lecture 4 - USP chapters part 2 Flashcards

1
Q

differentiate between cleaning and sanitization

A

they are TWO DIFFERENT STEPS

cleaning first to just get the dust particles off

sanitization next using 70% isopropyl alcogol

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2
Q

the concept of MWQ is in what USP

A

795

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3
Q

what are “designated persons”

A

they are responsible and accountable for the performance and operation of the facility and personnel that are preparing CNSPs

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4
Q

what are “yearly reviews” done for and who is responsible for performing them

A

the designated person(s) are responsible

yearly review of quality assurance and quality control programs, as well as chemical hazard and disposal info

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5
Q

which USP chapter contains packaging and storage requirements

A

659

includes things like primary/secondary/tertiary and associated and ancillary components

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6
Q

who enforces “section 503a”

A

the FDA

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7
Q

explain the rules of when a drug can be compounded under section 503a****

A

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

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8
Q

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

A

true

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9
Q

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**

A

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

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10
Q

What is stated under section 503b

A

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

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11
Q

differentiate between 503a and 503b

A

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

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12
Q

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

A

TRUE

quality control is still maintained

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13
Q

aside from abiding by cGMP and having FDA inspections on a risk-based schedule, what other conditions must outsourcing facilities registered under 503b meet?

A

they must report adverse events and provide FDA with certain information about products they compound

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14
Q

under section 503b of the FD&C act, a compounder can register with the _____ as a _____

A

FDA as an outsourcing facility

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15
Q

w/o emulsion with a water content of 0.1

what is BUD

A

90 days

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16
Q
A