This website publishes administrative rules on their effective dates, as designated by the adopting state agencies, colleges, and
universities.
| Rule |
Rule 4729:5-3-01 | Disposal of controlled substances.
(A) As used in this rule: (1) "Controlled
substance" has the same meaning as in section 3719.01 of the Revised
Code. (2) "Controlled substance
proof-of-use sheet" means a record that captures, at a minimum, the
following information: (a) Date; (b) Patient name; (c) Drug name; (d) Drug strength; (e) Quantity; and (f) The positive identification of the individuals authorized by
this rule who are responsible for removing the dangerous drugs from the
medication cart, or other storage area, and transferring the drugs to the
secure storage area. (3) "Non-retrievable" means the
condition or state to which a controlled substance shall be rendered following
a process that permanently alters that controlled substance's physical or
chemical condition or state through irreversible means and thereby renders the
dangerous drugs which are controlled substances unavailable and unusable for
all practical purposes. The process to achieve a non-retrievable condition or
state may be unique to a substance's chemical or physical properties. A
dangerous drug which is a controlled substance is considered non-retrievable
when it cannot be transformed to a physical or chemical condition or state as a
controlled substance or controlled substance analogue. The purpose of
destruction is to render the controlled substance(s) to a non-retrievable state
and thus prevent diversion of any such substance to illicit
purposes. (4) (a) "Positive identification" means a method of
identifying a person that does not rely on the use of a private personal
identifier such as a password, but must use a secure means of identification
that includes any of the following: (i) A manual signature on
a hard copy record; (ii) A magnetic card
reader; (iii) A bar code
reader; (iv) A biometric
method; (v) A proximity badge
reader; (vi) A board approved
system of randomly generated personal questions; (vii) A printout of every
transaction that is verified and manually signed within a reasonable period of
time by the individual who performed the action requiring positive
identification. The printout must be maintained for three years and made
readily retrievable; or (viii) Other effective
methods for identifying individuals that have been approved by the
board. (b) A method relying on a magnetic card reader, a bar code
reader, a proximity badge reader, or randomly generated questions for
identification must also include a private personal identifier, such as a
password, for entry into a secure mechanical or electronic system.
(5) "State or local
correctional facility" means any of the following: (a) A "state correctional institution," as defined in
section 2967.01 of the Revised Code; (b) A "local correctional facility," as defined in
section 2903.13 of the Revised Code. (B) A terminal distributor of dangerous
drugs shall dispose of controlled substance dangerous drugs in accordance with
21 C.F.R. 1317 (9/25/2023). The method of destruction must render the
controlled substances to a state of non-retrievable. Records of controlled
substance destruction that are required pursuant to 21 C.F.R. 1304 (9/25/2023)
shall be maintained for a minimum of three years and made readily
retrievable. (1) If a long term care
facility uses a method of destruction pursuant to 21 C.F.R. 1317 (9/25/2023),
the controlled substances transferred to a collection receptacle or mail-back
envelope must be completed by the director of nursing and witnessed by a nurse
licensed in accordance with Chapter 4723. of the Revised Code. The amount of
controlled substances transferred to the receptacle or mail-back envelope and
the method of disposal used must be documented with the positive identification
of both individuals on the corresponding controlled substance proof-of-use
sheet. (C) If a pharmacy is servicing a long
term care facility or a consultant pharmacist is employed by a long term care
facility and is having a pharmacist engage in the on-site destruction of
ultimate user (i.e., patient-owned) controlled substances in the custodial care
of nursing staff, the pharmacy or consultant pharmacist shall have policies and
procedures in place to ensure compliance with and shall comply with all the
following: (1) Upon discontinuation
of a patient's use of a controlled substance medication, a nurse and
director of nursing, or other pharmacy or pharmacist-approved supervisory
nurse, must document the removal of the patient's medication from the
medication cart or storage area and record the transfer of the drugs to a
secure storage area for disposal. (2) The record of the
controlled substances removed from the medication cart, or other area of
storage, for disposal shall be made on a controlled substance proof-of-use
sheet. The proof-of-use sheet shall be maintained on-site at the location
licensed as a terminal distributor of dangerous drugs for a minimum of three
years from the date of removal and made readily retrievable. (3) An Ohio licensed
pharmacist or the director of nursing and another pharmacy or
pharmacist-approved supervisory level nurse may destroy an ultimate user's
controlled substances using an on-site method at the location licensed as a
terminal distributor of dangerous drugs. Both individuals shall personally
witness and document the destruction of the controlled substance medication
pursuant to paragraph (C)(4) of this rule. The on-site method does not have to
meet the definition of non-retrievable but must render the drug unavailable and
unusable. (4) A record of
controlled substances destroyed shall be made containing the date of
destruction, patient name, drug name, drug strength, quantity, method of
destruction and the positive identification of the two individuals listed in
paragraph (C)(3) of this rule responsible for the destruction. (5) The record of
controlled substance destruction pursuant to paragraph (C)(4) of this rule
shall be maintained on-site at the location licensed as a terminal distributor
of dangerous drugs for a minimum of three years from the date of destruction
and made readily retrievable. (6) Controlled substances
shall be destroyed pursuant to this paragraph no later than ten days from the
date the patient's controlled substance medication is removed from the
medication cart or storage area in accordance with paragraph (C)(1) of this
rule. (D) A state or local correctional
facility may engage in the on-site destruction of ultimate user (i.e.,
patient-owned) controlled substances in the custodial care of nursing staff, as
follows: (1) The correctional
facility shall be licensed as a category III terminal distributor of dangerous
drugs. (2) The responsible
person shall have policies and procedures in place to ensure compliance with
and shall comply with all the following: (a) Upon discontinuation of a patient's use of a controlled
substance medication, the responsible person, director of nursing or a licensed
pharmacist and another responsible person-approved nurse or corrections officer
must document the removal of the patient's medication from the medication
cart or storage area and record the transfer of the drugs to a secure storage
area for disposal. (b) The record of the controlled substances removed from the
medication cart, or other area of storage, for disposal shall be made on a
controlled substance proof-of-use sheet. The proof-of-use sheet shall be
maintained on-site at the location licensed as a terminal distributor of
dangerous drugs for a minimum of three years from the date of removal and made
readily retrievable. (c) The responsible person, director of nursing, or a licensed
pharmacist and another responsible person-approved nurse or corrections officer
may destroy ultimate user controlled substances using an on-site method at the
location licensed as a terminal distributor of dangerous drugs. Both
individuals shall personally witness and document the destruction of the
controlled substance medication pursuant to paragraph (D)(2)(d) of this rule.
The on-site method does not have to meet the definition of non-retrievable but
must render the drug unavailable and unusable. (d) A record of controlled substances destroyed shall be made
containing the date of destruction, patient name, drug name, drug strength,
quantity, method of destruction and the positive identification of the two
individuals listed in the paragraph (D)(2)(c) of this rule responsible for the
destruction. The record of controlled substance destruction shall be maintained
on-site at the location licensed as a terminal distributor of dangerous drugs
for a minimum of three years from the date of destruction and made readily
retrievable. (e) Controlled substances shall be destroyed no later than ten
days from the date the patient's controlled substance medication is
removed from the medication cart or storage area in accordance with paragraph
(D)(2)(a) this rule. (E) The unused portion of a controlled
substance resulting from administration to a patient from a licensee's
stock or emergency supply may be destroyed using an on-site method by any
person legally authorized under Chapters 3719. and 4729. of the Revised Code
and this division of the Administrative Code to possess controlled substance
dangerous drugs. The on-site method does not have to meet the definition of
non-retrievable but must render the drug unavailable and unusable. A record of
such destruction shall be made in accordance with 21 C.F.R. 1304 (9/25/2023)
and shall be maintained for a minimum of three years from the date of
destruction and made readily retrievable to the board of pharmacy upon
request.
Last updated July 1, 2024 at 5:25 PM
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Rule 4729:5-3-02 | Report of theft or significant loss of dangerous drugs, controlled substances, and drug documents.
Effective:
October 31, 2021
(A) A terminal distributor of dangerous
drugs shall notify the following upon discovery of the theft or significant
loss of any dangerous drug or controlled substance, including drugs in transit
that were either shipped from or to the licensed location: (1) The state board of
pharmacy, by telephone or other method determined by the board, immediately
upon discovery of the theft or significant loss; (2) If a controlled
substance, the drug enforcement administration (DEA) pursuant to 21 C.F.R.
1301.76 (9/9/2014); (3) Law enforcement
authorities pursuant to section 2921.22 of the Revised Code. (B) The theft or significant loss of
controlled substances shall be reported by a licensee using the federal DEA
report form regardless if the controlled substances are subsequently recovered
and/or the responsible parties are identified and action is taken. Information
reported in the federal form regarding such theft or significant loss shall be
filed with the state board of pharmacy, in a manner determined by the board, by
the licensee within thirty days following the discovery of such theft or
significant loss. (1) An exemption may be
obtained upon sufficient cause if the federal form cannot be filed within
thirty days. (2) A request for a
waiver of the thirty-day limit must be requested in a manner determined by the
board. (C) The theft or significant loss of
non-controlled dangerous drugs shall be reported to the state board of
pharmacy, in a manner determined by the board, by the licensee within thirty
days following the discovery of such theft or significant loss of
non-controlled dangerous drugs. The report shall be filed regardless if the
dangerous drugs are subsequently recovered and/or the responsible parties are
identified and action is taken. (1) An exemption may be
obtained upon sufficient cause if the form cannot be filed within thirty
days. (2) A request for a
waiver of the thirty-day limit must be requested in a manner determined by the
board. (D) A terminal distributor of dangerous
drugs shall, immediately upon discovery, notify the state board of pharmacy, in
a manner determined by the board, and law enforcement authorities of any theft
or loss of uncompleted prescription blank(s) used for writing a prescription,
written prescription order(s) not yet dispensed and original prescription
order(s) that have been dispensed. (E) A terminal distributor of dangerous
drugs shall, immediately upon discovery, notify the state board of pharmacy, in
a manner determined by the board, law enforcement authorities and the drug
enforcement administration (DEA) pursuant to 21 C.F.R. 1305.16 (9/9/2014) of
the theft or loss of any DEA form 222.
Last updated October 31, 2021 at 12:26 AM
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Rule 4729:5-3-03 | Inspections and corrective actions.
(A) Pursuant to section 3719.13 of the
Revised Code, an entity licensed by the state board of pharmacy as a terminal
distributor of dangerous drugs is subject to an on-site inspection by the
board. An authorized board employee may, without notice, carry out an on-site
inspection or investigation of an entity licensed by the board. Upon
verification of the board employee's credentials, the employee shall be
permitted to enter the licensed entity. (B) Submission of an application for a
license as a terminal distributor of dangerous drugs with the state board of
pharmacy constitutes permission for entry and on-site inspection by an
authorized board employee. (C) If an employee of the state board of
pharmacy identifies a violation specified in paragraph (D) of this rule, the
employee may provide written notice, in a manner determined by the board, of
the nature of the observed violations to the responsible person on the license
or application. The licensee or applicant may also be subject to disciplinary
actions pursuant to Chapter 4729. of the Revised Code and this division of the
Administrative Code. (D) Violations may include any of the
following: (1) Violating any rule of
the board; (2) Violating any
provision of Chapter 4729. of the Revised Code; (3) Violating any
provision of the "Federal Food, Drug, and Cosmetic Act," 52 Stat.
1040 (1938), 21 U.S.C. 301, or Chapter 3715. of the Revised Code;
or (4) Violating any
provision of the federal drug abuse control laws or regulations or Chapter
2925. or 3719. of the Revised Code. (E) The licensee or applicant shall
submit to the board within thirty days of a written notice provided in
accordance with paragraph (C) of this rule, in a manner determined by the
board, either of the following: (1) The action(s) the
licensee or applicant has taken to correct the violation(s) and the date of
implementation of the corrective action(s); or (2) An explanation
disputing the observed violations.
Last updated July 1, 2024 at 5:26 PM
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Rule 4729:5-3-04 | Verification of licensure prior to sale or purchase.
(A) Before a terminal distributor of
dangerous drugs may purchase dangerous drugs at wholesale, the terminal
distributor shall query the board's online roster (available on the
board's website: www.pharmacy.ohio.gov) to confirm any of the
following: (1) The seller is
licensed to engage in the sale of dangerous drugs in accordance with section
4729.52 of the Revised Code; or (2) The seller is
licensed to engage in the occasional sale or distribution of dangerous drugs at
wholesale in accordance with rule 4729:5-3-09 of the Administrative
Code. (B) If no documented query is conducted
before a purchase is made, it shall be presumed that the purchase of dangerous
drugs by the terminal distributor is in violation of section 4729.51 of the
Revised Code. If a licensed terminal distributor of dangerous
drugs conducts a documented query at least annually and relies on the results
of the query in purchasing dangerous drugs, the terminal distributor shall be
deemed not to have violated section 4729.51 of the Revised Code in making the
purchase. (C) Before a terminal distributor of
dangerous drugs may make a sale of dangerous drugs pursuant to rule 4729:5-3-09
of the Administrative Code, the terminal distributor shall query the
board's online roster (available on the board's website:
www.pharmacy.ohio.gov) to determine if the purchaser is licensed as
either: (1) A terminal
distributor of dangerous drugs. For a limited terminal distributor of dangerous drugs license, a
terminal distributor shall also review a current version of the
licensee's drug list to ensure the purchaser is authorized to possess the
drugs ordered. (2) A distributor of
dangerous drugs in accordance with division 4729:6 of the Administrative
Code. (D) Paragraph (C) of this rule does not
apply when a terminal distributor sells or distributes dangerous drugs at
wholesale to any of the following: (1) A terminal
distributor, manufacturer, outsourcing facility, third-party logistics
provider, repackager, or wholesale distributor that is located in another
state, is not engaged in the sale of dangerous drugs within this state, and is
actively licensed to engage in the sale of dangerous drugs by the state in
which the distributor conducts business; or (2) Any of the exempted
persons described in section 4729.541 of the Revised Code. (E) A terminal distributor of dangerous
drugs may make a sale of a dangerous drug to any of the exempted persons
described in section 4729.541 of the Revised Code in accordance with rule
4729:5-3-09 of the Administrative Code and shall ensure the purchaser meets the
exemption criteria. To confirm a purchaser meets the exemption criteria, the
terminal drug distributor shall comply with the all the following: (1) Provide the
purchaser, in a manner determined by the board, the requirements in Ohio law of
when a purchaser shall hold a license as a terminal distributor of dangerous
drugs; (2) If the purchaser is a
prescriber, verify the prescriber is appropriately licensed in this state to
prescribe drugs or dangerous drugs or drug therapy related devices in the
course of the individual's professional practice; (3) Require the purchaser
who claims an exemption to the terminal distributor of dangerous drug licensing
requirement to annually attest in writing, which may include an electronic
signature, that the purchaser meets the licensing exemptions in section
4729.541 of the Revised Code; and (4) Ensure that all
attestations are maintained by the terminal distributor for a period of three
years following the date the attestation is signed by the
purchaser.
Last updated November 26, 2024 at 4:55 PM
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Rule 4729:5-3-05 | Confidentiality of patient records.
(A) Records relating to the practice of
pharmacy, the administration of drugs, or any patient specific drug transaction
are not a public record. A person having custody of, or access to, such records
shall not divulge the contents thereof, or provide a copy thereof, to anyone
except: (1) The patient, or owner
if the patient is an animal, for whom the prescription or medication order was
issued. (2) The prescriber who
issued the prescription or medication order, or a subsequent treating
prescriber. (3) Licensed health care
personnel who are responsible for the care of the patient. (4) A member, inspector,
agent, or investigator of the state board of pharmacy or any federal, state,
county, or municipal officer whose duty is to enforce the laws of this state or
the United States relating to drugs and who is engaged in a specific
investigation involving a designated person or drug. (5) An agent of an Ohio
licensing agency that is responsible for the licensure or registration of a
health professional authorized to prescribe drugs as defined in section 4729.01
of the Revised Code when enforcing that agency's chapter of the Revised
Code. (6) A state or federal
agency charged with the responsibility of providing medical care (i.e.
medicaid, medicare, workers' compensation, etc.) for the patient upon a
written request by an authorized representative of the agency requesting such
information. (7) An agent of a medical
insurance company who provides prescription insurance coverage to the patient
upon authorization and proof of insurance by the patient or proof of payment by
the insurance company for those medications whose information is
requested. (8) An agent who
contracts with the terminal distributor of dangerous drugs as a "business
associate" in accordance with the regulations promulgated by the secretary
of the United States department of health and human services pursuant to the
federal standards for privacy of individually identifiable health
information. (9) Any person, other
than those listed in paragraphs (A)(1) to (A)(8) of this rule, only when the
patient has given consent for such disclosure in writing. Any consent must be
signed by the patient and dated. Any consent for disclosure is valid until
rescinded by the patient. In an emergency, the terminal distributor of
dangerous drugs may disclose the information when, in the professional judgment
of the pharmacist or healthcare provider, it is deemed to be in the best
interest of the patient. A pharmacist or healthcare provider making an oral
disclosure in an emergency situation must prepare a written memorandum showing
the patient's name, the date and time the disclosure was made, the nature
of the emergency, and the names of the individuals by whom and to whom the
information was disclosed. (B) Testimonial privilege is not waived
for any communication between a prescriber, a pharmacist, and a patient
pursuant to section 2317.02 of the Revised Code. (C) Records relating to the practice of
pharmacy, the administration of drugs, or any patient specific drug transaction
which may be required as evidence of a violation shall be released, upon
request, to a member, inspector, agent, or investigator of the state board of
pharmacy or any state, county, or municipal officer whose duty is to enforce
the laws of this state or the United States relating to drugs and who is
engaged in a specific investigation involving a designated person or drug. Such
person shall furnish a receipt to the person having legal custody of the
records. If the record is a prescription, the receipt shall list the following
information: (1) Prescription
identification number; or, if an order for medication, the name of the
patient; (2) The drugs prescribed
or ordered; (3) Quantity of drugs
prescribed, dispensed, administered or personally furnished; (4) Name of the
prescriber; (5) Date, name of agency,
and signature of person removing the records. (D) All such records, including consents,
memoranda of emergency disclosures, and written requests pursuant to paragraph
(A)(9) of this rule, shall be kept on file at the terminal distributor of
dangerous drugs for a period of three years in a readily retrievable
manner. (E) All patient records maintained by a
terminal distributor of dangerous drugs shall be maintained in accordance with
the following: (1) For human patients,
the Health Insurance Portability and Accountability Act of 1996 (HIPAA);
and (2) All state and federal
laws, rules, and regulations.
Last updated July 1, 2024 at 5:26 PM
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Rule 4729:5-3-06 | Storage of adulterated drugs.
To prevent their use, adulterated drugs, as defined
in agency 4729 of the Administrative Code, shall be stored in a separate and
secure area apart from the storage of drugs used for dispensing, personally
furnishing, compounding, and administration. (A) Adulterated drugs shall be stored no
longer than one year from the date of adulteration or expiration by those
holding a terminal distributor of dangerous drugs license. Adulterated drugs
shall be stored in a manner that prohibits access by unauthorized
persons. (B) Dangerous drugs, other than
controlled substances, may be destroyed utilizing proper methods of disposal
and following the record keeping requirements noted in agency 4729 of the
Administrative Code, or may be donated to a pharmacy school pursuant to
sections 3715.88 to 3715.92 of the Revised Code. Methods of disposal of
non-controlled dangerous drugs shall prevent the possession or use of the drugs
by unauthorized persons. (C) Dangerous drugs that are controlled
substances shall be disposed of pursuant to rule 4729:5-3-01 of the
Administrative Code.
Last updated July 1, 2024 at 5:27 PM
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Rule 4729:5-3-07 | Controlled substances inventory requirements.
(A) Unless otherwise stated in this
division of the Administrative Code, all category III terminal distributor
licensees shall complete a controlled substances inventory in accordance with
21 CFR 1304.11 (9/9/2014). (B) All controlled substance inventories
performed in accordance with this rule shall be conducted on an annual basis.
The annual inventory may be taken on any date which is within thirteen months
of the previous inventory date. (C) The terminal distributor's
responsible person shall be responsible for completing and maintaining this
inventory record at the location licensed as a terminal distributor of
dangerous drugs. (D) All inventory records shall be
maintained for a period of three years from the completion date of the
inventory and made readily retrievable. (E) When a drug or compound is added to
the schedule of controlled substances by state or federal law, rule or
regulation, a terminal distributor shall complete an inventory pursuant to this
rule of all stocks of such drug or compound no later than ten days of the drug
or compound being added to the schedule. (F) In the event a terminal distributor
of dangerous drugs commences business with no controlled substances on hand,
this fact shall be recorded as the initial inventory.
Last updated April 15, 2024 at 1:33 PM
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Rule 4729:5-3-08 | Sales of dangerous drugs on-line.
(A) All persons selling or offering to
sell dangerous drugs via the internet at retail, into, out of, or within Ohio
must be properly licensed with the state board of pharmacy. (B) All terminal distributors of
dangerous drugs who sell or offer to sell dangerous drugs at retail 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) Except as provided in paragraph (F)
of this rule, all terminal distributors of dangerous drugs who sell or offer to
sell dangerous drugs at retail on the internet to persons located in Ohio shall
maintain a digital pharmacy accreditation from the national association of
boards of pharmacy, as approved by the board. (D) Websites owned and/or maintained by a
terminal distributor of dangerous drugs who sell or offer to sell dangerous
drugs at retail on the internet to persons located in Ohio or any other state
must provide the following information to the public: (1) Name under which the
terminal distributor is licensed to do business as in Ohio. (2) Full address of the
licensed location. (3) Telephone number
where the terminal distributor may be contacted during regular business
hours. (4) A list of the states
in which the terminal 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. (E) Any Ohio licensed terminal
distributor requesting personal information from the public by way of the
internet (e.g., questionnaire forms, e-mail, etc.) must provide for security
and confidentiality of the information. This portion of the website must also
provide information regarding how the personal information will be used,
pursuant to all federal and state laws, rules, and regulations, and ensure that
such information is not used for purposes not disclosed without the written
informed consent of the patient or person submitting personal
information. (F) A veterinarian, licensed under
Chapter 4741. of the Revised Code, may sell or offer to sell dangerous drugs
via the internet only when the internet pharmacy that fulfills the dangerous
drug prescription or facilitates the sale of the dangerous drug maintains a
digital pharmacy accreditation from the national association of boards of
pharmacy.
Last updated July 1, 2024 at 5:27 PM
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Rule 4729:5-3-09 | Occasional sale and drug transfers.
(A) The term "occasional sale"
as used in section 4729.51 of the Revised Code means a wholesale sale of a
commercially manufactured dangerous drug to a person licensed in accordance
with section 4729.52 of the Revised Code, terminal distributor of dangerous
drugs or any entity or person exempted from licensure as a terminal distributor
of dangerous drugs by any of the following: (1) A pharmacy licensed
as a terminal distributor of dangerous drugs; (2) A licensed terminal
distributor of dangerous drugs that is not a pharmacy, but only as authorized
in section 4729.51 of the Revised Code; (3) A local health
department, as defined in paragraph (H) of this rule, licensed as a terminal
distributor of dangerous drugs for the purpose of improving or promoting public
health within the department's jurisdiction, but only for the sale of
non-controlled dangerous drugs; or (4) A drug repository
program pursuant to rule 4729:5-10-07 of the Administrative Code. (B) The dosage units of all dangerous
drugs distributed by the pharmacy pursuant to this rule shall not exceed five
per cent of the total dosage units dispensed by the pharmacy during the same
calendar year. (C) The limits set forth in this rule do
not apply to the following: (1) A licensed terminal
distributor of dangerous drugs as described in paragraph (A)(2) of this rule;
(2) Pharmacies that are
also licensed to conduct sales of dangerous drugs in accordance with section
4729.52 of the Revised Code; and (3) Drug repository
programs pursuant to rule 4729:5-10-07 of the Administrative Code.
(D) The requirements of this rule do not
apply to the transfer of dangerous drugs pursuant to paragraph (E) of this
rule. (E) A licensed terminal distributor of
dangerous drugs having more than one licensed location may transfer or deliver
dangerous drugs from one licensed location to another licensed location owned
by that terminal distributor if the license issued for each location is in
effect at the time of the transfer or delivery. Such transfer or delivery
includes either of the following: (1) Intracompany sales,
which includes any transaction or transfer between any division, subsidiary,
parent or affiliated or related company under the common ownership and
control. (2) The sale, purchase,
or transfer of a drug or an offer to sell, purchase, or transfer of a drug
among hospitals or other health care entities that are under common control.
Common control means the power to direct or cause the direction of the
management and policies of a person or an organization, whether by ownership of
stock, voting rights, by contract, or otherwise. (F) Occasional sales by a licensed
terminal distributor shall comply with the reporting requirements set forth in
division 4729:8 of the Administrative Code. (G) "Drug shortage," with
respect to an occasional sale, means a drug on the United States food and drug
administration's drug shortage list that is not commercially available
regardless of the reason that the drug is not available, including the absence
of a manufacturer for the drug or the lack of a readily available supply of the
drug from a manufacturer or wholesaler. (H) "Local health department'
means a department operated by a board of health of a city or general health
district or the authority having the duties of a board of health as described
in section 3709.05 of the Revised Code.
Last updated November 26, 2024 at 4:55 PM
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Rule 4729:5-3-10 | Employment of individuals with felony convictions.
(A) Pursuant to 21 C.F.R. 1301.76
(6/22/2023), a terminal distributor of dangerous drugs that is a United States
drug enforcement administration registrant shall not employ in a position which
allows access to controlled substances any person who has been convicted of a
felony relating to controlled substances, or who, at any time, has had an
application for drug enforcement administration registration denied, revoked,
or surrendered for cause. "For cause" means surrendering a
registration in lieu of, or as a consequence of, any federal or state
administrative, civil, or criminal action resulting from an investigation of
the individual's handling of controlled substances. (B) Paragraph (A) of this rule does not
apply if a waiver is obtained by a licensee pursuant to 21 C.F.R. 1307.03
(3/9/2010).
Last updated July 1, 2024 at 5:28 PM
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Rule 4729:5-3-11 | Transmission of outpatient prescriptions.
Effective:
December 1, 2020
(A) Oral transmission by a prescriber or
a prescriber's agent of an original outpatient prescription authorized by
a prescriber shall comply with the requirements of rule 4729:5-5-15 of the
Administrative Code. For any oral outpatient prescription transmitted by an
agent of a prescriber, the prescriber's agent must provide the
agent's first and last name when transmitting the prescription. An oral
prescription may be transmitted by a prescriber or prescriber's agent to a
recording device or voice mail service. (B) Original written outpatient
prescriptions shall be authorized and signed by a prescriber, in the same
manner as the prescriber would sign a check or legal document, and may be
transmitted by the prescriber or the prescriber's agent by facsimile
machine to a pharmacy. (1) The facsimile of the
prescription must include the identification number of the facsimile machine
which is used to transmit the prescription, the full name of the prescriber
and, if applicable, the full name of the prescriber's agent transmitting
the prescription to the pharmacy. (2) The prescription must
comply with the requirements of rule 4729:5-5-15 of the Administrative
Code. (3) The original
prescription signed by the prescriber from which the facsimile is produced
shall not be issued to the patient. The original prescription signed by the
prescriber must remain with the patient's records at the location where it
was issued for three years from the date of issuance. Following the successful
transmission of the prescription, the word "VOID" or
"FAXED" shall be written or stamped on the face of the original
prescription in a manner that does not destroy any of the original information
contained on the prescription. (4) Outpatient
prescriptions for schedule II controlled substances may be transmitted by
facsimile in accordance with 21 C.F.R. 1306.11 (5/1/2019) and shall meet the
facsimile requirements of this rule. (C) Outpatient prescriptions may be transmitted by means of
an electronic prescription transmission system that complies with the
prescription requirements in rule 4729:5-5-15 of the Administrative
Code. (1) An outpatient
prescription transmitted by means of an electronic prescription transmission
system shall include the full name of the prescriber's agent transmitting
the prescription. (2) A controlled
substance outpatient prescription shall only be transmitted by means of an
electronic prescription transmission system if the system complies with 21 CFR
1311 (5/1/2019). (3) Except as provided in paragraphs
(C)(4) and (C)(5) of this rule, no prescriptions may be transmitted by means of
an electronic prescription transmission system that converts the prescription
into a computer-generated fax or scanned image. (4) A non-controlled prescription may be
transmitted by means of an electronic prescription transmission system that
converts the prescription into a computer-generated fax or scanned image if all
the following apply: (a) The transmission is conducted by means of a board
approved system that meets the prescription requirements of rule 4729:5-5-15 of
the Administrative Code. (b) The prescription transmission system operates within a
closed-system. A closed system includes any system whereby prescription
information is transmitted directly between: (i) Any division,
subsidiary, parent or affiliated or related company under common ownership and
control; or (ii) One or more
contracted entities. Contracted means having a written agreement (to include
business associate agreements) between one or more prescribers and a pharmacy
and shall not include a third-party intermediary unless otherwise approved by
the board. (5) A non-controlled
prescription may be converted into a computer-generated fax by a board approved
third-party intermediary only if the conversion is necessitated by a temporary
telecommunication outage of the third-party intermediary or receiving
pharmacy.
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Rule 4729:5-3-12 | Protocols and pre-printed orders for medication administration.
(A) A terminal distributor of dangerous
drugs may distribute or dispense dangerous drugs pursuant to a protocol. As
used in this rule, "protocol" means a definitive set of written
treatment guidelines with orders for drugs and their specified dosages for
administration to individuals under the following circumstances: (1) The provision of
medical services to individuals in an emergency situation when the services of
a prescriber authorized by the revised code to prescribe dangerous drugs as
part of their professional practice are not immediately available. An emergency
situation may manifest itself by acute symptoms of sufficient severity that an
authorized individual providing medical services under this paragraph could
reasonably expect the absence of immediate medical attention to result in
placing the health of the individual or, with respect to a pregnant woman, the
health of the woman or her unborn child, in serious jeopardy; serious
impairment to bodily functions; or serious dysfunction of any bodily organ or
part. Examples of emergency situations includes cases such as heart attacks,
severe burns, extravasation, overdoses, cyanide poisonings, electrocutions, or
severe asthmatic attacks; (2) The administration of
biologicals or vaccines to individuals for the purpose of preventing
diseases; (3) The administration of
vitamin K for prevention of vitamin K deficient bleeding in
newborns; (4) The administration of
erythromycin for prevention of ophthalmia neonatorum; and (5) The administration of
influenza antiviral treatment and chemoprophylaxis to residents and health care
personnel at an institutional facility, as defined in agency 4729 of the
Administrative Code, according to current guidance issued by the United States
center for disease control and prevention. (B) A protocol described in paragraph (A)
of this rule shall: (1) Include a description
of the intended recipients to whom the drugs are to be administered; drug name
and strength; instructions of how to administer the drug, dosage, and
frequency; signature of a prescriber or some other form of positive
identification of the prescriber as defined in agency 4729 of the
Administrative Code; and date of signature; (2) Be administered by an
individual authorized by law to administer the drugs; (3) Be made readily
retrievable; (4) Be reviewed as
necessary to ensure patient safety and practice in accordance with acceptable
and prevailing standards of care; and (5) Be maintained by the
terminal distributor of dangerous drugs for a period of three years from the
date of authorization or reauthorization following any modification or
amendment. (C) A terminal distributor of dangerous
drugs may distribute or dispense dangerous drugs for administration pursuant to
a pre-printed order. As used in this rule, "pre-printed order" means
a patient specific and dose specific order for the administration of a specific
drug or drugs prescribed by a licensed health care professional authorized to
prescribe drugs. The prescriber must complete an assessment and make a
diagnosis prior to initiating a pre-printed order in accordance with the
prescriber's scope of practice. The pre-printed order may only be
initiated upon the order of a prescriber authorized by law to prescribe the
drugs listed in the pre-printed orders. The drugs shall be administered by an
individual authorized by law to administer the drugs. (D) A pre-printed order described in
paragraph (C) of this rule shall: (1) Include the name of
the patient; drug name and strength; specific instructions of how to administer
the drug, dosage, and frequency; instructions of any patient specified dosage
range based on objective measures such as calculations and patient physiologic
data; signature of the prescriber or some other form of positive identification
of the prescriber as defined in agency 4729 of the Administrative Code; and
date of signature; (2) Apply only to those
drugs for which the therapeutic dose is significantly lower than the dose
expected to cause detrimental adverse effects; (3) Can be performed
without requiring the exercise of medical judgment; (4) Will lead to results
that are reasonably predictable and safe; (5) Can be performed
safely by the individual authorized to administer the drugs and without the
need for repeated medical assessments; (6) Be maintained by the
terminal distributor of dangerous drugs for a period of three years from the
date of initiation. A pre-printed order which becomes a permanent part of the
patient's medical record shall be deemed to meet the requirements of this
paragraph; (7) Be made readily
retrievable; (8) If performed
improperly, would not present a danger of immediate and serious harm to the
patient; and (9) Be reviewed as
necessary to ensure patient safety and practice in accordance with acceptable
and prevailing standards of care. (E) Nothing in this rule shall be
construed to otherwise prohibit the dispensing or administration of dangerous
drugs pursuant to a protocol that is specifically authorized in the Revised
Code or agency 4729 of the Administrative Code. (F) For purposes of this rule, a terminal
distributor of dangerous drugs may distribute or dispense dangerous drugs for
administration to animals pursuant to a protocol in accordance with the
provisions of paragraphs (A) and (B) of this rule or a pre-printed order in
accordance with the provisions of paragraphs (C) and (D) of this
rule.
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Rule 4729:5-3-13 | Temporary removal of dangerous drugs from a licensed location.
Effective:
December 26, 2021
No licensed terminal distributor of dangerous drugs shall engage in the sale or other distribution of dangerous drugs at retail or maintain possession, custody, or control of dangerous drugs for any purpose at any establishment or place other than that or those described in the license issued by the state board of pharmacy to such terminal distributor, except as follows: (A) A licensed health professional authorized to prescribe drugs may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph. (B) A person authorized to personally furnish or dispense naloxone in accordance with a physician approved protocol. The naloxone shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The authorized person shall maintain direct supervision and control over the naloxone removed from the terminal distributor. If direct supervision is not provided, the naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph. (C) A licensed health care professional, in accordance with their applicable scope of practice, who provides immunizations or any other non-controlled substance dangerous drugs that may be administered in accordance with a protocol or valid prescriber's order may temporarily remove dangerous drugs from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients. The dangerous drugs shall be returned to the licensed terminal distributor of dangerous drugs within twenty-four hours, unless otherwise approved by the board. The licensed health professional shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. The responsible person on the terminal distributor of dangerous drugs license shall be responsible for compliance with the requirements of this paragraph. (D) An emergency medical service (EMS) organization providing emergency medical services and in accordance with Chapter 4729:5-14 of the Administrative Code. (E) A veterinarian licensed pursuant to Chapter 4741. of the Revised Code may maintain a supply of dangerous drugs obtained from a licensed terminal distributor of dangerous drugs at another location in order to treat current or prospective patients. A veterinarian shall maintain direct supervision and control over the dangerous drugs and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs and any hypodermics shall be physically secured in a manner to prevent unauthorized access and all reasonable efforts shall be made to store the drugs at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Any drugs maintained pursuant to this paragraph are subject to inspection by a board of pharmacy agent and shall be subject to all recordkeeping, labeling, theft or significant loss reporting, disposal, and inventory requirements of division 4729:5 of the Administrative Code. Records shall be maintained by the terminal distributor of dangerous drugs in accordance with Chapter 4729:5-20 of the Administrative Code. The responsible person on the terminal distributor of dangerous drugs license from which the drugs are obtained shall be responsible for compliance with the requirements of this paragraph. A veterinarian maintaining dangerous drugs in accordance with this rule shall only obtain the drugs from single terminal distributor and shall not co-mingle drug stock from another terminal distributor of dangerous drugs. The terminal distributor of dangerous drugs shall also maintain the following records for controlled substance dangerous drugs removed from the terminal distributor of dangerous drugs that are stored off-site for more than twenty-four hours: name, strength, dosage form, and quantity of the controlled substance dangerous drugs, the positive identification of the veterinarian who removed the drugs, and the address of the location where the drugs are maintained. Corresponding records shall also be maintained for any controlled substances returned to the terminal distributor's inventory of dangerous drugs from the off-site location. All records required in accordance with this paragraph shall be readily retrievable and maintained for at least three years from the date of removal or return. Failure by a veterinarian to exercise supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code or adequate safeguards as required in division (C) of section 4729.55 of the Revised Code shall be deemed a violation of this rule. (F) A person licensed or certified under Chapter 4765. of the Revised Code may maintain a supply of medical oxygen and/or naloxone obtained from a licensed terminal distributor of dangerous drugs in order to treat current or prospective patients in the event of an emergency. The medical oxygen and/or naloxone shall be maintained for an amount of time as determined by written authorization from the licensee's medical director. Medical oxygen and naloxone shall only be administered in accordance with the licensee's protocol or valid prescriber order. The individuals authorized by to this paragraph shall maintain personal supervision and control over the medical oxygen and/or naloxone removed from the terminal distributor. If personal supervision is not provided, the medical oxygen and/or naloxone shall be physically secured in a manner to prevent unauthorized access and shall be stored at temperatures and conditions which will ensure the integrity of the medical oxygen and/or naloxone prior to its use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. (G) A certified officer, as defined in section 4729.533 of the Revised Code, may maintain a supply of dangerous drugs, as authorized in rule 4729:5-15-05 of the Administrative Code, obtained from a licensed terminal distributor of dangerous drugs with a chemical capture classification at another location in order to engage in chemical capture. A certified officer shall maintain direct supervision and control over the dangerous drugs, equipment, and any hypodermics removed from the terminal distributor. If direct supervision is not provided, the dangerous drugs, equipment, and any hypodermics shall be physically secured in a manner to prevent unauthorized access and all reasonable efforts shall be made to store the drugs at temperatures and conditions which will ensure the integrity of the drugs prior to their use as stipulated by the USP/NF and/or the manufacturer's or distributor's labeling. Any drugs maintained pursuant to this paragraph are subject to inspection by a board of pharmacy agent and shall be subject to all recordkeeping, labeling, theft or significant loss reporting, disposal, and inventory requirements of division 4729:5 of the Administrative Code. Records shall be maintained by the terminal distributor of dangerous drugs in accordance with Chapter 4729:5-15 of the Administrative Code. The responsible person on the terminal distributor of dangerous drugs license from which the drugs are obtained shall be responsible for compliance with the requirements of this paragraph. A certified officer maintaining dangerous drugs in accordance with this rule shall only obtain the drugs from single terminal distributor and shall not co-mingle drug stock from another terminal distributor of dangerous drugs. The terminal distributor of dangerous drugs shall also maintain the following records for controlled substance dangerous drugs removed from the terminal distributor of dangerous drugs that are stored off-site: name, strength, dosage form, and quantity of the controlled substance dangerous drugs, the positive identification of the certified officer who removed the drugs, and the address of the location where the drugs are maintained. Corresponding records shall also be maintained for any controlled substances returned to the terminal distributor's inventory of dangerous drugs from the off-site location. All records required in accordance with this paragraph shall be readily retrievable and maintained for at least three years from the date of removal or return. Failure by a certified officer to exercise supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code or adequate safeguards as required in division (C) of section 4729.55 of the Revised Code shall be deemed a violation of this rule. (H) An opioid treatment program operating a mobile opioid treatment program in accordance with rule 4729:5-21-05 of the Administrative Code. (I) As used in this rule, "direct supervision" means an individual authorized pursuant to this rule is in the immediate area and within visual range of dangerous drugs and/or hypodermics to deter and detect diversion.
Last updated December 27, 2021 at 5:43 PM
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Rule 4729:5-3-14 | General security requirements.
(A) All terminal distributors of
dangerous drugs shall provide effective controls and procedures
to: (1) Deter and detect the
theft and diversion of dangerous drugs; and (2) Ensure supervision
and control of dangerous drugs, as required in division (B) of section 4729.55
of the Revised Code, and adequate safeguards to ensure that dangerous drugs are
being distributed in accordance with all state and federal laws, as required in
section 4729.55 of the Revised Code. (B) Substantial compliance with the
standards set forth in this division of the Administrative Code may be deemed
sufficient by the state board of pharmacy after evaluation of the overall
security system and needs of the licensee or applicant. In evaluating the
overall security system of a licensee or applicant, the state board of pharmacy
may consider any of the following factors, as deemed relevant, for compliance
with security requirements: (1) The type of activity
conducted; (2) Type and form of
dangerous drugs handled; (3) Quantity of dangerous
drugs handled; (4) Location of the
premises and the relationship such location bears on security
needs; (5) Type of building
construction comprising the facility and the general characteristics of the
building or buildings; (6) Type of vaults,
safes, and secure enclosures or other storage system (e.g. automatic storage
and retrieval system) used; (7) Type of closures on
vaults, safes, and secure enclosures; (8) Adequacy of key
control systems and/or combination lock control systems; (9) Adequacy of
electronic detection and alarm systems, if any, including use of supervised
transmittal lines and standby power sources; (10) Extent of
unsupervised public access to the facility, including the presence and
characteristics of perimeter fencing, if any; (11) Adequacy of
supervision over authorized employees having access to areas containing
dangerous drugs; (12) Procedures for
handling business guests, visitors, maintenance personnel, and non-employee
service personnel; and (13) Adequacy of the
licensee's or applicant's system for monitoring the receipt,
manufacture, distribution, and disposition of dangerous drugs in its
operation. (C) When physical security controls
become inadequate as a result of a significant increase in the quantity of
dangerous drugs in the possession of the licensee during normal business
operation, the physical security controls shall be expanded and extended
accordingly. (D) Any applicant seeking to determine
whether a proposed security system substantially complies with, or is the
structural equivalent of, the requirements set forth in this division of the
Administrative Code may submit any plans, blueprints, sketches, or other
materials regarding the proposed security system to the state board of
pharmacy.
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Rule 4729:5-3-15 | Use of hospital and other institution D.E.A. registrations.
Effective:
December 1, 2020
(A) As used in this rule, "hospital
or other institution" has the same meaning as in Part 1301 of the Code of
Federal Regulations. (B) A
prescriber who is an agent or employee of a hospital or other institution may,
when acting in the normal course of business or employment, administer,
personally furnish, or prescribe controlled substances under the "Drug
Enforcement Administration" (D.E.A.) registration of the
hospital. (C) A
person pursuing an approved training program within the jurisdiction of the
hospital or other institution and authorized to write prescriptions pursuant to
paragraph (B) of rule 4729:5-1-02 of the Administrative Code may administer,
personally furnish, or prescribe controlled substances under the registration
of the hospital or other institution. Persons pursuing such approved training
programs may function in sites outside the physical confines of the hospital or
other institution only if such sites are part of the training program and the
persons are under the employment and jurisdiction of the hospital or other
institution administering the approved program. While functioning in the
outside sites, such persons may continue to use the internal code assigned by
the hospital or other institution administering the approved program, upon
mutual agreement of the hospital or other institution and the outside
site. (D) The administering, personally furnishing, or
prescribing must be done in the usual course of the person's professional
practice and only within the scope of the person's employment in the
hospital or other institution. (E) Each person so authorized must be assigned a specific
internal code number by the hospital or other institution which will be used as
a suffix to the hospital D.E.A. registration number. Such internal code number
shall consist of numbers, letters, or a combination thereof, shall be preceded
by a hyphen, and no more than ten characters in length, excluding the hyphen. A
current list of the internal codes and the corresponding individual prescribers
must be kept by the hospital or other institution and made available at all
times to other registrants, state board of pharmacy designated agents,
investigators of the state medical board, and federal, state, county, or
municipal law enforcement agencies for verification. A current list of internal codes and the
corresponding individual prescribers shall be filed with the state board of
pharmacy, in a manner and format determined by the board. Additions, deletions
or changes to the list must be submitted to the state board of pharmacy within
ten business days of any such addition, deletion or change. (F) A
pharmacist practicing under a consult agreement, as authorized in section
4729.39 of the Revised Code, shall not prescribe controlled substances under
the registration of the hospital or other institution.
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Rule 4729:5-3-16 | Returned drugs.
(A) No drug that has been dispensed
pursuant to a prescription or personally furnished by a prescriber and has left
the physical premises of the terminal distributor of dangerous drugs shall be
returned to the terminal distributor or dispensed or personally furnished
again, except as follows: (1) Drugs dispensed for
inpatients, as defined in agency 4729 of the Administrative Code, or personally
furnished to inpatients provided that: (a) The drugs are packaged in unopened, single-dose or
tamper-evident containers; and (b) The drugs have not been in the possession of the
ultimate user. (2) Drugs dispensed for
inpatients, as defined in agency 4729 of the Administrative Code, in accordance
with rule 4729:5-9-02.11 of the Administrative Code. (3) Drugs dispensed for outpatients in
accordance with rules 4729:5-5-22 and 4729:5-5-18 of the Administrative
Code. (4) Drugs dispensed for patients, which
have not been dispensed or personally furnished directly to the ultimate user,
that require further manipulation prior to administration. (5) Drugs donated to a drug repository
program in accordance with Chapter 4729:5-10 of the Administrative
Code. (6) Drugs returned for
destruction or disposal in accordance with division 4729:10 of the
Administrative Code and rule 4729:5-5-14 of the Administrative
Code. (7) Hazardous drugs for
destruction or disposal in accordance with all applicable federal, state, and
local laws, rules, and regulations. (B) As used in this rule, "hazardous
drug" means any drug listed on the national institute for occupational
safety and health's list of antineoplastic and other hazardous drugs in
healthcare settings as referenced in rule 4729:7-1-01 of the Administrative
Code. (C) Except as provided in section 4729.43 of the Revised
Code, nothing in this rule prohibits a terminal distributor of dangerous drugs
from administering a dangerous drug that was dispensed or personally furnished
directly to a patient or patient's caregiver.
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Rule 4729:5-3-17 | Automated pharmacy systems.
(A) As used in this rule: (1) "Automated
pharmacy system" means a mechanical system that performs operations or
activities, other than administration, relative to storage, packaging,
compounding, dispensing, or distribution of dangerous drugs that collects,
controls, and maintains transaction information and records. "Automated pharmacy system" does not
include an "automated drug storage system" utilized by institutional
facilities pursuant to Chapter 4729:5-9 of the Administrative Code or other
locations licensed as terminal distributors of dangerous drugs. (2) "Dispense" means the final
association of a drug with a particular patient pursuant to a prescription,
drug order, or other lawful order of a prescriber and the professional judgment
of and the responsibility for interpreting, preparing, compounding, labeling,
and packaging a specific drug. (a) In the case of an
automated pharmacy system that dispenses dangerous drugs without the final
association by a pharmacist, the system shall capture the positive
identification of the pharmacist authorizing the patient specific prescription
in the system prior to its dispensation. (b) Nothing in this paragraph shall prohibit an automated
pharmacy system from being utilized to restock an automated drug storage system
utilized by institutional facilities pursuant to Chapter 4729:5-9 of the
Administrative Code or other locations licensed as terminal distributors of
dangerous drugs. (3) "Positive
identification" has the same meaning as in rule 4729:5-5-01 of the
Administrative Code. (4) "Tamper evident" means a package, storage
container or other physical barrier that is sealed or secured in such a way
that access to the drugs stored within is not possible without leaving visible
proof that such access has been attempted or made. (B) An automated pharmacy system shall be
approved by the board prior to its implementation by the terminal distributor
of dangerous drugs. (1) Prior to the approval
of an automated pharmacy system, the board shall receive a request from the
responsible person on the terminal distributor of dangerous drugs license. Upon
notification, the board shall conduct an inspection of the system to determine
if it meets the requirements of this rule. (2) For automated
pharmacy systems that dispense dangerous drugs in accordance with paragraph
(A)(2)(a) of this rule, the responsible person of the licensed terminal
distributor of dangerous drugs shall be required to have a pharmacist verify
for accuracy all dangerous drugs dispensed by the system for a continuous
forty-five-day period. The responsible person shall compile metrics, using a
form developed by the board, documenting the performance of the system during
this period. Unless otherwise approved by the board, the accuracy metrics
during the forty-five day pharmacy review period shall be no less than
ninety-nine and nine hundred eighty-five thousandths (99.985) per
cent. (3) Approval of all
automated pharmacy systems shall be site-specific. (C) An automated pharmacy system shall be
located on the premises of a licensed terminal distributor of dangerous drugs.
(D) A terminal distributor of dangerous
drugs operating an automated pharmacy system shall maintain the following
documentation on-site in a readily retrievable manner: (1) The
manufacturer's name and model; (2) A description of how
the automated pharmacy system is used; and (3) Policies and
procedures for system operation, safety, security, accuracy, patient
confidentiality, access, and malfunction. (E) All records maintained in accordance
with this rule, including documentation of quality assurance metrics, shall be
readily retrievable and maintained for period of three years. (F) For automated pharmacy systems that
dispense dangerous drugs in accordance with paragraph (A)(2)(a) of this rule,
the terminal distributor of dangerous drugs shall implement a quality assurance
program to determine continued appropriate use of the automated pharmacy
system. The quality assurance program shall monitor the performance of the
automated pharmacy system, ensure the system is in good working order and
accurately prepares the correct strength, dosage form, and quantity of the drug
prescribed or ordered. At a minimum, the quality assurance program shall
consist of a review of at least five per cent of all dispensed prescriptions
over the daily operational hours of the automated pharmacy system.
(G) If an automated pharmacy system that
dispenses dangerous drugs in accordance with paragraph (A)(2)(a) of this rule
selects an incorrect drug, the terminal distributor shall immediately institute
a one hundred per cent pharmacist verification of all drugs dispensed. The one
hundred per cent verification procedure shall continue until such time as the
terminal distributor can document that the cause of the error has been
determined and addressed and that the system is no longer making
errors. (H) A registered or certified pharmacy
technician, pharmacy technician trainee, pharmacy intern, or nurse licensed in
accordance with Chapter 4723. of the Revised Code may stock an automated
pharmacy system provided that: (1) Except as provided in
paragraph (H)(2) of this rule, the container, canister, or other dangerous drug
storage device being stocked by the technician, trainee, intern, or nurse is
tamper-evident and is verified by a pharmacist and documented using positive
identification. (2) Pharmacist
verification requirements in paragraph (H)(1) of this rule do not apply if all
the following are met: (a) Verification is being conducted by a registered or
certified pharmacy technician, pharmacy intern, or nurse; and (b) The container, canister, or other dangerous drug
storage device being stocked is properly identified by bar code or other such
secondary information system, which has been verified by a pharmacist to ensure
the proper drug is being placed into and recognized as the correct drug by the
system. (3) The utilization of a
bar code, electronic verification, or similar verification process shall
require an initial quality assurance validation by a pharmacist and shall be
followed by a quarterly quality assurance review by a pharmacist. (4) The positive
identification of the individual stocking the system is
documented. (5) A pharmacist is fully
responsible for all activities conducted by the technician, trainee, intern, or
nurse. (6) A pharmacist must be
immediately available to answer questions or discuss the stocking of an
automated pharmacy system. (7) A registered pharmacy
technician or pharmacy technician trainee shall be acting under the personal
supervision of a pharmacist. (I) Except for an automated pharmacy
system in a long-term care facility, a pharmacist shall be physically present
at the terminal distributor of dangerous drugs to provide supervision of the
automated pharmacy system. (J) The automated pharmacy system shall
have security to prevent unauthorized individuals from accessing or obtaining
dangerous drugs and include safeguards to detect the diversion of dangerous
drugs. This shall include the use of tamper-evident containers, canisters, or
other storage devices for use in long-term care facilities. (K) The records kept by the automated
pharmacy system shall comply with the applicable record keeping requirements of
division 4729:5 of the Administrative Code and shall also capture all events
involving the contents of the automated pharmacy system. (L) If applicable, an automated pharmacy
system shall comply with the requirements set forth in 21 CFR 1301.27
(5/13/2005) for automated systems in long term care facilities.
Last updated June 4, 2021 at 8:24 AM
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Rule 4729:5-3-18 | Dangerous drug recall procedures.
Effective:
November 11, 2024
(A) A terminal distributor of dangerous
drugs shall develop and implement a written procedure for the management of
recalls by the manufacturer for dangerous drugs stocked by the terminal
distributor. Such procedures shall include, where appropriate, contacting
patients to whom the recalled drug products have been dispensed or personally
furnished. (B) The written procedure shall include, but not be limited
to, the following: (1) The terminal distributor shall make a reasonable
attempt to ensure that a recalled drug has been removed from inventory no later
than the next business day after receipt of the recall notice by the
responsible person or the responsible person's designee, and quarantined
until proper disposal, destruction, or return of the drug; (2) If the drug that is the subject to a recall is
maintained by the terminal distributor in a container without a lot number, the
terminal distributor shall consider this drug included in the recall;
and (3) Maintaining records for activities taken by the
terminal distributor in relation to a drug recall. (C) The written procedures shall be updated as necessary
and maintained in a readily retrievable manner. All records documenting recall
activities shall be maintained for three years and shall be made readily
retrievable.
Last updated November 12, 2024 at 8:39 AM
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Rule 4729:5-3-19 | Naloxone for emergency use and distribution via automated mechanisms.
(A) As used in this rule,
"tamper-evident" means a package, storage container or other physical
barrier that is sealed or secured in such a way that access to the drugs stored
within is not possible without leaving visible proof that such access has been
attempted or made. (B) In accordance with section 4729.515
of the Revised Code, a terminal distributor of dangerous drugs may acquire and
maintain a supply of naloxone for use in emergency situations and for
distribution through an automated mechanism. The naloxone may be maintained at
a location other than the location licensed as a terminal distributor of
dangerous drugs. (C) In the case of naloxone for use in
emergency situations, a terminal distributor of dangerous drugs shall do all of
the following: (1) Provide written
materials regarding the emergency administration of naloxone to any individual
who accesses the naloxone, to include: (a) Specific instruction to summon emergency services
pursuant to division (D)(2) of section 4729.515 of the Revised
Code. (b) Procedures for administering naloxone contained within
the kit, including the possible administration of multiple doses. (c) Performing rescue breathing and the use of a face
shield or other rescue breathing barrier device, which shall be provided with
the naloxone. (d) Proper method for placing an individual into the
recovery position. (2) Specify a process to
be used to notify the terminal distributor that the naloxone has been accessed
within a reasonable time of its being accessed, which may include any of the
following: (a) Documented checks of the emergency naloxone and its
required components, to be conducted at least every thirty days, by an employee
of the terminal distributor of dangerous drugs. The terminal distributor shall
include a telephone number where persons can report that the emergency naloxone
has been used and needs replenishment. (b) An automated alert that notifies the terminal
distributor when the emergency naloxone is accessed. (c) Any other method approved by the board's executive
director or the director's designee. (3) Except in instances
where naloxone is not commercially available, including the absence of a
manufacturer for the drug or the lack of a readily available supply of the drug
from a manufacturer or wholesaler, a terminal distributor of dangerous drugs
shall replace any naloxone and, if missing or used, any required components
(instructions, rescue breathing barrier device, etc.) no later than forty-eight
hours following notification that naloxone has been accessed in accordance with
paragraph (C)(2) of this rule. (4) Maintain the naloxone
in accordance with the manufacturer's or distributor's
instructions. (a) All naloxone maintained for emergency use in accordance
with this paragraph shall be sealed in a tamper-evident manner to ensure the
integrity of the drug. (b) Any naloxone that shows sign of tampering or
adulteration shall be immediately removed by the terminal distributor of
dangerous drugs and replaced within forty-eight hours of discovering the
naloxone has been tampered with or is adulterated. (c) A terminal distributor shall develop and implement a
policy to ensure that naloxone that exceeds its manufacturer's expiration
date is removed and properly disposed. (5) A terminal
distributor maintaining naloxone in accordance with this paragraph
shall: (a) Maintain a complete list that includes the address and
description of the location (e.g. first floor hallway, second floor conference
room, etc.) of where the terminal distributor maintains the naloxone for
emergency use. The list shall be immediately available for inspection upon
request of an employee of the board. (b) Keep a record of the naloxone maintained for emergency
use that includes the name, strength, dosage form, national drug code and
expiration date. Records shall be readily retrievable and maintained for a
period of three years. (c) Ensure the naloxone is maintained in a container or
device that is securely fastened to a permanent structure and is clearly marked
to indicate naloxone is available for emergency use. (6) The requirements of
this paragraph shall not apply to a service entity that maintains naloxone for
emergency administration in accordance section 4729.514 of the Revised
Code. (D) In the case of naloxone for
distribution through an automated mechanism, a terminal distributor of
dangerous drugs shall do all the following: (1) Ensure the mechanism
is securely fastened to a permanent structure or is of an appropriate size and
weight to reasonably prevent it from being removed from its intended
location. (2) Develop a process to
be used to monitor and replenish the inventory of naloxone maintained in the
automated mechanism, which may include any of the following: (a) Documented checks of the mechanism, to be conducted at
least every thirty days, by an employee of the terminal distributor of
dangerous drugs. (b) An electronic system to monitor the inventory of
naloxone within the mechanism. (c) Any other method approved by the Board's
executive director or the director's designee. (3) Provide written
educational materials to the person accessing the naloxone appropriate to the
dosage form of naloxone distributed, including, but not limited to, all of the
following: (a) Risk factors of opioid overdose. (b) Strategies to prevent opioid overdose. (c) Signs of opioid overdose. (d) Steps in responding to an overdose,
including: (i) The proper method for
placing an individual into the recovery position. (ii) Specific instruction
to summon emergency services pursuant to division (D)(2) of section 4729.515 of
the Revised Code. (e) Information on naloxone. (f) Procedures for administering naloxone. (g) Proper storage and expiration of naloxone product
distributed. (h) Information on where to obtain a referral for substance
abuse treatment. (i) Information, as required in paragraph (D)(4) of this
rule, on where individuals may call for additional questions regarding naloxone
administration. The telephone number must include the hours where an
appropriately trained representative is available to answer
questions. (4) Provide a telephone
number where individuals can call representatives with the requisite training
necessary to answer questions regarding naloxone administration. (5) Maintain the naloxone
in accordance with the manufacturer's or distributor's
instructions. (a) Any naloxone that shows sign of tampering or
adulteration shall be immediately removed by the terminal distributor of
dangerous drugs. (b) A terminal distributor shall develop and implement a
policy to ensure that naloxone that exceeds its manufacturer's expiration
date is removed and properly disposed. (6) A terminal
distributor maintaining naloxone in accordance with this paragraph
shall: (a) Maintain a complete list that includes the address and
description of the location (e.g. first floor hallway, second floor conference
room, etc.) of where the terminal distributor maintains an automated mechanism.
The list shall be immediately available for inspection upon request of an
employee of the board. (b) Maintain a record of the naloxone stored within the
automated mechanism that includes the name, strength, dosage form, national
drug code and expiration date. Records shall be readily retrievable and
maintained for a period of three years. (7) Naloxone removed from
an automated mechanism shall not be returned to the mechanism or transferred in
accordance with rule 4729:5-3-09 of the Administrative Code, except if it was
removed by an employee of the terminal distributor of dangerous
drugs. (E) The state board of pharmacy may grant
variances from this rule in cases in which: (1) The applicable
provision is not statutorily mandated. (2) Granting the variance
would not: (a) Be contrary to public interest; or (b) Compromise the integrity of the drug. (3) No party will be
injured by the granting of the variance. (F) An approval for a variance pursuant
to paragraph (E) of this rule may be revocable, may be granted for a limited
period or may be granted subject to the conditions as the state board of
pharmacy may prescribe.
Last updated April 8, 2021 at 1:19 PM
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Rule 4729:5-3-20 | Pharmacy pilot or research projects.
Effective:
March 11, 2022
(A) The purpose of this rule is to
specify the process and procedures to be followed when a licensee petitions for
approval of a pilot or research project for innovative system applications in
the practice of pharmacy that are not currently permitted under agency 4729 of
the Administrative Code. In reviewing projects, the board shall consider only
projects that expand pharmaceutical care services that contribute to positive
patient outcomes. (B) A project shall not expand the
definition of the practice of pharmacy as set forth in Chapter 4729. of the
Revised Code and shall not apply to licensees regulated under Chapter 3796. of
the Revised Code. (C) Approval of a project by the board
may include the grant of a limited exception to or a waiver of rules adopted
under Chapter 4729. of the Revised Code. Project approval, including limited
exception to or waiver of board rules, shall initially be for a specified
period of time not exceeding twenty-four months from commencement of the
project. (D) Following the completion of the
project period, the board may do any of the following based upon a review of
the final project report submitted in accordance with paragraph (I) of this
rule and any other factors or information the board deems
necessary: (1) Refuse to extend or
renew the project; (2) Approve the extension
or renewal of a project following consideration of a petition that clearly
identifies the need for extension and must include a report similar to the
final project report, which should describe and explain any proposed changes to
the originally approved and implemented project, and that justifies the need
for extending or renewing the term of the project; or (3) Approve the project
in perpetuity following a consideration of a petition that clearly identifies
and justifies the need to continue the project indefinitely. (E) A licensee who wishes the board to
consider approval of a project shall submit to the board a petition for
approval that contains at least the following information: (1) Responsible
pharmacist. Name, address, telephone number, and pharmacist license number of
each pharmacist responsible for overseeing the project. (2) Location of project.
Name, address, and telephone number of each specific location and, if a
location is a pharmacy, the pharmacy's terminal distributor of dangerous
drugs license number where the proposed project will be conducted. (3) Project summary. A
detailed summary of the proposed project that includes at least the following
information: (a) The goals, hypothesis, and objectives of the proposed
project. (b) A full explanation of the project and how it will be
conducted. (c) The time frame for the project including the proposed
start date and length of the project. The time frame may not exceed eighteen
months from the proposed start date of the project. (d) Background information or literature review to support
the proposed project. (e) The rule or rules to be waived in order to implement
the project, an explanation of why such a waiver would not be a detriment to
the public, to include procedures to be used during the project to ensure that
the public health and safety are not compromised as a result of the waiver, and
a request to waive the rule or rules. (F) Projects submitted shall be reviewed
as follows: (1) Staff review. Upon
receipt of a petition for approval of a project, board staff shall initially
review the petition. If the petition is incomplete or fails to meet the
board's outlined purpose, staff shall return the petition to the requestor
with a letter explaining the reason the petition is being returned. A petition
that has been returned pursuant to this paragraph may be amended or
supplemented as necessary and submitted for reconsideration. A petition that is
deemed appropriate and complete shall move on the board member review
process. (2) Board member review.
After initial staff review, two members of the board, appointed by the board
president, shall be provided the petition and any additional materials. Board
members shall conduct a review, in consultation with appropriate staff, and
make a recommendation to the full board. Board members conducting a review may
request additional documentation and information from the petitioner as part of
this review process. (3) Board review.
Following the board member review, the board shall consider the project request
at a regularly scheduled meeting of the board. Upon review, the board shall
either approve or deny the petition. The board shall not approve any such
project if such proposal might jeopardize public health or welfare. If the
board approves the petition, the approval: (a) Shall be specific for the project requested, with any
modifications the Board deems necessary for patient safety; (b) Shall approve the project for a specific time period;
and (c) May include conditions or qualifications applicable to
the project, including limited waivers of applicable/related
rules. (G) The project site and project
documentation shall be available for inspection and review by the board or its
representative(s) at any time during the approval or denial processes and, if a
project is approved, throughout the approved term of the project. (H) Project documentation shall be
maintained in a readily retrievable manner and available for inspection,
review, and copying by the board or its representative for at least three years
following completion or termination of the project. (I) The pharmacist responsible for
overseeing a project shall be responsible for submitting to the board any
reports required as a condition of a project, including the final project
report. (1) The final project
report shall include a written summary of the results of the project and the
conclusions drawn from those results. The final project report shall be
submitted to the board within ninety days after completion or termination of
the project. (2) The board shall
review any required report regarding the progress of a project and the final
project report at a regularly scheduled meeting of the board. (J) The board may rescind approval and
terminate projects, including those it has approved in perpetuity, pursuant to
the following: (1) If the board deems
the project does not the comply with the requirements of this rule or the
conditions of its approval, the board shall provide notice to the pharmacist
responsible for the project indicating the project's approval has been
rescinded. The notice shall provide sixty days for the pharmacist to address
any deficiencies prior to the termination of the project. If the deficiencies
cited in the notice are addressed, the board may reinstate the project prior to
its proposed termination date. (2) If the board has
reasonable cause to believe the project poses a threat of immediate or serious
harm to the public, the board shall provide notice to the pharmacist
responsible for the project indicating the project's approval has been
rescinded. The termination of the project shall take effect immediately.
(K) The petitioner and/or project's
responsible person may terminate the project earlier than requested but shall
provide notice within three business days of termination and a final project
report to the board to include an explanation of why the project was terminated
early. Upon either recission of approval or early project termination, any
waivers granted will be immediately revoked and the licensee will be required
to adhere to those rules that had been excepted or waived. (L) All documents pertaining to the
application, project, and reports are considered a public record under section
149.43 of the Revised Code and will be provided upon request, without notice to
the project's petitioners and/or responsible person. Petitioners
asserting that some or all of an application contains information exempt from
disclosure under Ohio law shall comply with the following: (1) Submit a memorandum
identifying the content not subject to disclosure under section 149.43 of the
Revised Code, including supporting legal authority for each assertion.
(2) Submit a redacted
version of the materials that the applicant agrees may be released without
prior notice to the applicant. (M) By submitting the application, the
petitioner understands, acknowledges, and agrees to all of the
following: (1) The board may
independently assess the merits of any public records exception claims made by
the petitioner. (2) The board may reject
a claim that information in an application is trade secret or a security or
infrastructure record if it determines that the petitioner has not established
that the content in question meets a delineated exception to public disclosure
under Ohio law, including the use of generic language encompassing substantial
portions of the application submission or simple assertions of a document
containing information exempt from public disclosure, without substantive
explanation of the basis. (3) The state of Ohio
does not assume liability for the use or disclosure of any unredacted
material. (4) The board is required
to comply with section 149.43 of the Revised Code, which is construed liberally
in favor of broad access, and any doubt shall be resolved in favor of
disclosure of public records. (N) The board will make reasonable
efforts to determine the initial approval or denial of a project submission
within ninety days of the submission of a completed project petition in
accordance with paragraph (E) of this rule. The board shall be required to make the initial
approval or denial of a project submission within one hundred and eighty days
of the submission of a completed project petition in accordance with paragraph
(E) of this rule. This timeframe may be extended by the board for good
cause. (O) Unless otherwise approved by the
board, a petition shall be deemed abandoned if the petitioner fails to submit
any requested documentation or information within thirty days after being
notified by the board. The board shall not be required to act on any abandoned
petition and the petition may be destroyed by board staff. If the petition is
abandoned, the petitioner shall be required to resubmit a new petition for
consideration pursuant to the requirements of this rule.
Last updated September 11, 2023 at 11:43 AM
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Rule 4729:5-3-21 | Point of dispensing locations during a public health emergency.
Effective:
October 6, 2023
(A) A board of health, as defined in
section 3701.048 of the Revised Code, that is licensed as a terminal
distributor of dangerous drugs may temporarily remove dangerous drugs upon the
governor's declaration of an emergency that affects the public
health. (B) The dangerous drugs removed from a location licensed as
a terminal distributor shall be used to establish a point of dispensing
location or locations in the event of a declared public health emergency to
administer, deliver, dispense, or distribute drugs in accordance with protocols
developed pursuant to section 3701.048 of the Revised Code. (C) The dangerous drugs shall be returned to the board of
health within seventy-two hours of the cessation of the public health
emergency. An individual listed in divisions (B) and (C) of section 3701.048 of
the Revised Code shall maintain personal supervision and control over the
dangerous drugs removed from the terminal distributor. (D) If personal supervision is not provided, the dangerous
drugs shall be physically secured in a manner to prevent unauthorized access
and diversion. The drugs shall be stored at temperatures which will ensure the
integrity of the drugs prior to their use as stipulated by the USP/NF and/or
the manufacturer's or distributor's labeling. (E) All point of dispensing 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.
(F) 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.
Last updated October 6, 2023 at 8:42 AM
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