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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

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
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
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
how csos started
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
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
applying for a digital certificate
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
csos benefits
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
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 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
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
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
Thank You For Your Time

Open For Questions

Contact Information:

David Kessler

254-718-2778

dkessler@legisym.com

www.legisym.com