NAPLEX 2026 nonsterile compounding, sterile compounding, hazards

NONSTERILE COMPOUNDING

Compounded medications are prepared for ______, based on a _____

An individual patient, based on a prescription

Outsourcing 340B facilities are obviously different

Further than sterile/non-sterile, how else may compounding may be defined?

Hazardous/nonhazardous

Who sets the minimal acceptable standards for compounding?

United States Pharmacopeia (USP)

USP Chapters below ___ are required

Below 1000 are required

USP ___ - Nonsterile preparations

USP ___ - Sterile preparations

USP ___ - hazardous drugs

USP 795 - Nonsterile preparations

USP 797 - Sterile preparations

USP 800 - hazardous drugs

What are some possible routes of administration for non-sterile medications?

Oral

Via Gtube

Rectal

Vaginal

Nasal

Otic (ear)

Topical

Which administration types must be compounded in a sterile environment

IV

Ophthalmic

What are the 3 reasons non-sterile compounding may be used

To create a unique dose or formulation (Solid tab to liquid)

To avoid an excipient

To add flavor

A non-sterile compounding space can be in ____ ___. It must have a ____ ____, separate from _____ ____.

Equipment stored ____ the ____. Temperature monitored ___ or ___.

Must have ____ and ____ _____ (Hot and cold).

room air ; designated space, separate from dispensing area

off the floor

monitored daily or continuously

Sink and purified water (Hot and cold)

When must personnel complete training for nonsterile compounding?

Initially and every 12 months

Demonstrate proficiency in core competencies

What 3 things must equipment have before use?

Must be Clean

Calibrated

Compatible (w/ compound)

What is required garbing for non-sterile compounds?

gloves and hands washed for >30 secs

Metal spatulas should not be used with compounds containing ____ ____ or _____. Instead, use ____ spatula.

metal ions or corrosives ; rubber

What is the sensitivity requirement of a torsion (class A/class III) balance?

Minimal amount that can be removed/added before the scale moves 1 division unit

How to calculate the minimum weighable quantity (MWQ)

MWQ = Sensitivity req/ 0.05 (aka Acceptable error rate)

What minimum volume must be measured when measuring liquids

Never measure volumes < 20% of capacity

5 ml/0.2 = 25 mL max

Missing expiration date for INGREDIENTS (not drugs): Assign a conservative date no more than ____ yrs than when pharmacy received ingredient.

3 yrs

Which measure device is most accurate for measuring small liquids

Syringes

What is the purpose of excipients?

Make a dosage form more stable, functional or palatable

What is the purpose of a surfactant?

To lower surface tension between two ingredients or phases

Used to make the ingredients miscible

True false: Surfactants are ampiphillic, and what does that mean?

True - Have both a hydrophilic head and a lipophilic tail

effect of wetting or levigating agents

Decrease surface tension between liquid and a solid

What are examples of Suspending agents?

Ora-Plus (bland)

Ora-Sweet

Glycol and Gels can serve as what?

Delivery vehicles

Polyethylene glycol (PEG)

Poloxamer (pluronic lecithin organogel)

What is the purpose of an emulsifier?

to mix immiscible liquids

The HLB number determines what?

The type of surfactant needed to make an suspension

What are the types of surfactants?

Wetting/levigating agent

Suspending agent

Foaming agents

Glycols

Emulsifiers

An HLB number <10 means what?

More lipid soluble liquid.

Used for water in oil emulsions

good for mixing water into oil

An HLB > 10 means what?

More hydrophilic

Used for oil in water emulsions

Good for mixing oil into water

What are common binders

Acacia

Starch

Sucrose syrup

What are common topical diluents

Petrolatum

Mineral oil

What are common liquid diluents

Water

Alcohol

Glycerin

What are common tablet/capsule diluents

Lactose

Starches

calcium salts

Cellulose powder

True/False: Never add a preservative to a compounded medication for a neonate?

True - can accumulate

BUD > 0.6 Aw

No perservatives: _____

Preservative: ____

14 days ; 35 days

BUD < 0.6

Oral liquid: ____

Other: _____

90 days ; 180 days

STERILE COMPOUNDING

SVP versus LVP Acronyms

SVP: small volume parenteral ; ≤ 100 mL

LVP: large volume parental ; > 100 mL

PEC versus SEC Acronyms

PEC: primary engineering control ; sterile hood that provides ISO 5 air for sterile compounding

SEC: secondary engineering control ; room containing ISO 7 air where sterile hood is located

Anteroom ISO Rating

8

CAI Acronym

compounding aseptic isolator

closed-front ISO 5 sterile hood used for non-hazardous drugs "glove-box"

RABS Acronym

restricted access barrier system

closed-front ISO 5 sterile hood (includes CAI's); known as "glove-box"

The lower the particle count, the ___ the air (hoods)

cleaner

In an ISO 7 room air, the ACPH (air changes per hour) must be at least ___ Air change per hour (ACPH). (20 for ISO 8)

30 ACPH

What are the 2 Types of PEC's

1. laminar airflow workbench (LAFW) - "horizontal laminar airflow"

2. compounding aseptic isolator (CAI) - has unclassified air without a buffer area or anteroom, therefore must have a visible and defined perimeter around the area

Glovetip Fingertip Test and Media-Fills must be completed every 6 months for ___ and every 3 months for ___

6 months: Category 1 & 2's

3 months: Category 3's

If liquid from a media-fill test stays clear after ___ days, the compounder passed the test

14 days incubation

Air and Surface Testing

Air Sampling Frequency:

Surface Sampling Frequency:

Air Sampling Frequency: every 6 months

Surface Sampling Frequency: every 30 days

PEC's must be on for ___ minutes before beginning compounding (if shut off)

30 minutes

Category 1 CSP's: ISO 5 PEC Preperation in SCA

Room Temp BUD:

Fridge BUD:

Frozen BUD:

Room Temp BUD: < 12 hours

Fridge BUD: ≤ 24 hours

Frozen BUD: 45-90 days

T/F: Category 2 CSP's BUD is longer than Category 1

TRUE

Category 2 CSP's: ISO 5 PEC Preparation in Clean Room

Room Temp BUD:

Fridge BUD:

Frozen BUD:

Room Temp BUD: 1-45 days

Fridge BUD: 4-60 days

Frozen BUD: 45-90 days

Category 3 CSP's BUD extend to as long as

180 days due to sterility testing and other qualifications needed

Category 3 CSP's: ISO 5 PEC Preparation in Clean Room + Qualifications

Room Temp BUD:

Fridge BUD:

Frozen BUD:

Room Temp BUD: 60-90 days

Fridge BUD: 90-120 days

Frozen BUD: 120-180 days

Immediate-use Medications BUD

4 hours under any storage condition

HEPA Filters should be Re-Certified every ___ months

6 months

HAZARDOUS COMPOUNDING

Describe the characteristics that consider a drug to be hazardous

Carcinogenic

Teratogenic

Have reproductive toxicity

Cause organ damage at low doses

Genotoxic

Which hazardous categories drugs require special handling?

Antineoplastics

Reproductive risk

Hormones

Transplant drugs

Others

Non-neoplastics on NIOSH list

1. 5-alpha reductase inhibitors: ____, ____

2. Abortifacients: mifepristone, misoprostol

3. Anticoagulants: Warfarin

4. Antivirals: _____, ____, _____

5. Antiseizure meds: _____, _____, fosphenytoin, _____, ____, _____

6. Benzos: ______, _____

7. DM meds: _____

8. HF meds: ____

9. Hepatitis meds: ____

10. PAH meds: Ambrisentan (bosentan, macitentan), ______

11. SSRIs: ______

12. Thionamides: _____, ______

13. Hormones: Androgens, estrogens, progestins, _____, ____/____, Ulipristal

14. Auto-immune condition meds: acitretin, ______, ______, ______, teriflunomide

15. Transplant meds: cyclosporine, tamsulosin, mycophenalate, sirolimus

dutasteride, finasteride

cidofovir, gancliclovir, valganciclovir

carbamazepine, oxcarbezapine, phenytoin, valproate, topiramate

clonazepam, temazepam

exenatide

spironolactone

ribavirin

riociguat

paroxetine

oxytocin, SERD/SERMS (fulvestrant, raloxifene, tamoxifen)

azathioprine, fingolimod, leflunomide

Which drugs have reproductive risk and require special handling?

Pregnancy category x, some D and some C

Paroxetine

Methotrexate

Misoprostol, mifepristone

Ribavirin

5-alpha reductase inhibitors (dutasteride, finasteride)

Biological safety cabinets have a ____ airflow where air flows ____ from HEPA filter at top of hood.

Containment ventilated enclosures are _____ containment hoods with HEPA-filtered air. _____ compounding only/

Compounding aseptic containment isolators have ____-____ and can be located in a ___ or ____

vertical ; downwards

powder ; sterile

glove-box ; SEC or SCA

Generally each type of compounding requires its own separate room, when is there an exception?

Hazardous sterile and non-sterile compounds may be prepared in the same room if it is at least ISO 7 and the PECs are at least 1 meter apart from each other

What are some requirements of hazardous compounding rooms? All contaminated air must be _____ ventilated. All rooms must be _____ _____. Emergency hand/eye wash sink must be available and nearby

externally ventilated ; negative pressure

What PPE must be worn when preparing hazardous sterile compounds?

Head/hair covers

TWO pairs of shoe covers

Gown

TWO pairs of chemotherapy gloces

What PPE must be worn when administering hazardous/antineoplastic preparations?

TWO pairs of gloves

Plus a gown if injectable

What PPE must be worn when receiving and storing hazardous drugs?

Single gloves are okay

Discuss some good practices of storing and receiving hazardous drugs: Do not store on the floor. Store ____ from non-HDs and in an ____ ventilated, ___ ___ room with at least ___ ACPH store separately from non-HDs and in an externally ventilated, negative pressure room with at least 12 ACPH. Must be labeled as hazardous and identify the contents

separately; externally ventilated ; negative pressure room ; 12 ACPH

What is the yellow hazardous waste bin used for?

Trace chemo

Ex. gloves, gowns, shoe covers, empty vials/iv bags/iv tubes/syringes/vials

What is the black hazardous waste bin used for?

Bulk chemo

Ex. unused/partially empty iv bags/syringes/vials

Describe how hazardous areas and equipment must be cleaned

Once daily in this order:

Deactivation and decontamination

Cleaning

Disinfecting if sterile

Describe the deactivation and decontamination step of hazardous cleaning

2% bleach (sodium hypochloride) or peroxide

Reduces HD toxicity then removes HD residues

Describe the cleaning step of hazardous cleaning

Germicidal detergent such as Quat. ammonium

Removes dirt and microbial contamination

Describe the disinfecting step of hazardous cleaning

If area is sterile

70% isopropyl alcohol

Inhibits or destroys microorganims

Describe what should happen if there is a hazardous spill

1. everyone must leave the room, close the door, and post keep out signs

2. garb for cleaning a spill: chemo gown, gloves, eye/face protection, NIOSH certified respirator

3. dispose of all spill waste as hazardous - use a spill kit

Describe what should happen if a personnel is exposed to a hazardous spill

Remove contaminated garments

Immediately wash exposed skin with soap/water

Immediately flush eye(s) if exposed

Send for emergency medical evaluation