reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:4 - Probation › Chapter 4729:4-1 - Probation Committee › Section 4729:4-1-02 - Applicability

Current through all regulations passed and filed through July 1, 2024
(A) No person,
			 except an approved treatment provider, shall purport to be or operate as a
			 treatment facility for the purpose of administering care in the detoxification
			 and rehabilitation of an impaired licensee or registrant.
(B) The rules in this division of the
			 Administrative Code are applicable to all licensed pharmacists, pharmacy
			 interns, and any other board licensees or registrants, including pharmacy
			 technician trainees, registered pharmacy technicians, and certified pharmacy technicians.
(C) Should the board have reason to believe
			 that a pharmacist, pharmacy intern or other licensee or registrant suffers from
			 impairment because of conduct or behavior committed or displayed by the
			 individual, the board may compel the individual to be examined by an approved
			 treatment provider. If the licensee or registrant fails to submit to an
			 assessment as ordered by the board, or if the assessment discloses impairment,
			 or if there is an admission of impairment, or if the board has other reliable,
			 substantial, and probative evidence demonstrating impairment, the board may:
(1) Refer the licensee or registrant for
			 treatment;
(2) Initiate action
			 against the licensee or registrant pursuant to Chapters 119., 3719. and 4729.
			 of the Revised Code; or
(3)
			 Summarily suspend the license or registration of an individual pursuant to rule
			 4729:4-1-07 of the
			 Administrative Code if the licensee or registrant's continued practice poses a
			 danger of immediate and serious harm to others.
Ohio Administrative Code › Title 4729:4 - Probation › Chapter 4729:4-1 - Probation Committee › Section 4729:4-1-03 - Requirements for approved treatment providers

Current through all regulations passed and filed through July 1, 2024
(A)
								An approved
			 treatment provider, as defined in rule
			 4729:4-1-01
			 of the Administrative Code, shall meet or exceed the following
			 requirements:
(1)
									Certification, as determined by the board, by the Ohio
			 department of mental health and addiction services pursuant to Chapter 5119. of
			 the Revised Code.
(2)
									Any other treatment provider approved by the board, to
			 include:
(a)
										An
			 out-of-state provider, when treatment has already been initiated or completed;
			 or
(b)
										Any provider not certified in accordance with paragraph
			 (A)(1) of this rule.
(3)
									Any treatment
			 provider must be approved prior to a licensee or registrant participating in
			 the program, unless the board finds exceptional circumstances exist, in which
			 case the board may approve the treatment provider during or after
			 treatment.
Ohio Administrative Code › Title 4729:4 - Probation › Chapter 4729:4-1 - Probation Committee › Section 4729:4-1-06 - Requirements for approved monitoring programs

Current through all regulations passed and filed through July 1, 2024
(A)
								An approved
			 monitoring program, as defined in rule
			 4729:4-1-01
			 of the Administrative Code, must be approved by the state board of pharmacy and
			 shall meet or exceed the following requirements:
(1)
									Have board
			 approved policies and procedures which shall include, but not be limited to,
			 the following:
(a)
										The program's standards and procedures for
			 care;
(b)
										The program's standards and training/approval process
			 for personnel.
Ohio Administrative Code › Title 4729:4 - Probation › Chapter 4729:4-1 - Probation Committee › Section 4729:4-1-07 - Summary suspension of a licensee or registrant

Current through all regulations passed and filed through July 1, 2024
(A) An impaired licensee or registrant may be
			 summarily suspended without a prior hearing pursuant to section
			 3719.121 of the Revised Code if,
			 in the opinion of the board, the impaired licensee or registrant poses a danger
			 of immediate and serious harm to others by:
(1) Refusing to seek evaluation, treatment,
			 and rehabilitation for a substance abuse/chemical dependency related
			 impairment;
(2) Not signing and/or
			 complying with the treatment and/or monitoring
			 contract from an approved treatment provider or monitoring program;
(3) Resuming practice before the approved
			 treatment provider or monitoring program has made an assessment and recommends
			 that the licensee or registrant is capable of practicing;
(4) A relapse, as defined in rule
			 4729:4-1-01 of the
			 Administrative Code, of substance abuse/chemical dependency at any
			 time.
Ohio Administrative Code › Title 4729:4 - Probation › Chapter 4729:4-1 - Probation Committee › Section 4729:4-1-08 - Probation committee

Current through all regulations passed and filed through July 1, 2024
(A)
								The probation
			 committee shall consist of two board members appointed by the board president.
			 One alternate board member will be selected in order to perform probation
			 committee functions when an appointed member has a conflict of interest or is
			 unavailable. Each appointee will serve for a period of two years and, at least
			 one of the committee members appointed should include a board member who has
			 previously served on the committee.
(B)
								The probation
			 committee shall approve the form and content of the probation report document,
			 which probationers will be required to submit.
(C)
								Board staff shall
			 review probationer reports and refer reports that meet criteria designated by
			 the probation committee to the committee for review.
(D)
								The probation
			 committee shall meet at least annually with each probationer on a schedule to
			 be determined based, in part, on reports, the probationer's length of time on
			 probation, and/or substantive violations of probation.
(E)
								The probation
			 committee shall review probationer reports to ensure a probationer possesses
			 the requisite judgment, skill, and competence necessary to ensure public safety
			 in the practice of pharmacy.
(F)
								The probation
			 committee shall be responsible for all of the following:
(1)
									Reviewing
			 referrals from treatment providers and recovery monitors as to matters of
			 non-compliance;
(2)
									Reviewing complaints received by the board regarding a
			 probationer's actions;
(3)
									Reviewing deviation requests from board orders and
			 approving, denying, or modifying requests;
(4)
									Reviewing
			 self-reports of non-compliance that do not pose a danger of immediate and
			 serious harm to others;
(5)
									Issuing warning letters to probationers for
			 non-substantive violations of board orders.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-1 - Definition of Dangerous Drugs › Section 4729:5-1-01 - Definitions - terminal distributors of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
As used in this division:
(A) "Terminal distributor of dangerous drugs"
			 or "terminal distributor" means a person who is engaged in the sale of
			 dangerous drugs at retail, or any person, other than a manufacturer,
			 repackager, outsourcing facility, third-party logistics provider, wholesale
			 distributor, or pharmacist, who has possession, custody, or control of
			 dangerous drugs for any purpose other than for that person's own use and
			 consumption.
(1) A terminal distributor of
			 dangerous drugs includes pharmacies, hospitals, nursing homes, and laboratories
			 and all other persons who procure dangerous drugs for sale or other
			 distribution by or under the supervision of a pharmacist, licensed health
			 professional authorized to prescribe drugs or any other person authorized by
			 the board of pharmacy.
(2) A
			 terminal distributor shall comply with the provisions set forth in this
			 division.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-1 - Definition of Dangerous Drugs › Section 4729:5-1-02 - Licensed health professional authorized to prescribe drugs

Current through all regulations passed and filed through July 1, 2024
(A) The following persons licensed in
			 accordance with Chapters 4715., 4723., 4725., 4729., 4730., 4731., and 4741. of
			 the Revised Code are authorized by law to write prescriptions for drugs or
			 dangerous drugs in the course of the person's professional practice:
(1) Chapter 4715. of the Revised Code:
			 dentist.
(2) Chapter 4725. of the
			 Revised Code: optometrist, if that person holds a current therapeutic
			 pharmaceutical agents certificate as defined in section
			 4725.01 of the Revised
			 Code.
(3) Chapter 4731. of the
			 Revised Code: doctor of medicine, doctor of osteopathic medicine and surgery,
			 and doctor of podiatry.
(4) Chapter
			 4741. of the Revised Code: doctor of veterinary medicine.
(5) Chapter 4723. of the Revised Code:
			 advanced practice registered nurse in accordance with paragraph (D) of this
			 rule.
(6) Chapter 4730. of the
			 Revised Code: physician assistant in accordance with paragraph (E) of this
			 rule.
(7) Chapter 4729. of the
			 Revised Code: pharmacist in accordance with paragraph (F) of this
			 rule.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-2 - Licensing and Renewal of Terminal Distributor › Section 4729:5-2-01 - Responsible person - terminal distributor

Current through all regulations passed and filed through July 1, 2024
(A) Except as provided in paragraph (B) of
			 this rule, for a pharmacy licensed as a terminal distributor of dangerous
			 drugs:
(1) Only a pharmacist may be the
			 responsible person whose name appears on the terminal distributor of dangerous
			 drugs license for a pharmacy as defined in division (A) of section
			 4729.01
			 of the Revised Code. A pharmacist shall be the responsible person for no more
			 than one such pharmacy or campus unless granted permission in accordance with
			 paragraph (G) of this rule.
(2) The
			 responsible person shall be responsible for the practice of the profession of
			 pharmacy, including, but not limited to, the supervision and control of
			 dangerous drugs as required in division (B) of section
			 4729.55
			 of the Revised Code, adequate safeguards as required in division (C) of section
			 4729.55
			 of the Revised Code, security and control of dangerous drugs and maintaining
			 all drug records otherwise required.
(3) The person to whom the terminal
			 distributor of dangerous drugs license has been issued and all pharmacists on
			 duty are responsible for compliance with all state and federal laws,
			 regulations, and rules governing the distribution of drugs and the practice of
			 pharmacy.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-2 - Licensing and Renewal of Terminal Distributor › Section 4729:5-2-02 - Terminal distributor of dangerous drugs licensing and renewal

Current through all regulations passed and filed through July 1, 2024
(A)
								All terminal distributor of dangerous drugs licenses
			 issued pursuant to Chapter 4729. of the Revised Code shall expire on the
			 thirty-first day of March of every odd-numbered year. A license shall be
			 renewed biennially according to the provisions of sections
			 4729.54 and
			 4729.55 of the Revised Code and
			 the standard renewal procedure of Chapter 4745. of the Revised
			 Code.
(B)
								An initial terminal distributor of dangerous drugs
			 license issued on or after the thirtieth day of January of every odd-numbered
			 year shall receive an expiration date of the thirty-first day of March of the
			 next odd-numbered year.
(C)
								A terminal distributor of dangerous drugs who seeks to
			 renew a license shall submit an application for renewal and pay the required
			 fee in accordance with section
			 4729.54 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 terminal
			 distributor of dangerous drugs who has experienced a change in responsible
			 person pursuant to rule
			 4729:5-2-01 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 terminal distributor of dangerous drugs who has
			 experienced a change in description pursuant to rule4729:5-2-03 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 rule4729:5-2-03 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 terminal distributor of dangerous drugs license shall be in
			 accordance with sections
			 4729.55 and
			 125.18 of the Revised
			 Code.
(G)
								Licensure pursuant to section
			 4729.54 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 4729:5 - Dangerous Drugs › Chapter 4729:5-2 - Licensing and Renewal of Terminal Distributor › Section 4729:5-2-03 - Change in description of a terminal 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 terminal
			 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 proprietorship,
			 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 per cent stock purchase by another corporation or other
			 business entity.
(5) Two
			 wholly-owned subsidiaries of a parent company are merged.
(6) A currently licensed terminal 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 portion 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 4729:5 - Dangerous Drugs › Chapter 4729:5-2 - Licensing and Renewal of Terminal Distributor › Section 4729:5-2-04 - Procedure for discontinuing business as a terminal distributor of dangerous drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								A terminal
			 distributor of dangerous drugs who plans to discontinue business activities
			 shall file a notice with the 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 terminal
			 distributor discontinuing business.
(2)
									The name,
			 address, and license number of the terminal distributor or other authorized
			 entity where the dangerous drugs will be transferred.
(3)
									The name and
			 address of the secured location where the records of purchase and sale will be
			 kept in accordance with this division of the Administrative
			 Code.
(4)
									The proposed date of discontinuing
			 business.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-01 - Disposal of controlled substances

Current through all regulations passed and filed through July 1, 2024
(A) As used in this rule:
(1) "Controlled substance" has the same
			 meaning as in section
			 3719.01 of the Revised
			 Code.
(2) "Controlled substance
			 proof-of-use sheet" means a record that captures, at a minimum, the following
			 information:
(a) Date;
(b) Patient name;
(c) Drug name;
(d) Drug strength;
(e) Quantity; and
(f) The positive identification of the
			 individuals authorized by this rule who are responsible for removing the
			 dangerous drugs from the medication cart, or other storage area, and
			 transferring the drugs to the secure storage area.
(3) "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.
(4)
(a)
			 "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:
(i) A manual signature on a hard copy
			 record;
(ii) A magnetic card
			 reader;
(iii) A bar code
			 reader;
(iv) A biometric
			 method;
(v) A proximity badge
			 reader;
(vi) A board approved
			 system of randomly generated personal questions;
(vii) 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
(viii) Other effective methods
			 for identifying individuals that have been approved by the board.
(b) A method relying on a magnetic
			 card reader, a bar code reader, a proximity badge reader, or randomly generated
			 questions for identification must also include a private personal identifier,
			 such as a password, for entry into a secure mechanical or electronic
			 system.
(5) "State or
			 local correctional facility" means any of the following:
(a) A "state correctional institution," as
			 defined in section 2967.01 of the Revised
			 Code;
(b) A "local correctional
			 facility," as defined in section
			 2903.13 of the Revised
			 Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-02 - 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 terminal distributor of dangerous drugs
			 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 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-03 - 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 the state board of pharmacy as a terminal distributor of
			 dangerous drugs 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 employee shall
			 be permitted to enter the licensed entity.
(B) Submission of an application for a
			 license as a terminal distributor of dangerous drugs 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 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-04 - Verification of licensure prior to sale or purchase

Current through all regulations passed and filed through July 1, 2024
(A)
								 Before a terminal distributor of dangerous drugs may
			 purchase dangerous drugs at wholesale, the terminal distributor shall query the
			 board's online roster (available on the board's website: www.pharmacy.ohio.gov)
			 to confirm any of the following:
(1)
									The seller is licensed to engage in the sale of
			 dangerous drugs in accordance with section
			 4729.52 of the Revised Code;
			 or
(2)
									The seller is licensed to engage in the occasional sale
			 or distribution of dangerous drugs at wholesale in accordance with rule
			 4729:5-3-09
			 of the Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-05 - Confidentiality of patient records

Current through all regulations passed and filed through July 1, 2024
(A) Records relating to the practice of
			 pharmacy, the administration of drugs, or any patient specific drug transaction
			 are not a public record. A person having custody of, or access to, such records
			 shall not divulge the contents thereof, or provide a copy thereof, to anyone
			 except:
(1) The patient, or owner if the
			 patient is an animal, for whom the prescription or medication order was
			 issued.
(2) The prescriber who
			 issued the prescription or medication order, or a subsequent treating
			 prescriber.
(3) Licensed health
			 care personnel who are responsible for the care of the patient.
(4) A member, inspector, agent, or
			 investigator of the state board of pharmacy or any federal, state, county, or
			 municipal officer whose duty is to enforce the laws of this state or the United
			 States relating to drugs and who is engaged in a specific investigation
			 involving a designated person or drug.
(5) An agent of an Ohio licensing agency that
			 is responsible for the licensure or registration of a health professional
			 authorized to prescribe drugs as defined in section
			 4729.01 of the Revised Code when
			 enforcing that agency's chapter of the Revised Code.
(6) A state or federal agency charged with
			 the responsibility of providing medical care (i.e. medicaid, medicare, workers'
			 compensation, etc.) for the patient upon a written request by an authorized
			 representative of the agency requesting such information.
(7) An agent of a medical insurance company
			 who provides prescription insurance coverage to the patient upon authorization
			 and proof of insurance by the patient or proof of payment by the insurance
			 company for those medications whose information is requested.
(8) An agent who contracts with the terminal
			 distributor of dangerous drugs as a "business associate" in accordance with the
			 regulations promulgated by the secretary of the United States department of
			 health and human services pursuant to the federal standards for privacy of
			 individually identifiable health information.
(9) Any person, other than those listed in
			 paragraphs (A)(1) to (A)(8) of this rule, only when the patient has given
			 consent for such disclosure in writing. Any consent must be signed by the
			 patient and dated. Any consent for disclosure is valid until rescinded by the
			 patient.
In an emergency, the terminal distributor of dangerous drugs
				may disclose the information when, in the professional judgment of the
				pharmacist or healthcare provider, it is deemed to be in the best interest of
				the patient. A pharmacist or healthcare provider making an oral disclosure in
				an emergency situation must prepare a written memorandum showing the patient's
				name, the date and time the disclosure was made, the nature of the emergency,
				and the names of the individuals by whom and to whom the information was
				disclosed.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-06 - Storage of adulterated drugs

Current through all regulations passed and filed through July 1, 2024
To prevent their use, adulterated drugs, as defined in agency
				4729 of the Administrative Code, shall be stored in a separate and secure area
				apart from the storage of drugs used for dispensing, personally furnishing,
				compounding, and administration.
(A) Adulterated drugs shall be stored no
			 longer than one year from the date of adulteration or expiration by those
			 holding a terminal distributor of dangerous drugs license. Adulterated drugs
			 shall be stored in a manner that prohibits access by unauthorized
			 persons.
(B) Dangerous drugs, other
			 than controlled substances, may be destroyed utilizing proper methods of
			 disposal and following the record keeping requirements noted in agency 4729 of
			 the Administrative Code, or may be donated to a pharmacy school pursuant to
			 sections 3715.88 to
			 3715.92 of the Revised Code.
			 Methods of disposal of non- controlled dangerous drugs shall prevent the
			 possession or use of the drugs by unauthorized persons.
(C) Dangerous drugs that are controlled
			 substances shall be disposed of pursuant to rule
			 4729:5-3-01 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-07 - Controlled substances inventory requirements

Current through all regulations passed and filed through July 1, 2024
(A)
								Unless otherwise
			 stated in this division of the Administrative Code, all category III terminal
			 distributor licensees shall complete a controlled substances inventory in
			 accordance with
			 21 CFR
			 1304.11 (9/9/2014).
(B)
								All controlled
			 substance inventories performed in accordance with this rule shall be conducted
			 on an annual basis. The annual inventory may be taken on any date which is
			 within thirteen months of the previous inventory date.
(C)
								The terminal
			 distributor's responsible person shall be responsible for completing and
			 maintaining this inventory record at the location licensed as a terminal
			 distributor of dangerous drugs.
(D)
								All inventory
			 records shall be maintained for a period of three years from the completion
			 date of the inventory and made readily retrievable.
(E)
								When a drug or
			 compound is added to the schedule of controlled substances by state or federal
			 law, rule or regulation, a terminal distributor shall complete an inventory
			 pursuant to this rule of all stocks of such drug or compound no later than ten
			 days of the drug or compound being added to the schedule.
(F)
								In the event a
			 terminal distributor of dangerous drugs commences business with no controlled
			 substances on hand, this fact shall be recorded as the initial
			 inventory.
Effective: 3/1/2019
Five Year Review
				(FYR) Dates: 03/01/2024
Promulgated Under:
				119.03
Statutory
				Authority: 4729.26,
				3719.28
Rule
				Amplifies: 4729.54,
				4729.55
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-08 - Sales of dangerous drugs on-line

Current through all regulations passed and filed through July 1, 2024
(A) All persons selling or offering to sell
			 dangerous drugs via the internet at retail, into, out of, or within Ohio must
			 be properly licensed with the state board of pharmacy.
(B) All terminal distributors of dangerous
			 drugs who sell or offer to sell dangerous drugs at retail on the internet to
			 persons located in Ohio or any other state must make such sales only in
			 compliance with all state and federal laws, rules, and regulations governing the legal distribution of
			 dangerous drugs.
(C) Except as
			 provided in paragraph (F) of this rule, all terminal distributors of dangerous
			 drugs who sell or offer to sell dangerous drugs at retail on the internet to
			 persons located in Ohio shall maintain a digital
			 pharmacy accreditation  from the national association of boards of
			 pharmacy, as approved by the board.
(D) Websites owned and/or maintained by a
			 terminal distributor of dangerous drugs who sell or offer to sell dangerous
			 drugs at retail on the internet to persons located in Ohio or any other state
			 must provide the following information to the public:
(1) Name under which the terminal distributor
			 is licensed to do business as in Ohio.
(2) Full address of the licensed
			 location.
(3) Telephone number
			 where the terminal distributor may be contacted during regular business
			 hours.
(4) A list of the states in
			 which the terminal distributor may legally sell dangerous drugs.
(5) The name, address, and how the state licensing agency and the drug
			 enforcement administration may be contacted in each state in which the person
			 is authorized to do business. This may include a link to the agency's and the
			 drug enforcement administration's website.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-09 - Occasional sale and drug transfers

Current through all regulations passed and filed through July 1, 2024
(A) The term "occasional sale" as used in
			 section 4729.51 of the Revised Code
			 means a wholesale sale of a commercially manufactured dangerous drug to a
			 person licensed in accordance with section
			 4729.52 of the Revised Code,
			 terminal distributor of dangerous drugs or any entity or person exempted from
			 licensure as a terminal distributor of dangerous drugs by
			 any of the following
								:
(1) A
			 pharmacy licensed as a terminal distributor of dangerous drugs;
(2) A licensed terminal distributor of
			 dangerous drugs that is not a pharmacy, but only as authorized in section
			 4729.51 of the Revised
			 Code;
(3)
									A local health department, as defined in paragraph (H)
			 of this rule, licensed as a terminal distributor of dangerous drugs for the
			 purpose of improving or promoting public health within the department's
			 jurisdiction, but only for the sale of non-controlled dangerous drugs;
			 or
(4)
									A drug repository program pursuant to rule
			 4729:5-10-07 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-10 - Employment of individuals with felony convictions

Current through all regulations passed and filed through July 1, 2024
(A) Pursuant to
			 21 C.F.R.
			 1301.76 (6/22/2023), a
			 terminal distributor of dangerous drugs that is a United States drug
			 enforcement administration registrant shall not employ in a position which
			 allows access to controlled substances any person who has been convicted of a
			 felony relating to controlled substances, or who, at any time, has had an
			 application for drug enforcement administration registration denied, revoked,
			 or surrendered for cause.
"For cause" means surrendering a registration in lieu of, or as
				a consequence of, any federal or state administrative, civil, or criminal
				action resulting from an investigation of the individual's handling of
				controlled substances.
(B)
			 Paragraph (A) of this rule does not apply if a waiver is obtained by a licensee
			 pursuant to 21 C.F.R.
			 1307.03 (3/9/2010).
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-11 - Transmission of outpatient prescriptions

Current through all regulations passed and filed through July 1, 2024
(A)
								Oral transmission
			 by a prescriber or a prescriber's agent of an original outpatient prescription
			 authorized by a prescriber shall comply with the requirements of rule
			 4729:5-5-15 of the Administrative Code. For any oral outpatient prescription
			 transmitted by an agent of a prescriber, the prescriber's agent must provide
			 the agent's first and last name when transmitting the prescription. An oral
			 prescription may be transmitted by a prescriber or prescriber's agent to a
			 recording device or voice mail service.
(B)
								Original written
			 outpatient prescriptions shall be authorized and signed by a prescriber, in the
			 same manner as the prescriber would sign a check or legal document, and may be
			 transmitted by the prescriber or the prescriber's agent by facsimile machine to
			 a pharmacy.
(1)
									The facsimile of the prescription must include the
			 identification number of the facsimile machine which is used to transmit the
			 prescription, the full name of the prescriber and, if applicable, the full name
			 of the prescriber's agent transmitting the prescription to the
			 pharmacy.
(2)
									The prescription must comply with the requirements of
			 rule 4729:5-5-15 of the Administrative Code.
(3)
									The original
			 prescription signed by the prescriber from which the facsimile is produced
			 shall not be issued to the patient. The original prescription signed by the
			 prescriber must remain with the patient's records at the location where it was
			 issued for three years from the date of issuance. Following the successful
			 transmission of the prescription, the word "VOID" or "FAXED" shall be written
			 or stamped on the face of the original prescription in a manner that does not
			 destroy any of the original information contained on the
			 prescription.
(4)
									Outpatient prescriptions for schedule II controlled
			 substances may be transmitted by facsimile in accordance with
			 21 C.F.R.
			 1306.11 (5/1/2019) and shall meet the
			 facsimile requirements of this rule.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-12 - Protocols and pre-printed orders for medication administration

Current through all regulations passed and filed through July 1, 2024
(A)
								A terminal distributor of dangerous drugs may
			 distribute or dispense dangerous drugs pursuant to a protocol. As used in this
			 rule, "protocol" means a definitive set of written treatment guidelines with
			 orders for drugs and their specified dosages for administration to individuals
			 under the following circumstances:
(1)
									The provision of medical services to individuals in an
			 emergency situation when the services of a prescriber authorized by the revised
			 code to prescribe dangerous drugs as part of their professional practice are
			 not immediately available. An emergency situation may manifest itself by acute
			 symptoms of sufficient severity that an authorized individual providing medical
			 services under this paragraph could reasonably expect the absence of immediate
			 medical attention to result in placing the health of the individual or, with
			 respect to a pregnant woman, the health of the woman or her unborn child, in
			 serious jeopardy; serious impairment to bodily functions; or serious
			 dysfunction of any bodily organ or part. Examples of emergency situations
			 includes cases such as heart attacks, severe burns, extravasation, overdoses,
			 cyanide poisonings, electrocutions, or severe asthmatic
			 attacks;
(2)
									The administration of biologicals or vaccines to
			 individuals for the purpose of preventing diseases;
(3)
									The
			 administration of vitamin K for prevention of vitamin K deficient bleeding in
			 newborns;
(4)
									The administration of erythromycin for prevention of
			 ophthalmia neonatorum; and
(5)
									The
			 administration of influenza antiviral treatment and chemoprophylaxis to
			 residents and health care personnel at an institutional facility, as defined in
			 agency 4729 of the Administrative Code, according to current guidance issued by
			 the United States center for disease control and prevention.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-14 - General security requirements

Current through all regulations passed and filed through July 1, 2024
(A)
								All terminal
			 distributors of dangerous drugs shall provide effective controls and procedures
			 to:
(1)
									Deter
			 and detect the theft and diversion of dangerous drugs; and
(2)
									Ensure
			 supervision and control of dangerous drugs, as required in division (B) of
			 section 4729.55 of the Revised Code, and
			 adequate safeguards to ensure that dangerous drugs are being distributed in
			 accordance with all state and federal laws, as required in section
			 4729.55 of the Revised
			 Code.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-16 - Returned drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								No drug that has
			 been dispensed pursuant to a prescription or personally furnished by a
			 prescriber and has left the physical premises of the terminal distributor of
			 dangerous drugs shall be returned to the terminal distributor or dispensed or
			 personally furnished again, except as follows:
(1)
									Drugs dispensed
			 for inpatients, as defined in agency 4729 of the Administrative Code, or
			 personally furnished to inpatients provided that:
(a)
										The drugs are
			 packaged in unopened, single-dose or tamper-evident containers;
			 and
(b)
										The drugs have not been in the possession of the
			 ultimate user.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-17 - Automated pharmacy systems

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this
			 rule:
(1)
									"Automated pharmacy system" means a mechanical system that
			 performs operations or activities, other than administration, relative to
			 storage, packaging, compounding, dispensing, or distribution of dangerous drugs
			 that collects, controls, and maintains transaction information and
			 records.
"Automated pharmacy system" does not
				include an "automated drug storage system" utilized by institutional facilities
				pursuant to Chapter 4729:5-9 of the Administrative Code or other locations
				licensed as terminal distributors of dangerous drugs.
(2)
									"Dispense" means
			 the final association of a drug with a particular patient pursuant to a
			 prescription, drug order, or other lawful order of a prescriber and the
			 professional judgment of and the responsibility for interpreting, preparing,
			 compounding, labeling, and packaging a specific drug.
(a)
										In the case of an
			 automated pharmacy system that dispenses dangerous drugs without the final
			 association by a pharmacist, the system shall capture the positive
			 identification of the pharmacist authorizing the patientspecific prescription
			 in the system prior to its dispensation.
(b)
										Nothing in this
			 paragraph shall prohibit an automated pharmacy system from being utilized to
			 restock an automated drug storage system utilized by institutional facilities
			 pursuant to Chapter 4729:5-9 of the Administrative Code or other locations
			 licensed as terminal distributors of dangerous drugs.
(3)
									
			 "Positive identification" has the same meaning as in rule
			 4729:5-5-01
			 of the Administrative Code.
(4)
									"Tamper evident"
			 means a package, storage container or other physical barrier that is sealed or
			 secured in such a way that access to the drugs stored within is not possible
			 without leaving visible proof that such access has been attempted or
			 made.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-19 - Naloxone for emergency use and distribution via automated mechanisms

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in this rule, "tamper-evident" means a package,
			 storage container or other physical barrier that is sealed or secured in such a
			 way that access to the drugs stored within is not possible without leaving
			 visible proof that such access has been attempted or made.
(B)
								In accordance
			 with section
			 4729.515
			 of the Revised Code, a terminal distributor of dangerous drugs may acquire and
			 maintain a supply of naloxone for use in emergency situations and for
			 distribution through an automated mechanism. The naloxone may be maintained at
			 a location other than the location licensed as a terminal distributor of
			 dangerous drugs.
(C)
								In the case of naloxone for use in emergency
			 situations, a terminal distributor of dangerous drugs shall do all of the
			 following:
(1)
									Provide written materials regarding the emergency
			 administration of naloxone to any individual who accesses the naloxone, to
			 include:
(a)
										Specific instruction to summon emergency services pursuant
			 to division (D)(2) of section
			 4729.515
			 of the Revised Code.
(b)
										Procedures for administering naloxone contained within
			 the kit, including the possible administration of multiple
			 doses.
(c)
										Performing rescue breathing and the use of a face
			 shield or other rescue breathing barrier device, which shall be provided with
			 the naloxone.
(d)
										Proper method for placing an individual into the
			 recovery position.
Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-3 - Disposal of Controlled Substances › Section 4729:5-3-20 - Pharmacy pilot or research projects

Current through all regulations passed and filed through July 1, 2024
(A)
								The purpose of
			 this rule is to specify the process and procedures to be followed when a
			 licensee petitions for approval of a pilot or research project for innovative
			 system applications in the practice of pharmacy that are not currently
			 permitted under agency 4729 of the Administrative Code. In reviewing projects,
			 the board shall consider only projects that expand pharmaceutical care services
			 that contribute to positive patient outcomes.
(B)
								A project shall
			 not expand the definition of the practice of pharmacy as set forth in Chapter
			 4729. of the Revised Code and shall not apply to licensees regulated under
			 Chapter 3796. of the Revised Code.
(C)
								Approval of a
			 project by the board may include the grant of a limited exception to or a
			 waiver of rules adopted under Chapter 4729. of the Revised Code. Project
			 approval, including limited exception to or waiver of board rules, shall
			 initially be for a specified period of time not exceeding twenty-four months
			 from commencement of the project.
(D)
								Following the
			 completion of the project period, the board may do any of the following based
			 upon a review of the final project report submitted in accordance with
			 paragraph (I) of this rule and any other factors or information the board deems
			 necessary:
(1)
									Refuse to extend or renew the project;
(2)
									Approve the
			 extension or renewal of a project following consideration of a petition that
			 clearly identifies the need for extension and must include a report similar to
			 the final project report, which should describe and explain any proposed
			 changes to the originally approved and implemented project, and that justifies
			 the need for extending or renewing the term of the project; or
(3)
									Approve the
			 project in perpetuity following a consideration of a petition that clearly
			 identifies and justifies the need to continue the project
			 indefinitely.