Or. Admin. Code § 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).
Notes
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
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