Lab 2 Post Lab Quiz Flashcards
USP 795
(2 parts)
- master formulation record
- compunding record
master formulation record
- MFR MUST be created for each unique formulation of a CNSP
- the MFR is a reciepe for the drug preparation that must be followed
- a book that contains all the MFR in the pharmacy is like cookbook (unlike cookbook you must follow the reciepes exactly so the CNSP is the same each time)
compounding record
- the record that MUST be completed each time a prepartion is compounded
- it refers to a MFR
T/F: is MFR the basis of compunding?
TRUE - master formulation record can be used as the basis for preparing the compunding record
master formulation record include…
(11 parts)
- name, strength, activity and dosage form of CNSP
- identities and amounts of all componets
- conntainer
- complete instrctuctiin of how to prepare CNSP - includes steps
- physical description of the final CNSP
- BUD date
- reference to support the assigned BUD and storage requirments
- calculations
- labeling
- quality control
- othe rinfo needed to describe the compounding process – ensure repeartability
compounding records include…
- name, strengthm acticity, dosage form of CNSP
- date and time of preparation
- assigned internal identification numbver
- method to indetifiy the indivuduals involved in the compounding process and verify the steps
- name, vendor, manufacturor, lot number, exp date
- weight
- assigned BUD and storage equiremnet
- total qunatity
- calculations, concnetrations, strength of API
- physical description of final CNSP
- results of quality control procedures
- MFR reference for the CNSP
labeling
to prevent errors during storage, dispensing and use
labeling consists of …
(2 parts)
- label on the immediate container
- all other written, printed or graphic matter associated with the article dispensed
label on the immediate container include
- assigned internal identification number
- active ingriedint, amount, activity, concentration
- storage conditions
- BUD
- dosage form
- total amount of volume if its not obvious from the container
labeling on the dispensed CNSP include
- route of admin
- indication that the prepartion is compounded
- any applicable special handling instrctution
- any applicable warning statemnets
- compunding facility name, contact info if the CNSP is to be sent outside of the facility or healthcare system in which it was compunded
T/F: USP/NF is a living document
TRUE - published annually and updated quarterly
USP/NF consists of…
(4 parts)
- front matter
- general notice and requiremnts
- general chapters
- mongraphs
front matter
describes its function, authority and procedures for providing input
general notices an requirments of USP/NF
genral info, definition, broad specifications and standards
general chapters
standard methods, miminum oractices, and specifications