10.6 Nonprescription Products: OTC Labeling & Packaging, Pseudoephedrine, Iodine, Schedule V & Other Restricted OTC Sales

10.6 Nonprescription Products: OTC Labeling & Packaging, Pseudoephedrine, Iodine, Schedule V & Other Restricted OTC Sales

Blueprint item 3.8 covers "requirements for the distribution and/or dispensing of non-prescription pharmaceutical products," including labeling, packaging and repackaging, and "dispensing-restricted, non-prescription drugs."

OTC labeling and packaging

• Drug Facts label (21 CFR 201.66): OTC drugs carry a standardized panel listing the active ingredients (with the purpose of each), uses, warnings, directions, other information (such as storage), and inactive ingredients. A product lacking required labeling is misbranded.
• Tamper-evident packaging (21 CFR 211.132): most OTC drugs must be in tamper-evident packaging, with a label statement describing the feature.
• Child-resistant packaging: the PPPA covers listed OTC products above threshold amounts, such as aspirin, acetaminophen over 1 g per package, ibuprofen over 1 g, iron over 250 mg elemental, and diphenhydramine over 66 mg (Section 10.4).
• Repackaging: changing an OTC product's container or labeling to further distribute it is "repackaging" under Utah law (§ 58-17b-102(66)) and brings manufacturer-type labeling duties. Dispensing an OTC drug on a practitioner's order is dispensing, and a § 58-17b-602 label applies (§ 58-17b-102(22)).
• Store signs: a non-pharmacy business may display "packaged drugs," "drug sundries," or "nonprescription drugs" without being treated as a pharmacy (§ 58-17b-501(3)(b)).
• Counseling: a technician may counsel on OTC drugs and dietary supplements under the supervising pharmacist's direction (R156-17b-601(1)(j)). Questions about prescription drugs go to a pharmacist or intern.

Pseudoephedrine, ephedrine, and phenylpropanolamine

Utah (§ 58-37c-208)

• Quantity: a retail distributor or mobile retail vendor may not sell more than 3.6 grams in any 24-hour period, regardless of the number of transactions. A mobile retail vendor is also limited to 7.5 grams per 30 days.
• Storage: products must be kept where customers can't reach them, or in a locked display case only employees can open. Non-liquid products must be in blister packs of no more than two dosage units per blister.
• Identification: the buyer must show government-issued photo ID with date of birth.
• Log: the buyer provides or writes name, address, date of birth, the date and time, and a signature. The seller verifies identity and records the brand name and quantity. Keep the log at least two years from the most recent entry.
• Warning: the log or a prominent sign must include the federal false-statement warning (18 U.S.C. § 1001).
• Confidentiality: log information may be released only to law enforcement enforcing controlled substance laws, or to the purchaser about their own purchases.
• Possession: an unlicensed person who possesses more than 9 grams is guilty of a class A misdemeanor. Pharmacists, retailers, and others possessing it in the regular course of lawful business, and people with a valid prescription, have an affirmative defense (§ 58-37c-207). Online sales use an electronic tracking system (§ 58-37c-209).

Federal CMEA (21 CFR Part 1314)

Federal law adds a 9-gram limit per 30 days per purchaser (7.5 grams for mail-order or mobile sales), requires sellers to self-certify with DEA and train employees, and requires the logbook. Utah pharmacies comply with both sets of rules.

Iodine matrix above 1.5% (§ 58-37c-204)

Iodine at concentrations above 1.5% by weight, a methamphetamine precursor, may be sold only:

• as a prescription drug on a prescription from a Utah-licensed veterinarian or physician. The prescription must state a specified number of refills, may be electronic, and may be filled by someone other than the prescriber; or
• to a person engaged in livestock animal husbandry.

A retailer must store it so the public can't reach it without an employee's help, and keep a record (receipts are enough) of each buyer. Selling to an unqualified buyer is a class B misdemeanor. Crystal iodine sales by licensed regulated sellers require photo ID, a signed certificate, and a thumbprint (§ 58-37c-202).

Schedule V without a prescription (federal rule)

21 CFR 1306.26 allows a pharmacist to dispense a Schedule V product that is not a prescription drug under the FDCA without a prescription, but only if:

• a pharmacist makes the sale (a non-pharmacist may complete the cash transaction after the pharmacist decides);
• no more than 240 mL or 48 dosage units of an opium-containing product, or 120 mL or 24 dosage units of any other controlled substance, is sold to the same purchaser in 48 hours;
• the purchaser is at least 18 and shows identification if not known to the pharmacist;
• a bound record book records the buyer's name and address, product, quantity, date, and pharmacist; and
• other federal, state, or local law doesn't require a prescription.

Most codeine combinations are now prescription drugs, so this pathway is rarely used. In Utah, gabapentin (Schedule V) is a prescription drug and is always dispensed on a prescription. Utah's statute requires a written prescription whenever federal law requires one (§ 58-37-304(3)(a)).

Other restricted or behind-the-counter items

• Naloxone 4 mg nasal spray has been approved for OTC sale since 2023. Prescription products and insurance billing still use the standing order or pharmacist prescribing (Section 7.1).
• Levonorgestrel 1.5 mg emergency contraception is OTC with no age restriction. Ulipristal requires a prescription.
• Human insulins (regular, NPH, 70/30) are federally non-prescription but are typically kept behind the counter so the pharmacist can counsel. Analog insulins require a prescription.
• Tobacco and nicotine: OTC nicotine replacement is labeled for adults. Pharmacist prescribing of prescription cessation products is covered in Section 6.3.