Chapter 480-22 REQUIREMENTS OF A PRESCRIPTION UNDER ORDER
Except as noted herein, any term contained in this chapter
shall have the same meaning as set forth in O.C.G.A. §§ 16-13-21,
26-3-2,
26-4-5, and Title 43, Chapter
34.
| (1) |
For a
controlled substance prescription drug order to be legal, it must be issued for
a legitimate medical purpose by an authorized individual practitioner acting in
the usual course of his or her professional practice. The responsibility for
the proper prescribing of controlled substances is upon the prescribing
practitioner, but the pharmacist is responsible for the proper filling of the
prescription drug order. Any person knowingly filling a purported prescription
drug order, as well as the person issuing it, shall be subject to disciplinary
action. |
| (2) |
A controlled substance
prescription drug order issued by an individual practitioner, in his or her
name or written "For Office Use" to obtain a controlled substance for the
purpose of general dispensing or administration to patients in his/her office
shall not be filled by a pharmacist. |
| (1) |
All controlled
substance prescription drug orders issued by the authorized practitioner shall
bear the prescribing practitioner's name, address, telephone number and the
Drug Enforcement Administration (DEA) permit number assigned to the
practitioner for that corresponding address, and each shall be signed and dated
on the same day when issued. At the time of dispensing, at a minimum, each
shall bear the name and address of the patient, the drug name, strength, dosage
form, quantity prescribed, directions for use, and indications for any refills
or zero for none.
| (a) |
A practitioner shall
sign a prescription in the same manner as he or she would sign a check or legal
document, except as the rules allow regarding the issuance of electronic or
facsimile prescriptions. Such controlled substance prescription drug orders
shall be written with ink or indelible pencil, pen, typewriter, or printer and
shall either be done manually or electronically via computer, as defined by the
Board, and signed by the practitioner. Such prescription drug orders may be
prepared for the practitioner's signature by the practitioner's authorized
agent, but the practitioner is responsible for ensuring that the prescription
conforms to all essential respects to the laws and regulations. |
| (b) |
A hard copy prescription drug order for
any Schedule II controlled substance must be on security paper.
| 1. |
If a hard copy of an electronic data
prescription drug order for any Schedule II controlled substance is given
directly to the patient, the manually signed order must be on security paper.
|
|
|
| (2) |
If a
practitioner gives a hard copy of an electronic visual image prescription drug
order directly to the patient or his/her agent, the hard copy must be printed
on security paper with the wording that indicates the signature was
electronically generated. |
| (3) |
Practitioners may electronically transmit prescription drug orders directly to
the pharmacy of the patient's choice where the prescription 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 and any other applicable state or federal law or
regulation for dispensing of a controlled substance prescription drug order
transmitted via electronic means. |
| (4) |
Practitioners not registered with the
DEA, but affiliated with hospitals or other institutions, shall include the
registration number of the hospital or other institutions as well as the
special internal code assigned to the authorized practitioner by the hospital
or other institution, as provided for in federal regulations
21 CFR
1301.22 (c), in lieu of a DEA registration
when prescribing or issuing a controlled substance drug order.
| (a) |
Each such hand written prescription drug
order shall meet the requirements of Rule
480-22-.04(a) and
shall have the name of the practitioner stamped, typed or hand printed on it,
as well as the signature of the practitioner, along with the telephone number
where the practitioner can be contacted for verification. |
| (b) |
Such prescription drug orders can only be
issued by such practitioner for patients treated as a part of his/her duties at
such hospital or other institution. |
|
| (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. |
The refilling of a prescription for a schedule II (C-II)
controlled substance is prohibited.
| (1) |
The partial filling of a schedule II (C-II) prescription drug order is
permissible, if the pharmacist is unable to supply the full quantity prescribed
in a written or emergency oral prescription drug order, and the pharmacist
makes a notation on the face of the written prescription drug order of the
quantity supplied (dispensed).
| (a) |
Except as
provided for in paragraph (b), the remaining portion of the prescription drug
order may be filled within 72 hours of the first partial filling. |
| (b) |
After this 72 hour period, the remaining
quantity shall not be dispensed, thereby causing the remaining quantity to be
void. No additional quantity may be dispensed without receipt of a new
prescription drug order. |
|
| (2) |
A prescription drug order for a schedule
II (C-II) controlled substance written for a patient in a Long Term Care
Facility (LTCF), a hospice patient, or for a patient with a medical diagnosis
documenting a terminal illness may be filled in partial quantities.
| (a) |
If there is any question whether a
patient may be classified as having a terminal illness (TI), the pharmacist
must contact the prescribing practitioner prior to partially filling the
prescription drug order. The pharmacist must record on the prescription drug
order whether the patient is "terminally ill", a "hospice patient", or a "LTCF
patient". |
| (b) |
A prescription drug
order may not be partially filled unless it contains the notation "terminally
ill","hospice patient", or "LTCF patient", or it shall be deemed an unlawful
prescription drug order. |
| (c) |
For
each partial filling, the dispensing pharmacist shall record on the back of the
prescription drug order (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. |
| (d) |
The total quantity of a schedule II
(C-II) controlled substance dispensed in all partial fillings may not exceed
the total quantity prescribed. Such C-II prescription drug orders may be
partially filled for a period not to exceed 60 days from the dispensing date or
sooner if the medication is discontinued. |
|
| (3) |
Information pertaining to current
schedule II (C-II) prescription drug orders for patients in a LTCF, a hospice,
or for terminally ill patients may also be maintained in a computerized system
if this system has the capability to permit the following:
| (a) |
Output (display or printout) of the
original prescription drug order serial number, date of dispensing,
identification by name of the prescribing practitioner, identification by name
of the patient, address of the LTCF, hospice, the hospital, or residence of the
patient, identification of the medication dispensed to include, dosage, form,
strength, and quantity, listing of the partial fillings that have been
dispensed under each prescription drug order, and the information required in
this rule. |
| (b) |
Immediate updating
of the prescription drug record each time a partial filling is
conducted. |
| (c) |
Retrieval of
partially filled C-II prescription drug order information is the same as
required by Rule
480-22-.09 for Schedule III and IV
prescription refill information. |
|
| (1) |
A pharmacist or pharmacy intern/extern may dispense Schedule III, IV and V
Controlled Substances (C-III, IV, V), as defined by O.C.G.A. §§ 16-13-27,
16-13-28, and
16-13-29, pursuant to:
| (a) |
A written prescription drug order bearing
the signature of a practitioner as permitted by this rule; |
| (b) |
A facsimile of a written, signed
prescription drug order transmitted directly to the pharmacy with the
requirements contained in O.C.G.A. § 26-4-80, by the practitioner of
the practitioner's agent; |
| (c) |
An
oral prescription drug order made by an individual practitioner and promptly
reduced to writing by the pharmacist or pharmacy intern/extern to a hard copy;
and |
| (d) |
A written prescription drug
order transmitted via electronic means other than a facsimile, if it meets the
requirements and limitations for electronically transmitted prescription drug
orders set forth in O.C.G.A. § 26-4-80, and
Rules as set forth by the Board. Such electronically received prescription drug
orders must be promptly reduced to hard copy, except as follows: |
|
| (2) |
Permanent records of
electronic prescriptions do not have to be reduced to hard copy provided the
following requirements are met:
| A). |
Electronic
prescription data must be maintained in the original format received for a
minimum of two years; and |
| B). |
Reliable backup copies of the information are readily retrievable and stored in
a secure and fireproof (minimum 1hr UL approved) container, stored in a secured
offsite location or backed up to a documented offsite secure storage device
within 48 hours following each work day. |
|
| (3) |
A pharmacy must either file the original
prescription drug order or generate a hard copy prescription drug order to be
filled, both of which are required to contain all of the information required
by this chapt |
| (4) |
Upon dispensing a
C-III, IV, or V controlled substance, the dispensing pharmacist shall ensure
that his or her initials, the dispensing date, and the prescription serial
number appear on the face of or the rear of each such prescription. Nothing
shall prohibit the use of a computer-generated label to fulfill the
requirements of this paragraph and/or the requirements of this Rule.
| (a) |
All such information shall be placed on
the prescription drug order in such a manner that it does not cover or veil any
information required by this chapter or any other rule or law to appear on such
prescription. |
|
| (5) |
Prescription drug orders for schedule C-III, IV, or V controlled substances
shall be maintained either in a separate prescription drug order file for such
C-III, IV, or V drug orders only or in such a form that they are readily
retrievable from the other prescription drug orders of the pharmacy.
| (a) |
A prescription drug order will be deemed
readily retrievable if, at the time it is initially filled, the face of the
prescription drug order is stamped in red ink in the lower right corner with
the letter "C" no less than 1 inch high and filed in the usual consecutively
numbered prescription drug order file for dangerous drugs; or |
| (b) |
A pharmacy which utilizes a computerized
record keeping system for prescription drug orders which permits identification
of prescription drug orders by serial number and retrieval of documents by
prescriber's name, patient's name, drug dispensed, and date filled, then there
is no requirement to mark hard copy prescriptions with a red "C". |
|
| (1) |
No prescription drug order for a C-III, IV, or V controlled substance shall be
filled or refilled more than six (6) months after the date on which such
prescription drug order was issued by the prescribing practitioner and no such
prescription drug order may be authorized to be refilled for the quantity
prescribed more than five (5) times.
| (a) |
Nothing shall prohibit the refilling of such a prescription drug order in
amounts less than the quantity prescribed as long as the total number of dosage
units authorized for dispensing both the original quantity plus the refill
quantities does not exceed six (6) months. |
|
| (2) |
The date of each refilling of a
prescription drug order shall be entered on the back of the prescription drug
order or in a computerized record system, with which all documents must be
uniformly maintained and readily retrievable. |
| (3) |
If the pharmacist initials and dates the
back of the prescription drug order, it shall be deemed that the full face
amount of the prescription has been dispensed. If an amount other than the full
face amount is dispensed, the quantity shall be noted next to the initials of
the pharmacist. |
| (4) |
The prescribing
practitioner may authorize additional refills of the original C-III, IV or V
controlled substance prescription drug order through an oral refill
authorization transmitted directly to the pharmacist or pharmacy intern/extern
working under the direct supervision of a licensed pharmacist provided the
following conditions are met:
| (a) |
The total
quantity of refills authorized, including the quantity of refills indicated on
the original prescription drug order does not exceed five (5) refills and does
not extend beyond six (6) months from the date of issue of the original
prescription drug order. |
| (b) |
The
pharmacist or pharmacy intern/extern that receives the oral authorization shall
record on the reverse side of the original prescription drug order the date,
quantity of refill, number of additional refills authorized (for the quantity
prescribed), and the initials showing who received the authorization from the
prescribing practitioner that issued the original prescription drug
order. |
| (c) |
The quantity of each
additional refill authorized is equal to or less than the quantity authorized
for the initial filling of the original prescription drug order. |
| (d) |
The prescribing practitioner must execute
or authorize a completely new and separate prescription drug order for any
additional quantities beyond the five (5) refills and/or six (6) month
limitation. |
| (e) |
If the
authorization comes from a practitioner that is not the original prescriber,
the authorization shall be treated as a new prescription drug order authorized
by the new prescribing practitioner. |
|
| (5) |
An automated data processing (ADP) or
computerized system may be used for the storage and retrieval of refill
information for prescription drug orders for C-III, IV or V substances, subject
to the requirements as set forth in Rule
480-27-.04. |
The partial filling of a C-III, IV, or V prescription drug
order is permissible, subject to the following requirements:
| (a) |
Each partial filling is recorded in the
same manner as a refill; |
| (b) |
The
total quantity dispensed in all partial fillings does not exceed the total
quantity prescribed; and |
| (c) |
No
dispensing occurs six (6) months after the date on which the prescription drug
order was issued. |
| (1) |
A pharmacist filling a prescription drug
order for a C-II, III, IV or V substance shall affix to the package a label
showing the following:
| (a) |
The name, address
and telephone number of the pharmacy; |
| (b) |
The prescription drug order serial
number; |
| (c) |
The date the
prescription was initially filled or refilled; |
| (d) |
The name of the patient; |
| (e) |
The name of the prescribing
practitioner; |
| (f) |
The directions
for use; |
| (g) |
The expiration date of
the dispensed drug; and |
| (h) |
Cautionary statements, if any, as required. |
|
| (2) |
All prescription drug orders for C-II,
III, IV or V controlled substances shall be kept in accordance with this
chapter. |
| (1) |
The transfer of original prescription
drug order information for a C-III, IV, or V substance for the purpose of
refill dispensing is permissible between pharmacies one time only.
| (a) |
However, pharmacies electronically
sharing a real-time, online computerized database may transfer the prescription
drug order information as many times as there are authorized refills, up to the
maximum of five (5) times, if it is within six (6) months from the date of
issuance. |
|
| (2) |
A transfer
is considered a communication between two licensed pharmacists and/or pharmacy
interns/externs. Transfers are subject to the following requirements:
| (a) |
The transferring pharmacist or pharmacy
intern/extern shall record the following information in either real time or at
the first opportunity after the transfer:
| 1. |
The word "VOID" must be written on the face of the original, hard copy,
invalidated prescription drug order; |
| 2. |
The following must be written on the back
of the original, invalidated prescription drug order: the name, address,
telephone number, and DEA number of the pharmacy to which it is transferred,
and the name of the pharmacist receiving the prescription information;
and |
| 3. |
The date of the transfer and
the name of the pharmacist transferring the information must be recorded on the
back of the prescription drug order. |
|
| (b) |
The pharmacist or pharmacy intern/extern
receiving the transferred prescription drug order information shall reduce it
to writing and record the following information:
| 1. |
The word "TRANSFER" shall be written on
the face of the transferred prescription drug order hard-copy; |
| 2. |
All information required to be recorded on
a prescript ion drug order pursuant to this chapter, which shall include:
| (i) |
Date the prescription drug order was
originally issued by the prescribing practitioner; |
| (ii) |
The number of refills authorized on the
original prescription drug order. |
|
|
| (c) |
Date the prescription drug order was
originally dispensed by the transferring pharmacy; |
| (d) |
Number of valid refills remaining, and
date(s) and pharmacy location(s) where any previous refills were
dispensed; |
| (e) |
The pharmacy's name,
address, telephone number, DEA number, and prescription serial number from
which the prescription information was transferred; and |
| (f) |
The name of the pharmacist who
transferred the prescription drug order. |
|
| (3) |
The original and transferred
prescription(s) must be maintained for a period of two yearsfrom the date of
the last refill. |
| (4) |
Pharmacies
electronically transferring a prescription drug order for the purpose of
refills must maintain the same information and record keeping requirements as
do pharmacies with manual, non-electronic record keeping systems. |
| (1) |
Under O.C.G.A. § 43-34-103(e.1), a physician
assistant (PA) licensed by the Georgia Composite Medical Board is permitted to
issue a prescription drug order or orders for any dangerous drugs, as defined
in O.C.G.A. § 16-13-71, or for any Schedule III,
IV, or V controlled substance without the co-signature of a supervising
physician under the following conditions:
| (a) |
The supervising physician has delegated the authority to prescribe dangerous
drugs and/or controlled substances in the PA's job description on file with the
Georgia Composite Medical Board. |
| (b) |
If the prescription is for controlled
substances, the PA has a DEA number. |
| (c) |
If the prescription is a hard-copy of an
electronic visual image prescription drug order given directly to the patient
or his/her agent, the hard copy must be printed on security paper with the
wording that indicates the signature was electronically generated. |
| (d) |
The prescription drug order must include
the following:
| (i) |
The name, address, and
telephone number of the supervising physician and the PA; |
| (ii) |
The patient's name and
address; |
| (iii) |
The drug name,
strength and quantity prescribed; |
| (iv) |
The directions to the patient with
regard to taking the drug; |
| (v) |
The
number of authorized refills, if any; |
| (vii) |
If applicable, the DEA permit number of
the PA. |
|
| (d) |
If the
prescription is transmitted by facsimile or computer, the prescription shall
include:
| (i) |
The complete name and address of
the supervising physician and the PA; |
| (ii) |
In the case of a prescription drug order
for a controlled substance, the DEA registration number of the PA; |
| (iii) |
The telephone number of the PA for
verbal confirmation; |
| (iv) |
The name
and address of the patient; |
| (v) |
The
time and date of the transmission; |
| (vi) |
The full name of the person transmitting
the order; and |
| (vii) |
The drug name,
strength and quantity prescribed; |
| (viii) |
The directions to the patient with
regard to taking the drug; |
| (ix) |
The
number of authorized refills, if any; |
|
| (e) |
No prescription drug order issued by a PA
can be used to authorize refills more than twelve (12) months past the date of
the original drug order. |
|
| (2) |
Under O.C.G.A. § 43-34-25, an advanced practice
registered nurse (APRN) who is recognized by the Georgia Board of Nursing as
having met the requirements to engage in advanced nursing practice, and whose
registered nurse license and advanced practice registered nurse license are in
good standing with the Georgia Board of Nursing, is permitted to issue a
prescription drug order or orders for any dangerous drugs, O.C.G.A. § 16-13-71 except for drugs intended
to cause an abortion to occur pharmacologically, or for any Schedule III, IV,
or V controlled substance without the co-signature of a delegating physician
under the following conditions:
| (a) |
The APRN
has been delegated the authority to issue prescription for the dangerous drugs
and controlled substances by a physician licensed by the Georgia Composite
Medical Board in a nurse protocol agreement and that agreement has been filed
with the Georgia Composite Medical Board. |
| (b) |
If the prescription is for controlled
substances, the APRN has a DEA number. |
| (c) |
If the prescription is a hard-copy of an
electronic visual image prescription drug order given directly to the patient
or his/her agent, the hard copy must be printed on security paper with the
wording that indicates the signature was electronically generated. |
| (d) |
The prescription drug order must include
the following:
| (i) |
The name, address, and
telephone number of the delegating physician and the APRN; |
| (ii) |
The patient's name and
address; |
| (iii) |
The drug name,
strength and quantity prescribed; |
| (iv) |
The directions to the patient with
regard to taking the drug; |
| (v) |
The
number of authorized refills, if any; |
| (vii) |
If applicable, the DEA permit number of
the APRN. |
|
| (d) |
If the
prescription is transmitted by facsimile or computer, the prescription shall
include:
| (i) |
The complete name and address of
the delegating physician and the APRN; |
| (ii) |
In the case of a prescription drug order
for a controlled substance, the DEA registration number of the APRN; |
| (iii) |
The telephone number of the APRN for
verbal confirmation; |
| (iv) |
The name
and address of the patient; |
| (v) |
The
time and date of the transmission; |
| (vi) |
The full name of the person transmitting
the order; and |
| (vii) |
The drug name,
strength and quantity prescribed; |
| (viii) |
The directions to the patient with
regard to taking the drug; |
| (ix) |
The
number of authorized refills, if any; |
|
| (e) |
No prescription drug order issued by an
APRN can be used to authorize refills more than twelve (12) months past the
date of the original drug order unless the prescription drug order is for oral
contraceptives, hormone replacement, or prenatal vitamins. Oral contraceptives,
hormone replacement and prenatal vitamins may be refilled up to twenty-four
(24) months from the date of the original drug order. |
|
| (3) |
Nothing in this Rule, Title 16, Chapter
13 or Title 43, Chapter 34, shall be construed to create a presumption of
liability, either civil or criminal, on the part of a pharmacist who in good
faith fills a prescription drug order presented by a patient that had been
issued by a PA or an APRN consistent with this Rule.
| (a) |
A pharmacist shall presume that a
prescription drug order issued by a PA or APRN was issued by a PA or APRN duly
licensed and qualified under Title 43, Chapter 34 to prescribe pharmaceutical
agents. |
| (b) |
A pharmacist shall
presume that the drug prescribed by the PA is a drug approved by the
supervising physician in the PA's job description and that the drug prescribed
by an APRN is a drug authorized by the delegating physician in the APRN's nurse
protocol agreement, unless the pharmacist has actual or constructive knowledge
to the contrary. |
|
| (4) |
Any
prescription drug order form containing less information than that described in
this Rule shall not be offered to or accepted by any pharmacist. |
| (1) |
Any drug scheduled under the Georgia
Controlled Substances Act (GCSA), but not scheduled under the Federal
Controlled Substances Act (FCSA), must be purchased, stored, inventoried,
recorded, distributed, or dispensed in the same manner as any other controlled
substance, except:
| (a) |
The manufacturer of
the product is not required to indicate the schedule of the drug on the label
of its commercial container; and |
| (b) |
The manufacturer of the product is not
required to print the symbol designating the schedule of the drug on the label
of its commercial container. |
|
| (2) |
A prescription drug order for any drug
scheduled under the GCSA, but not scheduled under the Federal CSA, must be
maintained in the same manner for the corresponding controlled substance
prescription drug order as previously set forth in this chapter
(480-22). |
| (1) |
For purposes of this rule, a practitioner
means:
| (a) |
A physician, dentist, podiatrist,
veterinarian, or other person licensed, registered, or otherwise authorized
under the laws of this state to distribute, dispense, with respect to, or to
administer a controlled substance or dangerous drug in the course of
professional practice in this state; |
| (b) |
An advanced practice registered nurse
(APRN) acting pursuant to the authority of Code Section 43-34-26.3. For
purposes of this chapter and Code Section 43-34-26.3, an advanced practice
registered nurse (APRN) who is registered with the Federal Drug Enforcement
Administration (DEA) and appropriate state authorities; or |
| (c) |
A physician's assistant acting pursuant
to the authority of subsection (e.1) of Code Section
43-34-103. For purposes of this
chapter and subsection (e.1) of Code Section
43-34-103, a physician's assistant
(PA) who is registered with the federal Drug Enforcement Administration (DEA)
and appropriate state authorities. |
|
| (2) |
Only a practitioner which has been issued
an individual permit number by the DEA and is licensed by its respective state
licensing board is authorized to or any other type of container. |
| (3) |
Any practitioner receiving, maintaining,
and dispensing professional drug samples shall maintain records of all drug
samples requested and received, along with a complete list of the specific
number and dosage of each professional drug sample and medication dispensed by
the practitioner and the person to whom the drug samples were dispensed; Such
records must be maintained for a minimum of two years by the practitioner at
each facility or office location where professional drug samples are received,
maintained, and dispensed. |
| (4) |
In
addition to the requirements of this rule, practitioners shall maintain all
professional drug samples as required by all applicable state and federal laws
and regulations. |
Ophthalmic topical products may be refilled without
authorization from a practitioner to prevent unintended interruptions in drug
therapy provided that:
| (1) |
The original
prescription order contains valid refills; |
| (2) |
Refills occur at 70 percent or greater of
the predicted days of use; and |
| (3) |
Refills are purchased through retail and/or mail order pharmacies. |
