Current through Rules and Regulations filed through March 20, 2024
(1) A pharmacist or pharmacy intern/extern
shall dispense a schedule II Controlled Substance (C-II), as defined by
O.C.G.A. §
16-13-26, only pursuant to a prescription drug order on security paper, except as
provided in subparagraphs (1)(a) and (1)(b) and paragraph (3) of this Rule.
(a) A C-II prescription drug order, meeting
the requirements of Rule
480-22-.03(1)(a), may be transmitted by the practitioner or the practitioner's agent, to a
pharmacy via facsimile machine or equipment. Prior to the practitioner's agent
transmitting such schedule II (C-II) prescription via facsimile machine, the
C-II prescription drug order, meeting the requirements of Rule
480-22-.03(1)(a), may be transmitted by the practitioner or the practitioner's agent, but not the
patient or patient's agent, to a pharmacy via facsimile machine or equipment.
The original written, signed prescription drug order must be presented to the
pharmacist prior to the actual dispensing of the schedule II (C-II) drug,
except as provided in paragraphs (4), (5) or (6) of this section.
(b) A pharmacist may dispense a C-II pursuant
to an electronic data prescription drug order where the prescription is
transmitted by the practitioner directly to the pharmacy and the prescription
otherwise meets the requirements of O.C.G.A. §§
16-13-41, 26-4-80, 26-4-80.1, 21 C.F.R. 1306, 21 C.F.R. 1311 or any other applicable state or federal law or
regulation for dispensing of a C-II prescription drug order transmitted via
electronic means.
(2)
Upon dispensing a schedule II (C-II) drug, the pharmacist shall physically sign
his or her name on either the face or rear of the schedule II (C-II)
prescription drug order in such a manner that the signature does not cover any
information required by this chapter. In addition, the pharmacist will ensure
that the dispensing date and the serial number for the prescription drug order
are indicated on either the face or the back of the C-II prescription drug
order.
(3) In the case of an
emergency situation, a pharmacist may dispense a schedule II (C-II) controlled
substance only upon receiving oral authorization of the prescribing
practitioner. For purposes of this paragraph, an emergency situation means a
situation in which the prescribing practitioner determines that immediate
administration of a schedule II (C-II) controlled drug is necessary, there is
no appropriate alternative treatment or drug in a schedule less than CII, and
it is not reasonably possible for the practitioner to provide a written
prescription drug order for the pharmacist dispensing the drug prior to
issuance. Such emergency prescription drug order is permissible provided that:
(a) The quantity prescribed and dispensed is
limited to the amount adequate to treat the patient during the emergency
period. Dispensing beyond the emergency period must be pursuant to an
additional written prescription drug order signed by the prescribing
practitioner;
(b) The prescription
drug order shall be immediately reduced to writing by the pharmacist or
pharmacy intern/extern working under the direct supervision of a licensed
pharmacist and shall contain all information required in Rule
480-22-.03, except for the signature
of the prescribing practitioner;
(c) If the prescribing practitioner is not
known to the pharmacist, the pharmacist must make reasonable effort to
determine that the oral authorization came from a licensed practitioner, such
effort may include a callback to the prescribing individual using his or her
telephone number and/or other good faith efforts to insure the practitioner's
identity; and
(d) Within 7 days
after authorizing an emergency oral prescription drug order, the prescribing
practitioner shall cause a written prescription drug order to be delivered to
the dispensing pharmacist for the emergency quantity prescribed. In addition to
conforming to the requirements of Rule
480-22-.03, the prescription shall
have written on its face "Authorization for Emergency Dispensing," and the date
of the oral order.
1. The written prescription
drug order shall be delivered to the pharmacist in person or by other means,
but if delivered by mail or common carrier it must be postmarked within the 7
day period. Upon receipt, the dispensing pharmacist shall attach this
prescription drug order to the emergency oral prescription drug order, which
had earlier been reduced to writing. The pharmacist shall notify the Georgia
Drugs and Narcotics Agency, if the prescribing practitioner fails to deliver a
written prescription drug order to the dispensing pharmacist.
(4) A prescription drug
order for a terminally ill patient, prepared in accordance with Rule 480-
22-.03 written for a Schedule II Controlled Substance as defined by O.C.G.A.
§
16-13-26, may be transmitted directly by the practitioner or the practitioner's agent to
the dispensing pharmacy by facsimile machine.
(a) Prior to the prescribing practitioner's
agent transmitting such Schedule II Controlled Substance prescription via
facsimile machine, the name of the agent and a telephone number for the
prescribing practitioner must be included in the face of prescription. The
information may be used for verification of the prescription.
(b) The facsimile serves as the original,
written prescription drug order for purposes of this paragraph, and it shall be
maintained in accordance with Rule 480-22-.04(7) and this chapter. After
transmission of the original prescription, the pharmacist should suggest that
the practitioner mark "VOID" across the face of the prescription, and that it
be maintained by the practitioner in the patient's medical record
chart.
(5) A
prescription drug order prepared in accordance with Rule 480-22-.04 written for
any C-II substance for a resident of Long Term Care Facility (LTCF) may be
transmitted directly by the prescribing practitioner or the practitioner's
agent, but not the patient or the patient's agent, to the dispensing pharmacy
by facsimile machine or equipment.
(a) The
practitioner, practitioner's agent, or pharmacist will note on the prescription
drug order that the patient is a LTCF patient by writing "LTCF" on the face of
the prescription.
(b) In addition
to the term LTCF being noted on the face of the prescription, whenever a
practitioner's agent transmits or a pharmacist receives such a prescription,
the name of the agent and the practitioner's telephone number or the name and
license number of the pharmacist must be included on the face of the
prescription. This information may be used for verification of the prescription
drug order.
(c) The facsimile
serves as the original, written prescription drug order for purposes of this
paragraph (c), and it shall be maintained in accordance with Rule 480-22-.04(a) and this chapter. After transmission of the original prescription, the
pharmacist should suggest that the practitioner mark "VOID" across the face of
the prescription, and that it be maintained by the practitioner in the
patient's medical record chart.
(6) A prescription drug order prepared in
accordance with Rule
480-22-.03 written for any Schedule
II Controlled Substance as defined by O.C.G.A. §
16-13-26, for a patient of a hospice program licensed by the State of Georgia Department
of Community Health may be directly transmitted by the practitioner or the
practitioner's agent, but not the patient or the patient's agent, to the
dispensing pharmacy by facsimile machine or equipment.
(a) The practitioner or practitioner's agent
will note on the prescription drug order that the patient is a hospice patient
by writing "HOSPICE" on the face of the prescription.
(b) In addition to the term "HOSPICE" being
noted on the face of the prescription, whenever a practitioner's agent
transmits such prescription, the name of the agent and the practitioner's
telephone number must be included on the face of the prescription. This
information may be used for verification of the prescription drug
order.
(c) The facsimile serves as
the original, written prescription drug order for purposes of this paragraph,
and it shall be maintained in accordance with Rule 480-22-.04(a) and this
chapter. After transmission of the original prescription drug order, the
pharmacist should suggest that the practitioner mark "VOID" across the face of
the prescription, and that it be maintained by the practitioner in the
patient's medical chart.
(7) Record keeping for Schedule II Controlled
Substances shall be as follows:
(a) Original
and all other hard copy schedule II (C-II) prescription drug orders shall be
maintained in a separate file from all other prescription drug
orders.
(b) Whenever a pharmacy
utilizes a computerized record keeping system in addition to hard copies to
record the dispensing of prescription drug orders for C-II drugs, such records
shall be immediately retrievable without delay in a printout form by the
prescribing practitioner's name, patient's name, drug name or date of
dispensing upon a verbal request from a representative of the Georgia Drugs and
Narcotics Agency (GDNA), and/or one of its agents.
(8) Whenever a pharmacist receives a
prescription for a C-II controlled substance, and either the quantity of the
drug to be dispensed or the strength of the drug to be dispensed has not been
included by the prescribing practitioner, or when the strength of the
prescribed drug is not immediately available, in order to dispense this drug,
the pharmacist must perform the following:
(a)
Contact and speak directly with the practitioner, not with an agent for the
practitioner, and inform the practitioner of the missing information on the
face of the prescription, or the problem with the prescription in question by:
1. Determining the quantity of the drug the
practitioner intended to be dispensed; or
2. Determining the strength of the drug the
practitioner intended to be dispensed; or
3. Informing the practitioner the drug in the
strength prescribed is not immediately available, but another strength of the
prescribed drug is available.
(b) Regarding the information provided by the
practitioner, the pharmacist must write the missing quantity, the missing
strength, or the changed quantity and strength of the prescribed drug on the
face of the prescription along with the initials of the pharmacist.
(c) On the back of the prescription, the
pharmacist must write the date and time the pharmacist spoke with the
practitioner, along with a brief explanation of the situation and how it was
resolved.
(d) Nothing in this rule
is intended to require a pharmacist in a hospice or LTCF setting to obtain a
new prescription drug order when changes are made to a patient's dosing
requirements. This action may be taken as long as the pharmacist verifies the
change(s) with the practitioner and makes a notation of the change(s) along
with the date of the change(s) on the original hardcopy prescription drug
order.
(9) A Schedule II
narcotic controlled substance prescription prepared in accordance with Rule
480-22-.03 and as defined by O.C.G.A.
§
16-13-26, to be compounded for the direct administration to a patient by parenteral,
intravenous, intramuscular, subcutaneous or intraspinal infusion may be
transmitted by the practitioner or the practitioner's agent to the pharmacy by
facsimile. The facsimile serves as the original written prescription for
purposes of this rule and it shall be maintained in accordance with this rule
and state and federal law.
O.C.G.A. §§
16-13-34, 16-13-39, 16-13-41, 26-4-5, 26-4-27, 26-4-28, 26-4-29, 26-4-60, 26-4-80.1, 26-4-82, and
26-4-111.
