Current through all regulations passed and filed through September 16, 2024
(A) A prescriber
who personally furnishes a dangerous drug, other than a sample drug pursuant to
section 3719.81 of the Revised Code,
shall affix to the container a label showing:
(1) The name and address of the
prescriber;
(2) The name of the
patient for whom the drug is intended;
(3) Name and strength of the dangerous
drug;
(4) Directions for
use;
(5) Date furnished;
and
(6) If a compounded drug, the
statement "Compounded Drug" or other similar statement shall also be displayed
prominently on the label.
(B) A prescriber who personally furnishes a
dangerous drug labeled as a sample and where the directions for use are
different from the directions on or in the sample container, the prescriber
shall affix a label to the sample container or provide written documentation
accompanying the sample that includes the following:
(1) Name of the prescriber;
(2) The name of the patient for whom the drug
is intended; and
(3) Directions for
use.
(C) For controlled
substances, quantities personally furnished to a patient are limited to a
seventy-two-hour supply and in any thirty day period quantities personally
furnished to all patients shall not exceed two thousand five hundred dosage
units pursuant to section
4729.291 of the Revised
Code.
(D) None of the following
shall be counted in determining whether the amounts specified in paragraph (C)
of this rule have been exceeded:
(1)
Methadone personally furnished to patients for the purpose of treating drug
dependence or addiction, if the prescriber meets the conditions specified in
21 CFR
1306.07 (6/23/2005);
(2) Buprenorphine personally furnished to
patients for the purpose of treating drug dependence or addiction as part of an
opioid treatment program licensed under section
5119.37 of the Revised
Code.
(3) Controlled substances
personally furnished to research subjects by a facility conducting clinical
research in studies approved by a hospital-based institutional review board or
an institutional review board accredited by the association for the
accreditation of human research protection programs.
(E)
(1) A
prescriber may designate a licensed health care professional acting within the
scope of the professional's practice and, under the personal supervision of a
prescriber or pharmacist, to prepare and package a dangerous drug that will be
personally furnished by the prescriber, a pharmacist, or a nurse in accordance
with paragraph (F) of this rule.
(2) The personal supervision requirement
listed in paragraph (E)(1) of this rule does not apply if a licensed health
care professional acting within the scope of the professional's practice is
preparing and packaging either of the following:
(a) Methadone for the purpose of treating
drug dependence or addiction; or
(b) Buprenorphine for the purpose of treating
drug dependence or addiction.
(3) A prescriber may designate an unlicensed
person, under the personal supervision of a prescriber or pharmacist, to
prepare and package a dangerous drug that will be personally furnished by the
prescriber or a pharmacist in accordance with paragraph (F) of this rule. An
unlicensed person shall not prepare and package any of the following dangerous
drugs:
(a) Anesthesia;
(b) Controlled substances; or
(c) Drugs administered
intravenously.
(F) Only a prescriber shall personally
furnish a drug. The act of personally furnishing shall be documented using
positive identification.
A prescriber may delegate the act of personally furnishing
pursuant to the following:
(1) A
prescriber may delegate the act of personally furnishing to a licensed
pharmacist. The delegated pharmacist shall document the act of personally
furnishing using positive identification.
(2) A prescriber may delegate the act of
personally furnishing methadone for the purpose of treating drug dependence or
addiction to a nurse
practicing in
accordance with Chapter 4723. of the Revised Code pursuant to
the following:
(a) The opioid treatment program utilizes an
automated methadone dispensing system that is routinely calibrated to ensure
the accuracy of the methadone personally furnished.
(b) The nurse shall document the act of
personally furnishing using positive identification.
(3)
A prescriber may
delegate the act of personally furnishing buprenorphine for the purpose of
treating drug dependence or addiction to a nurse practicing in accordance with
Chapter 4723. of the Revised Code. The nurse shall document the act of
personally furnishing using positive identification.
(G) Counseling.
(1) A prescriber, pharmacist or a delegate in
accordance with paragraph (H)(1) of this rule shall personally offer to
provide, or may provide in writing, the service of counseling pursuant to
paragraph (G)(2) of this rule to a patient or caregiver whenever any dangerous
drug is personally furnished. A prescriber or pharmacist shall not be required
to counsel a patient or caregiver when the patient or caregiver refuses, either
verbally or in writing, the offer of counseling or does not respond to the
written offer to counsel.
(2)
Prescriber or pharmacist counseling may include, but is not limited to, the
following:
(a) The name and description of the
drug;
(b) The dosage form, dose,
route of administration, and duration of drug therapy;
(c) The intended use of the drug and the
expected action;
(d) Special
directions and precautions for preparation, administration, and use by the
patient;
(e) Common adverse effects
or interactions and therapeutic contraindications that may occur, including
possible methods to avoid them, and the action required if they
occur;
(f) Techniques for
self-monitoring drug therapy;
(g)
Proper storage and disposal;
(h)
Action to be taken in the event of a missed dose; and
(i) The prescriber or pharmacist's comments
relevant to the patient's drug therapy, including other necessary information
unique to the specific patient or drug.
(H) Provision of dangerous drugs.
(1) A prescriber may delegate a licensed
healthcare professional acting within the scope of the professional's practice
to distribute dangerous drugs personally furnished by a prescriber or
pharmacist if all the following apply:
(a) A
prescriber or pharmacist provides personal supervision;
(b) Counseling is offered in accordance with
paragraph (G) of this rule; and
(c)
This task may be delegated in accordance with applicable state laws and
rules.
(2) Paragraph
(H)(1)(a) of this rule does not apply under any of the following circumstances:
(a) The drug is provided to the patient by a
licensed health care professional, acting within the scope of the
professional's practice, and the drug provided is either:
(i) Methadone for the purpose of treating
drug dependence or addiction and a prescriber or licensed pharmacist is
available for counseling by means of electronic communication during normal
hours of operation; or
(ii)
Buprenorphine for the purpose of treating drug dependence or addiction as part
of an opioid treatment program and a prescriber or licensed pharmacist is
available for counseling by means of electronic communication during normal
hours of operation.
(b)
The drug is being provided to a patient by a licensed pharmacist.
(c) A non-controlled dangerous drug is
provided to the patient by a licensed health care professional, acting within
the scope of the professional's practice, and a prescriber or pharmacist is
available for counseling by means of electronic communication during normal
hours of operation.
(I) No prescriber or pharmacist may
personally furnish to a patient to whom there is no valid prescriber patient
relationship, pursuant to applicable state and federal laws, regulations, and
rules.
(J) Personally furnishing
naloxone.
(1) Except as provided in paragraph
(J)(3) of this rule, an authorized individual personally furnishing naloxone on
behalf of a physician pursuant to a protocol established in accordance with
sections 4731.941 and
3707.561 of the Revised Code,
shall do all of the following:
(a) Prepare,
package, and label the naloxone in accordance with the requirements of this
rule.
(b) Conduct the final
association of the naloxone to the patient.
(c) Keep and maintain all records in
accordance with this chapter.
(d)
Conduct patient counseling, including training on the use of naloxone, as
specified in the physician protocol.
(2) An authorized individual personally
furnishing naloxone on behalf of a physician pursuant to a protocol established
in accordance with sections
4731.941 and
3707.561 of the Revised Code may
personally furnish the drug to themselves in order to assist an individual who
there is reason to believe is experiencing an opioid-related overdose if all of
the following conditions are met:
(a) The
authorized individual complies with the protocol established by the authorizing
physician, including having completed the training required by the
protocol.
(b) The authorized
individual has received training instructing them to summon emergency services
as soon as practicable either before or after administering naloxone.
(c) Such practice is authorized in the
physician approved protocol.
(3) An authorized individual personally
furnishing naloxone pursuant to paragraph (J)(2) of this rule shall not be
required to comply with paragraphs (J)(1)(a), (J) (1)(b) and (J)(1)(d) of this
rule.
(4) A terminal distributor of
dangerous drugs may also administer naloxone in accordance with section
4729.514 of the Revised
Code.
(K) Any patient
specific dangerous drug dispensed by a pharmacy that is provided to a patient
by a prescriber pursuant to rule
4729:5-5-14 of the
Administrative Code is the property of that patient and is not considered
personally furnishing. No prescriber that provides a patient with a drug
pursuant to rule
4729:5-5-14 of the
Administrative Code shall charge any additional fees or require any additional
monetary compensation for the dangerous drug.
(L) Paragraph (K) of this rule does not
prohibit a prescriber from charging a patient for any of the following:
(1) The cost of an office visit or any
expense related to the administration of a dangerous drug; or
(2) The cost of a dangerous drug dispensed by
a pharmacy to a patient if paid for by the prescriber.
