Dosage Exam 2 Flashcards
What is included in the United States Pharmacopeia (USP)?
Standards for:
-Medications
-Healthcare technologies
-Related products
Chapters >1000 in the USP are what?
Informational
Chapters <1000 in the USP are what?
Enforceable
True or False: USP has no role in enforcement
True
What is sterile compounding?
Combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance to create a sterile preparation
What products must be sterile?
-Injections/infusions
-Irrigation of internal body cavities (minus mouth, rectal, and sinus)
-Opthalmic dosage forms
-Aqueous preparations for pulmonary inhalation
-Baths and soaks for live organs/tissues
-Implants
What is USP <800>?
Deals with hazardous drugs
Hazardous Drugs: Handling in Healthcare Settings
True or False: Radiopharmaceuticals are not required to comply with <797>
True
Which chapter must radipharmaceuticals comply with?
USP <829>
Radiopharmaceuticals Preparation, Compounding, Dispensing, and Repackaging
Who does USP <797> apply to?
All persons who prepare compounded sterile preparations (CSPs) and all places where CSPs are prepared
-applies to more than just pharmacists
True or False: USP <797> deals with administration of products
False, this is out of its scope
What does it mean for a compounded sterile product (CSP) to be Category 1?
Compounded under the least controlled environmental conditions
-Assigned a Beyond Use Date (BUD) of 12 h or less at controlled room temperature (RT) or 24 h or less when refrigerated
-Needs a segregated compounding area or clean suite
What is the Beyond Use Date of a Category 1 CSP kept at controlled room temperature?
12 hours or less
What is the Beyond Use Date of a Category 1 CSP kept refrigerated?
24 hours or less
What does it mean for a compounded sterile product (CSP) to be Category 2?
Require more environmental controls and testing than Category 1
-Assigned a Beyond Use Date (BUD) of >12h at controlled room temperature or > 24h if refrigerated. Must not exceed limits (Max 45 days at room temp, 60 days refrigerated, 90 days in freezer)
What is the Beyond Use Date of a Category 2 CSP kept at controlled room temperature?
> 12h
Maximum: 45 days
What is the Beyond Use Date of a Category 2 CSP kept refrigerated?
> 24 h
Maximum: 60 days
What is the maximum Beyond Use Date of frozen Category 2 CSP?
90 days
What does it mean for a compounded sterile product (CSP) to be Category 3?
Undergo sterility testing supplemented by endotoxin testing when applicable. Most requirements of all the categories
What are the maximum Beyond Use Dates for Category 3 CSP that have been kept at room temperature, refrigerated, and frozen?
Room Temp: 90 days max
Refrigerator: 120 days max
Freezer: 180 days max
Who must complete training in appropriate compounding principles and practices?
Personnel who compound or have direct oversight of compounding personnel
How often must compounding training be done?
Initially and then at least every 12 months
For Category 1+2: Every 6 months
For Category 3: Every 3 months
How many times must initial garbing competency be achieved?
No fewer than 3 consecutive times
How is evaluation of training for garbing/compounding competency done?
Visual Observation
Gloved fingertip and thumb (GFT) sampling of both hands
*done after garbing but before applying alcohol to gloves