USP 797

USP <797> requirements must be met in__________healthcare settings that compound sterile preparations.

a. hospital b. most c. all d. joint commission accredited

c. all

Proper procedures and aseptic technique__________the risk of contamination.

a. greatly decrease b. somewhat increase c. somewhat decrease d. have no effect on

a. greatly decrease

__________contamination is the principle source of compounded sterile preparations contamination.

a. Filter b. Touch c. Water d. Air

b. touch

Cleaner air reduces the risk of contamination during compounding.

a. True b. False

a. true

Compounding isolators incorporate a different set of techniques than laminar airflow workbenches.

a. True b. False

a. true

Eating, drinking, and gum chewing are allowed in the ante area but not inside the buffer area surrounding the laminar air flow workbenches.

a. True b. False

b. false

Generally, aseptic manipulations should be performed at least__________inches inside the workbench.

a. 6 b. 9 c. 18

a. 6

The direct compounding area is the__________.

a. entire sterile compounding area b. buffer area c. area inside the laminar airflow workbench

c. area inside the laminar airflow workbench

Primary engineering controls must be certified__________,whenever the workbench is moved, or if filter damage is suspected.

a. every 6 months b. yearly c. weekly d. when problems are reported

a. every 6 months

HEPA filters should be cleaned periodically with sterile 70% isopropyl alcohol.

a. True b. False

b. false

The primary source of contamination inside a buffer area is__________.

a. a HEPA filter b. humans c. leaks d. broken ampules

b. humans

Although isolators give users mobility, flexibility, and dexterity, a cleanroom reduces the risk of coming into direct contact with harmful compounds.

a. True b. False

b. false

Biological Safety Cabinets and Compounding Aseptic Containment Isolators are used to prepare hazardous drugs.

a. True b. False

a. true

If a laminar flow workbench is turned off between aseptic processing sessions, it must be operated long enough to be free of room air in the critical area for at least__________.

a. 10 minutes b. 30 minutes c. 3 hours d. 30 seconds

b. 30 minutes

Which of the following DOES NOT introduce contamination?

a. Dust b. Dirt c. Pollen d. Skin flakes e. Lint f. Cosmetics g. All of the above can introduce contamination

g. all of the above

USP <797> contains specific requirements for the design and maintenance of appropriate cleanroom facilities.

a. True b. False

a. true

For all risk levels, the policies and procedures you establish must be__________.

a. strictly followed to be effective b. occasionally followed when time allows c. followed on a case-by-case basis

a. strictly followed to be effective

A laminar airflow workbench placed in a portion of the pharmacy (but not in the buffer area) is called a__________.

a. certified clean area b. certified ante area c. segregated compounding area d. satellite compounding room

c. segregated compounding area

A buffer area used for the preparation of non-hazardous drugs is under positive pressure.

a. True b. False

a. true

Which of the following can be re-worn if properly stored in the ante area?

a. Gown b. Gloves c. Shoe covers d. Masks

a. gown

Jewelry can be worn in the compounding area as long as the wearer is properly gowned.

a. True b. False

b. false

A glove fingertip test is done__________.

a. after garbing but before applying alcohol to gloves b. before garbing c. after garbing and applying alcohol to gloves d. after all compounded sterile preparations are prepared

a. after garbing but before applying alcohol to gloves

How often must training be conducted for personnel doing high-risk level compounding?

a. Every 3 months b. Every 6 months c. Once a year d. Once at date of hire

b. every 6 months

It is acceptable for technicians to compound as long as they have begun training.

a. True b. False

b. false

A successful media-fill test will show growth within 48 hours.

a. True b. False

b. false

Cleaning and disinfecting are different words for the same activity.

a. True b. False

b. false

Primary engineering controls need to be cleaned and disinfected__________.

a. at the beginning of each shift b. before each batch c. at least every 30 minutes during compounding d. when surfaces are visibly soiled e. when surface contamination is known or even suspected f. All of the above g. None of the above

f. all of the above

As part of standard operating procedure recommendations, personnel must clean and disinfect workspaces daily, including all primary engineering controls, equipment, cleanable work surfaces, and floors.

a. True b. False

a. true

IVs in cases should be removed from their outer cardboard boxes in the ante area.

a. True b. False

b. false

Walls, ceiling, and storage shelving must be cleaned and disinfected at least__________.

a. daily b. weekly c. monthly d. annually

c. monthly

Surface sampling tests the cleanliness of__________surfaces.

a. compounding b. exterior c. packaging

a. compounding

Sterile ingredients, components, devices, and mixtures exposed to air quality inferior to ISO 5 for more than one hour are considered__________.

a. low risk b. medium risk c. high risk

c. high risk

Multiple pooled sterile commercial products for multiple patients or one patient multiple times are considered__________.

a. low risk b. medium risk c. high risk

b. medium risk

CSPs prepared from nonsterile ingredients are considered__________.

a. low risk b. medium risk c. high risk

b. medium risk

If a pharmacist mixes an IV on the patient care unit during a code, it is considered __________risk level.

a. immediate b. low c. low with 12 hour beyond-use time

a. immediate

To ensure consistency in determining beyond-use dates, written policies and procedures must be in place.

a. True b. False

a. true

Who assumes final responsibility for proper packaging, handling, transport, and storage of all CSPs?

a. Shipping company b. Compounding pharmacist c. Hospital administration

b. compounding pharmacist

The FDA will exercise enforcement discretion if there is a problem regarding a sterile compound (such as a sterility problem with a CSP that affects the public health).

a. True b. False

a. true

State boards of pharmacy can enforce USP <797> if the state pharmacy law includes enforcement of the Food, Drug, and Cosmetic Act (FDC), if the state has its own FDC that mimics the federal act, or if the state has adopted rules concerning CSPs.

a. True b. False

a. true

A daily log must be kept for controlled room temperature, refrigerator, and freezer storage areas.

a. True b. False

a. true

What is the maximum beyond-use date for frozen CSPs at all risk levels?

a. 24 days b. 28 days c. 45 days d. 60 days

c. 45 days

After withdrawing a dose from a single-dose container, the remaining content can be stored for 24 hours.

a. True b. False

b. false

In general, opened single-dose bags, bottles, syringes, or vials can be used within__________if opened within a primary engineering control.

a. 1 hour b. 6 hours c. 24 hours

b. 6 hours

If a single-dose container has been opened in air quality worse than ISO 5, the contents must be used within__________.

a. 1 hour b. 6 hours c. 24 hours

a. 1 hour

Unless otherwise specified by the manufacturer, an opened multiple-dose vial can be used for a maximum of__________.

a. 7 days b. 28 days c. 30 days

b. 28 days