reglab/statecodes huggingface dataset:
Ohio Administrative Code › Title 4725 - Ohio Vision Professional Board › Chapter 4725-16 - Additional Therapeutic Pharmaceutical Agents › Section 4725-16-04 - Standards and procedures for review of "Ohio Automated Rx Reporting System" (OARRS)

Current through all regulations passed and filed through July 1, 2024
(A) For purposes of this rule:
(1) "OARRS" means the "Ohio Automated Rx
			 Reporting System" drug database established and maintained pursuant to section
			 4729.75 of the Revised
			 Code.
(2) "OARRS report" means a
			 report of information related to a specified patient generated by the drug
			 database established and maintained pursuant to section
			 4729.75 of the Revised
			 Code.
(3) "Personally furnish"
			 means the distribution of drugs by a prescriber to the prescriber's patients
			 for use outside the prescriber's practice setting.
(4) "Protracted basis" means a period in
			 excess of twelve continuous weeks.
(5) "Reported drugs" means all the drugs
			 listed in rule
			 4729-37-02 of the Administrative
			 Code that are required to be reported to the drug database established and
			 maintained pursuant to section
			 4729.75 of the Revised Code,
			 including:
(a) Controlled substances in
			 schedules II, III, IV, and V, and
(b) All dangerous drug products containing
			 carisoprodol or tramadol.
(c) Other
			 non-controlled dangerous drug products as listed in rule
			 4729-37-02 of the Administrative
			 Code in the definitions as paragraph (A)(5)(b) of this rule.
Ohio Administrative Code › Title 4725 - Ohio Vision Professional Board › Chapter 4725-19 › Section 4725-19-01 - Impaired practitioner rules and safe haven program

Current through all regulations passed and filed through July 1, 2024
(A)
								Definitions
(1)
									"License holder"
			 applies to the following license types:
(a)
										Ocularist
(b)
										Optician
(c)
										Optometrist
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-2 - Meetings › Section 4729-2-01 - Board meetings

Current through all regulations passed and filed through July 1, 2024
(A) In the absence of contrary action by the
			 board, the most current version of Robert's Rules of Order, newly revised,
			 shall apply unless in conflict with Chapter 2925., 3715., 3719., 3796., 4729.,
			 or 4752. of the Revised Code or agency 3796 or 4729 of the Administrative
			 Code.
(B) Any board member activity
			 undertaken in accordance with section
			 4729.03 of the Revised Code will
			 be compensated pursuant to the provisions of division (J) of section
			 124.15 of the Revised
			 Code.
(C) The board will elect a
			 president and vice-president, for the coming fiscal year, prior to the last
			 board meeting of the present fiscal year, as follows:
(1) Separate elections will be held for
			 president and vice-president, with the election of president occurring
			 first;
(2) Each board member will
			 cast a ballot for the president of his or her choice and the person receiving
			 the greatest number of votes will be elected president;
(3) Each board member will cast a ballot for
			 the vice-president of his or her choice. The person receiving the greatest
			 number of votes will be elected vice-president;
(4) In the event of a tie vote for either
			 office, a run-off election of the tied nominees will be conducted;
(5) No board member may serve successive
			 years in the office of president during a four-year appointment;
(6) The out-going president shall administer
			 the oath of office to the new officers at the final official meeting of the
			 board for the current fiscal year and the new officers shall take office on
			 July first of the new fiscal year.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-2 - Meetings › Section 4729-2-02 - Administration

Current through all regulations passed and filed through July 1, 2024
(A) The president
			 will appoint a board member, during the first meeting of each new fiscal year,
			 to be responsible for each of the following board matters:
(1) Citation review and issuance;
(2) Budget/finance;
(3) Continuing education, examination,
			 internship and licensure;
(4)
			 Legislation and external affairs;
(5) Ohio automated Rx reporting system
			 (OARRS);
(6) Physician assistant
			 policy committee, if applicable;
(7) Probation committee; and
(8) Rules review committee.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-2 - Meetings › Section 4729-2-03 - Notice of meetings and hearings

Current through all regulations passed and filed through July 1, 2024
(A)
								 Notice of
			 meetings.
Any person may obtain the time and
				place of all regularly scheduled meetings and the time, place, and purpose of
				all special meetings of the state board of pharmacy, as required by division
				(F) of section 121.22 of the Revised Code,
				by:
(1)
									
			 Calling the telephone number of the state board of pharmacy between the normal
			 business hours, Monday through Friday, state holidays excepted.
(2)
									 Consulting the
			 official record of all board of pharmacy regularly scheduled and special
			 meetings located at office of the state board of pharmacy.
(3)
									 Viewing the
			 state board of pharmacy's website.
(4)
									 Requesting the
			 information to be sent by the state board of pharmacy by
			 e-mail.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-2 - Meetings › Section 4729-2-04 - Public records

Current through all regulations passed and filed through July 1, 2024
(A)
								 Public records,
			 as defined in section
			 149.43 of the Revised Code,
			 maintained by the state board of pharmacy, are available for inspection at the
			 board office between normal business hours, Monday through Friday of each week,
			 state holidays excluded.
(B)
								 Copies of public records will be made available at
			 cost pursuant to the following conditions:
(1)
									 A request shall
			 be submitted to the board of pharmacy specifying which records are to be
			 copied, the number of copies, and the date that such copies are
			 needed.
(2)
									 Upon receipt of a request, the board shall determine
			 the cost to provide such copies. The copies will be prepared and provided only
			 when the board has been reimbursed for the cost.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-3 - Pharmacy Interns › Section 4729-3-01 - Disqualifying offenses

Current through all regulations passed and filed through July 1, 2024
(A)
								As used in agency
			 4729 of the Administrative Code, "disqualifying offense" means a criminal
			 offense that is contained in the list adopted pursuant to paragraph (B) of this
			 rule, and any existing or former criminal offense that is substantially
			 equivalent to those explicitly contained in the list under municipal ordinances
			 or laws of this state, any other state, or the United States, as required by
			 division (B) of section
			 9.79
			 of the Revised Code.
(B)
								The board of pharmacy shall issue a resolution
			 providing the list of specific criminal offenses for which a conviction,
			 judicial finding of guilt, or plea of guilty may disqualify an individual from
			 obtaining an initial license or registration issued by the
			 board.
(C)
								The resolution shall be updated as necessary and shall
			 be made available on the board's web site (
www.pharmacy.ohio.gov
).
(D)
								For the purposes of enforcing agency 4729 and 3796 of
			 the Administrative Code, a certified copy of a plea of guilty to, or a judicial
			 finding of guilt of any crime in a court of competent jurisdiction is
			 conclusive proof of the commission of all of the elements of that
			 crime.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-5 - Pharmacists-Administrative Provisions › Section 4729-5-01 - Recognized and approved schools of pharmacy

Current through all regulations passed and filed through July 1, 2024
(A)
								Pursuant to
			 section 4729.08 of the Revised Code, the
			 state board of pharmacy recognizes and approves all pharmacy programs or
			 schools of pharmacy that have candidate or accreditation status with the
			 accreditation council for pharmacy education (A.C.P.E.). The board, by
			 resolution, reserves the right to:
(1)
									Deny the recognition or approval of a pharmacy program
			 or school of pharmacy that meets A.C.P.E. candidate or accreditation status;
			 or
(2)
									Recognize or approve a pharmacy program or school of
			 pharmacy that does not meet A.C.P.E. candidate or accreditation
			 status.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-5 - Pharmacists-Administrative Provisions › Section 4729-5-15 - Prescriber

Current through all regulations passed and filed through July 1, 2024
(A) For purposes of division (Y) of section
			 3719.01 and division (I) of
			 section 4729.01 of the Revised Code, the
			 following persons, maintaining current licenses and in good standing, licensed
			 pursuant to Chapters 4715., 4725., 4731., and 4741. of the Revised Code, are
			 authorized by law to write prescriptions for drugs or dangerous drugs in the
			 course of their professional practice:
(1)
			 Chapter 4715. of the Revised Code: dentist.
(2) Chapter 4725. of the Revised Code:
			 optometrist, if that person holds a current "therapeutic pharmaceutical agents
			 certificate" as defined in division (H) of section
			 4725.01 of the Revised Code.
(3) Chapter 4731. of the Revised
			 Code: doctor of medicine, doctor of osteopathic medicine and surgery, and
			 doctor of podiatry.
(4) Chapter
			 4741. of the Revised Code: doctor of veterinary medicine.
(5)
									Chapter 4723. of
			 the Revised Code: advanced practice nurse in accordance with paragraph (D) of
			 this rule.
(6)
									Chapter 4730. of the Revised Code: physician assistant
			 in accordance with paragraph (E) of this rule.
(7)
									Chapter 4729. of
			 the Revised Code: pharmacist in accordance with paragraph (F) of this
			 rule.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-6 - Impaired Pharmacists › Section 4729-6-01 - Continuing education providers - definitions

Current through all regulations passed and filed through July 1, 2024
(A) "A.C.P.E." means the accreditation
			 council for pharmacy education.
(B)
			 "Continuing education unit" or "C.E.U." means ten contact hours of
			 participation in an organized continuing pharmacy education experience
			 presented by a provider listed in paragraph (C) of this rule.
(C) "Continuing pharmacy education" or
			 "continuing education", as required in section
			 4729.12 of the Revised Code, is
			 defined as post-licensure pharmacy education undertaken to maintain
			 professional competency to practice pharmacy, improve professional skills, and
			 preserve uniform qualifications for continuing the practice of the profession
			 for the purpose of protecting public health and welfare. Continuing pharmacy
			 education may be obtained from any of the following providers:
(1) A pharmacy jurisprudence program pursuant
			 to paragraph (E) of this rule;
(2)
			 An approved in-state provider of volunteer healthcare services in accordance
			 with rule
			 4729-6-03 of the Administrative
			 Code;
(3) An A.C.P.E. accredited
			 continuing education provider.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-6 - Impaired Pharmacists › Section 4729-6-02 - Criteria for in-state approved providers of pharmacy jurisprudence continuing education

Current through all regulations passed and filed through July 1, 2024
In-state providers of pharmacy jurisprudence continuing
				education who seek approval by the state board of pharmacy must demonstrate
				ability and willingness to offer quality pharmacy jurisprudence continuing
				education in a responsible manner and shall submit evidence of this on
				applications developed by the board. The minimum criteria shall include:
(A) There shall be a program director charged
			 with the administration of the continuing pharmacy education program that
			 serves as a liaison to the board. Unless otherwise approved by the board, the
			 program director shall be a pharmacist licensed to practice pharmacy in
			 Ohio.
(B) Providers shall award
			 pharmacy jurisprudence continuing education credit to successful participants
			 in units consisting of C.E.U.s.
(C)
			 Providers shall maintain a list of successful program or experience
			 participants and the participants' Ohio license or registration numbers for a
			 four-year
			 period to be made available to the board upon request.
(D) Providers shall award a certificate to
			 each successful participant containing at least the following information:
(1) The name of the provider;
(2) The completion date of the
			 experience;
(3) The name of the
			 participant;
(4) The title of the
			 experience;
(5) The number of
			 C.E.U.s the experience has been assigned;
(6) The program or experience identification
			 number according to the numbering system designated by the board;
(7) The manual signature, including a scanned
			 image, or the electronic signature of the program director listed in paragraph
			 (A) of this rule.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-6 - Impaired Pharmacists › Section 4729-6-03 - Criteria for in-state approved providers of continuing pharmacy education for providing volunteer health care services

Current through all regulations passed and filed through July 1, 2024
In-state providers seeking approval by
				the state board of pharmacy must demonstrate ability and willingness to monitor
				and report volunteer services for continuing pharmacy education provided in
				accordance with section
				4745.04 of the Revised Code in a
				responsible manner and shall submit evidence of this on applications developed
				by the board. The minimum criteria shall include:
(A)
								There shall be a
			 program director charged with the administration of the continuing pharmacy
			 education program that serves as a liaison to the board. The program director
			 shall be a designated representative of the entity that provides health care
			 services.
(B)
								Providers shall award continuing pharmacy education
			 credit to successful participants in units consisting of C.E.U.s and in
			 accordance with the requirements of section
			 4745.04 of the Revised
			 Code.
(C)
								Providers shall maintain a list of the number and date
			 of volunteer hours of participants and the participants' Ohio license or
			 registration numbers for a five-year period to be made available to the board
			 upon request.
(D)
								Providers shall award a certificate to each successful
			 participant containing at least the following information:
(1)
									The name of the
			 provider;
(2)
									The completion date of the experience;
(3)
									The name of the
			 participant;
(4)
									The title of the experience;
(5)
									The number of
			 C.E.U.s the experience has been assigned;
(6)
									The program or
			 experience identification number according to the numbering system designated
			 by the board;
(7)
									The manual signature, including a scanned image, or the
			 electronic signature of the program director listed in paragraph (A) of this
			 rule.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-7 - Continuing Education › Section 4729-7-01 - Severability

Current through all regulations passed and filed through July 1, 2024
If any provision of the rules in agency
				4729 of the Administrative Code or if the application of any provision of the
				rules in agency 4729 of the Administrative Code is held or found to be invalid,
				unconstitutional, void, or ineffective, the invalidity shall not affect any
				other provision of the rules in this agency, or the application of any other
				provision of the rules in this agency, that can be given effect without the
				invalid provision or application, and, to this end, the provisions of the rules
				in this agency are hereby declared severable.
Effective:
				7/8/2019
Five Year Review (FYR) Dates:
				07/08/2024
Promulgated
				Under: 119.03
Statutory
				Authority: 4729.26,
				3719.28
Rule
				Amplifies: 4729.26,
				3719.28
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-8 - Prescription Drug Collection › Section 4729-8-01 - Overdose reversal drugs

Current through all regulations passed and filed through July 1, 2024
Pursuant to section
				4729.01 of the Revised Code, the
				state board of pharmacy hereby designates the following dangerous drugs, which
				have been approved by the federal food and drug administration for the reversal
				of a known or suspected opioid-related overdose, as overdose reversal
				drugs:
(A)
								Naloxone; and
(B)
								Nalmefene.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-8 - Prescription Drug Collection › Section 4729-8-02 - Authorized collectors

Current through all regulations passed and filed through July 1, 2024
(A)
								An authorized
			 collector may operate a drug collection receptacle if they meet all of the
			 requirements specified in 21 CFR Part 1300, 21 CFR Part 1301, 21 CFR Part 1304,
			 21 CFR Part 1305, 21 CFR Part 1307 and 21 CFR Part 1317
			 (10/09/2014).
(B)
								If an authorized collector operates a drug collection
			 receptacle for the collection of non-controlled substances only, they shall
			 meet all of the requirements specified in paragraph (A) of this
			 rule.
(C)
								A long-term care facility may dispose of prescription
			 medications, including controlled substances, dangerous drugs, and
			 over-the-counter medications on behalf of an ultimate user who resides, or has
			 resided, at that long-term care facility pursuant to
			 21 CFR
			 1317.80.
(D)
								An authorized
			 collector may operate a mail-back program if they meet all of the requirements
			 specified in 21 CFR Part 1300, 21 CFR Part 1301, 21 CFR Part 1304, 21 CFR Part
			 1305, 21 CFR Part 1307 and 21 CFR Part 1317 (10/09/2014).
(E)
								If an authorized
			 collector operates a mail-back program for the collection of non-controlled
			 substances only, they shall meet all of the requirements specified in paragraph
			 (D) of this rule.
(F)
								An authorized collector shall indicate on a mail-back
			 package or drug collection receptacle that the collection of any of the
			 following is prohibited:
(1)
									Medical sharps and needles (e.g., insulin syringes),
			 iodine-containing medications, mercury-containing thermometers,
			 radiopharmaceuticals, antineoplastic agents (cancer chemotherapy drugs,
			 cytotoxic drugs), and compressed cylinders or aerosols (e.g., asthma inhalers);
			 and
(2)
									Schedule I controlled substances.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-8 - Prescription Drug Collection › Section 4729-8-03 - Law enforcement agencies

Current through all regulations passed and filed through July 1, 2024
(A)
								Law enforcement
			 agencies may operate a drug collection receptacle if all of the following
			 apply:
(1)
									The
			 receptacle is located inside the premises of the law enforcement
			 agency.
(2)
									The receptacle is placed in a location that is
			 accessible to the public during posted hours.
(3)
									The receptacle is
			 placed within reasonable view of law enforcement personnel or under continuous
			 video surveillance.
(4)
									The receptacle is securely fastened to a permanent
			 structure so that it cannot be removed and must be locked to prevent the
			 unauthorized retrieval of its contents.
(5)
									The receptacle is
			 clearly marked indicating the following information:
(a)
										No needles,
			 syringes, or lancets shall be placed in the receptacle.
(b)
										No
			 iodine-containing medications, mercury-containing thermometers,
			 radiopharmaceuticals, antineoplastic agents (cancer chemotherapy drugs,
			 cytotoxic drugs), and compressed cylinders or aerosols (e.g., asthma inhalers)
			 shall be placed in the receptacle.
(6)
									If a law
			 enforcement agency chooses to limit the types of drugs that are acceptable for
			 return, such limitations shall be clearly stated on or near the drug collection
			 receptacle.
(7)
									The law enforcement agency shall check the drug
			 collection receptacle regularly and remove deposits to prevent the receptacle
			 from reaching capacity.
(8)
									The law enforcement agency shall maintain the
			 confidentiality of the ultimate user disposing of the drugs pursuant to all
			 applicable state and federal laws, rules, and regulations.
(9)
									The drugs
			 collected shall be stored in a manner that prevents the diversion of controlled
			 substances and is consistent with that agency's standard procedures for storing
			 illicit controlled substances.
(10)
									The law
			 enforcement agency shall maintain custody and control of the contents deposited
			 in the drug collection receptacle until the drugs are destroyed pursuant to
			 rule
			 4729-8-04
			 of the Administrative Code.
(11)
									The law
			 enforcement agency shall maintain any records of removal, storage, or
			 destruction of the drugs collected in a manner that is consistent with that
			 agency's recordkeeping requirements for illicit controlled substances
			 evidence.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-8 - Prescription Drug Collection › Section 4729-8-04 - Procedure for destruction of collected drugs

Current through all regulations passed and filed through July 1, 2024
(A)
								All drugs
			 collected pursuant to this chapter shall be destroyed in compliance with
			 applicable federal, state, tribal, and local laws and regulations and shall be
			 rendered non-retrievable.
(B)
								The method of destruction shall ensure that the
			 confidentiality of the ultimate user is maintained pursuant to applicable state
			 and federal laws, rules, and regulations.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-11 - Controlled Substance Schedules › Section 4729-11-07 - Standard pharmaceutical references

Current through all regulations passed and filed through July 1, 2024
All editions, with cumulative changes, if any, of the following
				reference works are recognized and approved by the state board of
				pharmacy:
(A) "Drug Facts and
			 Comparisons";
(B) "Martindale: The
			 Extra Pharmacopoeia";
(C)
			 "Remington's Pharmaceutical Sciences";
(D) "United States Dispensatory";
(E) "United States Pharmacopeia/National
			 Formulary" ("USP/NF");
(F)
			 "American Hospital Formulary Service Drug Information" ("AHFS Drug
			 Information") ;
(G)
								A controlled substance reference table compiled by the
			 state board of pharmacy using any of the reference works listed in this rule.
			 This table shall be made available on the board's web site.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-01 - Definition of ephedrine

Current through all regulations passed and filed through July 1, 2024
Ephedrine is [ALPHA] -[-(Methylamino)ethyl]benzene-methanol;
				[ALPHA]-[1-(methylamino) ethyl]benzyl alcohol;
				2-methylamino-1-phenyl-1-propanol; 1-phenyl-1-hydroxy-2-methylaminopropane;
				1-phenyl-2-methylaminopropanol; [ALPHA] -
				hydroxy-[BETA]-methylaminopropylbenzene; a product which occurs in the Chinese
				herb Ma Huang (
Ephedra vulgaris
,
Ephedra
				sinica
Stapf.,
Ephedra equisetina
Bunge,
Gnetaceae
) and in several other Ephedra spp. Isomeric forms
				include
d
- and
l
-ephedrine as well as
d
-and
l
-pseudoephedrine with
l
-ephedrine and
d
-pseudoephedrine as the
				naturally occurring isomers.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-02 - Registration and licensure

Current through all regulations passed and filed through July 1, 2024
(A) Any person who manufactures, sells at
			 wholesale or retail, dispenses, imports or exports products containing
			 ephedrine, its salts or isomers, or who proposes to engage in such activities,
			 shall submit an application for registration as a wholesaler of dangerous drugs
			 and controlled substances or for licensure as a category III terminal
			 distributor of dangerous drugs to conduct such activities in accordance with
			 Chapters 3719. and 4729. of the Revised Code.
(B) This rule does not apply if the ephedrine
			 product is a food product or a dietary supplement that is specifically excepted
			 in division (K)(2) of section
			 3719.44 of the Revised
			 Code.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-03 - Security, storage, and sale

Current through all regulations passed and filed through July 1, 2024
(A) Schedule V products containing ephedrine
			 may be sold at wholesale or retail, and must be maintained in accordance with
			 Chapters 3719. and 4729. of the Revised Code and Chapters 4729-9 and 4729-11 of
			 the Administrative Code.
(B) This
			 rule does not apply if the ephedrine product is a food product or a dietary
			 supplement that is specifically excepted in division (K)(2) of section
			 3719.44 of the Revised
			 Code.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-04 - Inventory

Current through all regulations passed and filed through July 1, 2024
(A) Every registrant or licensee required to
			 keep records who possesses any quantity of ephedrine or schedule V drug
			 products containing ephedrine shall take an inventory pursuant to rules
			 4729-9-14
			 and
			 4729-9-16
			 of the Administrative Code.
(B)
			 This rule does not apply if the ephedrine product is a food product or a
			 dietary supplement that is specifically excepted in division (K)(2) of section
			 3719.44 of the Revised
			 Code.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-05 - Records

Current through all regulations passed and filed through July 1, 2024
(A) All practitioners, registrants, and
			 licensees required to keep records pursuant to Chapter 3719. of the Revised
			 Code and Chapters 4729-9 and 4729-11 of the Administrative Code shall maintain
			 such records for ephedrine and schedule V drug products containing
			 ephedrine.
(B) This rule does not
			 apply if the ephedrine product is a food product or a dietary supplement that
			 is specifically excepted in division (K)(2) of section
			 3719.44 of the Revised
			 Code.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-08 - Petitions for exception of ephedrine-containing products

Current through all regulations passed and filed through July 1, 2024
(A) A petition requesting that a drug product
			 containing ephedrine be excepted by the board of pharmacy from being legally
			 classified as a schedule V controlled substance stimulant may be submitted by
			 any person engaged in the legitimate manufacture or wholesale sale of such
			 products in the United States. The petition shall include the following
			 information:
(1) Full name, address, and
			 telephone number of the manufacturer.
(a) If
			 incorporated, the petition must include copies of the incorporation papers and
			 the names, dates of birth, addresses, and social security numbers of the
			 officers of the corporation and all stockholders holding more than ten per cent
			 of the stock.
(b) If a
			 proprietorship, the petition must include the name, address, date of birth, and
			 social security number of the owner(s).
(c) If a partnership, the petition must
			 include the names, addresses, dates of birth, and social security numbers of
			 the partners.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-09 - Exceptions

Current through all regulations passed and filed through July 1, 2024
Pursuant to division (K) of section
				3719.44 of the Revised Code,
				each of the following products containing ephedrine, its salts, its isomers, or
				the salts of its isomers is declared to be excepted from classification as a
				schedule V controlled substance:
(A)
			 All products that contain the isomer known as pseudoephedrine or its salts, but
			 do not also contain any of the isomer known as ephedrine or its
			 salts.
(B) "Breathe
			 Easy®" herb tea.
(C) "Bronkaid®
			 Dual Action" caplets.
(D)
			 "Hydrosal®" hemorrhoidal ointment.
(E) "Primatene®
			 Dual Action Formula" tablets.
(F)
			 "Primatene®" tablets.
(G) "SnoreStopTM"
			 tablets.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-12 - Ephedrine and Ephedrine-Containing Products › Section 4729-12-10 - Criteria to be considered in denying a petition for exemption or removing a drug product exemption

Current through all regulations passed and filed through July 1, 2024
(A) The board shall consider the following
			 factors in determining whether a particular over-the-counter (OTC) drug product
			 containing the schedule V controlled substance ephedrine is manufactured and
			 distributed for legitimate use in a manner consistent with the pertinent OTC
			 tentative or final monograph issued by the federal food and drug administration
			 and in a manner that reduces the likelihood of inappropriate use and/or abuse:
(1) The package size and the manner of
			 packaging;
(2) Distribution,
			 advertising, and promotion of the product;
(3) Labeling and the name of the
			 product;
(4) The potential,
			 duration, scope, and significance of inappropriate use and/or abuse;
(5) Other facts as may be relevant to and
			 consistent with the public health and safety.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-21 - Compressed Medical Gases › Section 4729-21-01 - Registration/licensure

Current through all regulations passed and filed through July 1, 2024
No person, whether located within or outside this state, shall
				possess or sell compressed medical gases in Ohio unless they are registered as
				a wholesale distributor of dangerous drugs or licensed as a category II or
				category III terminal distributor of dangerous drugs with the board.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-21 - Compressed Medical Gases › Section 4729-21-02 - Compressed medical gas fillers

Current through all regulations passed and filed through July 1, 2024
All dangerous drug distributors, wholesale and terminal, who
				fill containers with compressed medical gases must comply with the current good
				manufacturing practice regulations issued by the federal "Food and Drug
				Administration (F.D.A.)" pursuant to the "Federal Food, Drug and Cosmetic Act"
				(3/26/2015) and the current guidelines issued
				pursuant to Title
				21
				CFR 10.90
								(3/26/2015). Any deviation from the current guidelines
				issued by the federal F.D.A. must be submitted to the federal F.D.A. for
				written approval before implementation. Documentation that the different
				procedures have been approved shall be maintained by dangerous drug
				distributors for review and copying by agents of the board.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-21 - Compressed Medical Gases › Section 4729-21-03 - Records

Current through all regulations passed and filed through July 1, 2024
Records required by state and federal laws and rules or
				regulations issued pursuant to such laws governing the sale of dangerous drugs
				and the filling of containers with compressed medical gases shall be maintained
				for a period of three years at the licensed location for inspection and copying
				by board of pharmacy agents.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-21 - Compressed Medical Gases › Section 4729-21-04 - Requirements for a cryogenic medical gases safety program

Current through all regulations passed and filed through July 1, 2024
(A) A medical gases safety program developed
			 pursuant to section 4729.70 of the Revised Code
			 shall meet at least the following requirements:
(1) The instructors shall have the
			 appropriate education and experience to teach a program in medical gases
			 safety.
(2) The program shall be
			 presented to all individuals who fill, install, connect, or disconnect medical
			 gases contained in cryogenic vessels that are portable and intended for use in
			 administering direct treatment to one or more individuals.
(3) Successful participation and demonstrated
			 competency in a program must be completed prior to an individual filling,
			 installing, connecting, or disconnecting a medical gas contained within a
			 cryogenic vessel.
(4) The program
			 must include at least the following:
(a) The
			 description of a cryogenic vessel including at least the following:
(i) Valve inlet and outlet
			 connections.
(ii) Safety systems
			 associated with each outlet.
(iii)
			 Proper labeling.
(iv) Color
			 coding.
(v) Gas
			 identification.
(b) A
			 review of each medical gas listed in division (C)(2) of section
			 4729.70 of the Revised Code that
			 may be contained in a cryogenic vessel including at least the following:
(i) A description of the properties of the
			 gas and liquid.
(ii) The
			 precautions and warnings associated with the gas and liquid.
(iii) What to do when there is an exposure to
			 the gas or liquid.
(iv) What to do
			 in an emergency hazardous material situation with the gas or liquid.
(c) The proper installation of
			 cryogenic vessels including at least the following:
(i) Connecting and disconnecting supply
			 lines.
(ii) Recognizing
			 silver-brazed fittings or other acceptable mechanical means that make the
			 connection a permanent and integral part of the valve.
(iii) Recognizing that changing or adapting
			 the fittings for another gas service is strictly prohibited unless pursuant to
			 rule
			 4729-21-05
			 of the Administrative Code.
(iv)
			 Recognizing the appropriate devices through which medical gases are delivered
			 from cryogenic vessels.
(v)
			 Detecting and reporting leaks.
(vi)
			 Transporting cryogenic vessels appropriately within a facility.
(vii) Appropriate storage of cryogenic
			 vessels.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-21 - Compressed Medical Gases › Section 4729-21-05 - Modifying cryogenic vessels, connections, adaptors, and valves

Current through all regulations passed and filed through July 1, 2024
(A) No person shall modify a cryogenic
			 vessel, connection, or valve or adapt a connection for another gas service
			 pursuant to division (D) of section
			 4729.70 of the Revised
			 Code.
(B) Paragraph (A) of this
			 rule does not apply to an employee or agent of a firm owning the cryogenic
			 vessel and is charged with the responsibility of conducting applicable vessel
			 maintenance, changing service from one medical gas to another, or bringing a
			 vessel into compliance with section
			 4729.70 of the Revised Code.
(1) Such employee or agent shall meet at
			 least the following requirements:
(a)
			 Successful completion of a medical gases safety program pursuant to rule
			 4729-21-04
			 of the Administrative Code.
(b)
			 Successful participation and demonstrated competency in a cryogenic vessel
			 modification program administered by an instructor with the appropriate
			 education and experience. The program must be based on written and validated
			 procedures. The employee or agent must participate in the program annually and
			 it must include at least the following procedures:
(i) Removing, adding, or adapting cryogenic
			 vessel connections and valves.
(ii)
			 Modifying cryogenic vessels.
(iii)
			 Conducting cryogenic vessel maintenance.
(iv) Changing the cryogenic vessel from one
			 medical gas to another.
(v)
			 Bringing a cryogenic vessel into compliance with section
			 4729.70 of the Revised
			 Code.
(vi) Silver brazing or
			 welding techniques and certification of the individual if applicable.
(vii) Removing and adding suitable mechanical
			 means to make a connection a permanent and integral part of the
			 valve.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-21 - Compressed Medical Gases › Section 4729-21-06 - Sales of medical oxygen to S.C.U.B.A. divers

Current through all regulations passed and filed through July 1, 2024
(A) S.C.U.B.A. divers who hold a valid
			 certificate in the following nationally recognized S.C.U.B.A. diving certifying
			 organization programs may purchase, possess, and use medical oxygen for the
			 purpose of emergency care or treatment at the scene of a diving emergency
			 pursuant to divisions (B)(1)(i) and (C)(4) of section
			 4729.51 of the Revised Code:
(1) Diver alert network (DAN): oxygen first
			 aid for scuba diving injuries;
(2)
			 International association of nitrox and technical divers: oxygen provider
			 course;
(3) Professional
			 association of diving instructors (PADI): emergency first response;
(4) PADI: PADI oxygen first aid;
(5) PADI: rescue diver course;
(6) PADI: tec deep diver;
(7) Scuba schools international: medic first
			 aid emergency oxygen administration;
(8) Technical diving international-S.C.U.B.A.
			 diving international: diver advanced development program as a CPROX
			 administrator;
(9) YMCA: slam
			 rescue;
(10)
									 National association of underwater instructors (NAUI)
			 first aid;
(11)
									 NAUI rescue scuba diver;
(12)
									 NAUI advanced
			 rescue scuba diver;
(13)
									 NAUI first aid instructor;
(14)
									 NAUI oxygen
			 administration; and
(15)
									 NAUI instructor.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-22 - Oxygen › Section 4729-22-01 - Licensure

Current through all regulations passed and filed through July 1, 2024
Each person, whether located within or outside this state, who
				sells oxygen in original packages labeled as required by the "federal Food,
				Drug, and Cosmetic Act" to persons residing in this state, shall obtain a
				limited category II terminal distributor of dangerous drugs license from the
				board of pharmacy pursuant to the provisions of sections
				4729.54 and
				4729.55 of the Revised Code. A
				person who is a nonresident and is selling medical oxygen at retail to Ohio
				residents must also comply with the requirements in Chapter 4729-10 of the
				Administrative Code. This requirement shall not apply to persons already
				licensed to purchase, possess, and sell unlimited category II dangerous drugs
				at retail.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-22 - Oxygen › Section 4729-22-02 - Security, storage, and sale

Current through all regulations passed and filed through July 1, 2024
Medical oxygen may be sold only at retail to patients pursuant
				to an order from a prescriber in the course of their professional practice.
				Medical oxygen may be sold at retail and must be maintained in accordance with
				Chapters 3715. and 4729. of the Revised Code; rules
				4729-9-05,
				4729-9-11,
				4729-9-12,
				and Chapter 4729-21 of the Administrative Code; and the "Federal Food, Drug and
				Cosmetic Act".
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-22 - Oxygen › Section 4729-22-04 - Prescriber's order

Current through all regulations passed and filed through July 1, 2024
Before making an initial sale of medical oxygen to a patient,
				the retail seller must have an order issued by a prescriber in the course of
				the prescriber's professional practice. The order must include the full name
				and address of the patient, the positive identification of the prescriber, the
				manually printed, typewritten, electronically
				generated or preprinted full name and address of the prescriber, the
				telephone number where the prescriber can be personally contacted during normal
				business hours, and documentation of need. The
				prescriber's order may be transmitted electronically to the retail
				seller. This order must be renewed at least annually.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-25 - Nitrous Oxide › Section 4729-25-01 - Licensure

Current through all regulations passed and filed through July 1, 2024
Each person located within this state who wishes to purchase
				and possess nitrous oxide for the purpose of using it as a direct ingredient of
				food, pursuant to Title
				21
				CFR 184.1545
								(02/27/2015), shall obtain a limited category II
				terminal distributor of dangerous drugs license from the board of pharmacy
				pursuant to the provisions of sections
				4729.54 and
				4729.55 of the Revised
				Code.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-25 - Nitrous Oxide › Section 4729-25-02 - Security, storage, and use

Current through all regulations passed and filed through July 1, 2024
Food processors and retail sellers of food must purchase,
				store, and use nitrous oxide in accordance with Chapters 3715. and 4729. of the
				Revised Code; rules
				4729-9-05,
				4729-9-11,
				4729-9-12,
				and Chapter 4729-21 of the Administrative Code; and the "Federal Food, Drug and
				Cosmetic Act" (3/26/2015).
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-25 - Nitrous Oxide › Section 4729-25-03 - Records

Current through all regulations passed and filed through July 1, 2024
All food processors and retail sellers of nitrous oxide shall
				maintain records of purchase at wholesale and use in processing food for three
				years at the licensed location for inspection and copying by board of pharmacy
				agents.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-25 - Nitrous Oxide › Section 4729-25-04 - Report of theft or loss

Current through all regulations passed and filed through July 1, 2024
Each food processor and retail seller of food shall, upon
				discovery of the theft or significant loss of any nitrous oxide, notify the
				board of pharmacy and local law enforcement authorities pursuant to section
				2921.22 of the Revised Code.
				Thefts of nitrous oxide must be reported whether or not the nitrous oxide is
				subsequently recovered and/or the responsible parties are identified and action
				taken against them.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-27 - Peritoneal Dialysis Solutions › Section 4729-27-01 - Peritoneal dialysis solutions

Current through all regulations passed and filed through July 1, 2024
(A)
								For the purpose
			 of Chapter 4729. of the Revised Code, the term "peritoneal dialysis solutions"
			 shall mean the commercially available, unopened, sterile solutions whose only
			 purpose is to be instilled into the peritoneal cavity during the medical
			 procedure known as peritoneal dialysis.
(B)
								Each person,
			 whether located within or outside this state, who sells peritoneal dialysis
			 solutions in original packages labeled as required by applicable federal and
			 state laws, rules, and regulations to persons residing in this state, shall
			 obtain a limited category II terminal distributor of dangerous drugs license
			 from the board of pharmacy pursuant to the provisions of sections
			 4729.54,
			 4729.55, and
			 4729.551 of the Revised Code.
			 This requirement shall not apply to persons already licensed to purchase,
			 possess, and sell unlimited category II or III dangerous drugs at
			 retail.
(C)
								Peritoneal dialysis solutions may be sold at retail to
			 patients only pursuant to an order from a person authorized to prescribe
			 peritoneal dialysis solutions in the course of professional
			 practice.
(D)
								Peritoneal dialysis solutions may be sold at retail and
			 must be maintained in accordance with Chapters 3715. and 4729. of the Revised
			 Code; rules
			 4729-9-04,
			 4729-9-05,
			 4729-9-11,
			 4729-9-12
			 and
			 4729-9-17
			 of the Administrative Code; and applicable federal laws and
			 regulations.
(E)
								All retail sellers of peritoneal dialysis solutions
			 shall maintain records of purchase of peritoneal dialysis solutions at
			 wholesale and sale of peritoneal dialysis solutions at retail for three years
			 at the licensed location, or an alternate site approved by the board, for
			 inspection and copying by authorized board of pharmacy agents. The record of
			 sale must include, but is not limited to, the order issued by the person
			 authorized to prescribe peritoneal dialysis solutions in the course of
			 professional practice.
(F)
								Before making an initial sale of peritoneal dialysis
			 solutions to a patient, the retail seller must have an order issued by a person
			 authorized to prescribe peritoneal dialysis solutions in the course of the
			 professional practice. The order must include the full name and address of the
			 patient, the name and address of the prescriber, and the complete and accurate
			 identification of each such product to be provided to the patient.
Replaces: 4729-27-01. 4729-27-02; 4729-27-03, 4729-27-04,
				4729-27-05
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-35 - Drug Repository Programs › Section 4729-35-01 - Definitions

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729-35 of the Administrative Code:
(A) "Dangerous drug" has the same meaning as
			 in section 4729.01 of the Revised Code and
			 in rule
			 4729-9-01 of the
			 Administrative Code.
(B) "Drug
			 repository program" has the same meaning as in sections
			 3715.87 to
			 3715.873 of the Revised Code.
(C) "Hospital" has the same
			 meaning as in section
			 3715.87 of the Revised Code.
(D) "Institutional facility" has
			 the same meaning as in rule
			 4729-17-01
			 of the Administrative Code.
(E)
			 "Licensed health care professional" has the same meaning as in section
			 3715.872 of the Revised Code.
(F) "Nonprofit clinic" has the
			 same meaning as in section
			 3715.87 of the Revised Code.
(G) "Original sealed and
			 tamper-evident unit dose packaging" includes single unit dose packaging of oral
			 medications from a manufacturer or a repackager licensed with the federal food
			 and drug administration, or from a pharmacy licensed as a terminal distributor
			 of dangerous drugs, and includes injectables, topicals, and aerosols in the
			 manufacturer's or repackager's unopened original tamper-evident packaging.
Ohio Administrative Code › Title 4729 - State Board of Pharmacy › Chapter 4729-35 - Drug Repository Programs › Section 4729-35-02 - Eligibility requirements for a pharmacy, hospital, or nonprofit

Current through all regulations passed and filed through July 1, 2024
A pharmacy, hospital, or nonprofit clinic may elect to
				participate in the drug repository program, pursuant to sections
				3715.87 to
				3715.873 of the Revised Code, if
				all of the following requirements are met:
(A) Must be licensed as a terminal
			 distributor of dangerous drugs pursuant to section
			 4729.54 of the Revised Code.
(B) Must comply with all federal
			 and state laws, rules, and regulations.