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Title: | Diversion Control Division | CSOS (Controlled Substances Ordering System)
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Body: | DIVERSION CONTROL DIVISION
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CSOS (Controlled Substances Ordering System) Q&A
Home
Resources
Questions & Answers
CSOS (Controlled Substances Ordering System) Q&A
Question: How do electronic DEA 222 Order Forms work and what is required
to use them? (a.k.a. Controlled Substance Ordering System (CSOS) electronic
order forms)
Answer: The DEA Controlled Substance Ordering System (CSOS) allows for
secure electronic transmission of controlled substance orders without the
supporting paper DEA Order Form 222. Any registrant permitted to order
schedule II controlled substances may do so electronically via CSOS. The
use of electronic orders is optional; registrants may continue to issue
orders on a paper DEA Order Form 222 if they prefer.
The adoption of the CSOS standards is the only allowance for the electronic
transmission of schedule II controlled substance orders between controlled
substance manufacturers, distributors, pharmacies, and other DEA authorized
entities. CSOS uses Public Key Infrastructure (PKI) technology, which
requires CSOS users to obtain a CSOS digital certificate for electronic
ordering. The electronic orders must be signed using a digital signature
issued by the Certification Authority (CA) run by DEA. 21 CFR 1305.21(a).
Digital certificates can only be obtained by the person who signed the most
recent DEA registration or renewal application, a person authorized to sign
a registration application, or a person granted power of attorney by a DEA
registrant to sign orders. 21 CFR 1311.10(a) & (b). A registrant must
appoint a CSOS coordinator who will serve as that registrant's recognized
agent regarding issues pertaining to issuance of, revocation of, and
changes to, digital certificates issued under that registrant's DEA
registration 21 CFR 1311.20(a). A CSOS digital certificate will be valid
until the DEA registration under which it is issued expires or until the
CSOS CA is notified that the certificate should be revoked 21 CFR
1311.30(e), 1311.40(a). Certificates will be revoked if the certificate
holder is no longer authorized to sign schedule II orders for the
registrant, if the information on which the certificate is based changes,
or if the digital certificate used to sign electronic orders has been
compromised, stolen, or lost 21 CFR 1311.30(e), 1311.40(a).
A "Questions and Answers" page about the CSOS certificate is available on
the DEA E-Commerce Program website at www.DEAecom.gov. Applicants can
download the Diversion PKI CSOS Enrollment document and the CSOS
Subscriber's Manual for assistance on the enrollment process. DEA also
maintains a support line to assist applicants and subscribers with issues
pertaining to certificate enrollment, issuance, revocation, and renewal.
Staff is available from 8:00 a.m. to 5:50 p.m. Eastern Time, Monday through
Friday at 1-877-332-3266 if further assistance is needed. EO-DEA198,
October 5, 2020
Question: Are there restrictions in the use of electronic forms to order
controlled substances also known as the Controlled Substances Ordering
System?
Answer: Yes. Under 21 CFR 1305.25(a), an electronic order for controlled
substances may not be filled if any of the following occur:
The required data fields have not been completed;
The order is not signed using a digital certificate issued by DEA;
The digital certificate used has expired or been revoked prior to
signature;
The purchaser's public key will not validate the digital
certificate; or
The validation of the order shows that the order is invalid for any
reason.
If an order cannot be filled, the supplier must notify the purchaser and
provide a statement as to the reason (e.g., improperly prepared or
altered). A supplier may, for any reason, refuse to accept any order. If a
supplier refuses, a statement that the order is not accepted is sufficient.
21 CFR 1305.25(b).
When a purchaser receives an unaccepted electronic order from a supplier,
the purchaser must electronically link the statement of non-acceptance to
the original order. The original statement and all linked records for that
order must be retained for two years. 21 CFR 1305.25(c), 1305.27(a).
Neither a purchaser nor a supplier may correct a defective order. The
purchaser must issue a new order for the order to be filled. 21 CFR
1305.25(d). A supplier may void all (or part) of an electronic order by
notifying the purchaser of the voiding. If the entire order is voided, the
supplier must make an electronic copy of the order and indicate "void" on
the copy and return it to the purchaser. The supplier is not required to
retain a record of orders that are not filled. 21 CFR 1305.28(a). The
purchaser must retain an electronic copy of the voided order. 21 CFR
1305.28(b). Should a supplier partially void an order, the supplier must
indicate in the linked record that nothing was shipped for each item
voided. 21 CFR 1305.28(c). EO-DEA184, October 5, 2020
Disclaimer: Guidance documents, like this document, are not binding and
lack the force and effect of law, unless expressly authorized by statute or
expressly incorporated into a contract, grant, or cooperative agreement.
Consistent with Executive Order 13891 and the Office of Management and
Budget implementing memoranda, the Department will not cite, use, or rely
on any guidance document that is not accessible through the Department's
guidance portal, or similar guidance portals for other Executive Branch
departments and agencies, except to establish historical facts. To the
extent any guidance document sets out voluntary standards (e.g.,
recommended practices), compliance with those standards is voluntary, and
noncompliance will not result in enforcement action. Guidance documents may
be rescinded or modified in the Department's complete discretion,
consistent with applicable laws.
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DIVERSION CONTROL DIVISION
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