USP 795 General Compounding - Constantino

What is compounding

Drug prepared for an individual patient based on prescription. Compounded drugs are unique and not FDA approved. The dose or form can not be commercially available as a manufactured product.

Examples of Non-sterile preparations (CNSPs)

Solid oral preps

Liquid oral preps

Rectal preps

Vaginal preps

Topicals

Nasal preps

Otic preps

Exclusions from 795

Administration within 4 hours of prep

Nonsterile radiopharmaceuticals

Reconstitution on manufactured products

Repackaging of manufactured drugs

Splitting tablet

Who does 795 apply to

To all persons who prepare CNSPs and all places where CNSPs are prepared

Designated individual

To be responsible for the operations around compounding.

Responsibilities of the designated individual

Training program oversight

Selecting components

Monitoring and observing compound activities

Ensuring there are standard operating procedures

Following up on deficient practices and problems identified

SOPs for handling and storage of CNSPs

Requirements for non sterile compounding competency

Initial training, hands on demonstration of skills, and mandatory refresher every 12 months

Initial training

Personnel must learn and demonstrate proficiency in principles and hands on skills before independently compounding any non-sterile preparations

Annual refresher

Competency and documentation must be reevaluated and recorded at least once every 12 months

Categories of compounding

Simple: compounding kit instructions or USP monograph

Moderate: involves specialized calculations or a prep that has no established stability data

Complex: requires specialized training, equipment or procedures

Physical Space

Designed for non-sterile compounding and distinct location that is separate from the dispensing space. Ambient room air is allowed. Separate shelving and storage that is off the floor. Adequate plumbing and two types of water (potable and purified). Sink and soap.

Personal hygiene and garbing

Remove outer garments and jewelry. Proper hand washing. Shoe covers, head and facial hair covers, masks and gowns should be worn if needed for protections of the personnel and to prevent contamination. Gloves are must.

When does the work surface need to be cleaned

Beginning and end of shift, after spills, when surface is contaminated, and between compounding

When do floors need to be cleaned

Daily, after spills, after contamination

When do walls need to be cleaned

Every 3 months, after spills and when surface contamination occurs

When do ceilings need to be cleaned

When visibly soiled or contamination occurs

When do storage shelves need to be cleaned

Every 3 months, after spills and when surface contamination occurs

Master formulation record

Detailed record of procedures that describes how the CNSP is prepared. Each unique CNSP must have a master formulation record.

Compounding Record

Documents the actual compounding of a CNSP. Uses the master formulation record as basis of compounding

Components of master formulation record

Name, strength, and dosage form

Identifies all components

Container

Complete instructions

Physical description of the final CNSP

Assigned Beyond Use Date and storage requirement

References

Calculations for quantities and concentrations

Labeling requirements

QC procedures

Components of compounding record

Date and time of preparation

Assigned identification number (rx number, lot number)

Individuals involved in compounding and final verification

Name, manufacturer, lot number, and expiration date of each component

Component Receipt

For components other than conventionally manufactured products. Information including the receipt date, quantity received, supplier name, lot number, expiration date, and results of any in-house or third-party testing performed must be documented. The date of receipt by the compounding facility must be clearly and indelibly marked on each component package that lacks a vendor expiration date.

Packages of components (i.e., API and added substances) that lack a vendor’s expiration date must not be used by the compounding facility after 3 years from the date of receipt.

Non preserved aqueous dosage form BUD

Refrigerator 14 days

Preserved aqueous dosage form BUD

Room temp or fridge

35 days

Nonaqueous dosage form BUD

Room temp or fridge

90 days

Solid dosage form BUD

Room temp or fridge

180 days

How often must the counters and easily cleanable work surfaces within a nonsterile compounding area be cleaned and sanitized under standard operational conditions

At the beginning and end of each shift, and after spills or surface contamination