Compounding: USP 795 Flashcards
What are considered nonsterile products?
Tablets
Capsules
Liquids
Creams
Ointments
Rectal and vaginal suppositories
Nasal sprays and otic prepraration (except for use with perforated eardrums)
What is a designated person?
One or more individuals that oversee the responsibilities of compounding nonsterile preparations (CNSPs)
What is the designated person responsible for?
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
Requirement for SOPs
Need to be written (but can be electronic)
How often should SOPs be reviewed?
Annually, and PRN when new compounds, equipment, and other situations arise
How long should you keep the old policies for?
3 years
Does a designated person have to be an RPh?
No
795 training standards
All personnel involved need to be trained
There should be a training component that includes observation of making products
How often does competency must be documented?
Every 12 months
Personal hygiene and garbing: gloves
Must be worn at all times during compounding
Personal hygiene and garbing: garb
Not required, but should be assessed PRN based on products being compounding
Personal hygiene and garbing: what’s the purpose of garbing?
Protects products being made
Personal hygiene and garbing: purpose of PPE?
Protects the compounder from the products themselves
Personal hygiene and garbing: how to wash hands
Wash hands all the way up to elbows for at least 30 seconds with soap and water
Personal Hygiene and garbing: gloves
Should be latex and powder free
Are sterile gloves required for CNSPs
No
What to consider if other PPE’s needed
API
SDS
NIOSH
Components in compounds: API. What can it be referred to?
Bulk drug substance
Powder
Raw material
APIs should come from what kind of supplier?
A supplier that’s registered with the FDA
Products should be marked as what?
USP or NF on the container
What do you need to assess a product?
Certificate of Analysis
What does the Certificate of Analysis do?
Tells you the quality standards related to the component
What can’t be used as APIs?
Chemicals with ACS
APIs with no expiration date should be discarded when?
3 years from when you received it (not when you opened it)
Water use in CNSPs requirements
Needs to be purified water or better
What happens if a bottle of purified water is opened but you don’t use all of it?
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)
Building and facilities: what needs to be assessed?
Need to assess if compounding can generate airborne particles and what PPE is needed beyond gloves
If drugs can be aerosolized, what is needed?
A containment ventilated enclosure (CVE) or biological safety cabinet (BSC) is needed
What do you review for recommended ventilation control?
SDS
What do you need if you compound hazardous AND nonhazardous drugs?
You need two separate pieces of equipment for this
Exception to the two separate pieces of equipment for compounding hazardous and nonhazardous drugs
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
BUD for 795: nonpreserved aqueous dosage forms
14 days
Storage conditions for non preserved aqueous dosage forms
In the fridge
BUD for 795: preserved aqueous dosage forms
35 days
Storage conditions for preserved aqueous dosage forms
Fridge OR room temp
BUD for 795: PO non aqueous liquids
90 days
Storage conditions for PO non aqueous liquids
Fridge OR room temperature
BUD for 795: other nonaqueous dosage forms
180 days
Storage conditions for other nonaqueous dosage forms
Fridge OR room temperature
General record keeping: what is a master formulation record?
Recipe for the compound created before it’s made
General record keeping: what’s a compounding record?
Record AFTER the compound is made that has the list of ingredients, lot numbers, expiration dates, BUD, and copy of the Rx label
General record keeping: what should always be on the label?
BUD, and any other info required on Rx labels
