reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-06 - Controlled substances inventory requirements

All regulations passed and filed through January 1,
			 2024
(A) All category
			 III drug distributor licenses shall complete a controlled substances inventory
			 in accordance with 21 CFR 1304.11
			 (9/9/2014).
(B) The drug distributor's responsible person
			 shall be responsible for completing and maintaining this inventory
			 record.
(C) All inventory records
			 shall be maintained for a period of five years from
			 the completion date of the inventory and made readily retrievable.
(D) When a drug or compound is added to the
			 schedule of controlled substances by state or federal law, rule,
			 or regulation, a drug distributor shall complete an inventory pursuant to
			 paragraph (A) of this rule of all stocks of such substance no later than ten
			 days after the drug is added to the schedule.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-07 - Sales of dangerous drugs on-line

Current through all regulations passed and filed
			 through July 1, 2024
(A)
								All persons selling or offering to sell dangerous drugs
			 at retail or wholesale into, out of, or within Ohio must be appropriately
			 licensed by the state board of pharmacy.
(B)
								All drug
			 distributors licensed with the state board of pharmacy and who sell or offer to
			 sell dangerous drugs on the internet to persons located in Ohio or any other
			 state must make such sales only in compliance with all state and federal laws,
			 rules and regulations governing the legal distribution of dangerous
			 drugs.
(C)
								Websites owned and/or maintained by Ohio licensed
			 dangerous drug distributors who sell or offer to sell dangerous drugs on the
			 internet must provide the following information to the public:
(1)
									Name under which
			 the dangerous drug distributor is licensed to do business as in Ohio.
(2)
									Full
			 address of licensed location.
(3)
									Telephone number
			 where the drug distributor may be contacted during regular business
			 hours.
(4)
									A list of the states in which the dangerous drug
			 distributor may legally sell dangerous drugs.
(5)
									The name, address
			 and how the state licensing agency and the drug enforcement administration may
			 be contacted in each state in which the person is authorized to do business.
			 This may include a link to the agency's and the drug enforcement
			 administration's website.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-07 - Sales of dangerous drugs on-line

All regulations passed and filed through January 1,
			 2024
(A) All persons
			 selling or offering to sell dangerous drugs at  wholesale via the
			 internet into, out of, or within Ohio must be appropriately licensed by
			 the state board of pharmacy.
(B)
			 All drug distributors licensed with the state board of pharmacy and who sell or
			 offer to sell dangerous drugs on the internet to persons located in Ohio or any
			 other state must make such sales only in compliance with all state and federal
			 laws, rules, and regulations governing the legal
			 distribution of dangerous drugs.
(C) Websites owned and/or maintained by Ohio
			 licensed dangerous drug distributors who sell or offer to sell dangerous drugs
			 on the internet must provide the following information to the public:
(1) Name under which the dangerous drug
			 distributor is licensed to do business as in Ohio.
(2) Full address of licensed
			 location.
(3) Telephone number
			 where the drug distributor may be contacted during regular business
			 hours.
(4) A list of the states in
			 which the dangerous drug distributor may legally sell dangerous
			 drugs.
(5) The name, address, and how the state licensing agency and the drug
			 enforcement administration may be contacted in each state in which the person
			 is authorized to do business. This may include a link to the agency's and the
			 drug enforcement administration's website.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-08 - Distributor of dangerous drugs samples and complimentary supplies

Current through all regulations passed and filed
			 through July 1, 2024
(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 rule, samples may only be provided to and
			 furnished by a licensed prescriber as defined in rule
			 4729:5-1-02 of the
			 Administrative Code in accordance with paragraph (B) of this rule.
(2) "Complimentary supply" also known as
			 "starter packs," "initial dose packs," "starter stocks," "replacement
			 programs," or any other similar supply means a drug or pharmaceutical
			 preparation that is distributed without charge by licensed drug distributors to
			 pharmacies licensed as terminal distributors of dangerous drugs or prescribers
			 to assist patients in the initiation of drug therapy. A complimentary supply
			 shall not contain the markings or labeling of a sample drug.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-08 - Distributor of dangerous drugs samples and complimentary supplies

All regulations passed and filed through January 1,
			 2024
(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 rule, samples may only be provided to and furnished by a
			 licensed prescriber as defined in rule
			 4729:5-1-02 of the
			 Administrative Code in accordance with paragraph (B) of this rule.
(2) "Complimentary supply" also known as
			 "starter packs," "initial dose packs," "starter stocks," "replacement
			 programs," or any other similar supply means a drug or pharmaceutical
			 preparation that is distributed without charge by licensed drug distributors to
			 pharmacies licensed as terminal distributors of dangerous drugs or prescribers
			 to assist patients in the initiation of drug therapy. A complimentary supply
			 shall not contain the markings or labeling of a sample drug.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-3 - General Provisions › Section 4729:6-3-09 - Satellite distribution sites during a public health emergency

Current through all regulations passed and filed through July 1,
			 2024
(A)
								Upon the governor's declaration of an emergency that
			 affects the public health, the director of health may establish satellite
			 distribution sites under an existing wholesale distributor of dangerous drugs
			 license held by the department. The satellite distribution sites entitle each
			 location to distribute dangerous drugs in accordance with section
			 4729.52 of the Revised
			 Code.
(B)
								The director of health shall notify the board in
			 writing prior to establishing a satellite distribution site in accordance with
			 paragraph (A) of this rule.
(C)
								A satellite
			 distribution site established by the director of health shall comply with all
			 security and recordkeeping requirements for the distribution of dangerous drugs
			 in accordance with this division of the Administrative Code.
(D)
								All satellite
			 distribution sites established in accordance with this rule shall cease to
			 operate upon the cessation of the public health emergency but may be extended
			 at the request of the director of health.
(E)
								The board's
			 executive director, upon consultation with the board president, may grant
			 variances or extensions to the requirements set forth in this rule if it is
			 determined that such a variance is in the public interest.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-4 - Discipline › Section 4729:6-4-01 - Disciplinary actions

Current through all regulations passed and
			 filed through July 1, 2024
(A) The state board of pharmacy, in
			 accordance with Chapter 119. of the Revised Code, may impose any one or more of
			 the following sanctions on a person licensed as a distributor of dangerous
			 drugs for any of the causes set forth in paragraph (B) of this rule:
(1) Suspend, revoke, restrict, limit, or
			 refuse to grant or renew a license;
(2) Reprimand or place the license holder on
			 probation;
(3) Impose a monetary
			 penalty or forfeiture as set forth in section
			 4729.56 of
			 the Revised Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-5 - Wholesale Distributors › Section 4729:6-5-01 - Wholesale distributors - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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 a quarantine area for storage of dangerous drugs
			 that are damaged, deteriorated, misbranded, or adulterated, or that are in
			 immediate or sealed secondary containers that have been opened. Such drugs
			 shall be stored in accordance with paragraph (B) of this rule;
(4)
									Be maintained in
			 a clean and orderly condition;
(5)
									Be free from
			 infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Shall be
			 registered as a business entity with the appropriate state or local
			 authority(s) and must operate out of a location that is zoned for commercial
			 use and not out of a residence or personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-5 - Wholesale Distributors › Section 4729:6-5-01 - Wholesale distributors - general operations

All regulations passed and filed through January 1,
			 2024
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 a quarantine area for storage of
			 dangerous drugs that are damaged, deteriorated, misbranded, or adulterated, or
			 that are in immediate or sealed secondary containers that have been opened.
			 Such drugs shall be stored in accordance with paragraph (B) of this
			 rule;
(4) Be maintained in a clean
			 and orderly condition;
(5) Be free
			 from infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Be registered as a business entity
			 with the appropriate state or local authority(s) and must operate out of a
			 location that is zoned for commercial use and not out of a residence or
			 personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-5 - Wholesale Distributors › Section 4729:6-5-02 - Wholesale distributors - recordkeeping

Current through all regulations passed and filed
			 through July 1, 2024
(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 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 dates of receipt,
			 sale and distribution of the drugs.
(d) The name and principle address of the
			 purchaser or receiver and the address of the location where the drugs were
			 shipped.
(e) A system of records
			 and procedures shall be maintained which prevent the sale or other distribution
			 of dangerous drugs to any person not authorized in accordance with section
			 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-5 - Wholesale Distributors › Section 4729:6-5-02 - Wholesale distributors - recordkeeping

All regulations passed and filed through January 1,
			 2024
(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 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 dates of receipt, sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
(e) A system of
			 records and procedures shall be maintained which prevent the sale or other
			 distribution of dangerous drugs to any person not authorized in accordance with
			 section 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-6 - Virtual Wholesalers Distributors › Section 4729:6-6-01 - Virtual wholesalers - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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 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 dates of receipt, sale and
			 distribution of the drugs.
(d) The
			 name and principle address of the purchaser or receiver and the address of the
			 location where the drugs were shipped.
(e) A system of records and procedures shall
			 be maintained which prevent the sale or other distribution of dangerous drugs
			 to any person not authorized in accordance with section
			 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-6 - Virtual Wholesalers Distributors › Section 4729:6-6-01 - Virtual wholesalers - general operations

All regulations passed and filed through January 1,
			 2024
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 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 dates of receipt, sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
(e) A system of
			 records and procedures shall be maintained which prevent the sale or other
			 distribution of dangerous drugs to any person not authorized in accordance with
			 section 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-7 - Brokers › Section 4729:6-7-01 - Brokers - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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,
			 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 and quantity
			 of the drugs received, distributed, sold, disposed or returned.
(c) The dates of receipt, sale and
			 distribution of the drugs.
(d) The
			 name and principle address of the purchaser or receiver and the address of the
			 location where the drugs were shipped.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-7 - Brokers › Section 4729:6-7-01 - Brokers - general operations

All regulations passed and filed through January 1,
			 2024
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, 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 and quantity of the drugs received, distributed, sold,
			 disposed, or returned.
(c) The dates of receipt, sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-8 - Manufacturers › Section 4729:6-8-01 - Manufacturers - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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 area for storage of dangerous drugs
			 that are damaged, deteriorated, misbranded, or adulterated, or that are in
			 immediate or sealed secondary containers that have been opened. Such drugs
			 shall be stored in accordance with paragraph (B) of this rule;
(4)
									Be maintained in
			 a clean and orderly condition;
(5)
									Be free from
			 infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Shall be
			 registered as a business entity with the appropriate state or local
			 authority(s) and must operate out of a location that is zoned for commercial
			 use and not out of a residence or personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-8 - Manufacturers › Section 4729:6-8-01 - Manufacturers - general operations

All regulations passed and filed through January 1,
			 2024
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 area for storage of
			 dangerous drugs that are damaged, deteriorated, misbranded, or adulterated, or
			 that are in immediate or sealed secondary containers that have been opened.
			 Such drugs shall be stored in accordance with paragraph (B) of this
			 rule;
(4) Be maintained in a clean
			 and orderly condition;
(5) Be free
			 from infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Be registered as a business entity
			 with the appropriate state or local authority(s) and must operate out of a
			 location that is zoned for commercial use and not out of a residence or
			 personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-8 - Manufacturers › Section 4729:6-8-02 - Manufacturers - recordkeeping

Current through all regulations passed and filed
			 through July 1, 2024
(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 address of the location from which the drugs were
			 shipped.
(b) The name, national
			 drug code and quantity of the drugs received, distributed, sold, disposed or
			 returned.
(c) The dates of receipt,
			 sale and distribution of the drugs.
(d) The name and principle address of the
			 purchaser or receiver and the address of the location where the drugs were
			 shipped.
(e) A system of records
			 and procedures shall be maintained which prevent the sale or other distribution
			 of dangerous drugs to any person not authorized in accordance with section
			 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-8 - Manufacturers › Section 4729:6-8-02 - Manufacturers - recordkeeping

All regulations passed and filed through January 1,
			 2024
(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 address of the location from which
			 the drugs were shipped.
(b) The
			 name, national drug code and quantity of the drugs received, distributed, sold,
			 disposed, or returned.
(c) The dates of receipt, sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
(e) A system of
			 records and procedures shall be maintained which prevent the sale or other
			 distribution of dangerous drugs to any person not authorized in accordance with
			 section 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-9 - Repackagers › Section 4729:6-9-01 - Repackagers - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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 area for storage of dangerous drugs
			 that are damaged, deteriorated, misbranded, or adulterated, or that are in
			 immediate or sealed secondary containers that have been opened. Such drugs
			 shall be stored in accordance with paragraph (B) of this rule;
(4)
									Be maintained in
			 a clean and orderly condition;
(5)
									Be free from
			 infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Shall be
			 registered as a business entity with the appropriate state or local
			 authority(s) and must operate out of a location that is zoned for commercial
			 use and not out of a residence or personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-9 - Repackagers › Section 4729:6-9-01 - Repackagers - general operations

All regulations passed and filed through January 1,
			 2024
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 area for storage of
			 dangerous drugs that are damaged, deteriorated, misbranded, or adulterated, or
			 that are in immediate or sealed secondary containers that have been opened.
			 Such drugs shall be stored in accordance with paragraph (B) of this
			 rule;
(4) Be maintained in a clean
			 and orderly condition;
(5) Be free
			 from infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Be registered as a business entity
			 with the appropriate state or local authority(s) and must operate out of a
			 location that is zoned for commercial use and not out of a residence or
			 personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-9 - Repackagers › Section 4729:6-9-02 - Repackagers - recordkeeping

Current through all regulations passed and filed
			 through July 1, 2024
(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 address of the location from which the drugs were
			 shipped.
(b) The name, national
			 drug code and quantity of the drugs received, distributed, sold, disposed or
			 returned.
(c) The dates of receipt,
			 sale and distribution of the drugs.
(d) The name and principle address of the
			 purchaser or receiver and the address of the location where the drugs were
			 shipped.
(e) A system of records
			 and procedures shall be maintained which prevent the sale or other distribution
			 of dangerous drugs to any person not authorized in accordance with section
			 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-9 - Repackagers › Section 4729:6-9-02 - Repackagers - recordkeeping

All regulations passed and filed through January 1,
			 2024
(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 address of the location from which
			 the drugs were shipped.
(b) The
			 name, national drug code, and quantity of the
			 drugs received, distributed, sold, disposed, or
			 returned.
(c) The dates of receipt,
			 sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
(e) A system of
			 records and procedures shall be maintained which prevent the sale or other
			 distribution of dangerous drugs to any person not authorized in accordance with
			 section 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-10 - Outsourcing Facilities › Section 4729:6-10-01 - Outsourcing facilities - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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 storage of dangerous drugs
			 that are damaged, deteriorated, misbranded, or adulterated, or that are in
			 immediate or sealed secondary containers that have been opened. Such drugs
			 shall be stored in accordance with paragraph (B) of this rule;
(4)
									Be maintained in
			 a clean and orderly condition;
(5)
									Be free from
			 infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Shall be
			 registered as a business entity with the appropriate state or local
			 authority(s) and must operate out of a location that is zoned for commercial
			 use and not out of a residence or personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-10 - Outsourcing Facilities › Section 4729:6-10-01 - Outsourcing facilities - general operations

All regulations passed and filed through January 1,
			 2024
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 storage of
			 dangerous drugs that are damaged, deteriorated, misbranded, or adulterated, or
			 that are in immediate or sealed secondary containers that have been opened.
			 Such drugs shall be stored in accordance with paragraph (B) of this
			 rule;
(4) Be maintained in a clean
			 and orderly condition;
(5) Be free
			 from infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Be registered as a business entity
			 with the appropriate state or local authority(s) and must operate out of a
			 location that is zoned for commercial use and not out of a residence or
			 personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-10 - Outsourcing Facilities › Section 4729:6-10-02 - Outsourcing facilities - recordkeeping

Current through all regulations passed and filed
			 through July 1, 2024
(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 the address of the location from which the drugs were
			 shipped.
(b) The name, formulation
			 (i.e. active ingredients), dosage form and quantity of the drugs received,
			 distributed, sold, disposed or returned.
(c) The dates of receipt, sale and
			 distribution of the drugs.
(d) The
			 name and principle address of the purchaser or receiver and the address of the
			 location where the drugs were shipped.
(e) A system of records and procedures shall
			 be maintained which prevent the sale or other distribution of dangerous drugs
			 to any person not authorized in accordance with section
			 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-10 - Outsourcing Facilities › Section 4729:6-10-02 - Outsourcing facilities - recordkeeping

All regulations passed and filed through January 1,
			 2024
(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 the address of the location from which
			 the drugs were shipped.
(b) The
			 name, formulation (i.e., active ingredients),
			 dosage form, and quantity of the drugs received,
			 distributed, sold, disposed, or
			 returned.
(c) The dates of receipt,
			 sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
(e) A system of
			 records and procedures shall be maintained which prevent the sale or other
			 distribution of dangerous drugs to any person not authorized in accordance with
			 section 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-11 - Third Party Logistics Providers › Section 4729:6-11-01 - Third party logistics providers - general operations

Current through all regulations passed and filed
			 through July 1, 2024
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, temperature,
			 sanitation, humidity, space, equipment, and security conditions;
(3)
									Have a
			 quarantine area for storage of dangerous drugs that are damaged, deteriorated,
			 misbranded, or adulterated, or that are in immediate or sealed secondary
			 containers that have been opened. Such drugs shall be stored in accordance with
			 paragraph (B) of this rule;
(4)
									Be maintained in
			 a clean and orderly condition;
(5)
									Be free from
			 infestation by insects, rodents, birds, or vermin of any kind.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-11 - Third Party Logistics Providers › Section 4729:6-11-01 - Third- party logistics providers - general operations

All regulations passed and filed through January 1,
			 2024
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, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
(3) Have a quarantine area for storage of
			 dangerous drugs that are damaged, deteriorated, misbranded, or adulterated, or
			 that are in immediate or sealed secondary containers that have been opened.
			 Such drugs shall be stored in accordance with paragraph (B) of this
			 rule;
(4) Be maintained in a clean
			 and orderly condition;
(5) Be free
			 from infestation by insects, rodents, birds, or vermin of any kind;
(6)
									Shall be
			 registered as a business entity with the appropriate state or local
			 authority(s) and must operate out of a location that is zoned for commercial
			 use and not out of a residence or personal dwelling.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-11 - Third Party Logistics Providers › Section 4729:6-11-02 - Third party logistics providers - recordkeeping

Current through all regulations passed and filed
			 through July 1, 2024
(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
			 location from which the drugs were shipped.
(b) The name, national drug code and quantity
			 of the drugs received, distributed, sold, disposed or returned.
(c) The dates of receipt, sale and
			 distribution of the drugs.
(d) The
			 name and principle address of the purchaser or receiver and the address of the
			 location where the drugs were shipped.
(e) A system of records and procedures shall
			 be maintained which prevent the sale or other distribution of dangerous drugs
			 to any person not authorized in accordance with section
			 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:6 - Distribution of Dangerous Drugs › Chapter 4729:6-11 - Third Party Logistics Providers › Section 4729:6-11-02 - Third-party logistics providers - recordkeeping

All regulations passed and filed through January 1,
			 2024
(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 location from which the drugs were shipped.
(b) The name, national drug code, and quantity of the drugs received, distributed,
			 sold, disposed, or returned.
(c) The dates of receipt, sale, and distribution of the drugs.
(d) The name and principal
			 address of the purchaser or receiver and the address of the location where the
			 drugs were shipped.
(e) A system of
			 records and procedures shall be maintained which prevent the sale or other
			 distribution of dangerous drugs to any person not authorized in accordance with
			 section 4729.51 of the Revised Code.
			 Such procedures and records shall meet the requirements set forth in rule
			 4729:6-3-04 of the
			 Administrative Code.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-1 › Section 4729:7-1-01 - Compounding references

Current through all regulations passed and filed through July 1, 2024
As used in this division and in agency
				4729 of the Administrative Code:
(A)
								"The national
			 institute for occupational safety and health's list of antineoplastic and other
			 hazardous drugs in healthcare settings" means publication number 2016-161 or
			 any official supplement thereto (March 10, 2020).
(B)
								"United States
			 Pharmacopeia Chapter <795>" or "USP <795>" means United States
			 Pharmacopeia Chapter <795>, USP 43-NF 38, or any official supplement
			 thereto (March 10, 2020).
(C)
								"United States Pharmacopeia Chapter <797>" or
			 "USP <797>" means United States Pharmacopeia Chapter <797>, USP
			 43-NF 38, or any official supplement thereto (March 10, 2020).
(D)
								"United States
			 Pharmacopeia Chapter <800>" or "USP <800>" means United States
			 Pharmacopeia Chapter <800>, USP 43-NF 38, or any official supplement
			 thereto (March 10, 2020).
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-2 › Section 4729:7-2-01 - Definitions - pharmacy compounding

Current through all regulations passed and filed through July 1, 2024
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)
								"Business day"
			 means any day other than Saturday, Sunday or a holiday recognized by the state
			 of Ohio on which the offices of the board of pharmacy are not open for
			 business.
(D)
								"Compounding" means the preparation, mixing,
			 assembling, packaging, and labeling of one or more drugs. Compounding includes
			 the combining, admixing, mixing, diluting, pooling, reconstituting,
			 repackaging, or otherwise altering of a drug or bulk drug substance. A pharmacy
			 engaged in the following shall not be required to comply with 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.
(3)
									Sterile compounded drug preparations in accordance with
			 rule 4729:7-2-02 of the Administrative Code.
(4)
									The addition of a
			 flavoring agent to a conventionally manufactured drug product.
Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-2 › Section 4729:7-2-02 - Sterile compounding exemptions

Current through all regulations passed and filed through July 1, 2024
The following sterile drug compounding
				is exempted from the requirements of this chapter:
Preparation of a non-hazardous, conventionally
			 manufactured sterile products in accordance with the directions contained in
			 approved labeling provided by the product's manufacturer if preparation
			 complies with all the following:
(A)
									Administration of the drug product must begin within
			 one hour of beginning the preparation (e.g., within one hour of initial entry
			 into or puncture of a singledose container).
(B)
									Aseptic technique
			 must be followed. Procedures must be in place to minimize the potential for
			 contact with nonsterile surfaces, introduction of particulate matter or
			 biological fluids, and mix-ups with other products or compounded sterile
			 preparations.
(C)
									A pharmacist or prescriber performs the final check of
			 the product and documents that it was conducted using positive
			 identification.
(D)
									Any unused starting ingredient that is not labeled as a
			 multiple dose container must be discarded after preparation is
			 complete.
(E)
									Unless administered immediately, the drug product
			 described in this paragraph shall bear a label listing the name of the drug (if
			 not legible) and date and time prepared or beyond-use date.