9.2 Dispensing-Restricted Nonprescription Products: Pseudoephedrine, Exempt Schedule V & Others
Key Takeaways
Pseudoephedrine and ephedrine are Schedule V in Oregon, and since January 1, 2022 they may be sold without a prescription under ORS 475.230.
In Oregon, only a pharmacist, intern or licensed pharmacy technician may sell pseudoephedrine, from behind the pharmacy counter, to buyers 18 or older with government photo ID.
Oregon pseudoephedrine sales must be entered in NPLEx before the sale, are capped at 3.6 g per 24 hours and 9 g per 30 days, and are logged for two years.
A pharmacist may override an NPLEx stop-sale alert only to protect the buyer from imminent bodily harm, and pseudoephedrine is not reported to Oregon's PDMP.
Federal CMEA adds a 7.5 g per 30-day mail-order limit, and in Oregon nonprescription Schedule V products must be stored in the prescription area.
Why this matters
The blueprint calls out "dispensing-restricted, non-prescription drugs." In Oregon, the leading example is pseudoephedrine (PSE) and ephedrine. Oregon required a prescription for these from 2006 until 2021 HB 2648 took effect on January 1, 2022. They are still Schedule V controlled substances under Oregon rule (OAR 855-080-0026), so Oregon's restrictions are stricter than the federal Combat Methamphetamine Epidemic Act (CMEA).
Oregon PSE and ephedrine sales (ORS 475.230; OAR 855-080-0026)
| Requirement | Oregon rule |
|---|---|
| Who may sell | Only a licensee: a pharmacist, intern, Certified Oregon Pharmacy Technician or Pharmacy Technician. Never a non-licensed clerk |
| Where stored | Behind the pharmacy counter, inaccessible to the public. Oregon doesn't allow the CMEA "locked cabinet on the sales floor" option |
| Purchaser | At least 18 and shows a valid government-issued photo ID |
| Before the sale | Submit the following to the electronic tracking system, the National Precursor Log Exchange (NPLEx): the date and time; the purchaser's name, address and date of birth; the ID type, number and issuing agency; and the product name and grams of PSE or ephedrine |
| Stop-sale alert | If NPLEx says not to proceed, the sale may not happen. A pharmacist may override the alert only when, in their discretion, the sale is necessary to protect the purchaser from imminent bodily harm |
| Quantity limits | No more than 3.6 grams in 24 hours and 9 grams in 30 days |
| Log | The purchaser signs an electronic or written log with the date, name and grams. The pharmacy keeps it at least two years |
| Training | Staff are trained on the federal and state requirements |
| Law enforcement access | Through a lawfully issued subpoena accepted by the Board (ORS 475.230(5)(c); OAR 855-080-0029) |
| Not in the PDMP | PSE and ephedrine are excluded from Oregon's PDMP (ORS 431A.855(4)) |
Federal CMEA baseline (21 U.S.C. 830; 21 CFR 1314)
- Daily limit: 3.6 grams of base per purchaser per day.
- 30-day limit: 9 grams for retail sales, of which no more than 7.5 grams may be by mail order or mobile retail.
- Product stored behind the counter or in a locked cabinet.
- A logbook (written or electronic) with the purchaser's name, address and signature, the date and time, and the product and quantity, kept 2 years.
- Photo ID check.
- Retailers self-certify to DEA that employees are trained.
Oregon adds the controlled-substance classification, the licensee-only rule, the behind-the-pharmacy-counter storage, the 18-year age minimum and mandatory real-time electronic blocking.
Nonprescription Schedule V narcotic preparations (21 CFR 1306.26)
Federal law permits a pharmacist to sell certain Schedule V products, such as codeine-containing cough preparations, without a prescription, if state law allows. The federal conditions are:
- Only a pharmacist dispenses. A non-pharmacist may complete the cash transaction after the pharmacist has made the decision.
- The purchaser is at least 18 and shows identification if not known.
- Over 48 hours, no more than 240 mL (8 oz) or 48 dosage units of an opium-containing product, or 120 mL (4 oz) or 24 dosage units of any other Schedule V controlled substance.
- A bound record book records each sale. The book is kept 2 years federally, and 3 years under Oregon's general rule.
In Oregon, any nonprescription Schedule V controlled substance must be stored in the prescription area or a secured storage area (OAR 855-041-1020(4)). Remember that Oregon limits prescription Schedule V orders to 6 months and 5 refills (ORS 475.185(3)).
Other restricted or special nonprescription products
- Emergency contraception: levonorgestrel 1.5 mg is OTC without age restriction. Ulipristal requires a prescription, which an Oregon pharmacist may issue under the Board's emergency contraception protocol.
- Naloxone 4 mg nasal spray: OTC since 2023. Pharmacies must post notice that it is available. A pharmacist must dispense opioid antagonists under OHA's standing order on request.
- Gabapentin is prescription-only and unscheduled, but reported to the PDMP. It is a common distractor in "restricted product" questions.
Warning
In Oregon, a non-licensed cashier may not complete a PSE sale, even with NPLEx clearance. ORS 475.230 limits PSE transfers to pharmacists, interns and pharmacy technicians, and the Board's self-inspection form calls out "only licensed personnel may sell."
Worked example: grams of base
Pseudoephedrine HCl 30 mg tablets contain about 24.6 mg of PSE base each (82% base). A 24-tablet box therefore holds about 0.59 g of base. A purchaser could buy six such boxes (about 3.5 g) in a day without exceeding 3.6 g, but a seventh box (about 4.1 g) would exceed the daily limit. NPLEx tracks the totals in grams, which is why the transaction must be entered before the sale.
Exam scenario
A 19-year-old with a valid driver's license asks to buy 120 mg pseudoephedrine ER tablets at an Oregon pharmacy. A COPT enters the purchaser and product details into NPLEx, which returns a stop-sale alert because of earlier purchases. The COPT cannot override it. Only a pharmacist may override, and only to protect the purchaser from imminent bodily harm. That standard is almost never met by nasal congestion, so the sale should be declined, and the pharmacist may recommend a non-PSE alternative.
Who may complete a nonprescription pseudoephedrine sale in an Oregon pharmacy?
Any employee trained under the CMEA
Only the pharmacist-in-charge
Any cashier, once NPLEx approves the sale
A pharmacist, intern, Certified Oregon Pharmacy Technician or Pharmacy Technician
What are Oregon's purchase limits for nonprescription pseudoephedrine?
No more than 3.6 grams in 24 hours and 9 grams in 30 days
No more than 9 grams in 24 hours and 15 grams in 30 days
No more than 7.5 grams in 24 hours
No limit if the purchaser is over 21
NPLEx returns a stop-sale alert for a pseudoephedrine purchase. Under ORS 475.230, when may the sale proceed?
When the purchaser signs a written affidavit
Only if a pharmacist decides the transfer is necessary to protect the purchaser from imminent bodily harm
When a technician documents the reason in the log
Whenever the purchase is under 3.6 grams
Sections you finish are checked off in the contents.