Or. Admin. Code § 855-065-0012

Current through Register Vol. 63, No. 12, December 1, 2024

Section 855-065-0012 - Storage of Drugs

(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(d) A quarantine area for the separate storage of drugs that are outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, suspected counterfeit, otherwise unfit for distribution, or contained in immediate or sealed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.

Or. Admin. Code § 855-065-0012

BP 12-2006, f. & cert. ef. 12-19-06; BP 17-2022, amend filed 04/20/2022, effective 4/20/2022

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155 & ORS 689.305