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Is a Controlled Substance Ordering System (CSOS) right for you?

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. .

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Is a Controlled Substance Ordering System (CSOS) right for you?

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  1. 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.

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

  3. Official CSOS Information • DEA Website for CSOS • www.deaecom.gov • DEA Supplied CSOS Information • Enrolling in CSOS • Learning about CSOS • Enrollment and certificate status • CSOS reporting • CSOS support

  4. 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

  5. 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) 140-2 software

  6. Applying for a Digital Certificate • Buyers start by going to www.deaecom.gov/applycert.html • 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 www.deaecom.gov/CSOS_SubManual_IE.pdf

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. Thank You For Your Time Open For Questions Contact Information: David Kessler 254-718-2778 dkessler@legisym.com www.legisym.com

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