reglab/statecodes huggingface dataset:
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-4 - DUPLICATE WALL CERTIFICATES AND\OR LICENSES › Rule 480-4-.02 - Repealed

Current through Rules and Regulations filed through June 27, 2024
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-4 - DUPLICATE WALL CERTIFICATES AND\OR LICENSES › Rule 480-4-.03 - Repealed

Current through Rules and Regulations filed through June 27, 2024
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37, 26-4-76,
				 43-1-19.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-4 - DUPLICATE WALL CERTIFICATES AND\OR LICENSES › Rule 480-4-.04 - Repealed

Current through Rules and Regulations filed through June 27, 2024
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37, 26-4-76,
				 43-1-19.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-4 - DUPLICATE WALL CERTIFICATES AND\OR LICENSES › Rule 480-4-.05 - Repealed

Current through Rules and Regulations filed through June 27, 2024
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37, 26-4-76,
				 43-1-19.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-4 - DUPLICATE WALL CERTIFICATES AND\OR LICENSES › Rule 480-4-.06 - Repealed

Current through Rules and Regulations filed through June 27, 2024
O.C.G.A. Secs.
				 26-4-27,  26-4-28, 26-4-37.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-5 - BOARD ACTIONS AND CODE OF CONDUCT › Rule 480-5-.01 - Suspension, Revocation, or Other Actions on Licenses Issued by the Board

Current through Rules and Regulations filed through June 27, 2024
Under the authority granted by the Georgia Pharmacy Practice
				Act, O.C.G.A. T. 26, Ch. 4, and O.C.G.A. Section
				 43-1-19, the Georgia State Board of Pharmacy ("Board") shall have the power to
				reprimand, cancel, suspend, revoke, or otherwise restrict any license or permit
				issued by the Board. The specific grounds for disciplinary action are found in
				O.C.G.A. Section
				 43-1-19 and  O.C.G.A. T. 26, Ch. 4, and O.C.G.A. T. 16, Ch. 13. The Board shall have
				such duty, power, and authority as may be necessary to enforce O.C.G.A. T. 26,
				Ch. 4, O.C.G.A. T. 26, Ch. 3 and O.C.G.A. T. 16, Ch. 13, and any rules
				promulgated by the Board pursuant thereto.
O.C.G.A. Secs.
				 43-1-19,  26-4-49,  26-4-60,  26-4-113,  26-4-115,  16-13-37.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-5 - BOARD ACTIONS AND CODE OF CONDUCT › Rule 480-5-.02 - Responsibility of Owners and Pharmacist-In-Charge for Actions of License or Permittee

Current through Rules and Regulations filed through June 27, 2024
When the Board finds that a pharmacy, manufacturer, wholesale
				distributor, researcher or reverse drug distributor has violated the provisions
				of O.C.G.A. T. 16, Ch. 13, O.C.G.A. T. 26, Ch. 3, O.C.G.A. T. 26, Ch. 4 and/or
				the rules of the Board, the Board may issue any disciplinary order to any
				corporate owner, officer, owner, partner, or pharmacist-in-charge of the
				pharmacy, manufacturer, wholesale distributor, researcher or reverse drug
				distributor.
O.C.G.A. Secs.
				 43-1-19,  26-4-27,  26-4-28,  26-4-60,  26-4-82,  26-4-110,  26-4-113,  26-4-115.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-5 - BOARD ACTIONS AND CODE OF CONDUCT › Rule 480-5-.04 - Imparied Pharmacists, Interns and Externs

Current through Rules and Regulations filed through June 27, 2024
Pursuant to O.C.G.A. T.26, Ch. 4 and O.C.G.A. Section
				 43-1-19, whenever a pharmacist, intern or extern becomes unfit to practice pharmacy with
				reasonable skill and safety by reason of a mental or physical condition
				including impairment due to the use of alcohol, narcotics, stimulants, or other
				habit-forming drugs, the Board has the duty and authority to place appropriate
				conditions or limitations on that person's license, including conditions or
				limitations on that person's license, including suspension or revocation.
				Whenever such pharmacist, intern or extern is impaired or has otherwise
				endangered the public health and welfare while engaged in the practice of
				pharmacy, and any other Board licensee is aware of such impairment he/she has
				the obligation and duty to notify the Board of such impaired persons and their
				actions.
O.C.G.A. §§
									43-1-19,  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 480-5 - BOARD ACTIONS AND CODE OF CONDUCT › Rule 480-5-.05 - Cost Recovery

Current through Rules and Regulations filed through June 27, 2024
For any order issued in resolution of a disciplinary proceeding
				before the Board, the Board may direct any licensee found guilty of a charge
				involving a violation of any drug laws or rules to pay to the Board a sum not
				to exceed the reasonable cost of the investigation, and prosecution of the case
				and, in any case, not to exceed $25,000.00. The costs to be assessed shall be
				fixed by the Board and the costs so recovered shall be paid to the State of
				Georgia.
O.C.G.A. Secs.
				 43-1-19,  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 480-6 - PHARMACY LICENSES › Rule 480-6-.01 - Pharmacy Licenses

Current through Rules and Regulations filed through June 27, 2024
(1) Application for license:
(a) Applications must be filed with the
			 Georgia State Board of Pharmacy located at the Department of Community Health,
			 2 Peachtree Street, 6th Floor, Atlanta, GA 30303, along with the required
			 fee.
(b) Application for the
			 licensing of a pharmacy will be considered on the basis of the application
			 filed and an approval letter received from the Director of the Georgia Drugs
			 and Narcotics Agency certifying the pharmacy possesses the necessary facilities
			 and equipment for a license.
(c)
			 The application fee shall NOT be refundable.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.01 - Manufacturer's Permit

Current through Rules and Regulations filed through June 27, 2024
(1) Applications for registration for a
			 manufacturer's permit must be filed with the Office of the Georgia State Board
			 of Pharmacy ("Board") with the required fee.
(2) Registration of a manufacturer will be
			 considered on the basis of the application filed, fee paid, and a report from
			 the Director of the Georgia Drugs and Narcotics Agency (GDNA) certifying the
			 applicant possesses the necessary qualifications for a permit.
(3) Application fees shall NOT be
			 refundable.
(4) Permits shall not
			 be transferable. Permits become null and void upon the sale, or change of mode
			 of operation of the business, or location of business.
(5) Licenses are renewed for two years and
			 expire on June 30th of each odd numbered year and may be renewed upon the
			 payment of the required fee and the filing of an application for renewal. If
			 the application for renewal is not made and the fee paid before September 1st
			 of the odd numbered year, the license shall lapse and shall not be renewed, and
			 an application for reinstatement shall be required. Reinstatement is at the
			 sole discretion of the Board.
(6)
			 Upon request by the Board or its designee, any manufacturer holding a permit
			 issued by the Board that causes a dangerous drug or controlled substance
			 product to be marketed or distributed in this state shall provide, at no cost
			 to this state, a quantity of one gram or more of the pure compound of each such
			 product to the Georgia Drugs and Narcotics Agency. Such quantities of pure
			 compound will only be used for testing and analysis purposes.
(a) All quantities of a pure compound
			 provided to the Georgia Drugs and Narcotics Agency will be accounted for using
			 a perpetual inventory system, and a copy of each product inventory will be
			 available for review by the manufacturer providing the compound upon written
			 request to the Board.
(b) As the
			 manufacturer is required by this subsection to submit the dangerous drug or
			 controlled substance for analysis, the results of any chemical analysis shall
			 be considered a trade secret within the meaning of Code Section
			  50-18-72(b)(1).
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.02 - Drug Wholesale, Distribution Permits

Current through Rules and Regulations filed through June 27, 2024
(1) Definitions. For the purpose of this
			 chapter, definitions include:
(a) Blood means
			 whole blood collected from a single donor and processed either for transfusion
			 or further manufacturing.
(b) Blood
			 component means that part of blood separated by physical or mechanical
			 means.
(c) Brokerage means a firm
			 engaged in buying, selling, or distributing prescription drugs.
(d) Drug sample means unit of a prescription
			 drug that is not intended to be sold to, maintained by, or sold by any licensed
			 pharmacy.
(e) Manufacturer means
			 anyone who is engaged in manufacturing, preparing, propagating, compounding,
			 processing, packaging, repackaging or labeling of a prescription
			 drug.
(f) Prescription drug means
			 any drug required by Federal law or regulation to be dispensed only by a
			 prescription, including finished dosage forms and active ingredients subject to
			 Section 503(b) of the Federal Food, Drug, and Cosmetic Act.
(g) Wholesale distribution means
			 distribution, or brokerage, of prescription drugs to persons other than a
			 consumer or patient, but does not include:
1.
			 The sale, purchase, or trade of a drug or an offer to sell, purchase, or trade
			 a drug for emergency medical reasons; for purposes of this section,"emergency
			 medical reasons" includes transfers of prescription drugs by a retail pharmacy
			 to another retail pharmacy or other practitioner of the healing arts, except
			 that total sales of such drugs shall not exceed five percent (5%) of the total
			 dosage units for the transferor retail pharmacy.
2. The sale, purchase, or trade of a drug, or
			 the dispensing of a drug pursuant to a prescription;
3. The lawful distribution of drug samples by
			 manufacturers' representatives or distributors' representatives; or
4. The sale, purchase, or trade of blood and
			 blood components intended for transfusion.
h) Wholesale distributor means anyone engaged
			 in wholesale distribution or brokerage of prescription drugs, including but not
			 limited to, manufacturers, repackers, own-label distributors, private-label
			 distributors, jobbers, brokers, warehouses, including manufacturers' and
			 distributors' warehouses, chain drug warehouses, and whole drug warehouses,
			 independent wholesale drug traders, brokerage firms, and retail pharmacies that
			 conduct whole distributions.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.03 - Drug Wholesale Distribution Licensing Requirements

Current through Rules and Regulations filed through June 27, 2024
(1) Every drug wholesale distributor,
			 wherever located, who engages in drug wholesale distribution into, out of, or
			 within the State of Georgia must be licensed by the Georgia State Board of
			 Pharmacy in accordance with the laws and regulations of this State before
			 engaging in wholesale distribution of prescription drugs.
(2) Minimum Required Information for
			 Licensure: The Board requires the following from each wholesale drug
			 distributor as part of the initial licensing procedure and as part of any
			 renewal of such license.
(a) The name, full
			 business address, and telephone number of the licensee;
(b) All trade or business names used by the
			 licensee:
(c) Address, telephone
			 numbers, and the names of contact persons for the facility used by the licensee
			 for the storage, handling, and distribution of prescription drugs;
(d) The type of ownership or operations
			 (i.e., partnership, corporation, or sole proprietorship); and
(e) The name(s) of the owner and/or operator
			 of the licensee, including:
1. If a person,
			 the name of the person;
2. If a
			 partnership, the name of each partner, and the name of the
			 partnership;
3. If a corporation,
			 the name and title of each corporate officer and director, the corporate names,
			 and the name of the incorporation; and the name of the parent company, if
			 any;
4. If a sole proprietorship,
			 the full name of the sole proprietorship and the name of the business
			 entity.
(f) Where
			 operations are conducted at more than one location by a single drug wholesale
			 distributor, each such location shall be licensed by the Board.
(g) Every drug wholesale distributor in this
			 state, which is licensed by the Board, is required to be located in a
			 commercially zoned business district and possess the appropriate local business
			 license in order to conduct business. No drug wholesale distributor may be
			 located in or operate out of a residential dwelling, building, or location, or
			 a building, dwelling or location attached to a residential location. A drug
			 wholesale distributor located in a hospital pharmacy or a retail pharmacy is
			 deemed to meet this requirement.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.04 - Researcher's Permit

Current through Rules and Regulations filed through June 27, 2024
(1) Applications for registration must be
			 filed with the Office of the Georgia State Board of Pharmacy ("Board") with the
			 required fees.
(2) Registration of
			 a Researcher will be considered on the basis of the application filed and a
			 report from the director of the GDNA certifying the applicant possesses the
			 necessary qualifications for a permit.
(3) Application fees shall NOT be
			 refundable.
(4) Permits shall not
			 be transferable. Permits become null and void upon the change of mode,
			 operation and/or location of the permit-holder.
(5) Permits are renewable every two (2) years
			 and expire on June 30th of the even- numbered years. Permits may be renewed
			 upon the payment of the required renewal fee and the filing of the renewal
			 application form. If the application is not made and the fee not pa id before
			 September 1st of the even-numbered year, the permit shall lapse and shall not
			 be renewable except by application f or a new permit.
(6) Minimum Qualifications:
(a) The Board will consider the following
			 factors in determining eligibility for persons or entities applying for permits
			 to engage in research.
1. Any convictions of
			 the applicant under any Federal, State, or local laws related to dangerous
			 drugs or controlled substances;
2.
			 Any felony convictions of the applicant under any Federal, State, or local
			 laws;
3. The applicant's past
			 experience in research related to dangerous drugs including controlled
			 substances;
4. The furnishing by
			 the applicant of false or fraudulent material in any application made in
			 connection with drug research;
5.
			 Suspension or revocation by Federal, State or local government of any permit
			 currently or previously held by the applicant for drug research;
6. Compliance with the requirements under
			 previously granted permits or licenses, if any;
7. Compliance with requirements to maintain
			 and/or make available to the State licensing or permitting authority or to
			 Federal, State or local law enforcement officials those records required to be
			 maintained by researchers;
8. Any
			 other factors or qualifications such as age, education, training, etc. the
			 Board considers relevant to be inconsistent with the public health and safety;
			 and
9. Having a Peace Officer
			 Certification suspended or revoked by the Georgia Peace Officers Standard and
			 Training (POST) or other professional licensing authority.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.05 - Reverse Distributors

Current through Rules and Regulations filed through June 27, 2024
(1) Every firm, whether located inside or
			 outside the State of Georgia, which receives drugs for destruction, return
			 credit, or otherwise disposes of drugs received from a registrant located in
			 the State of Georgia which holds a permit or license to dispense or possess
			 drugs, shall be known as a Reverse Distributor or a Reverse Drug
			 Distributor.
(2) In order or any
			 Reverse Distributor, wherever located, to engage in the business of receiving
			 drugs for destruction, return credit, or other disposal from a registrant
			 located in Georgia, it must be licensed as a Reverse Distributor by the Georgia
			 State Board of Pharmacy ("Board").
(3) The minimum information required by the
			 Board in order to register a Reverse Distributor will be the same as required
			 under Rule
			  480-7-.03(2).
(4) The minimum requirements for applications
			 for registration as a Reverse Distributor with the Board will be the same as
			 required under Rule
			  480-7-.03(3).
(5) Personnel: The licensed Reverse
			 Distributor shall employ adequate personnel with the education and experience
			 necessary to safely and lawfully engage in the process of receiving drugs for
			 destruction, credit return, or other means of disposal. Each such person shall
			 have a working knowledge of the requirements for the law and rules for handling
			 such drugs.
(6) Violations:
(a) A license issued to a Reverse Distributor
			 pursuant to this part may be subject to revocation or suspension upon
			 conviction of the license holder of or an employee of a reverse distributor for
			 violations related to federal, state or local laws and/or rules.
(b) Violation of any provisions of any
			 applicable Board Rules shall be grounds for the suspension, revocation, or
			 other sanctions of the permit issued hereunder.
(c) Any action taken on a license pursuant to
			 this part shall be carried out pursuant to the Georgia Administrative Procedure
			 Act, O.C.G.A. Title 50, Chapter 13.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.06 - Background Investigations of Applicants

Current through Rules and Regulations filed through June 27, 2024
Whenever a person or firm applies for licensure under this
				Chapter, the GDNA has the authority to conduct whatever thorough background
				investigation necessary to ensure the applicant meets all
the
				requirements of this Chapter.
O.C.G.A. Secs.
				 26-4-27,  26-4-28,  26-4-29.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7 - PERMITS › Rule 480-7-.07 - Credit for Returned Expired Drugs

Current through Rules and Regulations filed through June 27, 2024
(1) Effective with all drug orders placed on
			 or after July 1, 2002, all wholesale drug distributors shall make adequate
			 provisions for the return of outdated prescription drugs, both full and partial
			 containers, for up to six months after the labeled expiration date for prompt
			 full credit or replacement.
(2)
			 Wholesale drug distributors shall establish a written policy consistent with
			 O.C.G.A. Section
			  26-4-115(c) 
			 providing for the return of outdated prescription drugs sold to a client by
			 such wholesale drug distributor. Such policy may include a procedure for the
			 drugs to be returned to the drug manufacturer, may include a requirement that
			 the drugs be returned in the original containers in which it was purchased, and
			 may include the use of a reverse drug distributor. Said policy shall be
			 available to the Board or its agents upon request.
(3) The Board has determined the following
			 listed drugs will be exempt from the requirements of this provision as they are
			 essential to health care treatment and have an expiration date of less than one
			 year from the date such drug is manufactured:
(a) Influenza Vaccines
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.02 - Listed Chemicals

Current through Rules and Regulations filed through June 27, 2024
Drugs or chemicals which are restricted by the Board or by law
				to wholesale distribution only by a firm licensed by the Board as a listed
				chemical wholesale distributor or a wholesale distributor, which are also known
				as listed chemicals, are as follows:
(1) Pseudoephedrine or a product containing
			 any quantity of this drug, except as follows:
(a) Pediatric products labeled pursuant to
			 federal regulation as primarily intended for administration to children under
			 12 years of age according to label instructions; and
(b) Products that the Board, upon application
			 of a manufacturer, exempts because the product is formulated in such a way as
			 to effectively prevent the conversion of the active ingredient into
			 methamphetamine or its salts or precursors.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.03 - Restriction on the Distribution of Listed Chemicals

Current through Rules and Regulations filed through June 27, 2024
Chemicals listed in 480-71-.02 may only be distributed to
				retail outlets by a listed chemical drug wholesale distributor licensed by the
				Board, or a wholesale distributor licensed by the Board. In order for any
				person or firm to conduct an act of brokerage for any dangerous drug,
				controlled substance, or listed chemical which is received by retail outlet or
				pharmacy in this state, regardless of where the shipment originates, such
				person or firm is required to be licensed as a wholesale distributor or a
				listed chemical wholesale distributor. Any manufacturer which distributes a
				drug to any wholesale distributor or listed chemical wholesale distributor
				located in the State of Georgia must have been issued the appropriate wholesale
				distributor permit from the Board. Having been issued a manufacturing pharmacy
				permit by the Board does not authorize a manufacturing firm to distribute drugs
				to any firm located in this state.
O.C.G.A. Secs.
				 16-13-30.3,  16-13-30.4,  26-4-113.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.05 - Denial of Licensure as a Listed Chemical Wholesale Distributor

Current through Rules and Regulations filed through June 27, 2024
(1) An application
			 for a license or permit provided for in this chapter may be denied by the Board
			 for reasons including, but not limited to:
(a)
			 Furnishing false or fraudulent material information in any application filed
			 under this rule or Chapter 13 of Title 16;
(b) Being convicted of a crime under any
			 state or federal law;
(c) Having
			 his or her federal registration suspended or revoked to manufacture,
			 distribute, or dispense controlled substances or listed chemicals;
(d) Violating the provisions of Chapter 4 of
			 Title 26 or Chapter 13 of Title 16;
(e) Being located in a place of
			 residence;
(f) Failing to maintain
			 effective controls against the diversion of products containing listed
			 chemicals to unauthorized persons or entities; and/or
(g) Any other factors or qualifications
			 provided by law or that the Board considers relevant to and consistent with the
			 public health and safety.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.06 - Records and Recordkeeping; Reporting Requirements

Current through Rules and Regulations filed through June 27, 2024
(1) Listed chemical wholesale distributors
			 and other wholesale distributors shall, at a minimum, maintain records
			 regarding the distribution of listed chemicals as follows:
(a) Produce and maintain, for a minimum of
			 three years from the date of the transaction, inventories and records of all
			 transactions regarding the receipt, sale, credit, transfer, disposition, and
			 distribution of all listed chemicals to any firm, person, or retail outlet
			 located in this State. Inventories and records shall be made available for
			 inspection and photocopying by any authorized agent of any State or federal
			 agency for a period of three (3) years following their creation date.
(b) Records described in this section that
			 are kept at the inspection site or that can be immediately retrieved by
			 computer or other electronic means shall be readily available for authorized
			 inspection during the retention period. Records kept at a central location
			 apart from the inspection site and not electronically retrievable shall be made
			 available for inspection within two working days of a request by an authorized
			 official of any State and federal governmental agency charged with enforcement
			 of these rules.
(c) Maintain an up
			 to date list of firms, persons or retail outlets with whom they do business in
			 regards to listed chemicals.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.07 - Requirements for Storage, Handling, Transport, and Shipment of Listed Chemicals

Current through Rules and Regulations filed through June 27, 2024
The following are required for the shipping, transporting,
				storage and handling of listed chemicals, and for the establishment and
				maintenance of listed chemical wholesale distribution records by listed
				chemical wholesale distributors and other wholesale distributors and their
				officers, agents, representatives, and employees:
(1) All facilities at which listed chemicals
			 are received, stored, warehoused, handled, held, offered, marketed, displayed,
			 or transported from shall:
(a) Be of suitable
			 construction to ensure that all listed chemicals in the facilities are
			 maintained in accordance with official compendium standards, such as
			 USP/NF;
(b) Be of suitable size and
			 construction to facilitate cleaning, maintenance, and proper listed chemical
			 wholesale distribution operations;
(c) Have adequate storage areas to provide
			 adequate lighting, ventilation, temperature, sanitation, humidity, space,
			 equipment, and security conditions;
(d) Have a quarantine area for storage of
			 listed chemicals that are outdated, damaged, deteriorated, misbranded,
			 adulterated, otherwise unfit for distribution, or that are in immediate or
			 sealed secondary containers that have been opened;
(e) Be maintained in a clean and orderly
			 condition; and
(f) Be free from
			 infestation of any kind.
(g) Shall
			 be a commercial location and not a personal dwelling or residence.
(h) Shall be duly registered with the DEA and
			 in compliance with all applicable laws and rules for the storage, distribution,
			 shipping, handling, and transporting of listed chemicals.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.08 - Security

Current through Rules and Regulations filed through June 27, 2024
(1) All facilities
			 used for listed chemical wholesale distribution shall be secure from
			 unauthorized entry:
(a) Access from outside
			 the premises shall be kept to a minimum and be well-controlled;
(b) The outside perimeter of the premises
			 shall be well-lighted;
(c) Entry
			 into areas where listed chemicals are held shall be limited to authorized
			 personnel;
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.09 - Storage

Current through Rules and Regulations filed through June 27, 2024
All listed chemicals shall be stored at appropriate
				temperatures and under appropriate conditions in accordance with requirements,
				if any, in the labeling of such listed chemicals, or with requirements in the
				current edition of an official compendium such as the USP/NF.
(1) If no storage requirements are
			 established for a listed chemical, the listed chemical may be held at
			 "controlled" room temperature, as defined in an official compendium such as
			 USP/NF, to help ensure that its identity, strength, quality, and purity are not
			 adversely affected.
(2) Appropriate
			 manual, electromechanical, or electronic temperature and humidity recording
			 equipment, and/or logs shall be utilized to document proper storage of listed
			 chemicals.
(3) Packaging of the
			 listed chemicals should be in accordance with an official compendium such as
			 USP/NF and identify any compromise in the integrity of the listed chemicals due
			 to tampering or adverse storage conditions.
(4) The record-keeping requirements in
			 480-7A-.06 shall be followed for the listed chemical wholesale distribution of
			 all listed chemicals.
O.C.G.A. Secs.
				 16-13-30.3,  16-13-30.4,  26-4-27,  26-4-28,  26-4-115.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.10 - Returned, Damaged, and Outdated Listed Chemicals

Current through Rules and Regulations filed through June 27, 2024
(1) Any drug or device that is outdated,
			 damaged, deteriorated, misbranded, adulterated, or otherwise deemed unfit for
			 human consumption shall be quarantined and physically separated from other
			 listed chemicals until they are returned to either the manufacturer or
			 wholesale distributor from which it was acquired or destroyed.
(a) When listed chemicals are adulterated, or
			 misbranded, notice of the adulteration, or misbranding shall be provided to the
			 Board and manufacturer or wholesale distributor from which it was acquired
			 within three (3) business days.
(b)
			 Any listed chemical returned to a manufacturer or wholesale distributor shall
			 be kept under proper conditions for storage, handling, and shipping,
			 transporting, and documentation showing that proper conditions were maintained
			 is provided to the manufacturer or wholesale distributor to which the drugs are
			 returned.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.11 - Violations

Current through Rules and Regulations filed through June 27, 2024
A license issued to a listed chemical wholesale distributor
				pursuant to this part may be subject to revocation, fines, suspension, or
				otherwise disciplined as provided by law, for reasons, including but not
				limited to the following:
(1) The
			 permit or license holder being convicted or being arrested, charged and
			 sentenced for violations of Federal, State, or local laws and/or regulations
			 relating the drugs.
(2) Violating
			 any of the provisions of any applicable Board laws or rules.
(3) If any owner, officer, designated
			 representative, or other significant person employed by the permit holder has:
(a) Furnished false or fraudulent material
			 information in any application filed under this Code section;
(b) Been convicted of a crime under any state
			 or federal law;
(c) Had his or her
			 federal registration suspended or revoked to manufacture, distribute, or
			 dispense controlled substances or listed chemicals;
(d) Violated the provisions of Chapter 4 of
			 Title 26 or Chapter 13 of Title 16;
(e) Failed to maintain effective controls
			 against the diversion of listed chemical products to unauthorized persons or
			 entities.
(f) Failed to comply with
			 the reporting requirements of this chapter; or
(g) Made a false statement in a report or
			 record required by this chapter or State law.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7A - LISTED CHEMICAL WHOLESALE DISTRIBUTOR › Rule 480-7A-.12 - Licensure Exception

Current through Rules and Regulations filed through June 27, 2024
Notwithstanding any other provision of this chapter, no person
				shall be required to obtain a license or permit for the sale, receipt,
				transfer, or possession of a listed chemical product when:
(a) Such lawful distribution takes place in
			 the usual course of business between agents or employees of a single regulated
			 person or entity; or
(b) A listed
			 chemical product is delivered to or by a common or contract carrier for
			 carriage in the lawful and usual course of the business of the common or
			 contract carrier or to or by a warehouseman for storage in the lawful and usual
			 course of the business of the warehouseman.
O.C.G.A. Secs.
				 16-13-30.4,  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 480-7B - DURABLE MEDICAL EQUIPMENT SUPPLIERS › Rule 480-7B-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(1) "Board" shall
			 mean the Georgia Board of Pharmacy.
(2) "Designated representative" means an
			 individual proposed by a DME supplier and approved by the Board as the
			 supervisor or manager responsible for ensuring the DME supplier's compliance
			 with all state and federal laws and regulations pertaining to practice as a DME
			 supplier.
(3) "Durable medical
			 equipment" or "DME" shall mean equipment for which a prescription is required,
			 including repair and replacement parts for such equipment, and which
(a) Can withstand repeated use;
(b) Has an expected life of at least three
			 years;
(c) Is primarily and
			 customarily used to serve a medical purpose;
(d) Generally is not useful to a person in
			 the absence of illness or injury; and
(e) Is appropriate for use in the
			 home.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7B - DURABLE MEDICAL EQUIPMENT SUPPLIERS › Rule 480-7B-.02 - DME Supplier Licensing Requirements

Current through Rules and Regulations filed through June 27, 2024
(1)
Licensing requirement.
A
			 person or entity located in the State of Georgia that provides durable medical
			 equipment to a consumer and submits a claim for reimbursement by a third party,
			 either directly or through a contractual arrangement, and any Medicare enrolled
			 out-of-state DME manufacture or wholesale distributor that provides durable
			 medical equipment to consumers in this state and who holds a valid license from
			 another state must hold a license issued by the Board. Licensure as a DME
			 supplier will be considered on the basis of the completion of a Board approved
			 application filed with the Board, payment of a fee, a report from GDNA
			 certifying that the applicant possesses the necessary qualifications for
			 licensure including meeting all safety standards and requirements established
			 by the Board, satisfactory licensure status in other states, and if located in
			 the State of Georgia, maintenance of an office or place of business in the
			 State of Georgia. When reviewing an application, the Board may determine that a
			 person or entity accredited by an organization recognized by the federal
			 Centers for Medicare and Medicaid Services has met all or some of the
			 requirements for licensure.
(2)
Applications Licensure as a DME supplier.
(a) The Board requires the following
			 information from each DME supplier as part of the initial licensing procedure:
1. The name, full business address, and
			 telephone number of the applicant;
2. All trade of business names used by the
			 applicant;
3. Address, telephone
			 number(s), and the name(s) of the proposed designated representative(s) for the
			 facility and evidence showing the qualifications of the proposed designated
			 representative(s) to serve;
4. The
			 type of ownership or operations (i.e. partnership, corporation, or sole
			 proprietorship);
5. The name(s) of
			 the owner and/or operator of the applicant, including:
(i) If a person, the name of the
			 person;
(ii) If a partnership, the
			 name of each partner and the name of the partnership;
(iii) If a corporation, the name and title of
			 each corporate officer and director, the corporate names, the name of the
			 incorporation, and the name of the parent company, if any;
(iv) If a sole proprietorship, the full name
			 of the sole proprietorship and the name of the business entity;
6. If located out of state, proof
			 of a valid, unexpired license to operate as a DME supplier in the compliance
			 with the laws and rules of the other state; and
7. Information necessary to demonstrate
			 compliance with O.C.G.A. Title 50, Chapter 36.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7B - DURABLE MEDICAL EQUIPMENT SUPPLIERS › Rule 480-7B-.03 - Designated Representatives for DME Suppliers

Current through Rules and Regulations filed through June 27, 2024
(1)
Requirement for Designated Representatives.
The Board shall only
			 issue a license to a DME supplier if a qualified individual has been approved
			 as a designated representative for the DME supplier. The designated
			 representative will provide sufficient and qualified supervision of the DME
			 supplier's place of business, ensuring compliance with all state and federal
			 laws and regulations. The designated representative shall ensure the protection
			 of the public health and safety in the handling, storage, warehousing,
			 distribution, and shipment of durable medical equipment in the DME supplier's
			 place of business. Where operations are conducted at more than one licensed
			 place of business by a DME supplier, each licensed place of business shall have
			 at least one designated representative present.
(2)
Qualifications of Designated
			 Representatives.
In order to serve as a designated representative, an
			 individual shall:
(a) Be at least 18 years of
			 age;
(b) Submit a Board approved
			 personnel certification form as part of the DME supplier's application to the
			 Board;
(c) Attest to the knowledge
			 and understanding of applicable state and federal laws and regulations relating
			 to the distribution of durable medical equipment, knowledge and understanding
			 of quality control systems, and knowledge and understanding of the United
			 States Pharmacopeia of federal Food and Drug Administration standards relating
			 to the safe storage, handling, and transport of durable medical
			 equipment;
(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;
			 and
(e) If the designated
			 representative is a licensed pharmacist, provide the state(s) of licensure,
			 license number(s), and license status(es) of said license(s).
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7B - DURABLE MEDICAL EQUIPMENT SUPPLIERS › Rule 480-7B-.04 - Compliance with investigations

Current through Rules and Regulations filed through June 27, 2024
A DME supplier licensee shall cooperate with the Board in any
				investigation involving durable medical equipment distributed by such DME
				supplier licensee from, into, or within this State. The licensee shall respond
				within ten (10) business days to all communications from the Board or its
				designee. Failure to respond or cooperate with the Board shall be grounds for
				the immediate suspension of the DME supplier license, pending a hearing on
				further disciplinary action by the Board. Failure to cooperate with the Board
				is grounds for disciplinary action by the Board.
O.C.G.A.
				§§
										26-4-5,  26-4-27,  26-4-28,  26-4-51,  26-4-60.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7B - DURABLE MEDICAL EQUIPMENT SUPPLIERS › Rule 480-7B-.05 - Required Reporting to the Board

Current through Rules and Regulations filed through June 27, 2024
(1)
State or Federal Actions.
A
			 DME supplier licensee must notify the Board within ten (10) business days of
			 the receipt of any final order or decision by any other licensing board or
			 federal agency of the imposition of disciplinary action or restriction by such
			 other licensing board or federal agency in which a license or privilege was
			 suspended or revoked. A final order or decision includes a consent order or
			 agreement and is any decision, regardless whether there still exists an
			 appellate right to the state or federal courts. Any revocation or suspension of
			 a state or federal license or permit may result in the immediate suspension of
			 the DME license by the Board, pending a final decision by the Board.
(2)
Felony convictions
. A DME
			 supplier licensee, its owner, or designated representative who is convicted
			 under the laws of this state, the United States, or any other state, territory,
			 or country of a felony shall be required to notify the Board of the conviction
			 within ten (10) days of the conviction. The failure to notify the Board of a
			 conviction shall be considered grounds for revocation of the DME supplier
			 license.
O.C.G.A.
				§§
										26-4-5,  26-4-27,  26-4-28,  26-4-28.2,  26-4-51,  26-4-60.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-7B - DURABLE MEDICAL EQUIPMENT SUPPLIERS › Rule 480-7B-.07 - Inspections

Current through Rules and Regulations filed through June 27, 2024
GDNA Agents, on behalf of the Board, may initially and/or
				periodically inspect a DME Supplier applicant's or licensee's office or place
				of business within this state. During such inspection, the GDNA Agents shall
				have the authority to inspect the facility and all inventories, and shall have
				the authority to examine, copy, or remove all records, including but not
				limited to purchase and sales records, repair records, employee records,
				background checks, and training records. At the conclusion of an inspection,
				the GDNA Agent(s) conducting the inspection shall have the responsibility of
				providing to such applicant or licensee a copy of a written inspection report
				on which any deficiencies or violations are made along with any
				recommendations. If a follow-up inspection is required due to deficiencies, the
				Board may charge the applicant or licensee a fee for the re-inspection as
				provided in its fee schedule established pursuant to paragraph (37) of
				subsection (a) of Code Section
				 26-4-28 to  cover the cost of such inspection.
O.C.G.A.
				§§
										26-4-5,  26-4-27,  26-4-28,  26-4-29,  26-4-51,  26-4-60.
Compilation of Rules and Regulations of the State of Georgia › Department 480 - RULES OF GEORGIA STATE BOARD OF PHARMACY › Chapter 480-8 - PRISON CLINIC PHARMACIES › Rule 480-8-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
For purposes of these Rules and Regulations, the following
				definitions apply:
(a) Prison Clinic
			 Pharmacy. Prison Clinic Pharmacy is defined as that portion of a prison
			 correctional facility which is engaged in 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 Georgia State Board of Pharmacy pursuant to Chapter 26-4 of
			 the Official Code of Georgia Annotated.
(b) Prison Clinic Pharmacy License. Prison
			 Clinic Pharmacy licenses are issued by the Georgia State Board of Pharmacy to
			 those said Prison Clinic Pharmacies, pursuant to the provisions of Chapter 26-4
			 of the Official Code of Georgia Annotated, whereas the license shall be subject
			 to special prison clinic pharmacy regulations as set forth herein, but exempt
			 from other certain regulations and requirements. To obtain the prison clinic
			 pharmacy license, there must be a Director of Pharmacy Services.
(c) Inpatient. In-patient shall mean an
			 inmate who is confined to an infirmary bed and is in the custody of and
			 assigned to an institution operated under the authority of the Georgia
			 Department of Corrections, or any county or municipal political
			 subdivision.
(d) Outpatient.
			 Out-patient shall mean an inmate who is in the custody of and assigned to an
			 institution operated under the authority of the Georgia Department of
			 Corrections, or any county or municipal political subdivision.
(e) Standard ward inventory. The Director of
			 the prison clinic pharmacy or their pharmacist designee may, in the best
			 interest of the patients served, establish one or more lists of the kind and
			 quantity of legend drugs to be kept at one or more locations at all times
			 within the said prison clinic and such stocks of legend drugs shall be known as
			 standard ward inventory. The use of standard ward inventory shall be minimized.
			 A copy of the list of items on standard ward inventory must be kept by the
			 Director of Pharmacy or their pharmacist designee.
(f) Prison Clinic Administrator. The Prison
			 Clinic Administrator is that individual prison official who is designated as
			 the person responsible for the operation of the portion of a prison or other
			 correctional institution responsible for the health care of the facility's
			 inmates.
O.C.G.A. Sec.
				 26-4-27,  26-4-28, 26-4-10, 26-4-37.