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P1 - Non-Sterile > Lab 2 Post Lab Quiz > Flashcards

Lab 2 Post Lab Quiz Flashcards

1
Q

USP 795
(2 parts)

A
  1. master formulation record
  2. compunding record
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2
Q

master formulation record

A
  • 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)
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3
Q

compounding record

A
  • the record that MUST be completed each time a prepartion is compounded
  • it refers to a MFR
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4
Q

T/F: is MFR the basis of compunding?

A

TRUE - master formulation record can be used as the basis for preparing the compunding record

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5
Q

master formulation record include…
(11 parts)

A
  1. name, strength, activity and dosage form of CNSP
  2. identities and amounts of all componets
  3. conntainer
  4. complete instrctuctiin of how to prepare CNSP - includes steps
  5. physical description of the final CNSP
  6. BUD date
  7. reference to support the assigned BUD and storage requirments
  8. calculations
  9. labeling
  10. quality control
  11. othe rinfo needed to describe the compounding process – ensure repeartability
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6
Q

compounding records include…

A
  1. name, strengthm acticity, dosage form of CNSP
  2. date and time of preparation
  3. assigned internal identification numbver
  4. method to indetifiy the indivuduals involved in the compounding process and verify the steps
  5. name, vendor, manufacturor, lot number, exp date
  6. weight
  7. assigned BUD and storage equiremnet
  8. total qunatity
  9. calculations, concnetrations, strength of API
  10. physical description of final CNSP
  11. results of quality control procedures
  12. MFR reference for the CNSP
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7
Q

labeling

A

to prevent errors during storage, dispensing and use

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8
Q

labeling consists of …
(2 parts)

A
  1. label on the immediate container
  2. all other written, printed or graphic matter associated with the article dispensed
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9
Q

label on the immediate container include

A
  1. assigned internal identification number
  2. active ingriedint, amount, activity, concentration
  3. storage conditions
  4. BUD
  5. dosage form
  6. total amount of volume if its not obvious from the container
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10
Q

labeling on the dispensed CNSP include

A
  1. route of admin
  2. indication that the prepartion is compounded
  3. any applicable special handling instrctution
  4. any applicable warning statemnets
  5. compunding facility name, contact info if the CNSP is to be sent outside of the facility or healthcare system in which it was compunded
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11
Q

T/F: USP/NF is a living document

A

TRUE - published annually and updated quarterly

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12
Q

USP/NF consists of…
(4 parts)

A
  1. front matter
  2. general notice and requiremnts
  3. general chapters
  4. mongraphs
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13
Q

front matter

A

describes its function, authority and procedures for providing input

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14
Q

general notices an requirments of USP/NF

A

genral info, definition, broad specifications and standards

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15
Q

general chapters

A

standard methods, miminum oractices, and specifications

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16
Q

monographs

A

specifications relating to particular drugs, excipents, manufactured drug products and compounded drug preparations

17
Q

monographs include…

A
  1. drugs - API
  2. excipients
  3. drug products - manufactured
  4. drug preparations - compounded

be able to distinguage types and identify monographs for compounded drug prepartions

18
Q

monograph for API

A
  • genrally shows the structure
  • lists USP reference standards to use for any assay
  • devotes most of teh monograph to the assay
  • purity
  • impirties
19
Q

monograph for drug product - manufactured by pharmaceutical company

A
  • defines the article that is labeled with the monograph title
  • devotes most of the monograph to the assay
  • contains specifications for pH, drug relase, etc
20
Q

monograph for a compunded preparation

A
  • has”compounded” in the title
  • defines the artcile that is labeled with the monograph title
  • contains a list of ingrients in a boxed tabel
  • contains mixing instructions
  • devites most of the text to assay
  • ## go to the end

performs test
speficiation for ph
package + storage
BUD
kabeling

P1 - Non-Sterile (1 decks)

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