USP 795

Question 1

what is the title of USP chapter 795?

Answer 1

pharmaceutical compounding - nonsterile preparations

Question 2

what are the basic things discussed in USP 795? (6pts)

Answer 2

1) responsibility of the compounder
2) certain minimum standards/equipment required
3) stability of compounded preparations/beyond-use dates
4) selection and ingredient qualities
5) checklist for compounding
6) necessary records and documentation

Question 3

what is the difference in regards to expiration dates between manufacturers and pharmacists?

Answer 3

manu - uses an expiration dates

pharm - uses beyond use dates (BUD)

Question 4

what us a basic responsibility of the compounder?

Answer 4

assurances of quality for ingredients, personel, finished preparations, processes, environment, stability, consistency, error prevention, and documentation

Question 5

what is the beyond use date for solids/non-aqueous liquids prepared from commercially available dosage forms?

Answer 5

25% of the remaining expiration date of the commercial product, or 6mo, whichever is earliest

Question 6

what is the beyond use date for solids/non-aqueous liquids prepared from bulk ingredients?

Answer 6

up to 6 months

Question 7

what is the beyond use date for water-containing formulations (prepared from ingr. in solid form)?

Answer 7

up to 14days when stored in fridge

Question 8

what is the beyond use date for all other compounds?

Answer 8

up to 30days or the intended duration of therapy, whichever is earliest

Question 9

what do you do if there are no USP or NF grade ingredients available?

Answer 9

select a reasonably high quality grade ingredient from a reliable source (like ACS grade)

Question 10

what is the 1st question to consider for every compounded preparation?

Answer 10

1) have the physical/chemical properties and medicinal, dietary, and pharmaceutical uses of the drug substances been reviewed?

Question 11

what is the 2nd question to consider for every compounded preparation?

Answer 11

2) are the quantity and quality of each active ingredient identifiable?

Question 12

what is the 3rd question to consider for every compounded preparation?

Answer 12

3)will the active ingredients be effectively absorbed, locally or systemically according to the Rx purpose, from the preparation and route of administration?

Question 13

what is the 4th question to consider for every compounded preparation?

Answer 13

4) are there added substances present from manufactured products which may cause an allergic rxn, irritation, or toxicity? anything that will affect stability/solubility of drug? will preservatives affect the compound?

Question 14

what is the 5th question to consider for every compounded preparation?

Answer 14

5) were all calcs and measurements confirmed to ensure accurate compounding?

Question 15

what is the 1st step in the compounding process?

Answer 15

judge to suitability of Rx to be compounded in terms of its safety and intended use

Question 16

what is the 2nd step in the compounding process?

Answer 16

perform necessary calcs to establish the amounts of ingr. needed

Question 17

what is the 3rd step in the compounding process?

Answer 17

identify equipment needed

Question 18

what is the 4th step in the compounding process?

Answer 18

wear the proper attire and wash hands

Question 19

what is the 5th step in the compounding process?

Answer 19

clean the compounding area and needed equipment

Question 20

what is the 6th step in the compounding process?

Answer 20

only one Rx should be compounded at one time in a specific area

Question 21

what is the 7th step in the compounding process?

Answer 21

assemble all necessary materials to compound the Rx

Question 22

what is the 8th step in the compounding process?

Answer 22

compound the preparation following the formulation record or prescription, according to the art and science of pharmacy

Question 23

what is the 9th step in the compounding process?

Answer 23

assess wt variation, adequacy of mixing, clarity, odor, color, consistency, and pH as appropriate

Question 24

what is the 10th step in the compounding process?

Answer 24

annotate the compounding log, and describe the appearance of the formulation

Question 25

what is the 11th step in the compounding process?

Answer 25

label the prescription containers

Question 26

what needs to be included on the prescription label? (6pts)

Answer 26

1) name, qnty, strength of preparation
2) internal identification # (lot#)
3) beyond use date
4) initials of compounder who prepared the label
5) any storage requirements
6) any other statements required by law

Question 27

what is the 12th step in the compounding process?

Answer 27

sign and date the Rx affirming that all procedures were carried out to ensure uniformity, identity, strength, quantity, and purity

Question 28

what is the 13th step (and last step) in the compounding process?

Answer 28

thoroughly and promptly clean all equipment and store properly

Question 29

why must records be kept?

Answer 29

for quality purposes and to enable another compounder to duplicate the preparation when prepared at a later time

Question 30

what is the formulation record used for?

Answer 30

to prepare the documentation for the compounding record

Question 31

what is the compounding record?

Answer 31

contains the sources and lot numbers of the ingredients, calcs, processes used, results of any testing done, an assigned BUD, ID#, name of compounder, quantity of preparation compounded, etc.