reglab/statecodes huggingface dataset:
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.03 - Manner of Issuance of a Controlled Substance Prescription Drug Order

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.04 - Requirements of a Schedule II (C-II) Controlled Substance Prescription Drug Order

Current through Rules and Regulations filed through June 27, 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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.05 - Refilling of a Schedule II (C-II) Controlled Substance Prescription Drug Order

Current through Rules and Regulations filed through June 27, 2024
The refilling of a prescription for a schedule II (C-II)
				controlled substance is prohibited.
O.C.G.A. Secs.
				 16-13-34,  16-13-41,  26-4-27.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.06 - Partial Filling of a Schedule II (C-II) Controlled Substance Prescription Drug Order

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.07 - Requirements of Schedule III, IV and V (C-III, IV, V) Controlled Substance Prescription Drug Orders

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.08 - Refilling of Schedule III, IV, and V (C-III, IV, V) Controlled Substance Prescription Drug Orders

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.09 - Partial Filling of Schedule III, IV, and V (C-III, IV, V) Controlled Substance Prescription Drug Ord

Current through Rules and Regulations filed through June 27, 2024
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.
O.C.G.A. Secs.
				 16-13-34,  16-13-39,  16-13-41,  26-4-27.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.10 - Labeling of Controlled Substance Prescription Drug Orders

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.11 - Transfer Between Pharmacies of Controlled Substance Prescription Drug Order Information for Refill Purposes

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.12 - Requirements of Prescription Drug Orders as Issued by a Physician's Assistant (PA), or an Advanced Practice Registered Nurse (APRN) Licensed to Practice in the State of Georgia

Current through Rules and Regulations filed through June 27, 2024
(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; and
(vi) If applicable, the DEA permit number of
			 the PA.
(e) 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;
(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; and
(x) The signature of the PA as provided in
			 Rule  480-27-.02(2)  or, in
			 the case of a controlled substances prescription, in accordance with
			  21 C.F.R. 1301.22.
(f) 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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.13 - Requirements of a Prescription Drug Order for Drugs that are Scheduled Under the Georgia Controlled Substances Act, but not Scheduled Under the Federal Controlled Substances Act

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.14 - Ordering and Receipt of Samples

Current through Rules and Regulations filed through June 27, 2024
(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.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-22 - REQUIREMENTS OF A PRESCRIPTION UNDER ORDER › Rule 480-22-.15 - Refilling of Ophthalmic Topical Products

Current through Rules and Regulations filed through June 27, 2024
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.
O.C.G.A. §§
									26-4-27,  26-4-28,  26-4-80.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-23 - PROCEDURAL RULES › Rule 480-23-.01 - Investigations and Hearings

Current through Rules and Regulations filed through June 27, 2024
(1) Proceedings by the Board in the exercise
			 of its authority to cancel, suspend, sanction, or revoke any license issued by
			 the Board shall be conducted in accordance with O.C.G.A. Tit le 50 Chapter 13,
			 the "Georgia Administrative Procedure Act." In all such proceedings, the Board
			 shall have the authority to compel the attendance of witnesses and production
			 of any book, writing, or document upon the issuance of a subpoena thereafter
			 signed by the Executive Director for the Board or the Director of the Georgia
			 Drugs and Narcotics Agency (GDNA).
(2) The Board shall have the authority to
			 conduct investigative interviews or board hearing, with or without the
			 necessity of utilizing the Office of the State Administrative Hearings, in
			 respect thereto.
(3) The Vice
			 President of the Board will be known as the investigative member of the Board
			 and shall have the following duties:
(a)
			 Serve as the contact member, or liaison member, between the Board and the
			 GDNA;
(b) Receive findings from
			 GDNA case reports and other investigations regarding possible violations of law
			 and report same to the Board;
(c)
			 Conduct investigative interviews on behalf of the Board; and
(d) Make various presentments,
			 recommendations, and findings from investigative interviews and other
			 miscellaneous sources to the Board.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-24 - NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS › Rule 480-24-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For purposes of these Rules and Regulations, the following
				definitions apply:
(a) Board. Board
			 shall mean the Georgia State Board of Pharmacy.
(b) GDNA. GDNA shall mean the Georgia Drugs
			 and Narcotics Agency.
(c) Hospice
			 emergency drug kits. A hospice emergency drug kit shall mean an emergency drug
			 kit placed by a provider pharmacy in a hospice licensed by the Department of
			 Human Resources.
(d) Unit dose. A
			 unit dose is a single dose of a medication(s), which is individually packaged,
			 sealed, and properly labeled to maintain the integrity and the identity of the
			 drug, and patient?ready at the time of dispensing by the pharmacist.
O.C.G.A. Secs.
				 16-13-34,  16-13-35,  16-13-39,  16-13-72,  26-4-27,  26-4-28,  26-4-29,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-24 - NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS › Rule 480-24-.02 - Personnel

Current through Rules and Regulations filed through June 27, 2024
(1) Consultant
			 Pharmacist. A consultant pharmacist is a pharmacist licensed to engage in the
			 practice of pharmacy in this state who is responsible for developing,
			 coordinating, and supervising pharmaceutical services in the nursing facility.
			 These services shall include, at a minimum, review of each patient's drug
			 regimen monthly and report of any irregularities to the Medical Director and
			 Administrator of the nursing facility, written reports of pharmaceutical
			 services, and monitoring of established policies and procedures for medication
			 handling and storage.
(2) Vendor
			 Pharmacist. A vendor pharmacist is a pharmacist licensed to engage in the
			 practice of pharmacy in this state who is responsible for supervising the
			 proper dispensing and delivery of drugs to a nursing facility. These services
			 shall include, at a minimum, proper drug labeling, storage, transport, and
			 record keeping in compliance with all federal, state and local laws and
			 regulations.
O.C.G.A. Secs.
				 16-13-34,  16-13-35,  16-13-39,  16-13-72,  26-4-27,  26-4-28,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-24 - NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS › Rule 480-24-.03 - Physical Requirements

Current through Rules and Regulations filed through June 27, 2024
The vendor pharmacist shall establish standards to ensure that
				all drugs are stored in a manner sufficient to insure the proper sanitation,
				temperature, light, ventilation, moisture control, segregation, and
				security.
O.C.G.A. Secs.
				 16-13-34,  16-13-35,  16-13-39,  16-13-72,  26-4-27,  26-4-28,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-24 - NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS › Rule 480-24-.04 - Drug Distribution

Current through Rules and Regulations filed through June 27, 2024
(1) Dispensing of all drugs to the facility
			 shall be pursuant to a legal prescription drug order for an individual
			 patients. Standing medication orders shall not be allowed. Policies may be
			 established by the vendor pharmacist in conjunction with the appropriate
			 committee of the facility. All drugs supplied to the facility must be obtained
			 from a pharmacy having a retail pharmacy permit.
(2) For use inside the facility, all drugs
			 dispensed shall be dispensed in appropriate containers, as defined by the Food
			 and Drug Administration and the Consumer Protection Agency, and adequately
			 labeled with the following information:
(a)
			 Name, address, and telephone number of the pharmacy;
(b) Date of issuance and identifying serial
			 number;
(c) Full name of
			 patient;
(d) Brand and/or generic
			 name of drug, strength, and quantity dispensed;
(e) Directions for use, which may be placed
			 on the container label or on a Medication Administration Record available and
			 consulted at the time of the administration of each dose, provided, however,
			 that both methods may be utilized inside a single facility;
(f) Name of physician prescribing;
(g) Required precautionary information
			 regarding controlled substances;
(h) Such other and further accessory
			 cautionary information as may be required or desirable for proper use and
			 absolute safety to the patient; and
(i) Expiration date.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-24 - NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS › Rule 480-24-.05 - Duties of Consultant Pharmacist

Current through Rules and Regulations filed through June 27, 2024
(1) A pharmacist serving as a consultant to a
			 facility must contract with the facility in writing for those services.
			 Notification must also be made to the Board in writing when a pharmacist
			 becomes a consultant to a facility. The pharmacist must also notify the Board
			 when the consultant services are terminated with a facility. When providing
			 contracted services the consultant pharmacist is held to the same professional
			 standards for a licensed pharmacist as set forth in state law and by the rules
			 and regulations of the Board.
(2)
			 The pharmacist, through the appropriate committee within the facility, shall
			 establish policies and procedures for safe and effective drug therapy,
			 distribution, use, and control. At a minimum, the pharmacist shall:
(a) Make periodic inspections, which shall
			 occur at least every 30 days, of drugs and medication records kept within the
			 facility. A written report of inspection shall be maintained at the facility;
			 and,
(b) Remove for proper disposal
			 any drugs or narcotics which are in a deteriorated condition, expired,
			 discontinued for use, or the patient for whom they are ordered is no longer a
			 patient These drugs shall be the responsibility of the vendor
			 pharmacy.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-24 - NURSING HOMES, LONG TERM CARE FACILITIES AND HOSPICE EMERGENCY DRUG KITS › Rule 480-24-.08 - Crisis Stabilization Unit (CSU) Emergency Drug Kits

Current through Rules and Regulations filed through June 27, 2024
Emergency drug kits may be placed in licensed Crisis
				Stabilization Units (CSU) by the pharmacy of the consultant or vendor
				pharmacist provided the following conditions are met:
(1) A record of the drugs to be kept in an
			 emergency drug kit must be kept in the CSU and the provider pharmacy;
(2) Drugs shall not be accessed for use from
			 the emergency drug kit in an emergency situation without a prescription drug
			 order from a licensed practitioner. A valid, signed prescription drug order for
			 any such drug must be issued to the vendor pharmacy, supplying the emergency
			 drug kit, within 72 hours of the drug being taken from the kit;
(a) Whenever an emergency drug kit is
			 accessed and a drug is removed, personnel shall immediately reseal the kit with
			 a tamper-proof, serial-numbered seal, with the seal serial number to be
			 recorded in a log along with the name of the person removing the drug and
			 resealing the kit and date the kit was opened;
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.02 - Applicability of Regulations

Current through Rules and Regulations filed through June 27, 2024
(1) All persons who manufacture, possess,
			 transport, or otherwise handle pharmaceuticals or radioactive materials
			 intended for radiopharmaceutical use prior to their arrival at a nuclear
			 pharmacy shall comply with the requirements of the Department's Rules and
			 Regulations for Radioactive Materials, and the requirements of the Rules and
			 Regulations of the Board.
(2) The
			 requirements of these Rules and Regulations are in addition to, and not in
			 substitution of, other applicable Rules and Regulations by the Department for
			 radioactive materials and applicable Rules and Regulations promulgated by the
			 Board for pharmacists and pharmacies.
(3) Nothing in these Rules and Regulations
			 shall be construed as requiring a licensed physician to obtain a separate
			 license as a nuclear pharmacist, when his/her use of radiopharmaceuticals is
			 limited to the diagnosis and treatment of his/her own patients.
(4) Nothing in these Rules and Regulations
			 shall be construed so as to require a licensed clinical laboratory which is
			 also licensed by the Department to handle radioactive materials to obtain the
			 services of a nuclear pharmacist, or to have a nuclear pharmacy license, unless
			 the laboratory is engaged in the commercial sale or resale of
			 radiopharmaceuticals.
(5) Nothing
			 in these Rules and Regulations shall be construed to require a department of
			 nuclear medicine which is located in a hospital of 250 beds or less, which has
			 a board certified radiologist in the practice of nuclear medicine, and which is
			 licensed by the Department to handle radioactive materials to obtain the
			 services of a nuclear pharmacist or to have a nuclear pharmacy
			 license.
O.C.G.A. Secs.
				 26-4-130, 26-4-138,
				 26-4-172,  26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.03 - Licensure of Nuclear Pharmacists

Current through Rules and Regulations filed through June 27, 2024
(1) Except as provided for in Rule
			  480-25-.02, all acts of compounding
			 and dispensing radiopharmaceuticals in the State of Georgia shall be performed
			 by persons licensed as nuclear pharmacists; provided, however, that licensed
			 pharmacists and licensed pharmacy interns/externs under the direct supervision
			 and control of a nuclear pharmacist may compound and dispense
			 radiopharmaceuticals without being separately licensed as nuclear
			 pharmacists.
(2) An applicant for a
			 license as a nuclear pharmacist shall:
(a) Be
			 a currently licensed pharmacist in the State of Georgia, and
(b) Submit to the Board a completed
			 application and the appropriate fee, on forms to be provided by the Board, and
			 an affidavit of training and experience which indicates that the applicant:
1. Meets the minimum requirements to use
			 radioactive materials as required by the Department's Rules and Regulations for
			 Radioactive Materials, and either
(i) Is
			 certified as a nuclear pharmacist by the Board of Pharmaceutical Specialties of
			 the American Pharmaceutical Association; or
(ii) Has completed a minimum of 200 contact
			 hours of didactic instruction in nuclear pharmacy from an accredited college of
			 pharmacy, and, completed a minimum of 500 hours of clinical nuclear pharmacy
			 training:
(I) Under the direct supervision of
			 a licensed nuclear pharmacist in a licensed nuclear pharmacy providing nuclear
			 pharmacy service; or
(II) In a
			 certified nuclear pharmacy residency program approved by the American Society
			 of Hospital Pharmacists or the Board; or
(III) In a structured nuclear pharmacy
			 training program of an accredited college of pharmacy.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.04 - Licensure of Nuclear Pharmacies

Current through Rules and Regulations filed through June 27, 2024
(1) No nuclear pharmacy shall be operated in
			 the State of Georgia without a valid permit.
(2) The governing body of the facility shall
			 submit a completed application with the required fee to the Board for a permit
			 using forms provided by the Board.
(3) Separate applications and permits are
			 required for nuclear pharmacies maintained on separate premises, even though
			 they are owned or operated by the same person(s), business or corporation; and
			 may be doing business under the same trade name.
(4) Permits are not transferable or
			 assignable.
(5) The applicant shall
			 comply with additional application requirements as may be required by the
			 Board.
(6) Following inspection and
			 evidence of compliance with these Rules and Regulations, the Board may issue a
			 nuclear pharmacy permit to the applicant(s). The Board may refuse to issue a
			 permit to any applicant for any of the grounds set forth in O.C.G.A. Section
			  26-4-113, and may also refuse to issue or revoke a permit if an applicant makes any false
			 statements in the application.
(7)
			 Permits shall be renewed biennially on even numbered years by application to
			 the Board for renewal.
(8) The
			 Board may limit, suspend, or revoke permits issued under the provisions of
			 these Rules and Regulations, or impose any other reasonable sanctions upon
			 holders of such permits upon violation of these Rules and Regulations or
			 violation of O.C.G.A. Section
			  26-4-113.
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37,
				 26-4-130, 26-4-138,
				 26-4-170,  26-4-172,  26-4-174,  26-4-176 to 
				 26-4-178,  43-1-4.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.05 - Inspections

Current through Rules and Regulations filed through June 27, 2024
(1) Any nuclear
			 pharmacy shall be open during all business hours for observation and
			 examination by properly identified representatives of the Board and the
			 Department.
(2) All nuclear
			 pharmacies shall be inspected by the Board prior to licensure and may be
			 inspected at the discretion of the Board or the Department to determine whether
			 it continues to meet these requirements.
O.C.G.A. Secs.
				 26-4-27 to 
				 26-4-29,  26-4-130, 26-4-138,
				 26-4-174,  26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.06 - Nuclear Pharmacy General Requirements

Current through Rules and Regulations filed through June 27, 2024
(1) In addition to complying with these Rules
			 and Regulations, nuclear pharmacies shall comply with the Rules and Regulations
			 of the Board and with all applicable Federal and State laws and regulations
			 pertaining to nonradioactive drugs and pharmaceuticals.
(2) The pharmacist in charge at a nuclear
			 pharmacy shall be a licensed nuclear pharmacist. All personnel performing tasks
			 in the preparation and distribution of radiopharmaceuticals shall be under the
			 direct supervision of a licensed nuclear pharmacist. All acts of compounding
			 and dispensing of radiopharmaceuticals shall be performed by the nuclear
			 pharmacist or by a pharmacist or pharmacy intern, under the direct supervision
			 and control of a nuclear pharmacist. A nuclear pharmacist shall be responsible
			 for all operations of the nuclear pharmacy and shall be in personal attendance
			 at all times when the acts of compounding and dispensing are performed and the
			 pharmacy is open for business.
(3)
			 Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with
			 acceptable professional standards of radiopharmaceutical quality
			 assurance.
(4) Radiopharmaceuticals
			 are to be dispensed only upon prescription drug order by a practitioner who is
			 authorized by the Department to possess, use, and administer radioactive
			 materials.
(5) A nuclear pharmacist
			 may transfer to authorized persons radioactive materials not intended for drug
			 use, in accordance with the Department Rules and Regulations for Radioactive
			 Materials. A nuclear pharmacy may also furnish radioactive materials for use to
			 practitioners, for individual patient use in accordance with subsection (4) of
			 this regulation.
(6) The amount of
			 radioactivity dispensed in each individual preparation shall be determined by
			 the nuclear pharmacist through radiometric methods immediately prior to
			 dispensing.
(7) Nuclear pharmacies
			 may redistribute Federal Food and Drug Administration approved
			 radiopharmaceuticals if the pharmacy does not possess the radiopharmaceuticals
			 in any manner or violate the product packaging. Such redistribution may only be
			 made to another nuclear pharmacy or other authorized person or
			 institution.
O.C.G.A. Secs.
				 16-13-71,  26-4-110,  26-4-130, 26-4-138,
				 26-4-174,  26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.07 - Space Requirements

Current through Rules and Regulations filed through June 27, 2024
(1) Nuclear pharmacies shall have adequate
			 space, commensurate with the scope of service required and provided and meet
			 the minimal space requirements of all pharmacies in the State.
(2) Nuclear pharmacies shall have a minimum
			 area, secured from unauthorized personnel, which comprise at least 600 square
			 feet designed for the compounding and dispensing and quality assurance of
			 radiopharmaceuticals.
(3) The
			 foregoing nuclear pharmacy areas shall be exclusive from other pharmacy areas
			 such as those for nonradioactive drugs and office space.
(4) Detailed floor plans shall be submitted
			 to the Board before the permit is granted.
O.C.G.A. Secs.
				 26-4-110,  26-4-130, 26-4-138,
				 26-4-174,  26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.08 - Equipment

Current through Rules and Regulations filed through June 27, 2024
(1) In addition to
			 other articles and equipment required by the Board for all pharmacies in the
			 State, the nuclear pharmacy shall have:
(a)
			 dose calibrator;
(b) vertical
			 laminar flow hood;
(c) single or
			 multiple channel scintillation analyzer;
(d) microscope and hemocytometer;
(e) adequate glassware, utensils, and
			 gloves;
(f) calculator;
(g) laboratory incubator;
(h) water or oil bath;
(i) aluminum ion test kit; and
(j) adequate apparatus and supplies for
			 performing chromatography.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.09 - Labeling

Current through Rules and Regulations filed through June 27, 2024
All radiopharmaceuticals dispensed from a nuclear pharmacy
				shall be dispensed in appropriate containers and labeled in accordance with the
				following:
(a) The immediate inner
			 container shall be labeled with:
1. the
			 identifying prescription number; and
2. the name of the radioactive
			 drug.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.10 - Library

Current through Rules and Regulations filed through June 27, 2024
In addition to any reference material required by the Board of
				all pharmacies in the State, a nuclear pharmacy shall maintain a reference
				library which shall include the following:
(a) Current U.S. Pharmacopoeia/National
			 Formulary with supplements or computer or electronic access to same;
(b) Computer or electronic access to Federal
			 and State Laws and Regulations relating to pharmacy practice in
			 Georgia;
(c) A minimum of three
			 texts dealing with nuclear medicine;
(d) Current Department of Human Resources
			 Rules and Regulations for Radioactive Materials.
O.C.G.A. Secs. 26-4-37,
				 26-4-110,  26-4-111,  26-4-130, 26-4-138,
				 26-4-174,  26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.11 - Records

Current through Rules and Regulations filed through June 27, 2024
The nuclear pharmacy shall maintain acquisition and disposition
				records as required by the Board of all pharmacies in the
				State.
O.C.G.A. Secs.
				 26-4-130, 26-4-138,
				 26-4-170,  26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.12 - Enforcement

Current through Rules and Regulations filed through June 27, 2024
The enforcement and administration of these Rules and
				Regulations shall be as prescribed in the Georgia Administrative Procedure Act,
				O.C.G.A., Title 50, Chapter 13, Title 26, Chapter 4, and Title 43, Chapter
				1.
O.C.G.A. §§
									26-4-130, 26-4-138,
				 26-4-170,  26-4-178,  43-1-19.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-25 - NUCLEAR PHARMACIES AND PHARMACISTS › Rule 480-25-.13 - Severability

Current through Rules and Regulations filed through June 27, 2024
In the event that any rule, sentence, clause or phrase or any
				of these rules and regulations may be construed by any court of competent
				jurisdiction to be invalid, illegal, unconstitutional, or otherwise
				unenforceable, such determination or adjudication shall in no manner affect the
				remaining rules or portions thereof and such remaining rules or portions
				thereof shall remain of full force and effect, as if such rule or portions
				thereof so determined, declared or adjudged invalid or unconstitutional were
				not originally a part hereof. It is the intent of the Board of Pharmacy to
				establish rules and regulations that are constitutional and enforceable so as
				to safeguard the health and well-being of the people of the
				State.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-130, 26-4-138,
				 26-4-178.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-26 - FEES › Rule 480-26-.01 - Fees

Current through Rules and Regulations filed through June 27, 2024
(1) All fees for
			 applications for pharmacist license, examinations, application and examination
			 fee for reciprocity, wall certificates, duplicate wall certificates, renewals,
			 late renewals, reinstatements, and all other fees which may be authorized by
			 law shall be established by the Board periodically as set forth on a fee
			 schedule and may be obtained from the Board office. Such fees must be paid
			 directly to the Board office.
(2)
			 Fees for the North American Pharmacist Licensing Examination (NAPLEX) portion
			 of any examination or the fee for National Association of Boards of Pharmacy
			 (NABP) electronic license score transfer process are separate from and not
			 included in the Georgia State Board of Pharmacy fee schedule. Such fees must be
			 paid directly to NABP.
(3) All fees
			 for applications for pharmacies and other licenses, renewals, late renewals,
			 and all other fees which may be authorized by law shall be established by the
			 Board periodically as set forth on a fee schedule and may be obtained from the
			 Board office.
(4) Pharmacist
			 license reactivation and reinstatement is considered at the discretion of the
			 Board once thirty (30) hours of approved pharmacy continuing education along
			 with the required fee, and any other requirements as set forth by Board policy
			 is received.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-41,  26-4-42,  26-4-44,  26-4-6,  26-4-49,  26-4-110,  26-4-115,  26-4-170.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-27 - REQUIREMENTS OF A PRESCRIPTION DRUG ORDER WHEN UTILIZING A COMPUTER OR OTHER ELECTRONIC MEANS › Rule 480-27-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For purposes of these Rules and Regulations, the following
				definitions apply:
(a) Authentication.
			 Any process by which the identities of the parties sending and receiving
			 electronic prescription data are verified.
(b) Automated Electronic Data Processing
			 System. A system utilizing computer software and hardware for the purpose of
			 record-keeping and/or receiving prescription drug orders. Any and all such
			 systems that are compatible and capable of interacting with, and electronically
			 transferring prescription drug data with any other system must be in compliance
			 with the rules of the Board for use in electronic prescription
			 monitoring.
(c) Board. The Georgia
			 State Board of Pharmacy.
(d)
			 Computer. Programmable electronic device capable of multi-function including
			 but not limited to storage, retrieval, and processing of information.
(e) Controlled Substances. Those drug items
			 regulated by federal law and/or the Georgia Controlled Substances
			 Act.
(f) Dangerous Drugs. Those
			 drug items and devices regulated by the Georgia Dangerous Drug Act.
(g) Digital ID. An authenticated identifiable
			 signature than can be attached to an electronic e-mail and is tamper
			 proof.
(h) Downtime. That period of
			 time when a computer is not operable.
(i) Electronic Means. An electronic device
			 used to send, receive, and/or store prescription drug order information,
			 including computers, facsimile machines, etc.
(j) Electronic Signature. An electronically
			 reproduced visual image signature or an electronic data signature of a
			 practitioner, which appears on, is attached to, or is logically associated with
			 an electronic prescription drug order.
(k) Facsimile. A hard copy prescription drug
			 order sent via a facsimile machine.
(l) Hard Copy. A fileable prescription drug
			 order which is written or printed via electronic means.
(m) Hardware. The fixed component parts of a
			 computer.
(n) HIPPA. The Health
			 Insurance and Portability and Accountability Act and the associated security
			 standards for the protection of electronic protected health
			 information.
(o) Intervening
			 Electronic Formatter. An entity that is not prohibited under O.C.G.A. Section
			  26-4-80(c)(1) and
			 (5), and that provides the infrastructure
			 that connects a computer or automated electronic data processing system or
			 other electronic device used by a prescribing practitioner with a computer or
			 automated electronic data processing system or another electronic device used
			 by the pharmacy to facilitate the secure transmission of:
1. An electronic prescription drug
			 order;
2. A refill authorization
			 request;
3. A communication;
			 and
4. Other patient care
			 information between a practitioner and pharmacy.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-27 - REQUIREMENTS OF A PRESCRIPTION DRUG ORDER WHEN UTILIZING A COMPUTER OR OTHER ELECTRONIC MEANS › Rule 480-27-.02 - Prescription Drug Order Requirements

Current through Rules and Regulations filed through June 27, 2024
(1)
			 Prescription drug orders shall include, but not be limited to, the following
			 information:
(a) Date of issue;
(b) Name and address of patient (or patient
			 location if in an institution);
(c)
			 Name, address, and telephone number of the prescriber;
(d) DEA registration number of the prescriber
			 in the case of controlled substances;
(e) Name, strength, dosage form and quantity
			 of drug prescribed;
(f) Number of
			 authorized refills;
(g) Directions
			 for use by patient;
(h) If a
			 written prescription drug order, the signature of the prescribing practitioner;
			 and
(i) Any cautionary statements
			 as may be required or necessary.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-27 - REQUIREMENTS OF A PRESCRIPTION DRUG ORDER WHEN UTILIZING A COMPUTER OR OTHER ELECTRONIC MEANS › Rule 480-27-.03 - Records of Dispensing

Current through Rules and Regulations filed through June 27, 2024
Records of dispensing for original and refill prescriptions are
				to be made and kept by pharmacies for two years and shall include, but not be
				limited to:
(a) Quantities
			 dispensed;
(b) Date of
			 dispensing;
(c) Serial number (or
			 equivalent if an institution);
(d)
			 The identification of the pharmacist responsible for dispensing;
(e) Documentation of satisfaction of state
			 requirements for drug product selection;
(f) Records of refills to date to include
			 date(s) of refills, and identification of pharmacist(s) dispensing
			 refills.
O.C.G.A. Secs.
				 16-13-39,  26-4-27,  26-4-28, 26-4-37,
				 26-4-50,  26-4-80,  26-4-81,  26-4-83, 43-34-26.2.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-27 - REQUIREMENTS OF A PRESCRIPTION DRUG ORDER WHEN UTILIZING A COMPUTER OR OTHER ELECTRONIC MEANS › Rule 480-27-.06 - Security

Current through Rules and Regulations filed through June 27, 2024
The computerized information provided by the system shall be
				used only by the pharmacy in which the data has been entered or a pharmacy
				sharing a common database. To maintain the confidentiality of patients'
				prescriptions, there must exist adequate safeguards or security of the
				records.
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37,
				 26-4-80.