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PHARMASTE · POCKET GUIDE

Compounding & hazardous-drug safety

Study essentials · Version 3 · Reviewed

A focused study guide for nonsterile and sterile preparation, beyond-use date (BUD) reasoning, compatibility, hazardous-drug controls and calculations. It is not an operational SOP, a complete USP course or a compliance checklist. Public USP FAQs were read; the full subscription chapters were not accessed. Apply the current full standards, product instructions, validated facility procedures and applicable laws in practice. Original evidence checked September 28, 2026; sterile-area teaching reviewed September 29, 2026; USP <800> FAQ updated January 21, 2026.

Put it into practice

1. Match the preparation to the patient and route

  • Compounding can meet a need that an FDA-approved product cannot meet, such as a required dosage form or excipient exclusion. The compounded preparation itself is not FDA-approved.
  • USP <795> addresses nonsterile compounding; <797> addresses sterile compounding; <800> adds hazardous-drug handling protections. A preparation can be subject to both a compounding chapter and <800>.
  • Reconstituting a manufactured nonsterile product exactly as its approved labeling directs is outside <795> compounding scope. Altering it beyond the labeling may be compounding.
  • Preserved does not mean sterile. Ophthalmic products and compounded aqueous inhalation preparations require sterility. Verify route-specific ingredient suitability as well as sterility.
  • This focused bank maps to NAPLEX outline codes 1.B.1 and 1.B.2, selected 1.C calculations, and 2.D medication handling. It does not reproduce whole-exam weights or establish readiness for licensure.

Pause & recall
Does approval of the starting tablet make its compounded liquid FDA-approved?

Sources: FDA: Compounding and the FDA — Questions and Answers (FDA page accessed September 28, 2026; revision date not shown) · USP General Chapter <795> FAQs (FAQ updated November 1, 2023) · USP General Chapter <797> FAQs (FAQ updated December 11, 2023) · USP General Chapter <800> FAQs (FAQ updated January 21, 2026) · NABP NAPLEX Content Outline (effective May 1, 2025)

2. Build quality into nonsterile preparation

  • Use a supported formulation and suitable ingredients. Water included in a CNSP must meet Purified Water, USP quality or better; a distilled label alone does not establish that specification.
  • The master formulation record provides the reusable preparation instructions. The compounding record documents the actual preparation; changing only the quantity does not by itself require a new master record.
  • Protect the designated compounding space from competing activities. Evaluate powder-generating steps and use the appropriate containment. Clean and sanitize shared equipment and surfaces using a suitable procedure.
  • Check the preparation’s identity, calculations, expected appearance, uniformity, label and assigned conditions. Even an internal stock CNSP needs its applicable label. An acceptable average can conceal nonuniform portions.
  • Unexpected contamination, separation or potency variation needs investigation before release. Assess the scope, including distributed preparations when relevant, and document corrective action.

Pause & recall
Why can a normal batch-average concentration conceal a dosing problem?

Sources: USP General Chapter <795> FAQs (FAQ updated November 1, 2023) · FDA: Compounding and the FDA — Questions and Answers (FDA page accessed September 28, 2026; revision date not shown) · FDA: Insanitary Conditions at Compounding Facilities (final guidance November 2020)

3. Reason through a beyond-use date

Swipe or scroll to read the full table.

Reason through a beyond-use date
QuestionLearning point
BUD or expiration?Manufacturer expiration data apply to the original product and its conditions. A compounder assigns the BUD for the new preparation, starting when preparation begins.
What can shorten the BUD?Consider the formulation, component limits, preservation or sterility, container-closure material, storage and applicable monograph. The shortest relevant quality limit controls.
How does water activity help?For <795> categorization, a_w below 0.6 is nonaqueous; a_w at least 0.6 is aqueous. It measures available water, not merely water percentage.
One supported default exampleA nonaqueous oral liquid with a_w below 0.6 has a 90-day default ceiling in the absence of a relevant monograph or formulation-specific stability evidence; other limits may shorten it. This is not a complete BUD table.
Can nonsterile dating be extended?Where the chapter permits extension, use applicable stability-indicating evidence. Aqueous extension also needs antimicrobial effectiveness support. The FAQ describes a 180-day ceiling absent a controlling monograph; a longer study alone does not authorize more.
Does cooling restart the clock?No. CSP storage periods are not additive. Do not refrigerate a preparation at the end of one assigned BUD and append a new full refrigerated period.
BUD or infusion duration?Administration must begin before a CSP’s BUD; the BUD is not itself an infusion hang-time rule. Follow product-specific administration and infection-control requirements.

Pause & recall
What happens when the microbial limit allows four days but chemical stability supports only one day?

Sources: USP General Chapter <795> FAQs (FAQ updated November 1, 2023) · USP General Chapter <797> FAQs (FAQ updated December 11, 2023)

4. Map sterile compounding spaces and protect critical sites

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Map sterile compounding spaces and protect critical sites
Area or controlFunction and exam distinction
Anteroom (ante area)Transition for garbing and material movement. A line of demarcation separates dirty and clean sides; the clean side leads to the buffer room. In a nonhazardous Category 2/3 cleanroom suite, ISO Class 8 or better. Under <797>, the handwashing sink may be in the anteroom or in a clean space outside it; follow facility procedures.
Buffer room (cleanroom)Classified room that houses the primary engineering control (PEC) for aseptic compounding. In a nonhazardous Category 2/3 cleanroom suite, ISO Class 7 or better and positive pressure. The buffer room is not itself the ISO Class 5 work zone.
PEC (hood or isolator)The work zone that provides ISO Class 5 or better air to exposed sterile components and critical sites. Perform aseptic manipulations inside the PEC. A nonhazardous setup may use a laminar airflow workbench or compounding aseptic isolator; the exact device and placement must satisfy the category.
Segregated compounding area (SCA)A defined, unclassified area containing a PEC; only Category 1 CSPs may be prepared there. Its PEC still provides ISO Class 5 or better air. Keep the handwashing sink at least 1 meter from the PEC; an SCA is not an ISO Class 7 buffer room.
Hazardous-drug containment when requiredFor sterile HD compounding that requires full <800> containment, an externally vented, negative-pressure containment secondary engineering control (C-SEC) houses an externally vented ISO Class 5 or better containment PEC (C-PEC), such as a suitable Class II biological safety cabinet or containment isolator. A classified HD buffer room is ISO Class 7 or better.
HD segregated area and risk assessmentA containment SCA (C-SCA) permits only Category 1 HD CSPs. A conventional laminar airflow workbench or compounding aseptic isolator offers no worker containment and cannot be used for manipulated NIOSH Table 1 antineoplastics or HD active ingredients. For certain other HDs, a documented drug- and dosage-form-specific assessment of risk may support alternative controls.
  • First air reaches a critical site directly from the HEPA filter without an intervening obstruction. Arrange supplies and hands so connections and other critical sites remain protected. Do not touch product-contact surfaces.
  • Personnel qualification, hand hygiene, garbing, glove integrity, environmental controls and representative media-fill evaluation support asepsis. Investigate failures and document corrective actions; a test is only one part of the system.
  • Current <797> Categories 1, 2 and 3 are not interchangeable with the old low-, medium- and high-risk labels. Category 3 requires additional controls and testing; one passing sterility result or room classification is insufficient.
  • Use a new needle and syringe for each injection and prepare medication in a clean area. In point-of-care use, do not share a single-dose vial between patients or pool its leftovers. Read the vial’s label.
  • Check compatibility for the exact product, concentration, diluent, container and conditions. AmBisome is reconstituted with preservative-free Sterile Water for Injection and then diluted with 5% dextrose; its label warns against saline. Follow all product preparation steps.
  • Withhold unexpected particles, cloudiness or leakage for evaluation. A clear appearance cannot prove sterility, chemical stability or acceptable endotoxin levels. A Category 2 injectable made with a nonsterile component and a BUD requiring sterility testing also requires bacterial endotoxin testing.

Pause & recall
In a standard nonhazardous cleanroom suite, name the transition room, the room housing the hood, and the ISO Class 5 workspace where exposed sterile manipulations occur.

Sources: USP General Chapter <797> FAQs (FAQ updated December 11, 2023) · USP General Chapter <800> FAQs (FAQ updated January 21, 2026) · FDA: Insanitary Conditions at Compounding Facilities (final guidance November 2020) · CDC: Single-Dose or Multi-Dose — Injection Safety for Healthcare Providers (CDC publication 306089-C; issue date not shown) · AmBisome U.S. prescribing information (label revised November 2024; DailyMed updated June 11, 2025)

5. Identify the hazardous drug and the actual task

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Identify the hazardous drug and the actual task
DecisionFoundation
Keep the local list currentUse the 2024 NIOSH list and its official update notices plus new labeling and hazard information. List absence does not prove a newly introduced drug is safe to handle without assessment.
Preserve the Table 1 qualifierFor <800>, its antineoplastic-specific requirements refer to antineoplastic drugs in NIOSH Table 1. Not every 2024 Table 1 drug is antineoplastic, and some antineoplastics appear in Table 2.
Recognize activities requiring containmentAny HD API and NIOSH Table 1 antineoplastic drugs requiring manipulation must follow the chapter’s containment requirements. An assessment of risk cannot simply waive these requirements.
Recognize eligible assessment-of-risk situationsSpecified final dosage forms and other HDs may qualify for alternative containment or work practices after a documented, implemented assessment. Examples include certain intact final dosage forms and manufactured Table 2 dosage-form manipulation. Check manufacturer requirements.
Assess each drug and dosage formInclude packaging, manipulation and exposure potential. Crushing an intact tablet changes the task. Consider a clinically appropriate alternative that avoids manipulation.
Distinguish guidance from requirementsNIOSH safe-handling recommendations help develop the occupational safety plan. Apply the full USP chapters, manufacturer instructions and relevant jurisdictional requirements when implementing practice.

Pause & recall
Can one risk assessment for all drugs in a NIOSH table replace individual dosage-form assessment?

Sources: USP General Chapter <800> FAQs (FAQ updated January 21, 2026) · NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 (December 2024; publication 2025-103) · NIOSH: Managing Hazardous Drug Exposures — Information for Healthcare Settings (April 2023; publication 2023-130) · NIOSH 2024 hazardous-drug list — publication and updates page (publication page July 25, 2025; additions notice July 17, 2025)

6. Combine containment, PPE and response planning

  • Use engineering controls, work practices and PPE together. A CSTD is supplemental; it does not turn a counter into a sterile containment environment. Confirm device compatibility with the drug.
  • Required containment must protect workers and the environment while the sterile process protects the preparation. When full <800> containment applies, the room has negative pressure to limit outward HD spread; a nonhazardous cleanroom suite has a positive-pressure buffer room. A conventional laminar-airflow workbench does not provide worker containment.
  • For HD compounding, select chemotherapy gloves tested to ASTM D6978 and a protective disposable gown with appropriate permeation data. Use two pairs of gloves, a sterile outer pair for sterile work, and the applicable head, hair and shoe coverings. Follow the complete garbing and doffing procedure.
  • An N95 filters particles; it does not remove gases or vapors. A loose surgical mask is not respiratory protection. Select respiratory and splash protection through the task assessment and respiratory-protection program.
  • Deactivation inactivates the drug; decontamination removes drug residue; disinfection controls microorganisms. Surface wipe sampling can help evaluate containment and cleaning but does not measure an individual’s absorbed dose.
  • Restrict access after a spill and activate trained responders with suitable supplies, PPE and disposal procedures. Assess possible exposure and arrange the indicated follow-up. Avoid spreading contamination on clothing, equipment or waste.

Pause & recall
Why does disinfecting a surface not demonstrate that hazardous-drug residue is gone?

Sources: USP General Chapter <800> FAQs (FAQ updated January 21, 2026) · NIOSH: Managing Hazardous Drug Exposures — Information for Healthcare Settings (April 2023; publication 2023-130)

7. Calculate ingredients and final delivery separately

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Calculate ingredients and final delivery separately
Supplied exercise dataCalculationCheck
150 mL at 12 mg/mL; suitable 300-mg tablets150 × 12 = 1,800 mg; 1,800 ÷ 300 = 6 tabletsUse the verified formulation; make to 150 mL final.
80 g at 2.5% w/w80 × 0.025 = 2.0 g active ingredientBase makes the total 80 g, not an additional 80 g.
120 mL at 4 mg/mL; stock 20 mg/mL120 × 4 ÷ 20 = 24 mL stockAdd compatible vehicle to the final volume.
750 mg; stock 50 mg/mL750 ÷ 50 = 15 mL stockStock volume is not infusion volume.
40 mEq in 500 mL final40 ÷ 0.5 = 80 mEq/LConvert mL to L; clinical suitability is separate.
180 mL over 90 minutes90 ÷ 60 = 1.5 h; 180 ÷ 1.5 = 120 mL/hUse the actual final volume and verified duration.

Pause & recall
When is the calculated volume the stock to withdraw rather than the final volume?

Sources: NABP NAPLEX Content Outline (effective May 1, 2025)

Abbreviations

API
active pharmaceutical ingredient
BUD
beyond-use date
CNSP
compounded nonsterile preparation
CSP
compounded sterile preparation
HD
hazardous drug
CSTD
closed-system drug-transfer device
HEPA
high-efficiency particulate air
PPE
personal protective equipment
SOP
standard operating procedure
a_w
water activity
NIOSH
National Institute for Occupational Safety and Health
ASTM
ASTM International, a standards organization
PEC
primary engineering control: ISO Class 5 or better work zone
SCA
segregated compounding area
C-PEC
containment primary engineering control
C-SEC
containment secondary engineering control
C-SCA
containment segregated compounding area

Sources & verification

Guide reviewed . Source checks are dated below. These selected teaching points use the guidance and product references below. Confirm current labeling, the patient's circumstances, and local protocols before applying a regimen.

  1. FDA: Compounding and the FDA — Questions and Answers (FDA page accessed September 28, 2026; revision date not shown) — Why patients need compounded drugs; approval status; quality risks · Checked https://www.fda.gov/drugs/human-drug-compounding/compounding-and-fda-questions-and-answers
  2. USP General Chapter <795> FAQs (FAQ updated November 1, 2023) — FAQs 3, 8, 10, 19, 23–34, 38–43, 48–57 and 60–66: scope, controls, records, quality and BUD reasoning · Checked https://pages.usp.org/rs/711-SXF-172/images/HQS%20-%20USP%20GC%20795%20FAQs.pdf?version=0
  3. USP General Chapter <797> FAQs (FAQ updated December 11, 2023) — FAQs 31, 50–65, 82, 84–98, 103, 157, 163–175: category/location, ante and buffer rooms, PECs, competency, inspection, endotoxins and BUD reasoning · Checked https://pages.usp.org/rs/711-SXF-172/images/USP_HQS_797_FAQs_December2023_V6__002.pdf?version=0
  4. USP General Chapter <800> FAQs (FAQ updated January 21, 2026) — FAQs 5, 11–16, 29–39, 48–64: C-SCA limits, required versus risk-assessed containment, negative-pressure room, C-PEC, PPE and handling · Checked https://pages.usp.org/rs/711-SXF-172/images/USP_HQS_800_FAQs_January2026.pdf?version=0
  5. NABP NAPLEX Content Outline (effective May 1, 2025) — Domains 1 and 2: 1.B.1, 1.B.2, 1.C.3, 1.C.5, 1.C.6 and 2.D; editorial mapping only · Checked https://nabp.pharmacy/wp-content/uploads/NAPLEX-Content-Outline.pdf
  6. FDA: Insanitary Conditions at Compounding Facilities (final guidance November 2020) — Final guidance III.A–B: contamination, first air, gloves, critical sites and corrective actions · Checked https://www.fda.gov/media/124948/download
  7. CDC: Single-Dose or Multi-Dose — Injection Safety for Healthcare Providers (CDC publication 306089-C; issue date not shown) — Vial labels; single-patient single-dose use; new needle and syringe; clean preparation area · Checked https://www.cdc.gov/injection-safety/media/pdfs/Injection-Safety-For-Healthcare-P.pdf
  8. AmBisome U.S. prescribing information (label revised November 2024; DailyMed updated June 11, 2025) — Directions for Reconstitution, Filtration and Dilution; Storage of AmBisome · Checked https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f7be6506-4d20-401e-a0ff-02ad7c33158a
  9. NIOSH List of Hazardous Drugs in Healthcare Settings, 2024 (December 2024; publication 2025-103) — Determining whether a drug is hazardous; developing a facility-specific list; site-specific risk assessment · Checked https://www.cdc.gov/niosh/docs/2025-103/pdfs/2025-103.pdf
  10. NIOSH: Managing Hazardous Drug Exposures — Information for Healthcare Settings (April 2023; publication 2023-130) — Chapters 3–8: risk assessment, engineering controls, PPE, surface contamination, spill and waste control · Checked https://stacks.cdc.gov/view/cdc/127519/cdc_127519_DS1.pdf
  11. NIOSH 2024 hazardous-drug list — publication and updates page (publication page July 25, 2025; additions notice July 17, 2025) — Current list access and July 17, 2025 additions notice; check future updates with the facility assessment · Checked https://www.cdc.gov/niosh/publications/hcp/numbered/2025-103.html

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