Medications Ch 9

Question 1

Important References

Answer 1

Stablility= USP Ch 795
Storage= USP Ch 659

Question 2

Stability

Answer 2

The extent to which a preparation retains within specified limits and throughout its period of storage and use the same properties and characteristics that is possessed at the time of compounding

Question 3

Stability is determined by

Answer 3

The chemical nature of the excipients of the compound and the interaction of those excipients

Question 4

Incompatibility

Answer 4

An undesired reaction between a drug and another drug, solution, container, or other substance

Question 5

Physical Incompatibilities

Answer 5

Can be see with the naked eye

Question 6

Chemical incompatibilities

Answer 6

require chemical testing

Question 7

BUD

Answer 7

Stands for Beyond use dating
-The date after which a compounded preparation shall not be used; determined from the date the preparation is compounded

Question 8

BUD replaces expiration date when

Answer 8

-A drug us compounded or admixed
-The dust cover is removed
-The rubber stopper is penetrated
-A drug that requires refrigeration is removed

Question 9

Non aqueous formulations BUD

Answer 9

6 months

Question 10

Aqueous Oral Formulations

Answer 10

14 days

Question 11

Aqueous topical, dermal, or mucosal liquid and semi-solid prep

Answer 11

30 days

Question 12

Refrigeration

Answer 12

Temp controlled between 2-8 degrees celcius

Question 13

Cold

Answer 13

Any temp not exceeding 8 degrees celcius

Question 14

Cool

Answer 14

Any temp between 8-15 degrees Celcius

Question 15

Excessive Heat

Answer 15

Any temp above 40 degrees celcius

Question 16

Controlled Room Temperature

Answer 16

Any temp between 20-25 degrees celcius

Question 17

Key storage rules

Answer 17

-Dry place
-Protect from freezing
-Protect from Light

Question 18

How is BUD assigned

Answer 18

Based on drug-specific and general stability information

Question 19

Insulin storage

Answer 19

stored at temps between 2-8 degrees Celcius before use
-Can be stored at room temp for 28 days

Question 20

sterility

Answer 20

The period of time in which the compound can remain free of microbial contamination

Question 21

USP ch 797

Answer 21

Addresses sterile compunding, including compounding requirements, sterility testing and dating

Question 22

Cold chain supply logistics

Answer 22

Use of temp monitoring devices with appropriate surveillance