Compounding ****

Question 1

USP compounding chapters

Answer 1

US Pharmacopeia
-non-sterile hazardous: USP 795 and 800
-non-sterile non-hazardous: USP 795
-sterile non-hazardous: USP 797
-sterile hazardous: USP 797 and 800

Question 2

Hazardous Drugs on the NIODH list

Answer 2

-antineoplastic: chemo drugs
-abx: telavancin
-anticoagulants: warfarin
-antifungals: fluxanazole, voriconazole
-antiretrovirals/HIV: abacavir, entevacir, Nevirapine, Zidovudine
-antivirals: cidofovir, ganciclovir, valganciclovir
-acne: isotretinoin
-BPH: dutasteride, finasteride
-hormones: androgens (testosterone), estrogens (estradiol), progesterones
-hyperthuriodism: methimazole, proplthiouracil
-renal disease: darbepoetin alfa
-transplant: azathioprine, cycsporine, tacrolimus, sirolimus

Question 3

Physical space: hazardous drug requirements

Answer 3

-containment: C-PEC or C-SEC
*negative air pressure
–> at least 12 air changes per house for nonsterile
–> at least 30 changes per hour for sterile

Question 4

Air quality requirements

Answer 4

-the lower the particle count/number, the cleaner the air

-ISO 5: in clean room - cleanest air
-ISO 7: in buffer room
-ISO 8/9: ambient room

-always use 70% isopropyl alcohol to clean things before bringing them into the PEC room

Question 5

Compounding room temp and testing regulations

Answer 5

-SEC room should be kept at 20C (68F) or cooler
–> fridge: 2-8C
–> freezer: -50 to -15C

-air sampling: done every 6 months
-surface sampling: w/ tryptic soy agar, polysorbate 80 and lecthin - done at the end of the say
–> action must be taken if > 3 CFUs in ISO 5 room or > 5 CFUs in ISO 7 area

Question 6

Hazardous drug compounding cleaning steps

Answer 6

Deactivation and Decontamination:
–> 2% bleach (sodium hypochlorite) or peroxide
Cleaning:
–> germicidal detergent (Quat, Ammonium, Phenolics)
Disinfection:
–> sterile 70% Isopropyl Alcohol