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Application of State and Federal
Laws
Nothing in this manual shall be construed as
authorizing or permitting any person to do any act which is not
authorized or permitted under federal or state laws. In addition, none
of the policy statements and information in this manual may be construed
as authorizing or permitting any person to do any act which is not
authorized. Use of a DEA controlled substance registration for
activities not authorized under state law is a violation of both federal
and state law.
Furthermore, this manual does not authorize a
pharmacist to refuse to meet any requirements in the most recent
publication of Title 21, Chapter II of the Code of Federal Regulations (21
CFR, Part 1300 to end). The CFR is the primary source for the Pharmacist’s
Manual. Printed copies of the complete regulations implementing
the Controlled Substances Act of 1970 may be obtained from:
Superintendent of Documents
U.S. Government Printing Office
Washington, D.C. 20402
Both the Code of Federal Regulations and the
Federal Register (which includes proposed and finalized regulations
implementing the CSA) are available on the Internet through the U.S.
Government Printing Office (GPO) website. This site, which provides
information by section, citation and key words, can be accessed at:
http://www.access.gpo.gov/nara/cfr/index.html
DEA registration grants pharmacies authority to
dispense controlled substances. However, DEA registered
pharmacies may only engage in those activities which are authorized
under state law in the jurisdiction where the pharmacy is located. In
many cases state law is more stringent than federal law, and must be
complied with in addition to federal law. Pharmacists should make sure
they understand their state and DEA controlled substance regulations.
Drug Enforcement Administration
The Drug Enforcement Administration (DEA) is the
primary agency within the Federal Government responsible for the
enforcement of the Controlled Substances Act (CSA). In cooperation with
state authorities and other federal agencies, DEA is tasked with
preventing the diversion of controlled substances for illicit purposes.
In carrying out its mission, DEA complies with international treaty
obligations, works closely with foreign as well as domestic state and
local governments, private industry, and other organizations concerned
with drug abuse and diversion.
The CSA, which became effective May 1, 1971,
consolidates into one piece of legislation many diverse laws passed by
Congress since the Harrison Narcotics Act of 1914, the first
comprehensive federal legislation to control addicting drugs. Subsequent
amendments to the CSA include the 1984 Diversion Control Amendments, the
Controlled Substance Registrant Protection Act of 1984, the Narcotic
Addict Treatment Act of 1984, the Chemical Diversion and Trafficking Act
of 1988, the Domestic Chemical Diversion Control Act of 1993, and the
Comprehensive Methamphetamine Control Act of 1996.
The provisions of the CSA are designed to improve
the administration and regulation of the manufacture, import/export,
distribution and dispensing of controlled substances by providing a
"closed system" for distribution. Under this closed system, a
controlled substance can be traced from the time it is manufactured to
the time it is dispensed to the ultimate user. This system has proven
effective in reducing the diversion of these substances from legitimate
channels to the illicit market.
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Schedules of Controlled Substances
The controlled substances and their derivatives
listed under the CSA can be found in the Code of Federal Regulations,
Title 21 under "Part
1308--Schedules of Controlled Substances."
The drugs and drug products under the jurisdiction
of the CSA are divided into five schedules. Controlled substances in
Schedules II-V have an accepted medical use in the United States, and
Schedule I substances do not. The characteristics and some
examples of the drugs in each schedule are outlined below.
Schedule I Substances
The substances in this schedule have a high
abuse potential and no accepted medical use in the United States.
This is the only schedule that includes drugs that are not available for
prescribing, dispensing or administering. DEA does allow for research
involving Schedule I substances. This requires a separate registration
as a researcher.
Examples of substances classified as Schedule I
narcotics include heroin, certain clandestinely made fentanyl analogs,
and propiram Some hallucinogenic substances found in Schedule I include
LSD, marijuana, and MDMA (Ecstasy).
Other examples of Schedule I substances are the
depressants methaqualone and gamma hydroxybutyric acid (GHB) and the
stimulant methcathinone.
Schedule II Substances
Substances in Schedule II have a high abuse
potential with severe psychological or physical dependence liability,
have an accepted medical use in the United States, and are available for
practitioners to prescribe, dispense and administer.
Some examples of single entity Schedule II
narcotics include morphine, codeine, hydrocodone, and opium. Other
Schedule II narcotic substances and their common name brand products
include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine
(Demerol®), oxycodone (Percodan®) and fentanyl (Sublimaze®).
Some examples of Schedule II stimulants include
amphetamine (Dexedrine®), Adderall ®), methamphetamine (Desoxyn®) and
methylphenidate (Ritalin®).
Other Schedule II substances include cocaine,
amobarbital, glutethimide, pentobarbital and secobarbital.
Schedule III Substances
The substances in this schedule have an abuse
potential which is less than those in Schedule II, but more than
Schedule IV substances.
Some examples of Schedule III narcotics include
products containing less than 15 milligrams of hydrocodone per dosage
unit (i.e., Vicodin®, Lorcet®, Tussionex®, and products containing
not more than 90 milligrams of codeine per dosage unit (i.e., codeine
with acetaminophen, aspirin or ibuprofen).
Other Schedule III substances include anabolic
steroids benzphetamine (Didrex®) phendimetrazine, buprenorphine (Buprenex®)
and any compound,
mixture, preparation or suppository dosage form containing amobarbital,
secobarbital, pentobarbital, dronabinol (Marinol ®) or ketamine.
Schedule IV Substances
The substances in this schedule have an abuse
potential less than those listed in Schedule III and more than
substances in Schedule V.
Some examples of Schedule IV narcotics include
propoxyphene (Darvon®), butorphanol (Stadol®), and pentazocine (Talwin-NX®).
The following benzodiazepine substances are also
found in Schedule IV. They include alprazolam (Xanax®), clonazepam (Klonopin®),
clorazepate (Tranxene®), diazepam (Valium®), flurazepam (Dalmane®),
halazepam (Paxipam®), lorazepam (Ativan®), midazolam (Versed®),
orazepam (Serax®), prazepam (Verstran®), temazepam (Restoril®),
triazolam (Halcion®), and quazepam (Doral®).
Other Schedule IV substances include barbital,
phenobarbital, chloral hydrate, ethchlorvynol (Placidyl®),
chlordiazepoxide (Librium®), ethinamate, meprobamate, paraldehyde,
methohexital, phentermine, diethylpropion, pemoline (Cylert®), mazindol
(Sanorex®), and sibutramine (Meridia®).
Schedule V Substances
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. Some examples are cough preparations containing not more than
200 milligrams of codeine per 100 milliliters or per 100 grams
(Robitussin AC®), Phenergan with codeine®).
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Registration Requirements
Every pharmacy which dispenses any controlled
substance must be registered with the DEA. Since DEA does not register
pharmacists, they must obtain their license to practice
pharmacy from their state regulatory authority. To obtain a DEA
registration, a pharmacy can request a DEA Form-224 (Application for New
Registration, see Appendix E)
from any DEA Registration Field Office (see Appendix
T) or from the DEA Headquarters Registration Unit in Washington,
D.C. at 1-800-882-9539 (Registration Call Center). DEA
Form 224 is also available online and in PDF format at
www.DEAdiversion.usdoj.gov. The DEA Form 224 is fully interactive,
including the acceptance of electronic credit card payments.
The completed DEA Form-224 must be submitted to:
Drug Enforcement Administration
Registration Unit
Central Station
P.O. Box 28083
Washington, D.C. 20038-8083
Pharmacy registrations must be renewed every three
years. The cost of the registration is annotated on the application
form. The certificate of registration must be maintained at the
registered location and kept available for official inspection. If a
person owns and operates more than one pharmacy, each place of business
must be registered.
Every pharmacy currently registered with DEA will
receive a renewal application approximately 45 days before the
registration expiration date. The renewal application will be sent to
the address listed on the current registration certificate. If the
renewal form is not received within 30 days before the expiration date
of the current registration, the pharmacy should contact the DEA
registration unit for their state (see Appendix
T), and request a renewal registration form.
Chemical Registration Requirements
Under DEA’s Chemical Control regulations there
is an exemption from the registration requirement for a retail
distributor. A retail distributor is defined as a grocery store, general
merchandise store, drug store, or other entity or person whose
activities as a distributor of legal drug products containing listed
chemicals pseudoephedrine, phenylpropanolamine (PPA), combination
ephedrine and single-entity ephedrine are limited almost exclusively to
sales for personal use, both in number and volume of sales, either
directly to walk-in customers or in face to face transactions. Personal
use means the distribution of below "threshold quantities"4
in a single transaction to an individual for legitimate
medical use.
Federal law requires any person who is engaged in
the wholesale distribution of drug products containing List I chemicals
to obtain a registration as a chemical distributor. A distributor who
does not meet all the requirements for a retail distributor is a
wholesale distributor.
Retail pharmacies that are registered to handle
controlled substances need not obtain a separate DEA chemical
registration for retail distribution of the drug products containing
pseudoephedrine, phenylpropanolamine (PPA), combination ephedrine and
single-entity ephedrine which are regulated as List I chemicals. If a
pharmacy desires to engage in the wholesale distribution of bulk
quantities of these drug products, the pharmacy will have to register
with DEA as a Chemical Distributor because these activities fall outside
of the definition of retail distributor. Therefore, the pharmacy would
be subject to the registration requirements that apply to wholesale
distributors.
To obtain a DEA Chemical Distributor registration,
a pharmacy can request DEA Form-510 (Application for Registration, see Appendix
M) from any DEA Registration Field Office (see Appendix
T)
For additional information see Chemical
Requirements: Comprehensive Methamphetamine Control Act of 1996.
4 The
quantity of a particular chemical, above which recordkeeping and other
control provisions of the CSA apply. See Appendix
A "Number of Tablets that Equal a Threshold (Regulated)
Transaction for Dosage Units of Marketed Products"
New Pharmacy Registration
Pharmacies seeking to become registered for the
first time must request a DEA Form-224 (Application for New
Registration, see Appendix E)
from any DEA Registration Field Office or the DEA Registration Unit in
Washington, D.C. at the address listed under Registration
Requirements.
Any pharmacy engaged in co-op buying of controlled
substances must also register as a distributor with the DEA. To obtain
this registration, a pharmacy must meet distributor (wholesaler)
security and recordkeeping requirements.
An affidavit system for expediting pharmacy
applications may be used to obtain a DEA registration number for a new
pharmacy or for transferring ownership of an existing pharmacy. If the
pharmacy has been registered by the state licensing agency, the
applicant may include an affidavit (see Appendix
P) to verify the existence of the state license with their
application (21 CFR
1301.17).
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Change of Business Address
Any time a pharmacy moves to a new physical
location or the postal address changes at the same location, a new DEA
certificate reflecting the new address must be obtained. It is the
pharmacy's responsibility to notify DEA about a change of address before
the effective date of the move. A written request for
modification of registration should be sent to the DEA Registration
Field Office responsible for their state (see Appendix
T). If the modification is approved, DEA will issue a new
certificate of registration and, if requested, new Schedule II order
forms (DEA Form-222, Official Order Form). A Renewal Application for
Registration (DEA Form-224a) will only be sent to the registered address
on file with DEA. It cannot be forwarded.
Affidavit for Renewal of
Retail/Chain Pharmacy Registration
Corporations that own or operate a chain of
pharmacies may submit a single DEA Form-224b (Retail Pharmacy
Registration Affidavit for Chain Renewal, see Appendix
G) that covers all the chain's pharmacy registrants. This
affidavit along with a list of the corporation's registrations is
provided in lieu of a separate DEA application for each pharmacy
registration. No registration may be issued unless the completed
affidavit is received by DEA. The corporation should retain a copy of
this affidavit with their readily retrievable records for the duration
of the registration covered by the affidavit. The corporation must
answer the questions listed on the affidavit as they pertain to each
registrant.
The original affidavit along with the registration
fee and the list of registrations should be mailed to:
Registration Chain Renewal
United States Department of Justice
Drug Enforcement Administration
Central Station
P.O. Box 28083
Washington, D.C. 20038-808
Denial, Revocation or Suspension
of Registration
Diversion of legitimately manufactured controlled
substances is a serious problem in the United States. Registrants serve
as the nation's primary guardians for preventing diversion and
controlling legitimate access to these drugs. The CSA provides the
Federal Government with additional legal resources for taking action
against those registrants who contribute to the diversion problem. The
U.S. Attorney General has the authority to suspend or revoke a DEA
registration upon a finding that the registrant has:
- Materially falsified any application
filed.
- Been convicted of a felony relating to a
controlled substance or a List I Chemical.
- Had his/her state license or registration
suspended, revoked or denied.
- Committed an act which would render his
registration inconsistent with the public interest.
- Been excluded from participation in a
Medicaid or Medicare program.
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Denial of Registration in
the Public Interest
The CSA gives the U.S. Attorney General authority
to deny any application for DEA registration or renewal if it is
determined that issuing a controlled substance registration would be
inconsistent with the public interest. In determining the public
interest, the CSA states the following factors will be considered:
- The recommendation of the appropriate state
licensing board or professional disciplinary authority.
- The applicant's experience in dispensing or
conducting research with respect to controlled substances.
- The applicant's conviction record under
federal or state laws relating to the manufacture, distribution or
dispensing of controlled substances.
- Compliance with applicable state, federal or
local laws relating to controlled substances.
- Such other conduct which may threaten the
public health and safety.
Termination of Registration
Any registrant who discontinues his/her business
or transfers it to another person must notify the nearest DEA
Registration Field Office (see Appendix
T) in writing before terminating the pharmacy's registration. Along
with the notification of termination of registration, the pharmacist
should send the DEA Certificate of Registration and any unused Official
Order Forms (DEA Form-222). The pharmacist should write or stamp the
word "VOID" across the face of each Official Order Form before
returning them to DEA. The notification to DEA should also indicate
where the controlled substance inventories and records will be kept and
how the controlled substances were transferred or destroyed. Records
involving controlled substances must be kept available for two years for
inspection and copying by the DEA. This requirement applies even though
the business has been discontinued.
Transfer of Business
A registrant transferring a pharmacy business to
another registrant shall notify the nearest DEA Registration Field
Office at least 14 days before the date of the proposed transfer and
provide the following information:
- The name, address, registration number of the
registrant discontinuing business;
- The name, address, registration number of the
registrant acquiring the pharmacy;
- Whether the business activities will be
continued at the location registered by the current business owner
or moved to another location. If the latter, give the address of
the new location.
- The date on which the controlled substances
will be transferred to the person acquiring the pharmacy (see Transfer
of Controlled Substances on page 10).
On the day the controlled substances are
transferred, a complete controlled substances inventory must be taken
and a copy of the inventory must be included in the records of both the
person transferring the business and the person acquiring the business.
Procedures for transferring the ownership of a pharmacy and a model
format for an affidavit to expedite the process are outlined in Appendix
Q.
If the registrant acquiring the pharmacy owns at
least one other pharmacy licensed in the same state as the pharmacy
being transferred, the registrant may apply for a new DEA registration
prior to the date of transfer. DEA will issue a registration which will
authorize the registrant to obtain controlled substances at the time of
transfer. But the registrant may not dispense controlled substances
until the pharmacy has been issued a valid state pharmacy license.
A DEA registration application for transferring
ownership of an existing pharmacy can be expedited if the applicant
includes an affidavit (see Appendix Q)
verifying that the pharmacy has been registered by the state licensing
agency. The affidavit verifying the existence of the state license
should be attached to the initial application for registration.
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Disposal of Controlled Substances
The pharmacy may hire an outside firm to
inventory, package and arrange for the transfer of its controlled
substances to another pharmacy, supplier or manufacturer. The pharmacy
is responsible for the actual transfer of the controlled substances and
for the accuracy of the inventory and records. The pharmacy may also
transfer the drugs to a distributor registered with DEA to destroy drugs
(reverse distributor). The pharmacy may not turn over any controlled
substances to a distributor unless the reverse distributor is
registered to destroy controlled substances. The pharmacy is responsible
for verifying that the reverse distributor is registered with DEA.
The records involving the transfer or destruction
of controlled substances must be kept readily available for two years
for inspection and copying by the DEA. The two primary methods for
disposing of controlled substances are transfer to another registrant or
destruction as explained in the following section.
Transfer of Controlled Substances
If a pharmacy goes out of business or is acquired
by a new pharmacy, it may transfer the controlled substances to another
pharmacy, supplier, manufacturer or distributor registered to dispose of
controlled substances.
To transfer Schedule II substances, the
receiving registrant must issue an Official Order Form (DEA Form-222,
U.S. Official Order Forms - Schedules I & II) to the
registrant transferring the drugs.
The transfer of Schedule III-V controlled
substances must be documented in writing to show the drug name, dosage
form, strength, quantity and date transferred. The document must include
the names, addresses and DEA registration numbers of the parties
involved in the transfer of the controlled substances.
To Another Pharmacy5
On the day the controlled substances are
transferred, a complete inventory must be taken which documents the drug
name, dosage form, strength, quantity, and date transferred. In addition
DEA Form-222 (Official Order Form) must be prepared to document the
transfer of Schedule II controlled substances. This inventory will serve
as the final inventory for the registrant going out of business and
transferring the controlled substances. It will also serve as the
initial inventory for the registrant acquiring the controlled
substances. A copy of the inventory must be included in the records of
each person. It is not necessary to send a copy of the inventory to the
DEA. The person acquiring the controlled substances must maintain all
records involved in the transfer of the controlled substances for two
years.
5
See also the section entitled "Controlled
Substance Distribution by Pharmacy".
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To Another Supplier or Manufacturer
Any pharmacy may transfer controlled substances to
a supplier or a manufacturer. The pharmacist must maintain a written
record showing:
- The date of the transaction.
- The name, strength, form and quantity of the
controlled substance.
- The supplier’s or manufacturer’s name,
address, and, if known, registration number.
- The DEA Form-222 will be the official record
for the transfer of Schedule II substances.
To a Reverse Distributor Registered to Dispose of
Controlled Substances
Any pharmacy may forward controlled substances to
DEA-registered reverse distributors who handle the disposal of drugs.
For further instructions see, Disposal of
Controlled Substances.
Destruction of Controlled
Substances
DEA recommends that any pharmacy seeking to
dispose of controlled substances first contact the nearest DEA Diversion
Field Office (see Appendix T) for
disposal instructions. In no case should drugs be forwarded to the DEA
unless the registrant has received prior approval from the DEA. The
DEA procedures established for the destruction of controlled substances
shall not be construed as altering in any way the state laws or
regulations for the disposal of controlled substances. Requests from
registrants seeking authorization to destroy controlled substances
without DEA presence, or requests from non-registrants desiring to
dispose of controlled substances will be handled as follows:
Once-a-Year DEA Authorization
for Destruction
Once each calendar year retail pharmacies may
request DEA authorization to destroy damaged, outdated or otherwise
unwanted controlled substances. The pharmacy must complete DEA Form-41
(Registrants Inventory of Drugs Surrendered, see Appendix
I), listing all drugs to be destroyed. In addition, the
pharmacy must prepare a letter requesting permission to destroy the
controlled substances, proposing a date and method of destruction, and
listing the names of at least two people who will witness the
destruction. The witnesses should be either a licensed physician,
pharmacist, mid-level practitioner, nurse, or a state or local law
enforcement officer. Both documents must be received by the nearest DEA
Diversion Field Office at least two weeks prior to the proposed
destruction date. After reviewing all available information, the DEA
office will then notify the registrant in writing of its decision. Once
the controlled substances have been destroyed, signed copies of the DEA
Form-41 must be forwarded to DEA. The pharmacist should contact local
environmental authorities prior to implementing the proposed method of
destruction to ascertain that hazards are not associated with the
destruction.
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Exception to DEA Authorization for
Destruction
Prior DEA authorization to destroy controlled
substances is not necessary when an authorized member of a state law
enforcement authority or regulatory agency witnesses the destruction.
Copies of a DEA Form-41 or state controlled substance destruction form
must be forwarded to the local DEA Diversion Office after the
destruction.
Reverse Distributors Authorized
to Destroy Controlled Substances
A pharmacy may at any time forward controlled
substances to DEA registered reverse distributors who handle the
disposal of drugs. The pharmacist may contact their local DEA Diversion
Field Office for an updated list of those reverse distributors in their
area. When a pharmacy transfers Schedule II substances to a
reverse distributor for destruction, the distributor must issue an
Official Order Form (DEA Form-222) to the pharmacy. When Schedule
III-V controlled substances are transferred to a reverse distributor
for destruction, the pharmacy should document in writing the drug name,
dosage form, strength, quantity and date transferred. The DEA registered
reverse distributor who will destroy the controlled substances is
responsible for submitting a DEA Form-41 to DEA when the drugs have been
destroyed. A DEA Form-41 should not be used to record the transfer of
controlled substances between the pharmacy and the registered reverse
distributor disposing the drugs
"Blanket Authorization" for Destruction of Controlled Substances
DEA will issue a "Blanket Authorization"
for destruction of controlled substances on a very limited basis to
those registrants who are associated with hospitals, clinics or other
registrants having to dispose of used needles, syringes or other
injectable objects only. This limited exception is granted because of
the probability that those objects have been contaminated by hazardous
bodily fluids. The pharmacist should contact their local DEA Diversion
Field Office for information about how to request such an authorization.
DEA will evaluate requests for a blanket authorization based on the
following guidelines:
- Frequency of destruction (i.e., daily,
weekly) and volume of drugs involved that warrant such
authorization.
- Method of destruction. Drugs must be
destroyed in such a manner that they are beyond reclamation.
- Registrant’s past history.
- Security at the pharmacy or registered
location.
- Name and position of the individual
responsible for the destruction.
Those registrants granted blanket authorization to
destroy controlled substances must complete DEA Form-41 (Registrants
Inventory of Drugs Surrendered, see Appendix
I).
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Security Requirements
The DEA requires pharmacies to keep Schedules II,
III, IV and V controlled substances in a locked cabinet or dispersed
through the non-controlled stock to deter theft. An electronic alarm
system is recommended.
Request for Employment Waiver for
Certain Pharmacy Employees
A pharmacy registrant (i.e., the registrant or
corporation which owns the pharmacy) must not employ in a
position which allows access to controlled substances, anyone who has
been convicted of a felony relating to controlled substances, or who, at
any time, has had an application for DEA registration denied, revoked,
or surrendered for cause. "For cause" means surrendering a
registration in lieu of, or as a consequence of, any federal or state
administrative, civil or criminal action resulting from an investigation
of the individual’s handling of controlled substances.
However, pharmacies desiring to employ an
individual who meets this definition may request an exception to this
requirement (see 21 CFR
1307.03) from DEA. The employer must have a waiver approved before
hiring the applicant. A waiver request should be sent to DEA
Headquarters, Office of Diversion Control, Washington, D.C. 20537.
A pharmacy registrant who applies for such a
waiver should understand that the following factors will be considered:
- A detailed description of the nature and
extent of the applicant’s past controlled substances violations.
- Activities of the applicant since the
violation.
- Current status of the applicant’s state
licensure.
- Extent of applicant’s proposed access to
controlled substances.
- Registrant’s proposed physical and
professional safeguards to prevent diversion by the applicant if
employed.
- Status of employing registrant regarding
handling of controlled substances.
- Other pertinent information uncovered by DEA
in its investigation of the applicant’s or registrant’s
handling of controlled substances.
- Such a waiver should not be considered unless
there are valid reasons to believe that diversion is unlikely to
occur.
Controlled Substance Theft or Loss
1. Notify DEA and Local Police
Immediately upon discovery of a theft or
significant loss of controlled substances, a pharmacy, as required by
regulation, must contact the nearest DEA Diversion Field Office (see
Appendix T) by telephone, facsimile or by a brief written message
explaining the circumstances. A pharmacy should also notify the local
police as may be required by state law. If there is a question as to
whether a theft has occurred or a loss is significant, a registrant
should err on the side of caution and report it to DEA.
DEA must be notified directly. This
requirement is not satisfied by reporting the theft or significant
loss in any other manner. For example, a corporation which
owns/operates multiple registered sites and wishes to channel all
notifications through corporate management or any other internal
department responsible for security must still provide notice directly
to DEA "upon discovery" and keep a copy for its records.
2. Complete DEA Form-106
A pharmacy shall also complete a DEA Form-106
(Report of Theft or Loss of Controlled Substances). To obtain a DEA
Form-106 (see Appendix J),
contact the nearest DEA Diversion Field Office (see
Appendix T). The DEA Form-106 will formally document the actual
circumstances of the theft or significant loss and the quantities of
controlled substances involved, once this information has been
determined conclusively. The pharmacy should send the original DEA
Form-106 and a copy to the DEA Diversion Field Office and keep a copy
for its records.
The DEA Form 106 must include the following information:
- Name and address of firm (pharmacy)
- DEA registration number
- Date of theft
- Name and telephone number of local police
department notified
- Type of theft (night break in, armed robbery,
etc.)
- Listing of symbols or cost code used by
pharmacy in marking containers (if any)
- Listing of controlled substances missing from
theft or significant loss
3. If Investigation Finds No Theft or Loss
If after an investigation of the circumstances
surrounding the theft or significant loss it is determined that no
such theft or significant loss occurred, no DEA Form-106 need be
filed.
However, the registrant should notify DEA
in writing of this fact in order to resolve the initial report and
explain why no DEA Form-106 was filed regarding the incident.
4. Registrant’s Responsibility for Identifying
"Significant Loss"
Although the CSA regulations do not define the
term "significant loss," it is the responsibility of the
registrant to use his/her best judgment to take appropriate action. A
significant loss depends, in large part, on the business of the
pharmacy and the likelihood of a rational explanation for a particular
occurrence. What would constitute a significant loss for a pharmacy
may be viewed as comparatively insignificant for a hospital or
distributor.
Further, the loss of a small quantity of
controlled substances, repeated over a period of time, may indicate a
significant problem for a registrant, a problem which must be reported
to DEA, even though the individual amounts of missing controlled
substances are not, in and of themselves, significant. Registrants
must report a loss upon discovery. In particular, a pharmacist should
be alert for suspicious or unexplained losses. Any signs of a break
in, physical entry or armed robbery should be reported. The burden
of responsibility is on the registrant to identify what is a
significant loss and make the required report to DEA.
Some factors to consider for determining
significant loss include:
- The schedule of the missing items.
- The abuse potential of the missing items.
- The abuse potential in your area of the
missing substance.
- The quantity missing (one tablet vs.
one bottle or container).
- Is this the first time this loss has
occurred? Has a similar loss occurred before?
- Was this loss reported to local law
enforcement authorities?
- If there is a question as to whether a loss
is significant, a registrant should err on the side of caution and
report it to DEA.
If it is determined that the loss is not
significant, place a record of the occurrence in your theft and
loss file for future reference.
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In-Transit Loss
When all or part of a shipment disappears, or
never reaches its intended destination, the supplier is responsible for
reporting the in-transit loss of controlled substances to DEA. A
pharmacy is responsible for reporting any loss of controlled substances
after a pharmacist has signed for or taken custody of a shipment. If
it’s discovered after that point that an in-transit loss or theft has
occurred, the pharmacist must submit a DEA Form-106.
Breakage/Spillage
DEA further wishes to clarify that the breakage of
controlled substances does not constitute a "loss" of
controlled substances. When there is breakage, damage or spillage or
some other form of destruction, any recoverable controlled substances
must be disposed of according to DEA requirements. Damaged goods may be
disposed of through shipment to a "reverse distributor" or by
a DEA approved process as defined in (Destruction
of Controlled Substances). When this disposal occurs, it must be
reported to DEA on a DEA Form-41 (Registrants Inventory of Drugs
Surrendered, see Appendix I).
Controlled Substance Registrant Protection
Act of 1984
Robberies, burglaries and assaults on pharmacists
and other registrants by those seeking controlled substances are a
serious problem in the United States. These crimes result in property
loss, serious injury to professionals and bystanders, and trafficking
which serves to fuel the drug abuse problem.
Federal Investigation
The Controlled Substances Registrant
Protection Act of 1984 (CSRPA) provides for the federal investigation of
pharmaceutical thefts and robberies if any of the following conditions
are met:
- Replacement cost of the controlled substances
taken is $500 or more.
- A registrant or other person is killed or
suffers "significant" bodily injury during the
commission of the robbery or theft of a controlled substance.
- Interstate or foreign commerce is involved in
planning or executing the crime.
Penalties Upon Conviction
The perpetrator convicted of violating the
CSRPA’s provisions is subject to the following penalties:
- Conviction for commission of burglary or
robbery can result in a maximum $25,000 fine and/or 20 years
imprisonment.
- Conviction for use of a dangerous weapon in
the commission of the crime can result in a maximum $35,000 fine
and/or 25 years imprisonment.
- If death results from the crime, the
convicted person can receive a maximum $50,000 fine and/or life
imprisonment.
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Recordkeeping Requirements
Every pharmacy must maintain complete and accurate
records on a current basis for each controlled substance purchased,
received, distributed, dispensed or otherwise disposed of. All records
of controlled substances must be maintained for two years. This
recordkeeping system allows a controlled substance to be tracked from
the time it is manufactured to the time it is dispensed to the ultimate
user. (Recordkeeping requirements for List I Chemicals are contained in
the Chemical Requirements
section.)
All records concerning controlled substances must
be maintained for at least two years for inspection and copying by duly
authorized DEA officials. Records and inventories of Schedule II
controlled substances must be maintained separately from all other
records of the registrant. All records and inventories of Schedule
III, IV and V controlled substances must be maintained either
separately from all other records or in such a form that the information
required is readily retrievable from the ordinary business records. (Recordkeeping
requirements for prescriptions are detailed in the Prescription
Records section.)
Readily retrievable means that:
- Certain records are kept by automatic data
processing systems or other electronic or mechanized recordkeeping
systems in such a manner that they can be separated out from all
other records in a reasonable time.
- And/or records are kept on which certain
items are asterisked, redlined or in some other manner visually
identifiable apart from other items appearing on the records.
Records that Must be Maintained
- Official Order Forms (DEA Form-222).6
- Power of Attorney authorization to sign Order
Forms.
- Receipts and invoices for Schedule III, IV,
and V controlled substances as well as "threshold
quantities"7 of List I
chemicals.
- All inventory records of controlled
substances, including the initial and biennial inventories.
- Records of controlled substances distributed
or dispensed (i.e., prescriptions) and threshold amounts of List I
chemicals distributed.
- Report of Theft or Loss (DEA Form-106).
- Inventory of Drugs Surrendered for Disposal (DEA
Form-41).
- Records of transfers of controlled substances
between pharmacies.
- DEA registration certificate.
6
DEA's Official Order Forms are the required records of receipt and
sale for Schedule II controlled substances.
7
The quantity of a particular chemical, above which recordkeeping and
other control provisions of the CSA apply. See Appendix
B "List I Chemicals with Domestic Threshold Amounts" .
Central Recordkeeping
A registrant desiring to maintain shipping and
financial records at a central location other than the registered
location must notify the nearest DEA Diversion Field Office (see Appendix
T). Unless the registrant is informed by the DEA that the permission
to keep central records is denied, the registrant may begin maintaining
central records 14 days after notifying DEA. Central recordkeeping
requirements are described in 21
CFR, 1304.04. Central recordkeeping permits are no longer issued by
the DEA.
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Prescription Records
Pharmacies have three options for filing
prescription records under the Code of Federal Regulations. If there is
a conflict between federal and state requirements for filing
prescriptions, DEA recognizes that the pharmacy must choose a filing
system that would comply with both federal and state law (Title
21 USC, Section 903).
All prescription records must be readily
retrievable for DEA inspection. Controlled substance prescriptions must
be filed in one of the following three ways:
Option 1 (Three separate files)
- A file for Schedule II drugs dispensed,
- A file for Schedule III, IV and V drugs
dispensed, and
- A file for prescription orders for all
noncontrolled drugs dispensed.
Option 2 (Two separate files)
- A file for all Schedule II drugs dispensed,
- A file for all other drugs dispensed (noncontrolled
and those in Schedule III, IV and V). If this method is used, a
prescription for a Schedule III, IV and V drug must be made readily
retrievable by use of a red "C" stamp not less than one
inch high.8
Option 3 (Two separate files)
- A file for all Schedule II-V controlled
substances. If this method is used, a prescription for a Schedule
III, IV and V drug must be made readily retrievable by use of a red
"C" stamp not less than one inch high.8
- A file for prescription orders for all
noncontrolled drugs dispensed.
8
If a pharmacy has an electronic recordkeeping system for prescriptions
which permits identification by prescription number and retrieval of
original documents by prescriber's name, patient's name, drug
dispensed and date filled, then the requirements to mark the hard copy
prescription with a red "C" is waived.
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Inventory Requirements
Inventory means a complete and accurate list of
all stocks and forms of controlled substances in the possession of the
registrant as determined by an actual physical count. The CFR also
requires that all inventories be maintained at the registered location
in a readily retrievable manner for at least two years for copying and
inspection. In addition, the inventory of Schedule II controlled
substances must be kept separate from those for all other controlled
substances.
Initial Inventory
When issued a DEA registration, a registrant must
take an initial inventory, which is an actual physical count of all
controlled substances in their possession. If there are no stocks of
controlled substances on hand, the registrant should make a record
showing a zero inventory. There is no requirement to submit a copy of
the inventory to the DEA.
The Code of Federal Regulations (CFR) requires
that the inventory include:
- The inventory date.
- The time the inventory is taken (i.e.,
opening or close of business).
- The drug name.
- The drug strength.
- The drug form (e.g., tablet, capsule, etc.).
- The number of units/volume.
- The total quantity.
DEA recommends that the inventory record include:
- The name, address and DEA registration number
of the registrant.
- The signature of the person or persons
responsible for taking the inventory.
Biennial Inventory
Following the initial inventory, the registrant is
required to take a biennial inventory (every two years), which requires
the same information as the initial inventory (see list above) of all
controlled substances on hand. The biennial inventory may be taken on
any date which is within two years of the previous inventory date. There
is no requirement to submit a copy of the inventory to DEA.
When taking the inventory of Schedule II
controlled substances, an actual physical count must be made. For the
inventory of Schedules III, IV and V controlled substances, an estimated
count may be made. An actual physical count must be made if the
container holds more than 1,000 dosage units and has been opened.
Inventorying Newly Scheduled Controlled
Substances
When a drug not previously controlled is
scheduled, the drug must be inventoried as of the effective date of
scheduling.
Inventory of Drugs for Destruction or
No Longer Saleable
Each controlled substance that is (1) damaged,
defective, or impure and is awaiting disposal, (2) held for quality
control purposes, or (3) maintained for extemporaneous compoundings,
must be inventoried.
The Code of Federal Regulations (CFR) requires
that the inventory include:
- The inventory date.
- The drug name.
- The drug strength.
- The drug form (e.g., tablet, capsule, etc.).
- The total quantity or total number of
units/volume.
- The reason why the substance is being
maintained.
- Whether substance is capable of being used in
the manufacture of any controlled substance in finished form.
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Ordering Controlled Substances
Schedule II Substances
Only Schedule I and II controlled substances are
ordered with a DEA Form-222 (Official Order Form, see Appendix
H). An Official Order Form is required for each distribution,
purchase or transfer of a Schedule II controlled substance.
When a controlled substance has been transferred
by DEA from Schedule II to another Schedule at the federal level, in
many states it remains in Schedule II pending any legislative or
administrative actions that may result from the federal action. Many
states require that transactions involving substances that they classify
as Schedule II be made via DEA Form-222 Official Order Forms. Where
federal and state laws or regulations conflict, the stricter applies.
When the use of DEA Form-222 Official Order Forms for the transfer of a
controlled substance is not required under federal law, its use as
mandated by these states does not violate federal law and is therefore
permitted.
Requesting Official Order Forms
Official Order Forms can be initially requested by
checking "block 3" on the application for new registration (DEA
Form-224). There is no charge. Send the form to:
Drug Enforcement Administration
Registration Unit
Central Station
P.O. Box 28083
Washington, D.C. 20038-8083
Once a registrant has received Official Order
Forms (DEA Form-222), a separate requisition form (DEA Form-222a) will
be mailed to the registrant to request additional Official Order Forms.
The registrant may also request Official Order Forms by calling either
the DEA Headquarters Registration Unit (toll free: 1-800-882-9539) or
the nearest DEA Registration Field Office (See
Appendix T).
Each book of DEA Official Order Forms consists of
seven sets of forms. Each pharmacy is provided a maximum of six books at
one time unless its needs exceed this limit. In such a case, the
pharmacy should contact the DEA Registration Field Office serving their
state (Appendix T).
Completing Official Order Forms
When ordering Schedule II substances, the
pharmacist is responsible for filling in the number of packages, the
size of the package and the name of the item. Each Official Order Form
must be signed and dated by a person authorized to sign a registration
application. (See Power of Attorney to Sign an
Official Order Form) When the items are received, the pharmacist
must document on the purchaser’s copy (copy 3) the actual number of
packages received and the date received.
Official Order Forms must be maintained separately
from the pharmacy’s other business records. However, this does not
preclude a registrant from attaching a copy of the supplier's invoice to
the related Order Form.
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." A supplier may refuse to accept an order for any of
these reasons. However, DEA has acknowledged some minor changes or
alterations may be accepted by a supplier. For example, suppliers may
correct Official Order Forms that have:
Minor errors, which lack inconsequential
information or
An incorrect date unintentionally annotated by the purchaser.
If an order is refused, the supplier should return
Official Order Form copies 1 and 2 to the purchaser with a
statement explaining the reason the order was refused.
DEA policy does not preclude the substitution of
identical products differing in packaging size from those initially
ordered, provided that the actual quantity received does not exceed the
amount initially ordered and that the National Drug Code number
reflected is that of the actual product shipped. For example, a
distributor may substitute 5 bottles of 100, 2mg tablets for 1 bottle of
500, 2mg tablets or any variation thereof.
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Power of Attorney to Sign an Official Order Form
Any registrant (pharmacy) may authorize one or
more individuals, whether or not they are located at the registered
location, to obtain and execute Official Order Forms by granting a power
of attorney to each such individual. The power of attorney must be
signed by the same person who signed the most recent application for
registration or renewal registration, as well as the individual being
authorized to obtain and execute Official Order Forms. The power of
attorney may be revoked at any time by the person who signed the power
of attorney. It is necessary to grant a new power of attorney when the
pharmacy completes a renewal registration, only if the renewal
application is signed by a different person. The power of attorney
should be filed with executed Official Order Forms as a readily
retrievable record. The power of attorney is not submitted to DEA.
Suggested formats for granting and revoking power
of attorney follow:
POWER OF ATTORNEY FOR DEA ORDER
FORMS
_________________________(Name of registrant)
_________________________(Address of registrant)
_________________________(DEA registration number)
I,
_______________________________________________(name of person granting
power), the undersigned, who is authorized to sign the current
application for registration of the above named registrant under the
Controlled Substances Act or Controlled Substances Import and Export
Act, have made, constituted, and appointed, and by these present, do
make, constitute, and appoint _________________________________(name of
attorney-in-fact), my true and lawful attorney for me in my name, place,
and stead, to execute applications for books of official order forms and
to sign such order forms in requisition for Schedule I and II controlled
substances, in accordance with Section 308 of the Controlled Substances
Act (21 U.S.C. 828) and part 1305 of Title 21 of the Code of Federal
Regulations. I hereby ratify and confirm all that said attorney shall
lawfully do or cause to be done by virtue hereof.
(Signature of person granting power) I,
_______________________(name of attorney-in-fact), hereby affirm that I
am the person named herein as attorney-in-fact and that the signature
affixed hereto is my signature.
Witnesses:
1. _______________________
2. _______________________
Signed and dated on the ____ day of
______________in the year_____ at _______________________________.
NOTICE OF REVOCATION OF POWER OF
ATTORNEY
The foregoing power of attorney is hereby revoked
by the undersigned, who is authorized to sign the current application
for registration of the above-named registrant under the Controlled
Substances Act or the Controlled Substances Import and Export Act.
Written notice of this revocation has been given to the attorney-in-fact
____________________________ this same day. (Signature of person
revoking power)
Witnesses:
1. ______________________
2. ______________________
Signed and dated on the _____ day of
_______________, in the year_____ at _____________________________.
Lost or Stolen Order Forms
When the pharmacist has not received a shipment of
controlled substances, he/she should first contact the supplier to
determine whether the original DEA Form-222 was received. If the
original order form has been lost or stolen, the pharmacist must
complete a second order form so the supplier can fill the original
order. The pharmacist must also prepare a statement which includes the
first order form’s serial number and date, and verify that the drugs
ordered were never received. Attach a copy of the statement to the
second order form that is sent to the supplier. The pharmacist must keep
a copy of the statement with copy 3 from the first and second order
forms.
A pharmacy, upon discovery of the loss or theft of
unused order forms, must immediately report the loss to the nearest DEA
Diversion Field Office (Appendix T),
and provide the serial numbers of each lost or stolen order form. If an
entire book or multiple books of order forms are lost or stolen, and the
serial numbers of the missing forms cannot be identified, the pharmacist
must report the approximate date of issuance (in lieu of the serial
numbers) to the DEA. If an unused order form reported stolen or lost is
later recovered or found, the pharmacy must immediately notify the
nearest DEA Diversion Field Office.
Schedule III-V Substances
The registrant (pharmacy) must keep a receipt
(i.e., invoice or packing slip) on which they record the date the drugs
were received and confirm that the order is accurate. These receipts
must be maintained in a readily retrievable manner for inspection by the
DEA.
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Prescription Requirements
To dispense controlled substances, a pharmacist
must know the requirements for a valid prescription which are described
in this section. A prescription is an order for medication which
is dispensed to or for an ultimate user. A prescription is not an
order for medication which is dispensed for immediate administration to
the ultimate user (e.g., an order to dispense a drug to an inpatient for
immediate administration in a hospital is not a prescription.)
A prescription for a controlled substance must be
dated and signed on the date when issued. The prescription must include
the patient’s full name and address, and the practitioner’s name,
address, and registration number. The prescription must also include the
drug name, strength, dosage form, quantity prescribed, directions for
use, and number of refills. Where an oral prescription is not permitted,
a prescription must be written in ink or indelible pencil or typewritten
and must be manually signed by the practitioner. An individual (i.e.,
secretary or nurse) may be designated by the practitioner to prepare
prescriptions for his/her signature. The practitioner is responsible for
making sure that the prescription conforms in all essential respects to
the law and regulations.
Who May Issue
A prescription order for a controlled substance
may be issued only by a physician, dentist, podiatrist, veterinarian,
mid-level practitioner or other registered practitioner who is:
- Authorized to prescribe controlled substances
by the jurisdiction in which he/she is licensed to practice; and
- Registered with DEA or exempted from
registration (i.e., Public Health Service and Bureau of Prison
physicians).
Verification of Practitioner
Registration
Construction of Valid DEA Registration Numbers for
Practitioners
Knowing how a DEA registration number is
constructed can be a useful tool for recognizing a forged prescription.
(For additional information regarding forged prescriptions, see Appendix
O) Prior to October 1, 1985, DEA registration numbers for
physicians, dentists, veterinarians and other practitioners started with
the letter A. New registration numbers issued to practitioners after
that date begin with the letter B. Registration numbers issued to
mid-level practitioners begin with the letter M. The first letter
of the registration number is followed by the first letter of the
registrant’s last name. (e.g., J for Jones or S for
Smith), and then a computer generated sequence of seven numbers (such as
MJ3614511). (See Mid-Level
Practitioner [MLP], regarding their authority to prescribe
controlled substances.)
Practitioner’s Use of a Hospital’s DEA Registration Number
An individual practitioner (e.g., intern, resident,
staff physician, mid-level practitioner) who is an agent or employee of a
hospital or other institution may, when acting in the usual course of
business or employment, administer, dispense or prescribe controlled
substances under the registration of the hospital or other institution in
which he or she is employed, provided that:
- The dispensing, administering, or prescribing
is in the usual course of professional practice;
- The practitioner is authorized to do so by
the state in which he or she is practicing;
- The hospital or institution has verified that
the practitioner is permitted to dispense, administer or prescribe
controlled substances within the state;
- The practitioner acts only within the scope
of employment in the hospital or institution;
- The hospital or institution authorizes the
practitioner to dispense or prescribe under its registration and
assigns a specific internal code number for each practitioner so
authorized (See example of a specific internal code number below);
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- A
current list of internal codes and the corresponding individual
practitioners is to be kept by the hospital or other institution.
This list is to be available at all times to other registrants and
law enforcement agencies upon request for the purpose of verifying
the authority of the prescribing individual practitioner. Pharmacists
should contact the hospital or other institution for verification
if they have any doubts in dispensing such a prescription.
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Exception to the Registration Requirement for
Public Health Service or Bureau of Prisons Personnel
Any official of the Public Health Service or Bureau of Prisons who is
authorized to prescribe, dispense or administer, but not to procure or
purchase, controlled substances in the course of his or her official
duties, is not required to be registered with DEA. Such officials must
specify their agency and service identification number of the issuing
official in lieu of a DEA registration number on any prescriptions for
controlled substances. The service identification number for a public
Health Service employee is his/her Social Security Number.
Registration Requirement for Military Personnel
The requirement for registration is waived for military physicians
who prescribe, dispense, or administer, but do not procure or purchase,
controlled substances in the course of official duties. Military
physicians issuing prescriptions must indicate the branch of service or
agency and the service identification number in lieu of the registration
number required on prescriptions. Such prescriptions may be filled off
base at community pharmacies.
Many computer systems at pharmacies are programmed to accept a DEA
registration number and the use of a service identification number
causes delays when dispensing a prescription. As a result, DEA has begun
to issue DEA registrations to active duty military physicians to
expedite the filling of prescriptions at community pharmacies.
Therefore, a prescription from a military physician must contain either
the service identification number or a DEA registration number of the
prescriber.
DEA will not issue registrations to mid-level practitioners (MLP) in
the military unless they are specifically licensed in the state where
they are stationed and the state allows the MLP to dispense controlled
substances.
Physicians and MLPs must obtain a separate DEA registration for any
work outside of official duties and they must follow the requirements of
the jurisdiction in which they are performing the non-official work.
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Mid-Level Practitioners
Mid-level practitioners (MLP) are registered and authorized by the
DEA and the state in which they practice to dispense, administer and
prescribe controlled substances in the course of professional practice.
Examples of MLPs include, but are not limited to, health care providers
such as nurse practitioners, nurse midwives, nurse anesthetists,
clinical nurse specialists, physician assistants, optometrists,
ambulance services, animal shelters, veterinarian euthanasia
technicians, nursing homes and homeopathic physicians.
MLPs may receive individual DEA registration granting controlled
substance privileges. However, such registration is contingent upon
authority granted by the state in which they are licensed. DEA registers
MLPs whose states clearly authorize them to prescribe, dispense and
administer controlled substances in one or more schedules. The fact that
an MLP has been issued a valid DEA registration number (beginning with
the letter M) will be evidence that he/she is authorized to prescribe,
dispense and/or administer at least some controlled substances.
However, it will still be incumbent upon the pharmacist who fills
the prescription to ensure that the MLP is prescribing within the
parameters established by the state in which he/she practices. MLP
authority to prescribe controlled substances varies greatly by state.
Check with your state licensing or controlled substances authority to
determine which MLP disciplines are authorized to prescribe controlled
substances in your state.
Purpose of Issue
To be valid, a prescription for a controlled substance must be issued
for a legitimate medical purpose by a practitioner acting in the usual
course of sound professional practice. The practitioner is responsible
for the proper prescribing and dispensing of controlled substances.
However, a corresponding responsibility rests with the pharmacist who
dispenses the prescription. An order for controlled substances which
purports to be a valid prescription, but is not issued in the usual
course of professional treatment, or for legitimate and authorized
research, is not a valid prescription within the meaning and intent of
the CSA. The individual who knowingly dispenses such a purported
prescription, as well as the individual issuing it, will be subject to
criminal and/or civil penalties and administrative sanctions.
A prescription may not be issued in order for an individual
practitioner to obtain a supply of controlled substances for the purpose
of general dispensing to his/her patients. Therefore, a prescription
written for office stock or "medical bag" use is not valid.
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Schedule II Substances
Schedule II substances require a written prescription which must be
signed by the practitioner. There is no time limit when a Schedule II
prescription must be filled after being signed by the physician.
However, the pharmacist must determine that the prescription is still
needed by the patient (e.g., a narcotic prescription filled several
weeks after being written.) Federal regulations place no quantity limits
on any prescriptions. For Schedule II substances, an oral order is only
permitted in an emergency situation. (See Emergency
Dispensing of Schedule II Controlled Substances.)
Refills
Refilling a Schedule II prescription is prohibited.
Facsimile Prescriptions for Schedule II Substances
In order to expedite filling the prescription, a prescriber may fax
the Schedule II prescription to the pharmacy, as authorized in a final
rule published in May 1994. This rule requires that the original
Schedule II prescription be presented to the pharmacist and verified
against the facsimile at the time the controlled substance is actually
dispensed. The pharmacist must make sure the original document is
properly annotated and filed with the records that are required to be
kept.
In an emergency, a practitioner may transmit a prescription for a
Schedule II controlled substance by facsimile or telephone to the
pharmacy, and the pharmacist may dispense the prescription. However, the
prescribing practitioner must provide a written, signed prescription to
the pharmacist within seven days, and the pharmacist must notify DEA if
he/she does not receive the prescription. (See Emergency
Dispensing of Schedule II Controlled Substances.)
Exceptions for Schedule II Facsimile Prescriptions
DEA also granted three exceptions to the facsimile prescription
requirements for Schedule II controlled substances. The facsimile of a
Schedule II prescription may serve as the original prescription as
follows:
- A practitioner prescribing Schedule II narcotic controlled
substances for a patient undergoing home infusion/intravenous (IV)
pain therapy, may transmit the prescription by facsimile. The
practitioner’s agent may also transmit the prescription to the
pharmacy. The pharmacy will consider the facsimile prescription a
"written prescription" and no further prescription
is required. All normal requirements of a legal prescription
must be followed.
- Practitioners prescribing Schedule II controlled substances for
patients in Long Term Care Facilities (LTCF), which are normally
filled and delivered to the facility by the pharmacy, may transmit a
prescription by facsimile to the dispensing pharmacy. The
practitioner’s agent may also transmit the prescription to the
pharmacy. The facsimile prescription serves as the original written
prescription for the pharmacy. No further original prescription is
required.
- A practitioner prescribing a Schedule II narcotic substance for a
patient in hospice care as certified by Medicare under Title XVIII
or licensed by the state,
may transmit a prescription to the dispensing pharmacy by facsimile regardless
of whether the patient resides in a hospice facility or other care
setting.
The practitioner’s agent may also transmit the prescription to the
pharmacy. The practitioner will note on the prescription that it is
for a hospice patient. The facsimile serves as the original written
prescription.
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Schedule III-V Substances
A prescription for controlled substances in Schedules III, IV and V
issued by a practitioner may be communicated either orally, in writing
or by facsimile to the pharmacist and may be refilled if so authorized
on the prescription.
Refills
Schedule III and IV controlled substances may be refilled if
authorized on the prescription. However, the prescription may only be
refilled up to five times within six months after the date of issue.
After five refills or after six months, whichever occurs first, a new
prescription is required. A patient is permitted to request a refill of
an existing Schedule III-V controlled substance prescription by sending
and e-mail to the pharmacy or by telephone
Schedule V controlled substances may only be refilled as authorized
on the prescription by the prescribing practitioner.
When a prescription for any controlled substance in Schedule III, IV,
or V is refilled, the following information must be entered on the back
of the prescription: the dispensing pharmacist’s initials, the date
the prescription was refilled, and the amount of drug dispensed on the
refill. If the pharmacist only initials and dates the back of the
prescription, the pharmacist will be deemed to have dispensed a refill
for the full face amount of the prescription.
Computerization of Prescription Information
A pharmacy is permitted to use a data processing system as an
alternative to the manual method for the storage and retrieval of
prescription order refill information for Schedules III, IV and V
controlled substances.
The computer system must provide on-line retrieval of original
prescription information for those prescriptions which are currently
authorized for refill. The information must include, but is not limited
to the original prescription number, date of issuance, full name and
address of the patient, the prescriber’s name, address, and DEA
registration number; the name, strength, dosage form and quantity of the
controlled substance prescribed; and the total number of refills
authorized by the prescriber.
In addition, the computer system must provide on-line retrieval of
the current refill history for Schedule III, IV, or V controlled
substance prescriptions. This information must include, but is not
limited to: the name of the controlled substance, the date of refill,
the quantity dispensed, the dispensing pharmacist’s identification
code, or name/initials for each refill, and the total number of refills
dispensed to date for that prescription. The pharmacist must verify and
document that the refill data entered into the system is correct. All
computer generated prescription/refill documentation must be stored in a
separate file at the pharmacy and be maintained for a two-year period
from the dispensing date. To meet the CFR recordkeeping requirements,
the pharmacy’s computer must comply with the following guidelines:
- If the system provides a hard copy printout of each day’s
controlled substance
prescription
refills, each pharmacist who refilled those prescriptions shall
verify their accuracy by signing and dating the printout as he/she
would sign a check or legal document.
This printout must be provided to each pharmacy which uses the
computer system within 72 hours of the date on which the refill
was dispensed. The printout must be verified and signed by each
pharmacist who dispensed the refills.
In lieu of such a printout, the pharmacy shall maintain a bound
log book, or separate file in which each pharmacist involved in
the day’s dispensing signs a statement verifying that the refill
information entered into the computer that day has been reviewed
by him/her and is correct.
A pharmacy computer system shall have the capability of printing
out any refill data which the pharmacy must maintain under the
Controlled Substances Act. For example, this would include a
refill-by-refill audit trail for any specified strength and dosage
form of any controlled substance, by either brand or generic name
or both, dispensed by the pharmacy. Such a printout must include:
- Prescribing practitioner’s name.
- Patient’s name and address.
- Quantity dispensed on each refill.
- Dispensing date for each refill.
- Name or identification code of the dispensing pharmacist.
- Original prescription number.
In any computerized system employed by a user pharmacy, the
central recordkeeping location must be capable of providing a
printout to a requesting pharmacy of the above information within 48
hours.
- In case a pharmacy's computer system experiences downtime, the
pharmacy must have a back-up procedure to document in writing
refills of Schedule III, IV and V substances. This procedure must
ensure that refills are authorized by the original prescription,
that the maximum number of refills has not been exceeded, and that
all required data is retained for on-line entry as soon as
possible.
- A pharmacy
may
use only one of the two systems described (i.e., manual or
computer).
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Facsimile Prescriptions for Schedule III-V Substances
Prescriptions for Schedules III-V controlled substances may be
transmitted by facsimile from the practitioner or an employee or agent
of the individual practitioner. The facsimile is considered to be
equivalent to an original prescription.
Telephone Authorization for Schedule III-V
Prescriptions
Only the practitioner can prescribe controlled substances and this
authority cannot be delegated to anyone else. A prescription issued by a
practitioner may be called in to a pharmacist by the practitioner or an
employee or agent of the individual practitioner. It is the
pharmacist’s responsibility to insure that these telephone
prescriptions are valid and properly authorized by the practitioner.
(See Pharmacist’s Guide to Prescription Fraud, Appendix
O)
Transfer of Prescription Information
DEA will allow the transfer of original prescription information for
Schedules III, IV and V controlled substances for the purpose of refill
dispensing between pharmacies on a one time basis, if permissible
under state law. (See Prescription
Requirements.)
Pharmacies electronically sharing a real time, online database may
transfer up to the maximum refills permitted by law and the
prescriber’s authorization. Such systems must contain the information
required for a valid prescription.
Prescription Monitoring Programs
A prescription monitoring program is a state-administered data
collection system used to gather prescription information. This
information may be made available to state and federal investigators on
a need-to-know basis.
Many states have adopted either a multiple copy prescription program
or an electronic data transmission system because they have proven to be
an effective tool for detecting pharmaceutical diversion, for developing
pharmacist and physician medical education programs that heighten
awareness about diversion, prescription drug abuse, drug trends, and for
tracking effective use of prescription medication within a state. For
the pharmacist, the data can be used to identify potential "doctor
shoppers," and those who attempt to obtain controlled substances by
fraud, forgery or deceit.
In the states that have adopted these programs, a large part of their
success has been attributed to the pharmacists’ participation. DEA
strongly endorses prescription monitoring programs and works closely
with the states on these programs.
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Dispensing Requirements
Required Information for
Prescription Labels
The pharmacist dispensing a prescription for a controlled substance
must affix to the container a label showing the pharmacy name and
address, the serial (prescription) number, date of initial dispensing,
the name of the patient, the name of the prescribing practitioner, and
directions for use and cautionary statements, if any, contained on the
prescription as required by law.
Federal Food and Drug Administration (FDA) regulations require that
the label of any drug listed as a "Controlled Substance" in
Schedules II, III, or IV of the Controlled Substances Act must, when
dispensed to or for a patient, contain the following warning: CAUTION:
Federal law prohibits the transfer of this drug to any person other than
the patient for whom it was prescribed.
Schedule II Substances
A pharmacist may dispense a Schedule II controlled substance, which
is a prescription drug as determined under the Federal Food, Drug and
Cosmetic Act, only pursuant to a written prescription signed by the
practitioner, except in an emergency situation as described in the
following section.
Emergency Dispensing
Emergency means that the immediate administration of the drug is
necessary for proper treatment of the intended ultimate user, that no
alternative treatment is available (including a drug which is not a
Schedule II controlled substance), and it is not possible for the
prescribing practitioner to provide a written prescription for the drug
at that time.
In a bona fide emergency, a practitioner may telephone a Schedule II
prescription to the pharmacy or transmit the prescription by facsimile
to the pharmacy, and the pharmacist may dispense the prescription
provided that:
- The drug prescribed and dispensed must be limited to the amount
needed to treat the patient during the emergency period.
Prescribing or dispensing beyond the emergency period must be
pursuant to a written prescription order.
- The prescription order must be immediately reduced to writing by
the pharmacist and must contain all information, except for the
prescribing practitioner’s signature.
- If the prescriber is not known to the pharmacist, the pharmacist
must make a reasonable effort to determine that the phone
authorization came from a valid practitioner, by verifying the
practitioner’s telephone number with that listed in the
directory and by making other good faith efforts to insure proper
identity.
- Within seven days after authorizing an emergency telephone
prescription, the prescribing practitioner must furnish the
pharmacist a written, signed prescription for the controlled
substance prescribed. The prescription must have written on its
face "Authorization for Emergency Dispensing."
The written prescription may be delivered in person or by mail,
which must be postmarked within the seven day period. Upon
receipt, the dispensing pharmacist must attach this written
prescription to the oral prescription reduced to writing by the
pharmacist. By law the pharmacist must notify the nearest DEA
Diversion Field Office if the prescriber fails to provide a
written prescription within seven days. If the pharmacist fails to
do so, his/her authority to dispense without a written
prescription will be void.
Partial Dispensing
The pharmacist may partially dispense a prescription for a Schedule
II controlled substance if he/she is unable to supply the full quantity
in a written or emergency oral (telephone) prescription, provided the
pharmacist notes the quantity supplied on the front of the written
prescription (or on a written record of the emergency oral
prescription). The remaining portion may be dispensed within 72 hours of
the first partial dispensing. However, if the remaining portion is not
or cannot be dispensed within the 72-hour period, the pharmacist must
notify the prescribing practitioner. No further quantity may be supplied
beyond the 72 hours, except on a new prescription.
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Exception for Schedule II Prescriptions at
Long Term Care Facilities
An exception has been made for patients in Long Term Care Facilities
(LTCF) and patients who have been diagnosed with a terminal illness. If
there is any question whether a patient may be classified as having a
terminal illness, the pharmacist must contact the practitioner prior to
partially filling the prescription. Both the pharmacist and the
prescribing practitioner have a corresponding responsibility to assure
that the controlled substance is for a terminally ill patient. The
pharmacist must record on the prescription whether the patient is
"terminally ill" or an "LTCF patient." A
prescription that is partially filled and does not contain the notation
"terminally ill" or "LTCF patient" will be deemed to
have been filled in violation of the CSA. In such cases, prescriptions
may be filled in partial quantities, including single dosage units. For
each partial filling, the pharmacist must note on the prescription (or
other uniformly maintained, readily retrievable record) the date the
prescription was partially filled, the quantity dispensed, the remaining
quantity and the identification of the dispensing pharmacist. Such
prescriptions are valid for a maximum of 60 days from the date of issue,
unless terminated earlier by discontinuance of the medication.
Internet Pharmacy
The actual physical location of the pharmacy which purchases, stores,
and dispenses controlled substances pursuant to prescription orders
processed by the Internet site must be registered with DEA. The web site
itself would not require a separate registration unless it is the same
physical location, since the web site does not store or dispense
controlled substances. For example, some Internet pharmacies maintain a
central pharmacy warehouse site and offices where prescriptions are
verified and substances shipped; this location must be registered with
DEA as a retail pharmacy. Other Internet sites allow patients to pick up
their prescriptions for controlled substances from a local pharmacy;
these pharmacies must be registered with DEA. In this case, the Internet
"pharmacy" has no obligations under DEA regulations because
the responsibility for assuring compliance with DEA regulations rests
with the actual pharmacy where controlled substances are dispensed.
The pharmacy must have a license from the state in which the
controlled substances are stored and dispensed and, in most instances,
from any state in which you plan to conduct business with customers.
Pharmacists should also be aware that many states require licenses for
the web site itself since these sites often provide services like
patient counseling. Being an Internet pharmacy does not change the
pharmacy’s responsibilities under DEA regulations. The pharmacy is
still authorized to sell controlled substances only when there is a
valid prescription from a DEA-registered practitioner who issued the
prescription in the usual course of his or her professional practice.
A pharmacist may dispense a Schedule II controlled substance only
after the patient or prescriber provides an original signed prescription
prior to dispensing. The label on the prescription filled must indicate
the location that dispensed the controlled substance.
Some Internet pharmacies have doctors who prescribe substances based
on an on-line questionnaire. Federal law requires that "A
prescription for a controlled substance to be effective must be issued
for a legitimate medical purpose by an individual practitioner acting in
the usual course of his professional practice" (21 CFR
1306.04(a)).
Every state separately imposes a similar acting requirement under its
laws. Under Federal and state law, for a doctor to be acting in the
usual course of professional practice, there must be a bona fide
doctor/patient relationship.
For purpose of state law, many state authorities, with the
endorsement of medical societies, consider the existence of the
following four elements as an indication that the legitimate
doctor/patient relationship has been established:
-A patient has a medical
complaint;
-A medical history has been
taken;
-A physical examination has
been performed; and
-Some logical connection
exists between the medical complaint, the medical history, the
physical examination, and the drug prescribed.
Electronic Transmission of Prescriptions
DEA is currently engaged in a project to establish the requirements
for secure electronic transmission of all controlled substance
prescriptions between the practitioner and the pharmacy.
Proposed security
requirements include:
- Authentication of the
prescriber
- Content integrity
- Non-repudiation of
involvement by parties to a transaction
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Schedule III-V Controlled
Substance Prescriptions
A pharmacist may dispense a Schedule III, IV, or V controlled
substance having received either a written prescription signed by a
practitioner, a facsimile of that prescription transmitted by the
practitioner or his/her agent to the pharmacy, or an oral prescription
made by an individual practitioner. The pharmacist must promptly reduce
the oral prescription to writing, including all required information. At
this time, DEA does not permit a prescription received via the internet
to be filled. If prescription information in received via the internet,
the pharmacist must contact the prescriber via telephone and receive an
oral prescription for the controlled substance including the full name
and address of the patient, the drug name, strength, dosage form,
quantity, prescribed directions for use, and the name, address, and
registration number of the practitioner. The pharmacist must then
immediately reduce the oral prescription to writing.
Partial Dispensing
The pharmacist may partially dispense a prescription for a Schedule
III-V controlled substance if the pharmacist notes the quantity
dispensed and initials the back of the prescription order. The partial
dispensing may not exceed the total amount authorized in the
prescription order. The dispensing of all refills must be within the six
month limit.
It is permissible to dispense a prescription for a quantity less than
the face amount prescribed resulting in the actual number of dispensings
being greater than the number of refills indicated on the prescription.
Dispensing Without a Prescription
In states where limited quantities of Schedule V preparations may be
sold over-the-counter, the pharmacist is responsible for making sure
that such sales comply with state law. Schedule V controlled substances
or any controlled substance listed in Schedule II, III or IV which is
not a prescription item under the Federal Food, Drug, and Cosmetic Act
may be dispensed without a prescription at retail provided that:
- Such distribution is made only by a pharmacist and not by a
non-pharmacist employee, even if under the direct supervision of a
pharmacist. However, after the pharmacist has fulfilled
professional and legal responsibilities, the actual cash, credit
transaction or delivery may be completed by a non-pharmacist.
- Because there is no physician determining the medical necessity
for a Schedule V over-the-counter product, the pharmacist must
ensure the medical necessity of the need for the product.
- Not more than 240 ml. (8 fluid ounces) or not more than 48 solid
dosage units of any substance containing opium, not more
than 120 ml. (4 fluid ounces) or not more than 24 solid dosage
units of any other controlled substance, may be distributed at
retail to the same purchaser in any given 48-hour period without a
valid prescription.
- The purchaser at a retail outlet is at least 18 years of age.
- For the retail purchase of a Schedule V controlled substance,
every customer the pharmacist does not know should be required to
provide suitable identification, including proof of age, where
appropriate.
- A Schedule V bound record book is maintained which contains the
name and address of the purchaser, name and quantity of controlled
substance purchased, date of each sale, and initials of the
dispensing pharmacist. This record book must be maintained for a
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