Or. Admin. Code § 855-115-0125

Current through Register Vol. 63, No. 8, August 1, 2024

Section 855-115-0125 - Responsibilities: Drugs, Records and Security

When practicing pharmacy per ORS 689, each Pharmacist must:

(1) Ensure the security of prescription drugs, pharmacy and patient records including:

(a) Provide adequate safeguards against loss, theft, or diversion; and

(b) Ensure only persons authorized by the Pharmacist access the areas where prescription drugs, pharmacy and patient records are stored by restricting access;

(2) Ensure that all records are maintained in accordance with state and federal laws and rules;

(3) Only receive drugs from an Oregon Registered Drug Outlet (e.g., Wholesaler, Manufacturer or Pharmacy);

(4) Comply with the drug storage rules for pharmacies in OAR 855-041-1036;

(5) Ensure drugs and devices that are recalled, outdated, damaged, deteriorated, misbranded, adulterated, counterfeit, or identified as suspect or illegitimate, or otherwise unfit for dispensing or administration must be documented, quarantined and physically separated from other drugs and devices until they are destroyed or returned to the supplier;

(6) Ensure each compounded drug is prepared in compliance with OAR 855-045;

(7) Ensure all computer equipment used for the practice of pharmacy:

(a) Establishes and maintains a secure connection to patient information to which they have access;

(b) Prevents unauthorized access to patient information; and

(c) Is configured so information from any patient records are not duplicated, downloaded, or removed from the electronic database if accessed remotely;

(8) Document accurately and maintain records in the practice of pharmacy including, but not limited to:

(a) Services provided;

(b) The date, time and identification of the licensee and the specific activity or functions performed; and

(c) Maintain records pertaining to the acquisition, storage, dispensing or administration, and disposal of drugs and devices; and

(9) Ensure reporting of data as required by federal and state regulations, including but not limited to:

(a) ALERT Immunization Information System (ALERT-IIS) per ORS 433.090, ORS 433.092, ORS 433.094, ORS 433.095, ORS 433.096, ORS 433.098, ORS 433.100, ORS 433.102, ORS 433.103, and ORS 433.104;

(b) Communicable diseases per ORS 433.004; and

(c) Vaccine Adverse Event Reporting System (VAERS) per 21 CFR 600.80 (v. 04/01/2023).

Or. Admin. Code § 855-115-0125

BP 16-2023, adopt filed 08/16/2023, effective 3/1/2024; BP 57-2024, amend filed 06/18/2024, effective 6/20/2024

Publications: Publications referenced are available for review at the agency.

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155