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Rules and Regulations of the State of Georgia
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Chapter 480-16 MISCELLANEOUS GUIDELINES FOR PHARMACISTS

Rule 480-16-.01 Report of Unlicensed Dispensing or Impaired Pharmacist

(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.

Rule 480-16-.02 Receipt of Prescription Drug Order by a Non-Pharmacy

(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.

Rule 480-16-.03 Return of Previously Dispensed Drugs or Devices

(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.

Rule 480-16-.04 Damaged Pharmaceuticals and Other Items

(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.

Rule 480-16-.05 Deceptive Advertising

(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.

Rule 480-16-.06 Theft, Loss, or Unaccounted for Controlled Substances

(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.

Rule 480-16-.07 Release of Confidential Prescription Drug Order Information

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:
1. The patient;
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.

Rule 480-16-.08 Purchase or Receipt of Drugs by a Pharmacy

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.