PT - Lesson 29 - Compounding Regulations and Considerations

Compounding regulations are created by which organization?

• NSF

• USP

• DEA

• CDC

Answer explanation

US Pharmacopeia was established speifically to set standards pertaining to pharmacy compounding.

Prior to penetration on a vial with a needle, the technician needs to ensure that the beveled edge of that needle is:

• on its side

• lubed properly

• facing down

• facing up

Answer explanation

In a effort to prevent coring, the technician brings the needle in at a 45-60 degree angle to ensure the beveled edge of the needle is facing up prior to penetration on a vial. This will push the core out of the way while penetrating going 90 degrees simultaneously

What document is needed to record what happens when a formulation is actually prepared?

• Material safety data sheet

• Formulations record

• Standard operating procedure

• Compounding record

Answer explanation

A compounding record is the written documentation of what actually happens when the items are compounded. It is very important when doing compounds that information is recorded.

The definition of Quality Assurance is:

• A program of activities used to guarantee that the procedures used in compouding a product lead to products that fulfill the specifications of the standards

• A program of activities used to guarantee that the procedures used in compounding a product lead to products that fulfill the specifications of HIPPA

• A program of activities used to verify that the procedures used in the compounding process were approved by the pharmacist

• All of the above

Answer explanation

A program of activities used to guarantee that the procedures used in compounding a product lead to products that fulfill the specifications of the standards.

In the absence of stability, any oral formulation containing water is assigned with a beyond use date (BUD) of:

• No later than 30 days

• No later than 25% of the time remaining until the products expiration date

• The same as the expiration date listed on the product

• No later than 14 days

Answer explanation

Generally an oral formulation containing water with no stability date is good for no more than 14 days. A solid formulation containing water such as a topical or a dermal is good for no more than 30 days in the absence of stability and all non-aqueous formulations are good for up to 6 months in the absence of stability.

The "punch" method is used for filling small numbers of capsules

• True

• False

Answer explanation

The body of the capsule is continuously pushed into the powder until it is full.

Suspensions are a three phase system consisting of a finely divided solid dispersed in a liquid.

• True

• False

Answer explanation

Preparing suspenions involves a 2 phase system that consists of starting with a finely divided solid - then the appropriate amount of a liquid is added to change the dosage form to another.

The best reference for obtaining storage requirements for a particular drug is the:

• Orange Book

• Drug Facts and Comparisons

• USF-NF

• CDC Info Guide

Answer explanation

USF-NF contains the regulations on drug storage information

The definition of Quality Control is

• A set of testing procedures that determine the quality of each ingredient

• A set of testing procedures that determine the quality of the equipment used to complete the compound

• A set of testing procedures that determine the quality of the compound formulation

• None of the above

Answer explanation

Quality control is a set of testing procedures that determines the quality of the compound formulation.

How long are multi-dose vials good for after the initial penetration?

• 60 days

• 14 days

• 28 days

• 20 days

Answer explanation

Medications such as insulin that come in multi-dose vials, can be used for up to 28 days after the initial pentration with a needle