How many federal requirements questions are on the PTCE?

15. PTCB publishes a percentage for every domain rather than an item count, and it gives Federal Requirements 18.75% of the paper. 15 is that percentage applied to the 80 scored items — worked out here rather than lifted from the document, which is why the percentage is shown alongside it so you can check the arithmetic.

Is this section timed?

Not on this page. These sets are for learning the material — each answer comes with an explanation straight away. When you want the whole paper, the full-length test runs the published clock. The real sitting is 90 questions in 110 minutes.

Are these real questions from the test?

No. Every question here is original, written to the published format. The real item banks are confidential and nobody outside the publisher has them.

PTCE federal requirements questions

Controlled substances, hazardous waste, restricted programmes, recalls and DSCSA serialisation.

2 15 of the 80 scored questions (18.75%)

24 questions in this set Untimed — explanation after each answer

PTCE federal requirements 1 of 10

Federal requirements rose from twelve and a half per cent of the exam to eighteen and three quarters under the outline effective January 2026. What does that mean for a candidate using older material?

What this type asks

The domain that grew most, and by a wide margin: twelve and a half per cent of the paper under the previous outline, eighteen and three quarters under the one in force — half as many questions again. It covers federal requirements for storing, handling and disposing of non-hazardous, hazardous and pharmacological substances and wastes; the requirements for controlled substance prescriptions and the DEA schedules; the whole controlled-substance lifecycle from receiving and ordering through labelling, dispensing, returning, take-back and destruction, and what happens on loss or theft; federal restricted drug programmes such as REMS; FDA recall requirements; and — new to the outline in force — FDA product serialisation, tracking, tracing, handling and quarantining under the Drug Supply Chain Security Act. If your revision material is weighted to the old outline, this is the domain it is shortest on, and it is the one that gained the most.

Federal requirements for storage, handling and disposal of hazardous and non-hazardous substances and wastesFederal requirements for controlled substance prescriptions and DEA schedulesReceiving, storing, ordering, labelling, dispensing, returning, take-back, loss or theft, and destruction of controlled substancesFederal restricted drug programmes and related processing (pseudoephedrine, REMS)FDA requirements for medication recallsFDA product serialisation, tracking, tracing, handling and quarantining (DSCSA)

Now do it with the clock running.

90 questions in 110 minutes — about 1.2 minutes each, which is the part no amount of untimed practice prepares you for.

Take the full PTCE test

The other question types

Medications Patient safety and quality assurance Order entry and processing Full timed test

Frequently asked

How many federal requirements questions are on the PTCE?: 15. PTCB publishes a percentage for every domain rather than an item count, and it gives Federal Requirements 18.75% of the paper. 15 is that percentage applied to the 80 scored items — worked out here rather than lifted from the document, which is why the percentage is shown alongside it so you can check the arithmetic.
Is this section timed?: Not on this page. These sets are for learning the material — each answer comes with an explanation straight away. When you want the whole paper, the full-length test runs the published clock. The real sitting is 90 questions in 110 minutes.
Are these real questions from the test?: No. Every question here is original, written to the published format. The real item banks are confidential and nobody outside the publisher has them.

Sources

Every figure on this page comes from one of the documents below, with the date it was read. Requirements change; if a source has moved on since that date, the source is right and this page is out of date.

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