Free Nonsterile Compounding Certificate Exam Practice Questions

Sample Practice Questions

Try these 10 sample questions from the Nonsterile Compounding Certificate Exam practice bank. Each includes the answer and explanation. Continue with the interactive practice above to review the full question set.

1. 1A technician reconstitutes a drug using a diluent and concentration that differ from the manufacturer's labeling. Which term describes this activity under USP <795>?

   1. A. Repackaging
   2. B. Nonsterile compounding
   3. C. Dispensing
   4. D. Administration

   Answer: B

   Explanation: USP <795> includes "reconstituting other than as provided in the manufacturer’s labeling" in its definition of nonsterile compounding. The changed diluent and concentration place this preparation within that definition.

   Reference: USP <795> Pharmaceutical Compounding—Nonsterile Preparations — Section 1, Introduction and Scope

2. 2A technician selects a bulk drug substance for a human CNSP intended to meet section 503A conditions. Which manufacturing-establishment status is required for that bulk substance?

   1. A. FDA establishment registration under section 510
   2. B. PCAB accreditation for compounding pharmacies
   3. C. State board of pharmacy facility licensure
   4. D. DEA registration for controlled substances

   Answer: A

   Explanation: FDA requires bulk substances to be "manufactured by an establishment that is registered under section 510 of the FD&C Act". Pharmacy licensure, PCAB accreditation, and DEA registration are real but distinct statuses; they do not substitute for this bulk-substance manufacturing-establishment registration.

   Reference: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Section III.A, condition 4, page 4

3. 3During nonsterile compounding, a technician identifies conditions under which a preparation may have become contaminated with filth. Actual contamination has not been demonstrated. What is the drug's classification under section 501(a)(2)(A)?

   1. A. Misbranded
   2. B. Counterfeit
   3. C. Adulterated
   4. D. Recalled

   Answer: C

   Explanation: FDA explains: "The drug itself need not actually be contaminated." Insanitary preparation conditions are sufficient for the adulterated classification under section 501(a)(2)(A); proof of contamination is unnecessary.

   Reference: Insanitary Conditions at Compounding Facilities: Guidance for Industry — Section I, Introduction, footnote 2, page 1

4. 4A human nonsterile preparation is to meet section 503A conditions. An applicable USP monograph exists for its bulk drug substance. Which quality standard must the technician use when checking the substance's suitability?

   1. A. The supplier's report of analysis
   2. B. The applicable USP or NF monograph
   3. C. The chemical's safety data sheet
   4. D. The preparation's master formulation

   Answer: B

   Explanation: FDA requires bulk substances "that comply with the standards of an applicable USP or National Formulary (NF) monograph, if one exists." The monograph sets the applicable compendial quality standards. A report of analysis supplies results, an SDS supplies hazard information, and a master formulation specifies preparation instructions.

   Reference: Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act — Section III.A, condition 3, page 3

5. 5A technician reads a sentence in an FDA compounding guidance document that uses should and cites no statutory or regulatory requirement. How should that word be interpreted?

   1. A. The action is suggested or recommended.
   2. B. The action is specifically prohibited.
   3. C. The action is legally mandatory.
   4. D. The action is formally exempted.

   Answer: A

   Explanation: FDA states: "The use of the word should in Agency guidances means that something is suggested or recommended, but not required." With no cited mandatory provision, the technician should interpret this as a recommendation.

   Reference: Insanitary Conditions at Compounding Facilities: Guidance for Industry — Section I, Introduction, page 2

6. 6An outsourcing facility has validated the reliability of a component supplier's analyses and plans to rely on its report for purity, strength, and quality. Which test must the facility still conduct on the component under 21 CFR 211.84(d)(2)?

   1. A. A specific sterility test
   2. B. A specific dissolution test
   3. C. A specific identity test
   4. D. A specific disintegration test

   Answer: C

   Explanation: The supplier-report alternative requires "at least one specific identity test" on the component by the manufacturer. Sterility, dissolution, and disintegration tests do not substitute for the required component identity verification.

   Reference: 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.84(d)(2)

7. 7At a CGMP-regulated facility, a technician uses a processing ingredient intended for drug production even though it will be removed before the finished preparation is obtained. Which regulatory term includes this ingredient?

   1. A. Drug product
   2. B. In-process material
   3. C. Representative sample
   4. D. Component

   Answer: D

   Explanation: 21 CFR 210.3 defines component as "any ingredient intended for use in the manufacture of a drug product, including those that may not appear in such drug product." Removal before completion does not prevent the ingredient from being a component.

   Reference: 21 CFR 210.3 — Definitions — 21 CFR 210.3(b)(3)

8. 8An approved ingredient lot at an outsourcing facility has experienced heat exposure that may have affected its quality. Which process must precede a new quality-unit approval or rejection decision under 21 CFR 211.87?

   1. A. Retesting or reexamination
   2. B. Label reconciliation
   3. C. Stock rotation
   4. D. Repackaging

   Answer: A

   Explanation: 21 CFR 211.87 requires affected components to be "retested or reexamined, as appropriate" before quality-unit approval or rejection. Reconciliation, rotation, and repackaging are real material-handling operations, but they do not re-establish the heat-exposed lot's identity, strength, quality, and purity.

   Reference: 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.87

9. 9While reviewing package information for a drug used in nonsterile compounding, a technician is screening for manufacturer's special handling information (MSHI) as defined by NIOSH. Which instruction meets that description?

   1. A. Follow specified special handling and disposal procedures.
   2. B. Keep the preparation within its specified temperature range.
   3. C. Keep the preparation within its specified protective package.
   4. D. Transport the preparation within its specified cold chain.

   Answer: A

   Explanation: NIOSH explains that "MSHI includes language that informs those handling the drug of the need to follow heightened handling and disposal procedures." It specifically excludes packaging and temperature-control language from MSHI. The special handling and disposal instruction meets the definition.

   Reference: Managing Hazardous Drug Exposures: Information for Healthcare Settings — Executive Summary, footnote 5, page iv

10. 10A technician at a CGMP-regulated facility has four lots of the same component. All were approved when received, remain suitable, and have no reason for a temporary rotation deviation. Which lot should be selected first?

    1. A. The lot received January 22
    2. B. The lot received January 15
    3. C. The lot received January 8
    4. D. The lot received January 1

    Answer: D

    Explanation: 21 CFR 211.86 requires rotation "so that the oldest approved stock is used first." With equal suitability and no applicable deviation, the January 1 lot is the oldest approved stock.

    Reference: 21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals — 21 CFR 211.86