ED 2

Question 1

State 3 reasons for requesting an extemp… preparation

Answer 1

1) Appropriate licensed formulation is unavailable
2) Allergy to excipients in licensed product
3) Sugar/Alcohol content of liquid prep too high for patient

Question 2

How can we meet the 5 principles set out in the guidance?

Answer 2

By ensuring quality assurance of the final product

Question 3

It is good practice to keep records of extemp products prepared in the pharmacy. TRUE or FALSE

Answer 3

TRUE

Question 4

State 5 things the record should include

Answer 4

1) Formula
2) Ingredients and quantities
3) Source of ingredients (e.g: Manufacturer)
4) Batch no (where possible) and expiry dates of all ingredients
5) Use by date of prepared product

Question 5

A clinical check must be done before preparing extemp product. TRUE or FALSE

Answer 5

TRUE

Question 6

Name 2 places official formulas for extemp preparations MUST be listed in ?

Answer 6

1) British Pharmacopoeia (BP)

2) British Pharmaceutical Codex (BPC)

Question 7

Name other sources official formulas can be listed in

Answer 7

• BNF
• Martindale
  (must have BP or BPC listed in title to be official)

Question 8

When checking the formulae, why should you start with the first ingredient ?

Answer 8

It is likely to be the primary active ingredient

Question 9

Does the 12th edition of the BPC contain official formulas. YES or NO

Answer 9

NO

Question 10

What type of containers are used for extemp preparations ?

Answer 10

Amber glass bottles and jars

Question 11

What type of products are stored in hexagonal ribbed amber glass dropper bottles ?

Answer 11

External products

Question 12

For unofficial formulas, quantitative measures must be added on label. TRUE or FALSE

Answer 12

TRUE

Question 13

How should the expiry date be stated on an extemp product ?

Answer 13

The exact date must be included on the label

Question 14

State 5 good practices in extemp preparations

Answer 14

1) Working area should be kept tidy
2) Equipment should be cleaned before starting
3) Use one ingredient at a time
4) Clearly label all ingredients
5) Clan and dry all equipments and working area before leaving

Question 15

What are the legal requirements for labelling of a BP or

BPC (licenced) formula product?

Answer 15

• Name of patient
• Name and address of pharmacy
• Date of dispensing
• Name of the product (or common name) including
  strength and formulation if required
• Directions for use
• Precautions for use (Cautionary and Advisory)
• KOOR(AS)OC
• Specific expiry date
• Storage conditions
• Common warning labels

Question 16

What are the legal requirements for labelling of a BP or

BPC (unlicenced) formula product?

Answer 16

• All of that for licensed formula PLUS the quantitative amount of each ingredient (this can be expressed as a % or the quantities
  used)