All registrants should maintain an established policy and procedure for handling and recordkeeping of samples. Registrants are permitted to maintain a file of records about the samples received with lot numbers and other information, however such records do not replace the perpetual inventory. Every sample administered or dispensed must be accounted for (patient name and address, date administered or dispensed, drug name/strength, lot number and sample amount). This inventory must be performed by a qualified, licensed individual such as a registered individual practitioner, nurse or pharmacist. All samples must be stored in a secure area, accessible only to authorized individuals.
In addition, all samples must be labeled and dispensed in accordance with Department regulations at 105 CMR 700.010.
For further information, please contact the Drug Control Program at (617) 983-6700.
This information is provided by the Drug Control Program within the Department of Public Health.