EX 5

review computation e4-5

COMPOUNDING

The preparation, mixing, assembling, altering,packaging, and labeling of a drug, drug delivery device in accordance with a licensedpractitioner/patient/pharmacists/compounderrelationship in the course if professional practice

COMPOUNDING

This is the Preparation of drug dosage forms for both human and animal

COMPOUNDING

This is the Preparation of drug or devices in anticipation of prescription drug orders based on routine, regularly observed prescribing patterns

COMPOUNDING

This is the Reconstitution or manipulation of commercial products that may require the addition of one or more ingredients

COMPOUNDING

This is the Preparation of drug or devices for the purpose of or as an incident to, research (clinical or academic), teaching or chemical analysis

Non-sterile compounding

____is also a process of customized medication but the environment is not completely free from viruses and bacteria.

non-sterile compounding

In ___, the risk of causing an infection is very low and there is no need for compounding the medications using sterile techniques.

• capsules

• suspensions

• solutions

• sugar-free/dye free/lactose-free formulations

non-sterile compounding medications are applied orally

___[4]

troches/solutions

non-sterile compounding medications are applied sublingually such as ___ ?

creams/gels/transdermal gels

non-sterile compounding medications are applied topically such as ___?

rectal/vaginal

non-sterile compounding medications are suppository __ ?

• Facilities and Environment

• Equipment

• Personnel and Training

• Ingredients

• Documentation

• Quality Control

• Waste Disposal

• Beyond Use Date

REQUIREMENTS FOR PROVIDING NON-STERILE COMPOUNDING SERVICES [8]

dispensing and counseling (Facilities and Environment)

[Facilities and Environment]
This Compounding area should be located sufficiently away from routine functions and high traffic area

• potential interruptions

• chemical contaminants

• dust and particulate matter

[Facilities and Environment]
Area should be isolated from ___,____, and sources of ___

• distractions

• unrelated activities

[Facilities and Environment]
A designated area free from ___ and __

one sink

[Facilities and Environment]
____should be located in or near the compounding area for hand washing before compounding operations

ventilation and lighting

[Facilities and Environment]
Proper___ and __ for accurate preparation.

• well lighted

• level and clean

[Facilities and Environment]
Work areas should be __
Work surfaces should be __

before and after use

[Facilities and Environment]"
Work surfaces must be sanitized ___

• food

• drinks

• personal items

[Facilities and Environment]
No presence of __ [3] in the compounding area.

• dust-collecting overhangs

• ledges

[Facilities and Environment]
The compounding area should not contain____ (e.g., ceiling utility pipes, hanging light fixtures) and _ __(e.g., windowsills)

• temperature

• humidity controls

[Facilities and Environment]
Proper storage conditions for raw materials, including ___ and ___

hazardous and non-hazardous materials

[Facilities and Environment]
Separate areas for ___ and ___ materials.

balances and volumetric

[Equipment]
Regular calibration of ___ and ___ tools.

Maintenance

[Equipment]
____schedules for equipment to ensure accuracy and reliability

pharmacist

[Personnel and Training]

The ____ who is responsible for ensuring that the best technical knowledge and skill, most careful and accurate procedures, and prudent professional judgment

• pharmacists

• compounding personnel

[Personnel and Training]
___ and ____ the they supervise should participate in programs designed to enhance and maintain competence in compounding

balances and measuring

[Personnel and Training]
Proper use of compounding equipment such ___ and ____as devices

Pharmaceutical techniques

[Personnel and Training]
___ are needed for preparing compounded dosage forms

• stability

• storage considerations

• handling procedures.

[Personnel and Training]
Properties of dosage forms to be compounded and related factors such as ___[3]

avoiding exposure

[Personnel and Training]
Handling of non-hazardous and hazardous materials in the work area, including protective measures for___, emergency procedures to follow in the event of exposure

chemical and pharmaceutical

[Personnel and Training]
Use and interpretation of ___ and ___symbols and abbreviations in medication orders and in product formulation directions

Personnel and Training

[Personnel and Training]
Pharmaceutical calculations

Attire

[Personnel and Training]
Personnel engaged in compounding should wear clean clothing appropriate for the duties they perform

Attire

[Personnel and Training]

• Protective apparel

• head cap

• mask

• laboratory gown

• gloves

USP/NF-grade

[Ingredients]
Use only ____ ingredients when available

Certificates of analysis (COA)

[Ingredients]
____ for raw materials must be reviewed and retained.

• expiration dates

• degradation.

[Ingredients]
Verify ___ and inspect materials for signs of ___

OSHA and USP <800>

[Ingredients]
Handle and store hazardous ingredients following ____ and _____ guidelines

Ingredients

[Ingredients]
Care must be exercised when using commercial drug products as a source of active ingredients. For example, extended-release or delayed-release products should not be crushed

liquid dosage forms

[Ingredients]
In Liquids ingredients- consider compounding ____ such as solutions, syrups, or elixirs

dry dosage form

[Ingredients]
Crystals or powders ingredients- final dosage form is intended to be a , options such as divided powders (powder papers) or capsules

liquids and dry ingredients

[Ingredients]
both __- liquid formulations such as solutions, suspensions, elixirs, syrups, and emulsions

Master Formula Record

___ should be created before compounding a preparation for the first time

Master Formula Record

The record shall be followed each time the preparation is mailed

• name

• strength

• dosage form

Master Formulation Record shall include: official or assigned ______ [3]of the preparation

active pharmaceutical ingredients

Master Formulation Record shall include: calculations needed to determine and verify quantities of components and doses of ______

• ingredients

• quantities

Master Formulation Record shall include: description of all___ and their ____

compatibility and stability

Master Formulation Record shall include: _____[2] information, including references when available

equipment

Master Formulation Record shall include: _____ needed to prepare the preparation, when appropriate

⚬ order of mixing

⚬ mixing temperatures or other environmental control

⚬ duration of mixing

Master Formulation Record shall include: mixing instruction that should include:

⚬ generic name and quantity or concentration of each ingredients

⚬ assigned Beyond Use Date (BUD)

⚬ storage condition

⚬ prescription or control number

Master Formulation Record shall include: labelling information:such as ___[4]

container

Master Formulation Record shall include: ____ in dispensing

final

Master Formulation Record shall include:
description of the ___ product

procedure and expected

Master Formulation Record shall include:
quality____and ___ result

Quality Control

The safety, quality, and performance of compounded preparations preparations depend on correct ingredients and calculations, accurate and precise measurements, appropriate formulation consideration and procedures

Verification

Double-check weights, volumes, and calculations.

Verification

Visual inspection for uniformity, color, and consistency.

Testing

Conduct pH checks for liquid preparations and verify the homogeneity of creams and ointments

Final Approval

Pharmacist review and sign-off before dispensing

waste disposal

Proper ____ in non-sterile compounding is essential for ensuring safety, environmental protection, and compliance with regulatory guidelines.

• EPA

• state regulations

Follow______and ____ for pharmaceutical and hazardous waste.

Environmental Protection Agency

EPA [meaning]

OSHA

Adhere to ____ standards for employee safety during handling.

Occupational Safety and Health Administration

OSHA[meaning]

Waste Disposal

Ensure all personnel are trained in waste segregation and disposal procedures.

Pharmaceutical Waste

Classification of Waste

Includes
►expired or unused raw materials

►leftover compounded products

►contaminated disposables (e.g., gloves, wipes)

Hazardous pharmaceutical waste

Classification of Waste
► Drugs listed under RCRA (Resource Conservation and Recovery Act) as hazardous due to toxicity, ignitability, corrosivity, or reactivity

Non-hazardous pharmaceutical waste

Classification of Waste

►Drugs that do not fall under hazardous classifications

Packaging Waste

Classification of Waste

►Containers

►wrappers

►boxes of raw materials.

Packaging Waste

Classification of Waste

► May include residual drug material
► require appropriate handling

Chemical Waste

Classification of Waste

Solvents or reagents used in the preparation process.

Chemical Waste

Classification of Waste May

require special disposal methods if hazardous.

Biological Waste

Classification of Waste

In cases where biological materials are compounded, they may generate biohazardous waste

Hazardous Pharmaceutical Waste

Waste Disposal in Non-Sterile Compounding:

Must be disposed of through licensed hazardous waste disposal services.

Hazardous Pharmaceutical Waste

Waste Disposal in Non-Sterile Compounding:

Includes drugs like chemotherapy agents, some antibiotics, and others listed as hazardous by EPA or local regulations

Non-Hazardous Pharmaceutical Waste

Waste Disposal in Non-Sterile Compounding:

should be sent to incinerators

Non-Hazardous Pharmaceutical Waste

Waste Disposal in Non-Sterile Compounding:

may be eligible for landfills, but only under regulatory guideline

Chemical Waste

Waste Disposal in Non-Sterile Compounding:

►certain acids or bases, can be neutralized before disposal

Chemical Waste

Waste Disposal in Non-Sterile Compounding: Licensed Facilities:

Disposal must be done through certified chemical waste management facilities

General and Packaging Waste

Waste Disposal in Non-Sterile Compounding:

Recycling: Clean, uncontaminated packaging materials can be sent for recycling.

General and Packaging Waste

Waste Disposal in Non-Sterile Compounding:

Regular Waste Disposal: Non-contaminated, non-recyclable waste can go to municipal waste systems.

Sharps waste

Waste Disposal in Non-Sterile Compounding:

Dispose of needles, blades, and syringes in FDA-approved sharps containers

Beyond Use Date

The ____ is the date after which a compounded preparation shall not be used

Beyond Use Date

It is determined from the date when the preparation is compounded

Beyond Use Date

Compounded preparations are intended for administration immediately

Non sterile preparation

_______ compounded are commonly packed in a tight, light resistant containers stored at controlled room temp. unless otherwise indicated

6

For Nonaqueous Formulations-The BUD is not later than the time remaining until the earliest expiration date of any API or_____ months, whichever is earlier.

14

For Water-Containing Oral Formulations-The BUD is not later than ___ days when stored at controlled cold temperatures.

30

For Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid Formulations-The BUD is not later than ____ days.