9.1 Nonprescription Drugs: Outlet Registration, Drug Facts Labeling & OTC Packaging
Key Takeaways
Registered Oregon drug outlets may sell OTC drugs, but other Oregon retailers must register as nonprescription drug outlets, renewing annually by January 31.
Oregon nonprescription outlets may sell drugs only in original, unbroken, properly labeled packages and may not repackage or relabel them.
A business that only gives away OTC opioid antagonists at no cost does not have to register as an Oregon drug outlet.
The FDA Drug Facts label lists active ingredients and purpose, uses, warnings, directions, other information and inactive ingredients.
Under OAR 855-041-1020, nonprescription Schedule V products, including pseudoephedrine, must be stored in the prescription area or a secured storage area.
Why this matters
Area 3.8 covers the distribution and dispensing of nonprescription products, including their labeling and packaging. OTC drugs are not free of regulation. Oregon requires registration of most outlets that sell them. Federal law dictates Drug Facts labeling and tamper-evident and child-resistant packaging. Pharmacies must keep certain OTC products under pharmacist control.
Who may sell OTC drugs in Oregon
- Any registered drug outlet, such as a retail pharmacy, may lawfully sell and distribute nonprescription drugs. Doing so is not improperly engaging in the practice of pharmacy (ORS 689.305(4)).
- A business that sells nonprescription drugs but is not a pharmacy, such as a grocery store, convenience store or gas station, must register as a nonprescription drug outlet (ORS 689.305(2)(a)(E); OAR 855-035). Division 035 sets several registration classes:
- General nonprescription outlets.
- Medical gases.
- Multiple vending machines (ORS 689.527 bars drug vending machines except as Board rules allow).
- A no-fee class for nonprofit food-distribution facilities such as food banks.
- Exemption: a business that only distributes OTC short-acting opioid antagonists at no cost does not have to register.
- Nonprescription outlet registrations renew annually by January 31 (seasonal outlets have until June 1).
- A store that has both a pharmacy and a front-store nonprescription registration is a double set-up. The pharmacy area must be enclosed floor to ceiling or at least 10 feet high, and posted with its hours when closed (OAR 855-041-2100).
Operating standards for nonprescription outlets (OAR 855-035)
Nonprescription outlets must:
- Sell drugs only in the original, unbroken packages, properly labeled under state and federal law. No repackaging or relabeling.
- Store drugs in sanitary, well-lit areas with appropriate temperature, ventilation and moisture control.
- Monitor expiration dates and quarantine outdated drugs, physically separating them until they are destroyed or returned.
- Never sell prescription drugs. Medical device, equipment and gas (MDEG) outlets may distribute specific prescription items, such as oxygen, under a practitioner's order, and keep records three years.
OTC labeling: Drug Facts (21 CFR 201.66)
FDA requires a standardized Drug Facts panel in this order:
- Active ingredient(s) with the amount per unit, and the purpose of each.
- Uses (indications).
- Warnings: when not to use; when to ask a doctor or pharmacist; side effects; when to stop use; pregnancy and breastfeeding; "keep out of reach of children"; and overdose instructions.
- Directions, by age group.
- Other information, such as storage, and inactive ingredients.
- Questions? with a phone number (optional).
A product that lacks required labeling, or carries false or misleading claims, is misbranded (FDCA 502; ORS 689.505(2)). Pharmacies that repackage OTC drugs for sale become responsible for compliant labeling. Prescription-only rules (ORS 689.505(5)) apply when an OTC drug is dispensed on a prescription, which is common for protocol-prescribed NRT or condoms. The prescription label requirements then apply.
OTC packaging
- Tamper-evident packaging (21 CFR 211.132) is required for most OTC human drugs sold at retail. The label must describe the tamper-evident feature.
- Child-resistant packaging (PPPA) applies to many OTC products, including aspirin, acetaminophen, iron-containing supplements, diphenhydramine, ibuprofen and naproxen. A manufacturer may market one package size without child-resistant packaging if it carries the statement "This package for households without young children" and child-resistant sizes are also available.
Products a pharmacy keeps under pharmacist or licensee control
| Product | Rule |
|---|---|
| Pseudoephedrine and ephedrine (Oregon Schedule V) | Behind the pharmacy counter, inaccessible to the public. Sold only by a licensee with age, ID and electronic-system checks (section 9.2) |
| Nonprescription Schedule V controlled substances | Stored within the prescription area or a secured storage area (OAR 855-041-1020(4)) |
| Emergency contraception (levonorgestrel 1.5 mg) | Federally OTC with no age limit. Oregon pharmacists may also prescribe emergency contraception under the Board protocol |
| Naloxone nasal spray 4 mg | FDA-approved OTC (2023). Also available by pharmacist prescription or OHA standing order. Pharmacies must post notice that it is available |
Pharmacist role at the OTC counter
Advice about an OTC product is counseling. A technician may not give it, because advising on therapeutic values is barred to technicians (OAR 855-125-0150), and a clerk certainly may not. A request like "What's safest with my warfarin?" belongs to the pharmacist. OTC drugs a patient uses belong in the patient record when relevant to DUR (OAR 855-041-1165(9)).
Tip
For a store selling OTC drugs without a pharmacy, the answer is a nonprescription drug outlet registration. For a registered pharmacy, OTC sales need no separate registration, unless the pharmacy runs as a double set-up with a front-store nonprescription registration.
Exam scenario
A gas station owner wants to sell ibuprofen and loratadine and to break bulk bottles into 10-tablet bags for travelers. The owner must register the station as a nonprescription drug outlet. It may sell only original, unbroken, properly labeled packages, so repackaging into bags is prohibited. The station must store the products appropriately and pull outdated stock. It may not stock pseudoephedrine, which must be kept behind a pharmacy counter and sold by a pharmacy licensee.
A convenience store with no pharmacy wants to sell acetaminophen and cetirizine in Oregon. What does Oregon law require?
No registration, because OTC drugs are unregulated
Registration as a nonprescription drug outlet with the Board, selling only original, unbroken, properly labeled packages
Registration as a retail drug outlet with a pharmacist-in-charge
A DEA registration
Which business is exempt from Oregon's nonprescription drug outlet registration requirement?
A grocery store selling ibuprofen
A gas station with a drug vending machine
A community organization that only distributes OTC naloxone at no cost
A hardware store selling diphenhydramine
A customer at an Oregon pharmacy asks a technician which OTC cough product is safest with their blood pressure medication. What should happen?
The question should be referred to the pharmacist, because advising on drug use is counseling, which technicians may not perform
The technician may answer if they have national certification
The technician may answer if the product is not a controlled substance
The cashier may answer from the Drug Facts label
Sections you finish are checked off in the contents.