Diversion Control Division, US Department of Justice, Drug Enforcement Administration

Pharmacist's Manual - APPENDIX A-N

Appendix A

This summary is provided as a quick reference to the provisions of the Controlled Substances Act. It is not intended to replace any statutory or regulatory requirement thereof. For complete guidance as to the provisions of each area indicated below, please check the appropriate section of this manual.

Summary of Controlled Substances Act Requirements

  Schedule II Schedules III & IV Schedule V
Registration Required Required Required
Receiving Records DEA Form 222 Invoices, readily retrievable Invoices, readily retrievable
Prescriptions Written1 prescriptions2 Written, oral, or fax Written, oral, or fax
Refills No No more than 5 within 6 months As authorized when prescription is issued or if renewed by a practitioner
Maintenance of Prescriptions Separate file Separate file or readily retrievable Separate file or readily retrievable3
Distribution Between Registrants DEA Form 222 Invoices Invoices
Security Locked cabinet or dispersed among non-controlled pharmaceuticals Locked cabinet or dispersed among non-controlled pharmaceuticals Locked cabinet or dispersed among non-controlled pharmaceuticals
Theft or Significant Loss Report to DEA and complete DEA Form 106 Report to DEA and complete DEA Form 106 Report to DEA and complete DEA Form 106

Note:  All records must be maintained for 2 years, unless state law requires a longer period.

1 Written prescriptions include paper prescriptions and electronic prescriptions that meet DEA’s requirements for such prescriptions.

2  Emergency prescriptionsrequire a signed follow-up prescription within seven days.
Exceptions: A facsimile prescription serves as the original prescription when issued to  residents of Long Term Care Facilities, hospice patients, or patients with a diagnosed terminal illness, or for immediate administration (21 C.F.R. § 1306.11(e), (f) and (g)).

3 The record of dispensing can also be a schedule V logbook, if state law allows.

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