CONTROLLED
SUBSTANCES PROCEDURES
Source: online version of the
Physician's Manual, An Informational Outline of the Controlled Substances
Act of 1970,
http://www.vetmed.wsu.edu/pharmacy/vm522p/dea_all.htm
The Controlled Substances
Act of 1970 became effective May 1, 1971. It conforms a host of diverse laws
into one piece of legislation. The law is designed to improve the
administration and regulation of manufacturing, distribution, and dispensing
of controlled substances by providing a “closed” system for legitimate
handlers of these drugs. Such a closed system should help reduce the
widespread diversion of these substances out of legitimate channels that
find their way into the illicit market.
Some researchers may be tempted to save money
by formulating anesthetic drugs themselves using chemical-grade compounds.
However, USDA APHIS regulations specifically forbid this practice.
Schedules of
Controlled Substances
The drugs and drug products that come under
the jurisdiction of the Controlled Substances Act are divided into five
schedules. Each drug has a code number that can be found on tables on the
DEA website. For a complete listing of all the controlled substances contact
any office of the Drug Enforcement Administration or look online (http://www.deadiversion.usdoj.gov/schedules/index.html).
The
Louisville DEA office requires that any individual researcher conducting
research with Schedule I substances must be independently registered with
the DEA, and provide a research protocol along with the application.
University of Kentucky researchers conducting research on any drugs in
Schedules II-V must also be independently registered with the DEA, including
on the application a complete list of the substances they are investigating.
Researchers who are using controlled substances as
a prelude or adjunct to research, such as for animal anesthesia, euthanasia,
and/or pain control, are not required to obtain individual
registrations; rather, the department head is to obtain the registration and
be responsible for purchasing, storing,
handling, and distributing any controlled substance used for pain
management, anesthesia and/or euthanasia for all researchers within that
department. (Per
letter received from Bobby Otero, Diversion Group Supervisor, DEA-Louisville
District Office, dated June 10, 2005 and addressed to Dr. Janet Rodgers in
UK DLAR.)
Examples of drugs in these
Schedules are as follows:
Schedule I
The substances in this
schedule are those that have no accepted medical use in the United States
and have a high abuse potential. Some examples are heroin, marijuana, LSD,
MDMA, peyote, mescaline, dihydromorphine, gamma hydroxybutyric acid, and
methaqualone.
Schedule II
The substances in this
schedule have a high abuse potential with severe psychic or physical
dependence liability. Schedule II controlled substances consist of certain
narcotic, stimulant and depressant drugs. Some examples are: morphine,
codeine, hydromorphone, meperidine (Demerol®), cocaine, oxycodone (OxyContin®),
amphetamine, methamphetamine, methylphenidate (Ritalin®), amobarbital,
pentobarbital (Nembutal®), and fentanyl.
Schedule III
The substances in this
schedule have an abuse potential less than those in Schedules I and II, and
include compounds containing limited quantities of certain narcotic drugs
and non-narcotic drugs such as: pentothal, thiamylal, derivatives of
barbituric acid except those that are listed in another schedule, many
steroids (androstenedione, dihydrotestosterone, anabolic steroids),
ketamine, boldenone (Equipoise®), buprenorphine (Buprenex®), hydrocodone
combination products (Lorcet®, Lortab®), tiletamine anesthetics (Telazol®),
veterinary euthanasia solutions containing pentobarbital such as
Beuthanasia®, and any compound, mixture, preparation or suppository dosage
form containing amobarbital, secobarbital or pentobarbital.
Schedule IV
The substances in this
schedule have an abuse potential less than those listed in Schedule III and
include such drugs as: butorphanol (Torbutrol® and Torbugesic®), barbital,
phenobarbital, chloral hydrate, methohexital (Brevital®), diazepam
(Valium®), midazolam (Versed®), and pentazocine (Talwin®).
Schedule V
The substances in this
schedule have an abuse potential less than those listed in Schedule IV and
consist primarily of preparations containing limited quantities of certain
narcotic and stimulant drugs generally for antitussive, antidiarrheal and
analgesic purposes.
Registration for a DEA License
Every person who administers,
prescribes or dispenses any controlled substance must be registered with the
Drug Enforcement Administration. Administer means to instill a drug
into the body of the patient. Dispense means to deliver a controlled
substance in some type of bottle, box, or other container to the patient.
(Under the Act, the definition of dispense also includes the
administering of a controlled substance). A physician or veterinarian is
required to register with the Drug Enforcement Administration by applying on
Form DEA-224, which can be completed online (http://www.deadiversion.usdoj.gov/online_forms.htm).
The same site is used by researchers, but they should complete Form DEA-225
instead. Physicians and other practitioners holding valid DEA licenses for
their medical practice should not order drugs on those registrations for
research use in animals.
(Suggested in a meeting between Bobby Otero and UK researchers conducted on
June 7, 2005.)
The registration must be
renewed every three years. The certificate of registration must be
maintained at the registered location and kept available for official
inspection. Every registrant currently registered with the Drug Enforcement
Administration will receive a renewal application approximately 60 days
before the expiration date of the registration.
If a registrant has more than
one office where controlled substances are administered and/or dispensed,
then each office must be registered. A registrant who moves a place of
practice must request a modification of registration (http://www.deadiversion.usdoj.gov/drugreg/change_requests/add_change.htm).
The request must be approved prior to the effective date of the move.
Employees
According to DEA
(http://www.deadiversion.usdoj.gov/pubs/manuals/sec/sec_req.htm),
“A practitioner must not employ an agent or individual who has had his
application for registration with the Drug Enforcement Administration (DEA)
denied or revoked at any time, and who, as a result of his employment, will
have access to controlled substances.”
Recordkeeping Requirements
Drug Administration
The
Louisville DEA office recommends that each department head holding a
registration develop a means of tracking which investigators are using
controlled substances. Specifically, they recommend that “the department
head assign internal identification
numbers to researchers in order
to account for and track who is using what, when, where, and why.”
(Per
letter received from Bobby Otero, Diversion Group Supervisor, DEA-Louisville
District Office, dated June 10, 2005 and addressed to Dr. Janet Rodgers in
UK DLAR.)
Although not specifically
required by DEA, other agencies with an interest in animal research do
require that individual records be kept of the drugs administered. The DEA’s
requirement for a “closed system” to document what happens to each drug,
from the time it is manufactured until it is used or destroyed, is generally
interpreted to mean that records of drug administration must be kept. These
records are in addition to periodic inventory, which is described below. The
UK Institutional Animal Care and Use Committee will request to see records
of drugs administered to animals during its semi-annual site visits. Other
site-visiting agencies, such as the USDA and AAALAC, may also request to see
these records.
DLAR has for many years used
forms such as the one in Appendix A to document the administration of all
controlled substances to animals. Handwritten records may be better than
computerized records, to ensure that the records are kept up to date as
drugs are used and the users can be tracked by their handwriting. Note that
the record includes all identifying information about the particular vial of
material, the dates and amounts administered, animal identification, and the
initials of the responsible person. Use only one form per vial of drug used,
and line out any unused rows when the vial is empty or expired. Frequently,
there will be slightly more (i.e. ketamine) or less (i.e. buprenorphine)
material in the vial than is indicated on the label. Indicate the exact
amounts drawn up and administered, rather than arbitrarily forcing the
amounts to come out correctly on the form.
Keep these administration
records along with the original receipts for two years, in case you are
inspected by the DEA.
Initial Inventory
A registrant must take an
inventory of all stocks of controlled substances on hand on the date he/she
first engages in such activities. In the event no controlled substances are
on hand at the initial inventory, a zero inventory should be recorded.
The inventory record must:
1.
List the name, address and DEA registration
number of the registrant.
2.
Indicate the date and time the inventory is
taken. i.e., opening or close of business.
3.
Be signed by the person or persons responsible
for taking the inventory.
4.
Be maintained at the location appearing on the
registration certificate for at least two years.
5.
Keep records of Schedule II drugs separate from
all other controlled substance records.
6.
Include the drug name, strength, form (i.e. tablets, injectable), number of
units, unit volume, and total quantity on hand.
Biennial Inventory
Every two years following the
date of the initial inventory, a new inventory is required. The information
required on the biennial inventory is the same as that for the initial
inventory. The biennial inventory date can be changed to a more convenient
date provided it is within six months of the required date and advance
written notification is given to the nearest DEA field office of the date on
which the registrant desires to take the inventory. A registrant must keep
the biennial inventory record for two years and is not required to submit a
copy to the DEA. Many registrants complete this inventory more often than
every two years to enhance security and recordkeeping. DLAR’s typical
practice is to take an inventory every 6 weeks.
All inventories and records of
controlled substances in Schedule II must be maintained separately from all
other records of the registrant. All inventories and records of controlled
substances in Schedules III, IV and V must be maintained separately or must
be in such form that they are readily retrievable from the ordinary records
of the registrant. This means that animal surgery, euthanasia or research
records are NOT sufficient for the inventory.
All records pertaining to
controlled substances shall be made available for inspection and copying by
duly authorized officials of the DEA.
Order Forms
In some cases, special order
forms (DEA-222) must be used when obtaining controlled substances. These
forms should be kept in a secure place, to avoid being stolen and falsified.
Schedule II drugs: A
registrant who has need for controlled substances in Schedule II must obtain
these drugs by the use of a triplicate order form (DEA-222). Order forms can
be obtained by requesting them on the initial application by checking block
“3” of the Form DEA-224 or 225. Once a registrant has obtained DEA order
forms, a separate requisition form, DEA-222A, will be mailed to the
registrant in order to request additional books. No charge is made for order
forms. Order forms can also be ordered online at
https://www.deadiversion.usdoj.gov/webforms/orderFormsRequest.jsp.
The Code of Federal Regulations requires that
the Official Order Form must be “complete, legible, and properly prepared,
with no signs of alteration, erasure or change of any description.”
Suppliers may refuse to accept forms that are not correctly and completely
filled out and signed.
A common omission on DEA
order forms is failure to complete the “number of packages” and “date
received” section. It is important that persons responsible for executing
Schedule II order forms verify the quantities received by dating and
completing the right hand side of the order form.
Schedule III-V drugs: A
registrant receiving controlled substances in these schedules must maintain
records of transactions by filing “supplier’s” invoices or maintaining a log
book. The date of controlled substance receipt and any differences from the
quantities ordered should be noted on the invoice. These records generally
contain the same information as order forms and are to be retained for a two
year period.
Security
A registrant who has
controlled substances stored in an office or lab must keep these drugs in a
securely locked, substantially constructed cabinet or safe.
It is recommended that the
controlled substance stock be kept to a minimum. Should it be necessary to
store a substantial quantity of controlled substances, DEA encourages having
security which exceeds the minimum requirements, such as a safe and alarm
system. Access to the controlled substance storage area should be restricted
to the absolute minimum number of employees.
Controlled Substance Theft
A registrant involved in the
loss of controlled substances must notify the nearest DEA field office
(The Louisville field office is
502-582-5905.)
of the theft or significant loss upon
discovery. The field office will provide information on what reports are
required. The registrant must make a report regarding the loss or theft by
completing DEA Form 106. Also, the registrant is required to notify the UK
police department of the theft. Thefts of drugs worth more than $500 may
mandate additional investigation by federal officials.
Discontinuance of Practice by a Registrant
The Registration Certificate
and any unused order forms must be returned by a registrant to the nearest
DEA field office upon discontinuance of practice. It is advisable that the
registrant write the word “VOID” across the face of the order forms prior to
forwarding to DEA. Information concerning the disposal of controlled
substances in the possession of a registrant at the time of discontinuance
of practice should be obtained from the nearest DEA field office.
Changes in Registrant Information
Changes in a registrant’s
name, address, or drugs required for research can be requested online at
http://www.deadiversion.usdoj.gov/drugreg/change_requests/index.html.
Disposal of Expired Drugs
Drugs (DEA-controlled or not)
may NOT be used past their expiration dates, by USDA regulation.
USDA APHIS Policy #3 (http://www.aphis.usda.gov/ac/policy/policy3.pdf):
“The use of expired medical materials such as drugs, fluids, or sutures on
regulated animals is not considered to be acceptable veterinary practice and
does not constitute adequate veterinary care as required by the regulations
promulgated under the Animal Welfare Act... The facility must either dispose
of all such materials or segregate them in an appropriately labeled,
physically separate location from non-expired medical materials… Drugs
administered to relieve pain or distress and emergency drugs must not be
used beyond their expiration date.”
Expired drugs must be clearly
labeled as expired and kept in a separate place within the securely locked
cabinet until they can be disposed of properly. Proper disposal may include
(a) administration of the drugs to an animal AFTER euthanasia with
non-expired drugs, (b) return to the supplier for credit or replacement, or
(c) sending to a DEA-registered “reverse distributor” for destruction.
Contact the DEA for further information and instructions if you have expired
drugs in your possession. Do not dispose of expired or contaminated drugs in
the sewer system. Do not dispose of a vial still containing drugs; it can be
used by someone wanting to divert the substance for illicit use. Be sure
your records indicate the disposition of any remaining drug left in the
vial, and are kept for two years past the date of disposition. Empty vials
may be disposed of in a proper sharps container.
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