reglab/statecodes huggingface dataset:
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.03 - Organization and Personnel

Current through Rules and Regulations filed through June 27, 2024
(1) The pharmacist has the responsibility and
			 authority to inspect and approve or reject all components, drug preparations
			 containers, closures, in-process materials, and labeling; and the authority to
			 prepare and review all compounding records to assure that no errors have
			 occurred in the compounding process. The pharmacist is also responsible for the
			 proper maintenance, cleanliness, and use of all equipment used in prescription
			 compounding practice.
(2)
			 Pharmacists who engage in drug compounding, and any other pharmacy personnel,
			 supervised by pharmacists, who assist in drug compounding, shall be competent
			 and proficient in compounding procedures and shall maintain that proficiency
			 through current awareness and training and documentation of that training.
			 Every pharmacist who engages in drug compounding and any other pharmacy staff
			 member who assists in compounding, must be aware of and familiar with all
			 details of these good compounding practices. Records of documentation of
			 training for all personnel must be maintained for a minimum of five (5)
			 years.
(3) All pharmacy personnel
			 engaged in the compounding of drugs shall wear clean clothing appropriate to
			 the operation being performed. Protective apparel, such as coats/jackets,
			 aprons, gowns, hand or arm coverings, or masks shall be worn as necessary to
			 protect personnel from chemical exposure and drug preparations from
			 contamination.
(4) Only personnel
			 authorized by the responsible pharmacist shall be in the immediate vicinity of
			 the drug compounding operation. Any person known at any time (either by medical
			 examination or pharmacist determination) to have an apparent illness or open
			 lesions that may adversely affect the safety or quality of a drug preparation
			 being compounded shall be excluded from direct contact with components, drug
			 preparation containers, closures, in-process materials, and drug preparations
			 until the condition is corrected or determined by competent medical personnel
			 not to jeopardize the safety or quality of the preparations being compounded.
			 All personnel who assist the pharmacist in compounding procedures shall be
			 instructed to report to the pharmacist any health conditions that may have an
			 adverse effect on drug preparations.
O.C.G.A. Secs.
				 26-4-5,  26-4-27,  26-4-28,  26-4-86.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.04 - Facilities and Equipment

Current through Rules and Regulations filed through June 27, 2024
(1) Facilities.
(a) Pharmacies engaging in compounding shall
			 have an adequate area for the orderly compounding of prescriptions, including
			 the placement of equipment and materials. The drug compounding area for sterile
			 preparations shall be separate and distinct from the area used for the
			 compounding of non-sterile drug preparations. The area(s) used for compounding
			 of drugs shall be maintained in a good state of repair.
(b) Bulk drugs and other chemicals or
			 materials used in the compounding of prescription drug orders must be stored in
			 adequately labeled containers in a clean, dry area or, if required, under
			 proper refrigeration.
(c) Adequate
			 lighting and ventilation shall be provided in all drug-compounding areas.
			 Potable water shall be supplied under continuous positive pressure in a
			 plumbing system free of defects that could contribute to contamination of any
			 compounded drug preparation. Adequate washing facilities, easily accessible to
			 the compounding area(s) of the pharmacy shall be provided. These facilities
			 shall include, but not be limited to, hot and cold water, soap or detergent,
			 and air dryers or single-use towels.
(d) Sewage, trash, and other refuse in and
			 from the pharmacy and immediate drug compounding area(s) shall be disposed of
			 in a safe and sanitary manner.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.06 - Labeling and Control of Excess Preparations

Current through Rules and Regulations filed through June 27, 2024
In the case where a quantity of compounded drug preparation is
				in excess of that to be initially dispensed is prepared, the excess preparation
				shall be labeled or documentation referenced with the complete list of
				ingredients (components), the preparation date, and the assigned beyond-use
				date based upon the pharmacist's professional judgment, appropriate testing, or
				published data. It shall also be stored and accounted for under conditions
				dictated by its composition and stability characteristics (e.g., in a clean,
				dry place on a shelf or in the refrigerator) to ensure its strength, quality,
				and purity as outlined in Rule
				 480-11-.07.
O.C.G.A. Secs.
				 26-4-5,  26-4-27,  26-4-28,  26-4-86.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.07 - Control of Components and Drug Preparation Containers and Closures

Current through Rules and Regulations filed through June 27, 2024
(1) Components,
			 drug preparation containers, closures, and bagged or boxed components of drug
			 preparation containers and closures used in the compounding of drugs shall be
			 handled and stored in a manner to prevent contamination and to permit
			 unhindered cleaning of the work area (e.g., floors) and inspection.
(2) Drug preparation containers and closures
			 shall not be reactive, additive, or absorptive so as to alter the safety,
			 identity, strength, quality, or purity of the compounded drug beyond the
			 desired result. Components, drug preparation containers, and closures for use
			 in the compounding of drug preparations shall be rotated so that the oldest
			 stock is used first. Container closure systems shall provide adequate
			 protection against foreseeable external factors in storage and use that can
			 cause deterioration or contamination of the compounded drug preparation. Drug
			 preparation containers and closures shall be clean and, where indicated by the
			 intended use of the drug, sterilized and processed to remove pyrogenic
			 properties to assure that they are suitable for their intended use.
(3) Drug preparation containers and closures
			 intended for the compounding of sterile preparations must be handled,
			 sterilized, processed and stored to remove pyrogenic properties to assure that
			 they are suitable for their intended purpose. Methods of cleaning, sterilizing,
			 and processing to remove pyrogenic properties shall be written and followed for
			 drug preparation containers and closures used in the preparation of sterile
			 pharmaceuticals. These processes shall be performed by pharmacists or under the
			 pharmacist's supervision.
O.C.G.A. Secs.
				 26-4-5,  26-4-27,  26-4-28,  26-4-86.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.08 - Records and Reports

Current through Rules and Regulations filed through June 27, 2024
(1) Any procedures or other records required
			 to be maintained in compliance with this chapter shall be retained for the same
			 period of time as required in chapter 480-10 of the Board Rules for the
			 retention of prescription files.
(2) All records required to be retained under
			 this chapter or copies of such records, shall be readily available for
			 authorized inspection during the retention period at the establishment where
			 the activities described in such records occurred. These records or copies
			 thereof shall be subject to photocopying or other means of reproduction as part
			 of any such inspection.
(3) Records
			 required under this chapter may be retained either as the original records or
			 as true copies, such as photocopies, microfilm, microfiche, electronic files or
			 other accurate reproductions of the original records. All records or reports
			 must be producible immediately if requested by the Board or an agent of the
			 GDNA or within forty-eight (48) hours if maintained in a central
			 database.
(4) In addition to
			 standard record and reporting requirements, the following records and reports
			 must be maintained for sterile pharmaceuticals:
(a) A policy and procedure manual, including
			 policies and procedures for cytotoxic and/or infectious waste, if applicable;
			 and
(b) Lot numbers and expiration
			 dates of all the components used in compounding sterile prescription drug
			 orders.
(c) This record-keeping
			 requirement does not apply when FDA approved and labeled sterile injectable
			 drug products, produced by registered pharmaceutical manufacturers, are
			 reconstituted under conditions as allowed by USP 797, and each such sterile
			 drug product must be administered within 24 hours of being
			 reconstituted.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.09 - Quality Assurance Program for Compounding and Preparation of Sterile Pharmaceuticals

Current through Rules and Regulations filed through June 27, 2024
(1) There shall be a documented, ongoing
			 quality assurance control program that monitors personnel performance,
			 equipment, and facilities. Appropriate samples of finished preparations shall
			 be examined to assure that the pharmacy is capable of consistently preparing
			 sterile pharmaceuticals meeting specifications.
(a) All clean rooms, ante rooms, barrier
			 isolators and laminar flow hoods shall be certified following procedures such
			 as those outlined in the CETA Certification Guide for Sterile Compounding
			 Facilities (CAG-003-2005) should be performed by a qualified individual no less
			 than every six months whenever the device or room is relocated, altered, or
			 major service to the facility is performed. Appropriate documentation and
			 records shall be maintained.
(b)
			 There shall be written procedures developed requiring sampling if microbial
			 contamination is suspected.
(c) If
			 bulk compounding of parenteral solutions is performed using non-sterile
			 chemicals, extensive end preparation testing must be documented prior to the
			 release of the preparation from quarantine. This process must include
			 appropriate tests for particulate matter and testing for pyrogens.
(d) There shall be documentation of quality
			 assurance audits at regular, planned intervals, including infection control and
			 sterile technique audits.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-11 - PHARMACEUTICAL COMPOUNDING › Rule 480-11-.10 - Exceptions

Current through Rules and Regulations filed through June 27, 2024
The requirements of this chapter do no apply to the compounding
				or mixing of FDA-approved drugs preparations pursuant to the manufacturer's
				directions for dispensing including but not limited to the reconstitution of
				oral suspensions, combination of the components of topical preparations,
				etc.
O.C.G.A. Secs.
				 26-4-5,  26-4-27,  26-4-28,  26-4-86.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-12 - SPECIALTY PHARMACY PRACTICE › Rule 480-12-.01 - Authority

Current through Rules and Regulations filed through June 27, 2024
The Georgia State Board of Pharmacy ("Board") has the authority
				to approve accreditation or certification programs for specialty pharmacy
				practice, included, but not limited to:
(a) Diabetes;
(b) Dyslipidemia;
(c) Asthma; and
(d) Anticoagulation.
O.C.G.A. Secs.
				 26-4-27,  26-4-28.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-12 - SPECIALTY PHARMACY PRACTICE › Rule 480-12-.02 - Certification

Current through Rules and Regulations filed through June 27, 2024
A certification in the management of a specific disease state
				recognizes that the pharmacist has demonstrated advanced knowledge and skills
				in the specified disease state necessary to instruct the patient and to assist
				in the management of the health care of the patient.
O.C.G.A. Secs.
				 26-4-27,  26-4-28.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-12 - SPECIALTY PHARMACY PRACTICE › Rule 480-12-.03 - Qualifications

Current through Rules and Regulations filed through June 27, 2024
(1) In order to
			 qualify for specialty pharmacy practice certification, the applicant must be a
			 pharmacist currently licensed and in good standing with the State of Georgia,
			 and pass an examination approved by the Board in the specific area of
			 speciality practice. A person who has already passed the examination and meets
			 all requirements may make application to the Board on a form approved by the
			 Board and pay the fee in the amount provided in the Board's fee
			 schedule.
(2) The board has
			 approved the Disease State Management Examinations of the National Association
			 of Boards of Pharmacy, or its successor organization.
(3) Licensed pharmacist who have a specialty
			 pharmacy practice certification must complete a minimum of ten (10) hours of
			 continuing education in each specific area of specialty during each biennium
			 renewal period. The hours obtained herein may be used to fulfill the continuing
			 education requirements as contained in Chapters
			  480-3-.01  and
			  480-3-.03.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-45.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For purposes of these Rules and Regulations, the following
				definitions apply:
(a) Hospital. As
			 defined by the Department of Human Resources;
(b) Hospital pharmacy. Hospital pharmacy is
			 defined as that portion of a hospital facility which is engaged in the
			 manufacture, production, sale and distribution of drugs, medications, devices,
			 and other materials used in the prevention, diagnosis and treatment of injury,
			 illness and disease (hereinafter referred to as "drugs"); and which is
			 registered with the State Board of Pharmacy pursuant to O.C.G.A. §
								26-4-110;
(c) Hospital pharmacy license. Hospital
			 pharmacy license shall mean a pharmacy license issued by the Georgia State
			 Board of Pharmacy to said hospital pharmacies, pursuant to the provisions of
			 O.C.G.A. Sections
			  26-4-27,  26-4-28 and 
			  26-4-110 whereas the licensee shall be subject to special hospital pharmacy regulations
			 as set forth herein, but exempt from other certain regulations and
			 requirements. To obtain the hospital pharmacy license, there must be employed a
			 Director of Pharmacy.
1. The Board authorizes
			 the holder of a hospital pharmacy license to service patients of Nursing Homes,
			 Long Term Care Facilities or Hospices as long as these entities are under the
			 same ownership as the hospital pharmacy; however, such entities can only be
			 serviced by the hospital pharmacy subject to the requirements as set forth by
			 Georgia State Board of Pharmacy Rules 480-24, the rule for providing services
			 to nursing homes, long term care facilities, and hospices. The hospital
			 pharmacy is prohibited from maintaining standard ward (Floor Stock) inventories
			 in such entities, but, it would allow the hospital pharmacy to supply emergency
			 kits.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.02 - Licensure and Registration

Current through Rules and Regulations filed through June 27, 2024
All hospital pharmacies shall renew biennially by June 30th of
				each odd-numbered year with the Georgia State Board of Pharmacy; certificates
				of registration shall be issued only to those hospital pharmacies which comply
				with the provisions of O.C.G.A. §
								26-4-110, and with these Rules and Regulations.
(a) Minimum Required Information for
			 Licensure. The Board requires the following information from each hospital
			 pharmacy as part of the initial licensing procedure and as part of any renewal
			 of such license:
(b) The name,
			 complete street address for the business, and telephone number of the
			 applicant/licensee;
(c) All trade
			 or business names used by the applicant/licensee;
(d) Address, telephone numbers, and the
			 name(s) of the Hospital Administrator;
(e) The type of ownership or operation (i.e.,
			 partnership, corporation, or sole proprietorship); and
(f) The name(s) of the owner and/or operator
			 of the applicant/licensee, including:
1. If a
			 partnership, the name of each partner, and the name of the
			 partnership;
2. If a sole
			 proprietorship, the complete name of the proprietor;
3. If a corporation, the name and title of
			 each corporate officer and director, the corporate name and the state of
			 incorporation; and the name of the parent company, if any.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.03 - Personnel

Current through Rules and Regulations filed through June 27, 2024
(1) Director of
			 Pharmacy. Each hospital pharmacy shall be directed by a pharmacist, hereinafter
			 referred to as the Director of Pharmacy, who is licensed to engage in the
			 practice of pharmacy in this State, and who is knowledgeable in and thoroughly
			 familiar with the specialized functions of hospital pharmacies. The Director of
			 Pharmacy shall be responsible for all activities of the hospital pharmacy, and
			 for meeting the requirements of the Georgia Pharmacy Laws and Rules and
			 Regulations of the Board of Pharmacy. The Director of Pharmacy or his/her
			 pharmacist designee should be employed on a fulltime basis consistent with
			 need.
(2) Supportive personnel. The
			 Director of Pharmacy shall be assisted by a sufficient number of additional
			 pharmacists, and ancillary personnel as may be required to operate such
			 pharmacy competently, safely, and to meet the needs of the patients of the
			 hospital facility.
(a) The Director of
			 Pharmacy shall insure that trained personnel shall be employed in the pharmacy.
			 The Director of Pharmacy shall develop and implement written policies and
			 procedures to specify the duties to be performed by such personnel. These
			 policies and procedures shall, at a minimum, specify that such personnel are
			 personally and directly supervised by a licensed pharmacist and that such
			 personnel are not assigned duties which may be performed only by licensed
			 pharmacists. The Director of Pharmacy shall be responsible for the
			 implementation of the written policies and responsible to the Georgia State
			 Board of Pharmacy for the activities of the pharmacy.
(b) Secretarial and clerical assistance and
			 support shall be provided as required to assist with record keeping, report
			 submission, and other administrative duties, provided such personnel do not
			 perform any dispensing duties.
(c)
			 Any licensed pharmacist performing pharmaceutical duties within the hospital
			 shall operate and fall under the supervision of the Director of
			 Pharmacy.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.04 - Absence of Pharmacist

Current through Rules and Regulations filed through June 27, 2024
(1) General. When a licensed pharmacist is
			 not physically present in the hospital and the pharmacy is closed, written
			 policies and procedures shall be prepared in advance by the Director of
			 Pharmacy for the provision of drugs to the medical staff and other authorized
			 personnel of the hospital by use of night cabinets and/or by access to the
			 pharmacy. The policies and procedures may include the use of remote order entry
			 pharmacist to ensure that in-patient needs are met at the hospital when a
			 licensed pharmacist is not physically present. All policies and procedures
			 providing for the use of night cabinets and/or access to the pharmacy when a
			 licensed pharmacist is not physically present shall be made available to the
			 Georgia State Board of Pharmacy, its designee, or a representative of the
			 Georgia Drugs and Narcotics Agency (GDNA), upon request.
(2) A hospital utilizing a remote order entry
			 pharmacist shall maintain a record of the name and address of such pharmacist,
			 evidence of current licensure in the State of Georgia, and the address of each
			 location where the pharmacist will maintain records of remote order
			 entries.
(3) A hospital pharmacy
			 shall be authorized to utilize remote order entry when:
(a) The licensed pharmacist is not physically
			 present in the hospital, the hospital pharmacy is closed, and a licensed
			 pharmacist will be physically present in the hospital pharmacy within 24 hours
			 or the next business day;
(b) When
			 at least one licensed pharmacist is physically present in the hospital;
			 or
(c) When it is a weekend and at
			 least one pharmacist is physically present in another hospital in this state
			 which remotely serves on weekends not more than four other hospitals under the
			 same ownership or management which have an average daily census of less than
			 twelve acute patients.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.05 - Physical Requirements. Amended

Current through Rules and Regulations filed through June 27, 2024
(1)
Area.
A hospital pharmacy
			 shall have within the hospital which it serves, sufficient floor space
			 allocated to it to insure that drugs are prepared in sanitary, well-lighted and
			 enclosed places, and which meet the other requirements of this section and the
			 Georgia Pharmacy Laws. The hospital pharmacy space requirements should be a
			 minimum of 10 square feet per hospital bed, which includes all areas assigned
			 and under the direct control of the Director of Pharmacy.
(a) The pharmacy of substance abuse treatment
			 or mental health facility shall be exempt from the minimum square footage
			 requirement provided that the pharmacy receives a satisfactory inspection from
			 the Georgia Drugs and Narcotics Agency that shows that the pharmacy space is
			 sufficient to supply the needs of the patients and that all aspect of the
			 management and operations of the pharmacy comply with the law and the rules of
			 the Board to ensure that the health, safety, and welfare of the patients served
			 by the pharmacy are protected. No application for licensure of a pharmacy of a
			 substance abuse treatment or mental health facility seeking an exemption shall
			 be approved without a satisfactory inspection.
(b) "Mental health facility" shall mean a
			 specialized hospital, inpatient unit, or other institution that is licensed to
			 provide twenty-four (24) hour care and has as its primary function the
			 diagnosing and treating of patients with psychiatric disorders.
(c) "Substance abuse treatment facility"
			 shall mean a specialized hospital, inpatient unit, or other institution that is
			 licensed to provide twenty-four (24) hour care and has as its primary function
			 the diagnosing and treating of patients with substance use disorders.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.07 - Administration of Drugs

Current through Rules and Regulations filed through June 27, 2024
(1) General. Drugs shall be administered only
			 upon the orders of those members of the medical staff who have been granted
			 staff privileges. Drugs shall be administered by authorized licensed personnel
			 in accordance with policies and procedures specified by the appropriate
			 committee of the facility, under applicable Law and Rules and Regulations, and
			 by usual and customary standards of good medical practice. The Director of
			 Pharmacy shall develop and implement policies and procedures concerning
			 self-administration of medication.
(2) Self-administration. Self-administration
			 of drugs by patients shall be permitted only when specifically authorized by
			 the patient's authorized practitioner, provided, however, the patient has been
			 educated and trained in the proper manner of self-administration and there is
			 no risk of harm to the patient. The Director of Pharmacy shall develop policies
			 and procedures relating to the self-administration of drugs.
O.C.G.A. Secs.
				 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 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.08 - Drugs from Outside Sources

Current through Rules and Regulations filed through June 27, 2024
The Director of Pharmacy shall establish policies and
				procedures relating to drugs brought into the hospital by patients or patients'
				family members. Such drugs shall not be administered unless they can be
				precisely identified. Administration shall be pursuant only to an authorized
				practitioner's prescription drug order. If such drugs are not to be
				administered, the medication shall be returned to an adult member of the
				patient's family or stored by the pharmacy and re- turned to the patient upon
				discharge. Medications received from an outside source, but not to be
				administered, may not be stored on the patient care unit. Nothing in this
				section shall prohibit another method of accomplishing the intent of this
				section provided such method is approved by an agent of the Board of
				Pharmacy.
O.C.G.A. Secs.
				 26-4-27 to 
				 26-4-29,  26-4-110,  26-4-115.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.09 - Investigational Drugs

Current through Rules and Regulations filed through June 27, 2024
Investigational drugs shall be properly labeled and shall be
				administered only under the personal and direct supervision of the principal
				practitioner- investigator or his/her authorized clinician(s) with prior
				approval of the appropriate committee(s) of the hospital. Investigational drugs
				shall be administered in accordance with an approved protocol that includes any
				requirements for a patient's appropriate informed consent. Nurses may
				administer such drugs only after they have been educated regarding such drugs
				by the clinician or the pharmacist. A central unit shall be maintained wherein
				essential information regarding such drugs may be obtained. Investigational
				drugs in use shall be properly stored, distributed, and controlled maintaining
				the confidentiality of patient-medical staff information. The Director of
				Pharmacy shall be responsible for policies and procedures concerning use of
				investigational drugs.
O.C.G.A. Secs.
				 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 480-13 - HOSPITAL PHARMACY REGULATIONS › Rule 480-13-.10 - Inspections

Current through Rules and Regulations filed through June 27, 2024
(1) Monthly. The
			 Director of Pharmacy shall no less than once per month, personally or by
			 qualified designee, inspect all matters within his/her jurisdiction and
			 responsibility and make appropriate written records of such inspections. Such
			 inspections shall, at a minimum, verify that:
(a) Drugs are dispensed only by licensed
			 pharmacists or licensed pharmacy interns acting under the direct supervision of
			 a licensed pharmacist;
(b)
			 Non-licensed pharmacy personnel are properly directed and supervised;
(c) Drugs for external use are stored
			 separately, and apart from drugs for internal use or injection;
(d) Drugs requiring special storage
			 conditions to insure their stability are properly stored;
(e) No outdated drugs are stocked in the
			 hospital pharmacy or the facility it serves;
(f) Distribution and administration of
			 controlled substances are properly and adequately documented and reported by
			 both pharmacy and other licensed medical personnel;
(g) Standard ward inventory (floor stock).
			 Verification of standard ward inventory lists and accountability, including
			 such updating, if applicable, are maintained;
(h) All necessary and required security and
			 storage standards are met;
(i)
			 Metric-apothecaries' weight and measure conversion tables and charts are
			 available;
(j) All policies and
			 procedures of the Director of Pharmacy and of appropriate committees of the
			 hospital relevant to the pharmacy are followed;
(k) All discounted and out-dated medications
			 are returned to the pharmacy for proper disposition; and
(l) Disinfectants and other similar supplies
			 intended for external use are stored separately and apart from drugs intended
			 for internal (oral) or parenteral use.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-14 - DRUGS AND NARCOTICS AGENCY CLASSIFICATIONS AND MINIMUM REQUIREMENTS FOR SPECIAL AGENTS AND DEPUTY DIRECTOR › Rule 480-14-.01 - Georgia Drugs and Narcotics Agency (GDNA) Classifications and Minimum Requirements for Special Agent and Deputy Director

Current through Rules and Regulations filed through June 27, 2024
The following shall apply to said personnel of the Drugs and
				Narcotics Agency:
(1) GDNA Special
			 Agent. A GDNA Special Agent shall be a graduate of a recognized school or
			 college of pharmacy and hold a current pharmacist license issued by the Georgia
			 State Board of Pharmacy (Board). Additionally, to qualify as a GDNA Special
			 Agent, the applicant shall have:
(a) Actively
			 practiced pharmacy for at least two (2) years;
(b) No private or public sanctions on his or
			 her pharmacist license or similar licenses issued by the Board, or any other
			 Board of Pharmacy or their equivalent;
1. No
			 prior convictions for any crime other than minor traffic offenses;
2. Successfully passed a personal background
			 investigation;
3. Completed and
			 passed the Georgia Peace Officers Standards and Training (P.O.S.T.) Basic
			 Mandate Training Course to become a Georgia P.O.S.T. Certified Peace Officer
			 within one (1) year of being hired; and
4. Such other experience, qualifications and
			 training as suitable for such employment.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-15 - PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL › Rule 480-15-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For purposes of this chapter, the following definitions shall
				apply:
(a) "Board" shall mean the
			 Georgia State Board of Pharmacy.
(b) "Certified pharmacy technician" shall
			 mean a registered pharmacy technician who has either successfully passed a
			 certification program approved by the Board, or has successfully passed an
			 employer's training and assessment program approved by the Board, or has been
			 certified by either the Pharmacy Technician Certification Board (PTCB) or any
			 other nationally recognized certifying body approved by the Board.
(c) "Pharmacist" shall mean an individual
			 currently licensed by this state to engage in the practice of
			 pharmacy.
(d) Pharmacist in charge"
			 means a pharmacist currently licensed in this state who accepts responsibility
			 for the operation of a pharmacy in conformance with all laws and rules
			 pertinent to the practice of pharmacy and the distribution of drugs and who is
			 personally in full and actual charge of such pharmacy and personnel.
(e) "Pharmacy intern" shall mean an
			 individual who is a student currently enrolled in an approved school or college
			 of pharmacy, has registered with the Board, and has been licensed as a pharmacy
			 intern, or a graduate of an approved school or college of pharmacy who is
			 currently licensed by the board for the purpose of obtaining practical
			 experience as a requirement for licensure as a pharmacist, or an individual who
			 has established educational equivalency by obtaining a Foreign Pharmacy
			 Graduate Examination Committee (FPGEC) certificate and is currently licensed by
			 the Board for the purpose of obtaining practical experience as a requirement
			 for licensure as a pharmacist.
(f)
			 "Pharmacy extern" shall mean an individual who is a student currently enrolled
			 in an approved school or college of pharmacy and who has been assigned by the
			 school or college of pharmacy for the purposes of obtaining practical
			 experience and completing a degree in pharmacy.
(g) "Registered Pharmacy technician" shall
			 mean those support persons registered with the board who are utilized in
			 pharmacies and whose responsibilities are to provide nonjudgmental technical
			 services concerned with the preparation for dispensing of drugs under the
			 direct supervision and responsibility of a pharmacist.
O.C.G.A. Secs.
				 26-4-5,  26-4-27,  26-4-28,  26-4-60,  26-4-80,  26-4-82,  26-4-84,  26-4-85,  26-4-88,  26-4-110.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-15 - PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL › Rule 480-15-.02 - Registration of Pharmacy Technicians and Continuing Education Requirements

Current through Rules and Regulations filed through June 27, 2024
(1)
			 Effective August 1, 2011, a pharmacy may only employ registered pharmacy
			 technicians to perform pharmacy technician duties.
(2) In order to be registered as a Pharmacy
			 Technician in this State, an applicant shall:
(a) Submit an application to the Board on the
			 form prescribed by the Board;
(b)
			 Attest that applicant is at least 17 years old;
(c) Attest that applicant is currently
			 enrolled in high school, or has a high school diploma, or has a GED, or has a
			 postsecondary education or college degree;
(d) Consent to, provide the necessary
			 information to conduct, and pay for a background check to be conducted by the
			 Board, its agent or a firm or firms approved by the Board, which background
			 check will include a criminal history, driver license history and other
			 information as the Board deems necessary, and will authorize the Board and the
			 Georgia Drugs and Narcotics Agency to receive the results;
(e) Submit the name and address of employer
			 and place of employment;
(f) Pay
			 application fees; and
(g) If
			 certified, submit evidence of training supporting designation as
			 certified.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-15 - PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL › Rule 480-15-.03 - Use of Registered Pharmacy Technicians and Other Pharmacy Personnel

Current through Rules and Regulations filed through June 27, 2024
(a) In
			 dispensing drugs, no individual other than a licensed pharmacist, intern or
			 extern working under direct supervision of a licensed pharmacist shall perform
			 or conduct those duties or functions which require professional judgment. It
			 shall be the responsibility of the supervising pharmacist to ensure that no
			 other employee of the pharmacy, excluding pharmacy interns or externs, performs
			 or conducts those duties or functions which require professional
			 judgment.
(b) For all prescription
			 drug orders, it shall be the responsibility of the Pharmacist on duty at a
			 facility to ensure that only a pharmacist or a pharmacy intern and/or extern
			 under the direct supervision of a pharmacist provides professional consultation
			 and counseling with patients or other licensed health care professionals and
			 that only a pharmacist or a pharmacy intern or an extern under the direct
			 supervision of a pharmacist accepts telephoned oral prescription drug orders or
			 provides or receives information in any manner relative to prescriptions or
			 prescription drugs.
(c) Registered
			 pharmacy technicians and other pharmacy personnel, i.e., clerks, cashiers,
			 observers, etc., in the prescription department shall be easily identifiable by
			 use of a name badge or other similar means which prominently displays their
			 name and the job function in which the personnel are engaging at that time. Any
			 pharmacy personnel or other person present in the pharmacy department must be
			 under the direct supervision of a licensed pharmacist.
(d) In the dispensing of all prescription
			 drug orders:
1. The pharmacist shall be
			 responsible for all activities of any registered pharmacy technician in the
			 preparation of the drug for delivery to the patient.
2. The pharmacist shall be present and
			 personally supervising the activities of any registered pharmacy technician at
			 all times.
3. When electronic
			 systems are employed within the pharmacy, registered pharmacy technicians may
			 enter information into the system and prepare labels; provided, however, that
			 it shall be the responsibility of the pharmacist to verify the accuracy if the
			 information entered and the label produced in conjunction with the prescription
			 drug order.
4. When a prescription
			 drug order is presented for filling or refilling, it shall be the
			 responsibility of the pharmacist to review all appropriate information and make
			 the determination as to whether to fill the prescription drug order,
			 and
5. Any other function deemed by
			 the Board to require professional judgment.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-15 - PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL › Rule 480-15-.04 - Duties of the Pharmacist in Charge Related to Registered Pharmacy Technicians

Current through Rules and Regulations filed through June 27, 2024
(a) The Pharmacist
			 in Charge shall be responsible for:
(1)
			 providing updated information to the Board in accordance with rules and
			 regulations regarding the registered pharmacy technicians employed in the
			 pharmacy for purposes maintaining the registry of registered pharmacy
			 technicians established by the Board pursuant to paragraph (7) of subsection
			 (a) of Code Section
			  26-4-28.
(2) Ensuring the reporting the separation of
			 employment or termination of any Registered pharmacy technician for any
			 suspected or confirmed criminal occupational-related activities committed or
			 any drug-related reason, including but not limited to Adulteration, abuse,
			 theft or diversion and shall include in the notice the reason for the
			 termination.
(3) Assuring that all
			 pharmacists and pharmacy interns and externs employed at the pharmacy are
			 currently licensed and that registered pharmacy technicians employed at the
			 pharmacy are currently registered with the Board of Pharmacy.
(4) Notifying the Board of any change in the
			 employment status of all registered technicians in the pharmacy within 10 days
			 of the technician's separation date from employment,
(5) Ensuring that registered pharmacy
			 technicians in the prescription department shall be easily identifiable by use
			 of a name badge or other similar means which prominently displays their name
			 and job title. The Pharmacist-in-Charge is responsible for ensuring that such
			 persons wear or display such identification at all times when they are working
			 in the prescription department.
(6)
			 Shall ensure that the current registration for each registered pharmacy
			 technician is readily accessible for inspection by the Board or Drugs and
			 Narcotics Agents.
(7) Ensuring that
			 a pharmacist is responsible for the dispensing of all prescription drug orders
			 and for all activities of any pharmacy technician in the preparation of the
			 drug for delivery to the patient, and that a pharmacist shall be present and
			 personally supervising the activities of any pharmacy technician at all
			 times.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-15 - PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL › Rule 480-15-.05 - Duties or Functions Prohibited from Being Performed by a Registered Pharmacy Technician

Current through Rules and Regulations filed through June 27, 2024
(a) In dispensing drugs, no individual other
			 than a licensed pharmacist shall perform or conduct those duties or functions
			 which require professional judgment. It shall be the responsibility of the
			 supervising pharmacist to ensure to that no other employee of the pharmacy,
			 excluding pharmacy interns or externs but including registered pharmacy
			 technicians, performs, or conducts those duties or functions which require
			 professional judgment. The following functions require the professional
			 judgment of a pharmacist, or a pharmacy intern or extern, under the direct
			 supervision of a pharmacist, and may not be performed by a registered pharmacy
			 technician:
(1) Acceptance of telephoned or
			 other oral prescriptions;
(2)
			 Transfers of prescription drug orders from another pharmacy or transfers of a
			 prescription drug order to another pharmacy;
(3) Patient counseling;
(4) Receiving information or providing
			 information about a prescription drug order;
(5) Making the determination as to whether to
			 refill the prescription drug order;
(6) Certification of a filled and finished
			 prescription drug order;
(7)
			 Weighing or measuring active ingredients without a mechanism of
			 verification;
(8) Compounding of
			 medication without a mechanism of verification;
(9) Giving a completed prescription to the
			 patient requesting same without the label and contents and the label being
			 verified by a pharmacist.
(10)
			 Reconstitution of prefabricated medication without a mechanism of
			 verification;
(11) Verification of
			 the constituents of final IV admixtures for accuracy, efficacy, and patient
			 utilization;
(12) Enter of order on
			 patient medication profiles without verification by a pharmacist;
(13) Provision of drug information that has
			 not been prepared or approved by the pharmacist;
(14) Review of the patient record for
			 therapeutic appropriateness; and
(15) Any other act prohibited by Board rule,
			 or law.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-15 - PHARMACY TECHNICIANS AND OTHER PHARMACY PERSONNEL › Rule 480-15-.06 - Other Pharmacy Personnel

Current through Rules and Regulations filed through June 27, 2024
(1) Effective June 1, 2016, a pharmacy may
			 permit pharmacy observers to shadow licensed pharmacists for the limited and
			 exclusive purpose of education about the practice of pharmacy.
(2) Requirements. In order to be pharmacy
			 observer, an individual must:
(a) Be at least
			 seventeen (17) years old;
(b) Be
			 currently enrolled in high school or in general education diploma preparation
			 courses; and
(c) Not have been
			 convicted of a felony and/or any offense that was related to drugs and have an
			 attestation by the principal of his/her school or parent or guardian stating
			 that the observer has neither been convicted of a felony or any offense that
			 was related to drugs.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-16 - MISCELLANEOUS GUIDELINES FOR PHARMACISTS › Rule 480-16-.01 - Report of Unlicensed Dispensing or Impaired Pharmacist

Current through Rules and Regulations filed through June 27, 2024
(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.
O.C.G.A. Secs. 26-4-37,
				 26-4-28,  26-4-60,  26-4-80,  26-4-112.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-16 - MISCELLANEOUS GUIDELINES FOR PHARMACISTS › Rule 480-16-.02 - Receipt of Prescription Drug Order by a Non-Pharmacy

Current through Rules and Regulations filed through June 27, 2024
(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.