1. Which legislation regulates medicines?
    Medicines Act 1968
  2. 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
  3. A doctor is allowed to import an unlicensed medicine for an individual pt
  4. An AVM GSL med can only be sold by a vet from his registered premises
  5. Records should be made in the poisons book for the supply of all part 1 and 2 poisons
  6. All poisons (dangerous substances) must be labelled with the name, address and phone no of supplier
  7. A non pharmacy retailer may sell 2 aspirin tabs taken out of a larger pack for the treatment of headaches
  8. Industrial denatured alcohol may not be prescribed for veterinary purposes
  9. Nurses do not require a manufacturers license to break bulk and repack tablets in the course of their professional duties
  10. All retail pharmacy businesses must be registered yearly with the Dept of Health
  11. All abbreviated advertisements for a medicinal product must contain all contraindications
  12. Professional samples of medicinal products can be supplied on an unlimited basis to general practitioners
  13. A child resistant container must be used for the supply of all strengths of methanol
  14. An aqueous soap solution, formulated for use as an enema, is classified as GSL
  15. A herbal practitioner cannot prescribe a herbal remedy for a person unless that are present in person
  16. A written prescription for a POM VPS must include the phone no of the prescriber
  17. 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
  18. A Body Corporate may lawfully conduct a retail pharmacy business, provided it has a pharmacist as a Superintendent
  19. A pharmacist whose name is removed from the Register by the FTP committee may apply for a restoration after 2 years
  20. What is the definition of a medicinal product as per the Medicines Act 1968?
  21. What is the definition of a borderline substance?
  22. What legislation covers medical devices?
    The Medical Devices Regs 2002
  23. It is mandatory for medical devices to have a CE mark
  24. What are considered to be medical devices?
    Sutures, dressings, contact lens care products, etc
  25. Not all medicinal products require market authorisations
  26. Products that were on the market prior to liscensing requirements of the Medicines Act were granted a product License of Right
  27. A product needs a marketing authorisation in order to be;

    Manufactured or assembled

    Imported or exported

    Sold or supplied
  28. A marketing authorisation application must include
    Detailed specification of product and constituents

    Legal category (proposed)

    Methods of manufacture and quality control
  29. 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
  30. What is the maximum period of time a marketing authorisation may be held before having to be renewed?
    Five years
  31. The marketing authorisation holder must inform the licensing authority of...
    Proposed changes

    Fresh information
  32. What must a marketing authorisation hold produce?
    Periodic safety update report
  33. What are the five types of maufacturers licenses?
    Manufacturers/importers license (human and veterinary)

    Manufacturers specials license (human and veterinary)

    Manufacturers investigational medicinal products
  34. Before granting a manufacturers/importers license the licensing authority must be satisfied regarding...
    The type of premises

    Equipment available

    Qualifications of supervisory staff

    Arrangements for storage and record keeping
  35. 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
  36. Manufacturers "specials" licenses allow the manufacture of unlicensed products
  37. Importers "specials" licenses allow the importation of unlicensed products from outside the EEA
  38. A pharmacist can supply Industrial Denatured Alcohol
    for medical use on the authority of a private dental prescription
  39. NICE may ban the sale of a herbal remedy if suspected
    adverse effects result from their use
  40. Manufacturers of Traditional Herbal Medicinal Products
    (THMP) require a manufacturers licence
    for the assembly of THMP
  41. In order to be valid a signed order for a Schedule 1
    poison must be dated and signed by the purchaser
  42. Part 2 poisons in any retail shop must only be stored
    in a cupboard or drawer reserved solely for the storage of poisons
  43. A herbal dealer can recommend, to a patient, the use
    of a herbal remedy for specific conditions and illnesses.
  44. A pharmacist-prepared label for a medicine supplied
    under the ‘cascade’ must contain the name of the prescribing veterinarian.
  45. To be valid a prescription for a POM-V must contain
    the name of the animal and its owner
  46. A prescription for a POM-V is valid for 6 months,
    unless a shorter period is stated
  47. It is illegal to advertise products for the treatment
    of mild infections to the general public in the UK.
  48. 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.
  49. A legal representative of a bankrupt pharmacist may
    carry on the retail pharmacy business for no more than 2 years.
  50. In the UK,
    the British Pharmacopoeia has more authority than the European Pharmacopoeia.
  51. An herbal practitioner needs a manufacturer’s licence
    for preparing mixtures of herbs for an individual patient.
  52. A Marketing Authorisation is required before a
    medicinal product can be advertised and/or sold in the UK
  53. The holder of a manufacturers licence is required to
    keep durable records of manufacturing procedures for 2 years.
  54. 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
  55. 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.
  56. A wholesaler’s
    licence is necessary for the sale by a pharmaceutical manufacturer of its own medicinal
  57. In the UK,
    completely denatured alcohol may be sold to any persons, in any quantity, at
    any time
  58. Unlicensed medicinal products can be advertised for medicinal purposes
  59. Medicinal products can be advertised with holding a marketing authorisation
  60. The Market authorisation holder must consent to adverts before they are released
  61. A PIL is considered to be advertising
  62. The sale of a labelled container/package is not considered to be advertising
  63. Only the MA holder needs to keep any records of advertising

    Advertisers/publishers also need to keep records
  64. 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
  65. POM medicines can be advertised to the public

    Only GSL and P meds can be advertised
  66. All controlled drugs may not be advertised
  67. Drugs for the treatment of cancer may be advertised
  68. Medicinal products to procure abortion can be advertised
  69. Chronic insomnia medication can be advertised
  70. Diabetic medications can be advertised
  71. Cardiovascular disease medication can't be advertised
  72. Bone disease medication can be advertised
  73. Liver, biliary and pancreatic disease medication can't be advertised
  74. Endocrine, genetic and respiratory disease medication can't be advertised
  75. Malignant condition medication can't be advertised
  76. STD medication can be advertised
  77. Medication to treat serious infections can be advertised
  78. Medication to treat serious muscular, neurological or GI disease can't be advertised
  79. Medication for psychiatric disease or conditions can be advertised
  80. 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
  81. Adverts can suggest that medical consultation or surgery is unnecessary
  82. Adverts can't suggest that effects are guaranteed or give misleading, improper terms to claims of recovery
  83. Adverts can suggest that the medicinal product is better than another identifiable product
  84. Adverts can't suggest that health will be enhanced by taking a medication or will be affected by not taking the medicine
  85. Natural products can claim that they are safe and efficacious in advertising because they are natural
  86. An advert can't claim a medicinal product has no side effects
  87. A product can use claims like "fast acting" and "24 hour relief" without having to back it up with clinical trial evidence
  88. Adverts for medicinal products can use endorsement from celebrities
  89. Adverts for medicinal products can refer to recommendations from scientists
  90. A medicinal product can use it's marketing authorisation to claim it's superiority over products without MA's
  91. Samples cannot be given out for promotional purposes
  92. If the promotion is a reminder then the advert need only feature the name of a product
  93. Advertising of vaccination campaigns and disease awareness campaigns are exceptions from advertising rule
  94. When advertising for PQPS online the websites should be aimed at PQPS preferably with restricted access
  95. Members of the public can be encouraged to access information meant for PQPS
  96. 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


    License number

    Name and address of MA holder

    Legal classification

    Cost ex VAT
  97. Abbreviated adverts for PQPS should contain...
    Name and address of the MA holder

    Legal classification

    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)
  98. Professional samples of a medicincal product may be supplied to PQPS for the purpose of acquiring experience in it's use may be given
  99. 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
  100. Promotional aids for PQPS (non monetary gift made for promotional purposes) are exempt from advertising requirements if they only contain the products name
  101. Accompanying written material with promotional aids must be compatible with the SPC and contain the legal classification
  102. Representation by commercially interested parties or others is not allowed for any product for which adverts aren't permitted
  103. 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
  104. 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
  105. All hazardous chemicals must be classified by...
    The hazard

    A description of the hazard by allocation of a risk phrase
  106. 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
  107. 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
  108. A chemical label must contain the name address and telelphone number of the supplier
  109. A chemical label must be able to be read horizontally
  110. Chemical labels must include...
    the indications of a general nature of risk and the symbols specified

    the risk and safety phrases
  111. Chemicals used by podiatrists are regulated as medical devices if they have medicinal claims
  112. A chemical used as a non medicinal poison is controlled by the Medicines Act 1968

    They are controlled by the Poisons Act 1972
  113. If used as a medicinal product then it is controlled by the Medicines Act
  114. Some substances in the poisons list are used as medicinal products
  115. A non medicinal poison or a poison is a substance included in the poisons list
  116. Part one poisons can only be sold by persons conducting a retail pharmacy business (with some exceptions)
  117. Part II poisons may only be sold by retail pharmacists and listed sellers of part II poisons
  118. Listed sellers of part II poisons may only sell part II poisons from listed premises in pre-packed containers
  119. Schedule 4 group one poisons contain poison but are completely exempt from controls as poisons (e.g. builders materials
  120. Schedule 4 group II poisons lists exemptions for certain poisons when in specified articles/substances (e.g. sulphuric acid in batteries)
  121. Schedule one poisons have special restrictions relating to storage, condition of sale and record of sale
  122. Schedule 5 poisons - some part II poisons may be sold by listed sellers only to persons in agriculture, horticulture or forestry industries
  123. 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
  124. Signed orders for schedule one poisons can be accepted from a person who requires a poison for their trade, business or profession
  125. Signed orders for Sch 1 poisons must contain;
    Signature of the purchaser

    Name and address of purchaser
  126. 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
  127. For Sch 1 poisons a record must be made in the poisons book which must be signed by the purchaser
  128. What details should be recorded in the poisons book for a sale of a Sch 1 poison?
  129. 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
  130. 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
  131. 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
    • stored underneath
  132. 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
    • agricultural/forestry/horticultural poisons
  133. 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
  134. 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
    • that person

    • 4) Person requiring poison for trade or
    • business
  135. Poisons can be sold from automated machines
  136. What are the three types of denatured alcohol?
    Completely denatured alcohol

    Industrial denatured alcohol

    Trade specific denatured alcohol
  137. No record is required for purchase of completely denatured alcohol
  138. There are restrictions on the retailing of completely denatured alcohol
  139. Any quantity of completely denatured alcohol may be purchased from an authorised distributor by a pharmacy
  140. 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

    Highly flammable

    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


    Horizontal labelling
  141. Pharmacists need authorisation from HMRC to obtain IDA
  142. 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
Card Set
pharmacy law