Extemporaneous compounding is the timely preparation of customized drug products according to a physician's prescription in order to meet individual patient needs that cannot be met by approved commercial products. It involves combining calculated amounts of ingredients into a uniform mixture. Extemporaneous compounding is used when commercial products do not have the needed dosage, strength, route of administration, or inactive ingredients are not suitable for a patient. Pharmacists must follow quality assurance procedures, label compounds properly, and ensure stability and safety.

1. Extemporaneous Compounding
Prepared By: Nishant Shrestha
M. Pharmacy (Clinical)

2. Extemporaneous compounding
• Extemporaneous compounding is defined as the timely preparation of
a drug product according to a physicians prescription, a drug formula,
or a recipe in which calculated amounts of ingredients are made into a
homogenous (uniform) mixture. Example: Captopril syrup Captopril
powder
• Extemporaneous compounding is done when certain medical needs of
individual patients cannot be met by the use of an approved
commercial drug product.

3. Reason and Purpose for Extemporaneous
Compounding
• Unavailable dosages, strengths and routes of commercial products
• Dilution of adult doses of medications to Pediatric/Geriatric strengths.
• Conversion of solid dosage forms to solutions or suspensions.
• Combination of topical dermatological products not available by the
manufacturer.
• Inactive ingredients of commercial products which may cause allergic
reactions in individuals.

4. Advantages of Extemporaneous
Compounding

5. Problems Encountered in Extemporaneous
Compounding

6. General Principles of Labelling

7. General Principles of Labelling

8. General Principles of Labelling

9. Quality Assurance and Safety of
Extemporaneous Preparation
• Pharmacist (or trained personnel) should prepare and dispense compounded products in a manner
that ensures product quality, safety and efficacy and in accordance with good compounding
practices, official standards and relevant scientific data and information (if such information
exists).
• Appropriate stability evaluation is performed or determined from the literature to establish reliable
expiry data to ensure that the finished preparations have their expected potency, purity, quality and
characteristics, at least until the labelled expiry date.
• There should be assurance that processes are always carried out as intended or specified and are
under control.
• The relevant master document should be selected and a product specific worksheet and label
should be prepared before starting preparation.
• Where a calculation is required, it should be independently checked by an appropriate second
person wherever possible.
• The check should be performed prior to preparation to minimize the chance of product wastage.

10. Use of suitable containers and correct
labelling
• Primary packaging of the product must be fit for purpose and adequately protect
the product from the environment whilst being compatible with the product.
• Ideally the product must be labelled with the necessary particulars, including any
special requirements for the safe handling or storage of the product:
• common name of product
• statement of the active ingredients expressed qualitatively and quantitatively per
dosage unit or for a given volume or weight
• dose and route of administration
• contents of the container by weight, volume or number of doses
• expiry date
• batch number
• name and address of patient

11. EXAMPLE:
Amiodarone hydrochloride oral liquid (Extemporaneous Preparation)
• Using a typical strength of 40 mg/mL
Amiodarone hydrochloride 200 mg tablets * 20
Ora-Plus 50mL
Ora-Sweet SF to 100 mL.
• Method guidance
• Tablets can be ground to a fine, uniformpowder in a pestle and mortar. A small amount of
Ora-Plus may be added to form a paste, before adding further portions of Ora-Plus up to
50% of the final volume. Transfer to a measuring cylinder. The Ora-Sweet can be used to
wash out the pestle and mortar before making the suspension up to 100% volume.
Transfer to an amber medicine bottle.
• Shelf-life
• 28 days refrigerated or at room temperature in amber glass. Shake the bottle.