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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 4729:6-5-02 | Wholesale distributors - recordkeeping.

...(A) Wholesale distributors of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the receipt, sale and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principle address of the seller or transferor, and the addre...

Rule 4729:6-5-02 | Wholesale distributors - recordkeeping.

...(A) Wholesale distributors of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the receipt, sale, and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principal address of the seller or transferor, and the addr...

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, includi...

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 4729:6-8-02 | Manufacturers - recordkeeping.

...(A) Manufacturers of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the manufacture, receipt, sale and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principle address of the seller or transferor, and the a...

Rule 4729:6-8-02 | Manufacturers - recordkeeping.

...(A) Manufacturers of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the manufacture, receipt, sale, and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principal address of the seller or transferor, and the ...

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 4729:6-9-02 | Repackagers - recordkeeping.

...(A) Repackagers of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the repackaging, receipt, sale and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principle address of the seller or transferor, and the add...

Rule 4729:6-9-02 | Repackagers - recordkeeping.

...(A) Repackagers of dangerous drugs shall establish and maintain inventories and records of all transactions regarding the repackaging, receipt, sale, and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principal address of the seller or transferor, and the ad...

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 4729:6-10-02 | Outsourcing facilities - recordkeeping.

...(A) Outsourcing facilities shall establish and maintain inventories and records of all transactions regarding the compounding, manufacturing, sale, receipt and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principle address of the seller or transferor, and ...

Rule 4729:6-10-02 | Outsourcing facilities - recordkeeping.

...(A) Outsourcing facilities shall establish and maintain inventories and records of all transactions regarding the compounding, manufacturing, sale, receipt, and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principal address of the seller or transferor, and...

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 4729:6-11-01 | 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 4729:6-11-02 | Third party logistics providers - recordkeeping.

...(A) Third party logistics providers shall establish and maintain inventories and records of all transactions regarding the receipt, sale and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principle address of the seller or transferor, and the address of the ...

Rule 4729:6-11-02 | Third-party logistics providers - recordkeeping.

...(A) Third-party logistics providers shall establish and maintain inventories and records of all transactions regarding the receipt, sale, and distribution or other disposition of dangerous drugs. (1) The records shall include, but not be limited to, the following information: (a) The source of the drugs, including the name and principal address of the seller or transferor, and the address of the...

Rule 4729:7-2-03 | Drugs compounded in a pharmacy.

...(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...