Denatured Alcohol

Question 1

What is denatured alcohol?

Answer 1

alcohol that has been made unsuitable for drinking by the addition of denaturants

• methylated spirits

Question 2

What is alcohol spirit?

Answer 2

alcohol of any description including all liquor mixed with alcohol and all mixtures/compounds/preparations made with alcohol but does NOT include denatured alcohol

Question 3

What is the legal basis of denatured alcohol?

Answer 3

Alcoholic Liquors Duties Act 1979
Denatured Alcohol Regs 2005

HM Revenue and Customs are involved with enforcing regulations

Question 4

What is a justice’s licence?

Answer 4

the license required to sell intoxicating liquor

Pharmacist’s are EXEMPT from this license when alcohol is used to make up a medicine (e.g. in a herbal medicine for extraction)

Question 5

What are the 3 different types of denatured alcohol?

Answer 5

• Completely Denatured (mineralised)
• Industrial Denatured Alcohol
• Trade Specific Denatured Alcohol

Question 6

What is completely denatured alcohol used for?

Answer 6

heating, lighting and general domestic use

Question 7

What regulations are there regarding completely denatured alcohol?

Answer 7

• can be supplied to anyone including the general public
• no restrictions on the quantity
• no conditions on the use
• can be purchased by a pharmacy from a wholesaler in any quantity
• no restrictions on retailing
• no records

but the premises may be visited by HM Revenue and Customs for suitability of storage

Question 8

What makes up completely denatured alcohol?

Answer 8

100 parts of volume of alcohol

• 3 parts of Isopropyl Alcohol
• 3 parts of Methyl Ethyl Ketone
• 1 gram of Denatonium Benzoate

also may contain synthetic organic dyestuff methyl violet

Question 9

What is industrial denatured alcohol made up of and what is it used for?

Answer 9

• 95% alcohol
• 5% Woof Naphtha (methanol)

used for industrial purposes as a solvent and for external medical applications

Question 10

What is trade specific denatured alcohol used for?

Answer 10

there are 11 different approved formulations

• skin preparations
• disinfectants

Question 11

How does a pharmacist obtain industrial/trade specific denatured alcohols?

Answer 11

have to get WRITTEN AUTHORISATION from HM Revenue and Customs and have to make an application for this

Question 12

What does the authorisation of industrial/trade specific denatured alcohols include?

Answer 12

• which denatured alcohol they are permitted to receive
• purpose for which the denatured alcohol is being used
• conditions

Question 13

How long is an authorisation from HM Revenue and Customs valid for?

Answer 13

Indefinitely but may be reviewed

Question 14

How much industrial/trade specific denatured alcohol can a pharmacist obtain?

Answer 14

if from an authorised producer/distributor - quantities of 20L or more

if from another authorised user (e.g. another pharmacist) - quantities of LESS than 20L

Question 15

What regulations must a pharmacist adhere to regarding industrial and trade specific denatured alcohols?

Answer 15

• only use the denatured alcohol as set out in authorisation
• keep records of all dealings
• keep written signed orders from medical practitioners
• provide an annual return if requested by HM Revenue and Customs
• keep stocks securely and the security is the pharmacist’s responsibility
• local revenue and customs may require special storage arrangements
• record the results of stock-takes and any actions taken

Question 16

What should a pharmacist do upon receipt of an industrial/trade specific denatured alcohol?

Answer 16

1. Record in stock account of the amount of denatured alcohol that has been received
2. Note the receipt details on the supplier’s dispatch document and take a copy for your own record
   - sign one copy as a receipt and return to your supplier and place the other copy in your records

would also make these records when supplying to someone else

Question 17

How much of industrial denatured alcohol and trade specific denatured alcohol would a pharmacist be able to sell/supply?

Answer 17

no more than 20L

• keep a COPY of the user’s written authorisation
• only supply for the purpose that is stated on the user’s authorisation

Question 18

What is the procedure for the supply of an industrial denatured alcohol via a prescription?

Answer 18

• make the supply straight to the patient
• for medical use, external use only
• make a record
• no need for a written authorisation

Question 19

What is the procedure for the supply of an industrial denatured alcohol via a written signed order?

Answer 19

• retain the written order
• order should include details of the quantity and the class of denatured alcohol
• no need for a written authorisation

Question 20

How much of industrial denatured alcohol would a pharmacist be able to supply via a wholesale deal?

Answer 20

ANY quantity as it is a wholesale deal

Question 21

Is a surgical spirit a type of denatured alcohol, and are they therefore regulated under the denatured alcohol regulations 2005?

Answer 21

NO, so is not regulated but contains

• ethanol
• methanol

has to be labelled as ‘for external use only’

Question 22

What are duty free spirits?

Answer 22

this is DRINKABLE alcohol but could be used for medicinal uses, which will be stated in their marketing authorisation

they CAN be used in the manufacture of any product prescribed by a doctor

Question 23

If a pharmacist wanted to make up a special using a duty free spirit, they would need a licence in order to do this - true or false?

Answer 23

TRUE

they would need to apply to HM revenue and Customs to obtain and use duty free spirits

Question 24

Are there any record requirements for duty free alcohol?

Answer 24

yes a record would need to be made in the stock book

Question 25

Is isopropyl alcohol a denatured alcohol and is it therefore regulated under the denatured alcohol regulations 2005?

Answer 25

NO it is not a denatured alcohol and is therefore not covered by the regulations

used in disinfectants most commonly, e.g. hand sanitiser