Illinois Administrative Code › Title 77 - PUBLIC HEALTH › Part 3100 - ILLINOIS CONTROLLED SUBSTANCES ACT › Section 3100.360 - Record and Inventorying Requirements Generally

Current through Register Vol. 48, No. 28, July 12, 2024
a) Every licensee shall keep records and
			 maintain inventories in conformance with the record keeping and inventorying
			 requirements of federal law, including the requirements prescribed in 21 CFR
			 1304 (April 1, 2014), and, for pharmacies, the rules promulgated pursuant to
			 the Pharmacy Practice Act (68 Ill. Adm. Code 1330).
b) All prescription information for
			 electronic controlled substance prescriptions shall be readily retrievable and
			 immediately available to any Division inspector upon request.
c) Every licensee shall conduct an annual
			 inventory that includes an inventory with an actual count of the inventory on
			 hand for all Schedule II Controlled Substances and an approximate inventory for
			 all Schedule III, IV and V Controlled Substances. The inventory shall be
			 maintained for a period of not less than 5 years.
d) After a loss or theft of controlled
			 substances, a licensee shall conduct an approximate count inventory with a
			 start date of the last inventory for the controlled substance that was either
			 lost or stolen.
e) In every
			 instance that a licensee is required by
			 21 CFR
			 1301.76 (April 1, 2014) to file with the DEA
			 a Report of Theft or Loss of Controlled Substances (Form 106), a copy shall be
			 sent to the Division within one business day after submission to the DEA, along
			 with the printed name of the person who signed the form. Failure to do so may
			 result in discipline of the licensee. This information should be sent to the
			 Drug Compliance Unit of the Division.
f) The following shall apply to all licensed
			 pharmacies:
1) Every licensee shall keep a
			 suitable book, file or electronic record keeping system in which shall be
			 preserved for a period of not less than 5 years the original, or an exact,
			 unalterable image, of every written prescription and the original transcript or
			 copy of every verbal prescription filled, compounded or dispensed. The book or
			 file of prescriptions shall at all reasonable times be open to inspection by
			 the duly authorized agents or employees of the Division.
2) Every prescription filled or refilled
			 shall contain in the prescription record the unique identifiers of the persons
			 authorized to practice pharmacy under the Pharmacy Practice Act who fills or
			 refills the prescription.
3)
			 Records kept pursuant to this Section may be maintained in an alternative data
			 retention system, such as a direct digital imaging system, provided that:
i) The records maintained in the alternative
			 data retention system contain all of the information required in a manual
			 record;
ii) The data processing
			 system is capable of producing a hard copy of the electronic record on the
			 request of the Division, its representative, or other authorized local, State,
			 or federal law enforcement or regulatory agency;
iii) The digital images are recorded and
			 stored only by means of a technology that does not allow subsequent revision or
			 replacement of the images; and
iv)
			 The prescriptions may be retained in written form or recorded in a data
			 recording processing system, provided that the order can be produced in printed
			 form upon lawful request.
4) As used in subsection (f)(3), "digital
			 imaging system" means a system, including people, machines, methods of
			 organization and procedures, that provides input, storage, processing,
			 communications, output and control functions for digitized representations of
			 original prescription records.