lecture 4 - USP chapters part 2 Flashcards
differentiate between cleaning and sanitization
they are TWO DIFFERENT STEPS
cleaning first to just get the dust particles off
sanitization next using 70% isopropyl alcogol
the concept of MWQ is in what USP
795
what are “designated persons”
they are responsible and accountable for the performance and operation of the facility and personnel that are preparing CNSPs
what are “yearly reviews” done for and who is responsible for performing them
the designated person(s) are responsible
yearly review of quality assurance and quality control programs, as well as chemical hazard and disposal info
which USP chapter contains packaging and storage requirements
659
includes things like primary/secondary/tertiary and associated and ancillary components
who enforces “section 503a”
the FDA
explain the rules of when a drug can be compounded under section 503a****
must always be compounded AFTER receiving a valid prescription order
however, THEREARE EXEMPTIONS WHEN IT CAN BE COMPOUNDED PRIOR TO RECEIVING PRESCRIPTION
-based on a HISTORY of receiving orders
-these orders have been generated within established relationship between the licensed pharmacist/physician/patient (under section 503A(a)(2)(B)
based on number of valid scripts received in a 30 day period in the last year
true or false**
under section 503a, it is almost never allowed to compound prior to receiving prescription, but there are some exceptions where it can be compounded prior to receiving
true
as mentioned, there are some exceptions to 503a in which things can be compounded BEFORE receiving a prescription for it.
however, explain the limitations of this**
the compounder can hold a MAXIMUM of 30 days supply of the compounded drug. the number of this supply is based on the number of valid prescriptions received in a 30 day period in the last year
for ex, let’s say in oct 2023 i got 500 prescriptions for this compounded RX. therefore, i can make a max of 500 compounded prescriptions in advance for october 2024, because this is theoretically a 30 day supply
CANNOT HOLD MORE THAN THAT
What is stated under section 503b
allows OUTSOURCING FACILITIES to compound products for the purpose of office stock in places like hospitals/clinics – to adminster in cases of EMERGENCY
in other words – hospitals, clinics and healthcare practicioners can obtain NON PATIENT SPECIFIC (patient specific is 503a) compounded drug products from outsourcing facilities that are registered under 503b for cases of emergency
differentiate between 503a and 503b
under 503a, it’s allowed for pharmacies to compound prescriptions based on a past history or provider/patient/pharmacist specific relationship
under 503b, OUTSOURCING FACILITIES can compound products (w/o prescription) for facilities like hospitals and clinics to keep as office stock in the case of an emergency
true or false
outsourcing facilities registered under 503b are required to abide by current good manufacturing processes and have FDA inspections on a risk-based schedule
TRUE
quality control is still maintained
aside from abiding by cGMP and having FDA inspections on a risk-based schedule, what other conditions must outsourcing facilities registered under 503b meet?
they must report adverse events and provide FDA with certain information about products they compound
under section 503b of the FD&C act, a compounder can register with the _____ as a _____
FDA as an outsourcing facility
w/o emulsion with a water content of 0.1
what is BUD
90 days
