CSPT #4

The USP Chapter 797 and 800 stated that hazardous drugs should be stored in a negative-pressure room with external ventilation and at least:

12 air changes per hour.

The beyond-use date (BUD) of any sterile compound mixed in a C-SCA is limited to:

12 hours.

For those new to compounding, how many successful gloved fingertip tests must be done and how many colony forming units (CFUs) are allowed?

3 sets of tests with no growth.

Which of the following is among the key elements of facility design in health care institutions where hazardous drugs are prepared?

A certified Class II biological safety cabinet in a negative-pressure buffer room.

Which of the following activities is considered "compounding" according to the Food and Drug Administration's definition of "compounding"?

A hospital creating a sterile admixture.

Which of the following is considered to be correct configuration for newly develop negative pressure lab?

A positive pressure ISO 7 anteroom and a negative pressure ISO 7 buffer room.

What is a media fill test intended to simulate?

Ability to aseptically mix a compounded sterile preparation

Chemotherapy gloves must be tested to (ASTM) standard D6978 (or its successor). What does ASTM represent?

American Society for Testing and Materials

The chemotherapy gloves worn when handling Hazardous drugs(HDs) must meet the American Society for Testing and Materials (ASTM) standard:

D6978

The Drug Quality and Security Act (DQSA) of 2013 Title 1 intent to:

Distinguishes regulation of traditional pharmacies and outsourcing facilities. AND Provides more oversight of large-scale compounding facilities.

What are the two key components of viability monitoring?

Electronic air sampling and surface sampling

General Chapter 800 requires mandatory wipe sampling test for detection of antineoplastic hazardous drugs (HDs) that may have escaped containment.

False

Only 10% of total products can be distributed out of state compounded by traditional compounding pharmacies.

False

Respondents to the 2016 survey of sterile compounding practices identified several barriers to compliance with USP Chapter 797 requirements. Which of the following is the most cited barrier to comply with sterile compounding requirements?

Financial and budget restrictions.

Which two solutions must be used at least daily to clean a primary engineering control used for nonhazardous preparations?

Germicidal detergent and sterile alcohol

Section 503A of DQSA requires:

I. A pharmacy may compound a prescription drug product only upon receipt of a valid prescription for an individual patient. II. Drugs that have been withdrawn from the market due to concerns about safety or a lack of efficacy may not be compounded. III. A pharmacy may not compound products that are essentially copies of commercially available drug products.

Which of the following engineering controls are appropriate for use with hazardous drugs?

I. CVE II. CaCI III. Class I or II BSC

Which of the following activities may increase the risk of exposing to hazardous drugs (HDs)?

I. Crushing tablets or opening capsules II. Pouring oral or topical liquids drugs from one container to another III. Expelling air from syringes previously used for hazardous drugs

Which of the following bulk drug substances is/are allowed in compounding by the Pharmacy Compounding Advisory Committee?

I. Diphenylcyclopropenone II. Squaric acid dibutylester III. Iodide

Which of the following is/are TRUE about wearing disposable gowns while preparing hazardous drugs?

I. Disposable gowns made of polyethylene-coated polypropylene or other laminate materials offer better protection than those made of uncoated materials II. Gowns must close in the back be long sleeved, and have closed cuffs that are elastic or knit. III. If no permeation information is available from the manufacturer for the gowns used, change them every 2-3 hours or immediately after a spill or splash.

Which of the following factors may increase the risk of exposing to hazardous drugs?

I. Dosage form of the drug. II. Types of hazardous drugs. III. Manipulation.

Which of the following statements is/are TRUE about using gowns while handling hazardous drugs?

I. Gowns for handling hazardous drugs are required to be disposable and long-sleeved with cuffs at the end. II. The gowns can be made of polyethylene-coated polypropylene or other laminate materials. III. Gowns must be designed to close in the back, not in the front.

Outsourcing facilities, as defined under the section 503B of DQSA, must:

I. comply with CGMP requirements. II. be inspected by FDA according to a risk-based schedule. III. provide FDA with certain information about the products they compound.

Which of the following primary engineering controls are designed for compounding nonhazardous sterile preparations?

Laminar air flow workbench and compounding aseptic isolator.

Antineoplastic HDs (Hazardous Drugs) and APIs (Active Pharmaceutical Ingredients) must be unpacked in an area that is:

Negative pressure relative to the surrounding areas AND neutral or normal pressure relative to the surrounding areas.

The pharmacy technician in RXCare Pharmacy's negative pressure lab compound only one hazardous drug product at a time. A patient wants to talk with the technician who compounded his drug. The technicians have asked a pharmacist in duty whether he can leave the lab with the gown on, speak with a patient, and then return to the lab to compound another preparation. The pharmacist's answer should be:

No.

Section 503B of the Federal Food, Drug, and Cosmetic Act addresses which of the following?

Outsourcing Facilities.

When must closed system drug-transfer devices be used?

Recommended for compounding; required for administering.

The PCAC has recommended that which of the following drugs be included on the "Do Not Compound" list?

Rofecoxib

If a facility is registered as an outsourcing facility and compounds drugs pursuant to patient-specific prescriptions, can those drugs qualify for exemptions under section 503A of the FDC Act?

Section 4.

Which of the following is TRUE when compounding in a compounding aseptic isolator or compounding aseptic containment isolator?

Sterile gloves are donned inside the compounding isolator chamber, and placed over the gauntlet gloves

Who maintains a list of antineoplastic and other hazardous drugs used in healthcare?

The National Institute for Occupational Safety and Health (NIOSH)

The DQSA addresses which of the following practices?

The compounding of sterile drugs for human use.

Which of the following statements IS NOT TRUE about using the chemotherapy gloves while compounding hazardous drugs?

The gloves are required to be powder-treated.

Facilities engaged solely in nonsterile compounding do not qualify to register as an Outsourcing facilities as defined under section 503B of DQSA.

True

Properly vented C-PECs provide eyes and respiratory protection, so no additional protection is required when compounding.

True

Does priming an IV administration set increase the risk of exposing to hazardous drugs (HDs)?

Yes

Which of the following is an example of supplemental engineering controls for containment?

closed-system drug-transfer device (CSTD).