Or. Admin. Code § 851-055-0078

Current through Register Vol. 63, No. 10, October 1, 2024

Section 851-055-0078 - Rules Relating to Controlled Substances

(1) In the administration, distribution, storage, prescribing, and dispensing of controlled substances, APRNs must comply with all applicable requirements in the CFR, Title 21, and state law, including but not limited to, ORS 430 and 475 and OAR 415 and 855.

(2) APRNs must not dispense a controlled substance without current dispensing authority.

(3) All APRNs with a DEA number must register with the Oregon Prescription Drug Monitoring Program (PDMP).

(4) Storage and inventory of controlled substances:

(a) Samples or quantities of controlled substances must be stored in a securely locked cabinet on the premises of the APRNs practice location.

(b) APRNs who receive samples or quantities of controlled substances must be responsible for the security, inventory, and disposal of these drugs.

(c) APRNs must maintain inventory records of controlled substances that they receive or distribute for a period of three years. The records must include:

(A) Drug name, amount received, date received, drug expiration date;

(B) Drug name, amount distributed, date distributed, to whom distributed; and

(C) Drug name and the date and place where it was returned for destruction.

(d) Controlled substances that are expired, deteriorated, or unwanted must be returned to a DEA registered disposal site or disposal system or law enforcement authorities. This does not include controlled substances which are properly wasted where they were to be administered. In this context, "properly wasted" means that on-site destruction of a controlled substance in conformance with applicable state and federal law. APRNs must not personally destroy controlled substances.

(e) Controlled substances must be transported in a secured, locked container.

(f) Client records must state the distribution of controlled substance samples.

(g) Theft of controlled substances must be immediately reported upon discovery to the DEA and to any other required authorities.

(h) APRNs who receive controlled substances must cooperate with the Oregon State Board of Pharmacy in their inspection of records and physical inventory of controlled substances. Inventory of all controlled substances must be taken by the prescriber responsible for their receipt and storage every year on the same date as the biennial inventory required by 21 CFR 1304.13.

(i) If requested by the Oregon State Board of Pharmacy, any APRN who receives controlled substances must submit a copy of inventory records from the preceding two years for review.

(5) Prescribing controlled substances

(a) APRNs must only prescribe the controlled substances from Schedules II-V, at the level provided for on their DEA certificate.

(b) Prior to prescribing the initial prescription for controlled substances and at intervals as determined by the prescriber based upon the client's response to the medication, APRNs must have a complete discussion with the client or person authorized to make health care decisions for the client regarding the diagnosis, as well as the risk, benefits, alternatives, side effects, and potential for addiction and withdrawal of the controlled substance, along with any other applicable precautions. These discussions must be documented in the client record. Documentation must include a plan for periodic review of the client's response to treatment and follow-up.

Or. Admin. Code § 851-055-0078

BN 13-2021, adopt filed 06/24/2021, effective 7/1/2021; BN 6-2023, amend filed 09/26/2023, effective 10/1/2023

Statutory/Other Authority: ORS 678.150, ORS 678.255, ORS 678.265, ORS 678.275, ORS 678.278, ORS 678.282, ORS 678.285, ORS 678.370, ORS 678.372, ORS 678.375, ORS 678.380 & ORS 678.390

Statutes/Other Implemented: ORS 678.150, ORS 678.255, ORS 678.265, ORS 678.275, ORS 678.278, ORS 678.282, ORS 678.285, ORS 678.370, ORS 678.372, ORS 678.375, ORS 678.380 & ORS 678.390