				4729:5-1-02
				of the Administrative Code but shall be limited to a prescriber practicing
				within the prescriber's applicable scope of practice.
(B) "Medical oxygen" means oxygen that meets
				the definition of a dangerous drug pursuant to section
				4729.01 of the Revised
				Code.
(C) "Peritoneal dialysis
				solution" or "dialysis solution" means a commercially manufactured, unopened,
				sterile dangerous drug solution that is intended to be instilled into the
				peritoneal cavity during the medical procedure known as peritoneal
				dialysis.
(D) "Readily retrievable"
				means that records maintained in accordance with this chapter shall be kept in
				such a manner that, upon request, they can be produced for review no later than
				three business days to an agent, officer or inspector of the board.
(E) "Responsible person" has the same meaning
				as defined in rule
				4729:5-2-01
				of the Administrative Code and is responsible for the supervision and control
				of dangerous drugs and medical gases as required in division (B) of section
				4729.55 of the Revised Code,
				adequate safeguards as required in division (C) of section
				4729.55 of the Revised Code,
				security and control of dangerous drugs and medical gases, and maintaining all
				drug records otherwise required.
(F) "Tamper-evident" means a package, storage
				container or other physical barrier is sealed or secured in such a way that
				access to medical gases or dangerous drugs stored within is not possible
				without leaving visible proof that such access has been attempted or made.
(G) The provisions of this chapter
				do not apply to a person or facility licensed as a terminal distributor of
				dangerous drugs that is specifically defined and required to comply with
				another chapter of this division (EMS organization, veterinary clinic,
				prescriber clinic, pain management clinic, animal shelter,
				etc.).
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-17 - Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions › Section 4729:5-17-02 - Medical oxygen - general provisions

Current through all regulations passed and filed through July 1, 2024
(A)
								Except as
			 provided in paragraph (H) of this rule, each person, whether located within or
			 outside of this state, who conducts retail sales of medical oxygen in this
			 state shall obtain a limited category II terminal distributor of dangerous
			 drugs license. The requirements of this paragraph do not apply to persons
			 currently licensed to purchase, possess, and sell dangerous drugs at retail in
			 accordance with division 4729:5 of the Administrative Code.
(B)
								All areas where
			 medical oxygen is stored shall be maintained in a clean and orderly condition.
			 Storage areas shall be maintained at conditions and temperatures which will
			 ensure the integrity of the medical oxygen prior to use as stipulated by the
			 manufacturer's or distributor's labeling.
(C)
								Medical oxygen
			 shall be secured in a tamper-evident manner to deter and detect unauthorized
			 access.
(D)
								All retail sellers of medical oxygen shall maintain
			 records of the purchase of oxygen at wholesale and the sale of oxygen at
			 retail, including prescriber orders, for three years at the licensed location.
			 All records shall be readily retrievable.
(1)
									A terminal
			 distributor intending to maintain records at a location other than the location
			 licensed by the state board of pharmacy must notify the board in a manner
			 determined by the board.
(2)
									Any such alternate location 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 4729:5-17 - Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions › Section 4729:5-17-03 - Nitrous oxide - general provisions.

Current through all regulations passed and filed through July 1, 2024
(A) Each person located within this state who
			 seeks to purchase and possess nitrous oxide for the purpose of using it as a
			 direct ingredient in food pursuant to Title
			 21
			 CFR 184.1545 (04/1/2018) shall obtain a
			 limited category II terminal distributor of dangerous drugs license.
(B) All areas where nitrous oxide is stored
			 shall be maintained in a clean and orderly condition. Storage areas shall be
			 maintained at temperatures and conditions which will ensure the integrity of
			 the nitrous oxide prior to use as stipulated by the manufacturer's or
			 distributor's labeling.
(C) Nitrous
			 oxide shall be secured in a tamper-evident manner to deter and detect
			 unauthorized access.
(D) All food
			 processors and retail sellers of food licensed in accordance with this rule
			 shall maintain records of purchase at wholesale and use in the processing food
			 for three years at the licensed location. All records shall be readily
			 retrievable.
(1) A terminal distributor
			 intending to maintain records at a location other than the location licensed by
			 the state board of pharmacy must notify the board in a manner determined by the
			 board.
(2) Any such alternate
			 location 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 4729:5-17 - Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions › Section 4729:5-17-04 - Compressed medical gasses - general provisions and safety program

Current through all regulations passed and filed through July 1, 2024
(A)
								Each person, whether located within or outside this
			 state, who seeks to possess or sell compressed medical gases in this state
			 shall maintain, based upon the person's business activities, a wholesale
			 distributor of dangerous drugs license in accordance with section
			 4729.52 of the Revised Code or
			 terminal distributor of dangerous drugs license in accordance with section
			 4729.54 of the Revised
			 Code.
(B)
								Wholesale or terminal distributors of dangerous drugs
			 who fill containers with compressed medical gases must comply with the current
			 good manufacturing practice regulations issued pursuant to the Federal Food,
			 Drug and Cosmetic ASct (4/1/2018) and the current regulations and guidelines
			 issued pursuant to Title
			 21
			 CFR 10.90 (4/1/2018).
(C)
								Records required
			 by state and federal laws, rules, and regulations governing the sale of
			 dangerous drugs and the filling of containers with compressed medical gases
			 shall be maintained for a period of three years at the licensed location. All
			 records shall be readily retrievable.
(1)
									A wholesale or
			 terminal distributor of dangerous drugs intending to maintain records at a
			 location other than the location licensed by the state board of pharmacy must
			 notify the board in a manner determined by the board.
(2)
									Any such
			 alternate location shall be secured and accessible only to authorized
			 representatives or contractors of the wholesale or terminal distributor of
			 dangerous drugs.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-17 - Medical Oxygen, Nitrous Oxide, Medical Gases and Dialysis Solutions › Section 4729:5-17-05 - Dialysis solutions - general provisions

Current through all regulations passed and filed through July 1, 2024
(A) Each person, whether located within or
			 outside this state, who sells peritoneal dialysis solutions in this state shall
			 obtain a limited category II terminal distributor of dangerous drugs license.
			 The requirements of this paragraph do not apply to persons currently licensed
			 to purchase, possess, and sell dangerous drugs at retail in accordnce with
			 divison 4729:5 of the Administrative Code.
(B)All areas where dialysis solution is
			 stored shall be dry, well-lit, well-ventilated, and maintained in a clean and
			 orderly condition. Storage areas shall be maintained at temperatures and
			 conditions which will ensure the integrity of the dialysis solution prior to
			 use as stipulated by the USP/NF and/or the manufacturer's or distributor's
			 labeling.
(C) Dialysis solutions
			 shall be secured in a tamper-evident manner to deter and detect unauthorized
			 access.
(D) All retail sellers of
			 peritoneal dialysis solutions shall maintain records of purchase of dialysis
			 solutions at wholesale and sale of dialysis solutions at retail for three years
			 at the licensed location. All records shall be readily retrievable.
(1) A terminal distributor intending to
			 maintain records at a location other than the location licensed by the state
			 board of pharmacy must notify the board in a manner determined by the
			 board.
(2) Any such alternate
			 location 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 4729:5-19 - Clinics and Prescriber Offices › Section 4729:5-19-01 - Clinics and prescriber offices - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-19 of the
				Administrative Code:
(A)
								"Clinic" or "prescriber office" means a facility
			 licensed as a terminal distributor of dangerous drugs in accordance with
			 section 4729.54 of the Revised Code
			 where a licensed prescriber, as specified in rule
			 4729:5-2-01
			 of the Administrative Code, or pharmacist serves as the responsible person on
			 the license and drugs are possessed on-site for administration or to personally
			 furnish. The facility shall comply with all requirements set forth in this
			 chapter. A clinic or prescriber office does not include a veterinary clinic as
			 defined in rule
			 4729:5-20-01
			 of the Administrative Code.
(B)
								"Controlled
			 substance" has the same meaning as in section
			 3719.01 of the Revised
			 Code.
(C)
								"Dangerous drug" has the same meaning as in section
			 4729.01 of the Revised
			 Code.
(D)
								"Dosage unit" means any of the following:
(1)
									A single pill,
			 capsule, ampule, or tablet;
(2)
									In the case of a
			 liquid solution, one milliliter;
(3)
									In the case of a
			 cream, lotion or gel, one gram; or
(4)
									Any other form of
			 administration available as a single unit.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-19 - Clinics and Prescriber Offices › Section 4729:5-19-02 - Personally furnishing dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								A prescriber who
			 personally furnishes a dangerous drug, other than a sample drug pursuant to
			 section 3719.81 of the Revised Code,
			 shall affix to the container a label showing:
(1)
									The name and
			 address of the prescriber;
(2)
									The name of the
			 patient for whom the drug is intended;
(3)
									Name and strength
			 of the drug;
(4)
									Directions for use;
(5)
									Date furnished;
			 and
(6)
									If a compounded drug, the statement "Compounded Drug"
			 or other similar statement shall also be displayed prominently on the
			 label.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-19 - Clinics and Prescriber Offices › Section 4729:5-19-03 - Security, control and storage of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A) The security and control of dangerous
			 drugs is the responsibility of the responsible person on the terminal
			 distributor of dangerous drugs license and the terminal distributor of
			 dangerous drugs.
(B) Except as
			 provided in paragraphs (F) and (G) of this rule, controlled substance dangerous
			 drugs shall be stored in a securely locked, substantially constructed cabinet
			 or safe to deter and detect unauthorized access.
(1) The cabinet or safe shall be placed in an
			 area that is not readily accessible to the public.
(2) The cabinet or safe shall remain locked
			 and secured when not in use.
(3) In
			 the case of a combination lock or access code, the combination or access code
			 shall be changed upon termination of employment of an employee having knowledge
			 of the combination or access code.
(4) In the case of a key lock, all keys shall
			 be maintained in a secure place that is inaccessible to anyone other than a
			 prescriber or pharmacist if not being used by a prescriber, pharmacist or a
			 licensed health care professional in accordance with paragraph (B)(6)(a),
			 (B)(6)(b), or (B)(6)(c) of this rule. All locks shall be kept in good working
			 order with keys removed therefrom.
(5) During non-business hours, the cabinet or
			 safe shall be maintained in an area secured by a physical barrier with suitable
			 locks, which may include a locked room or secure facility.
(6) Except as provided in paragraph
			 (B)(6)(a), (B)(6)(b), or (B)(6)(c) of this rule, only a prescriber or
			 pharmacist shall be able to access the cabinet or safe.
(a) A prescriber or pharmacist may provide a
			 licensed health care professional with a temporary key for the purposes of
			 accessing the cabinet or safe. A licensed health care professional shall return
			 the key provided in accordance with this paragraph to the prescriber or
			 pharmacist or to a secured location with restricted access (such as a lockbox)
			 no later than the end of the provider's shift or if there is no longer a
			 prescriber or pharmacist available to provide personal supervision.
(b) A prescriber or pharmacist may provide a
			 licensed health care professional with a key, combination or access code for
			 the purposes of accessing the cabinet or safe, if all the following conditions
			 apply:
(i) The cabinet or safe is maintained
			 in a room secured by a physical barrier with suitable locks that can only be
			 unlocked by a prescriber or pharmacist; and
(ii) The room is locked during non-business
			 hours or when there is no longer a prescriber or pharmacist available to
			 provide personal supervision.
(c) Any other method approved by the board's
			 executive director or the director's designee that provides effective controls
			 and procedures to guard against theft and diversion.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-19 - Clinics and Prescriber Offices › Section 4729:5-19-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								A clinic or
			 prescriber office shall keep a record of all dangerous drugs received,
			 administered, personally furnished, disposed, sold or
			 transferred.
(B)
								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.
			 An invoice from a drug distributor licensed in accordance with division 4729:6
			 of the Administrative Code containing the required information may be used to
			 meet this requirement.
(C)
								Records of temperature control monitoring described in
			 paragraph (K)(1) of rule
			 4729:5-19-03
			 of the Administrative Code shall include any of the following:
(1)
									For temperature
			 logs, either:
(a)
										The date and time of observation, the full name or the
			 initials of the individual performing the check, and the temperature recorded;
			 or
(b)
										For systems that provide automated temperature
			 monitoring, maintain a report that provides, at a minimum, the date and time of
			 observation and the temperature recorded.