Ohio Administrative Code Search

...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. (2) Manufacturers of dangerous drugs. (3) Outsourcing facilities. (4) Third-party logistics providers. (5) Re...

...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. (2) Manufacturers of dangerous drugs. (3) Outsourcing facilities. (4) Third-party logistics providers. (5) Re...

...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. (2) Manufacturers of dangerous drugs. (3) Outsourcing facilities. (4) Third-party logistics providers. (5) Re...

...(A) Upon the effective date of this rule: (1) All drug distributor licenses issued pursuant to section 4729.52 of the Revise Code shall be effective for a period of twelve months from the first day of July of each year. A license shall be renewed by the board for a like period, annually, according to the provisions of sections 4729.52 and 4729.53 of the Revised Code, and the standard renewal ...

...(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 busine...

...(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 d...

...(A) The following information shall be required on a form supplied by the state board of pharmacy from each person making application for a license as a distributor of dangerous drugs: (1) The name, full physical business address (not a post office box), and telephone number. (2) All trade, fictitious, or business names used by the licensee (e.g. "doing business as" or "formerly known as...

...(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 ...

...(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...