USP Chapter <800>

Question 1

What is USP 800?

Answer 1

it is an independent, scientific nonprofit organization that provides standards setting in compounding, biologics, pharmaceutical manufacturing, and other fields.

Question 2

When did USP 800 become official?

Answer 2

Dec. 1st, 2019

Question 3

What does USP 800 cover?

Answer 3

It describes practice and quality standards for handling hazardous drugs

Question 4

What is NIOSH?

Answer 4

National Institute for Occupational Safety –it maintains a list of antineoplastic and other HDs used in healthcare. Reviewed every 12 months

Question 5

What are the criteria a hazardous drug must fall under?

Answer 5

-carcinogenicity
-teratogenicity or other developmental toxicity
-reproductive toxicity
-organ toxicity at low doses
-genotoxicity
–a new drug that has a structure and toxicity profile that mimics an existing hazardous drug

Question 6

NIOSH categories

Answer 6

-antineoplastic drugs
-non-antineoplastic drugs
-non-antineoplastic drugs primarily have adverse reproductive effects

Question 7

Antineoplastic drugs

Answer 7

fluorouracil
hydroxyurea
megestrol
methotrexate
tamoxifen

Question 8

non-antineoplastic drugs

Answer 8

carbamazepine
estrogens
progesterone
phenytoin
spironolcatone

Question 9

drugs with reproductive effects

Answer 9

clonazepam
fluconazole
paroxetine
testosterone
topiramate
warfarin

Question 10

What does an assessment of risk consider?

Answer 10

-type of HD (antineoplastic, non-antineoplastic, reproductive risk)
-dosage form (tablet, capsule)
-risk of exposure
-packaging
-manipulation
-documentation of alternative containment strategies and/or work practices
-Reviewed annually, documented

Question 11

What is PPE?

Answer 11

personal protective equipment (PPE)

Question 12

What is PPE used for?

Answer 12

-PPE provides protection to reduce exposure to HD aerosols and residues
-Disposable PPE not reused
-sterile and nonsterile compounding

Question 13

Gloves

Answer 13

2 pairs of powder-free that meet American Society for Testing and Materials (ASTM) standard D6978. After compounding, outer glove can be removed to prevent contamination of the container when labeling or handling the completed compound.
-For sterile compounding, outer glove must be STERILE
-replace gloves every 30 minutes

Question 14

Gowns

Answer 14

-must be poly-coated, disposable, with long sleeves and knitted or elastic cuffs
Gowns must close in the back, not the front
-regular gown worn beneath HD gown for compounding in a cleanroom suite
-washable gowns NOT permitted for use with HDs
-Replace gowns every 2-3 hours, or immediately after a spill or splash

Question 15

Head, hair, shoe, and sleeve covers

Answer 15

wear full-coverage head and hair covers
2 pairs of shoe covers
shoe covers worn in HD handling area not worn in other areas

Question 16

Eye and Face Protection

Answer 16

wear full face shield to protect the eyes from splashes
add goggles if compounding outside of a C-PEC or containment isolator
eyeglasses or safety glasses do not protect eyes adequately from splash

Question 17

Respiratory Protection

Answer 17

Wear a fit-tested NIOSH-certified N95 respirator mask to protect against airborne particles and provide a barrier to splashes, droplets, and sprats around the nose and mouth -may wear regular face mask if biological safety cabinet (BSC) or containment isolator is being used

Question 18

PPE disposal

Answer 18

-trace contamination
-appropriate waste container
-disposal regulations– local, state, federal
-removal before leaving the area to limit contamination of other area

Question 19

Personnel Training

Answer 19

-all must be trained
-must occur before handling HDs independently
-Each employee must demonstrate
-Reassessed every 12 months; when new HD or new equipment used; w/ a new or significance change in process or SOP

Question 20

What does the training include?

Answer 20

-overview of entity’s. list of HDs and their risks
-review of the entity’s SOP related to the handling of HDs
-Proper use of PPE
-Proper use of equipment and devices (e.g., engineering controls)
-Response to known or suspected HD exposure
-Spill management
-Proper disposal of HDs and trace-contaminated materials

Question 21

Deactivation

Answer 21

-used to render compound inert or inactive
-Environmental Protection Agency (EPA)-registered oxidizers –peroxide formulations; sodium hypochlorite

Question 22

Decontamination

Answer 22

-purpose to remove HD residue
-alcohol; water; peroxide; sodium hypochlorite

Question 23

Cleaning

Answer 23

-used to remove organic and inorganic material
—germicidal detergent