[RegAffairs]Medication guide

["PAKHI RUSIA" <pakhirusia@rediffmail.com>]

Dear All,

Now a days USFDA is regularly asking to supply a medication guide 
(Patient Information Leaflet) to accompany each dispensing of the 
product, and they ask how many copies do you plan to provide with 
each pack.

For example if we have 30's count bottle pack and 100's count bottle 
pack how many medication guide should accompany each pack. Do we have 
any guidance by USFDA for the same.

Regards,
Pakhi