United States
Hong KongPseudoephedrine limits
A regulated seller may not sell more than 3.6 grams of ephedrine, pseudoephedrine or phenylpropanolamine base to a single purchaser in one day, under 21 CFR 1314.20.
On this page4 sections
A small, precise area of the domain that generates questions because the figures are exact and easy to test.
The daily limit
No more than 3.6 grams of ephedrine base, pseudoephedrine base or phenylpropanolamine base in scheduled listed chemical products to a single purchaser in one day. 21 CFR 1314.20.
Note that the limit is expressed in grams of base, not in packages or tablets. Converting from a product to a base weight is what a harder question will ask you to do.
A package labeled with a milligram strength per tablet is describing the salt in most cases. Questions that give you tablet counts and strengths are testing whether you convert before you compare against 3.6 grams, and the careless answer is to compare the product weight directly.
What else the rules require
- Sales are recorded in a logbook, written or electronic
- The purchaser presents identification and signs
- Product is kept behind the counter or in a locked cabinet
- Sellers are trained and the seller self-certifies
The logbook is a transaction record, not just a daily total. Except for the single-package exception specified in the regulation, it identifies the product and quantity, purchaser's name and address, and sale date and time. The seller records the product and quantity; the purchaser presents photo identification and signs. If the seller enters the purchaser's identifying information in an electronic system, the purchaser must verify it. The signature must remain linked to the specific sale record.
The record must be retained for at least two years and be readily retrievable for inspection. The logbook or an adjacent display must carry the federal warning about knowingly false entries. An electronic logbook is allowed, but it still has to preserve the required fields, purchaser signature, warning, and retrieval link. A screen that records a purchase but cannot retrieve the purchaser's earlier daily total would not satisfy the sale-limit purpose.
| Retail control | What the federal rule requires |
|---|---|
| Identity | Purchaser presents a qualifying photo ID, subject to specific regulatory alternatives. |
| Sale record | Product, quantity, purchaser identity, and date/time are linked to the transaction. |
| Purchaser attestation | Purchaser signs the written or electronic logbook; the electronic signature must link to the captured record. |
| Retention and retrieval | Retain logbook entries at least two years and make them readily retrievable for inspection. |
| Product access | Keep scheduled listed chemical products behind the counter or in a locked cabinet, subject to the rule's terms. |
Why these products are treated this way
They are listed chemicals, which means they can be used to manufacture controlled substances. The regime at 21 CFR Part 1314 is a diversion control measure rather than a clinical one.
That framing helps: the rules are about volume and identity, not about the patient's condition.
The state overlay
Several states impose stricter limits, require a prescription, or run their own tracking systems. The PTCE examines the federal position.
If your daily practice follows a stricter state rule, that is the answer to unlearn for this paper.
Common questions
What is the pseudoephedrine daily limit?
3.6 grams of base to a single purchaser in one day, under 21 CFR 1314.20.
Is the limit in grams of product?
No, grams of base. Converting from the product is what harder questions test.
What else is required at sale?
A logbook entry, identification, a signature, and product kept behind the counter or locked.
Why are these products regulated?
They are listed chemicals usable in manufacturing controlled substances, so the regime is diversion control.
Do state rules matter for the exam?
No. Several states are stricter, but the PTCE examines the federal position.