Current through Register Vol. 63, No. 3, March 1, 2024
(1) As
a condition for receiving and retaining a wholesale distributor registration
issued under these rules, an applicant must satisfy the Board that the
applicant has and will continuously maintain acceptable storage and handling
conditions and facilities standards for each facility at which drugs are
received, stored, warehoused, handled, held, offered, marketed, or displayed,
or from which drugs are transported, including:
(a) Suitable construction of the facility and
appropriate monitoring equipment to ensure that drugs in the facility are
maintained in accordance with labeling or in compliance with official
compendium standards.
(b) Suitable
size and construction to facilitate cleaning, maintenance, and proper wholesale
distribution operations.
(c)
Adequate storage areas to provide appropriate lighting, ventilation,
temperature, sanitation, humidity, space, equipment, and security
conditions.
(d) A quarantine area
for the separate storage of drugs that are outdated, damaged, deteriorated,
misbranded, adulterated, counterfeit, suspected counterfeit, otherwise unfit
for distribution, or contained in immediate or sealed secondary containers that
have been opened.
(e) Maintenance
of the facility in a clean and orderly condition.
(f) Maintenance of the facility in a
commercial, nonresidential building.
(g) Freedom of the facility from infestation
by insects, rodents, birds or vermin of any kind.
(2) The facility must be equipped with
appropriate manual, electromechanical, or electronic temperature and humidity
recording equipment, devices, and logs to document proper storage of
drugs.
(3) The facility must meet
security standards including but not limited to:
(a) An entry system that restricts access to
areas where drugs are held, to authorized personnel.
(b) An after-hours central alarm system or a
comparable entry detection system.
(c) Adequate outside perimeter
lighting.
(d) Safeguards against
theft and diversion, including employee theft and theft or diversion
facilitated or hidden by tampering with computers or electronic records.
