Ohio Admin. Code 4729:5-16-01 - Laboratories - definitions
As used in Chapter 4729:5-16 of the Administrative Code:
(A)
"Laboratory" means any facility licensed as a terminal
distributor of dangerous drugs in accordance with section
4729.54 of the Revised Code
where dangerous drugs and controlled substances are possessed for scientific,
clinical or instructional purposes. The facility shall comply with all
requirements set forth in this chapter. A laboratory does not include any of
the following:
(1)
A laboratory licensed under Chapter 3796. of the
Revised Code; or
(2)
Any other person or facility licensed as a terminal
distributor of dangerous drugs that is specifically defined and required to
comply with another chapter of this division (EMS organization, veterinary
clinic, pain management clinic, animal shelter, etc.).
(B)
"Anonymous sample" means an unknown substance submitted to a
laboratory for qualitative and or quantitative analysis.
(C)
"Controlled
substance" has the same meaning as in section
3719.01 of the Revised Code but
shall not include exempt chemical preparations as defined in paragraph (E) of
this rule.
(D)
"Dangerous drug" has the same meaning as in section
4729.01 of the Revised
Code.
(E)
"Exempt chemical preparation" means a chemical or
compound approved by the United States drug enforcement administration pursuant
to
21 CFR
1308.23 (12/30/2016).
(F)
"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.
(G)
"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.
(H)
"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. A
prescriber at a laboratory who personally furnishes a dangerous drug shall
comply with the requirements of rule
4729:5-19-02 or
4729:5-20-02 of the
Administrative Code.
(I)
(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 such as 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 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.
(J)
"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.
(K)
"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 and controlled substances 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 controlled substances and
maintaining all drug records otherwise required.
Replaces: 4729-13-01
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 3719.01, 4729.01, 4729.55, 4729.57
Prior Effective Dates: 04/01/1978, 07/01/1989, 07/01/1994, 01/01/2009, 01/20/2015
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