USP <795>, <797>, <800> in Compounding

What does USP

Non-sterile compounding.

What is a simple non-sterile compound?

Requires a formula/recipe with established stability.

What is a moderate non-sterile compound?

Requires special calculations or procedures.

What is a complex non-sterile compound?

Requires special training, equipment, or environment.

What is the beyond-use date (BUD) for non-aqueous formulations?

6 months (or earliest API expiration).

What is the BUD for water-containing oral formulations?

14 days refrigerated.

What is the BUD for water-containing topical/dermal formulations?

30 days.

What is trituration?

Grinding into a fine powder.

What is levigation?

Reducing particle size with a liquid.

What is geometric dilution?

Mixing powders of unequal amounts proportionally.

What are common levigating agents for oil-based products?

Mineral oil.

What is a common levigating agent for aqueous systems?

Glycerin or propylene glycol.

What is the ointment composition of oil and water?

80% oil, 20% water.

What is the cream composition of oil and water?

~50/50.

What is the lotion composition of water?

Mostly water.

What is a wetting agent?

Helps powders disperse in liquids.

What is a surfactant?

Lowers surface tension between phases.

What is an emulsifier?

Stabilizes oil + water mixtures.

What is an example of anionic surfactant?

Sodium lauryl sulfate.

What is an example of nonionic surfactant?

Polysorbate (Tween).

What is the base of capsules made of?

Gelatin (animal) or HPMC (veg).

What is a eutectic mixture?

Two solids form liquid when mixed.

Which compounding tool avoids cross-contamination?

Ointment slabs/parchment paper.

What is a glidant?

Improves powder flow (e.g., magnesium stearate).

What must be included in a compounding record?

Ingredients, lot numbers, quantities, date, preparer, pharmacist signature.

What must a master formulation record contain?

Recipe, ingredients, instructions, calculations, quality checks.

What is the minimum PPE for non-sterile compounding?

Gloves + lab coat.

What is the requirement for a non-sterile compounding area?

Dedicated area; separate from dispensing.

Where must hazardous non-sterile compounding be done?

In a C-PEC (containment hood) under negative pressure.

What is the function of a balance?

Accurate measurement of solid ingredients.

What is the minimum weighable quantity for a Class III torsion balance?

120 mg.

What is the calibration requirement for balances?

Checked daily and documented.

What are plasticizers used for in compounding?

Make capsules/ointments smooth (e.g., glycerin).

What is heat of solution?

Heat change when solute dissolves.

When do you refrigerate compounded products?

When stability requires; follow BUD guidelines.

What is a suspending agent?

Keeps particles dispersed (e.g., Ora-Plus).

What should be avoided when compounding with volatile APIs?

High temperatures.

What must be on a compounded product label?

BUD, storage, ingredients, concentration, warnings.

What documentation is required for cleaning equipment?

Cleaning logs.

What does 'QS' mean in compounding?

Quantity Sufficient (to final volume).

What does USP

Sterile compounding.

What is the primary engineering control (PEC)?

Laminar airflow hood / biological safety cabinet.

What type of airflow does PEC use?

HEPA-filtered ISO 5 air.

What is the ISO classification for a buffer room?

ISO 7.

What is the ISO classification for an ante-room?

ISO 8 (non-Haz), ISO 7 (Haz).

What is the BUD for low-risk CSP at room temperature?

48 hours.

What is the BUD for low-risk CSP refrigerated?

14 days.

What is the BUD for low-risk CSP frozen?

45 days.

What are examples of medium-risk CSP?

Batch prep, parenteral nutrition.

What is the room-temperature BUD for medium-risk CSP?

30 hours.

What defines high-risk CSP?

Non-sterile ingredients or non-sterile equipment used.

What is the room-temperature BUD for high-risk CSP?

24 hours.

What is the refrigerated BUD for high-risk CSP?

3 days.

What is the frequency for the gloved fingertip test?

Initially × 3 passes, then yearly (low/medium risk) or semiannual (high-risk).

What is the purpose of the media fill test?

Demonstrates aseptic technique.

What is the cleaning frequency for PEC?

Beginning of shift, before/after each batch, after spills, q30 mins.

What surfaces are cleaned with?

Initially detergent, then 70% IPA.

What is the BUD of immediate-use CSP?

1 hour.

What does first air in hood refer to?

Air directly from HEPA filter hitting critical sites.

What is the zone of turbulence concept?

Disruption of airflow; avoid blocking HEPA.

What type of sterile gloves are used?

Powder-free sterile gloves.

What is the hand hygiene time?

30 seconds.

What is the proper garbing order?

Shoe covers → hair → face → wash → gown → gloves.

What is the pressure in non-hazard sterile compounding rooms?

Positive pressure.

What is the pressure for hazardous compounding?

Negative pressure.

What is the PEC for hazardous sterile compounding?

Class II BSC or CACI.

What is the SEC for hazardous sterile compounding?

C-SEC under negative pressure.

What is the HD buffer room ISO requirement?

ISO 7.

What are the required air changes per hour for hazardous rooms?

30 ACPH.

Where does the HD hood vent?

Vented to outside.

What is an isolator?

Glovebox providing isolating environment.

Which disinfectant kills spores?

Bleach (sodium hypochlorite).

How to neutralize bleach residue?

IPA or sterile water.

What does USP

Training, cleaning, certification, environmental monitoring.

What is the frequency of environmental sampling?

Q6 months.

What does USP

Handling of hazardous drugs (HDs).

What are examples of hazardous drugs?

Chemo, warfarin, hormones, teratogens.

What is the engineering control for HD non-sterile compounding?

C-PEC under negative pressure.

What is the storage requirement for HDs?

Separate, negative-pressure room.

What is the PPE for HD compounding?

Double gloves, gown, shoe covers, respirator as needed.

What is the difference between HD deactivation and decontamination?

Deactivate: neutralize drug. Decontaminate: remove residue.

What is the HD cleaning order?

Deactivate → decontaminate → clean → disinfect.

What are the transport requirements for HDs?

Sealed containers; no pneumatic tubes.

What must spill kits contain?

Gowns, gloves, absorbents, HD waste bags.

What is the disposal method for HD waste?

Yellow trace waste bags; black RCRA for bulk.

How often should chemo gowns be changed?

Every 2-3 hours or after spill.

What is the HD compounding training frequency?

Initial and annually.

What does HD exposure documentation include?

Personnel, drug, amount, incident details.

Where must HD receiving be done?

Neutral/negative pressure area.

How long must C-PEC run before starting work?

30 minutes.

What must HD final prep include?

Closed system transfer device (CSTD) when possible.

What is the pressure arrangement for HD sterile compounding?

Negative pressure.

How many gloves are required for HD garbing?

Double (outer sterile inside hood).

What to do after a chemo spill?

PPE → absorb → clean → HD waste → document.

What is the labeling requirement for chemo transport?

"Hazardous Drug."

What training is required for staff handling HDs?

Competency + PPE + spill management.

What type of room is required for HD compounding?

C-SEC with negative pressure.

What is the frequency for HD testing & certification?

q6 months.

Where must HD syringes be capped?

Inside the hood.

What is the minimum ACPH for hazardous rooms?

12 for non-sterile; 30 for sterile.