Is a Controlled Substance Ordering System (CSOS) right for you? An overview of CSOS background, compliance, benefits and available solutions. Disclaimer: This is not a DEA sponsored/endorsed CSOS presentation. Legisym and IBS are not speaking on behalf of the DEA.

Who Can Benefit From CSOS Businesses using DEA Form 222 – Manufacturers / Compounders – Suppliers / Wholesalers – Re-packagers – Reverse Distributors – Internal hospital / pharmacy transfers – Testing Laboratories

Official CSOS Information DEA Website for CSOS – DEA Supplied CSOS Information – Enrolling in CSOS – Learning about CSOS – Enrollment and certificate status – CSOS reporting – CSOS support

How CSOS started Paper Reduction Act of 1999 – Allows for electronic signatures when practical – DEA looks at Public Key Infrastructure (PKI) DEA Commissioned Study – Final report issued in February 2000 – Work began on DEA technical infrastructure – In 2004, paper form had a cost to marketplace of $39 DEA Final Rule (21 CFR Parts 1305 and 1311) – Issued April 2005

What is a Digital Certificate In cryptography, a digital certificate is an electronic file which uses a digital signature to bind together a public key with an identity. A valid digital signature gives a recipient reason to believe that the message was created by a known sender, and that it was not altered in transit. Issued by a Certifying Authority (CA) in this case DEA For CSOS, it is used to officially sign a controlled substance order For CSOS, must be stored in Federal Information Processing Standard (FIPS) software

Applying for a Digital Certificate Buyers start by going to Processing time typically 4 to 6 weeks Receive electronic and paper notification Issued to an individual person for a specific time period Installation instructions provided by DEA at

CSOS Benefits Eliminates the paper Form 222 – No line item limits Reduces operational expenses – Removes many of the manual processes – Removes expediting charges of the form – Reduces inventory levels (move towards JIT) Improves DEA compliance – Data accuracy on orders – More timely and accurate customer validation Improves delivery times and service

Reporting Periodic ARCOS Reporting – All requirements stay the same – Must include all CSOS orders 48 Hour CSOS EDI ARCOS Reporting – In addition to periodic ARCOS report – Electronically submitted via EDI process to DEA

DEA Compliance – CSOS DEA Final Rule – 21 CFR Parts 1305 & 1311 – Mandatory and optional audit requirements CSOS Certification – Drummond Group is the only certifying authority for CSOS applications

Commercially Available CSOS Three software companies offer a CSOS application Traditional Client / Server – Hardware installed in facility – Software installed and maintained on server and at client (PC) locations – Pricing: License Fees, User Fees, Maintenance Fees Software as a Service (SaaS) – Deployed over the Internet – Remove hardware requirement – Remove software install – Pricing: Per transaction only

Is CSOS Right For You YES – if your customers are asking for CSOS and your feeling competitive pressure YES – for improving compliance and order accuracy YES – if your market strategy includes the distribution of CII products YES – for lowering inventory levels and moving towards JIT YES – for improving delivery times and service levels

Thank You For Your Time Open For Questions Contact Information: David Kessler