Beyond Use Date Session 5

What are we looking for in a visual inspection?

1- Hazy/cloudy appearance 2- Precipitates 3- Color change 4- formation of gas 5-separation of contents 6- temp. changes 7- crystallization

How to determine BUD?

1- direct testing or literature 2- manufacturer information 3-USP recommendations 4-Theoretical predictions

List resources used to assign BUDs (3/4)

1-Stability of Compound (found in literature) (a.k.a Trissel) 2-Sterility of the compound

How is a visual inspection of a CSP done?

1-agitated/mixed 2-hold it up against the light 3- check against a contrasting background

What is the difference between expiration dates and BUD's (4/4)

Expiration DATE: 1-assigned by manufacturer 2-determined using extensive analytical testing Beyond-use DATE: 1-assigned by a pharmacist 2-determined based on available scientific evidence or per manufacturer recommendations

T/F. BUD date is assigned by manufacturer

F. by pharmacist expiration date is assigned by manufacturer

T/F. expiration date are determined based on available scientific evidence or per manufacturer recommendations.

F. that BUD, expiration date is determined by using extensive analytical testing

What's a Trissel?

Trissel's stability of compounded formulations

T/F. a CSP CANNOT be labeteled with the term "expiration date" or any variance thereof

True. it must be labeled with a different phrase "do not use after (DATE and TIME)"

Expiration date

manufacturer defined term based on very specific testing used for commercially available products

Define Beyond-use dates (BUD)s (1/4)

the date or time after which a compounded sterile preparation (CSP) may not be stored or transported and is calculated from the date or time of compounding