Ohio Administrative Code Search

...(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) This rule only applies to compounded drugs intended for animal use by licensed veterinarians. (B) Pharmacies located in Ohio shall comply with the applicable compounding requirements of this chapter. (C) Pharmacies licensed as nonresident terminal distributors shall comply with the applicable requirements of rule 4729:5-8-04 of the Administrative Code. (D) In accordance with applicable fed...

...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 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 21 U.S.C. section 353a (...

...(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...

...(A) Notwithstanding any provision of this chapter of the Administrative Code, a prescriber may delegate a pharmacist to perform medication validation ("final check") of a finished compounded drug preparation prior to it being administered to a patient. (B) A pharmacist performing medication validation in accordance with paragraph (A) of this rule shall comply with the record keeping provision...

...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. (B) "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 Administrative Code: (1) Wholesale distributors of dangerous drugs, inc...

...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...

...(A) Pharmacies pursuant to paragraphs (A) and (B) of rule 4729:8-3-01 of the Administrative Code that dispense drugs listed in Chapter 4729:8-2 of the Administrative Code to outpatients shall report the following dispensing information to the board of pharmacy in accordance with rule 4729:8-3-03 of the Administrative Code: (1) Pharmacy drug enforcement administration registration number. If not a...

...(A) All prescription dispensing information or prescriber personally furnishing information required to be submitted to the board of pharmacy pursuant to rule 4729-8-3-02 of the Administrative Code must be transmitted in the following format specified by the "American Society for Automation in Pharmacy" (ASAP) for prescription monitoring programs: ASAP Version 4.2A Standard for Prescription Drug ...

...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...

...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...

...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...

...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...

...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...

...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...

...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...

...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...

...Pursuant to section 3719.41 of the Revised Code, controlled substance schedule IV is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code. (A) Narcotic drugs Unless specifically excepted by federal drug abuse control laws or unless listed in another schedule, any material, compound, mixture, or preparation that conta...

...Pursuant to section 3719.41 of the Revised Code, controlled substance schedule IV is hereby established, which schedules include the following, subject to amendment pursuant to section 3719.43 or 3719.44 of the Revised Code. (A) Narcotic drugs Unless specifically excepted by federal drug abuse control laws or unless listed in another schedule, any material, compound, mixture, or preparation that conta...

...Pursuant to section 3719.41 of the Revised Code, controlled substance schedule V 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-narcotic preparations Narcotic drugs containing non-narcotic active medicinal ingredients. Any compound, mixture, or preparation that contains any of the followin...