Delaware News: Controlled Substance Records and Inventory Requirements

Topics: Controlled substances

Published in the June 2009 Delaware State Board of Pharmacy News

As a reminder, controlled substance inventories must be taken at least biennially after the initial inventory is taken. The biennial inventory may be taken on any date that is within two years of the previous biennial inventory date.
The initial inventory date is an inventory of all stocks of controlled substances on hand on the date the registrant first engages in the manufacture, distribution, or dispensing of controlled substances. In the event a person commences business with no controlled substances on hand, he or she shall record this fact as the initial inventory.
Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken, and it shall be maintained in written, typewritten, or printed form at the registered location. An inventory taken by use of an oral recording device must be promptly transcribed. Controlled substances shall be deemed to be “on hand” if they are in the possession of or under the control of the registrant, including substances returned by a customer, ordered by a customer but not yet invoiced, stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples. A separate inventory shall be made for each registered location and each independent activity registered. In the event controlled substances in the possession of or under the control of the registrant are stored at a location for which he or she is not registered (example: interim box in a nursing home), the substances shall be included in the inventory of the registered location to which he or she is subject to control or to which the person possessing the substance is responsible. The inventory may be taken either as of the opening of business or as of the close of business on the inventory date and it shall be indicated on the inventory.