Ill. Admin. Code tit. 77 § 3100.360

Current through Register Vol. 48, No. 45, November 8, 2024

Section 3100.360 - Record and Inventorying Requirements Generally

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.

Ill. Admin. Code tit. 77, § 3100.360

Amended at 39 Ill. Reg. 3656, effective 2/27/2015