Compounding: USP 795

Question 1

What are considered nonsterile products?

Answer 1

Tablets
Capsules
Liquids
Creams
Ointments
Rectal and vaginal suppositories
Nasal sprays and otic prepraration (except for use with perforated eardrums)

Question 2

What is a designated person?

Answer 2

One or more individuals that oversee the responsibilities of compounding nonsterile preparations (CNSPs)

Question 3

What is the designated person responsible for?

Answer 3

Developing and overseeing policies and procedures
Ensure compliance with laws, regulations, and standards
Ensure competency of all personnel involved in compounding products
Ensure environmental controls of facilities used for storing and compounding CNSPs

Question 4

Requirement for SOPs

Answer 4

Need to be written (but can be electronic)

Question 5

How often should SOPs be reviewed?

Answer 5

Annually, and PRN when new compounds, equipment, and other situations arise

Question 6

How long should you keep the old policies for?

Answer 6

3 years

Question 7

Does a designated person have to be an RPh?

Answer 7

No

Question 8

795 training standards

Answer 8

All personnel involved need to be trained
There should be a training component that includes observation of making products

Question 9

How often does competency must be documented?

Answer 9

Every 12 months

Question 10

Personal hygiene and garbing: gloves

Answer 10

Must be worn at all times during compounding

Question 11

Personal hygiene and garbing: garb

Answer 11

Not required, but should be assessed PRN based on products being compounding

Question 12

Personal hygiene and garbing: what’s the purpose of garbing?

Answer 12

Protects products being made

Question 13

Personal hygiene and garbing: purpose of PPE?

Answer 13

Protects the compounder from the products themselves

Question 14

Personal hygiene and garbing: how to wash hands

Answer 14

Wash hands all the way up to elbows for at least 30 seconds with soap and water

Question 15

Personal Hygiene and garbing: gloves

Answer 15

Should be latex and powder free

Question 16

Are sterile gloves required for CNSPs

Answer 16

No

Question 17

What to consider if other PPE’s needed

Answer 17

API
SDS
NIOSH

Question 18

Components in compounds: API. What can it be referred to?

Answer 18

Bulk drug substance
Powder
Raw material

Question 19

APIs should come from what kind of supplier?

Answer 19

A supplier that’s registered with the FDA

Question 20

Products should be marked as what?

Answer 20

USP or NF on the container

Question 21

What do you need to assess a product?

Answer 21

Certificate of Analysis

Question 22

What does the Certificate of Analysis do?

Answer 22

Tells you the quality standards related to the component

Question 23

What can’t be used as APIs?

Answer 23

Chemicals with ACS

Question 24

APIs with no expiration date should be discarded when?

Answer 24

3 years from when you received it (not when you opened it)

Question 25

Water use in CNSPs requirements

Answer 25

Needs to be purified water or better

Question 26

What happens if a bottle of purified water is opened but you don’t use all of it?

Answer 26

Can be stored in the fridge for later use, just add a BUD to the water (which can be set to whatever SOP is at the facility)

Question 27

Building and facilities: what needs to be assessed?

Answer 27

Need to assess if compounding can generate airborne particles and what PPE is needed beyond gloves

Question 28

If drugs can be aerosolized, what is needed?

Answer 28

A containment ventilated enclosure (CVE) or biological safety cabinet (BSC) is needed

Question 29

What do you review for recommended ventilation control?

Answer 29

SDS

Question 30

What do you need if you compound hazardous AND nonhazardous drugs?

Answer 30

You need two separate pieces of equipment for this

Question 31

Exception to the two separate pieces of equipment for compounding hazardous and nonhazardous drugs

Answer 31

If it’s negative pressure, you can use it for occasional nonhazardous compounding, but you can’t do this in reverse where you use a hazardous CVE for occasional nonhazardous drugs

Question 32

BUD for 795: nonpreserved aqueous dosage forms

Answer 32

14 days

Question 33

Storage conditions for non preserved aqueous dosage forms

Answer 33

In the fridge

Question 34

BUD for 795: preserved aqueous dosage forms

Answer 34

35 days

Question 35

Storage conditions for preserved aqueous dosage forms

Answer 35

Fridge OR room temp

Question 36

BUD for 795: PO non aqueous liquids

Answer 36

90 days

Question 37

Storage conditions for PO non aqueous liquids

Answer 37

Fridge OR room temperature

Question 38

BUD for 795: other nonaqueous dosage forms

Answer 38

180 days

Question 39

Storage conditions for other nonaqueous dosage forms

Answer 39

Fridge OR room temperature

Question 40

General record keeping: what is a master formulation record?

Answer 40

Recipe for the compound created before it’s made

Question 41

General record keeping: what’s a compounding record?

Answer 41

Record AFTER the compound is made that has the list of ingredients, lot numbers, expiration dates, BUD, and copy of the Rx label

Question 42

General record keeping: what should always be on the label?

Answer 42

BUD, and any other info required on Rx labels