Chapter 480-16 MISCELLANEOUS GUIDELINES FOR PHARMACISTS
| (1) |
Report of
unlicensed dispensing. No licensed pharmacist of this state shall knowingly
allow any unlicensed person to fill prescriptions (except as provided under the
direct and personal supervision of a Georgia licensed pharmacist) or practice
pharmacy while impaired in any place of business.
Any pharmacist having knowledge that a pharmacist or drug store
owner allows or encourages any unlicensed person to illegally fill
prescriptions or practice pharmacy while impaired shall report such action
within ten (10) days to the Director of the Georgia Drugs and Narcotics Agency
(GDNA) and upon his failure to report such acts to the director, which shall be
grounds for sanctions on such licensed person's license.
|
| (1) |
No person or
entity other than an establishment licensed under O.C.G.A. 26-4 shall engage in
the practice of accepting and receiving prescriptions and forwarding same to a
drug store or pharmacy to be filled and returned to the forwarding agency,
which, in turn, delivers the filled prescriptions to the patient or agent of
the patient and collects the charge there |
| (2) |
It shall be illegal for any person or
entity to attempt to or to eliminate the patient/pharmacist contact, and for
any such person or entity to prevent a pharmacist from properly supervising and
controlling the dispensing of prescription drugs. Such pharmacist-patient
contact is essential to the proper practice of pharmacy care.
| (a) |
It shall be deemed detrimental to the
health, safety, and welfare of the people of the State of Georgia for any firm,
partnership, corporation, or business, other than a Pharmacy licensed by the
Board under O.C.G.A. 26-4, to accept or receive any prescription drug
order; |
| (b) |
Such practice is
prohibited, and any such practice taking place shall be discontinued
immediately upon verbal or written notice of the Board or the Georgia Drugs and
Narcotics Agency. |
|
| (3) |
In
order for a patient to authorize a licensed medical practitioner to hold,
administer, or deliver the patient's prescription drug at his or her office
location, and the drug was previously dispensed and delivered to the
practitioner's office by a pharmacy, the patient must first provide the
pharmacy with written authority to conduct such a delivery. |
| (1) |
It shall be unlawful, and a violation of
these rules, for any licensed pharmacist or pharmacy licensed under O.C.G.A.
26-4 to accept for refund purposes, or otherwise, any unused portion of a drug
which has been previously dispensed via a prescription drug order and delivered
to the patient or patient's caregiver, except where permitted under state
and/or federal law or regulation.
| (a) |
Such
receipt is deemed detrimental to the public health due to the likelihood that
such drugs, once out of the control of the pharmacy, could have been tampered
with, been adulterated, or become contaminated with communicable diseases
and/or contagious diseases under the holder thereof; |
| (b) |
In addition, such receipt would tend to
create a health problem if placed in stock and could be reused by any licensed
pharmacist or pharmacy. |
|
| (2) |
Nothing in this Rule shall be meant to be
in conflict with Board Rule 480-10-. 17, which allow a pharmacy to receive
unused, manufacturer's unit-dose packaged drugs from a Medicaid patient
residing in a long term care facility. |
| (3) |
Nothing in this Rule shall prohibit an
authorized collector from collecting controlled substances for the purposes of
destruction as authorized in the Secure and Responsible Drug Disposal Act of
2010 ("Disposal Act"), any regulations promulgated thereunder, and Ga. Comp. R.
& Regs. c. 480-50. |
| (1) |
Any drugs, poisons, narcotics, family
remedies, grocers' drugs, flavoring extracts, essences, toilet articles, stock
powders, veterinary supplies, proprietary preparations and any and all other
and similar items intended for internal or external use of humans or animals
which have been subjected to heat and/or water resulting from fire and/or water
damage to a building or storage area in which said items were stored or
retained is prohibited from being introduced into the stream of retail commerce
without first causing an inspection of said items to determine their
suitability for use as intended.
| (a) |
Certain
of the above classes of items when subjected to heat and/or water as a result
of fire and/or water damage to a building or storage area in which said items
are stored or retained are chemically altered or otherwise contaminated and
therefore rendered unsafe and unfit for use of man or animal as
intended. |
| (b) |
If certain of the
above classes of items or units thereof are entered into the stream of retail
commerce and sold for the internal or external use of humans or animals
following their having been subjected to heat and/or water as a result of fire
and/or water damage as aforesaid without first being inspected to determine
their suitability for use as intended, they shall be considered adulterated or
misbranded and will be subject to confiscation. Those persons placing them into
the stream of retail commerce shall be subject to penalties and/or reprimands
by the Board. |
|
| (2) |
Within
three (3) days following any damage by fire and/or water to a building or
storage area in which any of the above said items are stored or retained,
written notice shall be forwarded to the Director of the Georgia Drugs and
Narcotics Agency (GDNA) at his office, by the person or his agent with custody
or control of the said items informing the Director of the GDNA of the
circumstances and requesting an immediate inspection of said items. |
| (3) |
Within three (3) days from his receipt of
such written notice the Director of the GDNA shall cause an inspection to be
made of said items for the purpose of determining their suitability for use as
intended and within a reasonable time after the completion of said inspection,
the Director of the GDNA shall forward to the person from whom he received such
notice a report of the result of said inspection and an authorization to
release said items for retail sale if the facts so indicate. |
| (4) |
The office of the Director of the GDNA is
charged with the enforcement of the provisions of this regulation. |
| (1) |
No person or entity licensed under
O.C.G.A. 26-4 shall engage in fraudulent or deceptive advertising or
promotional procedures with respect to drugs, devices, cosmetics, poisons, or
other substances subject to the provisions of O.C.G.A. Sections 16-13 or
26-3. |
| (1) |
The theft,
loss, or unaccounted for controlled substances must, within three (3) days of
its discovery, must be reported to the Drug Enforcement Administration and the
GDNA. |
| (2) |
A written report must be
made regarding any theft, loss or unaccounted for controlled substances by
completing a DEA Form 106.
| (a) |
Within ten
(10) days of receiving such DEA Form 106, the original and one copy of the
report must be sent to the Drug Enforcement Administration; and |
| (b) |
One copy must be sent to the
GDNA. |
|
| (3) |
The report
shall include the following information:
| (a) |
Full name and address of the pharmacy;(e) List of cost codes, or identification
symbols on package stolen; and |
| (b) |
Pharmacy DEA registration number; |
| (c) |
Date of theft, loss, or discovery of
missing controlled substance; |
| (d) |
Type of incident, i.e. theft, loss, etc.; |
| (e) |
List of cost codes, or identification
symbols on package stolen; and |
| (f) |
List of the controlled substances missing. |
|
Confidential prescription drug order information means
information maintained by the pharmacist in the patient's records or which is
communicated to the patient as part of patient counseling which is privileged
and may be released only to the patient, to the patient's designee, or to those
practitioners and other pharmacists where, in the pharmacist's professional
judgement, such release is necessary to protect the patient's health and well
being; and to such other persons or government agencies authorized by law to
receive such confidential information.
| (a) |
An electronically transmitted
prescription drug order from a prescriber to a pharmacist shall be considered a
highly confidential transaction and the said transmission shall not be
compromised by interventions, control, change, altering, or manipulation by any
other person or party in any manner whatsoever; |
| (b) |
Any pharmacist that transmits, receives,
or maintains any prescription drug order or prescription drug order refill
authorization either orally, in writing, or electronically shall ensure the
security, integrity, and confidentiality of the prescription and any
information contained therein; |
| (c) |
Information contained in the patient medication record or profile shall be
considered confidential as defined by this Rule. |
| (d) |
Confidential information may be released
to the following:
| 2. |
The patient's authorized
representative; |
| 3. |
The prescriber,
or other licensed health care practitioners then caring for the
patient; |
| 4. |
Another licensed
pharmacist for purposes of transferring a prescription or as a part of a
patient's drug utilization review, or other patient counseling
requirements; |
| 5. |
The Board, or its
representative; or |
| 6. |
Any law
enforcement personnel duly authorized to receive such information such as a
GDNA agent, DEA Agent, or Georgia Medicaid Agent. |
|
| (e) |
In accordance with O.C.G.A. 24-9-40(b),
26-4-80 and these rules, a pharmacist may release confidential information to
such persons not mentioned in 480-16-. 08(d) only upon the receipt of the
following:
| 1. |
A written authorization for
release signed by the patient, or his or her parents or duly appointed
guardian, such as in the case of a minor; |
| 2. |
An subpoena issued and signed by an
authorized government official; or |
| 3. |
A court order issued and signed by a judge
of an appropriate court. |
|
| (f) |
A letter from an attorney requesting
confidential information without being accompanied by an official subpoena or
court order is not considered a valid mechanism to cause a pharmacist to
release such requested confidential information. |
| (g) |
Any pharmacist releasing information
under written authorization or waiver of the patient, his or her parents or
duly appointed guardian, such as in the case of a minor, or appropriate court
order or subpoena shall not be liable to the patient or any other person;
provided, further, that the privilege shall be waived to the extent that the
patient places his or her care and treatment or the nature and extent of his or
her injuries at issue in any administrative, civil, or criminal
proceeding. |
All pharmacies are required to purchase or receive dangerous
drugs and/or controlled substances from a firm licensed by this state as a drug
wholesaler, distributor or manufacturer.
