Free PTCB Hazardous Drug Management Exam Flashcards

Consider elimination, substitution, engineering controls, administrative controls, and PPE, in that order of preference. Patient treatment needs can limit elimination or substitution. Ventilated containment controls exposure at its source; procedures and training govern safe work; PPE adds a final barrier. Work practices belong within the overall program, not a reason to replace required engineering controls.

A containment primary engineering control provides personnel/environmental containment and ISO Class 5 air for sterile compounding, for example an appropriately installed BSC or CACI. A horizontal LAFW protects the preparation but directs air toward the worker. It cannot replace containment for HD APIs or NIOSH Table 1 antineoplastics. Other eligible HDs require a documented assessment of risk before alternative controls are used.

A Class II Type A2 cabinet recirculates part of its air; for sterile HD work its exhaust must be routed outdoors appropriately. A Type B2 cabinet exhausts all its air externally and is commonly selected for volatile components. HEPA filters capture particles, not chemical vapors. Select and certify the whole cabinet–ventilation system for the actual drug and task; B2 is not a universal requirement for every HD.

A compounding aseptic containment isolator (CACI) is designed to protect personnel and the sterile preparation during material transfer and compounding. A conventional CAI lacks equivalent HD containment. Sterile HD C-PECs require external exhaust and an appropriate C-SEC; an isolator is not an exemption from room controls. Sterile compounding certification is required at least every 6 months and after changes that can affect performance, such as relocation or major service.

The containment secondary engineering control is the room around the C-PEC. It has fixed walls, external exhaust, appropriate air exchange, and negative pressure of 0.01–0.03 inches water column relative to adjacent areas. Maintain required pressure and airflow even when not in use. Use pressure monitoring and documented checks; the room type determines the applicable air-change requirement.

A sterile HD cleanroom buffer room is ISO Class 7, externally vented, negative to adjacent spaces, and generally requires at least 30 air changes per hour. The anteroom leading to that negative-pressure room is also ISO Class 7; its pressure relationship prevents entry of unclassified air. Do not apply the 12 ACPH C-SCA/nonsterile-room minimum to this ISO 7 buffer-room design.

A containment segregated compounding area is an unclassified, fixed-wall, externally vented negative-pressure room with at least 12 ACPH and an appropriate sterile C-PEC. Under current USP guidance, only Category 1 HD CSPs may be prepared there. Category 1 BUD ceilings are 12 hours at controlled room temperature or 24 hours refrigerated; stability or other constraints can require less. Old low/medium-risk labels are not the current classification.

Use a personnel/environment-protective C-PEC, such as a CVE or suitable BSC. It must exhaust externally (preferred) or have separately testable redundant HEPA filters in series. Place it in an externally vented, fixed-wall negative-pressure C-SEC with at least 12 ACPH. These are full-containment requirements; an authorized assessment of risk may support alternatives for eligible other HDs, but not an exemption for HD APIs.

Stop compounding and secure affected work according to the emergency SOP. Do not resume merely because the blower restarts. Confirm restored performance, required deactivation/decontamination/cleaning and sterile-area disinfection, and the manufacturer’s recovery time; assess affected preparations. Keep required ventilation operating during normal use. Maintenance or repair may require recertification before release to service.

A closed-system drug-transfer device limits escape of drug and entry of environmental contaminants. It supplements rather than replaces the C-PEC. USP recommends it for compounding. For administration, it is required for NIOSH Table 1 antineoplastic HDs when the dosage form allows. In either case, the device must be physically and chemically compatible with the specific drug.

Wipe sampling is recommended, not a universal USP 800 mandate; baseline and periodic sampling can assess containment. There is no established universally acceptable HD surface-contamination limit. If residue is detected, identify, document, and contain its cause; reassess practices, training, cleaning, and engineering controls, then resample to check effectiveness. A negative result for one marker does not prove every drug or surface is clean.

The toxicity criteria include carcinogenicity, developmental toxicity, reproductive toxicity, genotoxicity, organ toxicity at low doses, and similarity to an existing HD’s structure/toxicity. The current definition also recognizes manufacturer special-handling information. NIOSH’s list evaluation concerns FDA CDER-approved human drugs, excluding drugs otherwise regulated by the Nuclear Regulatory Commission; relevant human drugs may also be used in veterinary care.

Table 1 includes drugs with manufacturer special-handling information and/or the specified carcinogen classifications: NTP known human carcinogens or IARC Group 1/2A. Table 2 contains other drugs meeting the NIOSH definition. These are not simply antineoplastic versus non-antineoplastic groups. For USP 800’s specific antineoplastic rules, identify antineoplastic drugs within Table 1. Consult current NIOSH updates and product labeling, not a frozen table alone.

Review and document the facility list at least every 12 months, and evaluate a newly introduced agent or dosage form before handling it. Use the current NIOSH list, subsequent updates, manufacturer handling information, and the facility’s actual inventory. The published list is not exhaustive for every newly marketed drug; absence alone does not establish safety.

Full chapter containment applies to HD APIs and NIOSH Table 1 antineoplastics requiring manipulation beyond counting/repackaging. Eligible final dosage forms and other HDs may be evaluated individually by drug and dosage form. Document hazard, exposure potential, packaging, manipulation, and the chosen alternative controls/work practices; review at least annually. Table 2 membership is not a declaration of safety, and manufacturer requirements still apply.

The facility assigns one or more people responsibility for implementing its HD program, overseeing compliance, personnel competency, and environmental controls. They must understand the standards and applicable rules; USP 800 does not set a universal training-hour minimum or require the role to be held by a pharmacist. Delegation and accountability must be clear in the SOPs.

Train personnel for their assigned activities and document competency before independent HD handling. Reassess at least every 12 months and update training when drugs, equipment, procedures, or hazards change. Training must include exposure prevention and response, not only exam knowledge. Separate sterile-compounding competency requirements can impose additional intervals and demonstrations.

USP 800 recommends medical surveillance; it does not itself require a universal program. A program can include baseline health/exposure history, appropriate occupational-health evaluation, follow-up, and assessment after incidents. Medical professionals determine examinations and tests. Explain reproductive risks and establish a process for requesting protective reassignment; do not prescribe one laboratory panel or imply confidentiality can be ignored.

For covered hazardous chemicals, OSHA HazCom requires a written program, appropriate labeling, training, and readily accessible SDS information during each work shift. Applicability has specific exemptions, so not every intact final-use drug package has identical duties. SDS sections 4, 6, and 8 address first aid, accidental release, and exposure controls/PPE. Use the actual product SDS and facility response plan.

Under 29 CFR 1910.1020, covered medical records generally remain for employment plus 30 years, and exposure records for at least 30 years, unless a specific standard or exception applies. Certain separately kept minor first-aid records are excepted. SDS originals need not be kept for 30 years if the required chemical identity, use location, and use dates are preserved. Do not apply one retention rule to every document.

NIOSH identifies occupational drug hazards; RCRA classification concerns waste and depends on listed-waste criteria or hazardous characteristics. A drug’s HD status does not automatically make every discarded item RCRA hazardous waste. Determine the actual waste classification and applicable state rules. Healthcare facilities covered by the federal prohibition must not sewer hazardous waste pharmaceuticals; a drain is not a disposal shortcut.

The chapter became official December 1, 2019 and compendially applicable to the extent 795/797 apply on November 1, 2023. USP develops standards; enforcement depends on the relevant regulator, jurisdiction, and accreditation requirements. OSHA obligations can apply separately. Do not present one date as the date every state adopted all provisions or limit HD safety to pharmacists.

Deactivation reduces the drug’s hazardous activity. Decontamination removes HD residue. Cleaning removes organic/inorganic material. Disinfection addresses microorganisms and follows cleaning in sterile compounding areas. Use agents and methods appropriate to the drug, surface, and equipment. One product may perform more than one function, but no generic four-word sequence proves a surface is safe.

Alcohol used for microbial disinfection does not establish that the HD has been deactivated or removed; it may spread residue. Check drug labeling for an appropriate deactivator; USP’s FAQ recommends an EPA-registered oxidizer when none is specified. Follow validated product instructions, compatibility and rinsing requirements. No single agent reliably neutralizes every HD, and cleaning chemicals must not be mixed casually.

Soil and residue can interfere with disinfectant contact and effectiveness. Remove HD contamination and other soil using the approved process, then apply the appropriate sterile-area disinfectant for its required contact time. Disinfection is not chemical deactivation, and chemical decontamination is not sterilization. Follow the applicable 797 schedule and equipment/product instructions.

The SOP must address routine deactivation, decontamination and cleaning, sterile-area disinfection, spills, service/certification, and airflow interruptions. Include the area beneath a removable work tray; OSHA’s HD guidance describes at least monthly cleaning there. Apply current 797 frequencies to sterile work rather than assuming one interval covers every surface, task, and CSP category.

Treat the underside and trough as potentially contaminated. Use the trained SOP, chemotherapy gloves, protective gown, and eye/face and respiratory protection selected for the exposure. Keep the blower operating when the procedure permits and maintain the safe sash position. Do not assume any PAPR protects against vapors; filters/cartridges must match the hazard. Classify contaminated waste correctly rather than relying only on bin color.

Keep kits accessible where a release could occur. Include warning signs, appropriate chemotherapy gloves/gown, eye protection, absorbent materials, tools for broken glass, and suitable labeled waste containers; provide the selected respirator through the respiratory-protection program. Define training, spill-size limits, and escalation. An N95 does not remove vapors, and a yellow bag is not universal authorization for disposal.

Alert others, isolate the area, and attend immediately to exposed people using the SDS and emergency plan. Only trained, appropriately protected staff should clean a spill within their response capability; escalate larger or uncontrolled releases. Contain liquid without spreading it, collect glass with tools, perform the approved decontamination/cleaning, and document exposure and disposal. Do not treat every spill as safe for an untrained employee to handle.

Under 40 CFR 266.507, eligible stock/dispensing bottles, vials or ampules up to 1 liter or 10,000 pills, and unit-dose containers can be empty after normal removal of their contents. A syringe can be empty when its plunger is fully depressed. IV bags and other containers have their own rules. Do not substitute a universal 3%-by-volume test, routine triple rinsing, or yellow/black color for the actual legal classification.

A final dosage form may be dispensed without further containment when no additional manipulation is required, unless the manufacturer requires it or visible leakage/dust indicates an exposure hazard. For counting, repackaging, or other eligible activities, implement the facility’s documented assessment of risk and SOP. “Final dosage form” does not mean every product is safe to crush or open on a counter.

NIOSH Table 1 antineoplastic tablets and capsules must not be placed in automated counting or packaging machines. Machine stress may generate powdered contamination; this rationale does not create a low-stress-machine exception. For tablets/capsules of HDs that are not Table 1 antineoplastics, a facility assessment of risk may permit machine use. Follow the drug-specific equipment, cleaning and exposure-control SOP; this is not a blanket exemption.

Use dedicated suitable counting equipment and follow the facility’s drug/dosage-form SOP for gloves and containment. Avoid unnecessary abrasion and inspect for damaged product or dust. Decontaminate equipment according to the approved process before subsequent use; an alcohol wipe alone does not establish drug removal. Keep HD equipment separate from non-HD counting to prevent cross-contamination.

Manipulation beyond counting/repackaging requires the chapter’s full containment: an appropriate C-PEC within the required C-SEC and task-specific PPE. Prefer a suitable commercially available final form when clinically appropriate. An enclosure or crushing pouch alone is not a replacement for required engineering controls. Verify product suitability and pharmacist authorization before changing a dosage form.

Keeping intact doses in manufacturer packaging can reduce open counting and handling. It does not erase hazard labels or manufacturer instructions. Repackaging must follow the applicable assessment of risk and SOP, and Table 1 antineoplastic tablets/capsules must not use prohibited automated equipment. Do not assume all packaging machines cause volatilization or that every package is approved for every drug.

Clearly identify required HD handling precautions during transport and provide product-specific storage, administration, caregiver protection, and disposal advice through the responsible professional. Avoid crushing or opening a product unless specifically authorized. Unused medicines should follow the product and local disposal/take-back instructions; not every take-back site accepts every product. Occupational waste rules should not be presented as identical household rules.

795 addresses nonsterile preparation quality, 797 sterile preparation quality, and 800 hazardous-drug exposure controls. A hazardous preparation can require both the relevant compounding chapter and 800. Category 1/2/3 in 797 concerns sterile preparation conditions and BUDs, not the NIOSH hazard table. Check both microbial quality and worker/environmental containment rather than using one to excuse the other.

Use secure Luer-lock connections and an appropriate syringe size; OSHA guidance recommends the dose occupy no more than three-fourths of the syringe. Avoid pressurizing vials and follow compatible device instructions. Prime administration tubing with a compatible non-HD solution using the approved containment/CSTD process. These practices supplement engineering controls and aseptic technique; they do not establish zero exposure.

It is a test practice for resistance to chemotherapy-drug permeation. Select powder-free gloves tested to the standard and consult the manufacturer’s drug-specific results and change instructions. A generic examination glove label is not equivalent. A passing test does not make a glove impermeable to every HD for an unlimited time; inspect and replace damaged or contaminated gloves promptly.

For HD compounding, place the inner glove under the gown cuff and the outer glove over it. NIOSH describes 30 minutes as a generally accepted maximum, subject to manufacturer information and the facility assessment. Replace sooner after damage or suspected contamination. Sterile work also requires the applicable sterile outer-glove and aseptic practices; a time interval never overrides evidence of failure.

Use a disposable gown shown to resist the relevant HDs, with a closed front, back closure, long sleeves and close-fitting cuffs. An ordinary cloth coat is not equivalent. Follow manufacturer permeation data; the USP 800 gown provision uses a 2–3-hour change interval if that information is unavailable. Replace immediately after a spill/splash and do not rewear disposable PPE. Time alone cannot establish that a contaminated gown is safe.

A surgical mask is not a respirator. A fit-tested N95 filters appropriate particles but not gases or vapors. A PAPR or elastomeric respirator is protective only with the correct approved filters/cartridges and operating conditions. OSHA requires a respiratory-protection program, medical evaluation, training and applicable fit testing. Uncontrolled, unknown or excessive exposures require escalation rather than assuming a cartridge respirator is sufficient.

Use appropriate chemical splash goggles and face protection when the task can splash outside containment; ordinary spectacles or a face shield alone are not equivalent to goggles. Ensure suitable emergency eyewash access and follow the SDS and emergency plan immediately after exposure. Eyewash requirements concern actual unobstructed access and performance, not a universal 55-foot permission to place it farther away.

The outer pair limits tracking of HD residue out of the C-SEC. Don and remove covers in the designated areas under the facility’s garbing/doffing procedure; remove the outer pair before leaving the negative-pressure room. Head/hair covers, gowns, and two pairs of chemotherapy gloves are also part of the full HD-compounding PPE requirements; shoe covers alone do not provide containment.

Remove the outer sterile HD gloves inside the C-PEC. Remove the HD gown and outer shoe covers in the designated doffing area before leaving the negative-pressure room. Remaining garb is handled according to the room arrangement and SOP. Dispose in the appropriate waste stream and wash hands with soap and water after glove removal. Avoid transferring contaminated surfaces to skin, handles, or clean equipment.

Use a designated neutral- or negative-pressure area, not a positive-pressure or sterile-compounding area. The receiving space need not be a separate room. At least one pair of ASTM D6978-tested gloves is specified when unpacking Table 1 antineoplastics; the SOP determines other PPE based on drug, packaging condition and task. Train receiving staff and keep spill resources accessible.

Stop routine unpacking, isolate the package, notify the responsible person, and follow the tiered receiving/spill SOP. Contain it without unnecessary handling; return or dispose through an authorized process. Opening or salvaging contents requires an appropriate controlled location and trained staff with exposure-matched PPE. Do not automatically put a leaking carton into any available cabinet or declare every returned package RCRA waste.

NIOSH Table 1 antineoplastics needing manipulation beyond counting/repackaging, and HD APIs, require separate storage that prevents exposure in an externally vented negative-pressure room with at least 12 ACPH. Refrigerated Table 1 antineoplastics require a dedicated HD refrigerator in a negative-pressure area with at least 12 ACPH. Other eligible drugs may have alternatives under facility policy/assessment of risk; secure containers against breakage.

USP 800 prohibits pneumatic-tube transport of any liquid HD and any NIOSH Table 1 antineoplastic HD because breakage can contaminate the system. Use packaging that maintains integrity and minimizes leakage or breakage, with required handling identification and trained transport staff. Other transport methods still need a facility assessment and SOP; absence of this specific prohibition is not blanket approval.

No. Occupational HD status, DOT transport classification, and RCRA hazardous-waste status are different determinations. External shipments need appropriate packaging, labeling, stability controls and carrier compliance. Apply DOT hazardous-material requirements when the shipment meets their criteria, and waste manifest requirements when applicable to the waste. Consult trained shipping/waste personnel rather than assigning a classification from the NIOSH label alone.

The pad can obstruct the airflow needed for containment, even when the blower is running. Keep front and rear grilles clear, avoid crowding the work chamber, and arrange only necessary supplies according to the cabinet’s instructions. An absorbent pad controls small drips; it cannot compensate for disrupted protective airflow.

Address the person’s exposure immediately: remove contaminated clothing or PPE carefully, wash affected skin with soap and water, and obtain medical attention under the exposure protocol. Report and document the incident. Follow the product SDS; surface deactivators such as bleach are not skin treatments. Do not postpone first aid until the spill is cleaned.

Dry sweeping can spread contaminated dust. Use the approved wet-wiping method and dedicated equipment, progressing from less contaminated toward more contaminated areas without carrying dirty wipes into clean areas. Contain used wipes and liquids in the appropriate waste stream. Drug- and surface-compatible agents still matter; moving residue is not proof of deactivation.

No. Stop using the cabinet and notify the responsible person. OSHA’s HD guidance calls for decontamination and filter replacement when liquid reaches the HEPA filter or powder contaminates its clean side. Trained service personnel must manage the contaminated filter, with performance verification before return to use. A clean-looking tray does not resolve internal contamination.

No. Needleless design reduces needlestick risk but does not by itself establish containment of drug or vapor. Select the required compatible CSTD and secure connections using device instructions. Do not replace a required CSTD with an ordinary needleless connector merely because both avoid a needle; each addresses a different exposure pathway.

Residual drug can remain in the bag and tubing. Keeping the set intact avoids opening additional connections that can leak or release droplets. Follow the facility’s HD disposal procedure without disconnecting tubing just to sort the pieces or clipping contaminated sharps. Any required separation must be handled through the approved device-specific procedure by trained personnel.

Use the designated oral syringe and clear route labeling, not an IV syringe with a compatible Luer tip. The oral device’s different connector helps prevent accidental IV administration. Keep oral devices separate from injection devices and confirm the prescribed route. Follow the product’s HD handling and disposal instructions as well; connector design does not remove exposure hazards.

It catches small leaks or droplets and protects the underlying surface when positioned according to the administration procedure. It does not seal the connection, deactivate the drug, or replace a required CSTD. Replace contaminated pads using the approved handling and waste procedure; a saturated pad can become a source of contamination.

Inspect the infusion set, pump and connections for leakage during use; normal pump operation does not prove the system is leak-free. If leakage is found, alert the administering professional and use the facility’s patient-care and exposure-response procedure. Do not continue simply because the pump has not alarmed or attempt an unapproved repair.

No. A required tight-fitting respirator needs fit testing before initial use, when its facepiece changes, and at least annually; relevant physical changes can require another test. Perform a user seal check every time it is donned. Facial hair or other PPE must not interfere with the seal. A seal check is not a substitute for the formal fit test either.

No. Reusable eye protection and compatible respirator components need the manufacturer-approved decontamination and cleaning procedure. Filters and cartridges are not treated as washable facepieces; replace or discard them according to the respiratory-protection program and manufacturer instructions. Keep contaminated items out of clean storage until correctly processed. Disposable HD PPE must not be reprocessed for reuse.

The bag becomes a surface handled by transport and receiving staff. Contaminating its exterior defeats that barrier even if the closure is sound. Surface-decontaminate the finished preparation and package it using the approved clean transfer or isolator pass-through procedure. Keep unused transport bags out of the work chamber during compounding and preserve required sterility.

No. Packaging must also maintain the drug’s specified temperature, stability and any required sterility for the expected journey. Select insulation and other shipping materials using product and vendor information and the transport mode. If those conditions cannot be assured, consult the responsible pharmacist before dispatch; do not invent a universal temperature or allowable excursion.

Secure doses in suitable sealed, identified containers and use a cart with protection against packages falling or breaking. Confirm that the trained transporter has immediate access to spill supplies and knows the response procedure. A cart is a transport method, not containment by itself; do not leave loose doses on an unprotected shelf.