Ohio Administrative Code Search

...(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 determin...

...(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 4...

...(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...

...(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. (2) "Prescriber" has the same meaning as in secti...

...(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. (2) "Prescriber" has the same meaning as in secti...

...(A) As used in this rule: (1) "Sample" means a dangerous drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one time, had been placed in a container plainly marked as a sample by a manufacturer. Except as provided in paragraph (E) of this ru...

...(A) As used in this rule: (1) "Sample" means a dangerous drug or pharmaceutical preparation that would be hazardous to health or safety if used without the supervision of a licensed health professional authorized to prescribe drugs, or a drug of abuse, and that, at one time, had been placed in a container plainly marked as a sample by a manufacturer. Except as provided in paragraph (E) of this ru...

...The following requirements shall apply to all persons licensed as a wholesale distributor of dangerous drugs with a virtual wholesaler classification: (A) Virtual wholesalers shall establish and maintain inventories and records of all transactions regarding the receipt, sale and distribution or other transfer of dangerous drugs. (1) The records shall include, but not be limited to, the following inf...

...The following requirements shall apply to all persons licensed as a wholesale distributor of dangerous drugs with a virtual wholesaler classification: (A) Virtual wholesalers shall establish and maintain inventories and records of all transactions regarding the receipt, sale, and distribution or other transfer of dangerous drugs. (1) The records shall include, but not be limited to, the following in...

...The following requirements shall apply to all persons licensed as a manufacturer of dangerous drugs: (A) All facilities shall: (1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; (2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions; (3) Have a quaran...

...The following requirements shall apply to all persons licensed as outsourcing facilities: (A) All facilities shall: (1) Be of suitable size and construction to facilitate cleaning, maintenance, and proper operations; (2) Have storage areas designed to provide adequate lighting, ventilation, temperature, sanitation, humidity, space, equipment, and security conditions; (3) Have a quarantine ar...

...As used in this chapter of the Administrative Code: (A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms. (B) "Beyond-use date" means either the date or time and date after which a compounded drug preparation must not be used or administration must not begin. The beyond-use date is determined from the date/time that preparation of the compounded drug is initiated. (C...

...(A) For all non-sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <795>. This paragraph does not apply to non-sterile compounded preparations exempted from the requirements of this chapter in accordance with paragraph (C) of rule 4729:7-2-01 of the Administrative Code. (B) For all sterile compounded drug preparations, the pharmacy shall comply...

...(A) For all non-sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <795>. This paragraph does not apply to non-sterile compounded preparations exempted from the requirements of this chapter in accordance with paragraph (C) of rule 4729:7-2-01 of the Administrative Code. (B) For all sterile compounded drug preparations, the pharmacy shall comply...

...As used in Chapter 4729:7-3 of the Administrative Code: (A) "Antineoplastic" means a dangerous drug that blocks the formation of neoplasms. (B) "Beyond-use date" or "beyond-use dating" means either the date or time after which a compounded drug preparation must not be used, or administration must not begin, and must be discarded. The beyond-use date is determined from the date/time that prepa...

...(A) Licensing exemptions. Persons listed in divisions (A)(1) to (A)(3) of section 4729.541 of the Revised Code shall be exempted from licensure as a terminal distributor of dangerous drugs as required in division (D)(1) of section 4729.541 of the Revised Code for any of the following: (1) The preparation of a device, as defined in Title 21 U.S. Code section 321 (12/13/2016), containing dangerous...

...(A) Except as provided in paragraph (L) of this rule, all non-hazardous, non-sterile compounded drug preparations shall be prepared in accordance with United States pharmacopeia chapter <795>. (B) Except as provided in paragraph (C) of this rule, all non-hazardous, sterile compounded drug preparations, shall be prepared in accordance with United States pharmacopeia chapter <797>. (C) For all...

...(A) The responsible person of a facility where a prescriber is engaged in the compounding of immediate-use, sterile non-hazardous dangerous drug preparations in accordance with paragraph (B) of this rule shall be responsible for all the following: (1) Developing and implementing appropriate compounding procedures; (2) Overseeing facility compliance with this rule; (3) Compliance with Title ...

...(A) The responsible person of a facility where a prescriber is engaged in the compounding or handling of hazardous dangerous drugs shall be responsible for all of the following: (1) Developing and implementing appropriate compounding policies and procedures; (2) Overseeing facility compliance with this rule; (3) Compliance with Title 21 U.S. Code section 353a (November 27, 2013) and all other ...

...(A) The responsible person shall maintain the following records relating to the compounding of dangerous drugs: (1) All drug orders and records, including logs, relating to the compounding of drugs. Such drug orders and records may be retained by any process providing an exact duplicate of the original order or prescription. (2) All records maintained pursuant to this rule may be electronica...

...As used in division 4729:8 of the Administrative Code: (A) "Controlled substance" has the same meaning as in section 3719.01 of the Revised Code and Chapter 4729:9-1 of the Administrative Code. (B) "Central fill pharmacy" has the same meaning as in rule 4729:5-5-19 of the Administrative Code. (C) "Distributor of dangerous drugs" or "drug distributor" means the following persons licensed in ac...

...The following entities are required to submit the specified dispensing, personal furnishing, or wholesale sale information in accordance with this chapter of the Administrative Code to the state board of pharmacy for the operation of the drug database: (A) All pharmacies located within this state and licensed as a terminal distributor of dangerous drugs shall report all drugs listed in Chapter 4729:8-2...

...(A) Pursuant to section 4729.80 of the Revised Code, the following persons shall be permitted to access opioid treatment program data provided by the Ohio department of mental health and addiction services in accordance with section 4729.772 of the Revised Code: (1) Prescriber and prescriber delegates as authorized under section 4729.80 of the Revised Code; (2) Pharmacist and pharmacist ...

...(A) Pursuant to section 4729.80 of the Revised Code, the following persons shall be permitted to access drug overdose data provided by the Ohio department of health in accordance with section 4729.772 of the Revised Code: (1) Prescriber and prescriber delegates as authorized under section 4729.80 of the Revised Code; (2) Pharmacist and pharmacist delegates as authorized under section 4729.80...

...Pursuant to section 3719.41 of the Revised Code, controlled substance schedule I is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code. (A) As used in this rule: (1) "Synthetic" unless specifically excepted or unless listed in another schedule, means any substance, material, compound, mixture, or preparation that contains any qu...