BP Monographs for Formulated Preparations

[johannes]

Hi,
The BP contains monographs on formulated preparations.
I am keen on to know more about them; the history of those, the purpose of these, their regulatory status,
and the current status of use.

Best wishes,

joha

[JM342]

Dear Joha
As far as I understand it, they have no special regualtory status - if a manufactuter wishes to market any of these preparations, they still need to submit a full regulatory dossier. Prices of generics being what they are, I am not sure whether there is any incentive for companies to develop and market these products.

There are several texts dealing with these traditional formulations - try the RPSGB library - they could probably point you in the right direction.

[johnep]

I used to work for a company that produced large range of BP products and formulations. Comparable texts are the USP and EP.
When the CSA demanded specs for every product, I was given the task and just copied the BP or BPC monographs. Complete waste of time to me, but we got our PLRs and I got used to writing a marketing version of a spec sheet.
No computers in those days so all written in long hand and typed up by my secretary.
johnep

[JM342]

Aah the good old days...

[Nik]

...with young attractive secretaries !