reglab/statecodes huggingface dataset:
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-16 - MISCELLANEOUS GUIDELINES FOR PHARMACISTS › Rule 480-16-.03 - Return of Previously Dispensed Drugs or Devices

Current through Rules and Regulations filed through June 27, 2024
(1) It shall be unlawful, and a violation of
			 these rules, for any licensed pharmacist or pharmacy licensed under O.C.G.A.
			  26-4 to  accept for refund purposes, or otherwise, any unused portion of a drug
			 which has been previously dispensed via a prescription drug order and delivered
			 to the patient or patient's caregiver, except where permitted under state
			 and/or federal law or regulation.
(a) Such
			 receipt is deemed detrimental to the public health due to the likelihood that
			 such drugs, once out of the control of the pharmacy, could have been tampered
			 with, been adulterated, or become contaminated with communicable diseases
			 and/or contagious diseases under the holder thereof;
(b) In addition, such receipt would tend to
			 create a health problem if placed in stock and could be reused by any licensed
			 pharmacist or pharmacy.
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-.04 - Damaged Pharmaceuticals and Other Items

Current through Rules and Regulations filed through June 27, 2024
(1) Any drugs, poisons, narcotics, family
			 remedies, grocers' drugs, flavoring extracts, essences, toilet articles, stock
			 powders, veterinary supplies, proprietary preparations and any and all other
			 and similar items intended for internal or external use of humans or animals
			 which have been subjected to heat and/or water resulting from fire and/or water
			 damage to a building or storage area in which said items were stored or
			 retained is prohibited from being introduced into the stream of retail commerce
			 without first causing an inspection of said items to determine their
			 suitability for use as intended.
(a) Certain
			 of the above classes of items when subjected to heat and/or water as a result
			 of fire and/or water damage to a building or storage area in which said items
			 are stored or retained are chemically altered or otherwise contaminated and
			 therefore rendered unsafe and unfit for use of man or animal as
			 intended.
(b) If certain of the
			 above classes of items or units thereof are entered into the stream of retail
			 commerce and sold for the internal or external use of humans or animals
			 following their having been subjected to heat and/or water as a result of fire
			 and/or water damage as aforesaid without first being inspected to determine
			 their suitability for use as intended, they shall be considered adulterated or
			 misbranded and will be subject to confiscation. Those persons placing them into
			 the stream of retail commerce shall be subject to penalties and/or reprimands
			 by the Board.
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-.05 - Deceptive Advertising

Current through Rules and Regulations filed through June 27, 2024
(1) No person or entity licensed under
			 O.C.G.A.  26-4 shall engage in fraudulent or deceptive advertising or
			 promotional procedures with respect to drugs, devices, cosmetics, poisons, or
			 other substances subject to the provisions of O.C.G.A. Sections  16-13 or 
			  26-3.
O.C.G.A. Secs.
				 16-13-34,  26-3-16,  26-4-27,  26-4-28,  26-4-60.
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-.06 - Theft, Loss, or Unaccounted for Controlled Substances

Current through Rules and Regulations filed through June 27, 2024
(1) The theft,
			 loss, or the discovery of unaccounted for controlled substances, within three
			 (3) days of its discovery, must be reported to the GDNA.
(2) A written report must be made regarding
			 any theft or significant loss, as defined under
			  21 C.F.R. 1301.76, of controlled substances by
			 completing a DEA Form 106 and submitted to the Drug Enforcement Administration,
			 with a copy to the GDNA.
(3) The
			 report shall include the following information:
(a) Full name and address of the
			 pharmacy;
(b) Pharmacy DEA
			 registration number;
(c) Date of
			 theft, loss, or discovery of missing controlled substance;
(d) Type of incident, i.e. theft, loss,
			 etc.;
(e) List of cost codes, or
			 identification symbols on package stolen; and
(f) List of the controlled substances
			 missing.
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-.07 - Release of Confidential Prescription Drug Order Information

Current through Rules and Regulations filed through June 27, 2024
Confidential prescription drug order information means
				information maintained by the pharmacist in the patient's records or which is
				communicated to the patient as part of patient counseling which is privileged
				and may be released only to the patient, to the patient's designee, or to those
				practitioners and other pharmacists where, in the pharmacist's professional
				judgement, such release is necessary to protect the patient's health and well
				being; and to such other persons or government agencies authorized by law to
				receive such confidential information.
(a) An electronically transmitted
			 prescription drug order from a prescriber to a pharmacist shall be considered a
			 highly confidential transaction and the said transmission shall not be
			 compromised by interventions, control, change, altering, or manipulation by any
			 other person or party in any manner whatsoever;
(b) Any pharmacist that transmits, receives,
			 or maintains any prescription drug order or prescription drug order refill
			 authorization either orally, in writing, or electronically shall ensure the
			 security, integrity, and confidentiality of the prescription and any
			 information contained therein;
(c)
			 Information contained in the patient medication record or profile shall be
			 considered confidential as defined by this Rule.
(d) Confidential information may be released
			 to the following:
1. The patient;
2. The patient's authorized
			 representative;
3. The prescriber,
			 or other licensed health care practitioners then caring for the
			 patient;
4. Another licensed
			 pharmacist for purposes of transferring a prescription or as a part of a
			 patient's drug utilization review, or other patient counseling
			 requirements;
5. The Board, or its
			 representative; or
6. Any law
			 enforcement personnel duly authorized to receive such information such as a
			 GDNA agent, DEA Agent, or Georgia Medicaid Agent.
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-.08 - Purchase or Receipt of Drugs by a Pharmacy

Current through Rules and Regulations filed through June 27, 2024
All pharmacies are required to purchase or receive dangerous
				drugs and/or controlled substances from a firm licensed by this state as a drug
				wholesaler, distributor or manufacturer.
O.C.G.A. §§
									26-4-27,  26-4-28,  26-4-60, and
				 26-4-113.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-17 - ISSUANCE OF INTRAVENOUS MAINTENANCE DRUGS TO REGISTERED PROFESSIONAL NURSES EMPLOYED OR CONTRACTED BY A HOME HEALTH AGENCY › Rule 480-17-.01 - Purpose

Current through Rules and Regulations filed through June 27, 2024
According to O.C.G.A.
				 16-13-72(4.2),
				a registered professional nurse licensed under O.C.G.A.
				 43-26-6 who is employed or contracted by a licensed home health agency may possess
				sterile saline, sterile water and diluted heparin for use as intravenous
				maintenance for use in a home health setting, and such nurse may administer
				such items to patients of the home health agency upon the order of a licensed
				physician. The State Board of Pharmacy shall be authorized to adopt regulations
				governing the storage, quantity, use and administration of such items; provided
				however, nothing in this paragraph or in such regulations shall be construed to
				restrict any authority of nurses existing under other provisions of the
				law.
O.C.G.A. Secs.
				 16-13-72(4.2),
				26-4-27.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-17 - ISSUANCE OF INTRAVENOUS MAINTENANCE DRUGS TO REGISTERED PROFESSIONAL NURSES EMPLOYED OR CONTRACTED BY A HOME HEALTH AGENCY › Rule 480-17-.02 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(1) Home Health
			 Agency. Home Health Agency (HHA) means a public, non-profit, or proprietary
			 organization which is licensed by the Georgia Department of Human Resources
			 (DHR) to engage in providing home health services to individuals who are under
			 a written plan of care of a physician, on a visiting basis in the places of
			 residence used as such individuals' homes' part-time or intermittent nursing
			 care provided by or under the supervision of a registered professional
			 nurse;
(2) Home Health Services.
			 Home Health Services (HHS) means those items and services furnished to an
			 individual according to a written plan of treatment signed by the patient's
			 physician, by a home health agency on a visit or hourly basis, in place of
			 temporary or permanent residence used as the individual's home;
(3) Hospital. Hospital means an institution
			 which is primarily engaged in providing to inpatients and outpatients, by or
			 under the supervision of physicians, diagnostic services and therapeutic
			 services for medical diagnosis, treatment, and care of injured, disabled, or
			 sick persons or rehabilitation services for the rehabilitation of injured,
			 disabled, or sick persons. Such term includes public, private, psychiatric,
			 rehabilitative, geriatric, osteopathic, and other specialty
			 hospitals.
(4) Issuing Pharmacy.
			 Issuing Pharmacy means a pharmacy licensed as a retail pharmacy by the Georgia
			 State Board of Pharmacy and which is authorized by this chapter to issue
			 Sterile Drug Intravenous (IV) Maintenance Kits (SDM Kits) for use in a home
			 health setting by registered professional nurses employed or contracted by a
			 licensed home health agency.
(5)
			 Registered Professional Nurse. Registered Professional Nurse (RN) means a
			 person who is authorized by a license issued under O.C.G.A.  43-26 to  practice
			 nursing as a registered professional nurse and is authorized to use the
			 abbreviation "RN".
(6) Sterile Drug
			 Intravenous Maintenance Kits. Sterile Drug Intravenous (IV) Maintenance Kits
			 (SDM Kits) are sealed containers whose contents are strictly limited to the
			 drugs sterile saline, sterile water, and diluted heparin, and which can only be
			 distributed by an Issuing Pharmacy to professional registered nurses employed
			 or contracted by a home health care agency.
O.C.G.A. Secs.
				 16-13-72(4.2),
				26-4-27.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.02 - Licensure and Registration

Current through Rules and Regulations filed through June 27, 2024
(1) All opioid treatment program (OTP)
			 clinics must have an on-site pharmacy. All such pharmacies shall obtain a
			 license by registering with the Georgia State Board of Pharmacy (Board). Such
			 license shall be renewed biennially with the Board. Before a Board license can
			 be issued, an opioid treatment program clinic must meet all the requirements
			 for licensure and registration as provided by both state and federal law and
			 all Board rules.
(2) Licensure and
			 Applications
.
Certificates of registration or
			 licensure shall be issued only to those opioid treatment program clinic
			 pharmacies who meet the following requirements:
(a) Submission of an application with the
			 following information:
1. The name, full
			 business address, and telephone number of the licensee;
2. All trade or business names used by the
			 licensee;
3. Address, telephone
			 number, and the name of the Director of Pharmacy
4. The type of ownership or operation (i.e.,
			 partnership, corporation, or sole proprietorship); and
5. The name(s) of the owner and/or operator
			 of the licensee, including:
(i) If a person,
			 the name of the person;
(ii) If a
			 partnership, the name of the partnership and the name of each
			 partner;
(iii) If a sole
			 proprietorship, the full name of the sole proprietorship and the name of the
			 business entity; or
(iv) If a
			 corporation, the corporate name, the name and title of each corporate officer
			 and director, the state of incorporation; and the name of the parent company,
			 if any.
(v) If operations are
			 conducted at more than one location by a single opioid treatment program clinic
			 pharmacy, each such location shall be licensed by the Board.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.03 - Personnel

Current through Rules and Regulations filed through June 27, 2024
The personnel shall be as follows:
(a) Director of Pharmacy Services. Each OTP
			 clinic pharmacy shall be under the direction of a Director of Pharmacy
			 Services, hereafter referred to as the Director. The Director shall:
1. Direct, oversee and be responsible for all
			 activities related to pharmacy transactions at an opioid treatment program
			 clinic pharmacy;
2. Be a pharmacist
			 licensed by the Board to practice;
3. Be charged with meeting all of the
			 requirements of applicable state and federal laws and rules;
4. Be employed on a full-time or part-time
			 basis consistent with the need and objectives of the OTP clinic.
5. Shall have such other duties and
			 responsibilities as set forth in this chapter.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.04 - Absence of a Pharmacist

Current through Rules and Regulations filed through June 27, 2024
The following regulations shall be followed in the absence of a
				pharmacist:
(1) General. Access to
			 drugs in the absence of a licensed pharmacist shall be limited to specifically
			 authorized licensed medical personnel consistent with policies and procedures
			 of the Director. Such areas shall be sufficiently secure to deny access by
			 unauthorized persons. The Director shall, in conjunction with the appropriate
			 committee of the narcotic treatment program clinic, develop a list of the drugs
			 to be accessible and shall ensure that:
(a)
			 Such drugs available therein, are properly labeled, with drug name, strength,
			 lot number and expiration date;
(b)
			 Only prepackaged drugs are available therein, in amounts sufficient for
			 immediate therapeutic requirements;
(c) Whenever access to such area shall have
			 been gained, written physician's orders and proof of use for controlled
			 substances are provided;
(d) All
			 drugs therein are inventoried no less than once per week. A system of
			 accountability must exist for all drugs contained therein; and
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.05 - Physical Requirements and Equipment

Current through Rules and Regulations filed through June 27, 2024
(1) Physical Area. An OTP clinic pharmacy
			 shall have within the clinic which it serves, sufficient floor space allocated
			 to it to insure that drugs are prepared in sanitary, well-lighted and enclosed
			 space, and which meet the other requirements of this section, the Georgia
			 Pharmacy laws, and other applicable state and federal laws and rules. Such
			 space shall be at a minimum 150 square feet. Such space shall include all areas
			 which are assigned and under the direct control of the Director.
(2) Minimum equipment. No OTP clinic pharmacy
			 licensed in accordance with O.C.G.A. Title 26, Ch. 4 shall engage in the
			 practice of filling, compounding or dispensing prescription drugs for an OTP
			 Clinic unless it shall possess the following items:
(a) Copies of and/or electronic access to
			 current reference materials appropriate to the practice of pharmacy related to
			 OTP. These reference materials shall be authoritative on at least the topics of
			 drug interactions; patient counseling; compounding and pharmaceutical
			 calculations; and generic substitution.
(b) Authoritative, current antidote
			 information as well as the telephone number of the regional poison control
			 information center shall be posted or readily available in areas both inside
			 and outside of the pharmacy where drugs are stored or patients are being cared
			 for.
(c) Current copies or
			 electronic or computer access to the following:
1. The Georgia Pharmacy Practice Act/Drug and
			 Cosmetic Act, O.C.G.A. §§
										26-4 and   26-3;
2. The Georgia Controlled Substances
			 Act/Dangerous Drug Act, O.C.G.A. §
										16-13;
3. The official rules of the Georgia State
			 Board of Pharmacy.
(d)
			 Equipment:
1. Sink in working condition with
			 both hot and cold running water;
2.
			 Two spatulas;
3. One oral solid
			 counting tray;
4. Typewriter, word
			 processor or computer with label printer;
5. A refrigerator in working order with a
			 thermometer.
6. Any other equipment
			 the Board may deem necessary for a specialized practice setting where such a
			 specialized practice takes place.
(e) Weighing and labeling:
1. Appropriate prescription labels consistent
			 with the requirements of O.C.G.A. §§
										16-13,  26-3 and   26-4;
			 and
2. Appropriate auxiliary labels
			 that should be used in the pharmacist's professional judgement.
3. If compounding onsite using components
			 which must be weighed, Class A Balance with an assortment of metric weights or
			 a Class I or II Electronic Balance.
(f) An adequate supply of drugs used in an
			 OTP Clinic setting.
(g) Assorted
			 sizes and types of appropriate dispensing containers.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.07 - Delivery of Drugs, General

Current through Rules and Regulations filed through June 27, 2024
(1) No drug shall be dispensed or
			 administered except upon receipt of a medication drug order written by a
			 licensed medical practitioner granted rights to prescribe in an OTP.
(a) A licensed medical practitioner must
			 write an initial dosing medication order for each patient prior to any
			 medication being dispensed or prepared by the OTP clinic pharmacy.
(b) In emergency situations, a verbal order
			 may be given by the physician and it must be signed by the physician within 72
			 hours, or such order would be considered a violation of these rules.
(c) Any adjustment to a patient's dosage
			 regimen is considered to be a new medication order. Such orders shall be
			 written per protocol developed by the clinic's medical director and signed by
			 the ordering physician within 72 hours.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.08 - Drugs From Outside Sources

Current through Rules and Regulations filed through June 27, 2024
(1) The Director shall establish policies and
			 procedures relating to drugs brought into the OTP clinic by outside sources.
			 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. These medications shall be kept in the pharmacy. 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 returned to
			 the patient upon discharge. Nothing in this section shall prohibit another
			 method of accomplishing the intent of this section provided such method is
			 approved by the Board.
O.C.G.A. Secs.
				 16-13-34,  16-13-41,  16-13-74,  26-4-27,  26-4-28,  26-4-80,  26-4-87,  26-4-110,  26-4-111.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.09 - Inspections

Current through Rules and Regulations filed through June 27, 2024
(1)Board
			 Inspection. The Board, through either the GDNA or by its qualified designee,
			 shall, at a minimum, inspect each OTP clinic pharmacy once every two (2) years
			 to verify compliance with the laws and these rules and regulations.
(a) The Director shall maintain a copy of the
			 inspection report in the OTP clinic pharmacy and shall submit a copy of the
			 report to the DHR Methadone Authority.
(b) Any discrepancies or deficiencies noted
			 shall be corrected within thirty (30) days of the inspection.
(c) Written notice of such corrections or a
			 plan of action to correct deficiencies shall be filed with the GDNA within
			 thirty (30) days after receipt of the inspection report.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-18 - OPIOID TREATMENT PROGRAM CLINIC PHARMACIES › Rule 480-18-.10 - Notification Required by the Georgia Department of Human Resources

Current through Rules and Regulations filed through June 27, 2024
Whenever the DHR central registry determines that a patient is
				improperly utilizing more than one OTP at the same time, and notifies the
				Director, the Director shall notify the Board and the GDNA.
O.C.G.A. Secs.
				 16-13-34,  16-13-43,  26-4-27,  26-4-28,  26-4-29,  26-4-60,  26-4-82,  26-4-111.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-19 - EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES › Rule 480-19-.01 - Excepted Sales of Non-Pseudoephedrine Schedule V Controlled Substances

Current through Rules and Regulations filed through June 27, 2024
Excepted Sales of Non-Pseudoephedrine Schedule V Controlled
				Substances. No person shall obtain or attempt to obtain, sell, dispense or
				otherwise dispose of any non-pseudoephedrine substance included in Schedule V
				of the Georgia Controlled Substances Act, except as herein provided, and as in
				compliance with all other applicable laws, rules and regulations. All terms
				used in this section shall have the same meaning as in O.C.G.A. T. 16, Ch. 14
				and T. 26, Ch. 4, as amended.
(a) A
			 physician or medical practitioner may dispense Schedule V substances for
			 legitimate medical purposes in the normal course of his/her professional
			 practice.
(b) A licensed
			 pharmacist, or intern acting under the immediate and direct supervision of a
			 licensed pharmacist, may sell, dispense or otherwise dispose of without
			 prescription not more than 4 oz. or 32 dosage units of an exempted
			 non-pseudoephedrine Schedule V controlled substance within any 48 hour period
			 of time, but only:
1. After applying
			 reasonable means or effort to determine that such is to be used for legitimate
			 medical purpos
e
s; and
2. After the purchaser has written his/her
			 signature, date of birth, address, city, state and zip code upon a register
			 which records and reflects the date of such transaction, the name, kind,
			 quantity and intended use of such Schedule V substance sold, dispensed, or
			 otherwise disposed of, and such records shall be maintained as required by
			 Schedule V records.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-19 - EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES › Rule 480-19-.02 - Exempt Non-Pseudoephedrine Schedule V Controlled Substances

Current through Rules and Regulations filed through June 27, 2024
Before the sale of any non-pseudoephedrine Schedule V
				Controlled Substance without a prescription, a licensed pharmacist should first
				determine whether or not the product to be sold is packaged in a container with
				not more than 4 ounces or 32 dosage units of the drug, and whether the label
				provided by the product manufacturer contains a Federal Caution or Warning. If
				such Legend or Warning or Rx Only indication is present on the manufacturer's
				label, this product cannot be sold without a prescription.
O.C.G.A. Secs.
				 16-13-22,  16-13-34,  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 480-19 - EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES › Rule 480-19-.03 - Over-thecounter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine

Current through Rules and Regulations filed through June 27, 2024
(a) No person shall obtain or attempt to
			 obtain, sell, dispense or otherwise distribute any exempt Schedule V controlled
			 substance drug product containing pseudoephedrine as listed under O.C.G.A.
			  16-13-29(5), except as herein provided, and as in compliance with all other applicable state
			 or federal laws, rules and regulations. All terms used in this section shall
			 have the same meaning as in O.C.G.A. T.16, Ch. 13 and T. 26, Ch. 4.
1) All exempt Schedule V controlled substance
			 pseudoephedrine containing drug products must be stored in a pharmacy's
			 prescription department.
2) All
			 pharmacy personnel who engage in the sale or distribution of exempt Schedule V
			 controlled substance containing drug products must complete the DEA's
			 self-certification training as required by the Combat Methamphetamine Epidemic
			 Act of 2005,
			  21 U.S.C. 830.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-19 - EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES › Rule 480-19-.04 - Record keeping for Over-the-counter (OTC) Sales of Exempt Schedule V Controlled Substance Drug Products containing Pseudoephedrine

Current through Rules and Regulations filed through June 27, 2024
(a) A record created this rule must be
			 maintained in the pharmacy at which the transaction occurred, except that
			 records may be kept either at a single, central location for the pharmacy or by
			 a third party information technology company on behalf of the pharmacy only if
			 the pharmacy has notified the GDNA of its intention to do so and received GDNA
			 approval.
(1) Written notification must be
			 submitted by registered or certified mail, return receipt requested, to the
			 Director, Georgia Drugs and Narcotics Agency, 40 Pryor Street, SW, Suite 2000,
			 Atlanta, Georgia 30303.
(2) This
			 notification must include telephone and address contact information as well as
			 a telephone number and email address for a point of contact person who is
			 responsible for providing requested record for either the pharmacy's central
			 record keeping location or any third party information technology
			 company.
(3) The Director of the
			 Georgia Drugs and Narcotics Agency shall issue written approval of any central
			 record keeping location or third party information technology company prior to
			 records being maintained in such a manner.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-19 - EXEMPT OVER-THE-COUNTER (OTC) SCHEDULE V CONTROLLED SUBSTANCES › Rule 480-19-.05 - Exceptions to Exempt Schedule V Controlled Substance Drug Products Containing Pseudoephedrine Sales

Current through Rules and Regulations filed through June 27, 2024
(a) Any drug product containing
			 pseudoephedrine which comes in a container packaged by the its manufacturer
			 with and its label contains a Federal Caution or Rx Only indication, this
			 product is not an exempt narcotic under this rule and cannot be sold as an
			 Exempt OTC Schedule V drug product and can only be dispensed by a pharmacist,
			 or pharmacy intern or pharmacy extern acting under the direct supervision of a
			 registered pharmacist upon receipt of a prescription issued by a licensed
			 practitioner.
(1) Such prescriptions should
			 be filed and maintained in the manner set forth for Schedule III, IV or V
			 controlled substance prescriptions.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-20 - REGISTRATION REQUIREMENTS UNDER GEORGIA CONTROLLED SUBSTANCES ACT › Rule 480-20-.01 - Registration of Retail Pharmacies, Hospital Pharmacies, Opioid Treatment Program Clinic Pharmacies, Clinic Pharmacies, Nuclear Pharmacies, Prison Clinic Pharmacies, Manufacturers, Drug Wholesalers and Distributors, Researchers, and Reverse Distributors

Current through Rules and Regulations filed through June 27, 2024
A person or firm issued a license or a permit by the Georgia
				Board of Pharmacy as a pharmacist, pharmacy intern, retail pharmacy, hospital
				pharmacy, opioid treatment program clinic pharmacy, clinic pharmacy, nuclear
				pharmacy, prison clinic pharmacy, manufacturer, drug wholesale distributor,
				researcher, or reverse distributor under the provisions of O.C.G.A.
				 16-13-35 and  registered with the Drug Enforcement Administration under the provisions of
				the Federal Controlled Substances Act are hereby registered likewise concerning
				the same schedules and substances under the Georgia Controlled Substances Act,
				and are exempt from the application and fee requirements of O.C.G.A.
				 16-13-34.
O.C.G.A. Secs.
				 26-4-27,  16-13-34..
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-20 - REGISTRATION REQUIREMENTS UNDER GEORGIA CONTROLLED SUBSTANCES ACT › Rule 480-20-.02 - Record-Keeping Requirements For Registrants

Current through Rules and Regulations filed through June 27, 2024
(1) Each registrant shall maintain records of
			 unusual orders of controlled substances received by the registrant and s hall
			 inform the Off ice of the Director of the Georgia Drugs and Narcotics Agency
			 (GDNA) of unusual orders when discovered by the registrant. For purposes of
			 this section, an unusual order shall include orders of greatly increased
			 quantity, orders deviating substantially from a normal pattern, and orders of
			 highly abnormal frequency.
(2)
			 Before distributing or transferring any controlled substance and/or a dangerous
			 drug, without a prescription drug or der, to any customer, a registrant must
			 ensure such customer is properly licensed or registered to purchase, receive,
			 or possess such drug(s) by maintaining, on file, a copy of the current license
			 or registration for any and all such customers. Any transfer, sale,
			 distribution of a drug to an unlicensed or unregistered customer shall be
			 deemed to be in violation of O.C.G.A.
			  26-4-115,  16-13-30 and /or 16-13-72.
O.C.G.A. §§
									16-13-34,  26-4-27,  26-4-115.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For the purpose of these rules and regulations, the following
				definitions apply:
(a) Retail Pharmacy
			 Providing Home Health Care Services. A retail pharmacy providing home health
			 care services is defined as a licensed retail pharmacy that routinely prepares
			 and dispenses compounded, sterile parenteral products to outpatients.
(b) Outpatient. An outpatient is defined as a
			 patient in the home environment or an institutionalized patient that is
			 receiving compounded, sterile parenteral products from a pharmacy outside the
			 institution.
(c) Compounded,
			 Sterile Parenteral Products. Compounded, sterile parenteral products are
			 defined as those parenteral drug products that require preparation by the
			 pharmacist and which must be sterile, stable, and effective when dispensed for
			 patient use.
O.C.G.A. Secs.
				26-4-3726-4-27,
				 26-4-28,  26-4-110,  26-4-111.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.02 - Registration

Current through Rules and Regulations filed through June 27, 2024
All retail pharmacies providing home health care services must
				have a current retail pharmacy permit. Therefore, they must comply with all
				retail pharmacy laws and regulations as well as the special regulations
				contained in these rules.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-110, and
				 26-4-111.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.03 - Personnel

Current through Rules and Regulations filed through June 27, 2024
(1)
			 Pharmacist-in-Charge. The pharmacist-in-charge at each retail pharmacy
			 providing home health care services shall be knowledgeable in the specialized
			 functions of preparing and dispensing compounded, sterile parenteral products,
			 including the principles of aseptic technique and quality assurance. This
			 knowledge is may be obtained through residency training programs, continuing
			 education programs, or experience in an IV admixture facility. The
			 pharmacist-in-charge shall be responsible for the purchasing, storage,
			 compounding, repackaging, dispensing, and distribution of all drugs and
			 pharmaceuticals. The pharmacist-in-charge shall also be responsible for the
			 development and continuing review of all policies and procedures, training
			 manuals, and the quality assurance programs. The pharmacist-in-charge may be
			 assisted by additional pharmacists adequately trained in this area of
			 practice.
(2) Supportive Personnel.
			 The pharmacist-in-charge may be assisted by supportive personnel. These
			 personnel shall have specialized training in this field, and shall work under
			 the direct supervision of a licensed pharmacist. The training provided to these
			 personnel shall be described in writing in a training manual. The duties and
			 responsibilities of these personnel must be consistent with their training and
			 experience.
(3) Secretarial
			 Personnel. Secretarial and clerical support shall be provided as required to
			 assist with record keeping and other administrative duties.
(4) Staffing. A licensed pharmacist shall be
			 accessible at all times at each such licensed facility to respond to patients'
			 and other health professionals questions and needs.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-110,  26-4-111.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.04 - Physical Requirements

Current through Rules and Regulations filed through June 27, 2024
The physical requirements are:
(a) Space. Each retail pharmacy providing
			 home health care services shall have a designated area for preparing
			 compounded, sterile parenteral products. This area shall be physically separate
			 from other areas and should be designed to avoid unnecessary traffic and
			 airflow disturbances. The minimum space shall be 150 square feet. It shall be
			 used only for the preparation of specialty products. It shall be of sufficient
			 size to accommodate a laminar airflow hood and to provide for the proper
			 storage of drugs and supplies under appropriate conditions of temperature,
			 light, moisture, sanitation, ventilation, and security.
(b) Equipment.
1. Laminar Airflow Hood; or Class 100 Clean
			 Room;
2. Infusion Pumps, if
			 appropriate;
3. Sink, in working
			 condition, with hot and cold running water, which is convenient to the
			 compounding area for the purpose of hand scrubs prior to compounding;
4. Equipment for light/dark field
			 examination;
5. Appropriate
			 disposal containers for used needles, syringes, etc., and if applicable,
			 cytotoxic waste from the preparation of chemotherapy agents;
6. A Class II, vertical flow biological
			 safety cabinet, if chemotherapy agents are routinely prepared;
7. Refrigerator/Freezer with a thermometer
			 and in working condition.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.05 - Drug Distribution and Control

Current through Rules and Regulations filed through June 27, 2024
Regulations are:
(a)
			 General. A drug distribution system is the entirety of that mechanism by which
			 a physician's prescription drug order is executed, from the time the drug is
			 ordered and received in the pharmacy, to the time the prescribed drug is
			 dispensed to the patient.
(b)
			 Purchasing. All drugs and pharmaceutical products purchased and dispensed by a
			 retail pharmacy providing home health care services shall meet national
			 standards of quality (USP-NF standards) and shall be clearly and accurately
			 labeled by the manufacturer or distributor as to contents.
(c) Policy and Procedure Manual. A policy and
			 procedure manual shall be prepared and maintained at each retail pharmacy
			 providing home health care services and be available for inspection by agents
			 of the Georgia Drugs and Narcotics Agency. The policy and procedure manual
			 shall set forth in detail the objectives and operational guidelines of the
			 pharmacy. The manual shall be reviewed and revised at a minimum on an annual
			 basis. A copy shall be provided to the Board of Pharmacy when applying for a
			 permit or engaging in this specialized area of practice.
(d) Prescription Drug Order. The pharmacist
			 or pharmacy intern/extern acting under the direct supervision of a licensed
			 pharmacist must receive a written or verbal prescription drug order from a
			 physician before dispensing any compounded, sterile parenteral product or other
			 drug. Prescriptions drug orders may be filed by patient, assigned consecutive
			 numbers, or any other system that assures a complete, retrievable and accurate
			 record. A new prescription drug order is required every six (6) months if the
			 physician does not specify a course of therapy. These prescriptions drug orders
			 shall, at a minimum, contain the following:
1.
			 Patient's full name;
2. Patient
			 address for a controlled substance;
3. Drug name, strength, and dispensing
			 quantity;
4. Patient directions for
			 use;
5. Date of issuance;
6. Prescriber's signature;
7. Prescriber's address and drug enforcement
			 administration identification code, if applicable;
8. Refill instructions.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.06 - Cytotoxic Agents

Current through Rules and Regulations filed through June 27, 2024
The following additional requirements are necessary for those
				retail pharmacies providing home health care services that routinely prepare
				chemotherapy agents to insure the protection of the personnel involved:
(a) All chemotherapy agents should be
			 compounded in a vertical flow, Class II, biological safety cabinet. If
			 possible, other products should not be compounded in this cabinet.
(b) Protective apparel shall be worn by
			 personnel compounding chemotherapy drugs. This shall include disposable masks,
			 gloves, and gowns with tight cuffs.
(c) Proper aseptic and safety techniques
			 shall be used by personnel compounding chemotherapy agents. This shall include,
			 at a minimum, utilizing syringes and sets with luer-lock fittings, and wrapping
			 alcohol swabs around needle and neck of vials when withdrawing cytotoxic
			 solutions from a vial.
(d)
			 Appropriate disposal procedures for cytotoxic waste must be developed that
			 comply with applicable state and federal regulations.
(e) Written policies and procedures for
			 handling both major and minor spills of cytotoxic agents must be
			 developed.
(f) Prepared doses of
			 chemotherapy must be dispensed and shipped or delivered in a manner to minimize
			 the risk of accidental rupture of the primary container.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-86,  26-4-87,  26-4-110,  26-4-111.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.07 - Patient Care Guidelines

Current through Rules and Regulations filed through June 27, 2024
(1) Primary Provider. There shall be a
			 designated practitioner responsible for the patient's medical care. There shall
			 be a clear understanding between the practitioner, the patient, and the
			 pharmacist of the responsibilities of each in the areas of the delivery of
			 care, the monitoring of the patient, and the reimbursement for services. The
			 responsibilities of each person shall be documented in the patient's
			 profile.
(2) Patient Counseling A
			 pharmacist shall provide to the patient or patient's care-giver any information
			 required for the use of the drugs, supplies and equipment being dispensed. The
			 pharmacist must document the patient's counseling in the pharmacy's patient
			 profile.
(3) Pharmacist-Patient
			 Relationship. It is imperative that a pharmacist-patient relationship be
			 established and maintained throughout the patient's course of therapy. The
			 patient should be contacted by the pharmacist at least quarterly. This contact
			 shall be documented in the patient's profile.
(4) Patient Monitoring. The pharmacist should
			 have access to clinical and laboratory data concerning each patient and should
			 monitor each patient's response to his drug therapy. Any unexpected or untoward
			 response should be reported to the prescribing physician. In the absence of the
			 pharmacist monitoring, it shall be documented in the patient's profile, which
			 health care provider has assumed this responsibility.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-60,  26-4-83,  26-4-85,  26-4-110,  26-4-111, and
				 43-1-19.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-21 - RETAIL PHARMACIES PROVIDING HOME HEALTH CARE SERVICES › Rule 480-21-.08 - Quality Control

Current through Rules and Regulations filed through June 27, 2024
There shall be a documented, ongoing quality control program
				that monitors personnel performance, equipment, and facilities. The end product
				shall be examined on a sampling basis as determined by the pharmacist-in-charge
				to assure that it meets required specifications.
(a) Hood Certification. All laminar flow
			 hoods shall be certified by Federal Standard 209B for operational efficiency at
			 least every 12 months. Appropriate records shall be maintained.
(b) Prefilters. Prefilters for the clean air
			 source shall be replaced on a regular basis and these activities shall be
			 documented.
(c) End Product
			 Sampling. There shall be written documentation that the end product has been
			 tested on a sampling basis for microbial contamination.
(d) Bulk Compounding. If bulk compounding of
			 parenteral solutions is performed utilizing nonsterile chemicals, extensive end
			 product testing must be documented prior to the release of the product from
			 quarantine. This process must include testing for sterility and
			 pyrogens.
(e) Expiration Dates. If
			 the product is assigned a lengthy expiration date (anything exceeding 10 days)
			 there must be in-house data or data in the literature to assure the sterility
			 and stability of the product at the time it is used by the patient.
(f) Quality Control Audits. There shall be
			 documentation of quality assurance audits at regular, planned
			 intervals.
O.C.G.A. Secs.
				 16-13-73, 26-3-80,
				 26-4-27,  26-4-28,  26-4-60,  26-4-86,  26-4-87,  26-4-110,  26-4-111.
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-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
Except as noted herein, any term contained in this chapter
				shall have the same meaning as set forth in O.C.G.A. §§
								16-13-21,  26-3-2,  26-4-5, and Title 43, Chapter 34.
O.C.G.A. Secs.
				 16-13-34,  16-13-74,  26-3-16,  26-4-27, 26-4-37, 26-4-53, 26-4-78,  43-34.
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-.02 - Purpose for Issuance of a Controlled Substance Prescription Drug Order

Current through Rules and Regulations filed through June 27, 2024
(1) For a
			 controlled substance prescription drug order to be legal, it must be issued for
			 a legitimate medical purpose by an authorized individual practitioner acting in
			 the usual course of his or her professional practice. The responsibility for
			 the proper prescribing of controlled substances is upon the prescribing
			 practitioner, but the pharmacist is responsible for the proper filling of the
			 prescription drug order. Any person knowingly filling a purported prescription
			 drug order, as well as the person issuing it, shall be subject to disciplinary
			 action.
(2) A controlled substance
			 prescription drug order issued by an individual practitioner, in his or her
			 name or written "For Office Use" to obtain a controlled substance for the
			 purpose of general dispensing or administration to patients in his/her office
			 shall not be filled by a pharmacist.
O.C.G.A. Secs.
				 16-13-34,  16-13-41,  26-4-27,  26-4-60,  26-4-80.