Significant Guidance Documents

On January 18, 2007, the President issued Executive Order 13422, Amendment to Executive Order 12866 for Regulatory Planning and Review.

On that same day, the Acting Administrator of the Office of Information and Regulatory Affairs within the Office of Management and Budget (OMB) issued a related document, the OMB Bulletin on Agency Good Guidance Practices (the GGP Bulletin). The primary focus of the Executive Order and GGP Bulletin is on improving the way the Federal government does business with respect to guidance documents – by increasing their quality, transparency, accountability, and coordination. Executive Order 13422 and the GGP Bulletin will ensure that guidance documents are of high quality, developed with appropriate agency review and public participation, and readily accessible by the public.

The Drug Enforcement Administration, Diversion Control Division, has issued guidance documents which are deemed "significant" as defined by Executive Order 13422 and the GGP Bulletin. Those guidance documents are posted on the Diversion Control Program website. In addition, the Diversion Control Division has also posted many other guidance documents on its website that are useful and helpful to the public and industry, though they do not rise to the level of "significant" guidance documents.

Persons wishing to provide feedback or complaints regarding Diversion Control significant guidance documents should contact:

Drug Enforcement Administration
Diversion Control Division
Liaison and Policy Section
8701 Morrissette Drive
Springfield, VA 22152

To ensure proper processing of comments received, please include "Significant guidance" in the subject of all comments. Further, please clearly identify the significant guidance document to which the comment pertains.

List of Significant Guidance Documents of the Drug Enforcement Administration Diversion Control Division

• Practitioner's Manual: A Guideline to the Practitioner's Responsibilities under the Controlled Substances Act of 1970 (August, 2006)
• Mid-Level Practitioner's Manual: An Informational Outline of the Controlled Substances Act of 1970 (January, 1993) (Under Revision - Refer to the Pharmacist's Manual for general guidance. If you have a specific question, contact your local DEA Office for assistance).
• Pharmacist's Manual: An Informational Outline of the Controlled Substances Act of 1970 (2010)
• Narcotic Treatment Programs: Best Practice Guideline (April, 2000)
• Chemical Handler’s Manual: A Guide to Chemical Control Regulations (April 2013)
• ARCOS Registrant Handbook (1997)
• A Security Outline of the Controlled Substances Act of 1970 (May, 1991)
• Policy Statement: Dispensing Controlled Substances for the Treatment of Pain [71 FR 52716; September 6, 2006] (Docket No. DEA-286)

Additional Resources

For further assistance in better understanding agency guidance and its relationship to current or proposed Federal regulations, please see http://www.regulations.gov