Lecture 4 - USP chapters

Question 1

true or false

USP is a governmental, not for profit public health organization

Answer 1

false - non government

Question 2

the USP provides drug standards that are enforced by….

Answer 2

the FDA under the FDCA act

Question 3

what organization provides the reference standards for tests and methods to measure quality assurance, among other things

Answer 3

USP

Question 4

*** explain the general trend of USP chapter numbers

Answer 4

the ones numbered UNDER 1000 are required and enforceable

the ones greater than 1000 are informational and not required. they work in concert with the mandatory chapters - describe the theory and analytical considerations

Question 5

true or false

USP800 - hazardous drugs - is mandatory

Answer 5

true - under 1000

Question 6

USP chapters that are numbered greater than 2000 are what?

Answer 6

specific for DIETARY SUPPLEMENTS

Question 7

how is the USP involved in compounding

Answer 7

they have compounded preparation MONOGRAPHS

contains formulations and quality assurance standards. helps practicioners to compound formulations where there is NO SUITABLE COMMERCIAL PRODUCT

Question 8

name 3 specific patient populations that may require compounding

Answer 8

pediatrics
geriatrics
veterinary (pets)

Question 9

** USP 71

Answer 9

sterility testing of products

Question 10

which USP chapter contains packaging and storage requirements***

Answer 10

USP 659

Question 11

nonsterile/sterile/hazardous USP chapters

Answer 11

nonsterile - USP 795
sterile - USP 797
hazardous - USP 800

Question 12

true or false

the sterility test USP chapter is required and enforceable

Answer 12

TRUE

its ch 71 – below 1000

Question 13

which USP chapter is QUALITY ASSURANCE in pharmaceutical compounding***

IS IT REQUIRED

Answer 13

USP1163

NO

Question 14

Which 2 USP chapters are about containers and container-performance testing

Answer 14

USP661 and 671

Question 15

true or false

USP chapters numbered greater than 1000 are considered informational

Answer 15

true

Question 16

what USP chapter is good compounding practices

Answer 16

USP 1075

Question 17

what USP chapter is pharmaceutical calculations in pharmacy practice

Answer 17

1160

Question 18

what USP chapter is prescription balances and volumetric apparatus used in compounding

Answer 18

1176

Question 19

what USP chapter is determining the BUD of compounded preparation and/or use stability info

Answer 19

1191

Question 20

when is it possible that the BUD may be longer than the standard 14, 35, 90, and 180 days rules??

Answer 20

if sterility tests are done according to USP 71 and they’re all passed – BUD may be longer

Question 21

what is CNSP and what USP chapter provides standards for it

Answer 21

USP 795 provides standard for COMPOUNDING NONTERILE PREPARATIONS

Question 22

USP 795 describes the requirements for quality controls for nonsterile preparations

give an example of this

Answer 22

labeled potency must be within 10% (above or below)

Question 23

**** name the 3 general categories of non-sterile compounding

Answer 23

simple, moderate, and complex

Question 24

differentiate between simple, moderate, and complex compounding**

Answer 24

simple - reconstituting or manipulating a commercial product. may require adding 1 or more ingredients - AS DIRECTED BY THE MANUFACTURER

moderate - preparation requires special calc or procedures to determine the qty of components needed. OR making a preparation in which the stability data for the specific formulation is NOT AVAILABLE

complex - requires SPECIAL TRAINING, environment, facilities, equipment, or procedures

Question 25

*** preparing hormone vaginal suppositories is considered what category of compounding and why

Answer 25

COMPLEX need special facility and ingredients

Question 26

is preparing capsules simple, moderate, or complex compounding***

Answer 26

COMPLEX - need special training and equipment

Question 27

**compounding an oral suspension with water what water do we use?

Answer 27

purified --- nonsterile compounding

Question 28

an example of moderate compounding is if stability data for that formulation is not available what must be done?

Answer 28

contact the manufacturer for stability info or run own stability tests may need to be conservative with assigning BUD

Question 29

*oral antibiotic comes as a powder and we have to add water what kind of compounding

Answer 29

simple

Question 30

*oral antibiotic has been reconstituted with water and the patient wants you to add FLAVOR what kind of compounding is this

Answer 30

still simple

Question 31

*preparing an ointment and stability info is missing. what kind of compounding is this

Answer 31

moderate

Question 32

* all ingredients in compounding should be purchased from where?

Answer 32

A RELIABLE SOURCE - for both active and inactive ingredients

Question 33

*who is allowed in the vicinity of compounding operations

Answer 33

ONLY authorized personnel

Question 34

*the processes used in compounding must be carried out how?

Answer 34

exactly as specified, so much so that they can be replicated and reproduced without an issue

Question 35

*all aspects of compounding procedures must be ____ in ____

Answer 35

documented in the compounding record

Question 36

***what is the written record before/after the compounding is done

Answer 36

before - master formulation record after - compounding record

Question 37

***** TRUE OR FALSE there should only be ONE preparation compounded at a time

Answer 37

TRUE

Question 38

what is "compendial quality" and is it required************

Answer 38

USP/NF grade ingredients these must be tried to obtain 1st HOWEVER, if not possible - can use: -chemically pure -analytical reagent grade -ACS certified (american chemical society) HOWEVER - caution should be used in these cases bc impurities may have side effects

Question 39

name 3 sources in which ingredients can be obtained when it's not possible to get compendial quality

Answer 39

chemically pure analytical reagent grade american chemical society (ACS) certfied

Question 40

1. USP/NF grade 2. 3.

Answer 40

2. - LAB GRADE 3. Technical or commercial grade

Question 41

differentiate between if something as "USP" at the end or "NF" at the end

Answer 41

both are compendial grade USP is for active ingredients and NF is for inactive

Question 42

****CONTAINERS WITH NO EXPIRATION DATE how must the compounder label the container?

Answer 42

must put date of receipt (when pt received) and assign an expiration themselves, no later than 3 years after the date of receipt the date chose must be based on 4 things -nature of component -degradation mechanism -container -storage conditions

Question 43

containers WITH expiration dates can be used before that expiration date when...

Answer 43

material stays in original container under conditions to avoid chemical dedcomposition minimal exposure of the material when some is withdrawn

Question 44

true or false it is okay to put something back into the container after taking it out

Answer 44

false it is now contaminated and should be discarded

Question 45

aqueous solution has preservative, but 1 excipient expires in 20 days what should BUD be

Answer 45

20 days

Question 46

which compounding documentation must include sources, lot numbers, and expiration dates of the components

Answer 46

the compounding record

Question 47

which compounding documentation must include a description of all the ingredients and their quantities

Answer 47

master formulation record

Question 48

results of quality control procedures must go in what compounding documentation?? give 2 examples of quality control procedures*********

Answer 48

compounding record weight range of filled capsules pH of aqueous liquids

Question 49

a drug adhered to the bottle it was dispensed in when compounding what must be done

Answer 49

document it in compounding record and recall the product. this is going to be an underdose since drug is sticking to the container and not being delivered

Question 50

***what USP chapter is involved with quality control

Answer 50

USP1163

Question 51

true or false under USP 1163, the compounder must have written procedures to describe the tests performed on the compounded preparation to ensure its integrity

Answer 51

TRUE --- involved with USP 1163 which is QUALITY CONTROL****

Question 52

Aside from quality control tests to ensure the integrity of the compounded product, name another important quality control aspect of USP1163

Answer 52

determining when recalls must be initiated if a recall must be done - need to notify prescriber and identify the patients who have received the CNSP (compounded nonsterile preparation), dispose of it, and DOCUMENT

Question 53

quality control of CNSP's are a combination of what 2 USPs

Answer 53

USP 795 and USP 1163

Question 54

name some patient counseling considerations when dispensing a compounded preparation

Answer 54

they must be told how to use, store, and dispose of it also be instructed to let pharmacist know of any adverse events or changes in the compound's physical appearance