Or. Admin. Code § 855-080-0026

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

Section 855-080-0026 - Schedule V

Schedule V consists of the drugs and other substances, by whatever official, common, usual, chemical, or brand name designated, listed in 21 CFR 1308.15 (04/01/2023); and

(1) Products containing pseudoephedrine or the salts of pseudoephedrine as an active ingredient.

(2) Products containing ephedrine or the salts of ephedrine as an active ingredient.

(3) Products containing phenylpropanolamine or the salts of phenylpropanolamine as an active ingredient.

(4) In order to provide non-prescription pseudoephedrine or ephedrine to a purchaser, a pharmacy must:

(a) Store all pseudoephedrine and ephedrine behind the pharmacy counter in an area that is inaccessible to the public;

(b) Utilize an electronic system meeting the requirements under ORS 475.230;

(c) Train individuals who are responsible for providing pseudoephedrine or ephedrine to purchasers on the requirements of the Combat Methamphetamine Epidemic Act of 2005 (Title VII of the USA PATRIOT Improvement and Reauthorization Act of 2005, P.L. 109-177), the Combat Methamphetamine Enhancement Act of 2010, P.L. 111-268, and use of the electronic system as described in ORS 475.230;

(d) Ensure that only a Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician provides pseudoephedrine or ephedrine to the purchaser after:

(A) Verifying that the purchaser is 18 years of age or older;

(B) Verifying the identity of the purchaser with valid government-issued photo identification; and

(C) Confirming the purchase is allowed via the electronic system; and

(e) Maintain an electronic log for at least three years from the date of the transaction that documents the following elements:

(A) Date and time of the purchase;

(B) Name, address and date of birth of the purchaser;

(C) Form of government-issued photo identification and the identification number used to verify the identity of the purchaser;

(D) Name of the government agency that issued the photo identification in (C);

(E) Name of product purchased;

(F) Quantity in grams of product purchased;

(G) Name or initials of Pharmacist, Intern, Certified Oregon Pharmacy Technician or Pharmacy Technician who provides the drug; and

(H) Signature of the purchaser. The signature of the purchaser may be recorded on a written log that also contains the transaction ID generated by the electronic system.

(5) All sales of pseudoephedrine or ephedrine are subject to the following quantity limits and restrictions:

(a) No more than 3.6 grams in a 24-hour period, no more than 9 grams in a 30-day period without regard to the number of transactions; and

(b) For non-liquids, product packaging is limited to blister packs containing no more than 2 dosage units per blister. Where blister packs are not technically feasible, the product must be packaged in unit dose packets or pouches.

(6) Sections (4) and (5) do not apply to a pseudoephedrine or ephedrine when the drug is dispensed pursuant to a prescription.

(7) Each pharmacy, Pharmacist, Intern, Certified Oregon Pharmacy Technician and Pharmacy Technician involved in the provision of pseudoephedrine or ephedrine to a purchaser must comply with the provisions of 21 CFR 1314.01 (04/01/2023), 21 CFR 1314.02 (04/01/2023), 21 CFR 1314.03 (04/01/2023), 21 CFR 1314.05 (04/01/2023), 21 CFR 1314.10 (04/01/2023), 21 CFR 1314.15 (04/01/2023), 21 CFR 1314.20 (04/01/2023), 21 CFR 1314.25, (04/01/2023); 21 CFR 1314.30 (04/01/2023), 21 CFR 1314.35 (04/01/2023), 21 CFR 1314.40 (04/01/2023), 21 CFR 1314.42 (04/01/2023), 21 CFR 1314.45 (04/01/2023); and 21 CFR 1314.50 (04/01/2023).

Or. Admin. Code § 855-080-0026

PB 4-1987, f. & ef. 3-30-87; PB 5-1991, f. & cert. ef. 9-19-91; BP 1-2007, f. & cert. ef. 6-29-07; BP 20-2021, amend filed 06/15/2021, effective 6/15/2021; BP 42-2021, amend filed 12/16/2021, effective 1/1/2022; BP 23-2022, temporary amend filed 04/22/2022, effective 4/22/2022 through 10/18/2022; BP 34-2022, amend filed 06/15/2022, effective 6/16/2022; BP 10-2023, amend filed 06/13/2023, effective 6/13/2023; 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 & ORS 475.230

Statutes/Other Implemented: ORS 475.035 & ORS 475.230