Flashcards in Law and ethics Denatured alcohol Deck (19)
Which section and act gives HM R&C the power to make regulations on alcohol?
Section 77 of the Alcoholic Liquor Duties Act 1979
What does section 78 do?
Allows them to give penalties for offences.
Where are the requirements for denatured alcohol set out?
Denatured alcohol regulations 2005.
Describe completely denatured alcohol
Most heavily denatured, used for heating lighting, cleaning and general domestic use. 90 parts alcohol, 9.5 parts wood naphtha or substitute, 0.5 parts crude pyridine to each 1000L and 3.75L of mineral naphtha (petroleum oil), 1.5 parts synthetic organic dyestuff (methyl violet).
How much CDA can a pharmacist obtain?
Pharmacists can obtain from wholesales in any quantity
Describe industrial denatured alcohol
Used for scientific and external medical applications. 95 parts alcohol, 5 parts wood naphtha or substitute (dependent on proportion of marker in mixture and if the mixture contains other substances the commissioner has approved).
Describe trade specific denatured alcohol
For specific trade use.
How would you apply for a new use of TSDA?
Contact NRU with: proposed formulation, use, why CDA, IDA and approved TSDA formulations would be unsuitable
Who can obtain TSDA?
Only people specifically authorised by HM R&C.
Describe the application for authority to receive IDA or TSDA
Pharmacists must be authorised by HM R&C (except for ready prepared medicinal product). Apply to NRU.
If approved, commissioner authorise in writing with; what you can receive, what it can be used for, conditions of use.
Users must give pharmacist a copy of authorisation before they can receive it.
How long do these authorisations last for?
Statements are valid indefinitely
Do medicinal/ veterinary practioners need to be authorised to obtain an IDA, if written against an Rx?
How much of IDA/TSDA can authorised users supply?
<20L at any one time.
Only licensed or authorised producers/distributors can supply >20L (wholesale dealing)
When should entry of premises be made? And how?
If stock of DA is held by pharmacist, entry needs to be made before beginning to hold.
Form EX103 for sole trader/partnerships. EX103A for incorporate company.
What are the conditions of use of IDA/TSDA?
Storage - under lock and key under the pharmacists possession.
Supply - following must be kept for inspection by local HM R&C officer: written statements from authorised users, written signed orders from medicinal practitioners (not for Rx)
Closing/transfer of business - authorisation revoked, NAS should be contacted.
Records - amount of DA received. One copy of suppliers dispatch documents signed as a receipt and returned to the supplier, the other copy retained don the premises for records.
Distribution - pharmacist should: hold and excise license for purpose of section 75 of the Act. Does not denature any alcohol on the premises where DA is kept. Deals or intends to deal wholesale in DA.
How does a pharmacist apply for license to distribute DA alcohol?
L5 should be sent to NRU and a letter stating which DA will be distributed.
What specific record must be kept for producers/distributors?
Purchases of materials used in production of DA
IMPORTS OF DA and details of country of origin
Class of DA
Quantities of alcohols, denaturalise, markers, dyes and DA held and used.
Results of stock takes and actions taken to resolve and surpluses/deficiencies.
Exports and sales
Copy authorisations received in support of orders for DA
When may a pharmacist be liable to penalties if there are unexplained losses of DA?
Where as a distributor, supplies have been made to users without a copy of authorisation
Supplies hav been made to users without a copy of authorisation.
Supples made to people who aren't authorised users
Has not been used in accordance within its authorised use