Term
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Definition
Each pharmacy shall have 2 binders:
Compounding Reference Binder
Compounding Working Binder |
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Term
COMPOUNDING
REFERENCE BINDER |
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Definition
SHOULD CONTAIN THE FOLLOWING:
-New compounding regulation requirements
-Operating procedures
-Training documents
-Calibration certificates for scales and hoods |
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Term
COMPOUNDING
WORKING BINDER |
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Definition
SHOULD CONTAIN THE FOLLOWING:
-Printed recipes or master formula record template
-Necessary logs required
-Certificates of analysis |
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Term
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Definition
-The log is intended to keep perpetual inventory of the chemicals and bulk substances used in the preparation of the compounded product
-The preparing tech and Rph must sign off on this log |
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Term
| FUTURE USE COMPOUNDED LOG |
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Definition
-A pharmacy may prepare and store a LIMITED QUANTITY of a compounded drug product in advance.
-A unique assigned lot number is assigned for each "FUTURE USE" compounded products. The format is divided into 3 parts separated by hypen:
-Date made
-Assigned numeric sequence
-Assigned an alpha letter
EX: 51013-1-A |
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Term
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Definition
| Any outsourced compounded products must be documented on this log (includes KP inpatient compounds) |
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Term
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Definition
A certificate of analysis is required:
Whenever a new lot of a chemical or bulk substance is received by the pharmacy for compounding use. |
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Term
| STABILITY CRITERIA AND BEYOND-USE-DATING |
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Definition
| The beyond-use date is the expiration date after which a compounded item should no longer be used and is determined from the date the preparation is compounded. |
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Term
STABILITY CRITERIA AND BEYOND-USE-DATINGNON-
AQUEOUS LIQUIDS AND SOLD FORMS |
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Definition
The beyond-use date is no later than 25% of the time remaining until the manufacturer's expiration date or 6 months, whichever comes first.
EX: LCD 10% in White Petrolatum |
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Term
STABILITY CRITERIA AND BEYOND-USE-DATINGFOR WATER
CONTAINING FORMULAS |
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Definition
The beyond-use date is no later than 14 days stored at cold temps between 2 and 8 C
EX: Reconstituting of Amoxicillin oral suspension |
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Term
STABILITY CRITERIA AND BEYOND-USE-DATINGFOR ALL
OTHER FORMULAS |
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Definition
The beyond-use date is no later than the intended duration of therapy or 30 days, whichever comes first.
EX: Dakin's Solution 7 days |
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