RXPREP Chapter 5: Compounding Flashcards
are compounded drugs FDA approved?
no - they meet unique needs. the dose or formulation cannot be commercially available
____ sets the standards for compounding preparations
USP
USP 795- non sterile
USP 797- sterile
USP 800- hazardous
Which 503 facility type are pharmacies that perform traditional compounding based on patient specific prescriptions?
503B
Which 503 facility type are regulated by the state boards of pharmacy
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
Section 503B allows compounding pharmacies that make sterile products for humans to register with the FDA as an ____ facility
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
503B pharmacies must follow what regulations
USP and CGMPs (same standard drug manufacturers use)
- increase product testing
- longer BUD
- FDA can perform inspections
Manufacturing:
regulation:
standards:
prescription:
indentifiers:
regulation: FDA
standards: USP and CGMPs
prescription: not required
indentifiers: NDC numbers
Traditional (503A) compounding: regulation: standards: prescription: indentifiers:
regulation: state boards
standards: USP
prescription: required
indentifiers: lot numbers
Outsourcing (503B) compounding: regulation: standards: prescription: indentifiers:
regulation: FDA, state license may be required
standards: USP and CGMPs
prescription: not required
indentifiers: must have lot number, may have NDC
ingredients that are acceptable for use will be listed in
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
all components in non sterile compounding should be stored off the floor
true
USP specifies refrigeration for what formulations only
water containing oral formulations only
what’s the BUD?
non sterile
does not contain water
stored at room temp
6 months
what’s the BUD?
non sterile
contains water
oral formulation
fridge
14 days
what’s the BUD?
non sterile
contains water
non-oral formulation
room temp
30 days
what are the exceptions to the BUD recommendations?
- 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
USP 797 formulations
IV, IM, SC, SQ, eye drops, inhalations, irrigations
in critical areas that are closest to exposed sterile drugs and containers, the air must be at least
ISO 5
The buffer area (SEC) must be at least ISO
ISO 7
the anteroom must be at least ISO8 if
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)
CSP risk level?
<3 sterile ingredients, no more than 2 entries into any 1 sterile container or device
low
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)
medium
TRN
CSP risk level?
non sterile ingredients and equipment
high
The default BUD is determined by…
the CSP risk level and the storage temperature
CSP risk level: low
room temperature
BUD:
CSP risk level:
room temperature
BUD:48 hours
CSP risk level: medium
room temperature
BUD:
CSP risk level:
room temperature
BUD: 30 hours
CSP risk level: high
room temperature
BUD:
CSP risk level:
room temperature
BUD: 24 hours
CSP risk level: low
fridge
BUD:
CSP risk level:
fridge
BUD: 14 days
CSP risk level: medium
fridge
BUD:
CSP risk level:
fridge
BUD: 9 days
CSP risk level: high
fridge
BUD:
CSP risk level:
fridge
BUD: 3 days
CSP risk level: any
frozen
BUD:
45 days
low risk compounds prepared in an ISO 5 PEC in an SCA receives what BUD
12 hour; whether its stored in fridge or room temp
immediate use CSPs BUD
one hour
how often should the hazardous list be reviewed?
every 12 months
the C-SEC must maintain ISO
7
C SEC can contain both sterile and non sterile C PECs
must be one meter apart
assessment of risk documents must be reviewed at least every __ months
12
how should HD drugs be stored?
NOT on the floor
separately from non HD drugs
negative pressure room with external ventilation and at least 12ACPH
pharmacies involved in HD compounding must perform wipe sampling of all compounding surfaces initially and every __ months
6 months
if the drug being repackaged is an FDA approved drug, USP and FDA guidance assigns a BUD of ___ months from the date of repackaging
6
