1. (1) Registrants, practitioners and Pharmacists as specified therein in the issuance, preparation, labeling, dispensing, recordkeeping and filing of prescriptions for controlled substances must comply with the provisions of 21 CFR 1306.01 (v. 04/01/2025), 21 CFR 1306.02 (v. 04/01/2025), 21 CFR 1306.03 (v. 04/01/2025), 21 CFR 1306.04 (v. 04/01/2025), 21 CFR 1306.05 (v. 04/01/2025), 21 CFR 1306.06 (v. 04/01/2025), 21 CFR 1306.07 (v. 04/01/2025), 21 CFR 1306.08 (v. 04/01/2025), 21 CFR 1306.09 (v. 04/01/2025); 21 CFR 1306.11 (v. 04/01/2025), 21 CFR 1306.12 (v. 04/01/2025), 21 CFR 1306.13 (v. 04/01/2025), 21 CFR 1306.14 (v. 04/01/2025), 21 CFR 1306.15 (v. 04/01/2025); 21 CFR 1306.21 (v. 04/01/2025), 21 CFR 1306.22 (v. 04/01/2025); 21 CFR 1306.23 (v. 04/01/2025), 21 CFR 1306.24 (v. 04/01/2025), 21 CFR 1306.25 (v. 04/01/2025), 21 CFR 1306.27 (v. 04/01/2025); and 21 CFR 1304.03(d) (v. 04/01/2025).
2. (2) Controlled substances listed in 21 CFR 1308.15 (v. 04/01/2025) as Schedule V are prescription drugs.

3. (3) Pseudoephedrine and ephedrine may be:

   1. (a) Provided to a patient without a prescription under ORS 475.230.
   2. (b) Dispensed to patient pursuant to a prescription which must follow the provisions of 21 CFR 1306.21 (v. 04/01/2025), 21 CFR 1306.22 (v. 04/01/2025); 21 CFR 1306.23 (v. 04/01/2025), 21 CFR 1306.24 (v. 04/01/2025), 21 CFR 1306.25 (v. 04/01/2025), and 21 CFR 1306.27 (v. 04/01/2025).

4. (4) For a Schedule II controlled substance prescription, a Pharmacist may:

   1. (a) Add the patient’s address based on information provided by the patient or patient's agent with appropriate verification;

   2. (b) Amend or add the following information after consultation with and agreement of the prescriber:

      1. (A) Drug strength;
      2. (B) Dosage form;
      3. (C) Drug quantity;
      4. (D) Directions for use;
      5. (E) Prescriber's address; and
      6. (F) Prescriber’s DEA registration number.

   3. (c) Amend the following information after consultation with and agreement of the prescriber, the:

      1. (A) Date the prescription was issued; and
      2. (B) Date the prescription can be filled.
   4. (d) For (b) and (c), the Pharmacist must document on the prescription the date of the prescriber’s authorization, the amendment or addition authorized, and the Pharmacist’s identity.

5. (5) For a Schedule II controlled substance prescription, a Pharmacist must not change the patient's name, the controlled substance prescribed except for generic substitution, and the name or signature of the prescriber.

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

Statutory/Other Authority

ORS 689.205

Statutes/Other Implemented

ORS 475.185 & ORS 475.188

History

BP 6-2026, amend filed 06/17/2026, effective 06/17/2026
BP 3-2025, amend filed 06/16/2025, effective 06/16/2025
BP 57-2024, amend filed 06/18/2024, effective 06/20/2024
BP 29-2023, amend filed 12/19/2023, effective 12/19/2023
BP 10-2023, amend filed 06/13/2023, effective 06/13/2023
BP 41-2022, minor correction filed 07/20/2022, effective 07/20/2022
BP 27-2022, amend filed 06/15/2022, effective 06/16/2022
BP 42-2021, amend filed 12/16/2021, effective 01/01/2022
BP 20-2021, amend filed 06/15/2021, effective 06/15/2021
BP 8-2010, f. & cert. ef. 6-29-10
BP 1-2007, f. & cert. ef. 6-29-07
PB 5-1991, f. & cert. ef. 9-19-91
PB 15-1989, f. & cert. ef. 12-26-89
1PB 6-1982, f. & ef. 8-6-82
1PB 8-1978, f. & ef. 10-17-78
1PB 6-1978(Temp), f. & ef. 7-1-78