O.C.G.A. § 26-4-115 — GA Code / Title 26 / Chapter 4 / Section 26-4-115
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-115
Status: in_force

(a) All persons, firms, or corporations, whether located in this state or in any other state, engaged in the business of selling or distributing drugs at wholesale in this state, in the business of supplying drugs to manufacturers, compounders, and processors in this state, or in the business of a reverse drug distributor shall biennially register with the board as a drug wholesaler, distributor, reverse drug distributor, supplier, outsourcing facility, or third-party logistics provider; provided, however, that out-of-state firms that conduct intracompany transfers of drugs to and have the same ownership as a licensed firm in this state shall not be required to register pursuant to this subsection; and provided, further, that out-of-state third-party logistics providers that are licensed by their resident state or by the federal Food and Drug Administration shall not be required to register pursuant to this subsection. The application for registration shall be made on a form to be prescribed and furnished by the board and shall show each place of business of the applicant for registration, together with such other information as may be required by the board. The application shall be accompanied by a fee in an amount established by the board for each place of business registered by the applicant. Such registration shall not be transferable and shall expire on the expiration date established by the executive director. Registration shall be renewed pursuant to the rules and regulations of the board, and a renewal fee prescribed by the board shall be required. If not renewed, the registration shall lapse and become null and void. Registrants shall be subject to such rules and regulations with respect to sanitation or equipment as the board may, from time to time, adopt for the protection of the public health and safety. Such registration may be suspended or revoked or the registrant may be reprimanded, fined, or placed on probation by the board if the registrant fails to comply with any law of this state, the United States, or any other state having to do with the control of pharmacists, pharmacies, wholesale distribution, reverse drug distribution, or outsourcing facility distribution of controlled substances or dangerous drugs as defined in Chapter 13 of Title 16; if the registrant fails to comply with any rule or regulation promulgated by the board; or if any registration or license issued to the registrant under the federal act is suspended or revoked.

(a) All persons, firms, or corporations, whether located in this state or in any other state, engaged in the business of selling or distributing drugs at wholesale in this state, in the business of supplying drugs to manufacturers, compounders, and processors in this state, or in the business of a reverse drug distributor shall biennially register with the board as a drug wholesaler, distributor, reverse drug distributor, supplier, outsourcing facility, or third-party logistics provider; provided, however, that out-of-state firms that conduct intracompany transfers of drugs to and have the same ownership as a licensed firm in this state shall not be required to register pursuant to this subsection; and provided, further, that out-of-state third-party logistics providers that are licensed by their resident state or by the federal Food and Drug Administration shall not be required to register pursuant to this subsection. The application for registration shall be made on a form to be prescribed and furnished by the board and shall show each place of business of the applicant for registration, together with such other information as may be required by the board. The application shall be accompanied by a fee in an amount established by the board for each place of business registered by the applicant. Such registration shall not be transferable and shall expire on the expiration date established by the executive director. Registration shall be renewed pursuant to the rules and regulations of the board, and a renewal fee prescribed by the board shall be required. If not renewed, the registration shall lapse and become null and void. Registrants shall be subject to such rules and regulations with respect to sanitation or equipment as the board may, from time to time, adopt for the protection of the public health and safety. Such registration may be suspended or revoked or the registrant may be reprimanded, fined, or placed on probation by the board if the registrant fails to comply with any law of this state, the United States, or any other state having to do with the control of pharmacists, pharmacies, wholesale distribution, reverse drug distribution, or outsourcing facility distribution of controlled substances or dangerous drugs as defined in Chapter 13 of Title 16; if the registrant fails to comply with any rule or regulation promulgated by the board; or if any registration or license issued to the registrant under the federal act is suspended or revoked.

(b) Every drug wholesaler, distributor, supplier, or outsourcing facility registered as provided in Chapter 13 of Title 16 or in subsection (a) of this Code section, except reverse drug distributors, shall: (1) Submit reports, upon request from the Georgia Drugs and Narcotics Agency, to account for all transactions with licensed persons or firms located within this state; such reportable transactions shall include all dangerous drugs and controlled substances as defined in Chapter 13 of Title 16. Such reports shall be submitted to the Georgia Drugs and Narcotics Agency; (2) Automatically submit reports of any excessive purchases of controlled substances by licensed persons or firms located within this state using the United States Drug Enforcement Administration guidelines to define excessive purchases as set forth under the provisions of 21 C.F.R. Section 1301 . Such reports shall be submitted to the Georgia Drugs and Narcotics Agency; and (3)(A) Comply with the requirements of Section 360eee, et seq., of the federal act, relating to drug supply chain security. (B) Each manufacturer of a drug subject to Section 360eee, et seq., of the federal act shall maintain at its corporate offices a current list of the authorized wholesale distributors of such drug. (C) The board shall establish rules and regulations relating to drug supply chain security based on the requirements of Section 360eee, et seq., of the federal act which are not inconsistent with, more stringent than, or in addition to any requirements applicable under Section 353(e) or Section 360eee of the federal act or any regulations issued thereunder and which are not inconsistent with any waiver, exception, or exemption pursuant to Section 360eee, et seq., of the federal act or any restrictions specified in Section 360eee-1 of the federal act.

(b) Every drug wholesaler, distributor, supplier, or outsourcing facility registered as provided in Chapter 13 of Title 16 or in subsection (a) of this Code section, except reverse drug distributors, shall:

(1) Submit reports, upon request from the Georgia Drugs and Narcotics Agency, to account for all transactions with licensed persons or firms located within this state; such reportable transactions shall include all dangerous drugs and controlled substances as defined in Chapter 13 of Title 16. Such reports shall be submitted to the Georgia Drugs and Narcotics Agency;

(1) Submit reports, upon request from the Georgia Drugs and Narcotics Agency, to account for all transactions with licensed persons or firms located within this state; such reportable transactions shall include all dangerous drugs and controlled substances as defined in Chapter 13 of Title 16. Such reports shall be submitted to the Georgia Drugs and Narcotics Agency;

(2) Automatically submit reports of any excessive purchases of controlled substances by licensed persons or firms located within this state using the United States Drug Enforcement Administration guidelines to define excessive purchases as set forth under the provisions of 21 C.F.R. Section 1301 . Such reports shall be submitted to the Georgia Drugs and Narcotics Agency; and

(2) Automatically submit reports of any excessive purchases of controlled substances by licensed persons or firms located within this state using the United States Drug Enforcement Administration guidelines to define excessive purchases as set forth under the provisions of 21 C.F.R. Section 1301 . Such reports shall be submitted to the Georgia Drugs and Narcotics Agency; and

(3)(A) Comply with the requirements of Section 360eee, et seq., of the federal act, relating to drug supply chain security. (B) Each manufacturer of a drug subject to Section 360eee, et seq., of the federal act shall maintain at its corporate offices a current list of the authorized wholesale distributors of such drug. (C) The board shall establish rules and regulations relating to drug supply chain security based on the requirements of Section 360eee, et seq., of the federal act which are not inconsistent with, more stringent than, or in addition to any requirements applicable under Section 353(e) or Section 360eee of the federal act or any regulations issued thereunder and which are not inconsistent with any waiver, exception, or exemption pursuant to Section 360eee, et seq., of the federal act or any restrictions specified in Section 360eee-1 of the federal act.

(3)(A) Comply with the requirements of Section 360eee, et seq., of the federal act, relating to drug supply chain security.

(3)(A) Comply with the requirements of Section 360eee, et seq., of the federal act, relating to drug supply chain security.

(B) Each manufacturer of a drug subject to Section 360eee, et seq., of the federal act shall maintain at its corporate offices a current list of the authorized wholesale distributors of such drug.

(B) Each manufacturer of a drug subject to Section 360eee, et seq., of the federal act shall maintain at its corporate offices a current list of the authorized wholesale distributors of such drug.

(C) The board shall establish rules and regulations relating to drug supply chain security based on the requirements of Section 360eee, et seq., of the federal act which are not inconsistent with, more stringent than, or in addition to any requirements applicable under Section 353(e) or Section 360eee of the federal act or any regulations issued thereunder and which are not inconsistent with any waiver, exception, or exemption pursuant to Section 360eee, et seq., of the federal act or any restrictions specified in Section 360eee-1 of the federal act.

(C) The board shall establish rules and regulations relating to drug supply chain security based on the requirements of Section 360eee, et seq., of the federal act which are not inconsistent with, more stringent than, or in addition to any requirements applicable under Section 353(e) or Section 360eee of the federal act or any regulations issued thereunder and which are not inconsistent with any waiver, exception, or exemption pursuant to Section 360eee, et seq., of the federal act or any restrictions specified in Section 360eee-1 of the federal act.

(c) The board shall be authorized to promulgate rules and regulations to facilitate compliance with this Code section. Such rules and regulations shall include a requirement that all wholesale drug distributors required to register pursuant to this Code section shall make adequate provision for the return of outdated drugs, both full and partial containers, for up to six months after the labeled expiration date for prompt full credit or replacement; provided, however, that such rules and regulations may also include a list of drugs exempted from the requirements of such provision that have been determined by the board as essential to health care treatment and having an expiration date of less than one year from the date such drug is manufactured.

(c) The board shall be authorized to promulgate rules and regulations to facilitate compliance with this Code section. Such rules and regulations shall include a requirement that all wholesale drug distributors required to register pursuant to this Code section shall make adequate provision for the return of outdated drugs, both full and partial containers, for up to six months after the labeled expiration date for prompt full credit or replacement; provided, however, that such rules and regulations may also include a list of drugs exempted from the requirements of such provision that have been determined by the board as essential to health care treatment and having an expiration date of less than one year from the date such drug is manufactured.

(d) The provisions of subsection (b) of this Code section shall not apply to any wholesaler, manufacturer, distributor, or supplier that only ships controlled substances directly to a licensed wholesaler within this state.

(d) The provisions of subsection (b) of this Code section shall not apply to any wholesaler, manufacturer, distributor, or supplier that only ships controlled substances directly to a licensed wholesaler within this state.

(e) Any person, firm, or corporation which violates any provision of this Code section shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than one year nor more than five years or by a fine not to exceed $25,000.00, or both.

(e) Any person, firm, or corporation which violates any provision of this Code section shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than one year nor more than five years or by a fine not to exceed $25,000.00, or both.

(f) Any practitioner who knowingly transfers any controlled substance or dangerous drug as such terms are defined in Chapter 13 of Title 16 by purchasing from or returning to a person, firm, or corporation which is not registered as required in subsection (a) of this Code section or as required in Chapter 13 of Title 16 shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than one year nor more than three years or by a fine not to exceed $10,000.00, or both.

(f) Any practitioner who knowingly transfers any controlled substance or dangerous drug as such terms are defined in Chapter 13 of Title 16 by purchasing from or returning to a person, firm, or corporation which is not registered as required in subsection (a) of this Code section or as required in Chapter 13 of Title 16 shall be guilty of a felony and, upon conviction thereof, shall be punished by imprisonment for not less than one year nor more than three years or by a fine not to exceed $10,000.00, or both.

(g) Transfers of drugs from a licensed hospital pharmacy to an entity that is affiliated with or owned by the hospital shall not be deemed wholesale distributors of drugs.

(g) Transfers of drugs from a licensed hospital pharmacy to an entity that is affiliated with or owned by the hospital shall not be deemed wholesale distributors of drugs.
O.C.G.A. § 26-2-181 — GA Code / Title 26 / Chapter 2 / Section 26-2-181
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-181
Status: in_force

The Commissioner is authorized to promulgate rules and regulations to govern the sampling and inspection of animals, poultry, and products quarantined or detained pursuant to this article and to implement and enforce this article.
O.C.G.A. § 26-4-81 — GA Code / Title 26 / Chapter 4 / Section 26-4-81
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-81
Status: in_force

(a) In accordance with this Code section, a pharmacist may substitute: (1) A drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or (2) A biological product with an interchangeable biological product.

(a) In accordance with this Code section, a pharmacist may substitute:

(1) A drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or

(1) A drug with the same generic name in the same strength, quantity, dose, and dosage form as the prescribed brand name drug product which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or

(2) A biological product with an interchangeable biological product.

(2) A biological product with an interchangeable biological product.

(b) If a practitioner of the healing arts prescribes: (1) A drug by its generic name, the pharmacist shall dispense the lowest retail priced drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or (2) A biological product by its nonproprietary name, the pharmacist shall dispense the lowest retail priced interchangeable biological product which is in stock.

(b) If a practitioner of the healing arts prescribes:

(1) A drug by its generic name, the pharmacist shall dispense the lowest retail priced drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or

(1) A drug by its generic name, the pharmacist shall dispense the lowest retail priced drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, pharmaceutically equivalent; or

(2) A biological product by its nonproprietary name, the pharmacist shall dispense the lowest retail priced interchangeable biological product which is in stock.

(2) A biological product by its nonproprietary name, the pharmacist shall dispense the lowest retail priced interchangeable biological product which is in stock.

(c) Substitutions as provided for in subsections (a) and (b) of this Code section are authorized for the express purpose of making available to the consumer the lowest retail priced: (1) Drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, both therapeutically equivalent and pharmaceutically equivalent; or (2) Interchangeable biological product which is in stock.

(c) Substitutions as provided for in subsections (a) and (b) of this Code section are authorized for the express purpose of making available to the consumer the lowest retail priced:

(1) Drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, both therapeutically equivalent and pharmaceutically equivalent; or

(1) Drug product which is in stock and which is, in the pharmacist's reasonable professional opinion, both therapeutically equivalent and pharmaceutically equivalent; or

(2) Interchangeable biological product which is in stock.

(2) Interchangeable biological product which is in stock.

(d)(1) Whenever a substitution is made, the pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed drug product or interchangeable biological product and its manufacturer. Such prescription shall be made available for inspection by the board or its representative in accordance with the rules of the board. (2) If a pharmacist substitutes a generic drug product for a brand name prescribed drug product when dispensing a prescribed medication, the brand name and the generic name of the drug product, with an explanation of “generic for (insert name of brand name prescribed drug product)” or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label; provided, however, that this paragraph shall not apply to medication dispensed for in-patient hospital services or to medications in specialty packaging for dosing purposes as defined by the board. (3) If a pharmacist substitutes an interchangeable biological product for a prescribed biological product when dispensing a prescribed medication, the name of the interchangeable biological product, with an explanation of “interchangeable biological product for (insert name of prescribed biological product)” or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription label; provided, however, that this paragraph shall not apply to biological products dispensed for in-patient hospital services, to hospital administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes as defined by the board. This paragraph shall apply to hospital retail pharmacies and to any biological products dispensed by a hospital for a patient's use or administration at home.

(d)(1) Whenever a substitution is made, the pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed drug product or interchangeable biological product and its manufacturer. Such prescription shall be made available for inspection by the board or its representative in accordance with the rules of the board.

(d)(1) Whenever a substitution is made, the pharmacist shall record on the original prescription the fact that there has been a substitution and the identity of the dispensed drug product or interchangeable biological product and its manufacturer. Such prescription shall be made available for inspection by the board or its representative in accordance with the rules of the board.

(2) If a pharmacist substitutes a generic drug product for a brand name prescribed drug product when dispensing a prescribed medication, the brand name and the generic name of the drug product, with an explanation of “generic for (insert name of brand name prescribed drug product)” or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label; provided, however, that this paragraph shall not apply to medication dispensed for in-patient hospital services or to medications in specialty packaging for dosing purposes as defined by the board.

(2) If a pharmacist substitutes a generic drug product for a brand name prescribed drug product when dispensing a prescribed medication, the brand name and the generic name of the drug product, with an explanation of “generic for (insert name of brand name prescribed drug product)” or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the drug may not appear upon the prescription label; provided, however, that this paragraph shall not apply to medication dispensed for in-patient hospital services or to medications in specialty packaging for dosing purposes as defined by the board.

(3) If a pharmacist substitutes an interchangeable biological product for a prescribed biological product when dispensing a prescribed medication, the name of the interchangeable biological product, with an explanation of “interchangeable biological product for (insert name of prescribed biological product)” or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription label; provided, however, that this paragraph shall not apply to biological products dispensed for in-patient hospital services, to hospital administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes as defined by the board. This paragraph shall apply to hospital retail pharmacies and to any biological products dispensed by a hospital for a patient's use or administration at home.

(3) If a pharmacist substitutes an interchangeable biological product for a prescribed biological product when dispensing a prescribed medication, the name of the interchangeable biological product, with an explanation of “interchangeable biological product for (insert name of prescribed biological product)” or similar language to indicate substitution has occurred, must appear on the prescription label and be affixed to the container or an auxiliary label, unless the prescribing practitioner indicated that the name of the biological product may not appear upon the prescription label; provided, however, that this paragraph shall not apply to biological products dispensed for in-patient hospital services, to hospital administered biological products for outpatients, or to biological products in specialty packaging for dosing purposes as defined by the board. This paragraph shall apply to hospital retail pharmacies and to any biological products dispensed by a hospital for a patient's use or administration at home.

(e) The substitution of any drug or biological product by a registered pharmacist pursuant to this Code section does not constitute the practice of medicine.

(e) The substitution of any drug or biological product by a registered pharmacist pursuant to this Code section does not constitute the practice of medicine.

(f) A patient for whom a prescription drug or biological product order is intended may instruct a pharmacist not to substitute a generic name drug in lieu of a brand name drug or an interchangeable biological product in lieu of a prescribed biological product.

(f) A patient for whom a prescription drug or biological product order is intended may instruct a pharmacist not to substitute a generic name drug in lieu of a brand name drug or an interchangeable biological product in lieu of a prescribed biological product.

(g) A practitioner of the healing arts may instruct the pharmacist not to substitute a generic name drug in lieu of a brand name drug or an interchangeable biological product in lieu of a prescribed biological product by including the words “brand necessary” in the body of the prescription. When a prescription is a hard copy prescription drug or biological product order, such indication of brand necessary must be in the practitioner's own handwriting and shall not be printed, applied by rubber stamp, or any such similar means. When the prescription is an electronic prescription drug or biological product order, the words “brand necessary” are not required to be in the practitioner's own handwriting and may be included on the prescription in any manner or by any method. When a practitioner has designated “brand necessary” on an electronic prescription drug or biological product order, a generic drug or interchangeable biological product shall not be substituted without the practitioner's express consent, which shall be documented by the pharmacist on the prescription and by the practitioner in the patient's medical record.

(g) A practitioner of the healing arts may instruct the pharmacist not to substitute a generic name drug in lieu of a brand name drug or an interchangeable biological product in lieu of a prescribed biological product by including the words “brand necessary” in the body of the prescription. When a prescription is a hard copy prescription drug or biological product order, such indication of brand necessary must be in the practitioner's own handwriting and shall not be printed, applied by rubber stamp, or any such similar means. When the prescription is an electronic prescription drug or biological product order, the words “brand necessary” are not required to be in the practitioner's own handwriting and may be included on the prescription in any manner or by any method. When a practitioner has designated “brand necessary” on an electronic prescription drug or biological product order, a generic drug or interchangeable biological product shall not be substituted without the practitioner's express consent, which shall be documented by the pharmacist on the prescription and by the practitioner in the patient's medical record.

(h) Within 48 hours, excluding weekends and holidays, following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the biological product and the manufacturer. The communication shall be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy record that is electronically accessible by the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber by using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where: (1) There is no interchangeable biological product approved by the federal Food and Drug Administration for the prescribed product; or (2) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

(h) Within 48 hours, excluding weekends and holidays, following the dispensing of a biological product, the dispensing pharmacist or the pharmacist's designee shall communicate to the prescriber the specific product provided to the patient, including the name of the biological product and the manufacturer. The communication shall be conveyed by making an entry into an interoperable electronic medical records system or through electronic prescribing technology or a pharmacy record that is electronically accessible by the prescriber. Otherwise, the pharmacist shall communicate the biological product dispensed to the prescriber by using facsimile, telephone, electronic transmission, or other prevailing means, provided that communication shall not be required where:

(1) There is no interchangeable biological product approved by the federal Food and Drug Administration for the prescribed product; or

(1) There is no interchangeable biological product approved by the federal Food and Drug Administration for the prescribed product; or

(2) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

(2) A refill prescription is not changed from the product dispensed on the prior filling of the prescription.

(i) The board shall maintain a link on its website to the current list of all biological products determined by the federal Food and Drug Administration to be interchangeable with a specific biological product.

(i) The board shall maintain a link on its website to the current list of all biological products determined by the federal Food and Drug Administration to be interchangeable with a specific biological product.

(j) Code Section 26-4-118 , “The Pharmacy Audit Bill of Rights,” shall apply to biological products and interchangeable biological products dispensed pursuant to this Code section.

(j) Code Section 26-4-118 , “The Pharmacy Audit Bill of Rights,” shall apply to biological products and interchangeable biological products dispensed pursuant to this Code section.
O.C.G.A. § 26-4-140 — GA Code / Title 26 / Chapter 4 / Section 26-4-140
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-140
Status: in_force

This article shall be known and may be cited as the “Third-party Prescription Program Law of 1983.”
O.C.G.A. § 26-5-7 — GA Code / Title 26 / Chapter 5 / Section 26-5-7
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-5-7
Status: in_force

No governing body shall operate a drug abuse treatment and education program without having a valid license or provisional license issued pursuant to this article.
O.C.G.A. § 26-2-161 — GA Code / Title 26 / Chapter 2 / Section 26-2-161
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-161
Status: in_force

Any person, firm, or corporation violating the terms of Code Section 26-2-157 , 26-2-158 , 26-2-159 , or 26-2-160 shall be guilty of a misdemeanor and, upon conviction thereof shall be fined an amount not exceeding $1,000.00 or imprisoned for a period not exceeding 12 months, or both, at the discretion of the court.
O.C.G.A. § 26-4-146 — GA Code / Title 26 / Chapter 4 / Section 26-4-146
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-146
Status: in_force

(a) On and after January 1, 1984, no person, corporation, or business entity shall serve as administrator of a program which has no administrator registered under this Code section unless that person, corporation, or business entity is registered as administrator of that program with the Commissioner.

(a) On and after January 1, 1984, no person, corporation, or business entity shall serve as administrator of a program which has no administrator registered under this Code section unless that person, corporation, or business entity is registered as administrator of that program with the Commissioner.

(b) No administrator may be registered unless the administrator gives bond to the Commissioner conditioned to pay all losses, damages, and expenses incurred as a result of any violation of this article by the administrator or the program being administered thereby. The bond shall be with a surety approved by the Commissioner in the amount of $200,000.00 or the total annual payments made in the immediately preceding year by all programs administered by that administrator, whichever is greater; provided, however, if the administrator is an insurance company licensed to transact insurance in this state or if the administrator is a self-insurer and is approved by the Commissioner, then such administrator shall not be required to give bond to the Commissioner.

(b) No administrator may be registered unless the administrator gives bond to the Commissioner conditioned to pay all losses, damages, and expenses incurred as a result of any violation of this article by the administrator or the program being administered thereby. The bond shall be with a surety approved by the Commissioner in the amount of $200,000.00 or the total annual payments made in the immediately preceding year by all programs administered by that administrator, whichever is greater; provided, however, if the administrator is an insurance company licensed to transact insurance in this state or if the administrator is a self-insurer and is approved by the Commissioner, then such administrator shall not be required to give bond to the Commissioner.

(c) No program shall be required to have more than one administrator registered and bonded under this Code section.

(c) No program shall be required to have more than one administrator registered and bonded under this Code section.

(d) An administrator may have his or her registration suspended or revoked by the Commissioner upon any violation of this article by the administrator or when any program administered by the administrator fails to conform to the requirements of this article. The refusal by the Commissioner to register an administrator and the suspension or revocation of an administrator's registration shall constitute a contested case for purposes of Chapter 13 of Title 50, the “Georgia Administrative Procedure Act.”

(d) An administrator may have his or her registration suspended or revoked by the Commissioner upon any violation of this article by the administrator or when any program administered by the administrator fails to conform to the requirements of this article. The refusal by the Commissioner to register an administrator and the suspension or revocation of an administrator's registration shall constitute a contested case for purposes of Chapter 13 of Title 50, the “Georgia Administrative Procedure Act.”

(e) Records, information, and other identifying matter obtained through the submission of a claim for reimbursement by a participating pharmacy shall be used exclusively and solely for the purposes of verification and payment to the participating pharmacy and policyholder and for no other purposes.

(e) Records, information, and other identifying matter obtained through the submission of a claim for reimbursement by a participating pharmacy shall be used exclusively and solely for the purposes of verification and payment to the participating pharmacy and policyholder and for no other purposes.
O.C.G.A. § 26-3-8 — GA Code / Title 26 / Chapter 3 / Section 26-3-8
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-3-8
Status: in_force

(a) A drug or device shall be deemed to be misbranded: (1) If its labeling is false or misleading in any particular; (2) If in package form unless it bears a label containing: (A) The name and place of business of the manufacturer, packer, or distributor; and (B) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the State Board of Pharmacy; (3) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with conspicuousness as compared with other words, statements, designs, or devices in the labeling and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use; (4) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, sulfonmethane, or any chemical derivative of such substance which has been found after investigation by the State Board of Pharmacy to be and by regulations under this chapter designated as habit forming, or any synthetic narcotic or drug unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning--May be habit forming”; (5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears: (A) The common or usual name of the drug if there is such; and (B) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient including the kind and quantity or proportion of any alcohol and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substance contained therein, provided that to the extent that compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the State Board of Pharmacy; (6)(A) Unless its labeling bears: (i) Adequate directions for use; and (ii) Adequate warnings against use by children or in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users. (B) Where any requirement of division (i) of subparagraph (A) of this paragraph as applied to any drug or device is not necessary for the protection of the public health, the State Board of Pharmacy shall promulgate regulations exempting such drug or device from such requirements; (7) If it is purported to be a drug the name of which is recognized in an official compendium unless it is packaged and labeled as prescribed therein, provided that the method of packing may be modified with consent of the State Board of Pharmacy. Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopeia; (8) If it has been found by the State Board of Pharmacy to be a drug liable to deterioration unless it is packaged in such form and manner and its label bears a statement or such precautions as the State Board of Pharmacy shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the State Board of Pharmacy shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements; (9)(A) If it is a drug and its container is so made, formed, or filled as to be misleading; (B) If it is an imitation of another drug; or (C) If it is offered for sale under the name of another drug; (10) If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof; or (11) If it is a drug intended for use by man which: (A) Is a habit-forming drug to which paragraph (4) of this subsection applies; (B) Because of its toxicity or other potentiality for harmful effect, the method of use, or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (C) Is limited by an effective application under Section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug unless it is dispensed only: (i) Upon a written prescription of a practitioner licensed by law to administer such drug; (ii) Upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist; or (iii) By refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(a) A drug or device shall be deemed to be misbranded:

(1) If its labeling is false or misleading in any particular;

(1) If its labeling is false or misleading in any particular;

(2) If in package form unless it bears a label containing: (A) The name and place of business of the manufacturer, packer, or distributor; and (B) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the State Board of Pharmacy;

(2) If in package form unless it bears a label containing:

(A) The name and place of business of the manufacturer, packer, or distributor; and

(A) The name and place of business of the manufacturer, packer, or distributor; and

(B) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the State Board of Pharmacy;

(B) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count, provided that reasonable variations shall be permitted and exemptions as to small packages shall be established by regulations prescribed by the State Board of Pharmacy;

(3) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with conspicuousness as compared with other words, statements, designs, or devices in the labeling and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(3) If any word, statement, or other information required by or under authority of this chapter to appear on the label or labeling is not prominently placed thereon with conspicuousness as compared with other words, statements, designs, or devices in the labeling and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(4) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, sulfonmethane, or any chemical derivative of such substance which has been found after investigation by the State Board of Pharmacy to be and by regulations under this chapter designated as habit forming, or any synthetic narcotic or drug unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning--May be habit forming”;

(4) If it is for use by man and contains any quantity of the narcotic or hypnotic substance alphaeucaine, barbituric acid, betaeucaine, bromal, cannabis, carbromal, chloral, coca, cocaine, codeine, heroin, marijuana, morphine, opium, paraldehyde, peyote, sulfonmethane, or any chemical derivative of such substance which has been found after investigation by the State Board of Pharmacy to be and by regulations under this chapter designated as habit forming, or any synthetic narcotic or drug unless its label bears the name and quantity or proportion of such substance or derivative and in juxtaposition therewith the statement “Warning--May be habit forming”;

(5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears: (A) The common or usual name of the drug if there is such; and (B) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient including the kind and quantity or proportion of any alcohol and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substance contained therein, provided that to the extent that compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the State Board of Pharmacy;

(5) If it is a drug and is not designated solely by a name recognized in an official compendium unless its label bears:

(A) The common or usual name of the drug if there is such; and

(A) The common or usual name of the drug if there is such; and

(B) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient including the kind and quantity or proportion of any alcohol and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substance contained therein, provided that to the extent that compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the State Board of Pharmacy;

(B) In case it is fabricated from two or more ingredients, the common or usual name of each active ingredient including the kind and quantity or proportion of any alcohol and also including, whether active or not, the name and quantity or proportion of any bromides, ether, chloroform, acetanilid, acetophenetidin, amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine, arsenic, digitalis, glucosides, mercury, ouabain, strophanthin, strychnine, thyroid, or any derivative or preparation of any such substance contained therein, provided that to the extent that compliance with the requirements of this subparagraph is impracticable, exemptions shall be established by regulations promulgated by the State Board of Pharmacy;

(6)(A) Unless its labeling bears: (i) Adequate directions for use; and (ii) Adequate warnings against use by children or in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users. (B) Where any requirement of division (i) of subparagraph (A) of this paragraph as applied to any drug or device is not necessary for the protection of the public health, the State Board of Pharmacy shall promulgate regulations exempting such drug or device from such requirements;

(6)(A) Unless its labeling bears: (i) Adequate directions for use; and (ii) Adequate warnings against use by children or in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users.

(6)(A) Unless its labeling bears:

(i) Adequate directions for use; and

(i) Adequate directions for use; and

(ii) Adequate warnings against use by children or in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users.

(ii) Adequate warnings against use by children or in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application in such manner and form as are necessary for the protection of users.

(B) Where any requirement of division (i) of subparagraph (A) of this paragraph as applied to any drug or device is not necessary for the protection of the public health, the State Board of Pharmacy shall promulgate regulations exempting such drug or device from such requirements;

(B) Where any requirement of division (i) of subparagraph (A) of this paragraph as applied to any drug or device is not necessary for the protection of the public health, the State Board of Pharmacy shall promulgate regulations exempting such drug or device from such requirements;

(7) If it is purported to be a drug the name of which is recognized in an official compendium unless it is packaged and labeled as prescribed therein, provided that the method of packing may be modified with consent of the State Board of Pharmacy. Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopeia;

(7) If it is purported to be a drug the name of which is recognized in an official compendium unless it is packaged and labeled as prescribed therein, provided that the method of packing may be modified with consent of the State Board of Pharmacy. Whenever a drug is recognized in both the United States Pharmacopeia and the Homeopathic Pharmacopoeia of the United States, it shall be subject to the requirements of the United States Pharmacopeia with respect to packaging and labeling unless it is labeled and offered for sale as a homeopathic drug, in which case it shall be subject to the provisions of the Homeopathic Pharmacopoeia of the United States and not to those of the United States Pharmacopeia;

(8) If it has been found by the State Board of Pharmacy to be a drug liable to deterioration unless it is packaged in such form and manner and its label bears a statement or such precautions as the State Board of Pharmacy shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the State Board of Pharmacy shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements;

(8) If it has been found by the State Board of Pharmacy to be a drug liable to deterioration unless it is packaged in such form and manner and its label bears a statement or such precautions as the State Board of Pharmacy shall by regulations require as necessary for the protection of public health. No such regulation shall be established for any drug recognized in an official compendium until the State Board of Pharmacy shall have informed the appropriate body charged with the revision of such compendium of the need for such packaging or labeling requirements and such body shall have failed within a reasonable time to prescribe such requirements;

(9)(A) If it is a drug and its container is so made, formed, or filled as to be misleading; (B) If it is an imitation of another drug; or (C) If it is offered for sale under the name of another drug;

(9)(A) If it is a drug and its container is so made, formed, or filled as to be misleading;

(9)(A) If it is a drug and its container is so made, formed, or filled as to be misleading;

(B) If it is an imitation of another drug; or

(B) If it is an imitation of another drug; or

(C) If it is offered for sale under the name of another drug;

(C) If it is offered for sale under the name of another drug;

(10) If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof; or

(10) If it is dangerous to health when used in the dosage or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof; or

(11) If it is a drug intended for use by man which: (A) Is a habit-forming drug to which paragraph (4) of this subsection applies; (B) Because of its toxicity or other potentiality for harmful effect, the method of use, or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or (C) Is limited by an effective application under Section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug unless it is dispensed only: (i) Upon a written prescription of a practitioner licensed by law to administer such drug; (ii) Upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist; or (iii) By refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(11) If it is a drug intended for use by man which:

(A) Is a habit-forming drug to which paragraph (4) of this subsection applies;

(A) Is a habit-forming drug to which paragraph (4) of this subsection applies;

(B) Because of its toxicity or other potentiality for harmful effect, the method of use, or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or

(B) Because of its toxicity or other potentiality for harmful effect, the method of use, or the collateral measures necessary to its use is not safe for use except under the supervision of a practitioner licensed by law to administer such drug; or

(C) Is limited by an effective application under Section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug unless it is dispensed only: (i) Upon a written prescription of a practitioner licensed by law to administer such drug; (ii) Upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist; or (iii) By refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(C) Is limited by an effective application under Section 505 of the federal act to use under the professional supervision of a practitioner licensed by law to administer such drug unless it is dispensed only:

(i) Upon a written prescription of a practitioner licensed by law to administer such drug;

(i) Upon a written prescription of a practitioner licensed by law to administer such drug;

(ii) Upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist; or

(ii) Upon an oral prescription of such practitioner which is reduced promptly to writing and filed by the pharmacist; or

(iii) By refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(iii) By refilling any such written or oral prescription if such refilling is authorized by the prescriber either in the original prescription or by oral order which is reduced promptly to writing and filed by the pharmacist.

(b) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of this Code section except paragraphs (1) and (9) of subsection (a) of this Code section if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of paragraph (11) of subsection (a) of this Code section.

(b) Any drug dispensed by filling or refilling a written or oral prescription of a practitioner licensed by law to administer such drug shall be exempt from the requirements of this Code section except paragraphs (1) and (9) of subsection (a) of this Code section if the drug bears a label containing the name and address of the dispenser, the serial number and date of the prescription or of its filling, the name of the prescriber, and, if stated in the prescription, the name of the patient and the directions for use and cautionary statements, if any, contained in such prescription. This exemption shall not apply to any drug dispensed in the course of the conduct of a business of dispensing drugs pursuant to diagnosis by mail or to a drug dispensed in violation of paragraph (11) of subsection (a) of this Code section.
O.C.G.A. § 26-5-5 — GA Code / Title 26 / Chapter 5 / Section 26-5-5
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-5-5
Status: in_force

The department shall create and promulgate minimum standards of quality and services for each designated class of programs. At least the following areas shall be covered in the rules and regulations:

(1) Adequate and safe buildings or housing facilities where programs are offered;

(1) Adequate and safe buildings or housing facilities where programs are offered;

(2) Adequate equipment for the delivery of programs;

(2) Adequate equipment for the delivery of programs;

(3) Sufficient trained or experienced staff who are competent in the duties they are to perform;

(3) Sufficient trained or experienced staff who are competent in the duties they are to perform;

(4) The content and quality of services to be provided;

(4) The content and quality of services to be provided;

(5) Requirements for intake, discharge, and aftercare of drug dependent persons;

(5) Requirements for intake, discharge, and aftercare of drug dependent persons;

(6) Referral to other appropriate agencies;

(6) Referral to other appropriate agencies;

(7) Continuing evaluation of the effectiveness of programs;

(7) Continuing evaluation of the effectiveness of programs;

(8) Maintenance of adequate records on each drug dependent person treated or advised;

(8) Maintenance of adequate records on each drug dependent person treated or advised;

(9) A formal plan of cooperation with other programs in the state to allow for continuity of care for drug dependent persons; and

(9) A formal plan of cooperation with other programs in the state to allow for continuity of care for drug dependent persons; and

(10) Criteria for providing priority in access to services and admissions to programs for drug dependent pregnant females.

(10) Criteria for providing priority in access to services and admissions to programs for drug dependent pregnant females.
O.C.G.A. § 26-2-27-1 — GA Code / Title 26 / Chapter 2 / Section 26-2-27-1
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-27.1
Status: in_force

(a) As used in this Code section, the term “ food processing plant ” means a commercial operation that manufactures food for human consumption and does not provide food directly to a consumer from that location. Such term shall not include a commercial operation that produces raw agricultural commodities and whose end product remains a raw agricultural product.

(a) As used in this Code section, the term “ food processing plant ” means a commercial operation that manufactures food for human consumption and does not provide food directly to a consumer from that location. Such term shall not include a commercial operation that produces raw agricultural commodities and whose end product remains a raw agricultural product.

(b)(1)(A) In order to protect the public health, safety, and welfare and ensure compliance with this article, the Commissioner shall by rule or regulation establish requirements for regular testing of samples or specimens of foods and ingredients by food processing plants for the presence of poisonous or deleterious substances or other contaminants rendering such foods or ingredients injurious to health. Such rules or regulations shall identify the specific classes or types of food processing plants, foods, ingredients, and poisonous or deleterious substances or other contaminants that shall be subject to such testing requirements and the frequency with which such tests shall be performed by food processing plants. (B) The Commissioner shall also promulgate rules and regulations establishing minimum standards and requirements for a written food safety plan, such as a hazard analysis critical control point plan, that may be submitted by an operator of a food processing plant to document and describe the procedures used at such plant to prevent the presence of hazards such as poisonous or deleterious substances or other contaminants that would render finished foods or finished ingredients as manufactured at such plant injurious to health, including preventive controls, monitoring to ensure the effectiveness of such controls, and records of corrective actions, including actions taken in response to the presence of known hazards. If an operator of a food processing plant, in its discretion, submits to the department a written food safety plan for such plant and such plan conforms to rules and regulations promulgated for purposes of this subparagraph, then such food processing plant shall comply with the requirements of such written food safety plan, including, but not limited to, any test regimen provided by such plan, in lieu of complying with a test regimen established by rules or regulations promulgated by the Commissioner pursuant to subparagraph (A) of this paragraph. (C)(i) The Commissioner shall impose a civil penalty for a violation of this subsection. (ii) The department shall adopt rules and regulations establishing a schedule of civil penalties that shall be imposed under this subsection. Civil penalties imposed pursuant to this subsection shall not exceed $5,000.00 for each violation; provided, however, that a food processing plant that knowingly fails to comply with the provisions of subparagraph (B) of this paragraph shall be punished by the imposition of a $7,500.00 civil penalty. In addition to such civil penalty, within 30 days of the determination by the Commissioner that such violation has occurred, such food processing plant shall submit to the Commissioner a written plan pursuant to subparagraph (B) of this paragraph. (iii) For purposes of this subsection, each day a violation continues after the period established for compliance by the Commissioner shall be considered a separate violation. (iv) When a civil penalty is imposed under this subsection, such penalty shall be subject to review in the manner prescribed by Article 1 of Chapter 13 of Title 50, known as the “Georgia Administrative Procedure Act.” (2) In addition to any regular tests required pursuant to paragraph (1) of this subsection, the Commissioner may order any food processing plant to have samples or specimens of its foods and ingredients tested for the presence of any poisonous or deleterious substances or other contaminants whenever in his or her determination there are reasonable grounds to suspect that such foods or ingredients may be injurious to health.

(b)(1)(A) In order to protect the public health, safety, and welfare and ensure compliance with this article, the Commissioner shall by rule or regulation establish requirements for regular testing of samples or specimens of foods and ingredients by food processing plants for the presence of poisonous or deleterious substances or other contaminants rendering such foods or ingredients injurious to health. Such rules or regulations shall identify the specific classes or types of food processing plants, foods, ingredients, and poisonous or deleterious substances or other contaminants that shall be subject to such testing requirements and the frequency with which such tests shall be performed by food processing plants. (B) The Commissioner shall also promulgate rules and regulations establishing minimum standards and requirements for a written food safety plan, such as a hazard analysis critical control point plan, that may be submitted by an operator of a food processing plant to document and describe the procedures used at such plant to prevent the presence of hazards such as poisonous or deleterious substances or other contaminants that would render finished foods or finished ingredients as manufactured at such plant injurious to health, including preventive controls, monitoring to ensure the effectiveness of such controls, and records of corrective actions, including actions taken in response to the presence of known hazards. If an operator of a food processing plant, in its discretion, submits to the department a written food safety plan for such plant and such plan conforms to rules and regulations promulgated for purposes of this subparagraph, then such food processing plant shall comply with the requirements of such written food safety plan, including, but not limited to, any test regimen provided by such plan, in lieu of complying with a test regimen established by rules or regulations promulgated by the Commissioner pursuant to subparagraph (A) of this paragraph. (C)(i) The Commissioner shall impose a civil penalty for a violation of this subsection. (ii) The department shall adopt rules and regulations establishing a schedule of civil penalties that shall be imposed under this subsection. Civil penalties imposed pursuant to this subsection shall not exceed $5,000.00 for each violation; provided, however, that a food processing plant that knowingly fails to comply with the provisions of subparagraph (B) of this paragraph shall be punished by the imposition of a $7,500.00 civil penalty. In addition to such civil penalty, within 30 days of the determination by the Commissioner that such violation has occurred, such food processing plant shall submit to the Commissioner a written plan pursuant to subparagraph (B) of this paragraph. (iii) For purposes of this subsection, each day a violation continues after the period established for compliance by the Commissioner shall be considered a separate violation. (iv) When a civil penalty is imposed under this subsection, such penalty shall be subject to review in the manner prescribed by Article 1 of Chapter 13 of Title 50, known as the “Georgia Administrative Procedure Act.”

(b)(1)(A) In order to protect the public health, safety, and welfare and ensure compliance with this article, the Commissioner shall by rule or regulation establish requirements for regular testing of samples or specimens of foods and ingredients by food processing plants for the presence of poisonous or deleterious substances or other contaminants rendering such foods or ingredients injurious to health. Such rules or regulations shall identify the specific classes or types of food processing plants, foods, ingredients, and poisonous or deleterious substances or other contaminants that shall be subject to such testing requirements and the frequency with which such tests shall be performed by food processing plants.

(b)(1)(A) In order to protect the public health, safety, and welfare and ensure compliance with this article, the Commissioner shall by rule or regulation establish requirements for regular testing of samples or specimens of foods and ingredients by food processing plants for the presence of poisonous or deleterious substances or other contaminants rendering such foods or ingredients injurious to health. Such rules or regulations shall identify the specific classes or types of food processing plants, foods, ingredients, and poisonous or deleterious substances or other contaminants that shall be subject to such testing requirements and the frequency with which such tests shall be performed by food processing plants.

(B) The Commissioner shall also promulgate rules and regulations establishing minimum standards and requirements for a written food safety plan, such as a hazard analysis critical control point plan, that may be submitted by an operator of a food processing plant to document and describe the procedures used at such plant to prevent the presence of hazards such as poisonous or deleterious substances or other contaminants that would render finished foods or finished ingredients as manufactured at such plant injurious to health, including preventive controls, monitoring to ensure the effectiveness of such controls, and records of corrective actions, including actions taken in response to the presence of known hazards. If an operator of a food processing plant, in its discretion, submits to the department a written food safety plan for such plant and such plan conforms to rules and regulations promulgated for purposes of this subparagraph, then such food processing plant shall comply with the requirements of such written food safety plan, including, but not limited to, any test regimen provided by such plan, in lieu of complying with a test regimen established by rules or regulations promulgated by the Commissioner pursuant to subparagraph (A) of this paragraph.

(B) The Commissioner shall also promulgate rules and regulations establishing minimum standards and requirements for a written food safety plan, such as a hazard analysis critical control point plan, that may be submitted by an operator of a food processing plant to document and describe the procedures used at such plant to prevent the presence of hazards such as poisonous or deleterious substances or other contaminants that would render finished foods or finished ingredients as manufactured at such plant injurious to health, including preventive controls, monitoring to ensure the effectiveness of such controls, and records of corrective actions, including actions taken in response to the presence of known hazards. If an operator of a food processing plant, in its discretion, submits to the department a written food safety plan for such plant and such plan conforms to rules and regulations promulgated for purposes of this subparagraph, then such food processing plant shall comply with the requirements of such written food safety plan, including, but not limited to, any test regimen provided by such plan, in lieu of complying with a test regimen established by rules or regulations promulgated by the Commissioner pursuant to subparagraph (A) of this paragraph.

(C)(i) The Commissioner shall impose a civil penalty for a violation of this subsection. (ii) The department shall adopt rules and regulations establishing a schedule of civil penalties that shall be imposed under this subsection. Civil penalties imposed pursuant to this subsection shall not exceed $5,000.00 for each violation; provided, however, that a food processing plant that knowingly fails to comply with the provisions of subparagraph (B) of this paragraph shall be punished by the imposition of a $7,500.00 civil penalty. In addition to such civil penalty, within 30 days of the determination by the Commissioner that such violation has occurred, such food processing plant shall submit to the Commissioner a written plan pursuant to subparagraph (B) of this paragraph. (iii) For purposes of this subsection, each day a violation continues after the period established for compliance by the Commissioner shall be considered a separate violation. (iv) When a civil penalty is imposed under this subsection, such penalty shall be subject to review in the manner prescribed by Article 1 of Chapter 13 of Title 50, known as the “Georgia Administrative Procedure Act.”

(C)(i) The Commissioner shall impose a civil penalty for a violation of this subsection.

(C)(i) The Commissioner shall impose a civil penalty for a violation of this subsection.

(ii) The department shall adopt rules and regulations establishing a schedule of civil penalties that shall be imposed under this subsection. Civil penalties imposed pursuant to this subsection shall not exceed $5,000.00 for each violation; provided, however, that a food processing plant that knowingly fails to comply with the provisions of subparagraph (B) of this paragraph shall be punished by the imposition of a $7,500.00 civil penalty. In addition to such civil penalty, within 30 days of the determination by the Commissioner that such violation has occurred, such food processing plant shall submit to the Commissioner a written plan pursuant to subparagraph (B) of this paragraph.

(ii) The department shall adopt rules and regulations establishing a schedule of civil penalties that shall be imposed under this subsection. Civil penalties imposed pursuant to this subsection shall not exceed $5,000.00 for each violation; provided, however, that a food processing plant that knowingly fails to comply with the provisions of subparagraph (B) of this paragraph shall be punished by the imposition of a $7,500.00 civil penalty. In addition to such civil penalty, within 30 days of the determination by the Commissioner that such violation has occurred, such food processing plant shall submit to the Commissioner a written plan pursuant to subparagraph (B) of this paragraph.

(iii) For purposes of this subsection, each day a violation continues after the period established for compliance by the Commissioner shall be considered a separate violation.

(iii) For purposes of this subsection, each day a violation continues after the period established for compliance by the Commissioner shall be considered a separate violation.

(iv) When a civil penalty is imposed under this subsection, such penalty shall be subject to review in the manner prescribed by Article 1 of Chapter 13 of Title 50, known as the “Georgia Administrative Procedure Act.”

(iv) When a civil penalty is imposed under this subsection, such penalty shall be subject to review in the manner prescribed by Article 1 of Chapter 13 of Title 50, known as the “Georgia Administrative Procedure Act.”

(2) In addition to any regular tests required pursuant to paragraph (1) of this subsection, the Commissioner may order any food processing plant to have samples or specimens of its foods and ingredients tested for the presence of any poisonous or deleterious substances or other contaminants whenever in his or her determination there are reasonable grounds to suspect that such foods or ingredients may be injurious to health.

(2) In addition to any regular tests required pursuant to paragraph (1) of this subsection, the Commissioner may order any food processing plant to have samples or specimens of its foods and ingredients tested for the presence of any poisonous or deleterious substances or other contaminants whenever in his or her determination there are reasonable grounds to suspect that such foods or ingredients may be injurious to health.

(c) Any food processing plant subject to any testing requirements pursuant to this Code section shall cause such required tests to be performed in accordance with testing standards and procedures established by rules and regulations of the Commissioner. Testing standards and procedures established by the Commissioner under this paragraph shall be consistent with standards presented in the federal Food and Drug Administration's Bacterial Analytical Manual and standards developed by the Association of Analytical Communities International, International Organization for Standardization, or another internationally recognized certification body.

(c) Any food processing plant subject to any testing requirements pursuant to this Code section shall cause such required tests to be performed in accordance with testing standards and procedures established by rules and regulations of the Commissioner. Testing standards and procedures established by the Commissioner under this paragraph shall be consistent with standards presented in the federal Food and Drug Administration's Bacterial Analytical Manual and standards developed by the Association of Analytical Communities International, International Organization for Standardization, or another internationally recognized certification body.

(d) A food processing plant shall be responsible for the cost of any testing required pursuant to this Code section and may conduct such testing either internally or via a third party, provided that subsection (c) of this Code section applies in either case.

(d) A food processing plant shall be responsible for the cost of any testing required pursuant to this Code section and may conduct such testing either internally or via a third party, provided that subsection (c) of this Code section applies in either case.

(e)(1) Whenever any person or firm that operates a food processing plant in this state obtains information from testing of samples or specimens of finished foods or finished food ingredients as manufactured at such food processing plant which, based on a confirmed positive test result, indicates the presence of a substance that would cause a manufactured food bearing or containing the same to be adulterated within the meaning of paragraph (1) of Code Section 26-2-26 , such person or firm shall report such test result to the department within 24 hours after obtaining such information. (2) Any person who knowingly fails to make the report required by paragraph (1) of this subsection shall be guilty of a misdemeanor. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.

(e)(1) Whenever any person or firm that operates a food processing plant in this state obtains information from testing of samples or specimens of finished foods or finished food ingredients as manufactured at such food processing plant which, based on a confirmed positive test result, indicates the presence of a substance that would cause a manufactured food bearing or containing the same to be adulterated within the meaning of paragraph (1) of Code Section 26-2-26 , such person or firm shall report such test result to the department within 24 hours after obtaining such information.

(e)(1) Whenever any person or firm that operates a food processing plant in this state obtains information from testing of samples or specimens of finished foods or finished food ingredients as manufactured at such food processing plant which, based on a confirmed positive test result, indicates the presence of a substance that would cause a manufactured food bearing or containing the same to be adulterated within the meaning of paragraph (1) of Code Section 26-2-26 , such person or firm shall report such test result to the department within 24 hours after obtaining such information.

(2) Any person who knowingly fails to make the report required by paragraph (1) of this subsection shall be guilty of a misdemeanor. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.

(2) Any person who knowingly fails to make the report required by paragraph (1) of this subsection shall be guilty of a misdemeanor. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.

(f) Records of the results of any tests required pursuant to this Code section shall be kept by a food processing plant and made available to the department for inspection for a period of not less than two years from the date the results were reported by the laboratory. Any person who knowingly violates this subsection shall be guilty of a misdemeanor. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.

(f) Records of the results of any tests required pursuant to this Code section shall be kept by a food processing plant and made available to the department for inspection for a period of not less than two years from the date the results were reported by the laboratory. Any person who knowingly violates this subsection shall be guilty of a misdemeanor. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.

(g) This Code section shall not apply to any food processing plant operating under a federal grant of inspection from the United States Department of Agriculture Food Safety and Inspection Service.

(g) This Code section shall not apply to any food processing plant operating under a federal grant of inspection from the United States Department of Agriculture Food Safety and Inspection Service.

(h) Any person who knowingly introduces into commerce finished foods or finished food ingredients as manufactured at a food processing plant knowing that it contains a substance that would cause a manufactured food bearing or containing the same to be adulterated within the meaning of paragraph (1) of Code Section 26-2-26 shall be guilty of a felony, and, upon conviction, shall be punished by imprisonment for not less than one nor more than 20 years, a fine not to exceed $20,000.00, or both. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.

(h) Any person who knowingly introduces into commerce finished foods or finished food ingredients as manufactured at a food processing plant knowing that it contains a substance that would cause a manufactured food bearing or containing the same to be adulterated within the meaning of paragraph (1) of Code Section 26-2-26 shall be guilty of a felony, and, upon conviction, shall be punished by imprisonment for not less than one nor more than 20 years, a fine not to exceed $20,000.00, or both. The punishment provided for in this subsection shall be supplemental to any other applicable provisions of law.
O.C.G.A. § 26-4-170 — GA Code / Title 26 / Chapter 4 / Section 26-4-170
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-170
Status: in_force

This article shall be known and may be cited as the “Nuclear Pharmacy Law.”
O.C.G.A. § 26-5-54 — GA Code / Title 26 / Chapter 5 / Section 26-5-54
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-5-54
Status: in_force

Notice of a proposed suspension or revocation of a license shall be provided in writing by the department to any licensee so affected within 90 days after the open enrollment period has closed or the grounds are discovered. Within ten days from receipt of such notice, the licensee so affected may request a hearing before the department. Upon receipt of such request for hearing in proper form, the department shall schedule a hearing within a reasonable time, but not later than 90 days.
O.C.G.A. § 26-4-114-1 — GA Code / Title 26 / Chapter 4 / Section 26-4-114-1
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-114.1
Status: in_force

(a) Any person, pharmacy, or facility located outside this state may apply to the board for a nonresident pharmacy permit which shall entitle the holder thereof to ship, mail, or deliver dispensed drugs, including but not limited to dangerous drugs and controlled substances, into this state. The board shall establish an application and require such information as the board deems reasonably necessary to carry out a background investigation of applicants and to ensure that the purposes of this Code section are met. Such application shall include: (1) Proof of a valid, unexpired license, permit, or registration to operate a pharmacy in compliance with the laws and rules of each state in which the applicant receives and dispenses prescription drug orders, including but not limited to orders for prescription drugs, dangerous drugs, and controlled substances; (2) Addresses, names, and titles of all principal corporate officers and the pharmacist in charge of dispensing drugs to residents of this state; and (3) A statement of whether the applicant is in compliance with all lawful directions and requests for information from the regulatory or licensing agencies of each state in which the applicant is licensed as well as all requests for information made by the board pursuant to this Code section.

(a) Any person, pharmacy, or facility located outside this state may apply to the board for a nonresident pharmacy permit which shall entitle the holder thereof to ship, mail, or deliver dispensed drugs, including but not limited to dangerous drugs and controlled substances, into this state. The board shall establish an application and require such information as the board deems reasonably necessary to carry out a background investigation of applicants and to ensure that the purposes of this Code section are met. Such application shall include:

(1) Proof of a valid, unexpired license, permit, or registration to operate a pharmacy in compliance with the laws and rules of each state in which the applicant receives and dispenses prescription drug orders, including but not limited to orders for prescription drugs, dangerous drugs, and controlled substances;

(1) Proof of a valid, unexpired license, permit, or registration to operate a pharmacy in compliance with the laws and rules of each state in which the applicant receives and dispenses prescription drug orders, including but not limited to orders for prescription drugs, dangerous drugs, and controlled substances;

(2) Addresses, names, and titles of all principal corporate officers and the pharmacist in charge of dispensing drugs to residents of this state; and

(2) Addresses, names, and titles of all principal corporate officers and the pharmacist in charge of dispensing drugs to residents of this state; and

(3) A statement of whether the applicant is in compliance with all lawful directions and requests for information from the regulatory or licensing agencies of each state in which the applicant is licensed as well as all requests for information made by the board pursuant to this Code section.

(3) A statement of whether the applicant is in compliance with all lawful directions and requests for information from the regulatory or licensing agencies of each state in which the applicant is licensed as well as all requests for information made by the board pursuant to this Code section.

(b) The board shall establish by rule an application fee and the biennial renewal fee for a permit under this Code section.

(b) The board shall establish by rule an application fee and the biennial renewal fee for a permit under this Code section.

(c) The board may only deny an application for a nonresident pharmacy permit for failure to comply with rules of the board or any requirements of this Code section or for good cause related to substantial evidence of misfeasance or malfeasance by the applicant. Applicants granted a permit under this Code section shall provide pharmacy care in a manner which does not endanger life and protects the health, safety, and welfare of the residents of this state. A pharmacy, facility, or entity licensed under Title 33 shall not be required to hold a nonresident pharmacy permit.

(c) The board may only deny an application for a nonresident pharmacy permit for failure to comply with rules of the board or any requirements of this Code section or for good cause related to substantial evidence of misfeasance or malfeasance by the applicant. Applicants granted a permit under this Code section shall provide pharmacy care in a manner which does not endanger life and protects the health, safety, and welfare of the residents of this state. A pharmacy, facility, or entity licensed under Title 33 shall not be required to hold a nonresident pharmacy permit.

(d) After an effective date established by rule of the board for the enforcement of the nonresident pharmacy permits, it shall be unlawful for any person, pharmacy, or facility that is located outside this state and that does not possess a nonresident pharmacy permit to ship, mail, or deliver prescription drug orders or to advertise its services in this state, or for any person who is a resident of this state to advertise the services of such person, pharmacy, or facility with the knowledge that the advertisement will or is likely to induce residents of this state to use such person, pharmacy, or facility for pharmacy care. Nothing in this subsection shall be construed to limit or prohibit interstate commerce, including but not limited to the practice of pharmacy by mail.

(d) After an effective date established by rule of the board for the enforcement of the nonresident pharmacy permits, it shall be unlawful for any person, pharmacy, or facility that is located outside this state and that does not possess a nonresident pharmacy permit to ship, mail, or deliver prescription drug orders or to advertise its services in this state, or for any person who is a resident of this state to advertise the services of such person, pharmacy, or facility with the knowledge that the advertisement will or is likely to induce residents of this state to use such person, pharmacy, or facility for pharmacy care. Nothing in this subsection shall be construed to limit or prohibit interstate commerce, including but not limited to the practice of pharmacy by mail.

(e) The board shall have the authority to promulgate rules and regulations governing the holder of a nonresident pharmacy permit under this Code section. Such rules and regulations shall minimally include the following requirements for nonresident pharmacy permit holders: (1) A permit holder's pharmacist in charge of dispensing drugs to residents of this state shall be licensed in his or her state of location; (2) A permit holder shall provide written notification to the board within ten days of any change of a permit holder's principal corporate officers or pharmacist in charge of dispensing drugs to residents of this state; (3) A permit holder shall file a change of location application upon any change to the permit holder's state of registration in addition to proof of the license, permit, or registration from the permit holder's new state of registration and the United States Drug Enforcement Administration registration for such new location; (4) A permit holder shall respond within ten calendar days to all communications from the board concerning emergency circumstances arising from errors in the dispensing of any drugs to residents of this state; (5) A permit holder shall provide written notification to the board of each location at which the permit holder maintains its records for all prescription drug orders dispensed to patients in this state so that the records are readily retrievable from the business records of the permit holder; and (6) A permit holder shall maintain a toll-free telephone number operational during the permit holder's regular hours of operation but not less than six days per week for a minimum of 60 hours per week that shall be used to provide and facilitate patient counseling. Such toll-free number shall be capable of receiving inbound calls from patients to the permit holder and shall be disclosed on the label affixed to each container of all dispensed and distributed drugs.

(e) The board shall have the authority to promulgate rules and regulations governing the holder of a nonresident pharmacy permit under this Code section. Such rules and regulations shall minimally include the following requirements for nonresident pharmacy permit holders:

(1) A permit holder's pharmacist in charge of dispensing drugs to residents of this state shall be licensed in his or her state of location;

(1) A permit holder's pharmacist in charge of dispensing drugs to residents of this state shall be licensed in his or her state of location;

(2) A permit holder shall provide written notification to the board within ten days of any change of a permit holder's principal corporate officers or pharmacist in charge of dispensing drugs to residents of this state;

(2) A permit holder shall provide written notification to the board within ten days of any change of a permit holder's principal corporate officers or pharmacist in charge of dispensing drugs to residents of this state;

(3) A permit holder shall file a change of location application upon any change to the permit holder's state of registration in addition to proof of the license, permit, or registration from the permit holder's new state of registration and the United States Drug Enforcement Administration registration for such new location;

(3) A permit holder shall file a change of location application upon any change to the permit holder's state of registration in addition to proof of the license, permit, or registration from the permit holder's new state of registration and the United States Drug Enforcement Administration registration for such new location;

(4) A permit holder shall respond within ten calendar days to all communications from the board concerning emergency circumstances arising from errors in the dispensing of any drugs to residents of this state;

(4) A permit holder shall respond within ten calendar days to all communications from the board concerning emergency circumstances arising from errors in the dispensing of any drugs to residents of this state;

(5) A permit holder shall provide written notification to the board of each location at which the permit holder maintains its records for all prescription drug orders dispensed to patients in this state so that the records are readily retrievable from the business records of the permit holder; and

(5) A permit holder shall provide written notification to the board of each location at which the permit holder maintains its records for all prescription drug orders dispensed to patients in this state so that the records are readily retrievable from the business records of the permit holder; and

(6) A permit holder shall maintain a toll-free telephone number operational during the permit holder's regular hours of operation but not less than six days per week for a minimum of 60 hours per week that shall be used to provide and facilitate patient counseling. Such toll-free number shall be capable of receiving inbound calls from patients to the permit holder and shall be disclosed on the label affixed to each container of all dispensed and distributed drugs.

(6) A permit holder shall maintain a toll-free telephone number operational during the permit holder's regular hours of operation but not less than six days per week for a minimum of 60 hours per week that shall be used to provide and facilitate patient counseling. Such toll-free number shall be capable of receiving inbound calls from patients to the permit holder and shall be disclosed on the label affixed to each container of all dispensed and distributed drugs.

(f) The board may revoke, suspend, or refuse to renew a permit of a permit holder for failure to comply with rules of the board or with any requirement of this Code section or for conduct which causes serious bodily or psychological injury to a resident of this state, provided that the board has referred the matter involving the conduct to the regulatory or licensing agency in the state in which the permit holder is located and the regulatory or licensing agency fails to initiate an investigation into the matter within 180 days of such referral or fails, in the board's judgment, to render sufficient resolution.

(f) The board may revoke, suspend, or refuse to renew a permit of a permit holder for failure to comply with rules of the board or with any requirement of this Code section or for conduct which causes serious bodily or psychological injury to a resident of this state, provided that the board has referred the matter involving the conduct to the regulatory or licensing agency in the state in which the permit holder is located and the regulatory or licensing agency fails to initiate an investigation into the matter within 180 days of such referral or fails, in the board's judgment, to render sufficient resolution.

(g)(1) As a prerequisite to registering or renewing a registration with the board, a nonresident pharmacy conducting sterile or nonsterile compounding for practitioners to use in patient care in the practitioner's office shall submit a copy of the most recent and current inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located that indicates compliance with the requirements of this chapter, including compliance with USP-NF standards for pharmacies performing sterile and nonsterile compounding. The inspection report required by this subsection shall not be required if the compounding within the facility is done pursuant to a prescription. Such inspection report shall be deemed current for the purpose of this subsection if the inspection was conducted: (A) No more than six months prior to the date of submission of an application for registration with the board; or (B) No more than two years prior to the date of submission of an application for renewal of a registration with the board. (2) If the nonresident pharmacy conducting sterile or nonsterile compounding has not been inspected by the regulatory or licensing agency of the jurisdiction in which it is located within the timeframes required in paragraph (1) of this subsection, the board may: (A) Accept an inspection report or other documentation from another entity that is satisfactory to the board; or (B) Make a request of the appropriate regulatory or licensing agency of the jurisdiction where the pharmacy is located to cause an inspection to be conducted by an agent duly authorized by the board. A nonresident pharmacy shall be responsible for paying any inspection fee incurred pursuant to this paragraph.”

(g)(1) As a prerequisite to registering or renewing a registration with the board, a nonresident pharmacy conducting sterile or nonsterile compounding for practitioners to use in patient care in the practitioner's office shall submit a copy of the most recent and current inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located that indicates compliance with the requirements of this chapter, including compliance with USP-NF standards for pharmacies performing sterile and nonsterile compounding. The inspection report required by this subsection shall not be required if the compounding within the facility is done pursuant to a prescription. Such inspection report shall be deemed current for the purpose of this subsection if the inspection was conducted: (A) No more than six months prior to the date of submission of an application for registration with the board; or (B) No more than two years prior to the date of submission of an application for renewal of a registration with the board.

(g)(1) As a prerequisite to registering or renewing a registration with the board, a nonresident pharmacy conducting sterile or nonsterile compounding for practitioners to use in patient care in the practitioner's office shall submit a copy of the most recent and current inspection report resulting from an inspection conducted by the regulatory or licensing agency of the jurisdiction in which it is located that indicates compliance with the requirements of this chapter, including compliance with USP-NF standards for pharmacies performing sterile and nonsterile compounding. The inspection report required by this subsection shall not be required if the compounding within the facility is done pursuant to a prescription. Such inspection report shall be deemed current for the purpose of this subsection if the inspection was conducted:

(A) No more than six months prior to the date of submission of an application for registration with the board; or

(A) No more than six months prior to the date of submission of an application for registration with the board; or

(B) No more than two years prior to the date of submission of an application for renewal of a registration with the board.

(B) No more than two years prior to the date of submission of an application for renewal of a registration with the board.

(2) If the nonresident pharmacy conducting sterile or nonsterile compounding has not been inspected by the regulatory or licensing agency of the jurisdiction in which it is located within the timeframes required in paragraph (1) of this subsection, the board may: (A) Accept an inspection report or other documentation from another entity that is satisfactory to the board; or (B) Make a request of the appropriate regulatory or licensing agency of the jurisdiction where the pharmacy is located to cause an inspection to be conducted by an agent duly authorized by the board. A nonresident pharmacy shall be responsible for paying any inspection fee incurred pursuant to this paragraph.”

(2) If the nonresident pharmacy conducting sterile or nonsterile compounding has not been inspected by the regulatory or licensing agency of the jurisdiction in which it is located within the timeframes required in paragraph (1) of this subsection, the board may:

(A) Accept an inspection report or other documentation from another entity that is satisfactory to the board; or

(A) Accept an inspection report or other documentation from another entity that is satisfactory to the board; or

(B) Make a request of the appropriate regulatory or licensing agency of the jurisdiction where the pharmacy is located to cause an inspection to be conducted by an agent duly authorized by the board. A nonresident pharmacy shall be responsible for paying any inspection fee incurred pursuant to this paragraph.”

(B) Make a request of the appropriate regulatory or licensing agency of the jurisdiction where the pharmacy is located to cause an inspection to be conducted by an agent duly authorized by the board.

A nonresident pharmacy shall be responsible for paying any inspection fee incurred pursuant to this paragraph.”
O.C.G.A. § 26-4-4 — GA Code / Title 26 / Chapter 4 / Section 26-4-4
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-4
Status: in_force

The “practice of pharmacy” means the interpretation, evaluation, or dispensing of prescription drug orders in the patient's best interest; participation in drug and device selection, drug administration, drug regimen reviews, and drug or drug related research; provision of patient counseling and the provision of those acts or services necessary to provide pharmacy care; performing capillary blood tests and interpreting the results as a means to screen for or monitor disease risk factors and facilitate patient education, and a pharmacist performing such functions shall report the results obtained from such blood tests to the patient's physician of choice; and the responsibility for compounding and labeling of drugs and devices.
O.C.G.A. § 26-2-28 — GA Code / Title 26 / Chapter 2 / Section 26-2-28
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-28
Status: in_force

A food shall be deemed to be misbranded if:

(1) Its labeling is false or misleading in any particular;

(1) Its labeling is false or misleading in any particular;

(2) It is offered for sale under the name of another food;

(2) It is offered for sale under the name of another food;

(3) It is an imitation of another food for which a definition and standard of identity have been prescribed by regulations as provided by Code Section 26-2-35 ; or if it is an imitation of another food that is not subject to paragraph (7) of this Code section, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated;

(3) It is an imitation of another food for which a definition and standard of identity have been prescribed by regulations as provided by Code Section 26-2-35 ; or if it is an imitation of another food that is not subject to paragraph (7) of this Code section, unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated;

(4) Its container is so made, formed, or filled as to be misleading;

(4) Its container is so made, formed, or filled as to be misleading;

(5)(A) In package form, unless it bears a label containing: (i) The name and place of business of the manufacturer, packer, or distributor; and (ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. However, under division (ii) of subparagraph (A) of this paragraph, reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the Commissioner; and a food shall not be deemed misbranded because of omission of the information required by division (i) of subparagraph (A) of this paragraph where such omission is authorized in writing by the Commissioner. (B) The Commissioner may authorize the omission from the label of packaged food of the name and place of business of the manufacturer, packer, or distributor upon a showing of undue hardship because of the size of the package, the material of which the package is made, or the disproportionate cost of compliance. Before authorizing such omission, the Commissioner shall require the filing of a certificate of territorial responsibility in a form prescribed by him. Failure to maintain on file with the Commissioner a correct current statement of territorial responsibility in accordance with the Commissioner's requirements shall terminate any such authorization previously granted;

(5)(A) In package form, unless it bears a label containing: (i) The name and place of business of the manufacturer, packer, or distributor; and (ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count. However, under division (ii) of subparagraph (A) of this paragraph, reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the Commissioner; and a food shall not be deemed misbranded because of omission of the information required by division (i) of subparagraph (A) of this paragraph where such omission is authorized in writing by the Commissioner.

(5)(A) In package form, unless it bears a label containing:

(i) The name and place of business of the manufacturer, packer, or distributor; and

(i) The name and place of business of the manufacturer, packer, or distributor; and

(ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

(ii) An accurate statement of the quantity of the contents in terms of weight, measure, or numerical count.

However, under division (ii) of subparagraph (A) of this paragraph, reasonable variations shall be permitted, and exemptions as to small packages shall be established by regulations prescribed by the Commissioner; and a food shall not be deemed misbranded because of omission of the information required by division (i) of subparagraph (A) of this paragraph where such omission is authorized in writing by the Commissioner.

(B) The Commissioner may authorize the omission from the label of packaged food of the name and place of business of the manufacturer, packer, or distributor upon a showing of undue hardship because of the size of the package, the material of which the package is made, or the disproportionate cost of compliance. Before authorizing such omission, the Commissioner shall require the filing of a certificate of territorial responsibility in a form prescribed by him. Failure to maintain on file with the Commissioner a correct current statement of territorial responsibility in accordance with the Commissioner's requirements shall terminate any such authorization previously granted;

(B) The Commissioner may authorize the omission from the label of packaged food of the name and place of business of the manufacturer, packer, or distributor upon a showing of undue hardship because of the size of the package, the material of which the package is made, or the disproportionate cost of compliance. Before authorizing such omission, the Commissioner shall require the filing of a certificate of territorial responsibility in a form prescribed by him. Failure to maintain on file with the Commissioner a correct current statement of territorial responsibility in accordance with the Commissioner's requirements shall terminate any such authorization previously granted;

(6) Any word, statement, or other information required by or under authority of this article to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(6) Any word, statement, or other information required by or under authority of this article to appear on the label or labeling is not prominently placed thereon with such conspicuousness, as compared with other words, statements, designs, or devices in the labeling, and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use;

(7) It purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by Code Section 26-2-35 , unless: (A) It conforms to such definition and standard; and (B) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients, other than spices, flavoring, and coloring, present in such food;

(7) It purports to be or is represented as a food for which a definition and standard of identity has been prescribed by regulations as provided by Code Section 26-2-35 , unless:

(A) It conforms to such definition and standard; and

(A) It conforms to such definition and standard; and

(B) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients, other than spices, flavoring, and coloring, present in such food;

(B) Its label bears the name of the food specified in the definition and standard and, insofar as may be required by such regulations, the common names of optional ingredients, other than spices, flavoring, and coloring, present in such food;

(8) It purports to be or is represented as: (A) A food for which a standard of quality has been prescribed by regulations as provided by Code Section 26-2-35 and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or (B) A food for which a standard or standards of fill of container have been prescribed by regulation as provided by Code Section 26-2-35 , and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(8) It purports to be or is represented as:

(A) A food for which a standard of quality has been prescribed by regulations as provided by Code Section 26-2-35 and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(A) A food for which a standard of quality has been prescribed by regulations as provided by Code Section 26-2-35 and its quality falls below such standard, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard; or

(B) A food for which a standard or standards of fill of container have been prescribed by regulation as provided by Code Section 26-2-35 , and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(B) A food for which a standard or standards of fill of container have been prescribed by regulation as provided by Code Section 26-2-35 , and it falls below the standard of fill of container applicable thereto, unless its label bears, in such manner and form as such regulations specify, a statement that it falls below such standard;

(9)(A) It is not subject to paragraph (7) of this Code section, unless it bears labeling clearly giving: (i) The common or usual name of the food, if any such name exists; and (ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each; (B) To the extent that compliance with the requirements of division (ii) of subparagraph (A) of this paragraph is impractical or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Commissioner; (C) The requirements of division (ii) of subparagraph (A) of this paragraph shall not apply to any carbonated beverage, the ingredients of which have been fully and correctly disclosed, to the extent prescribed by division (ii) of subparagraph (A) of this paragraph, to the Commissioner in an affidavit;

(9)(A) It is not subject to paragraph (7) of this Code section, unless it bears labeling clearly giving: (i) The common or usual name of the food, if any such name exists; and (ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each;

(9)(A) It is not subject to paragraph (7) of this Code section, unless it bears labeling clearly giving:

(i) The common or usual name of the food, if any such name exists; and

(i) The common or usual name of the food, if any such name exists; and

(ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each;

(ii) In case it is fabricated from two or more ingredients, the common or usual name of each such ingredient; except that spices, flavorings, and colorings, other than those sold as such, may be designated as spices, flavorings, and colorings without naming each;

(B) To the extent that compliance with the requirements of division (ii) of subparagraph (A) of this paragraph is impractical or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Commissioner;

(B) To the extent that compliance with the requirements of division (ii) of subparagraph (A) of this paragraph is impractical or results in deception or unfair competition, exemptions shall be established by regulations promulgated by the Commissioner;

(C) The requirements of division (ii) of subparagraph (A) of this paragraph shall not apply to any carbonated beverage, the ingredients of which have been fully and correctly disclosed, to the extent prescribed by division (ii) of subparagraph (A) of this paragraph, to the Commissioner in an affidavit;

(C) The requirements of division (ii) of subparagraph (A) of this paragraph shall not apply to any carbonated beverage, the ingredients of which have been fully and correctly disclosed, to the extent prescribed by division (ii) of subparagraph (A) of this paragraph, to the Commissioner in an affidavit;

(10) It purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Commissioner determines to be, and by regulations prescribes, as necessary in order fully to inform purchasers as to its value for such uses;

(10) It purports to be or is represented for special dietary uses, unless its label bears such information concerning its vitamin, mineral, and other dietary properties as the Commissioner determines to be, and by regulations prescribes, as necessary in order fully to inform purchasers as to its value for such uses;

(11) It bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact, provided that, to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Commissioner; or

(11) It bears or contains any artificial flavoring, artificial coloring, or chemical preservative, unless it bears labeling stating that fact, provided that, to the extent that compliance with the requirements of this paragraph is impracticable, exemptions shall be established by regulations promulgated by the Commissioner; or

(12) It is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded.

(12) It is a product intended as an ingredient of another food and when used according to the directions of the purveyor will result in the final food product being adulterated or misbranded.
O.C.G.A. § 26-2-430 — GA Code / Title 26 / Chapter 2 / Section 26-2-430
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-430
Status: in_force

This article shall be known and may be cited as the “Common-sense Consumption Act.”
O.C.G.A. § 26-3-10 — GA Code / Title 26 / Chapter 3 / Section 26-3-10
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-3-10
Status: in_force

(a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless: (1) An application with respect thereto has become effective under Section 505 of the federal act; or (2) When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof and prior to selling or offering such drug for sale, there has been filed with the State Board of Pharmacy an application setting forth: (A) Full reports of investigations which have been made to show whether or not such drug is safe for use; (B) A full list of the articles used as components of such drug; (C) A full statement of the composition of such drug; (D) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug; (E) Such samples of such drug and of the articles used as components thereof as the State Board of Pharmacy may require; and (F) Specimens of the labeling proposed to be used for such drug.

(a) No person shall sell, deliver, offer for sale, hold for sale, or give away any new drug unless:

(1) An application with respect thereto has become effective under Section 505 of the federal act; or

(1) An application with respect thereto has become effective under Section 505 of the federal act; or

(2) When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof and prior to selling or offering such drug for sale, there has been filed with the State Board of Pharmacy an application setting forth: (A) Full reports of investigations which have been made to show whether or not such drug is safe for use; (B) A full list of the articles used as components of such drug; (C) A full statement of the composition of such drug; (D) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug; (E) Such samples of such drug and of the articles used as components thereof as the State Board of Pharmacy may require; and (F) Specimens of the labeling proposed to be used for such drug.

(2) When not subject to the federal act unless such drug has been tested and has not been found to be unsafe for use under the conditions prescribed, recommended, or suggested in the labeling thereof and prior to selling or offering such drug for sale, there has been filed with the State Board of Pharmacy an application setting forth:

(A) Full reports of investigations which have been made to show whether or not such drug is safe for use;

(A) Full reports of investigations which have been made to show whether or not such drug is safe for use;

(B) A full list of the articles used as components of such drug;

(B) A full list of the articles used as components of such drug;

(C) A full statement of the composition of such drug;

(C) A full statement of the composition of such drug;

(D) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug;

(D) A full description of the methods used in and the facilities and controls used for the manufacture, processing, and packing of such drug;

(E) Such samples of such drug and of the articles used as components thereof as the State Board of Pharmacy may require; and

(E) Such samples of such drug and of the articles used as components thereof as the State Board of Pharmacy may require; and

(F) Specimens of the labeling proposed to be used for such drug.

(F) Specimens of the labeling proposed to be used for such drug.

(b) An application provided for in paragraph (2) of subsection (a) of this Code section shall become effective 60 days after the filing thereof, except that if the State Board of Pharmacy finds after due notice to the applicant and after giving him an opportunity for a hearing that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, he shall prior to the effective date of the application issue an order refusing to permit the application to become effective.

(b) An application provided for in paragraph (2) of subsection (a) of this Code section shall become effective 60 days after the filing thereof, except that if the State Board of Pharmacy finds after due notice to the applicant and after giving him an opportunity for a hearing that the drug is not safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof, he shall prior to the effective date of the application issue an order refusing to permit the application to become effective.

(c) This Code section shall not apply: (1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs, provided the drug is plainly labeled “For investigational use only”; or (2) To a drug sold in the state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act; or (3) To any drug manufactured, labeled, and sold for veterinary purposes.

(c) This Code section shall not apply:

(1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs, provided the drug is plainly labeled “For investigational use only”; or

(1) To a drug intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety in drugs, provided the drug is plainly labeled “For investigational use only”; or

(2) To a drug sold in the state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act; or

(2) To a drug sold in the state at any time prior to the enactment of this chapter or introduced into interstate commerce at any time prior to the enactment of the federal act; or

(3) To any drug manufactured, labeled, and sold for veterinary purposes.

(3) To any drug manufactured, labeled, and sold for veterinary purposes.

(d) An order refusing to permit an application under this Code section to become effective may be revoked by the State Board of Pharmacy.

(d) An order refusing to permit an application under this Code section to become effective may be revoked by the State Board of Pharmacy.
O.C.G.A. § 26-2-204 — GA Code / Title 26 / Chapter 2 / Section 26-2-204
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-204
Status: in_force

The Commissioner shall cause to be inspected at such times as he may deem proper each dairy and each meat, poultry, or dairy processing plant within this state. He shall require the correction of all unsanitary conditions found therein. He may take samples of dairy, poultry, or meat products or parts or portions thereof and cause them to be analyzed or tested by the state chemist. Such analyses or test records shall be preserved by the Commissioner and when sworn to by the state chemist shall be prima-facie evidence of violations of this article, rules and regulations, or standards or specifications adopted pursuant to this article.
O.C.G.A. § 26-4-40 — GA Code / Title 26 / Chapter 4 / Section 26-4-40
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-40
Status: in_force

(a) Except as otherwise provided in this chapter, it shall be unlawful for any individual to engage in the practice of pharmacy unless currently licensed to practice under the provisions of this chapter.

(a) Except as otherwise provided in this chapter, it shall be unlawful for any individual to engage in the practice of pharmacy unless currently licensed to practice under the provisions of this chapter.

(b) Practitioners authorized under the laws of this state to compound drugs and to dispense drugs to their patients in the practice of their respective professions shall not be required to be licensed under the provisions of this chapter; however, practitioners shall meet the same standards, record-keeping requirements, and all other requirements for the dispensing of drugs applicable to pharmacists.

(b) Practitioners authorized under the laws of this state to compound drugs and to dispense drugs to their patients in the practice of their respective professions shall not be required to be licensed under the provisions of this chapter; however, practitioners shall meet the same standards, record-keeping requirements, and all other requirements for the dispensing of drugs applicable to pharmacists.

(c) Any individual who, after hearing, shall be found by the board to have unlawfully engaged in the practice of pharmacy shall be subject to a fine to be imposed by the board for each offense. Each violation of this chapter pertaining to unlawfully engaging in the practice of pharmacy shall also constitute a felony punishable upon conviction thereof by a fine of not less than $500.00 nor more than $1,000.00 or by imprisonment for not less than two nor more than five years, or both.

(c) Any individual who, after hearing, shall be found by the board to have unlawfully engaged in the practice of pharmacy shall be subject to a fine to be imposed by the board for each offense. Each violation of this chapter pertaining to unlawfully engaging in the practice of pharmacy shall also constitute a felony punishable upon conviction thereof by a fine of not less than $500.00 nor more than $1,000.00 or by imprisonment for not less than two nor more than five years, or both.
O.C.G.A. § 26-4-62 — GA Code / Title 26 / Chapter 4 / Section 26-4-62
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-62
Status: in_force

Except as otherwise provided in this chapter or in Chapter 13 of Title 16, any violation of this chapter shall constitute a misdemeanor.
O.C.G.A. § 26-2-450 — GA Code / Title 26 / Chapter 2 / Section 26-2-450
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-450
Status: in_force

As used in this article, the term:

(1) “ Commissioner ” means the Commissioner of Agriculture of the State of Georgia.

(1) “ Commissioner ” means the Commissioner of Agriculture of the State of Georgia.

(2) “ Department ” means the Department of Agriculture of the State of Georgia.

(2) “ Department ” means the Department of Agriculture of the State of Georgia.

(3) “ Grade ‘A' raw milk for human consumption” means raw milk for human consumption produced by a permitted raw milk for human consumption producer, which meets all health, safety, and labeling standards of this article.

(3) “ Grade ‘A' raw milk for human consumption” means raw milk for human consumption produced by a permitted raw milk for human consumption producer, which meets all health, safety, and labeling standards of this article.

(4) “ Raw milk for human consumption ” means fluid whole milk in its natural state from healthy cows, or other hoofed animals, which is intended for human consumption and has been produced under such rules and regulations as may be prescribed by or pursuant to this article.

(4) “ Raw milk for human consumption ” means fluid whole milk in its natural state from healthy cows, or other hoofed animals, which is intended for human consumption and has been produced under such rules and regulations as may be prescribed by or pursuant to this article.
O.C.G.A. § 26-2-391 — GA Code / Title 26 / Chapter 2 / Section 26-2-391
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-391
Status: in_force

(a) A county or municipality shall be authorized to issue permits for the operation of nonprofit food sales and food service at events sponsored by the county, municipality, or an organization. For any permit issued pursuant to this Code section to be valid, the event must be held on property belonging to the sponsoring county, municipality, or organization or on the property of a party that has provided consent for use of such property for such event.

(a) A county or municipality shall be authorized to issue permits for the operation of nonprofit food sales and food service at events sponsored by the county, municipality, or an organization. For any permit issued pursuant to this Code section to be valid, the event must be held on property belonging to the sponsoring county, municipality, or organization or on the property of a party that has provided consent for use of such property for such event.

(b) A permit shall be valid for: (1) A period of up to 120 consecutive hours and another permit shall not be issued to the organization holding such permit until five days have elapsed from the date of the expiration of the permit; or (2) A continuous period of up to 12 weeks between May 15 and August 15 and four additional weeks during the calendar year, which may be composed of nonconsecutive periods, coinciding with holidays during which local school systems are not in session, provided that all food items are provided free of charge and the organization does not receive funding from the United States Department of Agriculture to operate a food program.

(b) A permit shall be valid for:

(1) A period of up to 120 consecutive hours and another permit shall not be issued to the organization holding such permit until five days have elapsed from the date of the expiration of the permit; or

(1) A period of up to 120 consecutive hours and another permit shall not be issued to the organization holding such permit until five days have elapsed from the date of the expiration of the permit; or

(2) A continuous period of up to 12 weeks between May 15 and August 15 and four additional weeks during the calendar year, which may be composed of nonconsecutive periods, coinciding with holidays during which local school systems are not in session, provided that all food items are provided free of charge and the organization does not receive funding from the United States Department of Agriculture to operate a food program.

(2) A continuous period of up to 12 weeks between May 15 and August 15 and four additional weeks during the calendar year, which may be composed of nonconsecutive periods, coinciding with holidays during which local school systems are not in session, provided that all food items are provided free of charge and the organization does not receive funding from the United States Department of Agriculture to operate a food program.

(c) At the request of the county or municipality issuing a permit pursuant to this Code section or at the request of a county or municipality sponsoring an event pursuant to subparagraph (a)(5)(C) of Code Section 26-2-21 or subparagraph (2)(E) of Code Section 26-2-370 , the county board of health shall: (1) Supply educational materials regarding food safety which may be provided to event organizers and the public; and (2) Conduct food safety inspections to ensure compliance with the provisions of Code Section 26-2-392 .

(c) At the request of the county or municipality issuing a permit pursuant to this Code section or at the request of a county or municipality sponsoring an event pursuant to subparagraph (a)(5)(C) of Code Section 26-2-21 or subparagraph (2)(E) of Code Section 26-2-370 , the county board of health shall:

(1) Supply educational materials regarding food safety which may be provided to event organizers and the public; and

(1) Supply educational materials regarding food safety which may be provided to event organizers and the public; and

(2) Conduct food safety inspections to ensure compliance with the provisions of Code Section 26-2-392 .

(2) Conduct food safety inspections to ensure compliance with the provisions of Code Section 26-2-392 .

(d) No fees shall be charged to an organization for the issuance of any permit pursuant to this Code section; provided, however, that the county board of health shall be authorized to impose a fee for inspections performed at the request of the issuing county or municipality. Such fee shall be fixed in a reasonable amount such that the proceeds of the fee do not exceed the total direct and indirect costs of conducting the inspection.

(d) No fees shall be charged to an organization for the issuance of any permit pursuant to this Code section; provided, however, that the county board of health shall be authorized to impose a fee for inspections performed at the request of the issuing county or municipality. Such fee shall be fixed in a reasonable amount such that the proceeds of the fee do not exceed the total direct and indirect costs of conducting the inspection.

(e) For purposes of this Code section, an event may include the provision of food at a third-party location within the same county.

(e) For purposes of this Code section, an event may include the provision of food at a third-party location within the same county.
O.C.G.A. § 26-5-20 — GA Code / Title 26 / Chapter 5 / Section 26-5-20
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-5-20
Status: in_force

Any program licensed or funded by the department under this article shall implement a priority admissions policy for the treatment of drug dependent pregnant females which provides for immediate access to services for any such female applying for admission, which access shall be contingent only upon the availability of space.
O.C.G.A. § 26-5-47 — GA Code / Title 26 / Chapter 5 / Section 26-5-47
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-5-47
Status: in_force

(a) The department shall, consistent with the requirements of this Code section, establish an application review process committee. The members of the committee shall include representation from department staff members and the Department of Behavioral Health and Developmental Disabilities.

(a) The department shall, consistent with the requirements of this Code section, establish an application review process committee. The members of the committee shall include representation from department staff members and the Department of Behavioral Health and Developmental Disabilities.

(b) Application requirements shall include, but not be limited to: (1) Data and details regarding treatment and counseling plans; (2) Biographical information and qualifications of owners, medical directors, counselors, and other required staff; (3) Data as determined by the department on currently licensed narcotic treatment programs within the region of the proposed location and within a 75 mile radius, whether or not such other programs are outside of the region; (4) Patient levels of currently licensed programs in the proposed region of care and within 75 miles, including: (A) The number of patients admitted to current narcotic treatment programs in the most recent month; and (B) The number of patients served by current narcotic treatment programs in the most recent month; (5) Data on demographic, social, health, economic, alcohol and drug related crimes, alcohol and drug overdoses, and hospital and emergency department admissions of individuals addicted to opioids for the program location; (6) Applicant experience operating a narcotic treatment program or working at such program, including a complete history of such experience both within this state and in any other state; (7) Program ownership in other locations, if any, including a complete and accurate description of narcotic treatment program experience, including whether the applicant currently holds, has held, or has had revoked any licenses, registrations, enrollments, accreditations, contracts, and network memberships. The applicant shall disclose any adverse actions against the applicant while employed by or as a result of ownership of a narcotic treatment program; (8) Evidence the applicant sought community input for the proposed location from substance abuse advocacy organizations, civic organizations, neighborhood associations, locally elected officials, and other groups; (9) Proof of notification of intent to file an application with all law enforcement offices within a 25 mile radius of the program location; (10) Proof of notification of intent to file an application with all drug courts within a 75 mile radius of the program location; (11) A narrative description of and information about adjoining businesses and occupancies within 200 feet of the facility, including a description of transportation access, traffic patterns, security features, local area police and crime reports, and neighborhood safety; and (12) A complete description of the facility's staff and patient parking.

(b) Application requirements shall include, but not be limited to:

(1) Data and details regarding treatment and counseling plans;

(1) Data and details regarding treatment and counseling plans;

(2) Biographical information and qualifications of owners, medical directors, counselors, and other required staff;

(2) Biographical information and qualifications of owners, medical directors, counselors, and other required staff;

(3) Data as determined by the department on currently licensed narcotic treatment programs within the region of the proposed location and within a 75 mile radius, whether or not such other programs are outside of the region;

(3) Data as determined by the department on currently licensed narcotic treatment programs within the region of the proposed location and within a 75 mile radius, whether or not such other programs are outside of the region;

(4) Patient levels of currently licensed programs in the proposed region of care and within 75 miles, including: (A) The number of patients admitted to current narcotic treatment programs in the most recent month; and (B) The number of patients served by current narcotic treatment programs in the most recent month;

(4) Patient levels of currently licensed programs in the proposed region of care and within 75 miles, including:

(A) The number of patients admitted to current narcotic treatment programs in the most recent month; and

(A) The number of patients admitted to current narcotic treatment programs in the most recent month; and

(B) The number of patients served by current narcotic treatment programs in the most recent month;

(B) The number of patients served by current narcotic treatment programs in the most recent month;

(5) Data on demographic, social, health, economic, alcohol and drug related crimes, alcohol and drug overdoses, and hospital and emergency department admissions of individuals addicted to opioids for the program location;

(5) Data on demographic, social, health, economic, alcohol and drug related crimes, alcohol and drug overdoses, and hospital and emergency department admissions of individuals addicted to opioids for the program location;

(6) Applicant experience operating a narcotic treatment program or working at such program, including a complete history of such experience both within this state and in any other state;

(6) Applicant experience operating a narcotic treatment program or working at such program, including a complete history of such experience both within this state and in any other state;

(7) Program ownership in other locations, if any, including a complete and accurate description of narcotic treatment program experience, including whether the applicant currently holds, has held, or has had revoked any licenses, registrations, enrollments, accreditations, contracts, and network memberships. The applicant shall disclose any adverse actions against the applicant while employed by or as a result of ownership of a narcotic treatment program;

(7) Program ownership in other locations, if any, including a complete and accurate description of narcotic treatment program experience, including whether the applicant currently holds, has held, or has had revoked any licenses, registrations, enrollments, accreditations, contracts, and network memberships. The applicant shall disclose any adverse actions against the applicant while employed by or as a result of ownership of a narcotic treatment program;

(8) Evidence the applicant sought community input for the proposed location from substance abuse advocacy organizations, civic organizations, neighborhood associations, locally elected officials, and other groups;

(8) Evidence the applicant sought community input for the proposed location from substance abuse advocacy organizations, civic organizations, neighborhood associations, locally elected officials, and other groups;

(9) Proof of notification of intent to file an application with all law enforcement offices within a 25 mile radius of the program location;

(9) Proof of notification of intent to file an application with all law enforcement offices within a 25 mile radius of the program location;

(10) Proof of notification of intent to file an application with all drug courts within a 75 mile radius of the program location;

(10) Proof of notification of intent to file an application with all drug courts within a 75 mile radius of the program location;

(11) A narrative description of and information about adjoining businesses and occupancies within 200 feet of the facility, including a description of transportation access, traffic patterns, security features, local area police and crime reports, and neighborhood safety; and

(11) A narrative description of and information about adjoining businesses and occupancies within 200 feet of the facility, including a description of transportation access, traffic patterns, security features, local area police and crime reports, and neighborhood safety; and

(12) A complete description of the facility's staff and patient parking.

(12) A complete description of the facility's staff and patient parking.

(c)(1) A program license shall be nontransferable for a change of a governing body. The department shall require currently operating programs that have a change of governing body to submit an application for such change in accordance with its rules and regulations. However, the department shall waive Code Section 26-5-46 , all other requirements under this Code section, and Code Section 26-5-48 if such governing body is in good standing with the department. (2) A program license shall be nontransferable for a change of location. The department shall require currently operating programs that have a change of location to submit an application for such change in accordance with its rules and regulations. However, the department shall waive the application requirements for a change of location of a currently operating program pursuant to Code Section 26-5-46 , all other requirements under this Code section, and Code Section 26-5-48 if such governing body is in good standing with the department, provided the change of location is within such program's current region established by this article.

(c)(1) A program license shall be nontransferable for a change of a governing body. The department shall require currently operating programs that have a change of governing body to submit an application for such change in accordance with its rules and regulations. However, the department shall waive Code Section 26-5-46 , all other requirements under this Code section, and Code Section 26-5-48 if such governing body is in good standing with the department.

(c)(1) A program license shall be nontransferable for a change of a governing body. The department shall require currently operating programs that have a change of governing body to submit an application for such change in accordance with its rules and regulations. However, the department shall waive Code Section 26-5-46 , all other requirements under this Code section, and Code Section 26-5-48 if such governing body is in good standing with the department.

(2) A program license shall be nontransferable for a change of location. The department shall require currently operating programs that have a change of location to submit an application for such change in accordance with its rules and regulations. However, the department shall waive the application requirements for a change of location of a currently operating program pursuant to Code Section 26-5-46 , all other requirements under this Code section, and Code Section 26-5-48 if such governing body is in good standing with the department, provided the change of location is within such program's current region established by this article.

(2) A program license shall be nontransferable for a change of location. The department shall require currently operating programs that have a change of location to submit an application for such change in accordance with its rules and regulations. However, the department shall waive the application requirements for a change of location of a currently operating program pursuant to Code Section 26-5-46 , all other requirements under this Code section, and Code Section 26-5-48 if such governing body is in good standing with the department, provided the change of location is within such program's current region established by this article.

(d) Upon application for an additional program by a current licensee, each location operated by such licensee shall be inspected. Any such location inspected within the preceding 36 months shall be exempt from such inspection requirement of this subsection. Such inspections are in addition to all other application requirements for an additional program application by such licensee.

(d) Upon application for an additional program by a current licensee, each location operated by such licensee shall be inspected. Any such location inspected within the preceding 36 months shall be exempt from such inspection requirement of this subsection. Such inspections are in addition to all other application requirements for an additional program application by such licensee.

(e) In the event an applicant is unable to obtain patient information from current programs as required by subsection (b) of this Code section, the department may direct current narcotic treatment programs to provide such information to the applicant.

(e) In the event an applicant is unable to obtain patient information from current programs as required by subsection (b) of this Code section, the department may direct current narcotic treatment programs to provide such information to the applicant.
O.C.G.A. § 26-4-111 — GA Code / Title 26 / Chapter 4 / Section 26-4-111
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-4-111
Status: in_force

(a) The board shall specify by rule the pharmacy licensure procedures to be followed, including but not limited to specification of forms for use in applying for such licensure and times, places, and applicable fees.

(a) The board shall specify by rule the pharmacy licensure procedures to be followed, including but not limited to specification of forms for use in applying for such licensure and times, places, and applicable fees.

(b) Applicants for licensure to distribute, manufacture, sell, purchase, or produce drugs or devices within this state shall file with the board a verified application containing such information as the board requires of the applicant relative to the qualifications for a license.

(b) Applicants for licensure to distribute, manufacture, sell, purchase, or produce drugs or devices within this state shall file with the board a verified application containing such information as the board requires of the applicant relative to the qualifications for a license.

(c) Pharmacy licenses issued by the board pursuant to this chapter shall not be transferable or assignable.

(c) Pharmacy licenses issued by the board pursuant to this chapter shall not be transferable or assignable.

(d) The board shall specify by rule minimum standards for responsibility of any person or pharmacy that has employees or personnel engaged in the practice of pharmacy, manufacture, distribution, production, sale, or use of drugs or devices in the conduct of their business. If the licensed person is a pharmacy located in this state, that portion of the facility to which such license applies shall be operated only under the direct supervision of a pharmacist licensed to practice in this state.

(d) The board shall specify by rule minimum standards for responsibility of any person or pharmacy that has employees or personnel engaged in the practice of pharmacy, manufacture, distribution, production, sale, or use of drugs or devices in the conduct of their business. If the licensed person is a pharmacy located in this state, that portion of the facility to which such license applies shall be operated only under the direct supervision of a pharmacist licensed to practice in this state.
O.C.G.A. § 26-2-378 — GA Code / Title 26 / Chapter 2 / Section 26-2-378
Georgia Code Title 26. Food, Drugs, and Cosmetics § 26-2-378
Status: in_force

(a) All food service establishments in this state which serve meat products that contain extenders, such as textured vegetable protein, textured soy flour, fortified textured vegetable protein, or other such products, shall display on their menus, or by placards visible to the public, information stating that the meat product contains extenders. Products which contain extenders shall not be advertised using names which designate all meat products. The menu or other advertisement must bear the same name that appears on the package when received from the processor and the ingredients statement as listed on the label.

(a) All food service establishments in this state which serve meat products that contain extenders, such as textured vegetable protein, textured soy flour, fortified textured vegetable protein, or other such products, shall display on their menus, or by placards visible to the public, information stating that the meat product contains extenders. Products which contain extenders shall not be advertised using names which designate all meat products. The menu or other advertisement must bear the same name that appears on the package when received from the processor and the ingredients statement as listed on the label.

(b) This Code section shall not be applicable to the serving of meat products which do not contain such an amount of extenders as to require additional labeling in accordance with other laws of the United States and laws of this state relating to meat products.

(b) This Code section shall not be applicable to the serving of meat products which do not contain such an amount of extenders as to require additional labeling in accordance with other laws of the United States and laws of this state relating to meat products.