USP 795 Flashcards
what is the title of USP chapter 795?
pharmaceutical compounding - nonsterile preparations
what are the basic things discussed in USP 795? (6pts)
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
what is the difference in regards to expiration dates between manufacturers and pharmacists?
manu - uses an expiration dates
pharm - uses beyond use dates (BUD)
what us a basic responsibility of the compounder?
assurances of quality for ingredients, personel, finished preparations, processes, environment, stability, consistency, error prevention, and documentation
what is the beyond use date for solids/non-aqueous liquids prepared from commercially available dosage forms?
25% of the remaining expiration date of the commercial product, or 6mo, whichever is earliest
what is the beyond use date for solids/non-aqueous liquids prepared from bulk ingredients?
up to 6 months
what is the beyond use date for water-containing formulations (prepared from ingr. in solid form)?
up to 14days when stored in fridge
what is the beyond use date for all other compounds?
up to 30days or the intended duration of therapy, whichever is earliest
what do you do if there are no USP or NF grade ingredients available?
select a reasonably high quality grade ingredient from a reliable source (like ACS grade)
what is the 1st question to consider for every compounded preparation?
1) have the physical/chemical properties and medicinal, dietary, and pharmaceutical uses of the drug substances been reviewed?
what is the 2nd question to consider for every compounded preparation?
2) are the quantity and quality of each active ingredient identifiable?
what is the 3rd question to consider for every compounded preparation?
3)will the active ingredients be effectively absorbed, locally or systemically according to the Rx purpose, from the preparation and route of administration?
what is the 4th question to consider for every compounded preparation?
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?
what is the 5th question to consider for every compounded preparation?
5) were all calcs and measurements confirmed to ensure accurate compounding?
what is the 1st step in the compounding process?
judge to suitability of Rx to be compounded in terms of its safety and intended use
what is the 2nd step in the compounding process?
perform necessary calcs to establish the amounts of ingr. needed
what is the 3rd step in the compounding process?
identify equipment needed
what is the 4th step in the compounding process?
wear the proper attire and wash hands
what is the 5th step in the compounding process?
clean the compounding area and needed equipment
what is the 6th step in the compounding process?
only one Rx should be compounded at one time in a specific area
what is the 7th step in the compounding process?
assemble all necessary materials to compound the Rx
what is the 8th step in the compounding process?
compound the preparation following the formulation record or prescription, according to the art and science of pharmacy
what is the 9th step in the compounding process?
assess wt variation, adequacy of mixing, clarity, odor, color, consistency, and pH as appropriate
what is the 10th step in the compounding process?
annotate the compounding log, and describe the appearance of the formulation
what is the 11th step in the compounding process?
label the prescription containers
what needs to be included on the prescription label? (6pts)
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
what is the 12th step in the compounding process?
sign and date the Rx affirming that all procedures were carried out to ensure uniformity, identity, strength, quantity, and purity
what is the 13th step (and last step) in the compounding process?
thoroughly and promptly clean all equipment and store properly
why must records be kept?
for quality purposes and to enable another compounder to duplicate the preparation when prepared at a later time
what is the formulation record used for?
to prepare the documentation for the compounding record
what is the compounding record?
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.
