Pharma Supply Chain

DEA – CSOS

CSOS Initial Certification

The CSOS (Controlled Substance Order System) Initial Certification provides software vendors of order management systems that place electronic orders for controlled substances with the required third-party review for conformance to application requirements in DEA Final Rule 21 CFR 1305,1311.

CSOS Recertification

The CSOS (Controlled Substance Order System) Recertification provides software vendors recertification after the application has been modified and where those modifications impact application requirements as defined in Final Rule 21 CFR 1305,1311.

DEA – EPCS

EPCS Initial Full Certification

Provides EHR software vendors that develop their own e-prescribing functionality or pharmacy applications with an initial EPCS certification as required by Interim Final Rule 21 CFR Parts 1311. Drummond’s EPCS Certification Process was approved by the Drug Enforcement Agency (DEA) on August 1, 2012.

EPCS Full Recertification

If you’re a software vendor that develops your own e-prescribing functionality or pharmacy application, this test provides you with the ability to re-certify every two years as required by Interim Final Rule 21 CFR 1311.

EPCS Application Change Attestation

If you’re a software vendor that develops your own e-prescribing functionality or pharmacy application, that made changes to an already certified EPCS application, this limited application review of the changes made can update the certification report already issued. Recertification every two years is still required.

EPCS NCPDP 20170701 Certification Update

If you’re a software vendor that develops your own e-prescribing functionality or pharmacy application, that made changes to an already certified EHR application, this review can update the certification report already issued through an attestation. This attestation will focus on review of NCPDP 20170701 (which replaces NCPDP 10.6) application updates which are required to be used starting on January 1, 2020.

EPCS Integration Review of e-Prescription Module

Provides software vendors of EHR applications that do not develop their own e-prescribing functionality but rather integrate a 3rd party EPCS module (Dr First, NewCrop, MDToolbox) a limited review of the DEA application requirements integration an EPCS module. The review focuses on the EPCS module application integration including review of Administrative functions and use of two-factor authentication (2FA).

GS1 EPCIS

EPCIS 1.2 GS1 Conformance Testing — Individual Test Scenario

Drummond provides conformance testing to drug supply chain software vendors and end-users of track and trace software seeking to meet DSCSA interoperability requirements through the use of the GS1 EPCIS 1.2 standard, through its GS1-Certified EPCIS Conformance Portal. GS1 issues GS1 EPCIS 1.2 Trustmarks for each passing test scenario. The test scenarios are defined in the GS1 US Rx EPCIS Conformance Testing Program Guide. Stakeholders include application developers, drug manufacturers and wholesalers, and dispensers.

EPCIS 1.2 GS1 Conformance Testing All Test Scenarios — Yearly Subscription

Drummond provides conformance testing to drug supply chain software vendors and end-users of track and trace software seeking to meet DSCSA interoperability requirements through the use of the GS1 EPCIS 1.2 standard. Drummond provides conformance testing through its GS1 Certified EPCIS Conformance portal. GS1 issues GS1 EPCIS 1.2 Trustmarks for each passing Test Scenario. The test scenarios are defined in the GS1 US Rx EPCIS Conformance Testing Program Guide. Stakeholders include: application developers, drug manufacturers and wholesalers, and dispensers.

EPCIS 1.2 GS1 Conformance Testing Manufacturer — Yearly Subscription

Provides you with twelve months of access to conformance testing of up to seven test scenarios as defined by GS1 for manufacturer to downstream trading partners. Manufacturer is allowed to test all test scenarios for at most two (2) versions of their application in a 12-month calendar period.

EPCIS 1.2 GS1 Conformance Testing Wholesaler — Yearly Subscription

Provides Wholesaler or software provider with a 12-month access to conformance testing of up to 9 test scenarios as defined by GS1 for manufacturer dispenser. Wholesaler is allowed to test all 9 test scenarios for at most two (2) versions of their application in a 12-month calendar period.