RXPREP Chapter 5: Compounding

Question 1

are compounded drugs FDA approved?

Answer 1

no - they meet unique needs. the dose or formulation cannot be commercially available

Question 2

____ sets the standards for compounding preparations

Answer 2

USP

USP 795- non sterile
USP 797- sterile
USP 800- hazardous

Question 3

Which 503 facility type are pharmacies that perform traditional compounding based on patient specific prescriptions?

Answer 3

503B

Question 4

Which 503 facility type are regulated by the state boards of pharmacy

Answer 4

503A

• must follow USP and state board regulations
• must register with DEA (if dispensing CS) and state board
• compounding for MEDICAL OFFICE USE is PROHIBITED

Question 5

Section 503B allows compounding pharmacies that make sterile products for humans to register with the FDA as an ____ facility

Answer 5

outsourcing

• can prepare meds in bulk and without a prescription written for an individual patient
• can also compound meds for office use
• more stringent guidelines

Question 6

503B pharmacies must follow what regulations

Answer 6

USP and CGMPs (same standard drug manufacturers use)

• increase product testing
• longer BUD
• FDA can perform inspections

Question 7

Manufacturing:

regulation:
standards:
prescription:
indentifiers:

Answer 7

regulation: FDA
standards: USP and CGMPs
prescription: not required
indentifiers: NDC numbers

Question 8

Traditional (503A) compounding:
regulation:
standards:
prescription:
indentifiers:

Answer 8

regulation: state boards
standards: USP
prescription: required
indentifiers: lot numbers

Question 9

Outsourcing (503B) compounding:
regulation:
standards:
prescription:
indentifiers:

Answer 9

regulation: FDA, state license may be required
standards: USP and CGMPs
prescription: not required
indentifiers: must have lot number, may have NDC

Question 10

ingredients that are acceptable for use will be listed in

Answer 10

USP national formulary (USP NF)

food chemicals codex (FCC)

*preferreably, ingredients should be manufactured at an FDA registered facility; if it doesn’t come from here, a certificate of analysis should be obtained to confirm quality

Question 11

all components in non sterile compounding should be stored off the floor

Answer 11

true

Question 12

USP specifies refrigeration for what formulations only

Answer 12

water containing oral formulations only

Question 13

what’s the BUD?

non sterile

does not contain water

stored at room temp

Answer 13

6 months

Question 14

what’s the BUD?

non sterile

contains water

oral formulation

fridge

Answer 14

14 days

Question 15

what’s the BUD?

non sterile

contains water

non-oral formulation

room temp

Answer 15

30 days

Question 16

what are the exceptions to the BUD recommendations?

Answer 16

• if any ingredients deteriorates easily, select shorter BUD
• if any ingredient expires before the BUD, use earlier date
• BUDs can be extended if stability data is obtained that determines the drug is stable for longer period

Question 17

USP 797 formulations

Answer 17

IV, IM, SC, SQ, eye drops, inhalations, irrigations

Question 18

in critical areas that are closest to exposed sterile drugs and containers, the air must be at least

Answer 18

ISO 5

Question 19

The buffer area (SEC) must be at least ISO

Answer 19

ISO 7

Question 20

the anteroom must be at least ISO8 if

Answer 20

if it opens into a positive pressure buffer area (non-haz)

or at least 7 if it opens to a negative pressure buffer area (hazardous sterile)

Question 21

CSP risk level?

<3 sterile ingredients, no more than 2 entries into any 1 sterile container or device

Answer 21

low

Question 22

CSP risk level?

> 3 sterile ingredients OR multiple doses of a sterile product withdrawn from the same vial to make several CSPs of the same product (a batch)

Answer 22

medium

TRN

Question 23

CSP risk level?

non sterile ingredients and equipment

Answer 23

high

Question 24

The default BUD is determined by…

Answer 24

the CSP risk level and the storage temperature

Question 25

CSP risk level: low
room temperature
BUD:

Answer 25

CSP risk level:
room temperature
BUD:48 hours

Question 26

CSP risk level: medium
room temperature
BUD:

Answer 26

CSP risk level:
room temperature
BUD: 30 hours

Question 27

CSP risk level: high
room temperature
BUD:

Answer 27

CSP risk level:
room temperature
BUD: 24 hours

Question 28

CSP risk level: low
fridge
BUD:

Answer 28

CSP risk level:
fridge
BUD: 14 days

Question 29

CSP risk level: medium
fridge
BUD:

Answer 29

CSP risk level:
fridge
BUD: 9 days

Question 30

CSP risk level: high
fridge
BUD:

Answer 30

CSP risk level:
fridge
BUD: 3 days

Question 31

CSP risk level: any
frozen
BUD:

Answer 31

45 days

Question 32

low risk compounds prepared in an ISO 5 PEC in an SCA receives what BUD

Answer 32

12 hour; whether its stored in fridge or room temp

Question 33

immediate use CSPs BUD

Answer 33

one hour

Question 34

how often should the hazardous list be reviewed?

Answer 34

every 12 months

Question 35

the C-SEC must maintain ISO

Answer 35

7

C SEC can contain both sterile and non sterile C PECs

must be one meter apart

Question 36

assessment of risk documents must be reviewed at least every __ months

Answer 36

12

Question 37

how should HD drugs be stored?

Answer 37

NOT on the floor

separately from non HD drugs

negative pressure room with external ventilation and at least 12ACPH

Question 38

pharmacies involved in HD compounding must perform wipe sampling of all compounding surfaces initially and every __ months

Answer 38

6 months

Question 39

if the drug being repackaged is an FDA approved drug, USP and FDA guidance assigns a BUD of ___ months from the date of repackaging

Answer 39

6