Ohio Admin. Code 4729:5-21-01 - Opioid treatment programs - definitions
As used in Chapter 4729:5-21 of the Administrative Code:
(A)
"Opioid Treatment Program" or "OTP" means a facility
that is licensed as a terminal distributor of dangerous drugs in accordance
with section 4729.54 of the Revised Code and
holds, or is in the process of applying for, a valid certification from the
substance abuse and mental health services administration of the United States
department of health and human services pursuant to
42 CFR
8.11 (3/19/2001). The facility shall comply
with all requirements set forth in this chapter. An OTP does not include an
office-based opioid treatment clinic as defined in Chapter 4729:5-18 of the
Administrative Code.
(B)
"Controlled substance" has the same meaning as in
section 3719.01 of the
RevisedCode.
(C)
"Dangerous drug" has the same meaning as in section
4729.01 of the Revised
Code.
(D)
"Dosage unit" means any of the following:
(1)
A single pill,
capsule, ampule, tablet;
(2)
In the case of a liquid solution, one
milliliter;
(3)
In the case of a cream, lotion or gel, one gram;
or
(4)
Any other form of administration available as a single
unit.
(E)
"Licensed health professional authorized to prescribe
drugs" or "prescriber" has the same meaning as in rule
4729:5-1-02 of the
Administrative Code but shall be limited to a prescriber practicing within the
prescriber's applicable scope of practice.
(F)
"Personal
supervision" means the person specified in rule shall be physically present at
the licensed location to deter and detect the diversion of dangerous
drugs.
(G)
"Personally furnish" or "personally furnishing" means
the final association of a drug with a patient by a prescriber prior to the
distribution to a patient for use outside the prescriber's practice
setting.
(H)
(1)
"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:
(a)
A manual
signature on a hard copy record;
(b)
A magnetic card
reader;
(c)
A bar code reader;
(d)
A biometric
method;
(e)
A proximity badge reader;
(f)
A board approved
system of randomly generated personal questions;
(g)
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
(h)
Other effective methods for identifying individuals
that have been approved by the board.
(2)
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.
(I)
"Readily
retrievable" means that records maintained in accordance with this chapter
shall be kept in such a manner that, upon request, they can be produced for
review no later than three business days to an agent, officer or inspector of
the board.
(J)
"Responsible person" has the same meaning as defined in
rule 4729:5-2-01 of the
Administrative Code and is responsible for the supervision and control of
dangerous drugs as required in division (B) of section
4729.55 of the Revised Code,
adequate safeguards as required in division (C) of section
4729.55 of the Revised Code,
security and control of dangerous drugs, and maintaining all drug records
otherwise required.
(K)
"Sample" means a dangerous drug or pharmaceutical
preparation that would be hazardous to health or safety if used without the
supervision of a licensed health professional authorized to prescribe drugs, or
a drug of abuse, and that, at one time, had been placed in a container plainly
marked as a sample by a manufacturer.
Notes
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 4729.51
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