What is meant by ‘primary packaging’ ?
the packaging in contact with the medicine
What packaging needs to be labelled?
both container (primary packaging) and outer packaging e.g. box containing tube
In what circumstances regarding labels is a person guilty of an offence having sold or supplied a product?
- knowing a package or package leaflet relating to medical product does not apply with applicable requirements
- knowing product is not accompanied by leaflet when required
A person who is guilty of supplying a medical product without a package leaflet when required or with an incorrect leaflet is liable to what?
- a maximum fine of £5000
- imprisonment of up to two years, or both
When did the defence from criminal prosecution for an inadvertent dispensing error become law?
April 2018
Under what section of the Medicines Act 1968 CANT employee and locum pharmacists be prosecuted for attaching the wrong label?
85.5
How do manufacturing labels differ from dispensing labels?
- dispensing labels read by specific patient, manufacturing by public (P, GSL), patient and pharmacist
- written by manufacturer not dispenser
What twenty things must be included on the manufacturing label?
- product name (braille)
- name of drug(s)
- strength
- amount of drug per dose unit
- total content
- list of excipients
- form
- method of administration
- route of administration
- instructions for use (if not POM)
- intended for use by …
- name and address of holder of MA
- MA number (MHRA)
- ‘keep out of reach and sight of children’
- P or POM in box if necessary
- batch number
- expiry date (month and year)
- necessary warnings
- storage requirements
- disposal requirements
An expiry date containing month and year on a manufacturing label suggests what?
Product expires the end of the given month
Unlicensed medicines do not have a MA and can be made by who?
- by a manufacturer who holds a ‘manufacturing specials licence’
- under the supervision of a pharmacist via ‘section 10 exemption’
What information must be included on blister packs? (exemption from usual rules of manufacturing labels)
- product name, strength, form
- drug name
- expiry date
- batch number
- for babies, children or adults
- MA holder’s name
What information must be included on small containers? (exemption from usual rules of manufacturing labels)
- product name, strength form
- drug name
- expiry date
- batch number
- for babies, children or adults
- method and route of administration
- MA holder’s name if possible
What is an MDS box?
Monitored Dosage System
What labels must be included within an MDS box?
A dispensing label for each medicine
What are the legal requirements for dispensing labels?
- patient name
- medicine name
- name and address of pharmacy
- directions for use
- date of dispense
- any precautions
What are optional additions to dispensing labels? (recommended to include!)
- total content
- form, strength, quantity
- ‘keep out of reach and sight of children’
What are some recommendations with regards to label design?
- emphasise the difference between similar medicine names
- do not add trailing zeros e.g. 2.5mg not 2.50mg
- body text size minimum of 12
- sans serif typefaces
How can packaging for medicines be designed in a manner to stick out from others?
- different strengths in different packaging
- discourage company colour schemes
- different forms in different packaging
What products must have ALL excipients (including non active) on the manufacturing label?
Topical, injectable or ophthalmic products
When is a product classed as for external use only?
- applied to skin or mucous membrane
- LOCAL effect
