Pharmacist's Manual - APPENDIX A-N
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|
|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.