compounding 3

What is USP 795

Pharmacuetical compounding for non sterile preparations

What are CNSPs

Compounded Non Sterile Preparations

Which CNSPs must comply with USP 795

Solid oral preperations

Liquid oral 

Rectal

VAginal 
topical 

Nasal

Otic

Which personnel must be CNSP trained

Nurses

Physcians

Vets

Dentists 

Neuropaths

Pharmacies 

hospitals

How often should personell be tested for CNSP preprations

Every 12 months

What personal items can preparers not wear

Remove personal outer garments

Remove hand, wrist and other garments

Remove earbuds and headphones

What hygeine procedures must personell follow

Wash hands with soap and water

Make sure gloves arent punctured or have holes 

How often do personell monitor temperature of storage areas

Once daily on days facility is open or continously with temp monitors

What time during compounding process whould equipment be cleaned

Before and after compounding

What criteria must the API the preparer chooses have

COA 

Comply with USP-NF

registered to FDA 

Purified Water or Sterile Water for Injection

What must personnel do before using an ingredient

re inspect all components

What is a master formulation record

What the compounding formula should ideally be by explaining compounding process to ensure repeatability

What is a compounding record 

Method to identify the indoviduals involved in the compounding process and individuals verifying the final CNSP

Should include name, vendor, manufacturer lot number and expiration of each component

What is the BUD for non preserved aqueous dosage forms

14 days in the refrigerator

What is the BUD for preserved aqueous dosage forms

35 days in controlled room temp or refrigerator

What is the BUD for Oral liquids non aqueous 

90 days controlled room temp or refrigerator

What is the BUD of other non aqueous dosage forms

180 days in controlled room temp or refrigerator

What is quality assurance

System od procedures, activiries, and oversight that ensures that the compounding process consistently meets quality standards

What is quality control 

Sampling testing and documentation of results consistently meets quality standarsd

Beyond Use Date

The date, hour and date after which a CNSP must not be used, stored or transported

What is a biological safety cabinet

Ventillated cabinet that thats used for compounding,

These cabinets are divided into Class I, Class II and Class III

Class II divided into

Type A1, A2, B1 B2 and C1

What is COA 

A report from the supplier of component, container or closure that accompanies supplier’s material and contains specifications and results of all analyses and a description of the material 

Closed system processing device

A device designed to reduce the potential exposure to personnel or contamination of the facility of CNSPs such as CVEs, BSCs and single use containment glove bags

What is a Containment Ventilated Enclosure

A full or partial enclisure to capture contain and remove airborne contaminants through HEPA and prevent release to work enviornment

What is Quality assurance 

System of procedures, activiies and oversight that ensure the compounding meets quality standards

What is Quality control

Sampling, testing, documentation of results taht taken together ensure the specification suspension

What is water activity

Measure of the fraction of total water that is unbound and freely available to participate in reactions or provide an enviornment that supports microbial growth

What is the water activity og tablets

0.427