Prescription Product Labeling and Assigning Beyond Use Date

28 cards   |   Total Attempts: 182
  

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Cards In This Set

Front Back
Compounding performed using established aseptic technique
Stertile Compounding
Sterile Compounding utilizes what ultmate device to provide sterile environment
Laminar air flow hood
In addition to the information provided on the typed label, it is sometimes necessary to use________ to provide supplementary information regarding proper and safe administration, use, or stroage of the product
Axillary labels
The Louisiana Board of Pharmacy says that
all practitioner administered compounds shall be packaged in a suitable container with a label containing, at a minimum, the following information: (9)
1.) Pharmacy’s name, address, and telephone number

2.) Practitioner’s name

3.) Name of preparation

4.)Strength and concentration

5.) Lot number

6.) Beyond use date

7.) Special storage requirements, if applicable

8.) Assigned identification number

9.) Pharmacist’s name or initials
The time during which the product may be expected to meet the requirements of the pharmacopeial monograph for purity and potency
Expiration Date
What is the & stated potency of expired drugs based on accelerated studies
90%
The date after which a compounded preparation should not to be used
Beyond-use date
How is the beyond-use date determined
from the date the preparation is compounded
T or F

Expiration dates are used for commercial products
True

It is put on the label of a drug product by the manufacturer or distributor of the product.
T or F

Beyond-use date is the exact time interval that the compounded preparation can be expected to retain its purity and otency based on general guidelines, literature references or actual real time stablility studies using prescribed conditions
False

It is an estimate
Who puts the beyond-use date on the containers?
Pharmacist
Beyond-use date are used to put on what type of drug?
Manufactured drugs
For prescription drug products dispensed in multi-dose containers, the USP allows use what dates:
1.) Manufacture’s expiration date

OR

2.) 1 year from the date the drug is dispensed. Whichever is faster
For products requiring reconstitution before use, which expiration date should you use?
The manufactureer's recommendation on the product labeing
Regarding assigning beyond-use date for compounded drug preparation, what is the major problem for pharmacist?
Stability of compounded formulations often is not known