The Electronic Prescribing of Controlled Substances IFR
To be Issued by DEA for Public Comments
The Drug Enforcement Administration is revising its regulations ”to provide practitioners with the option of writing prescriptions for controlled substances electronically.”
Office of National Coordinator (ONC) for Health IT emailed this notice on March 25, 2010. Summary from Interim Final Rule (IFR) can be seen below text from email.
“Yesterday (3/24) the Office of the Federal Register made available for public inspection an Interim Final Rule with Request for Comments from the Drug Enforcement Administration (DEA), Department of Justice on Electronic Prescribing of Controlled Substances. The Interim Final Rule specifies the rules that health care providers will need to follow in order to electronically prescribe controlled substances in accordance with the law. Since DEA published the Notice of Proposed Rulemaking for electronic prescribing of controlled substance, ONC, CMS, AHRQ and other HHS staff have worked closely with DEA to develop the policies in the Interim Final Rule. The Interim Final Rule is expected to be published in the Federal Register on Wednesday, March 31 and will include a 60 day comment period. To view the Interim Final Rules go to: http://www.federalregister.gov/inspection.aspx#spec_D”
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Electronic Prescriptions for Controlled Substances
Excerpts from IFR for inspection at site of Federal Register
Federal Register PDF of Interim Final Rule
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Parts 1300, 1304, 1306, 1311
[Docket No. DEA-218I]
RIN 1117-AA61
AGENCY: Drug Enforcement Administration (DEA), Department of Justice
ACTION: Interim Final Rule with Request for Comment.
SUMMARY: The Drug Enforcement Administration (DEA) is revising its regulations to provide practitioners with the option of writing prescriptions for controlled substances electronically. The regulations will also permit pharmacies to receive, dispense, and archive these electronic prescriptions. These regulations are an addition to, not a replacement of, the existing rules. The regulations provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing; additionally, the regulations will reduce paperwork for DEA registrants who dispense controlled substances and have the potential to reduce prescription forgery. The regulations will also have the potential to reduce the number of prescription errors caused by illegible handwriting and misunderstood oral prescriptions. Moreover, they will help both pharmacies and hospitals to integrate prescription records into other medical records more directly, which may increase efficiency, and potentially reduce the amount of time patients spend waiting to have their prescriptions filled.
DATES: This rule has been classified as a major rule subject to Congressional review. The effective date is [INSERT DATE 60 DAYS AFTER PUBLICATION IN THE FEDERAL REGISTER]. However, at the conclusion of the Congressional review, if the effective date has been changed, the Drug Enforcement Administration will publish a document in the Federal Register to establish the actual effective date or to terminate the rule. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of [INSERT DATE 60 DAYS AFTER DATE OF PUBLICATION IN THE FEDERAL REGISTER].
Written comments must be postmarked and electronic comments must be submitted on or before [INSERT DATE 60 DAYS FROM DATE OF PUBLICATION IN THE FEDERAL REGISTER]. Commenters should be aware that the electronic Federal Docket Management System will not accept comments after Midnight Eastern Time on the last day of the comment period.
ADDRESSES: To ensure proper handling of comments, please reference “Docket No. DEA-218” on all written and electronic correspondence. Written comments sent via regular or express mail should be sent to the Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA 22152. Comments may be sent to DEA by sending an electronic message to dea.diversion.policy@usdoj.gov. Comments may also be sent electronically through http://www.regulations.gov using the electronic comment form provided on that site. An electronic copy of this document is also available at the http://www.regulations.gov web site.
