How federal law restricts pseudoephedrine sales and REMS drugs
PTCB topic: Restricted drug programs (pseudoephedrine, REMS)
- One purchaser: at most 3.6 g of pseudoephedrine base per day.
- A buyer may get at most 9 g at retail in 30 days.
- Count grams of base, not boxes or salt, and round down.
- Check photo ID and keep the logbook at least 2 years.
- iPLEDGE: get REMS authorization before every isotretinoin fill. No refills.
Key facts
- A pharmacy may not sell one purchaser more than 3.6 grams of pseudoephedrine base in a calendar day, no matter how many transactions.
- A purchaser may not buy more than 9 grams of pseudoephedrine base at retail in a 30-day period; mobile retail vendors and mail-order sellers are limited to 7.5 grams per 30 days.
- Pseudoephedrine products are kept behind the counter or in a locked cabinet, and the purchaser shows a photo ID issued by a state or the federal government (or another identity document the rule accepts) and signs the logbook.
Show all 7 key factsShow fewer
- Each logbook entry is kept for at least 2 years; a single package containing no more than 60 mg of pseudoephedrine is exempt from the logbook.
- A REMS is a drug safety program FDA can require for certain prescription drugs with serious risks; it never applies to over-the-counter drugs.
- Under the iPLEDGE REMS, isotretinoin is dispensed only by certified pharmacies with a REMS authorization, as a 30-day supply at most and with no refills.
- Since February 24, 2025, FDA no longer expects pharmacies to take part in the Clozapine REMS, and clozapine is no longer on the REMS@FDA list.
Quick check1 question · 2 more at the end
Under federal law, what is the most pseudoephedrine base a pharmacy may sell to one purchaser in a single calendar day?
Correct answer: B.
Under the Combat Methamphetamine Epidemic Act (21 CFR 1314.20), a regulated seller such as a pharmacy may not sell one purchaser more than 3.6 grams of pseudoephedrine, ephedrine or phenylpropanolamine base in a calendar day, regardless of the number of transactions. Separately, a purchaser may not buy more than 9 grams of base in a 30-day period, and mobile retail vendors and mail-order sellers are held to 7.5 grams per 30 days. All limits are counted in grams of base, not grams of salt or number of boxes.
A 1.8 grams is half the daily limit; it is not a federal threshold.
B Correct: a regulated seller may not sell more than 3.6 grams of pseudoephedrine base to one purchaser in a calendar day, however many transactions there are.
C 7.5 grams is the 30-day limit for mobile retail vendors and mail-order sellers, not the daily limit.
D 9 grams is the purchaser's 30-day buying limit, not the daily sales limit.
Full lesson
Each part starts with its main idea. Open a part when you want the details.
The short answer: Under the Combat Methamphetamine Epidemic Act, a pharmacy may sell one purchaser no more than 3.6 grams of pseudoephedrine base per day, and a buyer may purchase no more than 9 grams in 30 days. Sales need photo ID and a logbook kept 2 years. A REMS is an FDA-required safety program; iPLEDGE requires REMS authorization before every isotretinoin fill.
1 Why are some legal drugs restricted at the pharmacy counter?Federal law adds extra steps for drugs whose risks need more than a label. 1 min
Federal law adds extra steps for drugs whose risks need more than a label. The 2026 PTCE outline groups two kinds together. The first is pseudoephedrine sales limits, set by the Combat Methamphetamine Epidemic Act (CMEA) and enforced by DEA. The second is FDA's Risk Evaluation and Mitigation Strategies (REMS).
Pseudoephedrine is a nasal decongestant that can also be used to make methamphetamine. The CMEA rules also cover ephedrine and phenylpropanolamine.
2 How much pseudoephedrine can one person get?Every federal limit is counted in grams of pseudoephedrine base, not in boxes or grams of salt. 1 min
Every federal limit is counted in grams of pseudoephedrine base, not in boxes or grams of salt.
| Limit | Who it binds |
|---|---|
| 3.6 g per calendar day | Seller, per purchaser, however many transactions |
| 9 g per 30 days | Purchaser, at retail |
| 7.5 g per 30 days | Mobile retail vendors and mail-order sellers, per purchaser |
A 60 mg tablet of pseudoephedrine hydrochloride holds only about 49 mg of base. That is why DEA's informational chart lists 73 of these tablets for one day, not 60.
3 What has to happen at the counter?A federal pseudoephedrine sale follows the same steps every time. 1 min
A federal pseudoephedrine sale follows the same steps every time.
- Keep products behind the counter or in a locked cabinet.
- Check a photo ID issued by a state or the federal government, or another accepted identity document.
- The buyer enters name, address, date and time and signs the logbook.
- Confirm the name matches the ID, then record the product and quantity sold.
- Hand the product directly to the purchaser.
Keep each logbook entry at least 2 years. A single package containing no more than 60 mg of pseudoephedrine needs no logbook entry, but it still stays behind the counter. Staff who sell these products must be trained, and the seller self-certifies with DEA.
4 How do you do the gram math?Subtract what the person already bought, then divide by the base per package and round down. 1 min
Subtract what the person already bought, then divide by the base per package and round down.
Example: the logbook shows 1.5 g bought today, and each box holds 0.96 g of base. That leaves 3.6 - 1.5 = 2.1 g, and 2.1 / 0.96 = 2.19, so only 2 boxes can be sold. For the 30-day check, add every purchase in the window and subtract from 9 g.
5 What is a REMS, and how does it reach the pharmacy?A REMS is a drug safety program that FDA can require for certain prescription drugs with serious risks. 1 min
A REMS is a drug safety program that FDA can require for certain prescription drugs with serious risks. The manufacturer builds and runs it, generics must have one too, and it never applies to over-the-counter drugs.
Many REMS rely on communication, such as a Medication Guide for patients or letters to prescribers. Stricter ones use elements to assure safe use (ETASU). Examples are certified prescribers and pharmacies, dispensing only in certain settings, or proof of a lab result before each fill. Current programs are listed on REMS@FDA.
6 What does iPLEDGE require for isotretinoin?The iPLEDGE REMS exists because isotretinoin can cause severe birth defects. 1 min
The iPLEDGE REMS exists because isotretinoin can cause severe birth defects.
- Only a certified pharmacy may dispense it, and only after it gets a REMS authorization for that fill.
- For a patient who can get pregnant, the REMS confirms a negative pregnancy test, counseling and contraception first.
- No more than a 30-day supply, and no refills.
- If the REMS dispensing date passes, the pharmacy does not dispense. The patient goes back to the prescriber for a repeat pregnancy test.
REMS programs change. On February 24, 2025, FDA said it no longer expects pharmacies to take part in the Clozapine REMS or report blood counts (ANC) before dispensing. Clozapine no longer appears on the REMS@FDA list.
7 What the technician doesThe technician runs the routine steps and hands judgment calls to the pharmacist. 1 min
The technician runs the routine steps and hands judgment calls to the pharmacist.
- Check ID, enter the logbook and do the gram math before ringing up pseudoephedrine.
- Refuse a sale that would exceed a limit, and involve the pharmacist if the customer disputes it.
- For REMS drugs, check certification and authorization before filling and flag any block to the pharmacist.
Common mistakes
The traps students fall into most. Read these before you practice.
Watch out: Count grams of pseudoephedrine base, not grams of the hydrochloride salt or number of boxes.
Watch out: Round a tablet or box count down, not up, because the limit cannot be exceeded.
Watch out: The 3.6-gram daily limit counts every sale that day, not just the current transaction.
Watch out: An isotretinoin prescription with refills gets one 30-day fill, not the refills.
How to remember it
Remember "3.6 a day, 9 a month, 2 years for the book" as the core pseudoephedrine numbers.
Self-check:
- Someone bought 4.5 g over the past 3 weeks. What is the most they can buy today, and which limit decides it?
- Why is the limit counted in base, not salt?
- What must a pharmacy obtain before every isotretinoin fill?
Show answers
- 3.6 g, and the daily limit decides.
- 30-day check: 9 g − 4.5 g = 4.5 g still allowed this month.
- Daily check: if none of it was bought today, the daily limit allows 3.6 g.
- The smaller number wins: 3.6 g is less than 4.5 g.
- Because every federal limit is set in grams of base.
- The salt weighs more than the base it contains.
- A 60 mg tablet of pseudoephedrine hydrochloride holds only about 49 mg of base.
- Counting salt grams would give the wrong total.
- A REMS authorization for that fill.
- Only a certified pharmacy may dispense isotretinoin under iPLEDGE.
- It needs the authorization before every fill, gives at most a 30-day supply and gives no refills.