reglab/statecodes huggingface dataset:
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-4 - ADMINISTRATIVE REVIEW, HEARINGS AND APPEALS › Rule 350-4-.29 - Appeal of Administrative Law Judge's Decision

Current through Rules and Regulations filed through June 27, 2024
(1) Any provider may petition for review of the Administrative
				Law Judge's decision within five (5) days from the date of that party's receipt
				of the decision. Such request shall be in writing and addressed to the
				Commissioner and shall state the legal or factual errors upon which the appeal
				is based.
(2) If any party fails to request review within five (5) days
				of the date of receipt of the adverse decision, that party shall have waived
				its right to any further review or revision of that decision.
(3) If a party requests a transcript of the proceedings, after
				receipt of the initial decision, that party will have an additional five (5)
				days from the date of receipt of the transcript in which to submit a written
				statement of legal or factual errors. However, a request for a transcript shall
				not in any manner lengthen the time [five (5) days from receipt of the
				decision] in which a request for review must be submitted.
(4) The final decision by the Commissioner shall be made within
				thirty (30) days after receipt of the request for review and shall be
				accessible by the public, subject to requirements for safeguarding confidential
				information. The parties shall be notified in writing of the final decision and
				of the provider's right to judicial review. The final decision and notice to
				the provider shall state the effective date of the decision. Should the
				Commissioner fail to issue his decision within thirty (30) days from his
				receipt of a request for review, the Administrative Law Judge's Decision shall
				be deemed affirmed, and the provider may proceed to appeal pursuant to Rule
				  350-4-.30.
O.C.G.A. Sec.
				  49-4-142(a), 153.
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-4 - ADMINISTRATIVE REVIEW, HEARINGS AND APPEALS › Rule 350-4-.30 - Appeal of the Commissioner's Decision

Current through Rules and Regulations filed through June 27, 2024
(1) Any provider adversely affected by a final decision of the
				Commissioner may have review thereof by appeal to the superior court in the
				county of residence of the provider or to the Superior Court of Fulton County.
				Such appeal shall be by petition which shall be filed in the clerk's office in
				such court within thirty (30) days after the final decision of the
				Commissioner. Such appeal shall be held in accordance with the "Administrative
				Procedure Act," Official Code of Georgia Annotated, Title 50, Chapter 13. A
				provider shall not appeal an adverse decision of the Commissioner to the
				superior court of the county of residence of the provider or the Superior Court
				of Fulton County unless the provider first exhausts the administrative remedies
				within the Department.
(2) The petition shall set forth the names of parties making
				the appeal, the decision being appealed, and the reason it is claimed to be
				erroneous.
(3) Enforcement of the decision being appealed shall not be
				stayed until and unless so ordered and directed by the reviewing court. Upon
				filing such petition, the petitioner shall serve on the Commissioner a copy
				thereof in the manner prescribed by law for service of process.
(4) Upon receipt of the appeal, the Commissioner shall transmit
				a certified copy of the hearing Record and a copy of any appeal therefrom to
				the superior court within thirty (30) days of receipt of the
				appeal.
O.C.G.A. Sec.
				  49-4-142(a), 153.
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-5 - DISCLOSURE OF INFORMATION ON MEDICAID APPLICANTS, RECIPIENTS AND PROVIDERS › Rule 350-5-.01 - Types of Applicant and Recipient Information to be Safeguarded

Current through Rules and Regulations filed through June 27, 2024
Any information which could be connected to an individual
				applicant or recipient in such a way as to disclose the individual's identity
				is confidential and shall be safeguarded. Such information includes:
(a) names, addresses, and all types of identification
				numbers;
(b) medical services proposed or provided to the
				individual;
(c) social and economic conditions or circumstances of the
				individual;
(d) agency evaluation of the individual's personal information;
				and
(e) medical data about the individual, including diagnosis and
				past history of disease or disability.
Ga. L. 1977, pp. 384,
				390; O.C.G.A. Sec.  49-4-142(a).
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-5 - DISCLOSURE OF INFORMATION ON MEDICAID APPLICANTS, RECIPIENTS AND PROVIDERS › Rule 350-5-.02 - Use of Applicant and Recipient Information

Current through Rules and Regulations filed through June 27, 2024
The types of information specified in Section .01 shall be used
				only for purposes directly connected with the administration of the State Plan.
				Such purposes include, but shall not be limited to:
(a) establishing eligibility;
(b) determining the amount of medical assistance;
(c) providing services for recipients; and
(d) conducting or assisting an investigation, prosecution, or
				civil or criminal proceeding related to the administration of the
				Plan.
Ga. L. 1977, pp. 384,
				390; O.C.G.A. Sec.  49-4-142(a).
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-5 - DISCLOSURE OF INFORMATION ON MEDICAID APPLICANTS, RECIPIENTS AND PROVIDERS › Rule 350-5-.03 - Access to Applicant and Recipient Information

Current through Rules and Regulations filed through June 27, 2024
(1) Access to the types of information specified in Section .01 shall be restricted to Department representatives or other persons, agencies,
				or organizations that are subject to standards of confidentiality comparable to
				those of the Department. Such persons, agencies, and organizations shall
				include providers of medical assistance and other entities contracting with the
				Department or otherwise authorized by law to perform one or more of the
				functions delineated in Section .02. Such access is available without the
				permission of the applicant or recipient, but shall be granted only where the
				entity seeking the information is performing one of the functions enumerated in
				Section .02, above.
(2) Before responding to a request for information from any
				person, agency, or organization that is not performing one or more of the
				functions delineated in Section .02, the Department must obtain written
				permission from the individual or the person legally responsible for the
				individual whenever possible. Confidential information about applicants or
				recipients shall be released without the individual's written permission only
				under the following conditions:
(a) An emergency situation exists in which:
1. prior attempts to contact the individual or legally
				responsible person for permission has been unsuccessful; or
2. a court of competent jurisdiction has ordered or subpoenaed
				information and the Department does not have sufficient time to notify the
				individual or legally responsible person before responding to the order or
				subpoena; or
3. release of such information is necessary to prevent loss of
				or risk to life or health; and
4. such release is not otherwise prohibited by law or
				regulation; and
5. written notification of the release is sent to the
				individual or the legally responsible person immediately after
				disclosure.
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-5 - DISCLOSURE OF INFORMATION ON MEDICAID APPLICANTS, RECIPIENTS AND PROVIDERS › Rule 350-5-.04 - Disclosure of Provider Information

Current through Rules and Regulations filed through June 27, 2024
Information maintained by the Department regarding providers
				may be disclosed to anyone who submits a written request therefor in accordance
				with all applicable federal and state laws and regulations, including but not
				limited to those concerning open records and trade secrets.
O.C.G.A. Sec.
				  49-4-142(a).
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-7 - INDIGENT CARE TRUST FUND - NURSING HOME PROVIDER FEE › Rule 350-7-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(1) "Medically indigent" means a person who meets the
				state-wide standards of indigency adopted by the Department which is a person
				with an income no greater than 200 percent of the federal poverty level
				guidelines as published by the United States Department Health and Human
				Services.
(2) "Nursing home" means a freestanding facility or distinct
				part or unit of a hospital required to be licensed or permitted as a nursing
				home under the provisions of O.C.G.A. Title 31, Chapter 8, Article 5, which is
				not owned or operated by the state or federal government.
(3) "Nursing Home that disproportionately serves the medically
				indigent" means a nursing home for which the patient days attributable to
				medically indigent residents account for more than 15 percent of the nursing
				home's total patient days during a 12-month period. For purposes of this
				computation, Medicare program patient days shall not be included in the nursing
				home's total patient days.
(4) "Patient day" means a day of care provided to an individual
				resident of a nursing home by the nursing home. A patient day includes the date
				of admission but does not include the date of discharge, unless the dates of
				admission and discharge occur on the same day.
(5) "Provider fee" means the fee imposed pursuant to these
				rules for the privilege of operating a nursing home.
(6) "Segregated account" means an account for the dedication
				and deposit of provider fees which is established within the Indigent Care
				Trust Fund.
(7) "State plan" means all documentation submitted by the
				Commissioner of the Department of Community Health to the United States
				Department of Health and Human Services, Center for Medicare and Medicaid
				Services, pursuant to Title XIX of the federal Social Security Act.
(8) "Trust fund" means the Indigent Care Trust Fund created
				pursuant to O.C.G.A. Title 31, Chapter 8, Article 6.
(9) "Waiver" means a waiver of the uniform tax requirement for
				permissible health care related taxes, as provided for in  42 C.F.R. §
									433.68(e)(2)(i)(ii).
O.C.G.A. Sec.
				  31-8-5.
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-7 - INDIGENT CARE TRUST FUND - NURSING HOME PROVIDER FEE › Rule 350-7-.03 - Use of Provider Fees

Current through Rules and Regulations filed through June 27, 2024
(1) The General Assembly is authorized to appropriate as state
				funds to the Department for use in any fiscal year all revenues dedicated and
				credited to the segregated account. These appropriations shall be made for the
				sole purpose of obtaining federal financial participation in the provision of
				support to nursing homes that disproportionately serve the medically indigent.
				Any appropriation from the segregated account for any purpose other than
				Medicaid payments to nursing homes shall be null and void.
(2) Revenues appropriated to the Department pursuant to these
				rules shall be used to match federal funds that are available for the purpose
				for which such trust funds have been appropriated.
(3) Appropriations from the segregated account to the
				Department shall not lapse to the general fund at the end of the fiscal
				year.
(4) The Department shall annually report to the General
				Assembly on the use of revenues credited to the segregated account and
				appropriated to the Department for the purposes outlined in these rules. Such
				report shall be submitted to the Lieutenant Governor, Speaker, legislative
				counsel and legislative budget officer no later than January 31 of each
				calendar year. Such reports shall be made available to the public as a public
				record.
O.C.G.A. Sec.
				  31-8-5.
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-7 - INDIGENT CARE TRUST FUND - NURSING HOME PROVIDER FEE › Rule 350-7-.04 - Open Records

Current through Rules and Regulations filed through June 27, 2024
All Department records related to the Indigent Care Trust Fund
				segregated account, except as provided for in Rule  350-7-.02(4)  shall be open
				for public inspection in accordance with the Open Records Act, O.C.G.A. §
								50-18-70
et seq.
O.C.G.A. Sec.
				  31-8-5.
Compilation of Rules and Regulations of the State of Georgia › Department 350 - DEPARTMENT OF MEDICAL ASSISTANCE › Chapter 350-7 - INDIGENT CARE TRUST FUND - NURSING HOME PROVIDER FEE › Rule 350-7-.05 - Applicability of Medical Assistance Generally

Current through Rules and Regulations filed through June 27, 2024
Except where inconsistent with O.C.G.A., Title 31, Chapter 8,
				Article 6A, the provisions of O.C.G.A., Title 49, Chapter 4, Article 7 (Georgia
				Medical Assistance Act of 1977) shall apply to the Department in carrying out
				the purposes of the nursing home provider fee.
O.C.G.A. Sec.
				  31-8-5.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › ADMINISTRATIVE HISTORY

Current through Rules and Regulations filed through June 27, 2024
The
Administrative History
following each Rule gives the date on which
								 the Rule was originally filed and its effective date, as well as the date on which any amendment or repeal
								 was filed and its effective date. Principal abbreviations used in the Administrative History are as
								 follows:
f. - filed
eff. - effective
R. - Rule (Abbreviated only at the beginning of the control number)
Ch. - Chapter (Abbreviated only at the beginning of the control number)
ER. - Emergency Rule
Rev. - Revised
Note: Emergency Rules
are listed in each Rule's Administrative History
								 by Emergency Rule number, date filed and effective date. The Emergency Rule will be in effect for 120 days or
								 until the effective date of a permanent Rule covering the same subject matter superseding this Emergency Rule
								 is adopted, as specified by the Agency.
Chapters 351-1 entitled "Organization," 351-2 entitled "Definitions," 351-3
								 entitled "Applications," 351-4 entitled "Class 1 and Class 2 Productions Licensees," 351-5 entitled
								 "Seed-to-Sale Tracking," 351-6 entitled "Dispensing Licensees," 351-7 entitled "Independent Laboratories,"
								 351-8 entitled "Enforcement" adopted. F. Mar. 16, 2023; eff. Apr. 5, 2023.
Rules  351-2-.01,  351-3-.02,  351-4-.02, .06, .07, .08, .09, .12,
								  351-6-.01, .02, .05, .09,
								  351-7-.01, .05, .07, .08, .09 amended. F. Nov. 9, 2023; eff. Nov.
								 29, 2023.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-1 - ORGANIZATION › Rule 351-1-.01 - Organization of the Commission

Current through Rules and Regulations filed through June 27, 2024
(1) The Georgia's Hope Act provides that the
								 Georgia Access to Medical Cannabis Commission ("GMCC" or the "Commission"), a State of Georgia executive
								 branch agency, is created to protect public health, safety, and welfare, and to provide for the regulated
								 production, growing, manufacturing, and dispensing of products in Georgia for the lawful access to medical
								 cannabis by patients on the Georgia Low-THC Oil Patient Registry.
(2) The Georgia's Hope Act further dictates the Commission's composition,
								 methods of appointment, and terms of office. The Act specifies Commission functions and duties thus providing
								 for the implementation of the Georgia's Hope Act through the adoption of rules and regulations.
(3) The Commission receives, reviews, and adjudicates complaints with
								 regard to its licensees, licensee conduct, cannabis, and products regulated by the Commission.
(4) The public may obtain information from and submit requests to the
								 Executive Director. The contact information for the GMCC Executive Director may be obtained from the
								 Commission's website at
www.gmcc.ga.gov
.
O.C.G.A. §§
										16-12-202,  16-12-203,  16-12-210,  50-13-3.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-1 - ORGANIZATION › Rule 351-1-.02 - Meetings, Officers, Duties

Current through Rules and Regulations filed through June 27, 2024
(1) The Commission shall meet as set forth in
								 Code Section  16-12-202.
(2) A
								 majority of the seven (7) Commission Members shall constitute a quorum.
(3) Annually, the Commission shall elect from its Members a Vice Chair, and
								 may elect additional officers from among its Members as it deems appropriate.
(4) The Chair shall preside at meetings, perform all duties of that office,
								 and appoint Commission Members to serve on committees as created. The Vice Chair shall preside in the absence
								 of the Chair and shall assume the duties of the Chair when necessary.
(5) Meetings of the Commission shall be conducted, to the extent
								 practicable and permissible, in accordance with Robert's Rules of Order, Newly Revised. The Chair of the
								 Commission, or the Member of the Commission acting in such capacity, shall have authority to make rulings
								 regarding procedural matters and issues coming before the Commission.
O.C.G.A. §§
										16-12-202,  16-12-203,  16-12-210,  16-12-224.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-1 - ORGANIZATION › Rule 351-1-.03 - Declaratory Rulings

Current through Rules and Regulations filed through June 27, 2024
(1) A person whose legal rights are affected by
								 the application of any statutory provision or any rule or order of the Commission may petition the Commission
								 to request a declaratory ruling thereon.
(a) The petition shall be sent by
								 certified mail, return receipt requested, addressed to the Executive Director at the Georgia Access to
								 Medical Cannabis Commission with the attention line referencing a petition for declaratory ruling. The
								 contact information for the Executive Director may be obtained from the Commission's website at
www.gmcc.ga.gov
.
(b)
								 Declaratory rulings shall not be made upon untrue, moot, contingent, or hypothetical facts or situations, but
								 only upon actual facts set forth in the petition requesting a declaratory ruling.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-1 - ORGANIZATION › Rule 351-1-.04 - Petition for Promulgation, Amendment, or Repeal of Rules

Current through Rules and Regulations filed through June 27, 2024
(1) Each petition for promulgation, amendment, or
								 repeal of rules shall be submitted in writing to the Commission. The petition shall be verified under oath by
								 the petitioner and shall include:
(a) The name, address, and contact
								 information of the petitioner;
(b) The full text of the rule
								 requested to be amended with the petitioner's proposed changes or desired language, the citation and full
								 text of the rule desired to be repealed, or the full text of the rule desired to be promulgated;
(c) A statement of the reason such rule should be amended, repealed, or
								 promulgated, including a statement of all pertinent existing facts which relate to petitioner's interest in
								 the matter; and
(d) Citations of legal authority, if any, which
								 authorize, support, or require the action requested by the petition.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-1 - ORGANIZATION › Rule 351-1-.05 - Fees

Current through Rules and Regulations filed through June 27, 2024
(1) All fee payments submitted to the Commission
								 are non-refundable.
(2) Fees shall be paid in U.S. funds; the
								 Commission may require certified funds at its discretion.
(3) The
								 fee schedule shall be made available at the Commission office and on the Commission's website.
(4) Checks returned for insufficient funds will be addressed, as set forth
								 in Code Section  16-9-20, and the Commission shall assess a processing fee, as
								 outlined on the fee schedule, for any returned check, money order, or payment.
(5) Notices for fees due are sent only as a courtesy.
O.C.G.A. §§
										16-9-20,  16-12-203,  16-12-206,  16-12-211,  16-12-212,  16-12-222.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-2 - DEFINITIONS › Rule 351-2-.01 - Definitions

Current through Rules and Regulations filed through June 27, 2024
(1) "Accreditation" means the
								 procedure by which an authoritative body gives formal recognition that an organization is competent to carry
								 out specific tasks and verifies that the appropriate quality management system is in place.
(2) "Act" means O.C.G.A. Sections
								  16-12-200 through 
								  16-12-236, as amended, and referred to as "Georgia's Hope
								 Act."
(3) "Action level" means the threshold at or above which
								 the testing of a product sample would result in a failed certificate of analysis for a given
								 analyte.
(4) "Adverse event" means an undesirable experience
								 associated with the lawful use of product in final packaged form where the outcome was death,
								 life-threatening complications, hospitalization, disability or permanent damage, congenital anomaly or birth
								 defect, required intervention to prevent permanent impairment or damage, or any other medical event that
								 required medical treatment.
(5) "Advertise" means, but is not
								 limited to, the act of publicizing, disseminating, soliciting, or circulating visual, oral, or written
								 communication to induce or persuade any person to purchase or consume any specific regulated cannabis. This
								 definition does not include education and consultation provided directly to patients and caregivers regarding
								 product safety information.
(6) "Agent" means a person who is
								 authorized to serve as a representative of an entity and whose signature has binding legal authority of such
								 an entity.
(7) "Analyte" means a chemical, compound, element,
								 bacteria, yeast, fungus, microbial, or toxin for which a product sample is tested by an independent
								 laboratory.
(8) "Applicant" means an entity applying for a
								 license as set forth in Code Section  16-12-200(1).
(9) "Batch" means a quantity of regulated cannabis harvested or produced
								 together at the same time by the same production licensee, the meaning of which shall include the following:
(a) "Harvest batch" means a specific quantity of regulated cannabis grown
								 under the same conditions, and harvested during a specified period of time from specified cultivation
								 space(s) using the same standards.
(b) "Manufactured batch" means
								 a quantity of regulated cannabis produced and manufactured together at the same time, using the same
								 standards.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-3 - APPLICATIONS › Rule 351-3-.01 - Class 1 and Class 2 Production License Applications

Current through Rules and Regulations filed through June 27, 2024
(1) An application for a Class 1 or Class 2
								 production license shall only be accepted during an open application period announced by the
								 Commission.
(2) An applicant for a Class 1 or Class 2 production
								 license shall submit the following to the Commission:
(a) A complete
								 application as required by the Commission; and
(b) The required
								 non-refundable application fee, as listed on the fee schedule, payable in certified funds.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-3 - APPLICATIONS › Rule 351-3-.03 - Renewals

Current through Rules and Regulations filed through June 27, 2024
(1) The responsibility to renew a license on or
								 before the expiration date remains with the respective licensee.
(2) A license expires upon the expiration date if a licensee has not filed
								 a renewal application and remitted all of the required application, where applicable, and payment of the
								 license fees prior to the expiration date.
(3) To apply for
								 renewal, a licensee shall submit a complete application and the required non-refundable annual renewal fee,
								 as listed on the fee schedule.
(a) A licensee shall apply for the renewal
								 prior to the expiration date.
(b) The licensee may submit a
								 renewal application, once the renewal period opens, prior to the expiration of its respective
								 license.
(c) When applying for a renewal, licensees shall update,
								 as needed, all information submitted in the initial application or the last renewal application, whichever
								 was last approved by the Commission. Licensees shall include all approved changes and modifications to such
								 application, if applicable to the respective licensee.
(d) Once
								 the licensee submits a complete and timely application for renewal, the license remains in active or valid
								 status pending renewal until the Commission renews the license. The Commission hereby delegates the authority
								 and responsibility to determine whether applications for renewal are approved, or denied, to the GMCC
								 Executive Director.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.01 - Production Pre-operational Inspections

Current through Rules and Regulations filed through June 27, 2024
(1) A production licensee shall submit to
								 pre-operational progress inspections conducted by the Commission or its employees to ensure and confirm that
								 the production licensee is fully operational as required by Code Section
								  16-12-223(a)(5).
(2) Prior to the inspection to be deemed fully operational, a production
								 licensee shall submit the following to the Commission:
(a) A satisfactory
								 report of full compliance with, and completion of, all applicable public safety inspections required by
								 local, state, and federal jurisdictions, including, without limitation, fire, building, health, and air
								 quality inspections; and
(b) A list of all plant strains and
								 cultivars which will be propagated and/or cultivated at the premises, which shall be maintained at the
								 premises during the term of the production license contract and provided to the Commission or its employees
								 upon request.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.02 - General Production License Rules

Current through Rules and Regulations filed through June 27, 2024
(1) A
								 production licensee shall conduct activities and operations as represented in the respective license contract
								 awarded by the Commission. Such license contract includes compliance with the following:
(a) Exhibits to the license contract;
(b) License contract amendments agreed to in writing between the licensee
								 and the Commission;
(c) The Act, as amended;
(d) The Commission's rules and regulations, as promulgated and amended;
								 and
(e) The Commission's policies and procedures, as
								 approved.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.03 - Security

Current through Rules and Regulations filed through June 27, 2024
(1) A production licensee is responsible for the
								 security of all regulated cannabis on the premises, including providing adequate safeguards against theft or
								 diversion of regulated cannabis.
(2) A production licensee shall
								 have a comprehensive security system to prevent and detect diversion, theft, or loss of regulated cannabis
								 utilizing commercial grade equipment, which shall, at a minimum, include:
(a) An alarm system which provides:
1. A
								 perimeter alarm;
2. A duress alarm;
3. A panic alarm;
4. A holdup
								 alarm; and
5. Sensors at all possible points of entry into the
								 facility to include all doors, windows, roof hatches, and skylights.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.04 - Propagation and Cultivation Operations

Current through Rules and Regulations filed through June 27, 2024
(1) Propagation space shall be used for growing
								 immature and non-flowering plants only.
(a) Mother plants in this space
								 shall not be utilized for harvest but for propagation only.
(b)
								 Immature or nonflowering plants in this space shall not be calculated in cultivation space.
(c) Plant material located in the propagation space intended for harvest
								 and production shall be entered in the Commission-approved tracking system.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.05 - Production Operations

Current through Rules and Regulations filed through June 27, 2024
(1) A production licensee shall ensure all phases
								 of production take place in designated, restricted access areas only.
(2) A production licensee shall document the formulation and size for each
								 batch produced.
(3) All ingredients, other than those naturally
								 occurring in or otherwise derived from cannabis, shall be approved by the U.S. Food and Drug
								 Administration.
(4) Each batch shall meet the following
								 requirements:
(a) Plant tags and plant strains shall be easily identifiable
								 and legible.
(b) Each immature plant batch shall consist of no
								 more than one hundred (100) immature plants.
(c) After a tagged
								 plant is harvested, it is part of a harvest batch.
(d) A harvest
								 batch shall be easily distinguishable from other harvest batches until the batch is manufactured into
								 products.
(e) Once the harvest batch is manufactured into
								 products, it is part of a manufactured batch.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.06 - Quality Control Procedures

Current through Rules and Regulations filed through June 27, 2024
(1) Prior
								 to distributing or transporting product in final packaged form to a dispensary or pharmacy, a production
								 licensee shall ensure the following:
(a) The production licensee contracts
								 with and uses an independent laboratory listed on the Commission's list of approved independent laboratories
								 as set forth in Code Section  16-12-217(b) for sample collection and
								 testing;
(b) The manufactured batch has passed all required
								 testing and has been issued a passing certificate of analysis; and
(c) Retest product in final packaged form, prior to or upon expiration of
								 an existing and passing certificate of analysis, to ensure such product continues to pass all required
								 testing.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.07 - Packaging and Labeling

Current through Rules and Regulations filed through June 27, 2024
(1) A
								 production licensee shall submit drafts of the packaging and labeling designs to the Commission for approval
								 prior to using such designs for the product. The Commission hereby delegates the authority and responsibility
								 to review packaging and labeling designs as set forth in Code Section
								  16-12-203(6), and determine whether such
								 designs shall be approved to the GMCC Executive Director. The licensee shall not use such designs unless they
								 have been approved by the GMCC Executive Director.
(2) A
								 production licensee shall package product in final packaged form on such licensee's premises. Packaging used
								 to contain product shall:
(a) Protect the product from contamination and
								 shall not expose the product to any toxic or harmful substance;
(b) Be tamper-evident or have tamper-evident features applied to such
								 packaging;
(c) Be opaque;
(d) Not imitate any packaging used for goods that are publicly known to be
								 marketed to minors;
(e) Not include the following so as to
								 attract or market to minors:
1. Any cartoon, comic drawing, a series of
								 drawings, or animation;
2. Words such as "candy" or "candies" or
								 any alternative spelling of such words; and
3. Depictions of
								 people or animals.
(f) Use only Commission-approved
								 trademarks, logos, or imagery;
(g) Be a child-resistant package;
								 and
(h) Be resealable if the product has more than one (1)
								 dose.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.08 - Inventory

Current through Rules and Regulations filed through June 27, 2024
(1) Upon the issuance of a
								 production license, a production licensee shall conduct an initial inventory, and thereafter a monthly
								 inventory, of regulated cannabis, which shall indicate the date on which the inventory was conducted and the
								 information on the persons who conducted such inventory.
(2) A
								 production licensee shall ensure the on-site inventory and the inventory reflected in the Commission-approved
								 tracking system reflect the same information.
(3) If a production
								 licensee identifies or becomes aware of a discrepancy between the on-site inventory and inventory reflected
								 in the Commission-approved tracking system, then such licensee shall conduct an audit within twenty-four (24)
								 hours of such finding and notify the Commission or its employees of any discrepancies of the following:
(a) Any plant designated for cultivation;
(b) Any plant designated for propagation;
(c) More than three percent (3%) of any harvest batch;
(d) More than three percent (3%) of any manufactured batch; or
(e) Any remediated or quarantined product.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.09 - Transportation

Current through Rules and Regulations filed through June 27, 2024
(1) A production licensee
								 shall ensure security and oversight throughout any transport of product, including, but not limited to,
								 compliance with the following:
(a) Transport of product to or from a
								 licensee, pharmacy, or independent laboratory shall be:
1. Transported only
								 by an authorized employee of a licensee or by an employee of an independent laboratory;
2. Entered into the Commission-approved tracking system and properly
								 reflected in inventory totals; and
3. Contained in a sealed
								 package that prevents cross-contamination and labeled as such.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.10 - Advertising and Marketing

Current through Rules and Regulations filed through June 27, 2024
(1) A production licensee shall ensure that
								 information regarding its products shall be accurate, truthful, and appropriately substantiated and as
								 permissible by the Act and these rules.
(2) A production licensee
								 may provide information regarding its products directly to physicians as set forth in Code Section
								  16-12-215, via:
(a) Electronic
								 communication;
(b) Printed mail pieces; or
(c) In-person communication.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.11 - Records

Current through Rules and Regulations filed through June 27, 2024
(1) A production licensee shall keep records
								 identified by these rules on the premises.
(2) All records shall
								 be provided to the Commission or its employees upon request.
(3)
								 A production licensee shall keep and maintain records in connection with the production license for at least
								 five (5) years from the date the record was created, unless a shorter time is specified in these rules or
								 otherwise specific by law.
(4) Records shall be kept in a manner
								 that allows the records to be made available upon request to the Commission or its employees.
(5) Records shall be legible and accurate.
(6) No person may intentionally misrepresent or falsify records, including
								 the use of software or other methods, to manipulate or alter the accuracy of growing or production
								 data.
(7) Records, whether physical or virtual, shall be stored
								 in a secured area where the records are protected from debris, moisture, contamination, hazardous waste,
								 fire, and theft.
(8) Records shall be kept of all regulated
								 cannabis produced, manufactured, transferred, recalled, and disposed of by the production licensee.
(9) A production licensee shall maintain all inventory, sales, and
								 financial records in accordance with generally accepted accounting principles.
(10) A production licensee shall retain a copy of all shipping manifests
								 for at least three (3) years.
(11) A production licensee shall
								 retain records of all testing, certificate(s) of analysis, and samples of each batch for at least twelve (12)
								 months.
(12) A production licensee shall maintain records
								 identifying the source of each ingredient used in the production and manufacturing of regulated cannabis,
								 including:
(a) The originating source of each ingredient;
(b) The date of receipt of the ingredient;
(c) The contractor's name and address;
(d) The grade and quantity of said ingredient; and
(e) The name of the ingredient and the contractor's control number or other
								 identifying number or symbol, if any, used by the contractor to identify the ingredient.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-4 - CLASS 1 AND CLASS 2 PRODUCTION LICENSEES › Rule 351-4-.12 - Product Recall Procedures

Current through Rules and Regulations filed through June 27, 2024
(1) If the
								 Commission receives information demonstrating that a recall is necessary to protect patients or to protect
								 public health and safety, and a production licensee does not initiate a recall, then the Commission may order
								 such recall until the risk to such health and safety is no longer present.
(2) A production licensee shall establish, maintain, and follow standard
								 operating procedures for licensee-initiated or Commission-ordered recalls of product in final packaged form.
								 Such procedures shall address, at a minimum, the following:
(a) Factors
								 that necessitate a recall;
(b) Employees responsible for
								 implementing the recall procedures;
(c) Notifications to
								 patients, caregivers, the public, and the Commission and its employees;
(d) The collection and transport of such recalled product from a dispensing
								 licensee or pharmacy to the originating production licensee; and
(e) Factors determining when a licensee-initiated recall may be
								 terminated.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-5 - SEED-TO-SALE TRACKING › Rule 351-5-.01 - Tracking System Operations

Current through Rules and Regulations filed through June 27, 2024
(1) Class 1 production licensees, Class 2
								 production licensees, and dispensing licensees shall select a vendor approved by the Commission for their
								 respective seed-to-sale tracking systems capable of utilizing an Application Programming Interface ("API")
								 designed to integrate with the Commission's state tracking system.
(2) Class 1 production licensees, Class 2 production licensees, and
								 dispensing licensees shall provide the Commission and its employees with access to their respective
								 seed-to-sale tracking systems.
(3) Class 1 production licensees,
								 Class 2 production licensees, and dispensing licensees shall be responsible for their respective selected
								 vendor. Violations of the Act and these rules shall result in citations and fines up to and including
								 revocation.
(4) Class 1 production licensees, Class 2 production
								 licensees, and dispensing licensees shall:
(a) Establish a
								 Commission-approved tracking system prior to engaging in any regulated cannabis production, transfer,
								 testing, or dispensing;
(b) Use a Commission-approved tracking
								 system as the primary inventory tracking system of record;
(c)
								 Use the tracking system to ensure regulated cannabis is identified and tracked from the point the regulated
								 cannabis is propagated from seed or cutting to the point the product in final packaged form is dispensed or
								 is otherwise disposed of;
(d) Maintain accurate and comprehensive
								 records regarding regulated cannabis waste that accounts for, reconciles, and evidences all waste activity
								 related to the disposal of regulated cannabis; and
(e) Reconcile
								 all on-premises and in-transit regulated cannabis inventories each day in the tracking system by the close of
								 business.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-5 - SEED-TO-SALE TRACKING › Rule 351-5-.02 - Approved Tracking System Requirements

Current through Rules and Regulations filed through June 27, 2024
(1) Any seed-to-sale tracking vendor shall not
								 have a direct or indirect financial interest in any licensee or registrant of the Commission.
(2) A Commission-approved tracking system vendor shall:
(a) Provide the Commission and its employees access to real-time tracking
								 data;
(b) Utilize an Application Programming Interface designed
								 to integrate with the Commission's state tracking system to include:
1.
								 Inventory management and tracking systems to shipping manifests;
2. Test results; and
3.
								 Dispensing point-of-sale data.
(c) Establish, document,
								 and maintain procedures to prevent fraud, abuse, and other unlawful or prohibited activities associated with
								 the production and dispensing of regulated cannabis in this state, and the ability to provide additional
								 tools for the administration and enforcement of the Act and these rules; and
(d) Institute procedures to ensure that the information in the system shall
								 not be disclosed or used for any purpose other than to ensure public health and safety, product quality and
								 efficacy, and compliance with the Act and these rules.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-5 - SEED-TO-SALE TRACKING › Rule 351-5-.03 - Plant and Product Tags

Current through Rules and Regulations filed through June 27, 2024
(1) Class 1 and Class 2 production licensees
								 shall only use plant and product tags that comply with the Act and the rules of the Commission.
(2) Class 1 and Class 2 production licensees shall only use plant and
								 product tags assigned by the tracking system to that licensee and shall not transfer unused tags to any other
								 licensee.
(3) Class 1 and Class 2 production licensees shall
								 maintain a sufficient supply of plant and product tags to support tagging in accordance with this
								 chapter.
(4) Plant and product tags shall be indelible and
								 tamper-evident.
(5) Plant and product tags shall not be
								 reused.
(6) All plants, samples, harvest batches, and
								 manufactured batches shall be issued a unique batch number in the inventory tracking system.
(a) Batch numbers cannot be reused.
(b) Each plant, sample, harvest batch, and manufactured batch shall have a
								 tag, with the correct unique batch number listed, placed on or otherwise affixed to it.
(c) The plant tag shall be legible, placed in a position that can be
								 clearly read, and shall be kept free from dirt and debris.
(d)
								 Each batch packaged in bulk together shall be easily identifiable with a bulk package tag
								 attached.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-5 - SEED-TO-SALE TRACKING › Rule 351-5-.04 - Loss of Access

Current through Rules and Regulations filed through June 27, 2024
(1) If a Class 1 production licensee, Class 2
								 production licensee, or dispensing licensee loses access to the tracking system for any reason, then the
								 respective licensee shall:
(a) Notify the Commission and its employees if
								 the loss of access exceeds twelve (12) hours; and
(b) Prepare and
								 maintain comprehensive tracking records detailing all licensed business that was conducted during the loss of
								 access.
Compilation of Rules and Regulations of the State of Georgia › Department 351 - GEORGIA ACCESS TO MEDICAL CANNABIS COMMISSION › Chapter 351-5 - SEED-TO-SALE TRACKING › Rule 351-5-.05 - Review and Auditing

Current through Rules and Regulations filed through June 27, 2024
(1) The Class 1 production licensee, Class 2
								 production licensee, or dispensing licensee shall review the inventory recorded in the Commission-approved
								 tracking system at least once every thirty (30) days to ensure its accuracy, including, at a minimum:
(a) Reconciling recorded inventory with physical inventory of regulated
								 cannabis in the tracking system; and
(b) Reviewing the Class 1
								 production licensee's, Class 2 production licensee's, or dispensing licensee's authorized users to document
								 and remove access for any users who are no longer authorized to enter information into the tracking
								 system.