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Which USP chapter establishes the minimum standards for nonsterile compounding in the United States?

USP <795>

USP <797>

USP <800>

USP <825>

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2026 Statistics

Key Facts: PTCB Nonsterile Compounding Exam

$89

Exam Fee

PTCB

Questions

PTCB

300/400

Passing Scaled Score

PTCB

80 min

Testing Time

PTCB

72%

Processes Domain Weight

PTCB

Nov 2023

USP <795> Revised Effective

USP

The PTCB Nonsterile Compounding Certificate is an assessment-based credential for active CPhTs. The 70-question, 80-minute exam costs $89 and requires a scaled score of 300 (of 400) to pass. It covers Regulations, Standards, and Guidelines (28%) and Nonsterile Compounding Processes (72%), with heavy emphasis on USP <795> revised (effective November 2023), BUD categories, and safe handling of hazardous drugs under USP <800>.

Sample PTCB Nonsterile Compounding Practice Questions

Try these sample questions to test your PTCB Nonsterile Compounding exam readiness. Each question includes a detailed explanation. Start the interactive quiz above for the full 100+ question experience with AI tutoring.

1Which USP chapter establishes the minimum standards for nonsterile compounding in the United States?

A.USP <795>

B.USP <797>

C.USP <800>

D.USP <825>

Explanation: USP General Chapter <795> Pharmaceutical Compounding — Nonsterile Preparations sets the minimum practice and quality standards for compounded nonsterile preparations (CNSPs). USP <797> governs sterile compounding, USP <800> addresses hazardous drug handling, and USP <825> covers radiopharmaceuticals.

2The revised USP <795> that replaced the 2014 version became officially compendially applicable on which date?

A.November 1, 2023

B.December 1, 2019

C.January 1, 2024

D.June 1, 2022

Explanation: The revised USP General Chapter <795> became official and compendially applicable on November 1, 2023. This revision tightened requirements around training, facility, equipment, BUDs, and quality assurance for nonsterile compounding. Prior to that date, the 2014 version remained in effect.

3Under Section 503A of the FDCA, compounded preparations must generally be prepared:

A.Based on a valid prescription for an individually identified patient

B.For office stock without a prescription in any quantity

C.Only in FDA-registered outsourcing facilities

D.Only by manufacturers with an approved NDA

Explanation: Section 503A of the Federal Food, Drug, and Cosmetic Act exempts traditional pharmacy compounding from certain FDA requirements only when the preparation is compounded based on a valid prescription for an individually identified patient. Office-stock compounding in large quantities falls under 503B outsourcing facilities, not traditional 503A compounding.

4Which federal agency is primarily responsible for enforcing USP compounding standards when they are incorporated into state pharmacy law?

A.State Boards of Pharmacy

B.FDA only

C.DEA exclusively

D.CMS

Explanation: Although USP develops the standards and the FDA enforces 503A/503B requirements, State Boards of Pharmacy are primarily responsible for enforcing USP <795> within licensed pharmacies through their state pharmacy practice acts. DEA regulates controlled substances, and CMS oversees reimbursement.

5Which of the following is the BEST definition of compounding as distinguished from manufacturing?

A.Preparing a medication pursuant to a prescription for a specific patient based on a practitioner-patient-pharmacist relationship

B.Producing large batches of drug products for national distribution

C.Any pharmacy activity involving weighing ingredients

D.Repackaging FDA-approved products into unit doses

Explanation: Compounding involves preparing, mixing, assembling, or packaging a drug pursuant to a valid prescription order based on a practitioner-patient-pharmacist relationship. Manufacturing involves large-scale production of drug products for general distribution. The triad relationship is the defining feature of 503A compounding.

6Under USP <795>, who is ultimately responsible for ensuring the quality of compounded nonsterile preparations in a pharmacy?

A.The designated person (typically a pharmacist)

B.The pharmacy technician who compounds

C.The state Board of Pharmacy inspector

D.The patient who receives the preparation

Explanation: USP <795> requires that the pharmacy have a designated person — typically a pharmacist — who is responsible for the oversight of compounding operations, training, standard operating procedures (SOPs), and the quality of compounded nonsterile preparations. Technicians may compound under supervision, but the designated person retains overall responsibility.

7Which of the following is NOT considered nonsterile compounding under USP <795>?

A.Preparing an IV admixture from sterile ingredients

B.Mixing a topical cream for a specific patient

C.Preparing an oral suspension from commercial tablets

D.Compounding a troche for a specific patient

Explanation: Preparing an IV admixture involves sterile compounding and is governed by USP <797>, not USP <795>. Topical creams, oral suspensions, and troches are common nonsterile dosage forms that fall under USP <795> when compounded pursuant to a prescription.

8Per USP <795>, minimum personnel training for compounding personnel must be documented and demonstrated:

A.Initially and at least every 12 months thereafter

B.Only once upon hire

C.Every 3 years

D.Only when SOPs change

Explanation: USP <795> requires initial training, demonstration of competency, and reassessment at least every 12 months for compounding personnel. Training topics must include hand hygiene, garbing, calculations, documentation, cleaning, and the specific compounding procedures performed.

9A Master Formulation Record (MFR) is required under USP <795> for:

A.Any CNSP prepared for more than one patient or from a compounding formula

B.Only batch preparations of 100 or more units

C.Only sterile compounded preparations

D.Only preparations containing controlled substances

Explanation: USP <795> requires a Master Formulation Record for any CNSP prepared from a compounding formula or for more than one patient. The MFR includes the name/strength/dosage form, ingredients and quantities, equipment needed, mixing instructions, BUD, container closure, labeling, and QA procedures.

10Which of the following must ALWAYS be documented in a Compounding Record (CR)?

A.The actual ingredients used, lot numbers, expiration dates, and the person who compounded it

B.Only the final BUD

C.Only the patient's name

D.Only the date of preparation

Explanation: Per USP <795>, a Compounding Record documents what was actually done for a specific preparation: the date, assigned internal ID, specific ingredients used with their lot numbers and expiration dates, quantities measured, the personnel who prepared and checked it, the final BUD, and any in-process or final QA checks. The CR is different from the MFR, which is the recipe.

About the PTCB Nonsterile Compounding Exam

Assessment-based certificate exam for Certified Pharmacy Technicians (CPhTs) who compound nonsterile preparations. The exam validates expertise in USP <795>, compounding processes, equipment, formulations, and required documentation.

Questions

70 scored questions

Time Limit

1 hour 20 minutes

Passing Score

300 (scaled, 0-400)

Exam Fee

$89 (PTCB)

PTCB Nonsterile Compounding Exam Content Outline

28%

Regulations, Standards, and Guidelines

USP <795>, <797>, <800>, 503A/503B, NIOSH HD list, designated person, SOPs, MFR/CR, training

72%

Nonsterile Compounding Processes

Drugs/components, dosage forms, container closure, equipment, weighing/measuring, garbing/PPE, cleaning/deactivation, environmental monitoring, QA documentation

How to Pass the PTCB Nonsterile Compounding Exam

What You Need to Know

Passing score: 300 (scaled, 0-400)
Exam length: 70 questions
Time limit: 1 hour 20 minutes
Exam fee: $89

Keys to Passing

Complete 500+ practice questions
Score 80%+ consistently before scheduling
Focus on highest-weighted sections
Use our AI tutor for tough concepts

PTCB Nonsterile Compounding Study Tips from Top Performers

1USP <795> revised (effective November 2023) drives most of the exam — read it cover to cover and memorize the BUD default categories

2Domain 2 is 72% of the exam — prioritize dosage forms, equipment, techniques, and documentation

3Practice aliquot, alligation, and percent-strength calculations until they are automatic

4Know when USP <800> applies (any NIOSH HD) and the garbing/C-PEC requirements

5Review the differences between compounding (503A) and manufacturing/outsourcing (503B)

Frequently Asked Questions

What is the PTCB Nonsterile Compounding Certificate exam fee?

The application fee for the PTCB Nonsterile Compounding Assessment-Based Certificate exam is $89. This is separate from and in addition to your active CPhT certification fee. PTCB requires a current CPhT credential to be eligible.

How many questions are on the PTCB Nonsterile Compounding exam?

The exam contains 70 multiple-choice questions. You have 1 hour and 20 minutes of testing time plus a 5-minute tutorial and 5-minute post-exam survey — 1 hour 30 minutes total. Questions are computer-based and delivered through PTCB's approved test delivery provider.

What is the passing score for the Nonsterile Compounding exam?

The exam uses a scaled score from 0 to 400. You need a minimum scaled score of 300 to pass. Scaled scoring adjusts for slight differences in exam form difficulty, so the raw number of correct answers required may vary slightly between forms.

Who is eligible for the PTCB Nonsterile Compounding Certificate?

You must hold an active PTCB CPhT or CPhT-Adv credential AND satisfy one of two pathways: (1) complete a PTCB-Recognized Education/Training Program for Nonsterile Compounding, or (2) document at least 12 months of full-time pharmacy technician work experience in the past 8 years, with at least 50% of that time spent independently compounding nonsterile preparations (verified by a supervisor attestation form).

What does the exam cover?

The exam has two domains. Domain 1 (28%) covers Regulations, Standards, and Guidelines — including USP <795> (revised November 2023), USP <800> for hazardous drugs, 503A vs 503B, terminology, regulatory bodies, roles, and documentation standards (MFR, CR, SOPs). Domain 2 (72%) covers Nonsterile Compounding Processes — drugs and components, dosage forms (creams, ointments, suspensions, capsules, suppositories, troches), container closure systems, equipment and calibration, weighing and measuring, compounding techniques (geometric dilution, trituration, levigation), garb/PPE, cleaning/deactivation, environmental monitoring, and QA documentation.

What are the USP <795> default Beyond-Use Dates?

Under revised USP <795>, default BUDs by category are: aqueous nonpreserved — 14 days refrigerated; aqueous preserved — up to 35 days (refrigerated or controlled room temperature); nonaqueous (water activity <0.60) — up to 90 days; solid dosage forms with no added water — up to 180 days. Longer BUDs require documented stability data, a USP monograph, or a validated stability-indicating study.

How should I prepare for the exam?

Master USP <795> revised (2023) cover to cover — it drives the majority of exam content. Learn the BUD categories, MFR/CR requirements, and the designated person's responsibilities. Review USP <800> for hazardous drugs and containment primary engineering controls. Practice calculations (aliquot method, alligation, percent strength, dilutions). Use 100+ exam-style practice questions to identify weak areas, and aim to consistently score 80%+ before scheduling.