Or. Admin. Code § 855-041-6270

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

Section 855-041-6270 - Institutional Drug Outlet Pharmacy Prescription Labeling

(1) Each pharmacy record keeping system must identify all pharmacy personnel involved in the repackaging including the pharmacist who verified the repackaged drug.

(2) Each repackaged drug, prepared by the pharmacy and intended for use within the facility must be in an appropriate container with a label that meets the requirements of OAR 855-041-1135 and includes:

(a) The brand or generic name and expiration date;

(b) The manufacturer and lot number, or an internal pharmacy code that references manufacturer and lot number;

(c) The strength of the drug.

(3) In-patient: Each drug dispensed to an in-patient other than in a unit-dose or manufacturer's unit-of-use packaging must be labeled with the following information:

(a) Name and location of patient;

(b) Name and strength of drug;

(c) Route of administration, when necessary for clarification;

(d) Manufacturer and lot number, or internal pharmacy code;

(e) Auxiliary labels as needed, and

(f) Expiration date.

(4) A drug that is provided for outpatient use must be dispensed by a retail drug outlet.

(5) When a new barcode or electronic label is used to identify a drug the pharmacist must verify and document the accuracy of the identification with all electronic verification systems prior to distribution.

(6) When a drug is added to a parenteral solution under the direct supervision of a pharmacist, the admixture must be labeled with a distinctive supplementary label that includes the:

(a) Name, quantity and concentration of the drug added and the primary solution;

(b) Date and time of addition;

(c) Expiration date;

(d) Scheduled time for administration;

(e) Infusion rate, when applicable;

(f) Name or initials of person performing admixture;

(g) Identification of the pharmacy where the admixture was performed; and

(h) Name or initials of the verifying pharmacist.

(7) The label applied at a secondary storage or remote storage area by a nurse or physician must include: the patient name or patient identifier, quantity and concentration of the drug added and the primary IV solution; the date and time of addition and the initials of the nurse or physician adding the drug.

(8) Nothing in this rule is intended to restrict or conflict with HB 2395 (2023), SB 450 (2023), SB 1043 (2023).

Or. Admin. Code § 855-041-6270

BP 3-2010, f. 4-29-10, cert. ef. 4-30-10; BP 45-2021, amend filed 12/16/2021, effective 12/16/2021; BP 35-2023, temporary amend filed 12/20/2023, effective 1/1/2024 through 6/28/2024; BP 5-2024, amend filed 02/15/2024, effective 2/15/2024

Statutory/Other Authority: ORS 689.205

Statutes/Other Implemented: ORS 689.155, ORS 689.505, 2023 HB 2395, 2023 SB 450 & 2023 SB 1043