Electronic Ordering of Controlled Substances (Interim Guidelines)

Introduction

March 12, 1999 Revised: August 12, 1999

The purpose of these guidelines is to assist the pharmaceutical industry, licensed dealers and value-added suppliers in developing and implementing electronic ordering systems designed to facilitate the secure ordering and accountability for narcotics and controlled substances.

The central issue with respect to an electronic ordering system is the prevention of diversion and loss of controlled substances.

The proposed electronic system must provide levels of security with respect to origin of the order, drug quantity, drugs ordered and secrecy of shipment, that is equal to or greater than that provided by current regulations applicable to written requisitions and receipts.

Key considerations are:

• The physical security at the location;
• Certification of the identity of the requester;
• Audit trail and Accountability - with provision for non-repudiation of origin and receipt;
• Integrity of the transmission to prevent interception and tampering;
• Security of the message e.g. encryption and certification authority.