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Questions and Answers
Extemporaneous dispensing is also known as compounding.
Extemporaneous dispensing is also known as compounding.
True (A)
Specials are only licensed medicines.
Specials are only licensed medicines.
False (B)
The hub pharmacy model is used in Belgium for compounding.
The hub pharmacy model is used in Belgium for compounding.
False (B)
Regulation 167 of the Human Medicines Regulations 2012 exempts the requirement of marketing authorization for Specials.
Regulation 167 of the Human Medicines Regulations 2012 exempts the requirement of marketing authorization for Specials.
Guidance Note 14-MHRA states that no record of procurement in pharmacy is required for Specials.
Guidance Note 14-MHRA states that no record of procurement in pharmacy is required for Specials.
Extemporaneous preparations only include batch-produced sterile products.
Extemporaneous preparations only include batch-produced sterile products.
Specials manufacturer can supply to anyone, including individuals.
Specials manufacturer can supply to anyone, including individuals.
The shelf life of a product with no formal stability data can exceed 30 days.
The shelf life of a product with no formal stability data can exceed 30 days.
The Peppermint Water Case resulted in the death of a 3-week old baby.
The Peppermint Water Case resulted in the death of a 3-week old baby.
It is important to picture the best-case scenario during risk analysis.
It is important to picture the best-case scenario during risk analysis.
Electronic Balances should not be checked daily with standard weights.
Electronic Balances should not be checked daily with standard weights.
The availability of Raw Materials is not important in the procurement and supply of specials.
The availability of Raw Materials is not important in the procurement and supply of specials.
Creams are more prone to microbial growth compared to ointments.
Creams are more prone to microbial growth compared to ointments.
Physical problems like cracking and caking are not common in formulation.
Physical problems like cracking and caking are not common in formulation.
The shelf life of a closed pack could be longer than that of an opened pack for certain products.
The shelf life of a closed pack could be longer than that of an opened pack for certain products.
Traditional terms Elixir, Mixture, Linctus are no longer used in pharmacy.
Traditional terms Elixir, Mixture, Linctus are no longer used in pharmacy.
Reefers are small cigars filled with drugs.
Reefers are small cigars filled with drugs.
Coal Tar Solution BP (20%) is a clear solution.
Coal Tar Solution BP (20%) is a clear solution.
Using the highest strength tablets is recommended to reduce overall excipients in oral liquids.
Using the highest strength tablets is recommended to reduce overall excipients in oral liquids.
It is vital to ensure correct clinical interpretation of prescription in order to prevent dispensing errors.
It is vital to ensure correct clinical interpretation of prescription in order to prevent dispensing errors.
Errors in pharmacy practice are usually insignificant.
Errors in pharmacy practice are usually insignificant.
Pharmacists should always use the same brand and strength to avoid errors.
Pharmacists should always use the same brand and strength to avoid errors.
The misuse of drugs is regulated by the Misuse of Drugs Act 1971.
The misuse of drugs is regulated by the Misuse of Drugs Act 1971.
Employment law is not relevant to pharmacy practice.
Employment law is not relevant to pharmacy practice.
The Orange Guide introduces the concepts of a Quality Assurance System and Good Manufacturing Practices.
The Orange Guide introduces the concepts of a Quality Assurance System and Good Manufacturing Practices.
Specials Manufacturing License requires three key personnel: Head of Production, Head of Quality Control, and Head of Research.
Specials Manufacturing License requires three key personnel: Head of Production, Head of Quality Control, and Head of Research.
Cleanrooms are not required for extemporaneous dispensing in the pharmaceutical industry.
Cleanrooms are not required for extemporaneous dispensing in the pharmaceutical industry.
What is another term for extemporaneous dispensing?
What is another term for extemporaneous dispensing?
Which of the following is considered as 'Specials' in the pharmaceutical context?
Which of the following is considered as 'Specials' in the pharmaceutical context?
In which country is all compounding performed in pharmacies?
In which country is all compounding performed in pharmacies?
What is the purpose of Regulation 167 of the Human Medicines Regulations 2012?
What is the purpose of Regulation 167 of the Human Medicines Regulations 2012?
According to Guidance Note 14 by MHRA, what must be done regarding the procurement of 'Specials'?
According to Guidance Note 14 by MHRA, what must be done regarding the procurement of 'Specials'?
In the context of extemporaneous preparations, what does 'Specials manufacturer' refer to?
In the context of extemporaneous preparations, what does 'Specials manufacturer' refer to?
What is the maximum shelf life if no formal stability data is available for a special?
What is the maximum shelf life if no formal stability data is available for a special?
What is a key requirement for the facilities in specials manufacturing?
What is a key requirement for the facilities in specials manufacturing?
What is an important requirement for equipment in specials manufacturing?
What is an important requirement for equipment in specials manufacturing?
What is the key advantage of an Unguator in the manufacturing process?
What is the key advantage of an Unguator in the manufacturing process?
Why should electronic balances be checked daily with standard weights?
Why should electronic balances be checked daily with standard weights?
What is a common problem with specials prescriptions related to creams and ointments?
What is a common problem with specials prescriptions related to creams and ointments?
How are ingredients of creams or ointments sometimes expressed on prescriptions?
How are ingredients of creams or ointments sometimes expressed on prescriptions?
What is one of the sources of formulae for specials manufacturing?
What is one of the sources of formulae for specials manufacturing?
What is important when considering the availability of raw materials for manufacturing specials?
What is important when considering the availability of raw materials for manufacturing specials?
What should be considered when formulating specials with regards to microbial considerations?
What should be considered when formulating specials with regards to microbial considerations?
What are commonly requested non-sterile dosage forms in specials manufacturing for application to the skin?
What are commonly requested non-sterile dosage forms in specials manufacturing for application to the skin?
Which term is used to refer to Reefers?
Which term is used to refer to Reefers?
What is the primary purpose of the Orange Guide?
What is the primary purpose of the Orange Guide?
What are the responsibilities of the Head of Production and the Head of Quality Control in Specials Manufacturing?
What are the responsibilities of the Head of Production and the Head of Quality Control in Specials Manufacturing?
What is the purpose of the Green Guide?
What is the purpose of the Green Guide?
Which document provides professional guidance for the procurement and supply of Specials?
Which document provides professional guidance for the procurement and supply of Specials?
What is the primary concern when scaling up from crushing tablets to using powder (API)?
What is the primary concern when scaling up from crushing tablets to using powder (API)?
What distinguishes extemporaneous dispensing in the pharmaceutical industry from compounding?
What distinguishes extemporaneous dispensing in the pharmaceutical industry from compounding?
What does the Green Guide provide rules and guidance for?
What does the Green Guide provide rules and guidance for?
Why is it important to ensure correct clinical interpretation of a prescription in pharmacy practice?
Why is it important to ensure correct clinical interpretation of a prescription in pharmacy practice?
What is the primary purpose of Regulation 167 of the Human Medicines Regulations 2012?
What is the primary purpose of Regulation 167 of the Human Medicines Regulations 2012?
What distinguishes extemporaneous dispensing in the pharmaceutical industry from compounding?
What distinguishes extemporaneous dispensing in the pharmaceutical industry from compounding?
What are 'Specials' commonly known as?
What are 'Specials' commonly known as?
What is the purpose of the Green Guide?
What is the purpose of the Green Guide?
Why is it important to ensure correct clinical interpretation of a prescription in pharmacy practice?
Why is it important to ensure correct clinical interpretation of a prescription in pharmacy practice?
What is the primary concern when scaling up from crushing tablets to using powder (API)?
What is the primary concern when scaling up from crushing tablets to using powder (API)?
What is a key consideration when making a suspension from tablets?
What is a key consideration when making a suspension from tablets?
Why is it important to check tablet characteristics when preparing oral liquids?
Why is it important to check tablet characteristics when preparing oral liquids?
What is the purpose of a Material Safety Data Sheet (MSDS) mentioned in the text?
What is the purpose of a Material Safety Data Sheet (MSDS) mentioned in the text?
What is a common ingredient mentioned for use in cream bases?
What is a common ingredient mentioned for use in cream bases?
What is the primary reason for emphasizing the full understanding of required calculations in pharmacy practice?
What is the primary reason for emphasizing the full understanding of required calculations in pharmacy practice?
Why should pharmacists always use the same brand and strength, with care for generics?
Why should pharmacists always use the same brand and strength, with care for generics?
Why is good practice to standardize to dose/5ml or dose/1ml in oral liquids?
Why is good practice to standardize to dose/5ml or dose/1ml in oral liquids?
'Reefers' mentioned in the text are associated with:
'Reefers' mentioned in the text are associated with:
What should be done when considering shelf life, closed and open pack sizes, and storage conditions?
What should be done when considering shelf life, closed and open pack sizes, and storage conditions?
What is the purpose of the Orange Guide mentioned in the text?
What is the purpose of the Orange Guide mentioned in the text?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What is the primary purpose of the Green Guide mentioned in the text?
What is the primary purpose of the Green Guide mentioned in the text?
Why should electronic balances be checked daily with standard weights?
Why should electronic balances be checked daily with standard weights?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What is a key consideration when making a suspension from tablets?
What is a key consideration when making a suspension from tablets?
Why is it important to check tablet characteristics when preparing oral liquids?
Why is it important to check tablet characteristics when preparing oral liquids?
What should be done when considering shelf life, closed and open pack sizes, and storage conditions?
What should be done when considering shelf life, closed and open pack sizes, and storage conditions?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What should be considered when formulating specials with regards to microbial considerations?
What should be considered when formulating specials with regards to microbial considerations?
What is another term for extemporaneous dispensing?
What is another term for extemporaneous dispensing?
Why should pharmacists always use the same brand and strength, with care for generics?
Why should pharmacists always use the same brand and strength, with care for generics?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What is the primary purpose of a Hub pharmacy model in the context of compounding?
What is the primary purpose of a Hub pharmacy model in the context of compounding?
What does Regulation 167 of the Human Medicines Regulations 2012 exempt from the requirement of marketing authorisation?
What does Regulation 167 of the Human Medicines Regulations 2012 exempt from the requirement of marketing authorisation?
What is the key role of Specials Manufacturers in the UK?
What is the key role of Specials Manufacturers in the UK?
What is the significance of Guidance Note 14 by MHRA in relation to the procurement of Specials?
What is the significance of Guidance Note 14 by MHRA in relation to the procurement of Specials?
In the context of extemporaneous dispensing, what distinguishes 'Specials' from other medicinal products?
In the context of extemporaneous dispensing, what distinguishes 'Specials' from other medicinal products?
What is the approach to compounding in certain European countries, such as Belgium?
What is the approach to compounding in certain European countries, such as Belgium?
What are the three traditional terms for oral solutions/suspensions?
What are the three traditional terms for oral solutions/suspensions?
What are some less common non-sterile dosage forms in specials manufacturing?
What are some less common non-sterile dosage forms in specials manufacturing?
What are the different cream bases mentioned in the text?
What are the different cream bases mentioned in the text?
What is the importance of calculation skills in pharmacy practice?
What is the importance of calculation skills in pharmacy practice?
What is the primary document that introduces the concepts of a Quality Assurance System and Good Manufacturing Practices for pharmaceutical manufacturers and distributors?
What is the primary document that introduces the concepts of a Quality Assurance System and Good Manufacturing Practices for pharmaceutical manufacturers and distributors?
What are the two key personnel required for a Specials Manufacturing License?
What are the two key personnel required for a Specials Manufacturing License?
What are the 6 principles for the procurement and supply of specials?
What are the 6 principles for the procurement and supply of specials?
What are the key requirements for facilities in specials manufacturing?
What are the key requirements for facilities in specials manufacturing?
What are the 8 requirements for facilities in specials manufacturing?
What are the 8 requirements for facilities in specials manufacturing?
What are some considerations when scaling up from crushing tablets to using powder (API)?
What are some considerations when scaling up from crushing tablets to using powder (API)?
What are the 9 requirements for equipment in specials manufacturing?
What are the 9 requirements for equipment in specials manufacturing?
What are some patients for whom 'Specials' are commonly required?
What are some patients for whom 'Specials' are commonly required?
What are the considerations for Risk Analysis in specials manufacturing?
What are the considerations for Risk Analysis in specials manufacturing?
What are some regulations that need to be complied with in the context of specials manufacturing?
What are some regulations that need to be complied with in the context of specials manufacturing?
What are the common problems with specials prescriptions?
What are the common problems with specials prescriptions?
What is emphasized as a potential consequence of errors in pharmacy practice?
What is emphasized as a potential consequence of errors in pharmacy practice?
What are the sources of formulae for specials manufacturing?
What are the sources of formulae for specials manufacturing?
What are some aspects to consider when managing patients in pharmacy practice?
What are some aspects to consider when managing patients in pharmacy practice?
What should be considered when formulating specials with regards to microbial considerations?
What should be considered when formulating specials with regards to microbial considerations?
What are the considerations for the shelf life, closed and open pack sizes, and storage conditions of specials?
What are the considerations for the shelf life, closed and open pack sizes, and storage conditions of specials?
What are the commonly requested non-sterile dosage forms for application to the skin in specials manufacturing?
What are the commonly requested non-sterile dosage forms for application to the skin in specials manufacturing?
What is the primary purpose of the Green Guide mentioned in the text?
What is the primary purpose of the Green Guide mentioned in the text?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
What is an important requirement for equipment in specials manufacturing?
What is an important requirement for equipment in specials manufacturing?
Study Notes
Extemporaneous Dispensing
- Also known as compounding or specials
- Specials are licensed medicines exempt from marketing authorization
- Hub pharmacy model used in Belgium for compounding
Regulation and Guidance
- Regulation 167 of Human Medicines Regulations 2012 exempts Specials from marketing authorization
- Guidance Note 14-MHRA states no record of procurement in pharmacy is required for Specials
Characteristics of Specials
- Shelf life can exceed 30 days without formal stability data
- Can be supplied to anyone, including individuals
- Manufacturer can be anyone, including pharmacists and doctors
Formulation and Manufacturing
- Creams are more prone to microbial growth compared to ointments
- Physical problems like cracking and caking are not common in formulation
- Using highest strength tablets recommended to reduce overall excipients in oral liquids
- Errors in pharmacy practice are usually insignificant
Quality and Safety
- The Orange Guide introduces Quality Assurance System and Good Manufacturing Practices
- Specials Manufacturing License requires three key personnel: Head of Production, Head of Quality Control, and Head of Research
- Cleanrooms not required for extemporaneous dispensing in pharmaceutical industry
Other
- Reefer refers to small cigars filled with drugs
- Coal Tar Solution BP (20%) is a clear solution
- The Misuse of Drugs Act 1971 regulates drug misuse
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Description
Test your knowledge on extemporaneous dispensing and 'specials' in the MPharm Programme Principles Of Extemporaneous Preparations. Learn about the definition of extemporaneous dispensing and the characteristics of 'specials'.
