ARKANSAS DEPARTMENT OF HEALTH
RULES AND REGULATIONS
PERTAINING TO CONTROLLED SUBSTANCES
SECTION 1.
REGISTRATION
Every Practitioner as defined as follows shall obtain a
registration from the Federal Drug Enforcement Administration, Department of
Justice unless exempted by Law.
A. A
physician, podiatric physician, osteopathic physician, dentist, veterinarian,
optometrist, scientific investigator, researcher, mid-level practitioner, or
other persons licensed, registered, or otherwise permitted to prescribe,
dispense, distribute, administer or conduct research with respect to controlled
substances in the course of professional practice or research in
Arkansas:
B. A pharmacy, hospital
or related institution, manufacturer, wholesaler, distributor or other
institutions or facilities, licensed, registered, or otherwise permitted to
distribute, dispense, conduct research with respect to, or to administer a
controlled substance in the course of professional practice or research in
Arkansas.
C. Persons authorized and
registered by the Director, Arkansas Department of Health to engage in research
on the use and effects of controlled substances, including persons conducting
instructional activities, conducting chemical analysis, or conducting animal
training or animal euthanasia with controlled substances in the course of
practice approved and registered by the Director.
D. A separate registration is required for
each principle place of business or professional practice at one general
physical location where controlled substances are maintained, manufactured,
distributed, imported, exported, or dispensed.
SECTION 2.
EXEMPT
PREPARATION
A. A
controlled substance listed in Schedule V which is not a prescription drug as
determined under the Arkansas Controlled Substances Act, may be dispensed by a
pharmacist without a prescription to a purchaser at retail provided,
THAT:
(a) such dispensing is
made only by a pharmacist;
(b) not
more than 240cc (8 ounces) of any such controlled substance containing Opium,
nor more than 120cc (4 ounces) of any other such controlled substance nor more
than 48 dosage units of any controlled substance containing Opium, nor more
than 24 dosage units of any other such controlled substance may be dispensed at
retail to the same purchaser in any given 48-hour period;
(c) the purchaser is at least 18 years of
age;
(d) the pharmacist requires
every purchaser of a controlled substance under this Section not known to him
to furnish suitable identification (including proof of age where appropriate);
and
(e) the pharmacist maintains a
bound record book for each sale of controlled substances under this Section
which shall document the name, address, and signature of the purchaser, the
name and quantity of the controlled substance purchased, the date of each
purchase, and the signature of the pharmacist who issued the controlled
substance to the purchaser.
SECTION 3.
SECURITY
REQUIREMENTS
A. All
practitioners shall provide effective controls and procedures to guard against
theft and diversion of controlled substances. Controlled substances listed in
Schedules I, II, III, IV and V (except injectable ephedrine kept for emergency
use in institutions), shall be stored in a double securely locked,
substantially constructed, permanent mounted cabinet. However, pharmacies may
disperse such controlled substances throughout the stock of non-controlled
substances in such a manner as to obstruct the theft or diversion of the
controlled substances.
SECTION
4.
PROCEDURE TN CASE OF
LOSS
A. Each practitioner
and long-term care facility shall notify the Division of Pharmacy Services and
Drug Control, Arkansas Department of Health immediately upon discovery of any
suspected loss, theft and/or diversion of any controlled substance, by calling
(501) 661-2325 or Fax No. (501) 661-2769. In addition, appropriate theft and
loss reports must be filed with the Division of Pharmacy Services and Drug
Control, Arkansas Department of Health.
SECTION 5.
CLASSIFICATION
OF CONTROLLED SUBSTANCES
A. Pursuant to Ark. Code Ann. §
5-64-201 et.
seq. the Commissioner of Narcotic Substances (the Director of the Arkansas
Department of Health) may add substances to or delete or reschedule all
substances enumerated in the Schedules, pursuant to the procedures of the
Administrative Procedure Act as amended §
25-15-201 et.
seq. with prior approval by the Arkansas Legislative Council.
B. The controlled substances listed in the
Schedules shall be included by whatever official, common, usual chemical or
trade name designated and shall be revised and republished annually. Pursuant
to §
5-64-216.
SECTION 6.
RECORDS OF CONTROLLED SUBSTANCES
A. Every practitioner and long-term care
facility shall keep a record of such controlled substances received,
administered, dispensed or professionally used otherwise than by prescription
in order to maintain complete accountability. The record shall in every case
show the date of receipt, the name and address of the person or business from
whom received, and the kind and quantity of such controlled substances
received.
B. The record shall show
the controlled substances sold, administered, dispensed or otherwise disposed
of; the date of selling, administering or dispensing; the name and address of
the person to whom or for whose use the controlled substances were sold,
administered or dispensed or the owner and species of animal for which the
controlled substances were sold, administered, or dispensed and the name,
strength and quantity of controlled substances. Persons engaged in research on
the use of controlled substances may withhold the name and other identifying
characteristics of individuals who are the subjects of the research.
C. Institutional practitioner and long-term
care facility records shall be designed so that all clinical personnel are
using the same records in caring for patients and if diversion does occur the
chance of discovery is increased. The basic records of receipt and disposition
of controlled substances within the institution are the patient medication
records and the controlled substances procurement and disposition records.
(a) Patient medication records shall consist
of at least (1) practitioners orders authorizing the dispensing and
administration of medications, (2) medication administration record indicating
the date, time and signature of licensed person administering controlled
substances to the patient and (3) the nurses notes indicating the date, time,
and condition of the patient before and after the PRN controlled substance was
administered and signature of the licensed person administering the controlled
substance.
(b) In addition to
patient medication records, a record of the procurement and disposition for a
controlled substance must be maintained.
(c) The disposition record shall reflect the
actual dosage administered to the patient, the patient's name, date, time, and
signature of the licensed person administering the controlled substance. Any
error of entry on the disposition and procurement record shall follow a policy
for correction of errors and accurate accountability. If the licensed person
who procures the controlled substance is not the licensed person who
administers the controlled substance, then both licensed persons must sign the
disposition record.
(d) When
breakage or wastage of a partial dose of a controlled substance occurs, the
amount administered and the amount wasted shall be recorded by the licensed
person who wasted the controlled substance and verified by the signature of
another licensed person who witnessed the wastage and how it was wasted.
Controlled substances shall be wasted in such a manner that such substances are
rendered unusable. (Licensed person, in this paragraph, are those who are
authorized by their current Practice Act to administer controlled substances,
to include those licensed by the Arkansas State Medical Board, Arkansas State
Board of Nursing, Arkansas State Board of Dental Examiners, and the Arkansas
State Podiatry Examining Board. Licensed pharmacists and paramedics shall also
be allowed to witness wastage of controlled substances.) If a licensed person
is not available to witness the wastage, the partial dose must be sent to the
Division of Pharmacy Services and Drug Control for destruction.
(e) Records to include electronic signatures
in a closed system (i.e. hospital) generated by automatic medication
distribution devices shall comply with these regulations unless specifically
exempted by the Division of Pharmacy Services and Drug Control. Polices and
procedures shall be developed to ensure security and accountability of
controlled substances and shall be approved administratively by the Division of
Pharmacy Services and Drug Control prior to usage of such automatic medication
distribution devices.
D.
Each practitioner shall maintain inventory records in one consolidated record
system of all controlled substances under the licensed practitioners control
and inventory shall be taken every two years as required by the
D.E.A.
E. Records of Scheduled I
and II substances shall be maintained separately from all other records.
Records of Schedule III, IV and V substances shall be maintained either
separately from all other records, or in such form that the information
required is readily retrievable from the ordinary business records for
inspection and copying by authorized agents of the Division of Pharmacy
Services and Drug Control, Arkansas Department of Health. Every record shall be
kept by the registrant for at least two (2) years.
F. Adequate accountability does not require
the use of a specific system or form, however the system employed shall be
designed so that all record keeping requirements are met. When an automated
data processing system is used for the storage and retrieval of prescription
orders for controlled substances, the system shall have the capability of
producing a printout of all data which the user practitioner is responsible for
maintaining under these regulation.
G. In LTCF'S all unwanted or discontinued
controlled substances shall be entered on Surrender Form PHA:DC -1 at the time
of transfer to the secured storage area. PHA:DC-1 requires the signature of two
licensed persons verifying this transfer. Form PHA:DC-1 shall be securely and
separately stored apart from all unwanted or discontinued controlled substance.
Accountability of discontinued controlled substances rests with the licensed
person receiving the discontinued controlled substances drugs until they are
submitted to the Division Pharmacy Services and Drug Control for
destruction.
SECTION 7.
SURRENDER OF UNWANTED CONTROLLED
SUBSTANCES
A. All
controlled substances no longer usable because of deterioration or expired
dating or are unwanted, shall be delivered in person or by registered mail or
other means of shipment with return receipt to: Division of Pharmacy Services
and Drug Control, Arkansas Department of Health, 4815 West Markham, Slot 25,
Little Rock, Arkansas 72205-3867 accompanied by all completed copies of Report
of Drugs Surrendered (Form PhA:DC-l) furnished by the Department of Health; or
may be destroyed only by authorized Agents of the Arkansas State Board of
Pharmacy or the Arkansas Department of Health on site.
B. Each controlled substance item submitted
for destruction by hospitals, LTCF, or related facilities shall be submitted at
least quarterly and each time there is a change in the licensed person
responsible for discontinued or unwanted controlled substances and identified
in such a manner to determine the exact location in the facility where it was
last recorded in accountability record to determine what person or persons had
access or administered such controlled substances during the time it was in
inventory in the facility.
C.
Non-DEA registered licensed healthcare facilities shall develop policy and
procedures to ensure that complete accountability is maintained on all
controlled substances. Policies & Procedures shall include specific
licensed person responsible for the unwanted or out of date controlled
substances removed from use in the facility.
SECTION 8.
CONTROLLED DRUG
PRESCRIPTION/ORDERS
A.
Issue of Prescriptions/Orders
(a) The term prescription means an order for
medication which is dispensed to or for an ultimate user but does not include
an order for medication which is dispensed for immediate administration to the
ultimate user, (e.g., an order to dispense a drug to a resident patient for
immediate administration in a licensed facility is not a prescription, however,
the record keeping requirements of Section 6 do apply to such
orders.)
(b) A prescription or an
order for controlled substances may be issued only by an individual
practitioner who is legally authorized to prescribe or order controlled
substances in the State of Arkansas and who holds a current Federal D.E.A.
Registration.
(c) In a setting
where non D.E.A Registered Nurse Practitioners, Advance Practice Nurses, and
Physicians Assistants are employed, a D.E.A. Registered Licensed Practitioner
must determine the need for a controlled substance to be issued to a patient.
Only the D.E.A. Registered Licensed Practitioner may then communicate the order
to the pharmacist, either by written signed prescriptions or by telephone
order. No standing orders or protocol for controlled substances shall be
valid
B.
Purpose of Issue
(a) A prescription, in order to be effective,
must be issued for legitimate medical purposes. The responsibility for the
proper prescribing and dispensing of controlled substances is upon the
practitioner, but a corresponding liability rests with the pharmacist who fills
the prescription.
(b) An order
purporting to be a prescription issued to an addict or habitual user of
controlled substances, not in the course of professional treatment but for the
purpose of providing the user with controlled substances sufficient to keep him
comfortable by maintaining his customary use, is not a prescription within the
meaning and interest of Ark. Code Ann. §
20-64-206,
and the person knowingly filling such an order, as well as the person knowingly
issuing it, shall be subject to the penalties provided by Ark. Code Ann. §
20-64-220.
(c) All prescriptions for controlled
substances shall be dated as of, and signed on, the day when issued and shall
bear 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 individual prescribing practitioner. A practitioner
shall sign a prescription in the same manner as he/she would sign a check or
legal document. When an oral order is not permitted, prescriptions shall be
written with ink or indelible pencil or typewriter and shall be manually signed
by the practitioner. The prescription may be prepared by the secretary or agent
for the signature of a practitioner, but the prescribing practitioner is
responsible in case the prescription does not conform in all essential respects
to the law and regulations. A corresponding liability rests upon the pharmacist
who dispenses a prescription not prepared in the form prescribed in these
regulations.
An intern, resident or foreign-trained physician, or physician
on the staff of a veterans administration facility, exempted from registration
under the Federal Act (
21CFR §
1301.24(c) ) shall include
on all prescriptions issued by him, the registration number of the hospital or
other institution and the special internal code number assigned to him by the
hospital or other institution as provided, in lieu of the registration number
of the practitioner as required by this section. Each written prescription
shall have the name of the practitioner stamped, typed or printed on it as well
as the signature in ink of the practitioner. In lieu of the registration number
of the practitioner required by this section, all prescriptions issued shall
include the branch of service or agency and service identification
number.
C.
Refilling of Prescriptions
a. No prescription for a controlled substance
listed in Schedule III or IV shall be filled or refilled more than six-months
after the date on which the prescription was issued and no such prescription
authorized to be refilled more than five times. Each refilling of a
prescription shall be entered on the back of the prescription or on another
appropriate document. If entered on another document, such as medication
record, the document must uniformly maintained and readily retrievable. The
following information shall be retrievable by the prescription number
consisting of the name and dosage form of the controlled substance, the date
filled or refilled, the quantity dispensed, initials of the dispensing
pharmacist for each refill, and the total number of refills for that
prescription. If the pharmacist merely initials and dates the back of the
prescription it shall be deemed that the full face amount of the prescription
has been dispensed. The prescribing practitioner may authorize additional
refills of Schedule III or IV controlled substance on the original prescription
through an oral refill authorization transmitted to the pharmacist provided the
following conditions are met:
(1) The total
quantity authorized, including the amount of the original prescription, does
not exceed five refills nor extend beyond six months from the date of issue of
the original prescription.
(2) The
pharmacist obtaining the oral authorization records on the reverse of the
original prescription the date, quantity of refill, number of additional
refills authorized, and initials the prescription showing who received the
authorization from the prescribing practitioner who issued the original
prescription.
(3) The quantity of
each additional refill authorized is equal to or less than the quantity
authorized for the initial filling of the original prescription.
(4) The prescribing practitioner shall
execute a new and separate prescription for any additional quantities beyond
the five refill, six-month limitation.
(b) As an alternative to the procedures
provided by subsection (a), an electronic data processing system may be used
for the storage and retrieval of refill information for prescription orders for
controlled substances in Schedule III and IV, subject to the following
conditions:
(1) Any such proposed electronic
data processing system shall provide on-line retrieval (electronic record or
hard-copy printout) of original prescription order information. This shall
include, but is not limited to, data such as the original prescription number,
date of issuance of the original prescription order by the practitioner, full
name and address of the patient, name, address and D.E.A. registration number
of the practitioner, and the name, strength, dosage form, quantity of the
controlled substance prescribed (and quantity dispensed if different from the
quantity prescribed), and the total number of refills authorized by the
prescribing practitioner.
(2) Any
such electronic data processing system must also provide on-line retrieval
(electronic record or hard-copy printout) of the current refill history for
Schedule III or IV controlled substance prescription orders (those authorized
for refill during the past six-months). This refill history shall include, but
is not limited to, the name of the controlled substance, the date of refill,
the quantity dispensed, the identification code, or name or initials of the
dispensing pharmacist for each refill and the total number of refills dispensed
to date for the prescription order.
(3) Documentation of the fact that the refill
information entered in to the computer each time a pharmacist refills an
original prescription order for a Schedule III or IV controlled substance is
correct shall be provided by the individual pharmacist who makes use of the
system. If such a system provides a hard-copy printout of controlled substance
prescription order refill data, that printout shall be verified, dated, and
signed by the individual pharmacist who refilled such a prescription order. The
individual pharmacist shall verify that the data indicated is correct and then
sign this document in the same manner he would sign a check or legal document
(e.g. J.H. Smith, or John H. Smith). This document shall be maintained in a
separate file at that pharmacy for a period of two years from the dispensing
date. This printout of the day's controlled substance prescription order refill
data must be provided to each pharmacy using such an electronic data processing
system within 72 hours of the date on which the refill was dispensed. It must
be verified and signed by each pharmacist who is involved with such dispensing.
All required information shall be entered on the records of all prescription
orders filled at the pharmacy including non-refillable prescriptions and shall
be maintained for a period of no less than two years. In lieu of such a
printout, the pharmacy shall maintain a bound log book or separate file in
which each individual pharmacist involved in such dispensing shall sign a
statement (in the manner previously described) each day, attesting to the fact
that the refill information entered into the computer that day has been
reviewed by him and is correct as shown. Such a book or file shall be
maintained at the pharmacy employing such a system for a period of two years
after the date of dispensing the appropriately authorized refill.
(4) Any such electronic data processing
system shall have the capability of producing a printout of any refill data
which the user pharmacy is responsible for maintaining under these regulations.
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). Such a printout shall include name of the prescribing
practitioner, name and address of the patient, quantity dispensed on each
refill, date of dispensing for each refill, name or identification code of the
dispensing pharmacist, and the number of the original prescription order. In
any electronic data processing system employed by a user pharmacy the central
record keeping location shall be capable of sending the printout to the
pharmacy within 48 hours, and if the Agent or Investigator requests a copy of
such printout from the user pharmacy, it shall, if requested to do so by the
Agent or Investigator, verify the printout transmittal capability of its system
by documentation (e.g., postmark).
(5) In the event that a pharmacy which
employs such an electronic data processing system experiences down-time, the
pharmacy shall have an approved auxiliary procedure which will be used for
documentation of refills of Schedule III and IV controlled substance
prescription orders. This auxiliary procedure shall insure that refills are
authorized by the original prescription order, that the maximum number of
refills has not been exceeded, and that all of the appropriate data is retained
for on-line data entry as soon as the computer system is available for use
again
(6) When filing refill
information for original prescription orders for Schedule III, IV or V
controlled substances, a pharmacy may use only one of the two systems described
in paragraphs (a) or (b) of this section.
D.
Partial Filling of
Prescriptions
(a) The
partial filling of a prescription for a controlled substance listed in Schedule
III, IV, or V is permissible provided that:
(1) Each partial filling is recorded in the
same manner as the refilling,
(2)
The total quantity dispensed in all partial fillings does not exceed the total
quantity prescribed, and
(3) No
dispensing occurs after six-months after the date on which the prescription was
issued.
(b) The partial
filling of a prescription for controlled substance listed in Schedule II is
permissible, if the pharmacist is unable to supply the full quantity called for
in a written or emergency oral prescription and he makes a notation of the
quantity supplied on the face of the written prescription (or written record of
the emergency oral prescription), first partial filing; however, if the
remaining portion is not or cannot be filled within the 72 hour period, the
pharmacist shall so notify the prescribing individual practitioner. No further
quantity may be supplied beyond 72 hours without a new prescription.
(c) A prescription for a Schedule II
controlled substance written for a patient in a long-term care facility (LTCF)
or for a patient with a medical diagnosis documenting a terminal illness may be
filled in partial quantities to include individual dosage units. If there is
any question whether a patient may be classified as having a terminal illness,
the pharmacist may 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 shall record on the prescription whether
the patient is "terminally ill" or an "LTCFpatient."
For each partial filling, the dispensing pharmacist shall record on
the back of the prescription ( or on another appropriate record, uniformly
maintained, and readily retrievable) the date of the partial filling, quantity
dispensed, remaining quantity authorized to be dispensed, and the
identification of the dispensing pharmacist. The total quantity of Schedule II
controlled substances dispensed in all partial fillings shall not exceed the
total quantity prescribed. Schedule II prescriptions for patients in a LTCF or
patients with a medical diagnosis documenting a terminal illness shall be valid
of a period not to exceed 60 days from the issue date unless sooner terminated
by discontinuance of medication.
(d) Information pertaining to current
Schedule II prescriptions for patients in a LTCF or for patients with a medical
diagnosis documenting a terminal illness may be maintained in a computerized
system if the system has the capability to permit:
(1) Output (display or print) of the original
prescription number, date of issue, identification of prescribing individual
practitioner, identification of patient, address of the LTCF or address of the
hospital or residence of the patient, identification of medication authorized
(to include dosage, form, strength and quantity), listing of the partial
fillings that have been dispensed under each prescription and the information
required in Section 8-B(c).
(2)
Immediate (real time) updating of the prescription record each time a partial
filling of the prescription is conducted.
(3) Retrieval of partial filled Schedule II
prescription information is the same as required by Section 8-B(c) for Schedule
III, IV and V prescription refill information.
(e) The authority to dispense Schedule II
prescriptions for partial quantities does not apply to other classes of
patients; such as a patient with severe intractable pain who is not diagnosed
as terminal.
E.
Telephone or Oral Prescriptions
(a) In the case of an emergency situation, as
defined by these Regulations, a pharmacist may dispense a controlled substance
listed in Schedule II upon receiving oral authorization of a prescribing
individual practitioner provided that the quantity prescribed and dispensed is
limited to the amount adequate to treat that patient during the emergency
period never more than 72 hours; (dispensing beyond the emergency period must
be pursuant to a written prescription signed by the prescribing individual
practitioner.) For the purposes of authorizing an oral prescription of a
controlled substance listed in Schedule II of the Arkansas Controlled Substance
List, the term "emergency situation" means those situations in which the
prescribing practitioner determines that:
(1)
Immediate administration of the controlled substance is necessary for proper
treatment of the intended ultimate user;
(2) Immediate administration of the
controlled substance is necessary for proper treatment of the intended ultimate
user;
(3) no appropriate
alternative treatment is available (which includes the administration of a drug
which is not a Schedule II drug); and
(4) it is not reasonably possible for the
prescribing practitioner to provide a written prescription to be presented to
the pharmacist dispensing the drug prior to the dispensing.
The prescription shall be immediately reduced to writing by the
pharmacist. Within 72 hours after authorizing an emergency oral prescription,
the prescribing individual practitioner shall cause a written prescription for
the emergency quantity prescribed to be delivered to the dispensing pharmacist.
Upon receipt, the dispensing pharmacist shall attach this prescription to the
oral emergency prescription which had earlier been reduced to writing.
b. A pharmacist may
dispense a controlled substance listed in Schedule III, IV or V pursuant to an
oral prescription made by an individual practitioner or communicated to a
pharmacist by an employee or agent to the individual practitioner, and promptly
reduced to writing by the pharmacist. The prescription shall contain all the
information required in the case of a written prescription except for the
written signature of the individual practitioner.
F.
Prescription
Transfers:
(a) The
transfer of original prescription information for a controlled substance listed
in Schedules III, IV, of V for the purpose of refill dispensing is permissible
between pharmacies on a one-time basis only. However, pharmacies electronically
sharing a real-time, on-line database may transfer up to the maximum refills
permitted by law and the prescriber's authorization. Transfers are subject to
the following requirements:
(1) The transfer
is communicable directly between two licensed pharmacists and the transferring
pharmacist records the following information:
(i) Write the word "VOID" on the face of the
invalidated prescriptions.
(ii)
Record on the reverse side of the invalidated prescription the name, address
and D.E.A. registration number of the pharmacy to which it was transferred and
the name of the pharmacist receiving the prescribing information.
(iii) Record the date of the transfer and the
name of the pharmacist transferring the information.
(b) The pharmacist receiving the
transferred prescription information shall reduce to writing the following:
(1) Write the word "TRANSFER" on the face of
the transferred prescription.
(2)
Provide all information required to be on a prescription pursuant to Federal
Law (
21 CFR
1306.05 ) and include:
(i) Date of issuance of original
prescription.
(ii) Original number
of refills authorized on original prescription.
(iii) Date of original dispensing.
(iv) Number of valid refills remaining and
date and location of previous refill(s).
(v)
Pharmacy's name, address, D.E.A registration number and original
prescription number from which the prescription information was
transferred:
(vi) Name of
pharmacist who transferred the prescription.
(vii) Pharmacy's name, address, DEA
registration number and prescription number from which the prescription was
originally filled
(3)
The original and transferred prescription shall be maintained for a period of
two years from the date of last refill.
G.
Facsimile:
(a) A prescription for a Schedule
I I controlled substance may be
transmitted by the prescribing practitioner to a pharmacy via facsimile
equipment, provided the original written, signed prescription is presented to
the pharmacist for review prior to the actual dispensing of the controlled
substance, except as noted in paragraphs (b) or (c) of this section. The
original prescription shall be maintained in accordance with Section
6.
(b) A prescription prepared in
accordance with Section 8-B(c) written for a Schedule II narcotic substance to
be compounded for the direct administration to a patient by parenteral,
intravenous, subcutaneous or intraspinal infusion may be transmitted by the
prescribing practitioner to the home infusion pharmacy by facsimile. The
facsimile serves as the original written prescription for purposes of this
paragraph and it shall be maintained in accordance with Section 6.
(c) A prescription prepared in accordance
with Section 8-B(c) written for a Schedule II substance for a resident of a
long-term care facility may be transmitted by the prescribing individual
practitioner to the dispensing pharmacy by facsimile. The facsimile serves as
the original written prescription for purposes of this paragraph and it shall
be maintained in accordance with Section 6.
(d) A pharmacist may dispense directly a
controlled substance listed in Schedule III, IV or V which is a prescription
drug, only pursuant to either a written prescription signed by a prescribing
individual practitioner or a facsimile of a written signed prescription
transmitted by the prescribing practitioner to the pharmacy or pursuant to an
oral prescription made by a prescribing individual practitioner and promptly
reduced to writing by the pharmacist, containing all information required in
Section 8-B(c), except for the signature of the prescribing practitioner. (e)
An institutional practitioner may administer or dispense directly (but not
prescribe) a controlled substance listed in Schedule III, IV or V only pursuant
to a written prescription signed by a prescribing individual practitioner, or
pursuant to a facsimile of a written prescription or order for medication
transmitted directly by the prescribing practitioner to the pharmacist, or
pursuant to an oral prescription made by a prescribing individual practitioner
and promptly reduced to writing by the pharmacist (containing all information
required in Section 8-B(c) except for the signature of the individual
practitioner or pursuant to an order for medication made by an individual
practitioner which is dispensed for immediate administration to the ultimate
user.
SECTION
9:
SCHEDULE II
PRESCRIPTION:
A.
Prescriptions written for Schedule II controlled substances may be dispensed up
to six (6) months from the date written if the dispenser is certain of the
validity of the prescription, except for patients classified as "terminally
ill" or a "long term care patient."
SECTION 10:
VIOLATIONS:
A. Any violation of these regulations of any
practitioner as defined in Section I, may be reported by the Division of
Pharmacy Services and Drug Control to the appropriate Licensing Board of the
violator for possible disciplinary action by the Licensing Board.
SECTION 11:
SUSPENSION. REVOCATION:
A. The registration issued by the Department
of Health to conduct procedures with controlled substances may be suspended or
revoked for the following reasons:
(a) The
registrant has violated any provisions of these regulations.
(b) The registrant has furnished false or
fraudulent material information in application for registration.
(c) The registrant has been convicted of a
felony under any State or Federal law relating to controlled
substances.
(d) The registrant has
had his/her Federal Registration to handle controlled substance suspended or
revoked.
(e) The registrant failed
to renew his/her registration within 60 days after registration
expired.
B. Proceeding
pursuant to such suspension or revocation shall be governed by the rules of
procedure of the State Department of Health
SECTION 12:
LABELING:
A.
Controlled drugs dispensed by a practitioner to a patient shall contain a label
bearing the date of dispensing; the name, address and telephone number of the
dispenser; the serial number of the prescription; the name of the patient; the
name of the prescribing practitioner, the name, strength, and quantity of the
medication dispensed, and directions for use including any required cautionary
statements.
B. This section shall
not apply to the dispensing of medication to inpatients in hospitals, or
manufacturers' samples in original containers issued by the prescribing
physician.
C. In an appropriate
manner, the prescribing practitioners may indicate that the name, strength and
quantity of the drug dispensed shall be deleted from the label.