Current through all regulations passed and filed through September 16, 2024
(A)
A testing
laboratory shall establish, maintain, and comply with the policies and
procedures contained in the operations plan submitted by the testing laboratory
as part of the application that was approved by the department. The operations
plan shall include policies and procedures for the analysis, storage, sample
inventory tracking, and transportation of plant material, medical marijuana
extract, and medical marijuana products. At a minimum, a facility's operations
plan shall accomplish the following:
(1)
Designate areas in the facility that are
compartmentalized based on function, including any areas to which access is
restricted, and including areas that segregate samples awaiting analysis from
those samples being analyzed or prepared for analysis, to prevent
cross-contamination;
(2)
Implement policies and procedures that provide best
practices for safe, secure, and proper testing of medical
marijuana;
(3)
Establish training and safety policies and procedures
to ensure that any person involved in analytical testing of medical
marijuana:
(a)
Has been fully trained in the safe operation and maintenance of any and all
instrumentation that will be used in the testing of medical marijuana, with
supporting documentation of the training;
(b)
Has been fully
trained in the safe use, handling, and storage of any and all chemicals that
will be used in the testing of medical marijuana, in accordance with OSHA
protocols, with supporting documentation of the training;
(c)
Has direct access
to applicable safety data sheets and labels; and
(d)
Has been fully
trained regarding compliance with Chapter 3796. of the Revised Code and the
rules promulgated in accordance with Chapter 3796. of the Revised
Code.
(4)
Document the chain of custody for all medical marijuana
in the inventory tracking system;
(5)
Establish a
standard for the facility to be maintained in a clean and orderly condition,
which includes free from infestation by rodents, insects, birds, and other
animals of any kind; and
(6)
Maintain a facility with adequate lighting,
ventilation, temperature, sanitation, equipment, and security for the testing
of medical marijuana, including the following:
(a)
A testing
laboratory shall keep all floors and benches free of debris, dust, and any
other potential contaminants;
(b)
A testing
laboratory shall use chemicals, cleaning solutions, and other sanitizing agents
generally accepted for laboratory use, and shall store them in a manner that
protects against contamination;
(c)
A testing
laboratory shall keep its equipment in a clean, professional environment and
maintain a cleaning and equipment maintenance log at the facility, including
preventive and routine maintenance plans and corresponding records, whether the
preventive or routine maintenance is performed by laboratory staff or by
service contract with third-parties or the original equipment
manufacturer;
(d)
A testing laboratory shall have its scales, balances,
or other weight and/or mass measuring devices routinely calibrated using
"National Institute of Standards and Technology" (NIST)-traceable reference
weights, at least once each calendar year; and
(e)
A testing
laboratory shall standardize all analytical test instrumentation using
reference materials traceable to reference material producers accredited to
ISO/IEC 17034 "General Requirements for the Competence of Reference Material
Producers" or the national metrology institute (NMI), where
available.
(B)
A testing
laboratory shall employ a scientific director who will be responsible for
supervision of all laboratory staff and for ensuring that the laboratory
achieves and maintains quality standards of practice. The scientific director
shall meet the following qualifications, at minimum:
(1)
A doctorate
degree in chemical, environmental, or biological sciences from an accredited
college or university and two years of post-degree laboratory experience;
or
(2)
A master's degree in chemical, environmental, or
biological sciences from an accredited college or university and four years of
post-degree laboratory experience.
(C)
A testing
laboratory shall employ the following methods of analysis:
(1)
Methods
established in accordance with "Cannabis Inflorescence: Standards of Identity,
Analysis, and Quality Control" (2014) monograph published by the "American
Herbal Pharmacopoeia"; or
(2)
Alternative methods that have been reviewed and
approved by the department. If the proposed methods are approved, the
department may require the testing laboratory to have the methods validated by
an independent third party, at the expense of the testing laboratory, prior to
the testing laboratory using the proposed methods to conduct testing
services.
(D)
A testing laboratory shall track and submit into the
inventory tracking system any information the department determines necessary
for tracking medical marijuana, including, but not limited to, transportation
of samples, sample inventory, and results of analysis.
