Compounding (795, 797)

Question 1

who performs 503-b compounding

Answer 1

outsourcing facilities

Question 2

what is 503-a

Answer 2

traditional compounding

Question 3

what is the limit of dispensing compounded products across state lines

Answer 3

<5% of scripts

Question 4

what is documented in sterile compounding assessment

Answer 4

training
equipment inspections
production records
certificates of analysis
temp log
SOPs, master formulation
cleaning

Question 5

what are under USP 795 non-sterile comp

Answer 5

nasal and sinus
orals
rectals
vaginals
topicals
otic

Question 6

what are BUD for 795 based on

Answer 6

water activity (Aw)

Question 7

USP 795 product
aqueous dosage form (Aw >/=0.60)
+
no preservative

BUD?
storage temp?

Answer 7

14d
fridge

Question 8

USP 795 product
aqueous dosage form (Aw >/=0.60)
+
preservative

BUD?
storage temp?

Answer 8

35 days
controlled room temp or fridge temp

Question 9

USP 795 product
non-aqueous dosage form (Aw <0.60)
oral liquid

BUD?
storage temp?

Answer 9

90d
controlled room temp or fridge

Question 10

USP 795 product
non-aqueous dosage form (Aw <0.60)
not oral liquid

BUD?
storage temp?

Answer 10

180d
controlled room temp or fridge

Question 11

oral ABX compounded with water and an Aw of 0.78, no preservative

BUD?
storage?

Answer 11

14d
fridge

Question 12

oral ABX compounded with water and an Aw of 0.78, + preservative

BUD?
storage?

Answer 12

35d
fridge or controlled room temperature

Question 13

what products are covered by USP 797

Answer 13

injections
infusions
irrigation for body cavities
ophthalmic
aqueous inhalants
organ and tissue fluids
implants

Question 14

USP 797

prepared in an ISO Class ______ or better PEC
BUD?

Answer 14

ISO Class 5 or better

BUD </= 12h if room temp
BUD </= 24h if fridge temp

Question 15

if prepared in ISO Class 5 clean room or better IN a clean room suite, what are the BUDs?

Answer 15

24 hours at controlled room temp
4 days in fridge temp
90 days frozen
(see table with green title)

Question 16

if a single dose product is used (vial), what is the BUD?

Answer 16

12h

Question 17

how long are multi-dose vials good for

Answer 17

28d MAX

Question 18

quality assurance vs quality control

Answer 18

assurance is prospective, control is retrospective

Question 19

can 503-b (outsourcing facilities) produce sterile or non sterile products?

Answer 19

must produce at least 1 sterile product
non sterile allowed too

‘for office use only’ (hospital, clinic, etc.) not for re sale

Question 20

if you have a suspect product, how long do you have to report it to the FDA

Answer 20

24h

Question 21

do you have to document when a patient requests non child resistant packaging

Answer 21

yes

Question 22

can a provider request non-child resistant packaging

Answer 22

no, only the patient can