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Ohio Administrative Code Search

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Rule 4729:6-2-03 | Criminal Records Checks.

...(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...

Rule 4729:6-2-03 | Criminal records checks.

...(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...

Rule 4729:6-2-04 | Drug Distributor Applications.

...(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...

Rule 4729:6-2-04 | Drug distributor applications.

...(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...

Rule 4729:6-3-01 | Disposal of controlled substances.

...(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 ...

Rule 4729:6-3-01 | Disposal of controlled substances.

...(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 ...

Rule 4729:6-3-02 | Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

...(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...

Rule 4729:6-3-02 | Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.

...(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...

Rule 4729:6-3-03 | Inspections and corrective actions.

...(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 ...

Rule 4729:6-3-03 | Inspections and corrective actions.

...(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...

Rule 4729:6-3-08 | Distributor of dangerous drugs samples and complimentary supplies.

...(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...

Rule 4729:6-3-08 | Distributor of dangerous drugs samples and complimentary supplies.

...(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...

Rule 4729:6-5-01 | Wholesale Distributors - General Operations.

...The following requirements shall apply to all persons licensed as a wholesale distributor 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...

Rule 4729:6-5-01 | Wholesale distributors - general operations.

...The following requirements shall apply to all persons licensed as a wholesale distributor 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...

Rule 4729:6-6-01 | Virtual wholesalers - general operations.

...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...

Rule 4729:6-6-01 | Virtual wholesalers - general operations.

...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...

Rule 4729:6-7-01 | Brokers - general operations.

...The following requirements shall apply to all persons licensed as a wholesale distributor of dangerous drugs with a broker classification: (A) Brokers shall establish and maintain records of all transactions regarding the transfer, sale, or other disposition of dangerous drugs. (1) The records shall include, but shall not be limited to, the following information: (a) The source of the drugs, includ...

Rule 4729:6-8-01 | Manufacturers - General Operations.

...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 quarantine...

Rule 4729:6-8-01 | Manufacturers - general operations.

...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...

Rule 4729:6-9-01 | Repackagers - General Operations.

...The following requirements shall apply to all persons licensed as a repackager 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 quarantine a...

Rule 4729:6-9-01 | Repackagers - general operations.

...The following requirements shall apply to all persons licensed as a repackager 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 quaranti...

Rule 4729:6-10-01 | Outsourcing Facilities - General Operations.

...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 area for s...

Rule 4729:6-10-01 | Outsourcing facilities - general operations.

...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...

Rule 4729:6-11-01 | Third-party logistics providers - general operations.

...The following requirements shall apply to all persons licensed as third-party logistics providers: (A) All facilities where dangerous drugs are stored, warehoused, handled, held, offered, marketed, or displayed 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, t...

Rule 4729:7-2-01 | Definitions - pharmacy compounding.

...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...