The sanctions available to the FTP committee of the GPhC are to; Dismiss the case, give a warning, fine, impose conditions, suspend, remove from register
A doctor is allowed to import an unlicensed medicine for an individual pt
An AVM GSL med can only be sold by a vet from his registered premises
Records should be made in the poisons book for the supply of all part 1 and 2 poisons
All poisons (dangerous substances) must be labelled with the name, address and phone no of supplier
A non pharmacy retailer may sell 2 aspirin tabs taken out of a larger pack for the treatment of headaches
Industrial denatured alcohol may not be prescribed for veterinary purposes
Nurses do not require a manufacturers license to break bulk and repack tablets in the course of their professional duties
All retail pharmacy businesses must be registered yearly with the Dept of Health
All abbreviated advertisements for a medicinal product must contain all contraindications
Professional samples of medicinal products can be supplied on an unlimited basis to general practitioners
A child resistant container must be used for the supply of all strengths of methanol
An aqueous soap solution, formulated for use as an enema, is classified as GSL
A herbal practitioner cannot prescribe a herbal remedy for a person unless that are present in person
A written prescription for a POM VPS must include the phone no of the prescriber
Where a pharmacist has been suspended by the FTP committee of the GPhC for at least 2 consecutive years, it may suspend the person indefinitely, if it thinks fit
A Body Corporate may lawfully conduct a retail pharmacy business, provided it has a pharmacist as a Superintendent
A pharmacist whose name is removed from the Register by the FTP committee may apply for a restoration after 2 years
What is the definition of a medicinal product as per the Medicines Act 1968?
What is the definition of a borderline substance?
What legislation covers medical devices?
The Medical Devices Regs 2002
It is mandatory for medical devices to have a CE mark
What are considered to be medical devices?
Sutures, dressings, contact lens care products, etc
Not all medicinal products require market authorisations
Products that were on the market prior to liscensing requirements of the Medicines Act were granted a product License of Right
A product needs a marketing authorisation in order to be;
Manufactured or assembled
Imported or exported
Sold or supplied
A marketing authorisation application must include
Detailed specification of product and constituents
Legal category (proposed)
Methods of manufacture and quality control
Before issuing a market authorisation the licensing authority must be satisfied that...
The product is safe and efficacious
Facilities for manufacture and QC are adequate to ensure conformity with specifications
What is the maximum period of time a marketing authorisation may be held before having to be renewed?
The marketing authorisation holder must inform the licensing authority of...
What must a marketing authorisation hold produce?
Periodic safety update report
What are the five types of maufacturers licenses?
Manufacturers/importers license (human and veterinary)
Manufacturers specials license (human and veterinary)
Manufacturers investigational medicinal products
Before granting a manufacturers/importers license the licensing authority must be satisfied regarding...
The type of premises
Qualifications of supervisory staff
Arrangements for storage and record keeping
The manufacturer must maintain adequate...
premises and plant for production and quality control
equipment and facilities to prevent deterioration
durable records for at least 5 years to enable any batch to be traced and recalled
Manufacturers "specials" licenses allow the manufacture of unlicensed products
Importers "specials" licenses allow the importation of unlicensed products from outside the EEA
A pharmacist can supply Industrial Denatured Alcohol
for medical use on the authority of a private dental prescription
NICE may ban the sale of a herbal remedy if suspected
adverse effects result from their use
Manufacturers of Traditional Herbal Medicinal Products
(THMP) require a manufacturers licence
for the assembly of THMP
In order to be valid a signed order for a Schedule 1
poison must be dated and signed by the purchaser
Part 2 poisons in any retail shop must only be stored
in a cupboard or drawer reserved solely for the storage of poisons
A herbal dealer can recommend, to a patient, the use
of a herbal remedy for specific conditions and illnesses.
A pharmacist-prepared label for a medicine supplied
under the ‘cascade’ must contain the name of the prescribing veterinarian.
To be valid a prescription for a POM-V must contain
the name of the animal and its owner
A prescription for a POM-V is valid for 6 months,
unless a shorter period is stated
It is illegal to advertise products for the treatment
of mild infections to the general public in the UK.
A full size advertisement for a medicinal product, intended for issue to a hospital doctor, must contain the legal classification and the cost ex VAT.
A legal representative of a bankrupt pharmacist may
carry on the retail pharmacy business for no more than 2 years.
In the UK,
the British Pharmacopoeia has more authority than the European Pharmacopoeia.
An herbal practitioner needs a manufacturer’s licence
for preparing mixtures of herbs for an individual patient.
A Marketing Authorisation is required before a
medicinal product can be advertised and/or sold in the UK
The holder of a manufacturers licence is required to
keep durable records of manufacturing procedures for 2 years.
The Responsible Pharmacist notice must contain the
RP’s name, their registration number, and state that they are in charge of the
pharmacy at that time
In an emergency, a pharmacist may sell a Schedule 1
poison if the purchaser (known to the pharmacist) offers to provide a signed
order within 5 days.
licence is necessary for the sale by a pharmaceutical manufacturer of its own medicinal
In the UK,
completely denatured alcohol may be sold to any persons, in any quantity, at
Unlicensed medicinal products can be advertised for medicinal purposes
Medicinal products can be advertised with holding a marketing authorisation
The Market authorisation holder must consent to adverts before they are released
A PIL is considered to be advertising
The sale of a labelled container/package is not considered to be advertising
Only the MA holder needs to keep any records of advertising
Advertisers/publishers also need to keep records
Advertising records need to be kept for how long?
Three years after last use of advert or 3 years after the end of any regulatory/self regulatory action
POM medicines can be advertised to the public
Only GSL and P meds can be advertised
All controlled drugs may not be advertised
Drugs for the treatment of cancer may be advertised
Medicinal products to procure abortion can be advertised
Chronic insomnia medication can be advertised
Diabetic medications can be advertised
Cardiovascular disease medication can't be advertised
Bone disease medication can be advertised
Liver, biliary and pancreatic disease medication can't be advertised
Endocrine, genetic and respiratory disease medication can't be advertised
Malignant condition medication can't be advertised
STD medication can be advertised
Medication to treat serious infections can be advertised
Medication to treat serious muscular, neurological or GI disease can't be advertised
Medication for psychiatric disease or conditions can be advertised
What must adverts contain?
Name of the medicine
Common name of the active ingredient (if only one)
Information on the correct use of medicine
A clear legible invitation to read the instructions on the label and leaflet
Adverts can suggest that medical consultation or surgery is unnecessary
Adverts can't suggest that effects are guaranteed or give misleading, improper terms to claims of recovery
Adverts can suggest that the medicinal product is better than another identifiable product
Adverts can't suggest that health will be enhanced by taking a medication or will be affected by not taking the medicine
Natural products can claim that they are safe and efficacious in advertising because they are natural
An advert can't claim a medicinal product has no side effects
A product can use claims like "fast acting" and "24 hour relief" without having to back it up with clinical trial evidence
Adverts for medicinal products can use endorsement from celebrities
Adverts for medicinal products can refer to recommendations from scientists
A medicinal product can use it's marketing authorisation to claim it's superiority over products without MA's
Samples cannot be given out for promotional purposes
If the promotion is a reminder then the advert need only feature the name of a product
Advertising of vaccination campaigns and disease awareness campaigns are exceptions from advertising rule
When advertising for PQPS online the websites should be aimed at PQPS preferably with restricted access
Members of the public can be encouraged to access information meant for PQPS
Adverts for PQPS must contain...
Name of product and active ingredient
Licensed indications for us
Route of administration
Dosage and method of use
Side effects, precautions and contraindications
Name and address of MA holder
Cost ex VAT
Abbreviated adverts for PQPS should contain...
Name and address of the MA holder
Name of product and active ingredient(s)
Indication that further information is available from the MA holder or SPC
Essential information compatible with SPC - at least one indication and required warnings
A recommendation that the PQSP consults the SPC
(Less than 420 sq cm)
Professional samples of a medicincal product may be supplied to PQPS for the purpose of acquiring experience in it's use may be given
What are the conditions associated with providing professional supplies?
Only supplied on an exceptional basis
Limited number supplied to any one recipient in any one year
Supplied in response to a written request, signed and dated
Supplier retains control and accountability
Sample is no larger than the smallest product pack available in the UK
Labelled correctly and with "free medical samples - not for resale"
Sample accompanied by a copy of the SPC
Promotional aids for PQPS (non monetary gift made for promotional purposes) are exempt from advertising requirements if they only contain the products name
Accompanying written material with promotional aids must be compatible with the SPC and contain the legal classification
Representation by commercially interested parties or others is not allowed for any product for which adverts aren't permitted
Controls on representation don't apply to who?
Pharmacists when dispensing an rx or counter prescribing
Nurses or midwives when treating a patient
Podiatrist in relation to treatment of the surface of the foot
CHIP regs require a supplier of a dangerous chemical to...
Identify the hazards of the chemical
Give information of the hazards to customers
Package the chemical safely
All hazardous chemicals must be classified by...
A description of the hazard by allocation of a risk phrase
Containers for chemicals must...
be impervious to the chemical and sufficiently stout to prevent leakage from risks of handling and transport
the outer surface of the bottle must be marked with a raise triangle and also braille warnings
Child resistant closures required for certain chemicals
Child resistant closures are required for which chemicals?
Toxic or very toxic
dichlomethane (above 1% in weight)
Methanol (3% or above by weight)
and other products
A chemical label must contain the name address and telelphone number of the supplier
A chemical label must be able to be read horizontally
Chemical labels must include...
the indications of a general nature of risk and the symbols specified
the risk and safety phrases
Chemicals used by podiatrists are regulated as medical devices if they have medicinal claims
A chemical used as a non medicinal poison is controlled by the Medicines Act 1968
They are controlled by the Poisons Act 1972
If used as a medicinal product then it is controlled by the Medicines Act
Some substances in the poisons list are used as medicinal products
A non medicinal poison or a poison is a substance included in the poisons list
Part one poisons can only be sold by persons conducting a retail pharmacy business (with some exceptions)
Part II poisons may only be sold by retail pharmacists and listed sellers of part II poisons
Listed sellers of part II poisons may only sell part II poisons from listed premises in pre-packed containers
Schedule 4 group one poisons contain poison but are completely exempt from controls as poisons (e.g. builders materials
Schedule 4 group II poisons lists exemptions for certain poisons when in specified articles/substances (e.g. sulphuric acid in batteries)
Schedule one poisons have special restrictions relating to storage, condition of sale and record of sale
Schedule 5 poisons - some part II poisons may be sold by listed sellers only to persons in agriculture, horticulture or forestry industries
A person buying a schedule one poison has to be known to the seller or pharmacist
If unknown they can be certified in writing by a householder or a polic officer in charge of a station
Signed orders for schedule one poisons can be accepted from a person who requires a poison for their trade, business or profession
Signed orders for Sch 1 poisons must contain;
Signature of the purchaser
Name and address of purchaser
In an emergency a seller may deliver a Sch 1 poison on reciving an undertaking that a signer order will be requisitioned within 48h
It's within 72h
For Sch 1 poisons a record must be made in the poisons book which must be signed by the purchaser
What details should be recorded in the poisons book for a sale of a Sch 1 poison?
If Sch 1 poisons are purchased by a signed order then the words "signed order" and a reference number take the place of a signature in the poisons book
Sale requirements of Sch 1 poisons to knowledge of person, records of sale and signature do not apply if it is to export to purchasers outside the UK, sale by manufacturer or wholesaler who regularly deals in poisons
Schedule 1 poisons may be stored;
In a cupboard or drawer reserved solely for the storage of poisons or
In a part of the premises partitioned or
On a shelf reserved for poisons with no food
Sch 1 poisons used in the agriculture, forestry or horticulture industry may be stored;
must NOT be stored on shelf OR
may only be stored in a cupboard or drawer reserved solely for storage of
Strychnine may only be sold to an officer of DEFRA who has a written authority for the killing of foxes under the Rabies Control Order 1974
Sales exempted by section 4 of the poisons act;
The following don't have to be sold under the control of a pharmacist
a) Sale of poisons by way of wholesale dealing
b) Poisons to be exported
c) Sales to registered doctors, dentists and vets
d) For use in any hospital, infirmary or dispensary
e) A business in which poisons are sold by
wholesaling or for use by purchasers in their
trade, business or profession to:
1) government department or Officer
2) for scientific education or research
3) medical treatment of persons employed by
4) Person requiring poison for trade or
Poisons can be sold from automated machines
What are the three types of denatured alcohol?
Completely denatured alcohol
Industrial denatured alcohol
Trade specific denatured alcohol
No record is required for purchase of completely denatured alcohol
There are restrictions on the retailing of completely denatured alcohol
Any quantity of completely denatured alcohol may be purchased from an authorised distributor by a pharmacy
What needs to be on a label for completely denatured alcohol?
Name - completely denatured alcohol
Name and address of supplier
Black flame on orange background
Keep locked up and out of reach of children
Keep container tightly closed
Keep away from sources of ignition. No smoking
Toxic by inhalation and if swallowed
Black cross on yellow background
Avoid contact with skin
In case of accident or if you feel unwell seek medical attention immediately and show label where possible
For external use only/not to be taken
Pharmacists need authorisation from HMRC to obtain IDA
Authorised pharmacists can obtain IDA from;
Authorised producer or distributor in quantities greater than 20L
From other authorised users, provided a copy of the authorisation is furnished prior to supply - quantities less than 20L