1.1.

Compounding/Extemporaneous Preparation

What is Compounding?

Compounding is the process where a pharmacist prepares a medicine specially for a patient.
Instead of giving a ready-made medicine from a factory, the pharmacist mixes, changes, or
prepares the medicine by hand.

This is done when commercial medicines are not suitable for the patient.

simply
Compounding means making a medicine that fits one specific patient’s needs.

Main Things Involved in Compounding

1. Making medicines for patients (humans and animals)

Pharmacists compound medicines for:

 People (children, adults, elderly)

 Animals (pets like dogs and cats, or farm animals)

This is needed when:

 The patient needs a special dose

 The patient is allergic to an ingredient in normal medicine
 The medicine is not available in the required form

Example:

 A child needs a smaller dose than adults.

 A dog needs a flavored liquid medicine instead of a tablet.

2. Making medicines based on common prescriptions

Sometimes, doctors often prescribe the same type of medicine for many patients.

In this case:

 The pharmacist prepares the medicine in advance

 This saves time and helps patients get their medicine faster

Example:

 A skin cream often prescribed by doctors can be prepared in small batches.

 A cough syrup commonly used in children can be compounded regularly.
⚠️These medicines are still made carefully and safely.

3. Changing or adding ingredients to commercial medicines

Sometimes, ready-made medicines do not suit the patient, so the pharmacist changes them.

This can include:

 Changing the form (tablet → liquid or cream)

 Removing an ingredient that causes allergy
 Adding ingredients to improve taste, stability, or effectiveness

Example:

 A patient cannot swallow tablets → the pharmacist makes it into a liquid.

 A child does not like the taste → a flavor is added.
 A patient is allergic to dye → the dye is removed.

4. Making medicines for research or teaching

Compounding is also used for:

 Scientific research
 Teaching pharmacy students

In these cases:

 Medicines are made for experiments

 Students learn how to prepare medicines correctly and safely

Example:

 Pharmacy students practice making ointments or syrups.

 Researchers test how different ingredients work together.

5. Making medicines for doctors’ offices

Sometimes, medicines are compounded specifically for clinics or doctors’ offices.

This helps because:

 Doctors can give medicine immediately to patients

 It is useful for emergency or routine treatments

Example:
  Eye drops prepared for an eye clinic
 Injection solutions prepared for a hospital department

1.2. Reasons and Benefits of Compounding

Compounding is done when regular, store-bought medications aren’t a good fit for a patient.
Here are some of the main reasons why compounding might be needed:

 Unavailable dosages or strengths: Sometimes, the right strength or dose of a medication

isn’t available from the manufacturer. The pharmacist can make it in the right dose for
the patient.
 Adjusting doses for kids or older adults: Medications often come in doses meant for
adults. If a child or older person needs a lower dose, compounding allows the pharmacist
to make a medicine with the correct amount of the active ingredient.
 Helping children who don’t like the taste of medicine: Some medicines taste bad, so
the pharmacist can make a version that tastes better (like turning a pill into a flavored
liquid).
 Making medicines easier to take: If someone has trouble swallowing pills, the
pharmacist might change the medicine from a pill to a liquid or even a topical cream.
 Creating custom creams or ointments: Sometimes, people need specific combinations
of medicines in a cream or ointment that the manufacturer doesn’t make. The pharmacist
can mix the ingredients to make the right product for that person.
 Changing ingredients for allergic reactions: If someone is allergic to a certain
ingredient in a commercial drug, compounding allows the pharmacist to remove that
ingredient and replace it with something else that is safe.
 Making medicines from raw materials: In some cases, pharmacists prepare medicines
like antiseptics or topical treatments from basic ingredients instead of ready-made
products.

The goal of compounding is to make sure that the medication works best for the person using it,
and helps them feel better or manage their condition.

1.3. Basic Requirements for Extemporaneous Preparation

When pharmacists make custom medicines, there are several important factors to make sure
everything is done safely and correctly. These are the basic requirements for extemporaneous
(custom) preparation:

A. Premises (The Place Where Compounding Happens)

The compounding area must be a clean, safe, and well-designed space. Here’s what that means:

1. Separate and Clean: There should be a special room set aside just for making custom
medications. It should be far away from busy areas with lots of people.
 2. Easy to Clean: The room should be easy to clean, with smooth walls, floors, and
ceilings. This reduces the chance of contamination (mixing things that shouldn’t be
mixed).
3. Well-Organized: The room should have enough space for different activities like:

 Weighing ingredients
 Mixing the medicines
 Quality control (checking if the medicine is made correctly)
 Storing ingredients and finished medicines

4. Clean Water and Good Equipment: The room needs hot and cold running water, and
there should be places to wash hands and clean equipment.
5. Stable Environment: The temperature, humidity, air quality, and lighting must be just
right, so nothing in the medicine gets ruined during preparation or storage.
6. Preventing Cross-Contamination: The layout of the room should prevent anything from
accidentally mixing with another ingredient that shouldn’t be.

B. Personnel (The People Making the Medicines)

The people involved in making the medicines need to be skilled and well-trained. This is very
important because compounding is a specialized job. Here’s what’s needed:

1. Education and Training: People doing compounding should be properly educated and
trained in how to make medicines safely and effectively. They should know what they’re
doing!
2. Skills: They must be able to use the right techniques, like mixing ingredients or
measuring them precisely.
3. Knowledge: They should know about the ingredients they’re using — like their
properties (stability, solubility) and how they work together in the medicine.
4. Safety: They must know how to handle dangerous materials and know what to do if
something goes wrong.
5. Pharmaceutical Calculations: They need to know how to calculate correct doses and
measurements for the custom medicines.

C. Equipment (Tools for Making the Medicines)

The tools and equipment used must be safe and suitable for making medicines. Here’s what is
needed:

1. Right for the Job: All equipment must be suitable for its specific purpose, and it
shouldn’t harm the quality of the medicine.
2. Regular Checks: Equipment needs to be regularly checked, cleaned, and maintained to
make sure it works properly and isn’t broken.
3. Clean Storage: Tools should be stored properly so they don’t get contaminated.
4. Types of Equipment: Some examples of equipment you might find in a compounding
room include:
  Microscopes: To look at very small particles.
 Test tubes: For mixing and storing small amounts of liquids.
 Balances: To weigh ingredients.
 Funnels: For transferring liquids.
 Spatulas: For scooping and transferring solids.

Any equipment that is broken should be clearly marked and removed until it’s repaired.

D. Materials (Ingredients for Making Medicines)

The materials used must be of high quality to ensure the medicine is safe and effective. Here’s
what is needed:

1. High-Quality Ingredients: Only good quality ingredients should be used in

compounding. For example, ingredients for making skin creams or ointments should be
carefully chosen.
2. Sourcing and Storing: Ingredients should be bought from trusted suppliers and stored in
clean, safe conditions to prevent contamination.
3. Check Quality: Every ingredient should come with proof that it’s high quality (like a
certificate from the supplier). This ensures the ingredients are what they claim to be.

E. Sanitation & Hygiene (Keeping Everything Clean)

Everything in the compounding area should be clean and hygienic. Here’s what needs to happen:

1. Clean Environment: The compounding room should be regularly cleaned, but not while
medicine is being prepared. Cleaning should be done at times when it won’t cause
contamination.
2. Personal Hygiene: Everyone working in the compounding room must wash their hands
and wear protective clothing, like gloves, masks, and shoe covers, to avoid contaminating
the medicine.
3. No Eating or Drinking: Eating or drinking is not allowed in the compounding area
because it can lead to contamination.
4. Proper Cleaning: Equipment should be cleaned thoroughly before and after each use to
make sure there are no leftover residues.

F. Documentation (Recording Everything)

Good documentation is essential in compounding. Everything must be recorded to avoid

mistakes and ensure quality. Here’s what needs to be done:

1. Written Procedures: There should be clear, written instructions for everything that
happens in the compounding process. This makes sure that it’s always done the same
way.
2. Tracking Materials: All materials used must be tracked, including:
  Where they came from (the supplier)
 The batch number (which is like a product ID)
 The expiration date
 How they were stored

3. Records: Records should include all details of the materials, like:

 What was received (name, type, quantity)

 The supplier’s batch number
 The date it was received
 Any safety instructions
 The shelf-life or expiration date

4. Safety Information: Each material should have safety and first aid instructions in case of
an emergency.
5. Retain Records: All documents should be kept for a certain amount of time — at least
the shelf life of the materials, plus an extra year.

1.4. General Steps of Compounding (Making Custom Medicines)

When making custom medicines, there are five main steps to follow:

A. Preparatory (Getting Ready)

Before starting, the pharmacist or technician needs to do a few things:

1. Check the Prescription: Make sure the prescription is safe for the patient, and that the
dosage and intended use are correct.
2. Wear the Right Clothes: They need to wear the proper attire and wash their hands
according to procedures.
3. Clean the Work Area: The compounding area and tools should be cleaned if necessary
to make sure there’s no contamination.
4. Do the Calculations: Calculate the right amounts of each ingredient needed.
5. Choose the Right Tools: Pick the correct equipment and make sure it’s clean.
6. Gather Materials: Collect all the ingredients and materials needed for making the
medication.

B. Compounding (Making the Medicine)

This step is the actual process of creating the medicine:

 Follow the Formula: The pharmacist follows the prescribed recipe (formulary record) or
the patient’s prescription.
 Record Everything: Keep a compounding log to document every step taken.

C. Final Check (Double-Check Everything)

After the medicine is mixed, the pharmacist needs to:

1. Check the Medicine: Make sure the medicine looks and smells right. Check the clarity,
color, texture, and pH.
2. Record the Information: Make a note in the compounding log about how the medicine
turned out.
3. Pack the Medicine: Put the medication in the correct container, check the weight, and
label it properly.

D. Sign-Off (Confirmation)

Before finishing, the pharmacist signs and dates the prescription to confirm that everything was
done correctly. This ensures the medicine has the right quality, strength, and ingredients.

E. Cleanup (Tidying Up)

After everything is done, clean up the area and tools:

1. Clean Equipment: Wash all the equipment used.

2. Clean the Area: Make sure the compounding space is clean and tidy.

1.5. Personal Protective Equipment (PPE)

Personal Protective Equipment (PPE) is clothing or gear worn to protect against infections or
harmful materials.

A. Types of PPE Used in Compounding

There are several types of PPE used to keep workers safe while making medicines:

1. Gloves – Protect hands from contamination.

2. Gowns/Aprons – Protect skin and clothes.
3. Masks & Respirators – Protect the mouth and nose from harmful particles.
4. Goggles – Protect the eyes from splashes or particles.

When choosing PPE, you need to think about:

 The type of exposure (like splashes, touching, or breathing in harmful substances).

 Durability and appropriateness (how long it needs to last and what type of protection is
needed).
 Fit (it should be comfortable and the right size for the person).

B. Gloves

 Common Use: Gloves are worn to protect hands from contamination.

  Types: Gloves can be made from latex, nitrile, or vinyl. Some people may need gloves
that don’t contain latex due to allergies.
 How to Choose: Gloves should fit comfortably, not be too tight or too loose, and should
not tear easily. They should be replaced if they become torn or dirty.

C. Gown or Apron

 Purpose: Gowns or aprons protect clothes and skin from contamination.

 Types:

 Isolation gowns are the most common and come in cotton or synthetic materials.
 Fluid-resistant gowns are needed if there is a chance of getting fluid on the
gown.

 When to Use: Use gowns if there's a risk of contamination of the arms or torso.

D. Face Protection

 Masks: Masks protect the mouth and nose from harmful fluids. They should fit tightly to
avoid leaks.
 Goggles: Protect eyes from splashes or particles. Regular glasses do not provide the same
protection as goggles.
 Face Shield: A face shield can protect the whole face if necessary.

E. Respiratory Protection

 Purpose: Respirators are used to protect against harmful particles or germs in the air.
 Types: N95, N99, or N100 respirators are most commonly used in healthcare to protect
from infectious diseases.
 When to Use: Respirators are worn when dealing with airborne infectious agents, like
tuberculosis.

F. Safely Don, Use, and Remove PPE

 Don PPE: Before working with harmful materials, put on the protective gear (PPE)
carefully.
 Use PPE Correctly: Be careful when wearing and using PPE to avoid contaminating
yourself or others.
 Remove PPE Safely: After finishing, take off the PPE in a way that doesn’t spread
contamination.

G. Sequence for Donning (Putting on) PPE

Here’s the order in which PPE should be put on:

1. Gown – First, put on the gown or apron to cover your body.

 2. Mask/Respirator – Next, put on a mask or respirator to cover the nose and mouth.
3. Goggles/Face Shield – After the mask, put on goggles or a face shield for eye protection.
4. Gloves – Last, put on gloves to protect your hands.

H. Put on PPE (How to Wear It)

 Gown: Select the right gown size and tie it around your neck and waist. If needed, use
two gowns for full coverage.
 Mask: Place it over your nose, mouth, and chin. Secure it with straps, ensuring it fits
snugly.
 Gloves: Select the correct size and put them on last. If you're wearing a gown, make sure
the cuffs are tucked inside the gloves to prevent exposure.

I. Safely Remove PPE

When removing PPE, follow this sequence to avoid touching contaminated areas:

1. Gloves: Take off the gloves first, as they are the most contaminated.
2. Face Shield/Goggles: Remove these next, handling only the clean parts.
3. Gown: Unfasten the gown and remove it carefully.
4. Mask/Respirator: Take off the mask or respirator last, handling only the straps.

J. Hand Hygiene

After removing PPE, always wash your hands thoroughly with soap and water or use hand
sanitizer. This is essential to prevent spreading germs.

These are the basic steps to follow for both compounding medicines and using personal
protective equipment (PPE) in a compounding pharmacy. Each step ensures safety and
cleanliness while preparing medications.

1.6. Cleaning Work Area and Equipment

Before any sterilization or disinfection, cleaning is essential. Cleaning removes dirt, debris, and
organic matter (like blood or body fluids) that can block disinfectants or sterilants from working.
If an instrument or equipment can't be properly cleaned, it can’t be effectively disinfected or
sterilized. Here’s a breakdown of the cleaning process:

1. Methods of Cleaning Instruments and Equipment

There are six main methods used to clean equipment:

1. Washing – Removing visible dirt and debris using water and detergent.
2. Sweeping – Physically sweeping away dust and debris from surfaces.
3. Wiping – Using a cloth or wipe to clean surfaces.
4. Disinfecting – Using chemicals or heat to kill harmful microorganisms.
 5. Soaking and De-scaling – Soaking items to loosen debris or remove mineral build-up.
6. Sterilization – The process of killing all microorganisms to make something sterile.

1. Manual Cleaning

When cleaning by hand, the process needs to be thorough:

1. Wear PPE: Personal protective equipment (PPE) like gloves, masks, and aprons should
be worn.
2. Rinse First: Before anything dries on the equipment, rinse it in tepid (warm) water (15-
18°C) to remove gross soil (like blood or tissue).
3. Disassemble Equipment: Take apart the instrument if possible to clean all parts
individually.
4. Use Detergent: Immerse the parts in warm water with a non-corrosive, non-abrasive,
biodegradable detergent or enzymatic cleaner (especially for fiber-optic instruments).
5. Clean Thoroughly: Make sure all visible dirt or contaminants are removed from all parts
of the equipment.
6. Rinse: After cleaning, rinse the parts with hot water (unless the manufacturer advises
against it).
7. Dry the Equipment: Dry the cleaned equipment using either a drying cabinet or a lint-
free cloth.
8. Inspect: After cleaning, inspect the equipment to ensure it is fully cleaned and free of
contaminants.

2. Enzymatic Cleaners

 Use: Enzymatic cleaners are used for cleaning items like fiber-optic instruments or
other equipment that is difficult to clean by regular methods.
 Caution: These cleaners can be hazardous, so it’s important to handle them carefully.

3. Ultrasonic Cleaners and Automated Washers

 Ultrasonic Cleaners: These devices use high-frequency sound waves to loosen dirt from
the equipment. They're effective for cleaning simple instruments and reduce the need for
handling the equipment.
 Automated Washers: These machines are designed to clean equipment without human
contact, making the process more efficient. However, ultrasonic cleaners don’t
disinfect; they just clean the items.

4. Disinfection

Disinfection eliminates many harmful microorganisms but does not sterilize. This is useful for
delicate or heat-sensitive equipment. There are three levels of disinfection:

1. High-Level Disinfection: Kills most microorganisms, except some bacterial spores. This
is used for heavily contaminated instruments.
 2. Intermediate-Level Disinfection: Inactivates most bacteria (except resistant spores) and
some viruses and fungi.
3. Low-Level Disinfection: Kills most bacteria, some viruses, and fungi, but cannot be
relied upon to kill resistant bacteria like M. tuberculosis.

Types of Disinfection:

1. Thermal Disinfection (Pasteurization): Uses heat and moisture to kill harmful

microorganisms. This is only for instruments that can handle heat.
2. Chemical Disinfection: Uses disinfectant chemicals, with effectiveness depending on
factors like:

 Temperature
 Contact time
 Concentration
 pH
 Amount of organic matter present on the instrument

5. Sterilization

Sterilization is the process of completely destroying all microorganisms. It is essential for

items that will be used in sterile body areas. The key steps include:

1. Cleaning: All equipment must be cleaned before sterilization to ensure that there is no
visible dirt.
2. Packaging: Materials should be wrapped or packed before sterilization to keep them
sterile.
3. Sterilization Methods: Instruments are sterilized using one of the following processes:

 Steam under Pressure (Autoclaving)

 Dry Heat
 Ethylene Oxide (Gas)
 Radiation
 Filtration

Types of Sterilization

1. Steam Under Pressure (Moist Heat)

 Most Common and Efficient: Uses steam to sterilize instruments. It's reliable and also
dries the instruments as part of the process.
 Conditions: Typically, steam is used at 121°C, 15lb/in² for 15-20 minutes.
 How it Works: The steam condenses on the instruments, transferring heat and killing
harmful microorganisms.

2. Dry Heat Sterilization

  How it Works: Uses hot air to kill pathogens through oxidation.
 Conditions: High temperature (170°C) for 1-2 hours.
 Benefits: Non-corrosive, so it's good for materials that could be damaged by moisture,
such as glassware and metal surgical tools.

3. Gaseous Sterilization (Ethylene Oxide)

 When Used: Ideal for heat-sensitive instruments or equipment with electronic

components.
 Process: Ethylene oxide gas is used to sterilize instruments. It can take 12-24 hours,
depending on conditions like temperature and humidity.
 Caution: Ethylene oxide is toxic and must be handled with care.

Mechanism: Ethylene oxide reacts with proteins in microorganisms, killing them by altering
their structure.

 Advantages: Can be used for heat-sensitive materials and has good penetration power.
 Disadvantages: Slow, expensive, and toxic.

4. Radiation Sterilization

 How It Works: Uses gamma radiation (usually from commercial sources) to sterilize
items. This method is ideal for large batches of equipment.
 Benefits: Sterilizes without heat, so items retain their properties.
 Disadvantages: High costs and potential changes in product quality.

5. Filtration Sterilization

 How it Works: Uses filters to physically remove microorganisms from liquids or gases.
 Applications: Used for heat-sensitive liquids (e.g., vaccines) or to filter air in clean
environments (like HEPA filters used in hospitals).
 Types of Filters:

 Membrane Filters: Commonly used to filter bacteria. 0.22 µm pores retain most
bacteria.
 HEPA Filters: Can filter particles as small as 0.3 microns, used in cleanrooms
and operating theaters.

Key Points to Remember:

 Cleaning is critical before any disinfection or sterilization process. If instruments are not
properly cleaned, disinfectants or sterilants cannot work effectively.
 Manual cleaning requires care in disassembling instruments, using safe detergents, and
ensuring that every surface is clean.
 Disinfection is not the same as sterilization. It reduces but doesn’t completely eliminate
microorganisms.
  Sterilization is required for instruments that will touch sterile body areas, and it can be
achieved using heat, gas, or radiation methods.

Summary

Extemporaneous preparation (compounding) is the process where pharmacists prepare

customized medicines to meet individual patient needs when commercial products are
unsuitable. It supports patient-centered care by adjusting doses, changing dosage forms,
improving taste, removing allergens, and preparing special formulations for humans, animals,
research, teaching, or clinical use.

Safe compounding requires proper premises, trained personnel, suitable equipment, high-
quality materials, strict sanitation and hygiene, accurate documentation, and correct use of
personal protective equipment (PPE). The compounding process follows defined steps:
preparation, compounding, final checking, sign-off, and cleanup.

Cleaning, disinfection, and sterilization of work areas and equipment are essential to prevent
contamination. Different methods are used based on the level of microbial control required,
including washing, disinfection, and sterilization techniques such as autoclaving, dry heat, gas,
radiation, and filtration.

Overall, compounding ensures medicines are prepared safely, accurately, and effectively to best
meet patient needs.