Or. Admin. Code § 855-143-0550

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

Section 855-143-0550 - Records: General Requirements

(1) The recordkeeping requirements OAR 855-143 are in addition to the requirements of other recordkeeping rules of the board. Unless otherwise specified, all records and documentation required by these rules, must be retained for three years and made available to the board for inspection upon request. Records must be stored onsite for at least one year and may be stored, after one year, in a secured off-site location if retrievable within three business days. Records and documentation may be written, electronic or a combination of the two.

(2) All required records for the Drug Outlet PPL must be maintained by the PPL Affiliated Pharmacy.

(3) Records retained by the PPL Affiliated Pharmacy must include, but are not limited to:

(a) Date, time and identification of each individual and activity or function performed on the PPL;

(b) Oregon licensed Pharmacist physical inspection of the PPL;

(c) Audiovisual communication system testing;

(d) Licensee training on the proper use of the PPL;

(e) Still image capture and store and forward images must be retained according to (1);

(f) Data and surveillance system data must be retained for 30 days except when a PPL Affiliated Pharmacy becomes aware of an incident that requires review of surveillance data, the PPL Affiliated Pharmacy must retain the data related to that incident for 6 months from the date of review; and

(g) Any errors or irregularities identified by the quality improvement program.

(4) Records of dispensing from a PPL must include the:

(a) Physical location of the PPL;

(b) Identification of the patient or patient's agent retrieving the prescription, non-prescription drugs, and supplies;

(c) A digital image of the individual to whom the prescription was dispensed.

(d) Date and time of transaction;

(e) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity;

(f) Each non-prescription drug and supply name, UPC or NDC number, and quantity; and

(g) Name of Oregon licensed Pharmacist or Oregon licensed Intern who provided counseling to the patient or patient's agent, if required, documentation that the counseling was performed or that the Pharmacist or Intern accepted the patient or patient's agent request not to be counseled.

(5) Records of stocking and destocking of prescriptions into or from a PPL must include the:

(a) Date and time;

(b) Each prescription number, patient name, prescriber name, drug name, strength, dosage form and quantity;

(c) Each non-prescription drug and supply name, UPC or NDC number, and quantity;

(d) Name and Oregon license number of the person stocking or destocking prescription, non-prescription drugs and supplies from the system; and

(e) Identity of the Oregon licensed Pharmacist who verifies that the system has been accurately stocked or destocked.

Or. Admin. Code § 855-143-0550

BP 21-2022, adopt filed 04/20/2022, effective 4/20/2022; BP 30-2022, amend filed 06/15/2022, effective 6/16/2022

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155, ORS 689.508 & ORS 689.527