Accountability for manufacturers' samples

All registrants must maintain effective physical security controls and records for all controlled substances (Schedules II-VI), including samples.
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Description

Regulations of the Department of Public Health at 105 CMR 700.000 et. seq. require all registrants to maintain effective physical security controls and records for all controlled substances (Schedules II-VI), including samples. The Department requires that registrants maintain a system that is able to effectively maintain an accurate inventory of all samples maintained on the premises (i.e. a perpetual inventory to determine if each product has been logged in and out appropriately). All registrants (health facilities as well as individual practitioners) should keep a running balance, which is credited and debited whenever samples are either received from drug companies or their representatives or dispensed to patients.

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.

Contact

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239 Causeway St.
Suite 500
Boston, MA 02114

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