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Question:

Which of these sets the rules and standards for sterile compounding?

A USP 797
explanation

There are several pieces of equipment used during sterile compounding, all of which are used within a class 5 clean room as outlined in USP 797. USP 797 addresses the requirements and equipment used in sterile compounding.

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Related Questions

How many phases are in a suspension?

Two

A suspension has two phases.

What is the maximum amount of time that can be assigned to a repackaged drug?

6 months

Repackaged medications can be assigned a beyond-use date that does not exceed 1⁄4 of the time remaining before the drug expires or a maximum of 6 months.

How do ampules differ from vials?

Ampules require the use of a filter needle.

A filter needle is used to remove very small particles of glass that may have fallen into the liquid when the ampule was broken.

Where should one place used syringes?

In a sharps container

USP ,797. requires that used syringes be placed in a sharps container.

Which of the following dosage forms is not an example of a solution?

Emulsion

A solution contains a solute that is dissolved in a solvent that may be aqueous, alcoholic, or hydroalcoholic. An emulsion is a dispersion that is a solute dispersed through a dispersing vehicle.

What type of substance is composed of 50% dextrose, 20% fat, and 10% amino acid?

Total parenteral nutrition

A total parenteral nutrition product consists of 50% dextrose, 20% fat, and 10% amino acid.

When making a sterile compound, what is the next step after setting all materials in the sterile compounding hood?

Uncap the vials and swab the rubber stopper with 70% isopropyl alcohol.

The appropriate order for sterile compounding is listed here:
1. Remove the plastic cap and swab the vial stopper with 70% isopropyl alcohol.
2. Swab all sterile surfaces being used during manipulation such as all vials and the injection port on the IV bag.
3. Uncap needle and withdraw a volume of air equal to the desired volume of liquid to be extracted.
4. Insert the needle into the vial at a 45-degree angle and the bevel side up (to avoid coring the vial) and then straighten out the needle. Do not block the airflow from the laminar flow hood.
5. Push air into the vial and extract the desired volume.
6. Remove the needle and inject contents into the IV bag through the specified port.
7. Discard the needle in the sharps container and throw all other waste in the appropriate trash bin.

Which of the following is not a sign of incompatibility?

nonuniform product

While some products are required to be uniform, some products such as suspensions are not uniform.

Which of the following can be used to curb infections in a hospital pharmacy?

All of the above

Infections can be curbed in a hospital pharmacy can be curbed through following universal precautions, following standards contained in USP ,797. that address personnel training, wearing personal protective equipment, using aseptic techniques, and proper preparation of various compounded sterile products.

Which of the following may be used in a parenteral solution?

Sterile water for injection USP

Sterile water for injection USP has been sterilized but has no antimicrobial agents and can be used in parenteral solutions. Purified water USP is not intended for parenteral administration and is used in the reconstitution of oral products. Water for injection USP is not sterile and cannot be used in aseptic compounding of sterile products. Sterile water for irrigation USP has been sterilized but contains no antimicrobial agents; it is used as an irrigating solution.

What should be used to clean a laminar flow hood?

70% isopropyl alcohol

USP ,797. requires that 70% isopropyl alcohol be used to clean a laminar flow hood.

Which dosage form can be prepared with either the compression mold or the fusion mold?

Suppositories

Suppositories may be compounded by either using a compression or fusion mold.

How often must HEPA filters be certified?

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Which dosage form releases carbon dioxide when it is dissolved in water?

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Effervescent salts are granules or powders; when dissolved in water, they effervesce and release carbon dioxide.