Compounding law

Preparation vs product
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Terms in this set (16)
Preparation vs product
Preparation = compounded drug
Product = commercially manufactured drug
How soon must administration of a drug product begin once preparation has begun to be exempt from sterile compounding laws?
Administration of the drug product must begin w/in ONE HOUR of beginning the preparation (ie within 1H of initial puncture)
True or false? For all antineoplastic compounded hazardous drug preparations listed in NIOSH, the pharmacy may either follow USP 800 or conduct a risk assessment.
FALSE! Antineoplastics must follow USP 800
What does a risk assessment for hazardous drugs compounded in a pharmacy entail?
1. Type of HD
2. Dosage form
3. Risk of exposure
4. Packaging
5. Manipulation
How often does a risk assessment for hazardous drugs need to be reviewed?
Every 12 months
Employees of reproductive capability must confirm in ___ that they understand the potential risks of handling hazardous drugs.
Writing
Compounded drug preparations dispensed to an inpatient shall be labeled according to the ____ labeling requirements of the administrative code.
Inpatient
Labels for compounds made in "bulk" shall contain:
1. Name, strength and qty of each active used in the preparation
2. Pharmacy control number
3. BUD
4. ID of repackager by final 7 digits of terminal distributor license #
5. Compound drug sticker
When and how much may a rph compound for a vet w/o a patient specific rx?
* Must not be a commercially available product*
1. Treat emergency situations or for diagnostic purposes
2. Limited quantity (consistent with BUD for time of use and what they are using it for)
3. Total dosage units throughout the year cannot exceed 5% of total units dispensed by the pharmacy
How much of a compounded preparation may a vet give to a patient?
7 days supply
BUD on sterile products without BUD from manufacturer and compounded by a prescriber?6HTrue or false. Prescribers can compound drugs regardless of patient-specific needs.False. May only compound is a specific patient need exists (no anticipatory compounding)For immediate-use sterile compounded drugs to be exempt from normal compounding rules, what must be true about the drugs going into the preparation?A simple transfer of not more than 3 commercially manufactured sterile non-hazardous drugs from the original container AND not more than 2 entries into any one container (either dilution fluid or administration container/device)BUD for immediate-use sterile compounded preparations?6H following preparation of drugBUD for immediate-use sterile compounded with buffered lidocaine containing antimicrobial preservatives?12HLabel on immediate-use sterile compounded if not administered immediately must contain?1. Patient name 2. Name & qty of each ingredient 3. BUD and time prepared 4. Name/initials of compounder