Medications Ch 9 Flashcards
Important References
Stablility= USP Ch 795
Storage= USP Ch 659
Stability
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
Stability is determined by
The chemical nature of the excipients of the compound and the interaction of those excipients
Incompatibility
An undesired reaction between a drug and another drug, solution, container, or other substance
Physical Incompatibilities
Can be see with the naked eye
Chemical incompatibilities
require chemical testing
BUD
Stands for Beyond use dating
-The date after which a compounded preparation shall not be used; determined from the date the preparation is compounded
BUD replaces expiration date when
-A drug us compounded or admixed
-The dust cover is removed
-The rubber stopper is penetrated
-A drug that requires refrigeration is removed
Non aqueous formulations BUD
6 months
Aqueous Oral Formulations
14 days
Aqueous topical, dermal, or mucosal liquid and semi-solid prep
30 days
Refrigeration
Temp controlled between 2-8 degrees celcius
Cold
Any temp not exceeding 8 degrees celcius
Cool
Any temp between 8-15 degrees Celcius
Excessive Heat
Any temp above 40 degrees celcius
Controlled Room Temperature
Any temp between 20-25 degrees celcius
Key storage rules
-Dry place
-Protect from freezing
-Protect from Light
How is BUD assigned
Based on drug-specific and general stability information
Insulin storage
stored at temps between 2-8 degrees Celcius before use
-Can be stored at room temp for 28 days
sterility
The period of time in which the compound can remain free of microbial contamination
USP ch 797
Addresses sterile compunding, including compounding requirements, sterility testing and dating
Cold chain supply logistics
Use of temp monitoring devices with appropriate surveillance
