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FEDERAL CONTROLLED SUBSTANCES ACT

FEDERAL CONTROLLED  Certain drugs have a potential for abuse

SUBSTANCES ACT leads to physical or psychological
dependence
 The U.S. federal government has
placed these drugs into Schedules (I, II,
III, IV, and V) and refers to them as
controlled substances
 The Attorney General of the United
States has the authority to add or
remove a drug or substance from one
of the federal Controlled Substances
 Act: This act, created in 1970, congress
established five schedules of controlled
substances; the schedules reflect the
relative potential for abuse

A. Schedules of controlled Schedule I (CI; C-I) NO accepted medical use in the United States.
substances highly addictive physically & physiologically; no
medical use

Heroin
Schedule II (CII; C-II) NOT be refilled.
The ordering and returning out of date require
a form EDA 222
Have a high abuse potential that may lead to
severe physical or psychological dependence

Oxycodone, Ritalin, morphine, dialotin

Schedule III (CIII; C-III).
May be refilled 5 times in a six month period.
have less potential for abuse/dependence than
schedule I or schedule II drugs
moderate or low physical dependence or
high psychological dependence
ex. hydrocodone (Hydrocet),

Tylenol 3

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 Schedule IV (CIV; C-IV).
Schedule V (CV; C-V).
DEA Registration Period
May be refilled 5 times in a 6 month period.
have less potential for abuse/dependence than
schedule II/III drugs;
limited dependence risk (phone/ refills)
ex. Ativan, Valium, and Xanax
Less potential for abuse than schedule II, III,
and IV
Drugs OTC (ex. cough suppressants &
diarrhea prep ( lomotil )
Upon first registration, business is assigned a
specific month of the year. Expiration date will
be the last day of the month designated

After the initial registration period, registration

B. Registration
requirements
Act regulates the use of
controlled substances by
requiring all entities that
lawfully handle them to
register with the federal
government, Specifically the
Drug Enforcement
Administration (DEA
expires 36 mo from initial expiration date
1-Entities that must A. Manufacturers and wholesalers( every
register year)
B. Dispensers (practitioners and
pharmacies)( reregister every 3 years)
C. Entities that lawfully handle any
controlled substance ( researchers,
clinics , laboratories, & teaching
institutions)

2. Separate registration for a. Manufacturing

separate activities b. Distributing
c. Dispensing controlled substances listed in
Schedules II to V (e.g., practitioners,
pharmacies)
d. Conducting research with controlled
substances listed in Schedules II to V
e. Conducting instructional activities with
controlled substances listed in Schedules II to V
f. Conducting a narcotic treatment program
using any narcotic drug listed in Schedules II,
III, IV, or V
g. Conducting research and instructional
activities with controlled substances listed in
Schedule I
h. Conducting chemical analysis with controlled
substances listed in any Schedule

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 i. Importing controlled substances
j. Exporting controlled substances
k. Participating in maintenance or
detoxification treatment and mixing,
preparing, packaging, or changing the dosage
form of a narcotic drug listed in Schedules II, III,
IV, or V for use in maintenance or
detoxification treatment by another narcotic
treatment program

3. Separate registrations 1. Pharmacy,

for separate locations.
2. Chain pharmacy
3. Hospital
Registration is not required for an office
that is used by a registrant where
controlled substances are neither stored
nor dispensed
4. Warehouses
A warehouse where controlled substances
are stored by or on behalf of a registrant is
not required to register unless one of the
following occurs

(1) Controlled substances are directly

distributed from the warehouse to a registered
location different from the location from which
the substances were shipped
(2) Controlled substances are directly
distributed from the warehouse to a person or
entity not required to register under the Act

4. Registration procedure Applications to become registered must be

submitted to the DEA on the appropriate form
A power of attorney allows with the required fee, information, and
one to lawfully act in place signature of one of the following
of another it remains valid a. The individual who owns and operates the
until revoked by the entity (business as an individual).
applicant b. A partner of the applicant (partnership).
c. An officer of the applicant, if a corporation,
corporate division, association, trusts, or other
entity.
d. One or more individuals who have been
granted a power of attorney by an applicant
 If an application is complete, it will be

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 5. Registration action by
the DEA.
a. Issuance of.
certificate of
registration
b. Denial of registration
6. Modification of
registration
7. Transfer of registration
Notify DEA 14 days before
transfer and provide
everything basically on the
new business.
Complete inventory must be
taken
. 8. Suspension or
revocation of registration
accepted for filing.
 If it is defective, the DEA will return the
application with a statement indicating
the reason for its non-acceptance
The application may be corrected and
resubmitted at any time
A certificate of registration will be issued by
the DEA when it determines that the
registration is required by law in order to
conduct such activity (e.g., manufacturing,
distributing, or dispensing a controlled
substance).
The certificate must be conspicuously
maintained and readily retrievable at the
registered location
If the DEA determines that a registration is not
required by law, it will issue an Order to Show
Cause why the registration should not be
denied
The applicant may request a hearing and
explain why the certificate of registration
should be issued. After the hearing, the DEA
may deny the application or issue the
certificate
when there is a change in:
1. The name or address
2. When the pharmacy seeks DEA
approval to dispense additional
controlled substances
 Only when the ownership of a
pharmacy is being transferred from one
entity to another
 Schedules II to V must be properly
disposed of or transferred to the new
entity
A) Order of suspension or revocation.
After a registrant has received an order
suspending or revoking its registration, it must
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 take the following action:
(1) Immediately deliver its certificate of
registration and any DEA 222 order forms in its
possession to the nearest office of the DEA.
(2) As instructed by the DEA, either:
 Deliver all controlled substances in its
possession to the nearest office of the
DEA or to authorized agents of the DEA,
or
 Place all controlled substances in its
possession under seal.
B) Imminent danger to public health or safety.
The DEA may serve on a registrant an order of
immediate suspension when it finds that there
is an imminent danger to the public health or
safety.
The immediate suspension remains in effect
until the conclusion of all proceedings, either
administrative proceedings by the DEA or
judicial proceedings
After receiving an order of immediate
suspension, the registrant must take the same
action as outlined previously
under.8.a.suspension, the registrant must take
the same action as outlined previously under
I.B.8.a.

9. Exemptions from a. Military officials (Including Public

registration Health Service and Bureau of Prisons
officials who are authorized to
prescribe, dispense, or administer, but
not to procure or purchase, controlled
substances in the course of their official
duties
b. Law enforcement officials.
c. Civil defense officials(Civil defense and
disaster relief organization officials)
d. Agents and employees of registrants

10. Termination of When the person:

registration. 1. dies
Must notify nearest DEA 2. Ceases legal existence (corporate
office dissolution, partnership dissolution) OR
Return+VOID any unused 3. Discontinues business or professional

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 Form-222
Explain how records will be
kept and controlled
substances destroyed or
transferred - Keep for 2 years
practice
The DEA must be notified promptly when any
of these occurs. In such a case, all controlled
substances in Schedules II to V must be
properly
disposed of

C. Required inventories
The Act requires all
pharmacies and hospitals
(every separately registered
location) to conduct an
initial inventory and
biennial inventory of all
controlled substances in
Schedules II, III, IV, and V
1. Initial inventory
A complete and accurate
inventory of all narcotics
before opening pharmacy.
 Must be taken on the date the entity
commences business and begins
dispensing controlled substances.
 If no controlled substances on hand, a
record of this fact must be maintained
as its initial inventory.

2. Biennial inventory  Biennial date: any date that is within 2

Every 2 years years of the previous (or initial) date.
 No requirement to submit a copy of the
inventory to DEA.

3. Inventory procedures a. All inventories must be maintained in a

written, typewritten, or printed form
and be conducted at either the opening
of business or the close of business on
the inventory date (which must be
noted on the inventory).
b. Separate inventory record for Schedule
II controlled substances

3. Inventory content a. Date the inventory is taken.

N.b: b. Each finished form of the substance
Extemporaneous (dosage form and strength).
Compounding: c. Number of units or volume of each
The on-demand finished form in each commercial
preparation of a drug container (e.g., 100-tablet bottle). For
product according to a opened commercial containers,
physician's prescription inventory must be taken as follows:
(1) Schedule II controlled substances,
an exact count or measure
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5. Inventory record
maintenance
Every inventory record
must be maintained at the
registered location (e.g.,
pharmacy, hospital) for at
least 2 years from the date
of the inventory.
6. Perpetual inventories
7. Newly controlled
substances or changes in
scheduling of a substance
(2) For Schedule III, IV, and V controlled
substances, an estimated count or
measure
Except that an exact count must be
taken if the container holds more
than1000 tablets or capsules.
d. For each controlled substance
maintained for extemporaneous
compounding, or for substances that
are damaged, defective, or impure and
awaiting disposal:
(1) Name of the substance
(2) Total quantity to the nearest metric
unit weight or the total number of units
of finished
form
(3) Reason the substance is being
maintained and whether it is capable of
use in the manufacture of any
controlled substance in finished form
a. Schedule II inventories must be maintained
separately from all other records of the
pharmacy.
b. Schedule III to V inventory records must be
maintained either separately from all other
records of the pharmacy or in such a manner
that the required information is readily
retrievable from ordinary business records of
the pharmacy. “Readily retrievable” means
that. the inventory records can be separated
out from all other records in a reasonable time
The Act does not require a dispenser
registrant (e.g., pharmacy, hospital) to
maintain a perpetual inventory of any
controlled substance
The inventory of that particular controlled
substance must be taken on the effective date
of the change.
If change in ownership
The inventory must be taken on the date of
transfer and serves as the final inventory of
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9. Inventory record
submission
D. Obtaining controlled 1. DEA Form 222
substances controlled substances must
be obtained from a
supplier (wholesaler,
manufacturer) by using
DEA Form 222
Order form for schedule II
meds
Notice of Revocation
a. Execution of Form
222
Form 222 may be executed
only on behalf of the
registrant named on the form .
if the registration has not
expired nor been revoked or
suspended. The form must be
prepared in triplicate as
provided by the DEA by use of commercial or bulk containers of a product.
a typewriter, pen, or indelible For each item, the form must contain:
pencil in the following
manner
8
the transferor and the initial inventory of the
transferee
 The Act does not require the
submission of inventory records to
anyone, including the DEA.
 The records must be maintained at the
registered location for inspection and
copying by authorized agents of the
DEA
Each order form is pre-printed with:
1. Name of registrant
2. Address of the registrant
3. Registration number of the registrant
4. The authorized activity for that registrant
5. The authorized schedules of drugs
6. The serial number of the form
Each form contains an original, duplicate, and
triplicate copy (Copy 1, Copy 2, and Copy 3,
respectively
Document revoking the Power of Attorney
Must be signed by the person who signed (or
was authorized to sign) the Power of attorney
and be filed with the Power of Attorney being
revoke
(1) Only one item may be ordered on each of
the 10 numbered lines on the form. The total
number of items ordered must be noted on the
form in the space provided
(2) One item may consist of one or more
commercial or bulk containers of a product.
A separate item must be made for different
(a) Name of the article ordered
(b) Finished or bulk form of the product
(dosage form and strength)
(c) Number of units or volume in each
commercial or bulk container (e.g., 100-tablet
bottle)
(d) Number of commercial or bulk containers
ordered
(e) If the article is not in pure form, the name
and quantity per unit of the controlled
substances contained in the article.

(3) The supplier’s name and address must be

included on the form. Only one supplier may
be listed on any one form

(4) The date of the order, and no form is valid

more than 60 days after its execution by the
purchaser
.
(5) The form must be signed either by
1. the person who signed the most recent
application for registration or
reregistration (registrant)
2. or by a person authorized to obtain and
execute order forms(by a power of
attorney)

.
(a) Any purchaser may authorize one or more
individuals (does not have to be an attorney-
at-law), whether or not located at the
registered location, to obtain and execute
222 Forms by executing a power of attorney
for the individual(s).

(b) The power of attorney must be signed by

the person who signed the most recent
application for registration or reregistration
and by the individual(s) receiving the power of
attorney.

This form must be similar or identical to the

DEA’s “Power of Attorney for DEA Order Forms

(c) Once properly executed, the individual

receiving the power of attorney may obtain
and sign DEA Form 222 to the same extent as

9
 the individual who signed the most recent
application for registration or reregistration
.
(d) The power of attorney must be filed with
the executed 222 Forms of the purchaser and
be retained for the same period as any order
form bearing the signature of the attorney
The power of attorney does not have to be
submitted to the DEA.
(6) Copies 1 and 2 must be submitted to the
supplier. Copy 3 must be retained by the
purchaser.
(7) When the ordered Schedule II controlled
substances are received by the pharmacy, the
following information must be recorded on the
retained Copy 3:
(a) Number of commercial or bulk containers
furnished on each item (or line)
(b) Date on which the containers are received
by the pharmacy
(8) DEA 222 Forms must be maintained at the
registered location (pharmacy or hospital) for
at least 2 years from their execution. The time
of execution would be the date the last entry
was made on Copy 3.
b. Cancellation by  A purchaser may cancel all or part of an
purchaser. order by notifying the supplier in
writing.
 The supplier must indicate the
cancellation on Copies 1 and 2 by
drawing a line through the canceled
items and printing the word items
shipped. “canceled” in the space
provided for number
 Likewise, a supplier may void all or part
of an order by notifying the purchaser
in writing and printing the word
“canceled” in the space provided for
number of items shipped

Unexecuted DEA Order Forms May be kept at a location other than that
printed on the form
c. Maintenance of DEA  Executed Copy 3 forms and Copies 1
and 2 of each unaccepted or defective

10
Form 222. form and the statement of refusal from
the supplier must be maintained by the
purchaser
 They must be kept separate from all
other records and be available for
inspection for at least 2 years.
 All forms must be maintained at the
registered location preprinted on the
form, and not at a central location

d. Loss or theft of DEA  Any used or unused form stolen

Form 222 from or lost by a purchaser or
supplier must be reported
immediately to the DEA.
 Such notification must include
the serial number of each form
lost or stolen
3-Electronic DEA Order  To order Schedule I and II drugs online
System (CSOS). must apply for a digital certificate for
Controlled Substances signing the order
Ordering System (US DEA)  A digital certificate is issued for each
location with a DEA registration.( each
pharmacy location has an individual
(CSOS) identification)
 The agency does not give a central
Controlled Substance registration for multiple locations (i.e.,
Ordering System: one registration serving multiple
electronic equivalent to
pharmacies [chains]).
DEA Form 222; allows
 One registration can have more than
electronic ordering and
record keeping one certificate if multiple people have
power of attorney
No ordering limit (DEA  Allows registrants to orders Schedules
Form 222 has 10 lines) III, IV, and V drugs and non-controlled
Can order CIII - CIV, as substances.
well as non-controlled
(A separate CSOS Signing Certificate is
drugs
required for each DEA Registrant number. In
cases where a person represents multiple
Faster, more accurate, Registrants or DEA Registrant numbers, then
decreased cost (labor & multiple Certificates will be issued.)
paperwork) The CSOS Certification Authority (CSOS CA) is
operated by DEA and issues CSOS Certificates
to approved DEA Registrants and Power of
Attorneys

11
 3. Obtaining Schedule III to  No special form for obtaining Schedule
V controlled substances. III to V controlled substances.
 Maintain a complete and accurate
record of receipt for each such
substance at registered location of the
pharmacy or hospital, or at a central
location, for 2 years

 when use central location , notify the

DEA first , indicating intention to keep
central records it may then be
maintained unless the DEA denies the
request to keep such records

 An invoice or packing slip will suffice as

a record of receipt, providing the
following information is included:

a. Name of the controlled substance

b. Finished form of the substance
(dosage form and strength)
c. Number of units or volume of the
finished form in each commercial
container (e.g., 100-tablet
bottle)
d. Number of commercial containers of
each such finished form received from
other persons
e. Date of actual receipt of each
commercial container
f. Name, address, and registration
number of the person from whom the
containers were received

E. Storage of controlled All controlled substances in Schedules II to V

substances must be stored one of the following :
1. In a securely locked, substantially
constructed cabinet
2. Dispersed throughout the stock of un-
Scheduled prescription medication to prevent
any theft or diversion

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F. Theft or significant loss
of Schedule II to V
controlled substances
G. Disposal of controlled
substances
H. Regular disposals of
controlled substances
Every registrant must promptly notify the
regional office of the DEA of the theft or
DEA Form 106. significant loss of any controlled substance in
Schedules II to V
. This report must be done using DEA Form
106.
Documents the destruction of CS
Every disposal of a controlled substance must
DEA Form 41 be accomplished by submitting DEA Form 41
to the DEA except for disposals pursuant to a
valid prescription, discussed in the succeeding
to dispose of the controlled text).
substances 1. By the transfer to a person or entity registered
in one of the following ways: with the DEA and authorized to possess the
Substance
Schedule II controlled substances must be
transferred by the use of the transferee’s
(another pharmacy or hospital, or the wholesaler
or manufacturer) DEA Form 222.( A written
record of the transfer of Schedule III to V
controlled substances must be kept for at least 2
years) including :
a. Name of the controlled substance
b. Finished form of the substance (dosage form
and strength)
c. Number of units or volume of the finished form
in each commercial container (e.g., 100-tablet
bottle)
d. Number of commercial containers of each
finished form transferred
e. Date of the transfer
f. Name, address, and registration number of
the transferee
2. By the delivery to an agent of the DEA or to the
nearest office of the DEA
3. By the destruction in the presence of an
agent of the DEA or other authorized person
4. By any other means that the DEA
determines to ensure that the substance does
not become available to unauthorized persons or
entities
 If a registrant (usually a hospital)
regularly disposes of controlled
substances in Schedules II to V,
 The DEA may authorize disposals
without prior approval in each instance
 If the DEA grants this authority, the
13

I. Dispensing of controlled
substances pursuant to a
valid prescription
2. Purpose of issuance of
14
registrant must keep records of each
disposal and file periodic reports to the
regional office of the DEA summarizing
the disposals.
Practitioner (who is granted prescribing
authority
physicians, dentists, podiatrists, and
veterinarians(authorized to dispense controlled
substances by the state) or in some
states(physician’s assistants, nurse
practitioners, certified nurse midwives,
psychiatric nurses, and mental
health clinical specialists
1-Authentication of DEA number.(verification)
Begin with A or B
AJ 4357782
(a) The digits in positions 1, 3, and 5 are
added together
4+5+7=16
(b) The digits in positions 2, 4, and 6 are
added together, then multiplied by 2.
3+7+8=18×2=36
36+16=52
The last digit of this sum should match the last
digit of the DEA number.
This no is valid
(2) Midlevel practitioner DEA numbers
begin with M
Second letter is the first letter of the
registrants last name
ex BR2398328
(3) DEA numbers for practitioners and
midlevel practitioners who are employees of
institutions.
The code number must consist of numbers,
letters, or a combination of numbers and
letters and must be a suffix to the institution’s
DEA number, preceded by a hyphen (e.g.,
AP0123456-10 or AP0123456-A12).
 For a legitimate medical purpose by a
practitioner
controlled substance
prescriptions
a. Legitimate medical
purpose
b. Usual course of
professional practice.
c. Restrictions on issuance
of a controlled substance
prescription
3. Manner of issuance of a
controlled substance
prescription
15
 Referred to as corresponding
responsibility of the pharmacist.
a reasonably prudent pharmacist would form
the opinion that a prescription was issued for a
legitimate medical purpose
,
all CS prescriptions from medical doctors are
deemed to be “in the usual course of
professional practice” as long as it is issued for
a human, regardless of whether the problem
being treated is within the doctor’s specialty
(1) Not for general dispensing.
(2)Not detoxification or maintenance
treatment.
only when conducted in properly registered
treatment programs
Methadone(40 mg tablets) are only available
to hospitals and facilities authorized for
detoxification and maintenance treatment of
opioid addiction
Methadone (5 mg and 10 mg) for the
treatment of pain are available to all
authorized registrants, including retail
pharmacies.
CS II must be written with ink or indelible
pencil or typewritten (except in cases of oral
emergency Schedule II prescriptions).
Schedule III to V controlled substance
prescriptions may be orally ordered by the
practitioner
Rx must originate with the practitioner.
Prescriptions may be prepared by either the
practitioner or an agent of the practitioner,
and communicated to the pharmacy by the
practitioner or the agent.
authorization for the prescription (or refill)
must
 All prescriptions for controlled substances
must include :
 Date of issue a. Full name and address of the patient
b. Date the prescription is issued and signed
 Patient's name (one and the same)
and address c. Drug name, dosage form, and strength
d. Quantity of drug prescribed
e. Directions for use
 Practitioner's f. Name, address, and DEA registration
name, address, number of the practitioner
and DEA g. The signature of the practitioner (no
registration preprinted or stamped signatures) as he or she
number would sign any legal document (all Schedule II
controlled substance prescriptions must be
 Drug name manually signed by the practitioner

 Drug strength

 Dosage form

 Quantity
prescribed

 Directions for use

 Number of refills
(if any)
authorized

 Manual signature
of prescriber

4. Emergency dispensing
of Schedule II controlled
substances

16

a. An oral Schedule II
controlled substance
b. Proper dispensing
5. Facsimile prescriptions
17
Exist when:
(1) The immediate administration of the
controlled substance is necessary for proper
treatment of the patient
.
(2) No appropriate alternative treatment is
available, including administration of a
controlled substance that is not in Schedule II.
(3) It is not necessarily possible for the
prescriber to provide rx to the person
dispensing the CS prior to dispensing
The quantity prescribed and dispensed must
be limited to the amount necessary to
adequately treat the patient during the
emergency period
the pharmacist must make a reasonable good-
faith effort to determine that the oral
authorization came from a registered
practitioner
(1) Delivery of written prescription
within 7 days of the oral authorization, deliver
a written prescription to the dispensing
pharmacist from The practitioner who
authorizes the emergency prescription
written on its face the words “Authorization
for Emergency
(2) Failure to deliver a written prescription
 The dispensing pharmacist must notify
the regional office of the DEA.
 Failure by the pharmacist to notify the
DEA serves to void the pharmacist’s
authority to dispense an oral
emergency Schedule II prescription.
 The pharmacist will be deemed to have
unlawfully dispensed a Schedule II
controlled substance
 Prescriptions for controlled substances
III, IV, and V (and nonfederal controlled
substances such as penicillin and
 furosemide) may be delivered to the
dispensing pharmacy via facsimile
machine.
 A facsimile prescription is deemed to be
the written, signed prescription from
the prescriber so long as it contains the
information required of all prescriptions
under federal law

 The prescription must be sent directly

from the prescriber or his or her
authorized agent to the pharmacy

 To facilitate dispensing of the

prescription via facsimile machine.
a. Schedule II controlled  No drug may be released to the patient
substances. until the original, signed prescription is
will serve as the original,
presented to the dispensing
signed prescription in the
following situations: faxing CII
pharmacist.
prescriptions?

in what situations may  For direct administration to a

faxed prescription serve as patient in a private residence,
original (1) Injectable home health setting may serve as the long-
- for resident of LTCF prescriptions term care facility, or hospice
-for pt in hospice care original prescription.
program certified by  The exception applies so long as the
Medicare or licensed by solution will be administered by means
state of parenteral, IV, IM, SC or intraspinal
-drug to be compounded for infusion.
direct administration by
parental, IV, intramuscular,
sq, intraspinal

Any facsimile Schedule II prescription

issued for a resident of a long-term care
(2) Long-term care facility facility may serve as the original, signed
prescriptions prescription

Any facsimile Schedule II narcotic prescription

issued for a patient enrolled in a hospice care
(3) Hospice patient program certified and/or paid for by Medicare
prescriptions under Title XVIII or licensed by state law may
Page 1211 CPR

18

6. Electronic data
transmission prescriptions
for noncontrolled
substances
a. Electronic data
transmission prescriptions
for controlled substances
7. Persons who may
dispense controlled
substance prescriptions.
8. Dispensing procedures
of controlled substances
pursuant to a prescription
a. Presentation to the
pharmacist
19
serve as the original prescription.
The prescriber, or his or her agent, must note
on the prescription that the patient is a
hospice patient.
Electronic signatures are recognized as legally
acceptable signatures of practitioners.
Legend drugs, except for controlled
substances, may be transmitted to pharmacies
via the Internet.
The DEA does not yet recognize electronic data
transmission prescriptions as a means of
communicating prescription information for
any controlled substance
.
A pharmacist DEA-registered pharmacy (or
hospital or other registered facility.
A pharmacy intern acting under the direct
supervision of his or her preceptor in a DEA-
registered facility may also dispense a
controlled substance pursuant to a prescription
 Schedules III and IV controlled
substance prescriptions are valid for 6
months from the date of issuance by
the practitioner
 Schedule II controlled substance
prescriptions have no time limit for
presentation under the Act, although
they are often recognized to be valid
for up to 6 months
 Schedule V controlled substance
prescriptions also have no set time
limit for presentation under the Act
 (1) Name of the controlled substance
(2) Finished form of the controlled substance
b. Information that must (dosage form and strength)
be recorded on the (3) Name and address of the person to whom it
prescription by the was dispensed
dispensing pharmacist (4) Date of dispensing
(5) Number of units or volume dispensed
(quantity)
(6) Written or typewritten name or initials of
the individual who dispensed the controlled
Substance
(7) Serial number of the prescription
(1) Name and address of the pharmacy
(2) Serial number assigned to the prescription
c. Required information on (3) Date of the initial filling of the prescription
prescription labels (for refills, the date originally filled)
(4) Name of the patient
(5) Name of the prescribing practitioner
(6) Directions for use, and cautionary
statements, if any
(7) For Schedule II, III, and IV controlled
substances, the federal crime transfer warning
must appear on the container:
“Caution: Federal law prohibits the transfer
of this drug to any person other than the
patient for whom it was prescribed”
no limitation
Limited to the good-faith and “legitimate
d. Allowable quantities medical purpose” standards.
that may be dispensed.
 2 years from the date of the original
dispensing or last refill, whichever is
e. Filing controlled later
substance
prescriptions  Must be available for inspection and
state law usually dictates the
copying by employees and agents of
method to be used as Follow :
the DEA and be filed segregated from
all other records.

 (a) One file for Schedule II controlled

(1) Using three separate substance prescriptions
files as follows  (b) One file for Schedule III, IV, and V

20
 controlled substance prescriptions
 (c) One file for un-Scheduled
prescription drugs

(a) One file for all controlled substance

(2) Using two separate prescriptions (II to V), as long as Schedule III,
files as follows IV, and V prescriptions have the letter “C”
stamped in red ink in the lower right corner
no less than 1 inch high
(b) One file for un-Scheduled prescription
drugs
(a) One file for Schedule II controlled
substance prescriptions
(3) Using two separate (b) One file for all other controlled substances
files as follows (III to V) and un-Scheduled prescription
drugs, as long as Schedule III, IV, and V
prescriptions have the letter “C” stamped in
red ink in the lower right corner no less than 1
inch high
IF computerized records that permits
identification by prescription number and
(4) In either (2) or (3) retrieval of original documents by
 prescriber’s name,
 patient’s name,
 drug dispensed,
 and date filled,
then the requirement to mark the hard copy
prescription with a red “C” is waived
 Prescriptions for Schedule II CS not be
refilled
f. Refill dispensing of  Schedules III and IV controlled
controlled substances. substances may be refilled up to 5
within 6 months from the date of issue
of the prescription

If computerized refill records are maintained,
(a)The computer must be able to provide
(1) Refill information  Online retrieval of the original
may be maintained prescription.
either manually or by
 Information, online retrieval of
the use of a computer
the refill history, a refill-by-refill
audit trail.
 An auxiliary procedure in those

21
 cases. where the system
experiences downtime
(b) The system must also allow the pharmacist
who refills a prescription to document that the
information he or she entered into the
computer is correct
.
` Each refill must record:
 Name & dose
(2) When dispensing a  Date filled & quantity dispensed
refill, the pharmacist  Initials of dispensing Rph for each refill
must record, on the
 Total # of refills for that rx
back of the original
 the good-faith and “legitimate medical
prescription
purpose” limitations apply here

or by computer, the
following information
Requirements for issuance:
 Each prescription issued is for a
g. multiple Schedule II legitimate medical purpose by an
prescriptions prescribed individual practitioner acting in the
on the same day to be usual course of his/her professional
filled sequentially practice.
 The individual practitioner must
provide written instructions on each
prescription indicating the earliest date
on which a pharmacy may fill each
prescription
 The issuance of multiple prescriptions is
permissible under applicable state laws.
 The individual practitioner complies
fully with all other applicable
requirements under the Controlled
Substances Act and implementing
regulations, as well as any additional
requirements under state law.
 Only receive a total of up to a 90-day
supply of a Schedule II controlled
substance

22

h. Partial dispensing of
controlled substances
(1) Partial dispensing of a
Schedule II controlled
substance.
(a) Inadequate supply.
(b) Terminally ill and
patients in LTCFs.
 It is the pharmacist’s
responsibility to
ensure that a patient
has a medical
diagnosis
documenting a
terminal illness.
 Or that the patient is
in an LTCF
23
 The Act does not prohibit the partial
dispensing of controlled substances in
Schedules III and IV.
 Each partial filling is recorded in the
same manner as refills.
 The total quantity dispensed in all
partial fillings does not exceed the total
quantity prescribed.
 No partial filling occurs after 6 months
from the date of issuance of the
prescription.
 All partial fillings of a Schedule V
prescription must not exceed the total
quantity prescribed.
 if the pharmacist is unable to supply the
full quantity or
 The prescription is for a terminally ill
patient or a patient in a long-term care
facility (LTCF).
 The dispensing pharmacist must note
on the face of the prescription the
amount dispensed.
 The remaining balance of the Schedule
II prescription must be dispensed
within 72 hrs of the first partial filling if
not notify the prescribing practitioner.
 The pharmacist may not dispense any
further amounts pursuant to this
prescription beyond the 72-hr period.
 Before any partial dispensing, the
pharmacist must record on the
prescription whether the patient is
“terminally ill” or an “LTCF patient.”
 Any partial dispensing without one of
these notations shall be deemed to be a
dispensing in violation of the Act
 The total amount of the Schedule II
substance dispensed in all partial fillings
must not exceed the total quantity
prescribed.
 Schedule II prescriptions for a

Terminally ill patient or a patient in an LTCF

are valid up to 60 days from the date of
issuance of the prescription by the
practitioner.
information must be recorded, either manually on
the back of the prescription or via computer

(i) Date of the partial filling

(ii) Quantity of drug dispensed
(iii) Remaining quantity authorized to be dispensed
(iv) Identification of the dispensing pharmacist

 Refill information concerning Schedules

III, IV, and V controlled substances may
i. Transfer of refill be transferred to another pharmacy
information for a only once.
controlled substance  Chain pharmacies may transfer refill
prescription. information for these controlled
substances up to the maximum number
of refills permitted by law and the
prescriber’s authorization.
 The communication must be made
directly between two licensed
pharmacists.
 Both the original prescription and the
transferred prescription must be
maintained for 2 years from the date of
the last refill.
 information must be recorded as
follows:

(a) Write the word “void” on the face of the
original prescription
(1) The transferring (b) On the back of the prescription, record the
pharmacist must:  Name.
 Address.
 DEA registration number (of the
pharmacy to which it was transferred).
 the name of the pharmacist receiving
the information
(c) Record

24

(2) The receiving
pharmacist must:
J. Dispensing of controlled
substances to a patient
without a prescription
Max amount of controlled
substance with opium OTC
Max amount of other
controlled substance OTC
K. Security considerations
25
 The date of the transfer.
 The name of the transferring
pharmacist.
(a) Write the word “transfer” on the face of
the transferred prescription.
include the following:
(i) Date of issuance of the original prescription
(ii) Original number of refills authorized on the
original prescription
(iii) Date the prescription was initially
dispensed
(iv) Number of valid refills remaining and the
date of the last refill
 (v) Pharmacy’s name.
 Address.
 DEA registration number.
 Original prescription number.
from which the prescription information
was transferred
(vi) Name of the transferring pharmacist.
a. Name and address of the purchaser
b. Name and quantity of controlled substance
purchased
c. Date of each purchase
d. Name or initials of the pharmacist who
dispensed the substance to the purchaser
240 mg (8oz) or 48 dosage units w/in 48 hours
120 ml (4 oz.) or 24 dosage units w/in 48 hrs.
1. Controlled substance seals (must be
packaged with such a seal.)
2. Felony convictions: No DEA registrant may
employ an individual who has access to
controlled substances if previously been
convicted of a felony offense related to
controlled substances.
3. Manufacturer’s label
Its label the symbol designating the Schedule
in which the controlled substance is listed.
 The symbol must appear in the upper right
corner of the label or be overprinted on the
label.
L. Record maintenance.
M. DEA inspections.
AIW -
Administrative
Inspection Warrant
N. Long-term–care
facilities (LTCFs)
26
 2 years at a central location after
notifying the DEA
 Executed DEA 222 Forms (Copy 3), all
controlled substance prescriptions, and
all inventories must be maintained at
the pharmacy, not centrally.
 All Schedule II controlled substance
records must be maintained separately
and readily retrievable from all other
records.
 Conducted only in a reasonable manner
and during regular business hours.
 Inspection may be conducted after
obtaining
 consent of the registrant or after the
DEA has obtained an administrative
warrant from a judge
 An application for an administrative
warrant must state with specificity the
nature, extent, and authority to
conduct the requested inspection.
 Inspector can Examine and copy all
records and reports. Inspect the
premises within reasonable limits.
Conduct a CS inventory.
 And the verification of compliance with
any requirement of the Act.
 If records are removed from the
registrant by the DEA, a receipt given to
the registrant will list the items taken
 An LTCF is defined as a nursing home,
retirement care, mental care, or other
facility or institution that provides
extended health care to resident

1. Emergency kits for
LTCFs.
Maintain CS in emergency
kits
O. Violations under the
Act:
Penalties for violations of the
Federal Controlled
Substances Act
27
patients.
 They are not required to be registered
with the DEA because the controlled
substance is dispensed to the ultimate
user (the patient) and is not issued by
or through the LTCF.
 LTCFs must contact the nearest DEA
Diversion Field Office for disposal
instructions.
The state sets forth procedures that require
the following:
a. Source of supply:
from a DEA-registered hospital/clinic,
pharmacy, or practitioner
b .security safeguards
Access to each emergency kit in the LTCF must
be restricted and the type and quantity of
controlled substances that may be placed in
the emergency kit must be specifically limited
c. Proper control, accountability, and record
keeping:
 Periodic physical inventories.
 records of the CS in the emergency kit,
& the disposition of these controlled
substances
d. Administration of controlled substances.
In case of emergency only LTCF personnel who
are authorized by an individual practitioner can
administer the controlled substances
e. Prohibited activities. Result in the state
revocation, denial, or suspension of having
emergency kits containing CS in an LTCF.
1. Civil penalty: (fine) of up to $10,000.
The government must prove that the violator
was negligent with respect to compliance
under the Act, as opposed to mere mistake or
inadvertence ‫خطأ ناشئ عن إهمال‬
2. Imprisonment
If an individual knowingly and intentionally
violates the Act, he or she may be sentenced to
a term of years, in addition to a civil penalty.
28