reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-20 - Veterinary Clinics › Section 4729:5-20-01 - Veterinary clinics - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-20 of the
				Administrative Code:
(A)
								"Veterinary clinic" or "clinic" means a facility
			 licensed as a terminal distributor of dangerous drugs in accordance with
			 section 4729.54 of the Revised Code
			 where a licensed veterinarian 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.
(B)
								"Animal aide" has the same meaning as in section
			 4741.01 of the Revised
			 Code.
(C)
								"Controlled substance" has the same meaning as in
			 section 3719.01 of the Revised
			 Code.
(D)
								"Dangerous drug" has the same meaning as in section
			 4729.01 of the Revised
			 Code.
(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 distribution of dangerous drugs
			 by a prescriber to the prescriber's patients for use outside the prescriber's
			 practice setting. For the purposes of this chapter, the prescriber shall be a
			 veterinarian.
(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 4729:5-20 - Veterinary Clinics › Section 4729:5-20-02 - Personally furnishing dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								A veterinarian
			 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 veterinarian;
(2)
									The name of the
			 patient for whom the drug is intended, which shall include the name of the
			 owner and identification of the animal or animals;
(3)
									Name and strength
			 of the dangerous 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 4729:5-20 - Veterinary Clinics › Section 4729:5-20-03 - 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 and the terminal distributor of
			 dangerous drugs.
(B) Except as
			 provided in paragraphs (F) and (G) of this rule,
			 controlled substances 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.
(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 if not being used by a veterinarian or a
			 veterinary technician 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
			 veterinarian shall be able to access the cabinet or safe.
(a) A veterinarian may provide a veterinary
			 technician with a temporary key for the purposes of accessing the cabinet or
			 safe. A veterinary technician shall return the key provided in accordance with
			 this paragraph to the veterinarian or a secured location with restricted access
			 (such as a lockbox) no later than the end of the technician's shift or if there
			 is no longer a veterinarian available to provide personal
			 supervision.
(b) A veterinarian may
			 provide a veterinary technician 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 veterinarian;
(ii)
			 The room is locked during non-business hours or when there is no longer a
			 veterinarian available to provide personal supervision.
(c) Any other method approved by the
			 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 4729:5-20 - Veterinary Clinics › Section 4729:5-20-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								A veterinary
			 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 (J) of rule
			 4729:5-20-03
			 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 4729:5-21 - Opioid Treatment Programs › Section 4729:5-21-01 - Opioid treatment programs - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-21 of the
				Administrative Code:
(A)
								"Opioid Treatment Program" or "OTP" means a facility
			 that is licensed as a terminal distributor of dangerous drugs in accordance
			 with section 4729.54 of the Revised Code and
			 holds, or is in the process of applying for, a valid certification from the
			 substance abuse and mental health services administration of the United States
			 department of health and human services pursuant to
			 42 CFR
			 8.11 (3/19/2001). The facility shall comply
			 with all requirements set forth in this chapter. An OTP does not include an
			 office-based opioid treatment clinic as defined in Chapter 4729:5-18 of the
			 Administrative Code.
(B)
								"Controlled substance" has the same meaning as in
			 section 3719.01 of the
			 RevisedCode.
(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, 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 4729:5-21 - Opioid Treatment Programs › Section 4729:5-21-02 - Personally furnishing dangerous drugs from an opioid treatment program

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 dangerous
			 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 4729:5-21 - Opioid Treatment Programs › Section 4729:5-21-03 - 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 and the terminal distributor of
			 dangerous drugs.
(B) All schedule
			 II controlled substances shall be maintained in accordance with
			 21
			 CFR 1301.72 (12/5/2018). Only prescribers,
			 pharmacists, and nurses licensed under Chapter 4723. of the Revised Code may
			 have access to schedule II controlled substances maintained in accordance with
			 this paragraph.
(C) All schedule
			 III through V controlled substances shall be maintained in accordance with
			 21
			 CFR 1301.72 (12/5/2018). Only prescribers,
			 pharmacists, and nurses licensed under Chapter 4723. of the Revised Code may
			 have access to controlled substances maintained in accordance with this
			 paragraph.
(D) When it is necessary
			 for employee maintenance personnel, nonemployee maintenance personnel, business
			 guests, or visitors to be present in or pass through storage areas maintained
			 in accordance with paragraphs (B) and (C) of this rule, the opioid treatment
			 program shall provide for adequate observation of the area by a prescriber,
			 pharmacist or nurse specifically authorized in writing.
(E) Controlled substances administered for
			 the treatment of opioid dependence or addiction may be administered directly to
			 the patient by any of the following:
(1) A
			 licensed prescriber, in accordance with the prescriber's scope of practice and
			 as authorized by federal or state law.
(2) A registered nurse or licensed practical
			 nurse pursuant to a valid order issued by a licensed prescriber.
(3) A pharmacist in accordance with a consult
			 agreement pursuant section
			 4729.39 of the Revised Code. The
			 pharmacist shall only administer the drug pursuant to a valid order by the
			 consulting physician.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-21 - Opioid Treatment Programs › Section 4729:5-21-04 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A)
								An OTP 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 (L)(1) of rule
			 4729:5-21-03
			 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 4729:5-21 - Opioid Treatment Programs › Section 4729:5-21-05 - Mobile opioid treatment programs

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule, "mobile opioid treatment program" has the same meaning as "mobile
			 narcotic treatment program" as used in 21 CFR part 1301
			 (7/12/2021).
(B)
								For any opioid treatment program intending to operate a
			 mobile opioid treatment program, the licensee shall notify the local drug
			 enforcement administration (DEA) office, in writing, its intent to do so, and
			 the opioid treatment program must receive explicit written approval from the
			 local DEA office prior to operating the mobile opioid treatment program. The
			 mobile opioid treatment program may only operate in the same state in which the
			 opioid treatment program is registered with the DEA.
(1)
									Licensees are not
			 required to obtain a separate terminal distributor of dangerous drugs license
			 for conveyances (mobile components) utilized by the licensee to transport
			 dangerous drugs away from licensed locations for use as part of a mobile opioid
			 treatment program. Vehicles must possess valid county/city and state
			 information (e.g., a vehicle identification number (VIN) or license plate
			 number) on file at the licensed location of the opioid treatment program
			 licensed by the board.
(2)
									A mobile opioid treatment program is not permitted to
			 reverse distribute, share, or transfer dangerous drugs from one mobile
			 component to another mobile component while deployed outside of the licensed
			 location. These mobile components of opioid treatment programs may not function
			 as hospitals, long-term care facilities, or emergency medical service vehicles,
			 and shall not transport patients.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-22 - Non-Limited Facilities › Section 4729:5-22-01 - Non-limited facilities - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-22 of the
				Administrative Code:
(A)
								"Non-limited facility" or "unlimited facility" means a
			 facility licensed as a terminal distributor of dangerous drugs in accordance
			 with section 4729.54 of the Revised Code
			 where drugs are possessed on-site for administration, dispensing, or personally
			 furnishing. The facility shall comply with all requirements set forth in this
			 chapter.
(1)
									Non-limited facilities include any of the following:
(a)
										Blood
			 banks;
(b)
										Custodial care or residential care
			 facilities;
(c)
										Pediatric respite care programs;
(d)
										Group
			 homes;
(e)
										Freestanding dialysis centers;
(f)
										Hospice care
			 facilities, except those facilities that obtain dangerous drugs using
			 pharmacy-supplied contingency stock;
(g)
										Infusion centers;
(h)
										Imaging centers; or
(i)
										Any other
			 facility as determined by the board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-22 - Non-Limited Facilities › Section 4729:5-22-02 - 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 rule 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;
(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 of controlled
			 substances.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-22 - Non-Limited Facilities › Section 4729:5-22-03 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A) A non-limited facility 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) of rule
			 4729:5-22-02 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 4729:5-23 - Limited Facilities › Section 4729:5-23-01 - Limited facilities - definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-23 of the
				Administrative Code:
(A)
								"Limited facility" means a facility licensed as a
			 limited category II or limited category III terminal distributor of dangerous
			 drugs in accordance with section
			 4729.54 of the Revised Code
			 where drugs are possessed on-site for administration, dispensing, or personally
			 furnishing. The facility shall comply with all requirements set forth in this
			 chapter.
(1)
									A
			 limited facility includes any of the following:
(a)
										Dog trainers
			 affiliated with an Ohio law enforcement agency;
(b)
										Home health care
			 providers, including those offering in-home services;
(c)
										Hospice care
			 providers of in-home services;
(d)
										Physical therapy
			 providers;
(e)
										Teaching institutions; and
(f)
										Any other
			 facility as determined by the board.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-23 - Limited Facilities › Section 4729:5-23-03 - Record keeping

Current through all regulations passed and filed through July 1, 2024
(A) A limited facility shall keep a record of
			 all dangerous drugs and controlled substances 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 or controlled
			 substances 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 (L) of rule
			 4729:5-23-02 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 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-1 - Definitions › Section 4729:6-1-01 - Definitions - distributors of dangerous drugs

Current through all
			 regulations passed and filed through July 1, 2024
As used in this division:
(A) "Distributor of dangerous drugs" or "drug
			 distributor" means the following persons licensed in accordance with section
			 4729.52
			 of the Revised Code:
(1) Wholesale
			 distributors of dangerous drugs, including:
(a) Brokers; and
(b) Virtual wholesalers.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-02 - Distributor of dangerous drugs licensing and renewal

Current
			 through all regulations passed and filed through July 1,
			 2024
(A)
								All drug distributor licenses issued pursuant to
			 Chapter 4729. of the Revised Code shall expire on the thirtieth day of June of
			 every odd-numbered year. A license shall be renewed biennially according to the
			 provisions of sections
			 4729.52 and
			 4729.53 of the Revised Code and
			 the standard renewal procedure of Chapter 4745. of the Revised
			 Code.
(B)
								An initial drug distributor license issued on or after
			 the first day of May of every odd-numbered year shall receive an expiration
			 date of the thirtieth day of June of the next odd-numbered
			 year.
(C)
								A drug distributor who seeks to renew a license shall
			 submit an application for renewal and pay the required fee in accordance with
			 section 4729.52 of the Revised Code,
			 including any transaction fee as required by section
			 125.18 of the Revised Code, on
			 or before the license expiration date.
(D)
								A drug
			 distributor who has experienced a change in responsible person pursuant to
			 section
			 4729:6-2-01 of the
			 Administrative Code and has not yet reported such change to the board, shall
			 submit the required notification prior to submitting a renewal
			 application.
(E)
								A drug distributor who has experienced a change in
			 description pursuant to rule
			 4729:6-2-05 of the
			 Administrative Code and has not yet reported such change to the board, shall
			 submit the required application and fee in lieu of a renewal application.
An application and fee submitted
				pursuant to rule
				4729:6-2-05 of the
				Administrative Code during the renewal period will qualify as a renewal
				application and be awarded an expiration date in accordance with paragraph (A)
				of this rule.
(F)
								The required fees for initial licensure and biennial
			 renewal of a distributor of dangerous drug license shall be in accordance with
			 sections 4729.52 and
			 125.18 of the Revised
			 Code.
(G)
								Licensure pursuant to section
			 4729.52 of the Revised Code is
			 not applicable to any facility owned or operated by the following:
(1)
									The United States
			 department of defense;
(2)
									The United States department of veterans affairs;
			 or
(3)
									Any other federal agency.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-03 - Criminal records checks

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								A new distributor of dangerous drug license will not be
			 issued until the following persons submit fingerprints to the Ohio bureau of
			 criminal identification and investigation (BCI&I) for a criminal records
			 check in accordance with paragraph (C) of this rule:
(1)
									The responsible
			 person on the application for licensure; and
(2)
									The following
			 persons based upon the drug distributor's business type:
(a)
										All partners of a
			 partnership.
(b)
										The sole proprietor of a sole
			 proprietorship.
(c)
										Except as provided in paragraph (A)(3) of this rule,
			 the president, vice president, secretary, treasurer, and chief executive
			 officer, or any equivalent position of a corporation and, if a corporation is
			 not publicly traded on a major stock exchange, each shareholder owning ten
			 percent or more of the voting stock of the corporation. If the director or the
			 director's designee determines other person(s) in the organizational structure
			 have substantial control, such as the power to influence management and
			 operational decision-making over the distribution of dangerous drugs, the
			 director or designee may require a criminal records check of those with
			 substantial control in addition to or in place of those persons set forth in
			 this paragraph.
(d)
										The agency director of a government
			 agency.
(3)
									For publicly traded corporations, the board's executive
			 director or the director's designee may waive the criminal records checks
			 required in paragraph (A)(2) (c) of this rule under the following
			 circumstances:
(a)
										The public traded corporation submits a request to the
			 executive director and includes the organizational structure of the
			 corporation, including all corporate officer positions responsible for
			 directing the distribution of dangerous drugs. The director or the director's
			 designee may request additional information about the corporation's
			 organizational structure.
(b)
										The executive
			 director or the director's designee approves an alternate list of corporate
			 officers that are required to submit a criminal records check. If approval is
			 not provided, the publicly traded corporation shall comply with paragraph
			 (A)(2)(c) of this rule.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-03 - Criminal records checks

All regulations passed and filed through January 1,
			 2024
(A)
								Unless otherwise approved by the board,
								a new
			 distributor of dangerous drug license will not be issued until the following
			 persons submit fingerprints to the Ohio bureau of criminal
			  investigation
			 (BCI) for a criminal records check in
			 accordance with paragraph (C) of this rule:
(1) The responsible person on the application
			 for licensure; and
(2) The
			 following persons based upon the drug distributor's business type:
(a) All partners of a partnership.
(b) The sole proprietor of a sole
			 proprietorship.
(c)
										All members of a limited liability company.
(i)
											If the limited
			 liability company has a member which is not a natural person, the limited
			 liability company's president, vice president, secretary, treasurer, and chief
			 executive officer, or any equivalent position.
(ii)
											If the limited
			 liability company's sole member is a publicly traded corporation, the
			 limited-liability company may seek a waiver pursuant to paragraph (A)(3) of
			 this rule.
(d) Except as provided
			 in paragraph (A)(3) of this rule, the president, vice president, secretary,
			 treasurer, and chief executive officer, or any equivalent position of a
			 corporation and, if a corporation is not publicly traded on a major stock
			 exchange, each shareholder owning ten percent or more of the voting stock of
			 the corporation. If the director or the director's designee determines other
			 person(s) in the organizational structure have substantial control, such as the
			 power to influence management and operational decision-making over the
			 distribution of dangerous drugs, the director or designee may require a
			 criminal records check of those with substantial control in addition to or in
			 place of those persons set forth in this paragraph.
(e)
										
										The executive director or any equivalent position of a
			 nonprofit organization.
(3) For publicly traded corporations, the
			 board's executive director or the 
									director's
			 designee may waive the criminal records checks required in paragraph (A)(2)(c)
			 of this rule under the following circumstances:
(a) The 
										publicly
			 traded corporation submits a request to the executive director and includes the
			 organizational structure of the corporation, including all corporate officer
			 positions responsible for directing the distribution of dangerous drugs. The
			 director or the 
										director's designee may request additional
			 information about the corporation's organizational structure.
(b) The executive director or the director's
			 designee approves an alternate list of corporate officers
			 
										who are
			 required to submit a criminal records check. If approval is not provided, the
			 publicly traded corporation shall comply with paragraph (A)(2)(c) of this
			 rule.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-05 - Change in description of a distributor of dangerous drugs

Current through all regulations passed and filed through July 1,
			 2024
(A)
								Any change in the ownership, business or trade name,
			 category, or address of a distributor of dangerous drugs requires a new
			 application, required fee, and license. The new application and required fee
			 shall be submitted within thirty days of any change in the ownership, business
			 or trade name, category, or address.
(B)
								A change of
			 ownership includes any of the following:
(1)
									A change of
			 controlling interest of ten per cent or more of a licensed corporation's
			 outstanding shares of voting stock.
(2)
									Any business
			 entity change from its original form, as licensed, to a sole proprietor
			 ownership, partnership, limited liability company, corporation or any other
			 business entity.
(3)
									An existing corporation ceases and a new corporation or
			 other business entity is formed.
(4)
									An existing
			 corporation continues and there is a one hundred percent stock purchase by
			 another corporation or other business entity.
(5)
									Two wholly-owned
			 subsidiaries of a parent company are merged.
(6)
									A currently
			 licensed drug distributor is purchased or operated by a different business
			 entity than what is listed on the original application, even if the location
			 maintains the original "doing business as" (DBA) and/or responsible
			 person.
(7)
									Any partnership change other than that which was
			 originally licensed.
(a)
										A partnership change is deemed to have occurred
			 when:
(i)
											There
			 is an addition or removal of one or more partners in a partnership to which a
			 license is issued.
(ii)
											The entity is sold and the sale becomes
			 final.
(b)
										For partnerships, a transfer of a proportion of
			 ownership among existing partners is not a change of ownership, if there is no
			 addition or removal of a partner.
(8)
									Any other
			 business model change as determined by the board to be a change of
			 ownership.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-06 - Procedure for discontinuing business as a distributor of dangerous drugs

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								A distributor of dangerous drugs who plans to
			 discontinue business activities shall file a notice with the state board of
			 pharmacy. The notice shall be submitted, in a manner determined by the board,
			 at least thirty days in advance of the proposed date of discontinuing business,
			 unless waived by the board's executive director or the director's designee due
			 to extraordinary circumstances beyond the licensee's control. This notice shall
			 include the following information:
(1)
									The name, address, and license number of the drug
			 distributor discontinuing business.
(2)
									If applicable,
			 the name, address, and license number of the drug distributor or other
			 authorized entity where the dangerous drugs will be transferred.
(3)
									The
			 name and address of the secured location where the records required to be
			 maintained in accordance with this division will be stored.
(4)
									The proposed date
			 of discontinuing business.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-2 - Licensure › Section 4729:6-2-06 - Procedure for discontinuing business as a distributor of dangerous drugs

All regulations passed and filed through January 1,
			 2024
(A) A distributor
			 of dangerous drugs who plans to discontinue business activities shall file a
			 notice with the state board of pharmacy. The notice shall be submitted, in a
			 manner determined by the board, within thirty days of
			 dicontinuation of business as a distributor of dangerous drugs.
								 This notice shall include the following
			 information:
(1) The name, address, and
			 license number of the drug distributor discontinuing business.
(2) If applicable, the name, address, and
			 license number of the drug distributor or other authorized entity where the
			 dangerous drugs will be transferred.
(3) The name and address of the secured
			 location where the records required to be maintained in accordance with this
			 division will be stored.
(4) The
			 proposed date of discontinuing business.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-01 - Disposal of controlled substances

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								As used in this rule:
"Non-retrievable" means the condition
				or state to which a controlled substance shall be rendered following a process
				that permanently alters that controlled substance's physical or chemical
				condition or state through irreversible means and thereby renders the dangerous
				drugs which are controlled substances unavailable and unusable for all
				practical purposes. The process to achieve a non-retrievable condition or state
				may be unique to a substance's chemical or physical properties. A dangerous
				drug which is a controlled substance is considered non-retrievable when it
				cannot be transformed to a physical or chemical condition or state as a
				controlled substance or controlled substance analogue. The purpose of
				destruction is to render the controlled substance(s) to a non-retrievable state
				and thus prevent diversion of any such substance to illicit
				purposes.
(B)
								A person licensed in accordance with section
			 4729.52 of the Revised Code or
			 this division of the Administrative Code shall dispose of controlled substance
			 dangerous drugs in accordance with 21 C.F.R. 1317 (1/1/2016). The method of
			 destruction must render the controlled substances to a state of
			 non-retrievable. Records of controlled substance destruction that are required
			 pursuant to 21 C.F.R. 1304 (1/1/2016) shall be maintained for a minimum of
			 three years and made readily retrievable to the board of pharmacy upon
			 request.
Replaces: 4729-9-06
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-01 - Disposal of controlled substances

All regulations passed and filed through January 1,
			 2024
(A) As used in this
			 rule:
"Non-retrievable" means the condition or state to which a
				controlled substance shall be rendered following a process that permanently
				alters that controlled substance's physical or chemical condition or state
				through irreversible means and thereby renders the dangerous drugs which are
				controlled substances unavailable and unusable for all practical purposes. The
				process to achieve a non-retrievable condition or state may be unique to a
				substance's chemical or physical properties. A dangerous drug which is a
				controlled substance is considered non-retrievable when it cannot be
				transformed to a physical or chemical condition or state as a controlled
				substance or controlled substance analogue. The purpose of destruction is to
				render the controlled substance(s) to a non-retrievable state and thus prevent
				diversion of any such substance to illicit purposes.
(B) A person licensed in accordance with
			 section 4729.52 of the Revised Code or
			 this division of the Administrative Code shall dispose of controlled substance
			 dangerous drugs in accordance with 21 C.F.R. 1317 (9/25/2023).
			 The method of destruction must render the controlled substances to a state of
			 non-retrievable. Records of controlled substance destruction that are required
			 pursuant to 21 C.F.R. 1304 (9/25/2023) shall be maintained for a minimum of
			 five
			 years and made readily retrievable to the board of pharmacy upon
			 request.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-02 - Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents

Current through all regulations passed and
			 filed through July 1, 2024
(A) A person licensed in accordance with
			 section
			 4729.52
			 of the Revised Code or this division of the administrative code shall notify
			 the following upon discovery of the theft or significant loss of any dangerous
			 drug or controlled substance, including drugs in transit that were either
			 shipped from or to the licensed location:
(1)
			 The state board of pharmacy, by telephone or other method determined by the
			 board, immediately upon discovery of the theft or significant loss;
(2) If a controlled substance, the drug
			 enforcement administration (DEA) pursuant to
			 21 C.F.R.
			 1301.76 (9/9/2014);
(3) Law enforcement authorities pursuant to
			 section
			 2921.22
			 of the Revised Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-03 - Inspections and corrective actions

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								Pursuant to section
			 3719.13 of the Revised Code, an
			 entity licensed by state board of pharmacy in accordance with section
			 4729.52 of the Revised Code or
			 this divsion of the Administrative Code is subject to an on-site inspection by
			 the board. An authorized board agent may, without notice, carry out an on-site
			 inspection or investigation of an entity licensed by the board. Upon
			 verification of the board agent's credentials, the agent shall be permitted to
			 enter the licensed entity.
(B)
								Submission of an
			 application for a license, in accordance with section
			 4729.52 of the Revised Code or
			 this divison of the Administrative Code, with the state board of pharmacy
			 constitutes permission for entry and on-site inspection by an authorized board
			 agent.
(C)
								If an agent of the state board of pharmacy identifies a
			 violation specified in paragraph (D) of this rule, the agent may provide
			 written notice, in a manner determined by the board, of the nature of the
			 observed violations to the responsible person on the license or application.
			 The licensee or applicant may also be subject to disciplinary actions pursuant
			 to Chapter 4729. of the Revised Code and this division of the Administrative
			 Code.
(D)
								Violations may include any of the following:
(1)
									Violating any
			 rule of the board;
(2)
									Violating any provision of Chapter 4729. of the Revised
			 Code;
(3)
									Violating any provision of the "Federal Food, Drug, and
			 Cosmetic Act," 52 Stat. 1040 (1938),
			 21
			 U.S.C. 301, or Chapter 3715. of the Revised
			 Code;
(4)
									Violating any provision of the federal drug abuse
			 control laws or regulations or Chapter 2925. or 3719. of the Revised
			 Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-03 - Inspections and corrective actions

All regulations passed and filed through January 1,
			 2024
(A) Pursuant to
			 section 3719.13 of the Revised Code, an
			 entity licensed by state board of pharmacy in accordance with section
			 4729.52 of the Revised Code or
			 this division of the Administrative Code is subject to an
			 on-site inspection by the board. An authorized board employee may,
			 without notice, carry out an on-site inspection or investigation of an entity
			 licensed by the board. Upon verification of the board
			 employee's credentials, the agent shall be permitted
			 to enter the licensed entity.
(B)
			 Submission of an application for a license, in accordance with section
			 4729.52 of the Revised Code or
			 this division of the Administrative Code, with the state
			 board of pharmacy constitutes permission for entry and on-site inspection by an
			 authorized board employee.
(C) If an employee of the
			 state board of pharmacy identifies a violation specified in paragraph (D) of
			 this rule, the employee may provide written notice, in a manner
			 determined by the board, of the nature of the observed violations to the
			 responsible person on the license or application. The licensee or applicant may
			 also be subject to disciplinary actions pursuant to Chapter 4729. of the
			 Revised Code and this division of the Administrative Code.
(D) Violations may include any of the
			 following:
(1) Violating any rule of the
			 board;
(2) Violating any provision
			 of Chapter 4729. of the Revised Code;
(3) Violating any provision of the "Federal
			 Food, Drug, and Cosmetic Act," 52 Stat. 1040 (1938),
			 21 U.S.C.
			 301, or Chapter 3715. of the Revised Code;
			 or
(4) Violating any provision of the federal
			 drug abuse control laws or regulations or Chapter 2925. or 3719. of the Revised
			 Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-04 - Verification of licensure prior to sale or purchase

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								As used in section
			 4729.60 of the Revised Code and
			 in this rule, "roster" means any of the following:
(1)
									The online roster
			 maintained as part of the board's elicensing system (available on the board's
			 website: www.pharmacy.ohio.gov);
(2)
									An electronic
			 list of licensees and registrants if maintained by the board;
			 and
(3)
									Any other format capable of meeting the requirements of
			 section 4729.60 of the Revised Code and
			 this rule that has been approved by the board.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-04 - Verification of licensure prior to sale or purchase

All regulations passed and filed through January 1,
			 2024
(A) As used in
			 section 4729.60 of the Revised Code and
			 in this rule, "roster" means any of the following:
(1) The online roster maintained as part of
			 the board's electronic licensing system (available on the board's
			 website:
www.pharmacy.ohio.gov
);
(2) An electronic list of licensees and
			 registrants if maintained by the board; and
(3) Any other format capable of meeting the
			 requirements of section
			 4729.60 of the Revised Code and
			 this rule that has been approved by the board.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-05 - Suspicious order monitoring and due diligence

Current through all
			 regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule:
(1)
									"Customer" means a person located in this state that orders
			 or seeks to order a reported drug from an Ohio licensed drug distributor and
			 includes the following:
(a)
										A licensed terminal distributor of dangerous drugs;
			 or
(b)
										A prescriber who possesses, or possesses for sale or
			 sells, at retail, a dangerous drug.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-06 - Controlled substances inventory requirements

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								All category III drug distributor licenses shall
			 complete a controlled substances inventory in accordance with section
			 1304.11 of the Code of Federal
			 Regulations (9/9/2014).
(B)
								The drug distributor's responsible person shall be
			 responsible for completing and maintaining this inventory
			 record.
(C)
								All inventory records shall be maintained for a period
			 of three years from the completion date of the inventory and made readily
			 retrievable.
(D)
								When a drug or compound is added to the schedule of
			 controlled substances by state or federal law, rule or regulation, a drug
			 distributor shall complete an inventory pursuant to paragraph (A) of this rule
			 of all stocks of such substance no later than ten days after the drug is added
			 to the schedule.