Ohio Administrative Code Search
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Rule 4729:6-3-08 | Distributor of dangerous drugs samples and complimentary supplies.
...dministrative Code and Chapters 4729., 3719., and 3715. of the Revised Code. (D) A drug distributor shall comply with rule 4729:6-3-04 of the Administrative Code prior to the sale or distribution of complimentary supplies and samples. (E) Nothing in this rule prohibits a pharmacist working, regardless of compensation, in a charitable pharmacy from dispensing a sample drug to a person in accordan... |
Rule 4729:6-3-08 | Distributor of dangerous drugs samples and complimentary supplies.
...dministrative Code and Chapters 4729., 3719., and 3715. of the Revised Code. (D) A drug distributor shall comply with rule 4729:6-3-04 of the Administrative Code prior to the sale or distribution of complimentary supplies and samples. (E) Nothing in this rule prohibits a pharmacist working, regardless of compensation, in a charitable pharmacy from dispensing a sample drug to a person in accordan... |
Rule 4729:6-6-01 | Virtual wholesalers - general operations.
...or other transfer 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 location from which the drugs were shipped. (b) The name, national drug code, quantity of the drugs received, distributed, sold, disposed or returned. (c) The ... |
Rule 4729:6-6-01 | Virtual wholesalers - general operations.
...or other transfer 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 location from which the drugs were shipped. (b) The name, national drug code, quantity of the drugs received, distributed, sold, disposed, or returned. (c) The... |
Rule 4729:6-8-01 | Manufacturers - general operations.
...ous 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 area for storage of dangerous drugs that are damaged, deteriorated, misbranded, ... |
Rule 4729:6-10-01 | Outsourcing facilities - general operations.
...acilities: (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 storage of dangerous drugs that are damaged, deteriorated, misbranded, ... |
Rule 4729:7-2-01 | Definitions - pharmacy compounding.
...h the provisions of this chapter: (1) The preparation of non-hazardous, conventionally manufactured non-sterile products in accordance with the directions contained in the approved labeling provided by the product's manufacturer. A pharmacist shall perform the final check of the product. (2) The preparation of radiopharmaceuticals as defined in agency 4729 of the Administrative Code. (... |
Rule 4729:7-2-03 | Drugs compounded in a pharmacy.
...ith paragraph (C) of rule 4729:7-2-01 of the Administrative Code. (B) For all sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <797>. This paragraph does not apply to sterile compounded drugs exempted from the requirements of this chapter in accordance with rule 4729:7-2-02 of the Administrative Code. (C) For all antineoplastic compounded ... |
Rule 4729:7-2-03 | Drugs compounded in a pharmacy.
...ith paragraph (C) of rule 4729:7-2-01 of the Administrative Code. (B) For all sterile compounded drug preparations, the pharmacy shall comply with United States pharmacopeia chapter <797>. This paragraph does not apply to sterile compounded drugs exempted from the requirements of this chapter in accordance with rule 4729:7-2-02 of the Administrative Code. (C) For all antineoplastic compounded ... |
Rule 4729:7-3-01 | Definitions - prescriber compounding.
...as the same meaning as in section 3719.01 of the Revised Code. (F) "Dangerous drug" has the same meaning as in section 4729.01 of the Revised Code. (G) "Dilution" means a process of reducing the concentration of a solute in solution, usually by mixing with a solvent. (H) "Hazardous drug" means any antineoplastic drug listed in table one on the national institute for occupational safety and ... |
Rule 4729:7-3-02 | Exemptions.
...tions. 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 drugs strictly in ... |
Rule 4729:7-3-03 | Non-Hazardous Drugs Compounded by a Prescriber.
...scriber shall comply with either: (1) Rule 4729:7-3-04 of the Administrative Code; or (2) United States pharmacopeia chapter <797>. (D) For all hazardous non-sterile and sterile compounded drug preparations, a prescriber shall comply with rule 4729:7-3-05 of the Administrative Code. (E) The responsible person of a facility where a prescriber is engaged in the compounding of dangerous drugs... |
Rule 4729:7-3-04 | Immediate-Use, Sterile Non-Hazardous Drugs Compounded by a Prescriber.
... responsible for all the following: (1) Developing and implementing appropriate compounding procedures; (2) Overseeing facility compliance with this rule; (3) Compliance with Title 21 U.S.C. section 353a (11/27/2013) and all other applicable federal and state laws, regulations and rules; (4) Ensuring training and competency of compounding personnel; (5) Ensuring that compounded drug pre... |
Rule 4729:7-3-05 | Hazardous drugs compounded by a prescriber.
...esponsible 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 applicable federal and state laws, regulations and rules; (4) Ensuring training and competency of compounding personnel; (5) Ensuring e... |
Rule 4729:7-3-06 | Record Keeping.
...e 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 electronically created and maintained, provided that the system that creates and maintain... |
Rule 4729:8-1-01 | Ohio automated rx reporting system - definitions.
...as 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 accordance with section 4729.52 of the Revised Code and division 4729:6 of the A... |
Rule 4729:8-3-01 | Entities required to submit information.
... Code in accordance with section 4729.771 of the Revised Code. (G) An opioid treatment program licensed as a terminal distributor of dangerous drugs is exempted from the reporting requirements of this division. (1) An opioid treatment program shall report patient information via the central registry established in rule 5122-40-08 of the Administrative Code. (2) Reporting of patient informat... |
Rule 4729:8-4-03 | Access to opioid treatment program data provided by the Ohio department of mental health and addiction services.
...ion 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 of the Revised Code; (3) The director of health as authorized under section 4729.80 of the Revised Code; (4) An individual listed in paragraphs (A)(1) and (A)(2) of this rule who i... |
Rule 4729:8-4-04 | Access to overdose data provided by the Ohio department of health.
...ion 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 of the Revised Code; (3) The director of health as authorized under section 4729.80 of the Revised Code; (4) An individual listed in paragraphs (A)(1) and (A)(2) of this rule who is... |
Rule 4729:9-1-01 | Schedule I controlled substances.
...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... |
Rule 4729:9-1-01 | Schedule I controlled substances.
...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 c... |
Rule 4729:9-1-01 | Schedule I controlled substances.
...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 c... |
Rule 4729:9-1-01 | Schedule I controlled substances.
...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... |
Rule 4729:9-1-02 | Schedule II controlled substances.
...Pursuant to section 3719.41 of the Revised Code, controlled substance schedule II is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code. (A) Narcotics-opium and opium derivatives Unless specifically excepted under federal drug abuse control laws or unless listed in another schedule, any of the following substan... |
Rule 4729:9-1-03 | Schedule III controlled substances.
...Pursuant to section 3719.41 of the Revised Code, controlled substance schedule III is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code. (A) Stimulants Unless specifically excepted under federal drug abuse control laws or unless listed in another schedule, any material, compound, mixture, or preparation that conta... |