The content outline, domain by domain

All four domains, and the federal parts each of them turns on.

The content outlineThe outline effective 6 January 2026 sets four domains: Medications 35 percent, Patient Safety and Quality Assurance 23.75 percent, Order Entry and Pr…
The 2026 blueprint changeThe outline effective 6 January 2026 moved weight onto Federal Requirements and Order Entry and off Medications and Patient Safety. Against the 80 sco…
What changed in Federal RequirementsFederal Requirements went from 12.5 percent to 18.75 percent of the paper, which is 10 scored questions to 15. The six knowledge areas did not change,…
What changed in MedicationsMedications fell from 40 percent to 35 percent, or 32 scored questions to 28. It remains the largest single domain, but it is no longer more than thre…
Is your material out of date?Check the domain weights first. Material giving Medications 40 percent and Federal Requirements 12.5 percent is written to the outline superseded on 6…
Medications domainMedications is 35 percent of the paper, 28 of the 80 scored questions, across six knowledge areas. Learning drugs by class serves four of the six; a f…
Generic and brand namesQuestions use brand and generic names interchangeably. Learning the pair together, and learning the class stems, lets you place drugs you never memori…
Drug classificationsTherapeutic classification is what duplication, interaction and indication questions are answered from. Learning the class structure serves four of th…
Therapeutic duplicationsA therapeutic duplication is two drugs from the same therapeutic class, or with the same effect, prescribed together. It is distinct from an interacti…
Drug interactionsAn interaction is one substance altering the action, absorption or metabolism of another. The exam tests recognition and referral rather than clinical…
Dosage forms and routesDosage forms describe the physical preparation and routes describe how it enters the body. Both are definitional knowledge that supports Sig interpret…
Strengths and durationStrength describes how much active ingredient a preparation contains, expressed in several notations. Duration connects to days supply, which is a cal…
Side effects and adverse effectsA side effect is a known secondary effect of a drug acting as expected. An adverse effect is harmful and unintended. An allergy is immune-mediated and…
Allergies and cross-sensitivityA drug allergy is an immune-mediated response. Cross-sensitivity means a reaction to one drug implies possible reaction to structurally related drugs,…
IndicationsAn indication is the condition a drug is used to treat. Learning one indication per therapeutic class covers this knowledge area efficiently.
Stability and storageStorage requirements protect a drug from losing potency or becoming unsafe. Temperature, light, moisture and reconstituted stability are the categorie…
Refrigerated and frozenRefrigerated and frozen products must be kept within defined ranges continuously. Monitoring and documenting storage temperature is the control, becau…
The top 200 drugsA top 200 list is a reasonable starting set and a poor finishing line. The exam samples widely, so the goal is placing unfamiliar drugs by class rathe…
Federal Requirements domainFederal Requirements is 18.75 percent of the paper, 15 of the 80 scored questions, across six knowledge areas. Nearly all of it sits in 21 CFR and 40 …
DEA schedulesThere are five schedules. Schedule I has no accepted medical use in the United States; II to V descend in abuse potential, and the handling rules tigh…
Schedule II rulesRefilling a Schedule II prescription is prohibited outright at 21 CFR 1306.12. Schedule I and II ordering requires DEA Form 222 or its electronic equi…
Schedule III to V refillsA prescription for a Schedule III or IV controlled substance may not be filled or refilled more than six months after the date it was issued, nor refi…
DEA Form 222DEA Form 222, or its electronic equivalent through the Controlled Substance Ordering System, is used to order Schedule I and II controlled substances …
RecordkeepingRecords and inventories of controlled substances must be maintained and kept available for at least two years, under 21 CFR 1304.04.
Biennial inventoryA biennial inventory of controlled substances may be taken on any date within two years of the previous biennial inventory date, under 21 CFR 1304.11.
Loss and theftTheft or significant loss of controlled substances is reported to DEA on Form 106. The registrant must also notify DEA upon discovery of the theft or …
DestructionDestruction of controlled substances is governed by 21 CFR Part 1317, which sets out authorized methods and the requirement that the substance be rend…
Pseudoephedrine limitsA regulated seller may not sell more than 3.6 grams of ephedrine, pseudoephedrine or phenylpropanolamine base to a single purchaser in one day, under …
REMSA Risk Evaluation and Mitigation Strategy is an FDA-required program attaching additional safety requirements to specific drugs, which can include enr…
FDA recall classesClass I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible consequences,…
Handling a recallThe procedure is to identify affected stock by lot number, quarantine it, follow the recall notice, and document. The recall class indicates urgency.
The DSCSAThe Drug Supply Chain Security Act establishes requirements for tracing prescription drugs through the supply chain, including product identification,…
SerializationSerialization gives each package a unique identifier so individual units can be traced through the supply chain, rather than only whole batches.
P list and U listThe P list at 40 CFR 261.33(e) identifies acutely hazardous discarded commercial chemical products. The U list at 261.33(f) identifies the other liste…
Hazardous disposalDiscarded pharmaceuticals that are listed hazardous wastes must be segregated into the appropriate waste stream. Under 40 CFR 261.3 a mixture containi…
NDC numbersA National Drug Code has three segments identifying the labeler, the product and the package size, under 21 CFR 207.33.
Labeling requirementsFederal drug labeling requirements sit in 21 CFR Part 201. What must appear on a dispensed prescription label is substantially a matter of state law, …
Adverse event reportingPostmarketing reporting of adverse drug experiences is required of applicants under 21 CFR 314.80. Practitioner and consumer reporting through MedWatc…
Patient Safety domainPatient Safety and Quality Assurance is 23.75 percent of the paper, 19 of the 80 scored questions, across six knowledge areas. It tests judgment rathe…
High-alert medicationsA high-alert medication carries a heightened risk of significant patient harm when used in error. The defining feature is the consequence of a mistake…
Look-alike sound-alikeLook-alike sound-alike medications are pairs whose names or packaging are similar enough to be confused. Controls include tall man lettering, physical…
Tall man letteringTall man lettering capitalizes the differing portion of similar drug names so the difference is visible at a glance. It addresses look-alike names spe…
Error preventionError prevention works best when it removes the opportunity for error rather than asking for more care. Controls that change the system outperform tho…
Types of errorsErrors are categorized by what went wrong: wrong drug, wrong dose, wrong patient, wrong form or route, wrong quantity, wrong label, or an omission.
Pharmacist interventionAnything requiring clinical judgment goes to the pharmacist: dosing concerns, interactions, duplications, allergy questions, counseling and any change…
MedWatch and reportingMedWatch is the FDA program for voluntary reporting of adverse events and product problems. Manufacturer postmarketing reporting is separate and manda…
Continuous quality improvementContinuous quality improvement uses reported events, including near misses, to identify and correct system weaknesses. Its premise is that most errors…
Infection preventionA named knowledge area covering hand hygiene, personal protective equipment, surface cleaning and the stricter environmental controls that apply to co…
Compounding standardsPublished pharmacy standards govern sterile compounding and the handling of hazardous drugs, covering environment, technique, personal protective equi…
Order Entry domainOrder Entry and Processing is 22.5 percent of the paper, 18 of the 80 scored questions, across four knowledge areas. Pharmacy calculations is the heav…
Sig codesSig codes encode route, frequency and timing. The exam tests the ones that resemble each other, so learning them in contrasting pairs beats learning a…
Pharmacy calculationsNearly every PTCE calculation reduces to dimensional analysis: write what you have, multiply by conversion factors arranged so the unwanted units canc…
ConversionsThe exam assumes fluency in a small set: 5 mL to a teaspoon, 15 to a tablespoon, 30 to a fluid ounce, 454 g to a pound, 2.2 pounds to a kilogram, and …
Weight-based dosingConvert the weight to kilograms first, multiply by the dose per kilogram, then convert the resulting mass to a volume using the product concentration.…
Days supplyDays supply is the total quantity dispensed divided by the quantity used per day. The difficulty is never the division; it is reading the Sig correctl…
Percentage and ratio strengthA percentage strength in a liquid is grams per 100 mL. A ratio strength of 1 to 1000 is one gram in 1000 mL. Converting either to mg per mL makes them…
AlligationAlligation finds the proportions of two preparations needed to produce an intermediate strength. Subtract diagonally: each part is the difference betw…
DilutionsThe amount of active ingredient does not change when you dilute. That gives the relationship: initial concentration times initial volume equals final …
IV flow ratesFlow rate is volume divided by time. Where the answer is wanted in drops per minute, multiply the rate in mL per minute by the drop factor of the admi…
Business mathsBusiness arithmetic covers markup, margin, discount, days supply against insurance, and inventory measures. Markup and margin are calculated from diff…
Lot numbers and datesA lot number identifies a manufacturing run and is how recalls are targeted. An expiration date is the manufacturer's guarantee of potency for the uno…
Beyond-use datingA beyond-use date is the date after which a product should not be used once it has been opened, reconstituted, repackaged or compounded. It is usually…
Equipment and suppliesA named knowledge area covering the devices used to measure and administer medications, and matching the right device to the preparation and the dose.
Returns and disposalA named knowledge area covering the return of dispensable stock to inventory, the handling of non-dispensable product, and the disposal of expired med…