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A registered individual practitioner is required to keep records of controlled substances in

schedules II, III, IV, and V which are administered in the lawful course of professional practice if
they regularly engage in dispensing or administering.

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.

These records include

ï all purchasing records
ï all administering and dispensing records
ï all Controlled Substance Ordering Forms (DEA Form 222), and
ï all physical inventories

Schedules I and II must be maintained separately from all other records of the registrant

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.

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£means they can be separated out from other records in a
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`urchasing records can be:

ï A copy of the invoice

ï A copy of the shipping document
ï A copy of the packing slip

`urchasing records must contain:

ï The name, address, and DEA number of the company from which the controlled
substance was purchased
ï The name of the controlled substance purchased
ï The size and strength of the controlled substance purchased
ï The amount purchased (which should match the amount received)

The purchasing record (invoice, shipping document, or packing slip) must be annotated with the
handwritten date of receipt. The date written on this document must match the date entered
in the "Date Received" column on your Record of Controlled Substance `urchases.




 
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Dispensing records must contain:

ï The name and address of person to whom administered/dispensed

ï The date administered/dispensed
ï The initials of person administering or dispensing on behalf of registrant
ï The name of the controlled substance
ï The strength and size of the controlled substance
ï The amount administered/dispensed (number of units or volume)

Use the Controlled Substance Tracking Sheet for the individual medication & the Controlled
Medication `atient Usage Tracking Sheet in the individual patients chart.



  

Controlled substance inventory is one of the most important aspects of the DEA program.
Inventory maintenance is the key to the loss detection, theft, and the diversion of controlled
substances. The Controlled Substance `hysical Inventory meets the DEA requirements for a
Controlled Substance inventory record.

 
   
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Security depends greatly on the type, quantity, and form of controlled substances being
dispensed. Schedule I, II, III, IV, and V controlled substances must be stored in a locked steel
cabinet or a locked substantially constructed cabinet. Controlled substances should not be
located near a glass panel where they can be visible from the outside.

Registrants must provide effective controls to guard against theft of controlled substances. This
includes limiting the number of keys and the number of employees who will have access to
these keys. Developing a key accountability standard operating procedure is recommended.
Only authorized personnel should be allowed in the laboratory where controlled substances are
used or stored. Authorized users names must be documented on the Controlled Substance
Authorized Users List, along with a completed and signed Controlled Substance `rogram Social
Security Release.

  Always ask visitors or individuals entering these areas for identification and why they are
there. When maintenance work is done in the controlled substance storage area the research
staff must maintain adequate observation.

 
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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.
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The Controlled Substances Act Summary, when passed by Congress in 1970, the CSA was
written solely to control diversion. It made no provision for the disposal of unused medications.
Once a product is dispensed, the CSA assumes that it will be taken as prescribed, with nothing
left over. The agency has come under criticism for regulations that make it difficult for
hospitals, long-term-care facilities, patients, and others to dispose of controlled substances
safely and affordably. The act does not contemplate this disposal issue. The statute does not
allow for the disposal of controlled substances.

Traditionally, unused medications have been flushed, washed down the drain, mixed with some
unpalatable substance such as coffee grounds or cat litter and disposed in trash, returned to
one of a handful of DEA-authorized disposal facilities, or given to local law enforcement.

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ï Flushing or washing down the drain puts controlled substances into surface water
supplies.
ï Medication put into trash that goes to landfills also leeches into the water supply.
ï Few DEA-approved waste-disposal facilities accept controlled substances from
individuals
ï Almost no law-enforcement agencies have the time, personnel, budget, or facilities to
accept unwanted medications.


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Shred unused unit-dose medications, including controlled substances. Run the unused blister
packs through industrial shredders, and then dump the chaff in solid waste, which is
incinerated.
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A Registrants Inventory of Drugs Surrendered (DEA Form 41) must be completed prior to
disposing of any DEA controlled substance. Two (2) copies of the form must be sent to the local
Indiana DEA branch and one (1) copy should be retained by the registrant for at least 2 years.

Disposal records must contain:

ï Îour DEA number, name, and address

ï The reverse distributor's DEA number, name, and address
ï 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.

There are three disposal options for expired or unwanted controlled substances recommended
by REM. REM should be contacted to help determine the correct disposal method.

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Some suppliers will take back pharmaceuticals for credit. If possible, this is the best
means of controlled substance disposal.
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Small quantities (less than 1 pound) can be disposed onsite by the DEA registrant using
the following six-step controlled substance disposal procedure:
i. Complete the Registrants Inventory of Drugs Surrendered (DEA Form 41) prior to
disposal.
ii. Forward this form to the DEA with a projected two week disposal date.
iii. At the end of the waiting period two individuals should be present as witnesses
to the disposal, verify the DEA Form 41 and inventory records.
iv. Forward two copies of the DEA Form 41 to the Agent in Charge of Florida DEA,
and keep one copy for the registrant͛s inventory records.
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For large quantities (greater than 1 pound), contact a Reverse Distributor. This option
transfers ownership of the controlled substance to a DEA-approved `harmaceutical
Returns `rocessor for re-use, re-sale or destruction at a hazardous waste incinerator.
This process may involve the completion of DEA Form 222 or DEA Form 41. Contact
information for reverse distributors is listed below.

‘ ational otification Center: (800) 636-9826

‘ Xuaranteed Returns: (800) 729-3279