The Importance of Pharmacists in 503B Outsourcing
A 503B Outsourcing Facility is a designation created by the FDA that establishes a new level of patient care and safety by ensuring adherence to…
A 503B Outsourcing Facility is a designation created by the FDA that establishes a new level of patient care and safety by ensuring adherence to…
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The Drug Enforcement Administration (DEA) Controlled Substance Ordering System (CSOS) allows for secure electronic transmission of Schedule I-V controlled substance orders without the supporting paper Form 222. The electronically transmitted order contains a digital version of a traditional written signature. The digital signature is accomplished through the use of a computer file known as a Digital Certificate.
Digital Certificates are issued by DEA to registrants who are already approved to accept shipments of controlled substances. Acquiring the digital certificate is a secondary process that takes place once the registrant decides to use CSOS to replace some or all of the paper Forms 222 they issue when ordering controlled substances. A single digital certificate can be used to place orders with any supplier who has a CSOS-enabled ordering system such as Express 222.
To get a digital certificate, a DEA registrant must enroll in the CSOS program through the DEA Web site. Every individual person who wants to sign electronic orders for controlled substances must enroll with DEA to acquire his or her own personal CSOS Certificate. The enrollment process begins on the DEA Web site, and ends with printing the application, getting it notarized, and mailing it. Prior to going to the Web site, a decision should be made regarding who in the organization will be allowed to sign electronic orders. If this decision is not made ahead of time, the enrollment process can become frustrating.
To make the decision, it might help to know that, for practical purposes, each person designated as a signer should have access to a computer with Microsoft Internet Explorer 7.0 or higher installed. It might also help to know that typically the person who now signs all your paper Forms 222 is the person who enrolls for the digital certificate. This person would go to the DEA’s Web site and Enroll as a Registrant. If only this one person will sign orders, this person also becomes the CSOS Coordinator, and the enrollment process is simple. It gets a bit more complicated if more than one person will be allowed to sign electronic orders. Please refer to the instructions on the DEA Web site or in the DEA help manual (link included below) if you will have more than one person signing electronic orders.
Once the decision has been made regarding who will be allowed to sign electronic orders, the enrollment process can be undertaken at this page on the DEA Web site: http://www.deaecom.gov/applycert.html
DEA has prepared a very helpful document that takes you through the enrollment process step by step, with pictures of the screens. This document is available for download here: http://www.deaecom.gov/CSOS_SubManual_IE.pdf
Once the enrollment process is complete, within about six weeks the DEA will send both an email and a postal mail. These two items (access code and password) must be married up in order for you to retrieve your digital certificate from the DEA Web site. The DEA help document explains in detail how to retrieve the file and install it in your Internet Explorer browser.
Once your digital certificate is installed in Internet Explorer, you can test it to make sure it’s ready to be used with your supplier’s Express222 ordering system. Simply go to the Web site at http://www.express222.com and run the certificate test. The test will allow you to safely sign a “dummy” order that does not actually get transmitted.