All
records of acquisition and disposition of controlled substances must be
retained. These
records must be in conformance with the record keeping and inventory
requirements of federal law. This
includes:- Prescriptions
- Receipts and invoices
- All inventory records
- Reports of theft loss, or surrender of controlled substances
- Form 222
All
records required shall be maintained for at least two years from the date of such inventory or records, for
inspection and copying by authorized employees of the DEA. Retaining records
for five years is advisable due to
the statue of limitations.
Schedules
I and II must be maintained separately from all other records of the
registrant, and Schedule III, IV, and V must be maintained either separately
from all other records of the registrant or in such form that the information
required is readily retrievable from the ordinary business records of the
registrant. DEA offers three options for the filing of controlled
substance prescriptions, two for paper and one for electronic records.
- Option 1: A pharmacy may maintain three separate files: one for Schedule II, one for Schedules III-V, and one for all other drugs.
- Option 2: A pharmacy may maintain two separate files: one for Schedule II, and one for all other drugs, in which the Schedule III-V drugs are made retrievable by use of a red “C” stamp not less than an inch high, a requirement that is waved if the pharmacy’s electronic record-keeping system permits identification by prescription number and retrieval of original documents by prescriber’s name, patient’s name, drug dispensed, and date filled.
- Option 3: A pharmacy may have electronic records, which are easily sorted. If prescriptions are received electronically they must be maintained electronically, and be readily retrievable from all other records.
Form 222
A triplicate
order form for schedule I and II controlled substances that must be obtained
directly from the DEA. The form must be filled out completely by the ordering
pharmacy, and signed and dated by the authorized person.
There
are 3 copies of the Form 222
1st Copy: Supplier
2nd Copy: DEA (forwarded
by the Supplier after the order is filled)
3rd Copy: Purchaser
Schedule I or II registrants can requests official DEA Form 222
on-line at:
Schedule III, IV, and V drug orders do not require a DEA Form
222. These drugs can be ordered directly from the manufacturer.
However, you may be asked to provide a copy of your DEA Registration before
your order will be prepared and shipped.
The DEA’s Controlled Substance Ordering System (CSOS) enables the
secure electronic transmission of orders that previously required the Form 222.
Details can be found at: www.deaecom.gov/csosmain.html
Note: The
registrant must immediately report any lost or stolen Form 222 to the nearest
DEA Diversion field Office, providing the serial number of each lost or stolen
form or, if it cannot otherwise supply individual serial umbers, the
approximate date of their issuance. The registrant must also report if a form
reported is later recovered.
For more information on loss and theft related to controlled
substances. Refer to Forgery Section.
Storage
California law does not expressly require that controlled
substances be kept separate from other drugs. Federal regulations require that
all controlled substances either be stored in a securely locked,
substantially-constructed cabinet, or be dispersed among noncontrolled stock in
such a manner as to obstruct their theft or diversion.
Disposal
To minimize waste, DEA registrants should only purchase quantities
they intend to use. Damaged, expired, unwanted, unusable, or non returnable
Controlled Substances must be accounted for, retained, and disposed of in
accordance with applicable State and Federal regulations. A Registrants Inventory of Drugs Surrendered (DEA Form 41) must
be completed prior to disposing of any DEA controlled substance.
Disposal records must contain:
- Your DEA number, name, and address
- The reverse distributor's DEA
number, name, and address
- The number of units (in finished
forms and/or commercial containers) disposed of in any manner, including
the manner of disposal
The disposal record must be dated to reflect
when the products were sent for destruction and left your inventory.
Picture Sources:
http://www.sussexdigitalfiling.blogspot.com
