USP 795

Question 1

Nonprofit Scientific organization founded in 1820.

Answer 1

United States Pharmacopeia (USP).

Question 2

T or F: USP is a regulatory agency.

Answer 2

False. USP does not itself enforce its rules.

Question 3

What is the mission of USP?

Answer 3

To improve global health through public standards and related programs that help ensure the quality, safety and benefit of medicines and foods.

Question 4

USP 795

Answer 4

Pharmaceutical Compounding-Nonsterile Preparations

Question 5

T or F: USP serves as a guideline for non-sterile compounding.

Answer 5

F: USP 795 is a STANDARD for compounding nonsterile medications to ensure patient benefit and reduce risks such as contamination, infection, or incorrect dosing.

Question 6

When performing nonsterile compounding, compliance with ________________ is required.

Answer 6

USP-795

Question 7

Combining, diluting, pooling, or other methods of mixing products and components; also include reconstituting products other than the way specifically listed in the manufacturer’s labeling.

Also includes compounding kits.

Answer 7

Nonsterile compounding.

Question 8

The following are examples of __________.
-prepackaging items
-splitting tablets
-reconstituting according to manufacturers labeling.

Answer 8

NOT NON-STERILE COMPOUNDING.

Question 9

The person responsible for overseeing all aspects of compounding at a facility.

Answer 9

Designated person.

Question 10

T or F: The designated person has to be a pharmacist.

Answer 10

False

Question 11

What gloves should be worn when compounding?

Answer 11

Latex-free, powder-free.

Question 12

Prior to compounding, hands and forearms should be washed with soap and water for ______________.

Answer 12

At least 30 seconds.

Question 13

Any substance or mixture of substances intended to be used in the compounding of a preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals affecting the structure and function of the body.

Answer 13

Active Pharmaceutical Ingredient

Question 14

API

Answer 14

Active pharmaceutical ingredient.

Question 15

What documentation is required for a compounding pharmacy at a minimum?

Answer 15

1. Master Formulation Records
2. Compounding Record
3. Standard operating procedures.

Question 16

The recipe for the CNSP…

Answer 16

Master formulation record.

Question 17

Master formulation records are required for _____________ compounds.

Answer 17

All.

Question 18

Record of ingredients used to make a CNSP.

Answer 18

Compounding Record

Question 19

Compounding records are required for _____________ compounds.

Answer 19

All.

Question 20

Can the master formulation record and compounding record be combined?

Answer 20

Yes.

Question 21

What is the maximum beyond use date for CNSPs with a stability study.

Answer 21

180 days.

Question 22

The beyond-use date of a nonpreserved aqueous dosage form is ____________.

Answer 22

14 days.

Question 23

How should a nonpreserved aqueous dosage form be stored?

Answer 23

In the fridge.

Question 24

The beyond-use date of a preserved aqueous dosage form is __________.

Answer 24

35 days.

Question 25

How should Preserved aqueous dosage forms be stored?

Answer 25

Fridge or room temp.

Question 26

The beyond-use date for oral non-aqueous liquids is __________.

Answer 26

90 day.

Question 27

How should oral nonaqueous liquids be stored?

Answer 27

Fridge or room temp.

Question 28

How should non-aqueous solid (other) dosage forms be stored?

Answer 28

Fridge or room temp.

Question 29

The beyond-use date of a non-aqueous solid (other) dosage form is ___________.

Answer 29

180 days.

Question 30

If an ingredients expiration date is shorter than the beyond use date, then ____.

Answer 30

The ingredients expiration date is the new beyond use date.

Question 31

What must a prescription label contain per USP 795.

Answer 31

1. Assigned internal lot number
2. Active components (amount/activity/concentration)
3. Dosage form
4. Amount/Volume in the container
5. Storage temp (if not room temp)
6. Beyond-use date.