Excemptions From Licensing

Question 1

True or false, pharmacists are exempt from licensing requirements?

Answer 1

True

Question 2

What conditions allow a pharmacist to prepare/dispense a customers own recipe for self administration or administration to someone in their care?

Answer 2

Can only use GSL ingredients and must use professional judgement.

Question 3

Is a licence needed for a pharmacist to sell their own products (nostrums)?

Answer 3

No but cannot advertise

Question 4

What can doctors and dentists do without the need for a licence?

Answer 4

Prepare and assemble products intended for an individual patient

Question 5

True or false, nurses and midwives require a licence to assemble (break bulk and repack) a product in the course of their profession for an individual patient?

Answer 5

False- do not require a licence to do this.

Question 6

What are the conditions that make a herbalist exempt from needing a manufacturers licence to manufacture/assemble herbal products?

Answer 6

Product must be manufactured/assembled by them (the herbalist), the product must not contain certain listed substances, herbalist must use their professional judgment as to treatment required, premises must be lockable, person it is for must be present

Question 7

True or false, a manufacturer/MA holder does not need a wholesale dealers licence to market their own products directly from their premises?

Answer 7

True

Question 8

True or false, a wholesale dealers licence is required for a product intended to be re-exported without alteration?

Answer 8

False-not required

Question 9

True or false, a wholesale dealers licence is not required to import a product specifically for an individual?

Answer 9

True

Question 10

Give the two examples of when a borderline substance requires a licence.

Answer 10

If they are promoted to HCPs (need MA) and if products for oral administration as food claim to be beneficial for a particular disease or are labelled with a dose for a medicinal purpose

Question 11

When do vitamin preparations need a licence?

Answer 11

If the dose exceeds 2500 units of vitamin A, 250 units of vitamin D, 25 micrograms of folic acid, 5 micrograms of cyanocobalmin, if fortified foods with added vitamins above the daily dose or if they are for oral administration as food and there are no written directions for dosage.

Question 12

In which cases do cosmetics require a licence?

Answer 12

If they contain any antibiotic, 0.004% or above of any hormone, more than 0.1% hexachlorophane and more than 1% resorcinal.